Monday, February 25, 2013

SHARP Focus: Secondary Use of EHR Data (SHARPn)

As part of the HITECH Act the ONC funded the Strategic Health IT Advanced Research Projects (SHARP) Program. The SHARP Program was created to fund research focused on achieving breakthrough advances to address well-documented problems that have impeded adoption of health IT. With scalpel-like precision, the hope is that this research will accelerate progress towards achieving nationwide meaningful use of health IT in support of a high-performing, continuously-learning health care system. Under the the Mayo Clinic of Medicine received $15 million to focus on Secondary Use of EHR Data.

The project: AREA 4 - Secondary Use of EHR Data (SHARPn), is a collaboration of 14 academic and industry partners to develop tools and resources that influence and extend secondary uses of clinical data. The project will enhance patient safety and improve patient medical outcomes through the use of an electronic health record (EHR). Traditionally, a patient’s medical information, such as medical history, exam data, hospital visits and physician notes, are stored inconsistently and in multiple locations, both electronically and nonelectronically.

Area four's mission is to enable the use of EHR data for secondary purposes, such as clinical research and public health. By creating tangible, scalable, and open-source tools, services and software for large-scale health record data sharing; this project will ultimately help improve the quality and efficiency of patient care through the use of an electronic health record. One year into the design and development of the SHARPn framework, they demonstrated end to end data flow and a prototype SHARPn platform, using thousands of patient electronic records sourced from two large healthcare organizations: Mayo Clinic and Intermountain Healthcare. The platform was deployed to:
(1) receive source EHR data in several formats,
(2) generate structured data from EHR narrative text, and
(3) normalize the EHR data using common detailed clinical models and Consolidated Health Informatics standard terminologies, which were
(4) accessed by a phenotyping service using normalized data specifications.

The program is working to assemble modular services and agents from existing open-source software to improve the utilization of EHR data for a spectrum of use-cases and focus on three themes: Normalization, Phenotypes, and Data Quality/Evaluation. The program was assembled into six projects that span one or more of these themes, though together constitute a coherent ensemble of related research and development. Finally, these services will have open-source deployments as well as commercially supported implementations.

Below are some videos of leaders in the project discussing some of the work.

Charles P. Friedman, PhD.; Former Chief Scientific Officer for Information Technology at the Office of the National Coordinator for Health Information Technology (ONC) in the U.S. Department of Health and Human Services speaks about the Strategic Health IT Advanced Research Projects (SHARP) Programs.

Standardize health data elements and ensure data integrity - Patient information can be stored using several different abbreviations and representations for the same piece of data. For example, “diabetes mellitus” (more commonly referred to as “diabetes”), can be referred to in a patient’s medical record alternately as “diabetic,” “249.00” and “DM.” The first phase of Mayo Clinic’s project, called “Clinical Data Normalization,” will work toward transforming this non-standardized patient data into one unified set of terminology. In this case, “diabetes mellitus,” “diabetic,” “249.00” and “DM” would all be re-named “diabetes.”

Stanley M. Huff, M.D.; SHARPn Co-Principal Investigator; Professor (Clinical) - Biomedical Informatics at University of Utah - College of Medicine and Chief Medical Informatics Officer Intermountain Healthcare. Dr. Huff discusses that to provide patient care at the lowest cost with advanced decision support requires structured and coded data.

Evaluate the progress and efficiency of Mayo Clinic’s project - Mayo Clinic will use an “Evaluation Framework” using the Nationwide Health Information Network, an Office of the National Coordinator for Health Information Technology program. Nationwide Health Information Network Exchange is a set of standards, services, and policies that enable secure health information exchange over the internet.

Calvin Beebe; SHARPn Chief Architect; Senior Technical Specialist at Mayo Clinic discusses the 'tracer-shot' pilot conducted in the SHARPn program where deidentified data from Intermountain Healthcare and Mayo Clinic was run through a pilot to normalize the data in a comparable and consistent manner for which secondary use information could be derived.

Find processes to make clinical data normalization, NLP and high-throughput phenotyping more efficient using fewer resources - This part of the process will focus on building adequate computing resources and infrastructures to accomplish the previous steps. Called “Performance Optimization,” this system will allow those seeking patient information to receive it quickly, increasing the efficiency of patient care while using fewer resources.

Marshall I. Schor, SHARPn Co-Investigator-Apache UIMA framework; Senior Technical Staff at TJ Watson Research Lab, IBM; Marshall describes the use of IBM Research: Unstructured Information Management Architecture (UIMA) in the SHARPn program.

Seek physically observable patient traits for further study - Physically observable traits, or phenotypes, can include growth and development, absorption and processing of nutrients, and the functioning of different tissues and organs. These traits result from interactions between a patient’s genes and environmental conditions. Mayo Clinic will use a process called “High-Throughput Phenotyping”, which uses clinical data normalization and NLP to identify and group a particular phenotype, such as Type 2 diabetes. This process will enhance a physician’s ability to identify and study individual phenotypes or groups of phenotypes.

Christopher G. Chute, M.D., Dr. P.H., SHARPn Principal Investigator; Professor of Medical Informatics and Associate Professor of Epidemiology at Mayo Clinic College of Medicine; Dr. Chute discusses phenotype characteristics for identifying patient cohorts (clinical trials, clinical decision support, quality numerator/denominators, etc).

Jyotishman Pathak, PhD.; SHARPn Co-Investigator; Assistant Professor of Medical Informatics at Mayo Clinic College of Medicine discusses the phenotyping tool.

Merge and standardize patient data from non-electronic forms with the EHR - Some important information, such as that from a physician’s radiology and pathology notes, is stored in “free text” form. Mayo Clinic’s project will first work to merge the patient information in free texts with that in the EHR. The next step of this project, called “Natural Language Processing” (NLP), will work toward classifying certain tags, such as “diabetic,” “DM” and “57 year old male” under specific categories, such as “disease” or “demographics.” NLP, in addition to clinical data normalization, will help improve patient care by reducing inconsistencies in patient data, providing physicians with more accurate and uniform information in a centralized location.

Guergana Savova, PhD; SHARPn Co-Investigator; Assistant Professor at Harvards Children's Hospital Boston. Dr. Savova discusses the steps to natural language processing or information extraction of clinical narrative.

Thursday, February 21, 2013

Consumer Technology Workgroup

A Federal advisory committee is any committee, board, commission, council, panel, task force, or other similar group that advises or recommends to the agency it is charged. The Federal Advisory Committee Act was enacted in 1972 to govern the behavior of these advisory committees. In 2005 the ONC formed its first advisory committee, the American Health Information Community. The committee met and formed the first workgroups, Biosurveillance, Consumer Empowerment, Chronic Care, and Electronic Health Records. Once the HITECH Act became law, the ONC continued to build and revise the previous Strategic Plan and the information acquired from the American Health Information Community. The committee was then replaced with the two current committees, Health IT Policy Committee and the Health IT Standards Committee (HITSC). Along with the National Committee on Vital and Health Statistics (NCVHS), these 3 committees advise and recommend the ONC to meet the HITECH Act mandates.

HITSC has formed a new workgroup, the Consumer Technology Workgroup (CTWG). HITSC is a Federal Advisory committee charged with making recommendations to the National Coordinator on standards, implementation specifications, and certification criteria for the electronic exchange and use of health information for purposes of adoption, consistent with the implementation of the Federal Health IT Strategic Plan, and in accordance by the HIT Policy Committee.

The CTWG is charged with providing recommendations on standards and interoperability issues and opportunities related to strengthening the ability of consumers, patients, and lay caregivers to manage health and health care for themselves or others. The workgroup will be chaired by Leslie Kelly Hall; Adjunct Professor at Northwestern Nazarene University, Senior Vice President at Healthwise, and a member of the HITSC. The workgroup should begin meeting in March. I have been asked to serve on this new workgroup and look forward to the opportunity.

State Health Departments Use Social Media to Disseminate Public Health Information

The Network of Web 2.0 Connections Among State Health Departments: New Pathways for Dissemination

With social media pervasive in virtually all aspects of society, public health organizations, including state health departments, are finding web-based social media sites such as Twitter and Facebook useful tools to spread public health information. A new study, led by Jenine K. Harris, PhD, assistant professor at the Brown School at Washington University in St. Louis, examined the use of social media by state health departments in the United States.

The study, published Feb. 7, 2013 in the journal Frontiers in Public Health Services and Systems Research, found, as of February 2012, 28 state health departments used Facebook and 41 used Twitter as tools to disseminate health information.

“Health departments seem to be realizing how widespread social media use is,” says Harris, who also is a faculty scholar in WUSTL’s Institute for Public Health. “With 67 percent of online Americans using at least one social media site, health information posted could potentially reach a large audience — including people from traditionally hard-to-reach lower income populations.”

State health departments adopting social media, Harris says, tend to be in more populated states with more urban residents and higher levels of Internet access. Adopting health departments also tended to have higher per-capita health department expenditures, more educated leadership, and a larger, younger staff.

The study was co-authored by Doneisha L. Snider, a student in the Brown School’s Master of Public Health (MPH) program and graduate research assistant at the Center for Public Health Systems Science; and Nancy Mueller, project coordinator and an alumnus of the MPH program.

“Although social media is a promising tool for health departments, we don’t yet know enough about who is connected to the health departments on social media and how effective it is in educating and informing those who are connected,” Harris says.

But she and her team are working on it. Harris recently received funding from the Robert Wood Johnson Foundation to examine adoption and use of social media by local health departments nationwide, with the long-term goal of developing best practices for social media use by health departments.

Visualization of the 2 networks (Figure) showed a larger and more connected network on Twitter than on Facebook; for visual clarity, SHDs not connected to others were not included in the Figure. The network of Facebook connections included 24 SHDs, with 38 total links among them (density = 0.01). The clustering coefficient for the Facebook network was 0.01, indicating few clusters. The Facebook network had 32 asymmetrical ties, which was 90.4% of all the connected pairs and 2.5% of all possible pairs in the network. Of the 38 links, only 7 were between 2 health departments in the same geographic region.

Wednesday, February 20, 2013

EHNAC Announces Public Launch of Direct Trusted Agent Accreditation Program (DTAAP)

The Electronic Healthcare Network Accreditation Commission (EHNAC), a non-profit standards development organization and accrediting body, has partnered with DirectTrust to create a national accreditation program for health information “trusted agent” service providers, including health information service providers (HISPs), certificate authorities (CAs) and registration authorities (RAs). Impetus for the initiative comes from the growth of electronic health records, health information exchanges, and programs such as Meaningful Use, which drive interoperability and data sharing among healthcare stakeholders.

Formal accreditation launched in early 2013 to selected beta organizations, and DirectTrust has already begun a testing and recognition program through which a number of HISPs and CAs have self-attested. This work has been integrated into the joint EHNAC and DirectTrust program. Criteria have been built on the “Security and Trust Specifications for HISPs, CAs and RAs” document developed by DirectTrust focusing on authentication of trust bundles, stakeholders and secure messaging. The criteria include the areas of privacy, security and confidentiality, technical performance, resources and implementation specifications, and include a self-attestation and site review(s).

“The privacy and security of protected health information are critical to the practice of medicine,” says Lee Barrett, executive director of EHNAC. “This accreditation will guarantee that organizations participating in Direct Project initiatives establish and uphold a superior level of trust for their stakeholders.”
"Directed exchange is email that is easy to use, secure, and identity-validated for both providers and patients, and is rapidly becoming the preferred method for secure inter-vendor exchange of health information," says David C. Kibbe, MD MBA, president and CEO of DirectTrust. "But everyone involved needs to have confidence that exchanging parties will protect the privacy of the messages, and assure the identity of senders and receivers during transport. Accreditation provides that industry-wide assurance in an efficient and trustworthy manner."

DirectTrust was formed by members within the Direct Project and was initially known as the Direct ‘Rules of the Road’ Workgroup. The Direct Project was launched in 2010 by the Office of the National Coordinator (ONC) as a national initiative that specifies Direct as a simple, secure, scalable, standards-based way for participants to send authenticated, encrypted health information directly to known, trusted recipients over the Internet. Adoption of the Direct standard has become an EHR requirement for Stages 2 and 3 of the Meaningful Use incentive program.

For more information or to apply for DTAAP accreditation, please visit the EHNAC website.

Electronic Health Record vendors face make-or-break year of client ultimatums and revolts

As many as 17% of physician practices are considering switching electronic health record vendors by the end of 2013, according to a new report from Black Book Rankings. With unmet expectations in system features, implementations, deliverables and client support issues mounting, 2013 may become the "Year of the Great EHR Vendor Switch."

“The high performance vendors that will emerge as viable past 2015 are those dedicating responsive teams to address customers’ current demands,” said Black Book’s managing partner Doug Brown. And those demand lists are growing longer and longer according to the survey responses. Users foretell of dozens, if not hundreds, of software firms underperforming badly enough to lose major market share as the industry evolves and struggling vendor solutions don't keep pace.

The independent insight Black Book gathered indicates many EHR firms have been so busy with backlogged implementations and selling product that development issues are being left on the back burner. Most concerning to current EHR users are unmet pleas for sophisticated interfaces with other practice programs, complex connectivity and networking schemes, pacing with accountable care progresses, and the rapid EHR adoption of mobile devices.

Brown upholds that the “meaningful use incentives created an artificial market for dozens of immature EHR products”. The sweeping Black Book survey also revealed that some popular "one size fits all" EHR products have not met the needs of several specialists and cannot continue to satisfy their client base with a lack of customizable or bespoke tools.

Nearly half of all Black Book EHR survey respondents scoring their respective vendor performances also answered the following set of questions on vendor switching.

The following aggregated responses are provided:

Are you dissatisfied enough with your EHR to consider making a change, and if so when?

  • 35%       No
  • 8%         Yes, but we cannot afford to abandon first/current EHR choice
  • 2%         Yes, within 3 months
  • 7%         Yes, within 6 months
  • 8%         Yes, within one year
  • 34%       Not sure, neither overly satisfied or dissatisfied
  • 6%         Yes, but no time frame

Of those debating or confirmed to be changing EHR vendors in the next year, from what type current EHR solution would you most consider switching to?

  • 51%        Web Based/ASP/SaaS/Hosted to another Web Based/ASP/SaaS/Hosted
  • 12%        Web Based/ASP/SaaS/Hosted to On-Premises Solution
  • 19%        On-Premises Solution to Web Based/ASP/SaaS/Hosted
  • 6%          On-Premises Solution to another On-Premises Solution
  • 12%        Unsure

Select top three compelling reasons for your practice to be considering vendor switch from current EHR?

  • 80%     Solution does not meet the Individual Needs of this Practice, including workflow
  • 79%     This Practice did not adequately assess our needs before selecting the original EHR
  • 77%     Design of solution is not suited for this Practice Specialty/Specialties
  • 44%    Vendor not responsive to requests and needs
  • 20%    Current EHR does not adequately communicate with other EHRs
  • 16%    Concerns that current EHR will not meet Accountable Care requirements
  • 12%    Current vendor is too focused on meaningful use achievement
  • 11%    Other practice software modules are not integrating with EHR
  • 5%      Setbacks have caused delays in reimbursement or disrupt work
  • 14%    Other

Black Book also conducted over 550 telephone interviews to drill down on the specifics of client complaints to note trends.

What three red flags are so currently compelling that current users would not consider a different EHR vendor as an option to replace the problematic vendor solution?

  • 32%     Mergers or Acquisitions occurring in this company
  • 26%     Senior Management in Disarray
  • 22%     Dissipating Market Share and Market Value
  • 22%     Internal staff have not mastered system
  • 16%     Disloyal customer base
  • 15%     Bad integrations evidence
  • 14%     Product Delays
  • 12%     History of abandoning clients
  • 12%     Past Customizations were Unaffordable
  • 6%      Overdependence on consultants for implementations and training

Features that were on EHR buyer wish lists three years ago are typically considered as basic system features now, according to those surveyed. First system implementations were decided on “must haves” of (in order): Document Management/Scanning/Storage, Electronic Prescribing, Order Management, Implementation Support, System Cost, and Alerts.

With these basic EHR fundamentals met, experienced users now seek innovative vendors who meet the compounding demands of practices, according to 2013 Black Book responses.

What are the top ten criteria you consider “must haves” in 2013 beyond basic EHR functionality? (in priority order)

  • 84%        Vendor Viability
  • 83%    Provider Data Integration and Network Data Sharing
  • 78%    Demonstrable Return on Investment and Clinical Improvements
  • 75%    Adoption of Mobile Devices including IPAD, IPHONE, Android and Tablets
  • 66%    HIE Support, Connectivity/Interoperability
  • 65%     Perfected interfaces with Lab, Pharmacy, Radiology, Rehabilitation, Post Acute Care
  • 65%     Perfected interfaces with Medical Billing partners/outsourcers and Revenue Cycle
  • 59%    System financing assistance
  • 58%    Patient Portal
  • 54%     Customized Workflow Management
  • 53%    Role-based Security
  • 50%    Enhanced Data Security, HIPAA Compliance and Patient Privacy Measures
  • 42%    Sharing Billing and Financial Data between disparate systems
  • 36%    Expert Coding
  • 35%    Practice Management expertise
  • 32%     Support evolving Accountable Care demands
  • 31%    Automated Patient Outreach
  • 26%    Clinical Analytics
  • 23%    Higher Specialty Usability
  • 23%    Decision support and population management
  • 20%     Internal messaging
  • 20%    Online managed care/insurance eligibility and terms
  • 17%     Customizable templates
  • 12%    EHR Mobility Applications and IOS Support


Does your EHR meet the needs of your individual practice specialty? “NO”

  • 88%    Nephrology
  • 85%    Urology
  • 80%    Ophthalmology
  • 75%    Gastroenterology
  • 72%    Orthopedics
  • 71%    Allergy & Immunology
  • 71%    ENT
  • 54%    Small Practices

Are you seeking a vendor who has demonstrated capabilities and success with vendors in your specialty as a replacement EHR?

  • 92%     Yes
  • 1%        No
  • 7%        Unsure


Is your practice satisfaction with current EHR vendor at a point where you would NOT consider vendor switch in the next 12-24 months? "YES"

  • 89%    Internal Medicine
  • 85%    Family Practice
  • 82%    General Practice
  • 80%    Pediatrics
  • 77%    Oncology & Hematology
  • 72%    OB/GYN
  • 70%    Large Practices
  • 62%    Geriatrics
  • 59%    Cardiology
  • 56%    General Surgery

Black Book’s annual Top EHR Vendor performance results was released February 15. More information is available at

Tuesday, February 12, 2013

Inaugural ONC Google Plus Hangout

On Tuesday February 12, 2013 the HHS Office of the National Coordinator hosted it's first Google + Hangout. The participants were:

  • Doug Fridsma, M.D., Ph.D. - Chief Scientist at ONC
  • Arien Malec - VP Strategy and Product Marketing at RelayHealth, Former Coordinator for the Direct Project
  • Deven McGraw - Director of the Health Privacy Project at CDT
  • John Moehrke - Principal Engineer: Interoperability and Security at GE
  • Vince Kuraitis - Principal, Better Health Technologies, LLC
  • Brian Ahier - Health IT Evangelist
  • John Travis - Senior Director and Solution Strategist, Regulatory Compliance at Cerner
  • Alice Leiter - Policy Counsel at Center for Democracy & Technology

It was a very interesting conversation and I look forward to future ONC Hangouts. This was a great example of government as a platform and I expect there will be some great uses of this tool for engaging the health IT community.

Friday, February 8, 2013

Update on the Federal Health Architecture

At the February 6, 2013 HIT Policy meeting Lauren Thompson, PhD the Director of the Federal Health Architecture (FHA) within the Office of Science and Technology at the Office of the National Coordinator for Health Information Technology gave an excellent overview of the FHA program. The FHA program is a partnership among Federal Agencies to advance health information interoperability among Federal Agencies, and the tribal, state, local and private sectors. Through FHA, Federal agencies have joined together to implement government-wide solutions for interoperable and secure health information exchange. The FHA serves in a coordinating and convening role, facilitating collaboration in military and Veterans healthcare, public health monitoring, disability services, tribal health services and many other critical Federal priorities. As Director of FHA, Lauren has been instrumental in energizing the Federal health community around common goals of establishing a cross-agency, strategically-focused governance structure, creating an interoperability architecture aligned with nationwide health information technology goals, evolving the CONNECT architecture toward an open source governance model driven by common standards and specifications, and more expansive outreach and communication with the Nationwide Health Information Exchange community.

Watson Fighting Cancer and Transforming Care

IBM and Memorial Sloan-Kettering Cancer Center today unveiled the first commercially developed Watson-based cognitive computing breakthroughs. These innovations stand alone to help transform the quality and speed of care delivered to patients through individualized, evidence based medicine.

To date, Watson has ingested more than 600,000+ pieces of medical evidence, two million pages of text from 42 medical journals and clinical trials in the area of oncology research. Watson has the power to sift through 1.5 million patient records representing decades of cancer treatment history, such as medical records and patient outcomes, and provide to physicians evidence based treatment options all in a matter of seconds.

“It can take years for the latest developments in oncology to reach all practice settings. The combination of transformational technologies found in Watson with our cancer analytics and decision-making process has the potential to revolutionize the accessibility of information for the treatment of cancer in communities across the country and around the world,” said Craig B.Thompson, M.D., President of Memorial Sloan-Kettering Cancer Center. “Ultimately, we expect this comprehensive, evidence-based approach will profoundly enhance cancer care by accelerating the dissemination of practice-changing research at an unprecedented pace.”

In less than a year, Memorial Sloan-Kettering has immersed Watson in the complexities of cancer and the explosion of genetic research which has set the stage for changing care practices for many cancer patients with highly specialized treatments based on their personal genetic tumor type. They have published a case study on the project which describes how the cancer center’s oncologists are training Watson to compare a patient’s medical information against a vast array of treatment guidelines, published research and other insights to provide individualized, confidence-scored recommendations to physicians.

"IBM's work with WellPoint and Memorial Sloan-Kettering Cancer Center represents a landmark collaboration in how technology and evidence based medicine can transform the way in which health care is practiced," said Manoj Saxena, IBM General Manager, Watson Solutions. "These breakthrough capabilities bring forward the first in a series of Watson-based technologies, which exemplifies the value of applying big data and analytics and cognitive computing to tackle the industries most pressing challenges."

The IBM Watson Cancer Diagnosis and Treatment Adviser demo was created in close collaboration with Memorial Sloan Kettering, one of the world's preeminent cancer treatment and research institutions. The demo scenario follows the interactions of a hypothetical oncologist and patient as they move through consultations, tests, treatment options, patient preferences and pre-authorization. It showcases IBM Watson's capabilities in natural language processing, hypothesis generation and evaluation, and machine learning.

IBM, Memorial Sloan-Kettering and WellPoint are introducing the first commercially based products based on Watson. These innovations represent a breakthrough in how medical professionals can apply advances in analytics and natural language processing to "big data," combined with the clinical knowledge base, including genomic data, in order to create evidence based decision support systems. These Watson-based systems are designed to assist doctors, researchers, medical centers, and insurance carriers, and ultimately enhance the quality and speed of care.

The new products include the Interactive Care Insights for Oncology, powered by Watson, in collaboration with IBM, Memorial Sloan-Kettering and WellPoint. The WellPoint Interactive Care Guide and Interactive Care Reviewer, powered by Watson, designed for utilization management in collaboration with WellPoint and IBM.

Tuesday, February 5, 2013

Health IT at the National Health Policy Conference

There was an excellent panel at the AcademyHealth National Health Policy Conference held February 4, 2013. First, Secretary Sebelius discussed the administration's health care policy priorities as key provisions of the Affordable Care Act come online over the next year. The health IT panelists included:
  • Farzad Mostashari, Office of the National Coordinator for Health Information Technology
  • David Blumenthal, The Commonwealth Fund
  • Paul Tang, Palo Alto Medical Foundation
  • Christine Bechtel, National Partnership for Women & Families
You can view the video from the event on C-SPAN HERE.

Dr. Mostashari outlined the ONC's three goals for creating better interoperability among providers for EHRs:
  • Develop specific technology standards for vendors to agree to in their EHR products
  • Outline reasons why providers need to be able to transfer information between practices, and in which circumstances information can be shared
  • Establish trust among patients that they will be able to obtain their information and that it won't be breached by others
"There have to be standards that you can reach or that the different vendors can agree to for being able to exchange complex information," Mostashari said.

Text of Secretary Sebelius speech:

Thank you, Lisa. I want to start by acknowledging our host, Academy Health. America’s health services researchers play an invaluable role in our efforts to build a more effective health care system and a healthier America.

You’re the ones who tell us where the need is greatest, which approaches are working, and when we need to go back to the drawing board. The foundation of a 21st century health care system in this country is going to be the evidence base that you’ve assembled.

I also wanted to specially acknowledge a leader who has done so much to advance health services research over the last few decades. As some of you know, Carolyn Clancy has announced that she will be leaving our department after 23 years at AHRQ, including the last ten as Director.

Carolyn’s record of accomplishment speaks for itself. She’s run AHRQ at a time when its profile has never been higher and demand for its insights has never been greater.

Under her leadership, AHRQ produced its first-ever annual reports on quality, safety, and disparities, finally giving us important benchmarks we can use to track our progress. And AHRQ-funded research has led directly to significant improvements in health outcomes in areas like health care-associated infections.

Carolyn has generously agreed to stay on until we find someone to fill her position. But today, I just want to say – on behalf of the department and millions of Americans benefitting from better, safer care – how grateful we are for her service. Thank you, Carolyn.

The last time I spoke at this conference was in 2010, a few weeks before the passage of the Affordable Care Act. Think about how far we’ve come since then.

When it comes to health insurance, consumers now have the strongest set of protections in history. More than three million young people have gained coverage through their parents’ plans. Preventive care is free for tens of millions of Americans. And seniors with the highest drug costs are getting big savings on their prescriptions.

At the same time, we’ve seen the start of a transformation in our health care delivery system. New models of care are proliferating. Already, more than two hundred and fifty health organizations, of all shapes and sizes, have agreed to form Accountable Care Organizations. That means as many as four million Medicare beneficiaries now get their care from providers whose bottom line is keeping them healthy. And these new models are spreading rapidly in states and the private market too.

In response to these changes and other new incentives, health care providers are embracing new data tools that make it easier to improve care and share information between providers and patients. Use of basic electronic health records has doubled since 2008. And more than 80 percent of hospitals have committed to being meaningful users of electronic health records by 2015.

Most importantly of all, these changes are translating into real improvements in people’s lives. For example, hospital readmissions in Medicare have fallen nationally and have dropped 25 percent or more in some communities. Meanwhile, we’ve had three years in a row of historically low growth in health care costs. While we can’t attribute this drop entirely to the law, it’s undoubtedly a positive sign.

The Affordable Care Act is the law of the land. It’s here to stay. And it is working. The wheels of progress in American health care are turning. But we’ve only just begun to see the difference this law can make.

In the coming months and years, we’ll have a huge opportunity to significantly speed up the transformation of health care in a way that will benefit all Americans. But we will need the continued efforts of partners, across the health care system and around the country, to achieve this law’s full potential.

That starts with expanding coverage to tens of millions of Americans who are currently outside the system. As you know, new marketplaces are now being built in every state that will make affordable coverage available to millions of Americans beginning January 1st. In addition, many states will be expanding their Medicaid programs.

For people without insurance, the benefits of coverage are huge. They’re more likely to get preventive care and checkups. They don’t have to weigh the cost of going to the emergency room when their five-year-old wakes up with a fever. There’s no risk of losing it all if they get seriously ill and run up a big hospital bill.

But the truth is that when our friends and neighbors can afford the health care they need, that’s not just good for them. It’s good for all of us. We all benefit when our premiums are no longer inflated with tens of billions of dollars in added costs for uncompensated care. We all benefit when workers can spend more time on the job, and kids can spend more time in school.

And one reason we need influential voices like yours to make these points is that several states are still weighing the decision about whether to expand their Medicaid programs – decisions that will affect whether millions of Americans can get coverage.

These states are being offered an incredible deal. If they expand their Medicaid programs to serve adults making up to around $1200 a month and families making up to around $2500 a month, then the federal government will pick up 100 percent of the bill for the first three years and at least 90 percent of the bill after that.

Think about that deal. In exchange for picking up a tiny fraction of the tab, states can dramatically expand health coverage for working families, increase productivity, save lives, and reduce their burden of uncompensated care. That’s as good a deal as any state is going to get, and you can help get these facts into the debate.

Merely expanding access to health insurance is not enough, however. Unless people know affordable coverage is now available to them – and unless they know how to get it – they’re going to remain on the outside of our health care system looking in.

That means over the next year we’re also going to have to reach out directly to millions of Americans who, in many cases, have not spent a lot of time in the health insurance market.

Some of these people may believe that affordable health insurance is out of reach for them. They’re so used to exorbitant premiums and insurance companies jerking them around that they’ve understandably come to believe that having coverage will never be an option.

Others are young people. If you have children in their twenties like I do, you know that health insurance is not always their top priority. I don’t always know what that priority is, but it’s not health insurance. Yet we know that young people often take the biggest risk when they go without coverage since they’re less likely to have the resources to cover care out of pocket.

If we’re going to fulfill the full promise of the Affordable Care Act and insure millions more Americans, we’ll need to reach these people. And we’ll need your help to do it.

Part of that is educating people about the new Marketplaces. They need to know that this is a whole new way to shop for health insurance. They’ll be able to submit a single application to find all the plans that fit their budget. Discrimination against pre-existing conditions will be outlawed. And there will be tax credits for working families that could save them money on their coverage right away. People can go to right now to learn more and sign up for updates to make sure they don’t miss out on new benefits.

Everyone can play a role in educating Americans about the new coverage options that are coming. If you’re a health care provider, you can start talking about them to your patients. If you’re a state or local official, you can share this information with people who seek out government services. If you’re a policy analyst, you can help identify better ways to locate the uninsured and motivate them to purchase coverage. If you’re a researcher, you can help make sure that once people get coverage, they also get the care they need, especially critical preventive services.

Many of us in this room have been arguing for decades that making health coverage affordable to all Americans is one of the best investments we can make as a nation. Now that we finally have the chance to make that happen, we need to do everything we can to make the most of it.

But the coverage expansion isn’t the only part of the law that is kicking into gear over the next year. In the years before the health care law passed, costs were rising at an unsustainable rate.

We often hear about the rising costs in Medicare and Medicaid, but it’s important to remember that this isn’t a unique characteristic of government health programs. In fact, Medicare and Medicaid costs have been growing more slowly than private insurance premiums. The driver is the growth in the underlying cost of care, which was putting equal pressure on family ledgers, corporate balance sheets, and local, state, and federal budgets.

But even though Medicare is not the problem, we knew it could be part of the solution. History shows that innovations in how we pay for care often begin with Medicare and then spread to the private insurance industry. And a critical part of the Affordable Care Act are the new payment models our department is rolling out to help health organizations change the way they deliver care.

Some of our early results have been very promising. I already mentioned the drop in hospital readmissions. We’ve also seen impressive results in our efforts to reduce health care-associated infections, with central line bloodstream infections down more than 40 percent. And in our Strong Start initiative, some participating hospitals are reporting that they’ve reduced their early elective deliveries to close to zero. That means fewer at-risk newborns and fewer admissions to the ICU, at an average cost savings of nearly $5,000 per delivery.

But for all the progress we’re seeing, change is not happening fast enough. Far too many patients still experience a health care system that is fragmented, unreliable, and often prohibitively expensive. Far too many health care providers are still content to sit back and let others blaze the trail towards a 21st century health care system. So my challenge to all of you today – and especially to the provider community – is to speed up the rate of change.

If you are already at the vanguard of transforming care, now is the time to take the next step forward. If you have been considering participating in a new care model, now is the time to take the plunge. If you have been waiting on the sidelines, now is the time to get in the game.

Health services researchers and policy analysts have a role to play. For years, you have helped identify our health care system’s biggest problems and evaluate solutions. But too often those results have come in a 200 page report five years after a study launched. We can’t afford to wait five years to find out what qualities make a successful ACO. We need that information in real time so we can use it to shape policy to have the biggest impact on people’s lives.

I want to be clear: the transformation I’ve talked about today will not happen overnight. When this conference convenes next February, there will still be uninsured Americans we need to cover. There will still be rising costs we need to control. There will still be models of care that need to be evaluated.

But we have a rare opportunity over the next year to make huge strides together in transforming our health care system. If we can take advantage of that opportunity, the payoff for the American people in better care, better health, and lower costs will be enormous.

Thank you.

Monday, February 4, 2013

The Physician Payment Sunshine Act Final Rule

On February 1, 2013 the Centers for Medicare & Medicaid Services (CMS) released the final regulations to implement the Physician Payment Sunshine Act—Section 6002 of the Affordable Care Act and will be published in the Federal Register on February 8, 2013. The Physician Payment Sunshine Act is designed to expose financial relationships between doctors and industry and requires physicians and teaching hospitals to annually report gifts and payments they receive from medical device and pharmaceutical manufacturers. Manufacturers must begin collecting the required data by August 1, 2013 and report the data to CMS by March 31, 2014. “You should know when your doctor has a financial relationship with the companies that manufacture or supply the medicines or medical devices you may need,” said Peter Budetti, M.D. CMS deputy administrator for Program Integrity. “Disclosure of these relationships allows patients to have more informed discussions with their doctors."

The final regulations to implement the Physician Payment Sunshine Act were supposed to be published in October 2011. Unfortunately, these regulations are 15 months overdue. Originally, the manufacturers were supposed to start collecting the payment data in January 2012 and report the relationships to CMS by Mar. 31, 2013. But CMS later pushed back the data collection date. Many groups have been urging CMS to publish the final rule. The uncertainty created by the delay in publishing the final rule has now given way to praise in some quarters. "This rule allows a long-delayed transparency measure to take effect," Allan Coukell, director of medical programs at The Pew Charitable Trusts, said in a statement. "Public reporting of the financial relationships between doctors and drug or medical device companies will protect patients and help restore trust in our healthcare system. We applaud the Centers for Medicare and Medicaid Services for issuing the Sunshine regulation, which will now allow manufacturers to comply with their reporting obligations under the law."

After hearing over 350 comments with respect to the continuing medical education (CME) industry, CMS has exempted payments or other transfers of value provided as compensation for speaking at a continuing education if certain conditions are met—which are consistent with the ACCME’s accreditation standards and standards for commercial support. "This decision recognizes the adequacy of current protections against inappropriate bias in CME, and acknowledges CME’s special role in educating physicians and improving patient outcomes." said the CME Coalition. "Further, by limiting CME support payments from the reporting rules required of direct physician payments, CMS has made it clear that pharmaceutical companies, medical device manufacturers, and other commercial supporters should not be discouraged from underwriting accredited CME activities."

The American Medical Association (AMA) was a bit more cautious in their praise. In a statement AMA President Jeremy Lazarus, MD. said: "The AMA will carefully review the new Physician Payment Sunshine Act rule. Physicians’ relationships with the pharmaceutical industry should be transparent and focused on benefits to patients. Our feedback during this rulemaking process was aimed at ensuring the new registry will provide a meaningful picture of physician-industry interactions and give physicians an easy way to correct any inaccuracies. As the rule is implemented, we will work to make sure physicians have up-to-date information about the new reporting process."

Payment categories will include consulting fees, honoraria, gifts, food, entertainment, and travel, among others. Stakeholders are required to report their payments if they are covered by any federal health program. So far ProPublica's Dollars for Docs tool has been the only freely available source for the public to search and analyze the payments made since 2009 by a dozen drug companies. ProPublica gathered the information from the companies' websites into one searchable, sortable database.

The Pharmaceutical Research and Manufacturers of America (PhRMA) said in a statement, "PhRMA remains committed to the principles of the Sunshine Act and continues to believe that careful implementation is essential to ensuring that Sunshine fulfills its objective of usable, transparent, and understandable sharing of information." And the Medical Imaging & Technology Alliance (MITA) issued a statement saying: "We appreciate that CMS has given device manufacturers 180 days after publication to implement the final regulations, so that our members have sufficient time to successfully implement the law."

Senator Chuck Grassley (R-Iowa), co-author of the original legislation, has been repeatedly urging for the regulations to be completed. Now, after the regulations have finally been published he said that "disclosure brings about accountability, and accountability will strengthen the credibility of medical research, the marketing of ideas and, ultimately, the practice of medicine."

"I will stay vigilant about how this law is implemented, especially after the delays seen already," Grassley added.

Friday, February 1, 2013

New Accountable Care and Health IT Workgroup

The HIT Policy Committee is forming a new workgroup on Accountable Care and Health IT. HIT Policy Committee's Accountable Care Workgroup will be charged with making recommendations on how HHS policies and programs can advance the EVOLUTION of a health IT infrastructure that enables providers to improve care and population health while reducing costs in accountable care models. The workgroup will focus on specific high priority areas where programs and policies can shape the availability and use of health IT infrastructure necessary for Accountable Care Organizations to realize the three part aim. If you are interested in being considered for membership on this workgroup, please register at