Push Blue Button for Personal Health Information: Markle Foundation

Health IT Investments Should Enable People to Download Their Own Information …at the click of a blue button
Press Release from Markle Foundation on August 31, 2010
PDF Version

Blue Button

Blue Button

Markle Connecting for Health Collaboration Agrees on ‘How To’ Policies

Veterans, Medicare beneficiaries near ‘blue button’ access

Markle collaboration includes support from 48 organizations; recommends specific privacy practices

NEW YORK (Aug. 31, 2010)
Representing a wide array of providers, consumers, technology companies, insurers, and privacy advocates—48 organizations today declared their support for a specific set of privacy and security practices for the “blue button.”

The public-private collaborative group envisions the blue button as a common offering among secure websites for patients and beneficiaries by medical practices, hospitals, insurers, pharmacies, laboratories, and information services.

“By clicking the blue button, you could get your own health information electronically—things like summaries of doctor visits, medications you are currently taking, or test results. Being able to have your own electronic copies and share them as you need to with your doctors is a first step in truly enabling people to engage in their health care,” said Carol Diamond, MD, MPH, managing director at Markle.

“This capability is not common today, but we have the opportunity to make it a basic expectation—especially now that billions of public dollars will be flowing to help subsidize health information technology,” Diamond said.

The paper is being released as Medicare and the U.S. Veterans Administration (VA) prepare to implement a blue button this fall that will, for the first time, allow beneficiaries to electronically download their claims or medical information in a common format from the My Medicare.gov and My HealtheVet secure websites.

President Obama announced the blue button for veterans in an August 3 address. “For the first time ever, veterans will be able to go to the VA website, click a simple blue button and download or print your personal health records so you have them when you need them, and can share them with your doctors outside of the VA,” the President said.

The Markle collaboration’s recommendations are timely because the American Recovery and Reinvestment Act requires that individuals be able to receive electronic copies of their records from providers’ electronic health record systems. In addition, new federal economic stimulus rules require health care providers and hospitals to deliver electronic copies of things like lists of medications, after-visit summaries, and lab results if they choose to participate in federal subsidies for using health information technology.

The Markle policy recommendations reflect consensus on one means by which this can be accomplished today, securely and efficiently. The group details privacy policies and practices for implementing the download capability with sound authentication and security safeguards and suggests practices to help individuals make informed choices about downloading their information. For example, it recommends specific language to remind individuals not to download or store their personal health information on shared computers.

Christine Bechtel, vice president of the National Partnership for Women & Families, and a member of the federal Health IT Policy Committee, supported the Markle policy paper.

“People see a lot of different health care providers over time, so giving them a convenient option to securely assemble their health information from multiple sources will help them better manage and coordinate their own care,” Bechtel said. “This capability is one of the simplest and most direct ways of helping patients and families see the benefits of the federal health IT investments that they, as taxpayers, have helped fund.”

The proposed privacy policies build on the Markle Common Framework for Networked Personal Health Information, a set of recommended practices for individual access to information and privacy. The framework, first released in 2006, is widely supported by a range of technology companies, insurers, provider groups, and consumer and privacy advocates.

“We recommend specific privacy policies to help individuals make informed choices about downloading their personal health information, and to emphasize sound authentication and security practices,” said Josh Lemieux, director of personal health technology at Markle. “By supporting this set of policies, a wide range of leaders commit to practices that encourage individual access to information in a way that respects privacy and security.”

The following organizations declared their support for the policy paper,

—The simple, but rarely offered, ability for people to download their health records should be a priority in the nationwide push to upgrade health information technology, according to a policy paper released today by the Markle Foundation. Markle Connecting for Health Policies in Practice: The Download Capability:

AARP • Allscripts Healthcare Solutions • American Academy of Family Physicians • American College of Cardiology • American College of Emergency Physicians • American Medical Association • Anakam Inc. • Axolotl • BlueCross BlueShield Association • Center for Connected Health • The Children’s Partnership • Center for Democracy and Technology • Center for Medical Consumers • Children’s Health Fund • Chilmark Research • Computer Sciences Corporation • Consumers Union • Dossia

Consortium • DrFirst • Google • Initiate, an IBM Company • The Institute for Family Health • Intel Corporation • Intuit Health • Keas, Inc. • LifeMasters-StayWell Health Management • Markle Foundation • McKesson Technology Solutions/RelayHealth • MedCommons • Medical Group Management Association • MedicAlert Foundation • Meditech • Microsoft Corporation • National Coalition for Cancer Survivorship • National Committee for Quality Assurance • National Partnership for Women & Families • National Quality Forum • NaviNet • Pacific Business Group on Health • PatientsLikeMe • Prematics, Inc. • Press Ganey • PricewaterhouseCoopers LLP • RTI International • Vanderbilt Center for Better Health • Visiting Nurse Service of New York • Wal-Mart Stores, Inc. • Wellport

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Markle Foundation works to improve health and national security through the use of information and technology. Markle collaborates with innovators and thought leaders from the public and private sectors whose expertise lies in the areas of information technology, privacy, civil liberties, health, and national security. Learn more about Markle at www.markle.org .

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Markle Connecting for Health is a public-private collaborative with representatives from more than one hundred organizations across the spectrum of health care and information technology specialists. Its purpose is to catalyze the widespread changes necessary to realize the full benefits of health information technology while protecting patient privacy and the security of personal health information. Markle Connecting for Health tackles the key challenges to creating a networked health information environment that enables secure and private information sharing when and where it is needed to improve health and health care. Learn more about Markle Connecting for Health at www.connectingforhealth.org .
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KEY LINKS
President Obama Talks about the Blue Button Initiative (VIDEO)

See Department of Veteran Affairs for Blue Button Initiative.

See Centers for Medicare and Medicaid Services about Blue Button Initiative.

ONC Selects Cincinnati, Detroit as final 2 Beacon Community Health IT Pilots

Cincinnati, Detroit selected as final health IT pilot communities under  innovative HHS Recovery Act Beacon Program
Received this HHS Press Release via email on Sept 2, 2010:

HHS Secretary Kathleen Sebelius today announced that Cincinnati and Detroit are the two final pilot communities selected under the new Beacon Community Program that is using health information technology to help tackle leading health problems in communities across the country.  At the same time, the program will also allow HHS to look for new ways to share the lessons learned by funded communities and, working with local and national health care foundations, develop support networks for other communities that want to employ similar innovative approaches. 

The two awardees announced today, Greater Cincinnati HealthBridge, Inc. in Cincinnati and Southeastern Michigan Health Association in Detroit, join 15 other projects selected in May for the Beacon Community Cooperative Agreement Program.  The other communities that previously received Beacon program funding include Tulsa, Okla.; Stoneville, Miss.; Brewer, Maine; Danville, Pa.; Salt Lake City, Utah; Indianapolis, Ind.; Spokane, Wash. New Orleans, La.; Rochester, Minn.; Providence, R.I.; Grand Junction, Colo.; Concord, N.C.; San Diego, Calif.; Hilo, Hawaii, and Buffalo, N.Y.  Beacon projects are expected to initially create dozens of new jobs in each of the communities paying an average of $70,000 per year for a total of over 1,100 jobs up-front, while accelerating development of a nationwide health IT infrastructure that will eventually employ tens of thousands of Americans.   

“The Beacon program uses health information technology tools to link health providers and other community-wide resources in new and innovative ways,” Secretary Sebelius said.  “Under the Beacon program, communities first identify leading health problems that are unique to their community, develop innovative, health IT-related strategies, and work together through community collaborations to implement their strategies and track their performance.”  

The Beacon Community awards are part of an overall $100 billion federal government investment in science, innovation and technology the Administration is making through the Recovery Act to spur domestic job creation in emerging industries and create a long-term foundation for economic growth.  There has been significant interest in the program, with over 100 applications for the final two Beacon program slots.  David Blumenthal, M.D., national coordinator for Health Information Technology, said the applications demonstrated widespread readiness in communities across America to use health IT to address specific challenges in health and health care. 

“Beacon communities are designed to point the way toward maximizing community resources to address specific health goals at the local level, including quality of care, the cost of care, and the health of the whole population,” Dr. Blumenthal said.  “We have seen first-hand through the Beacon application process that a great many communities have promising ideas and are starting to use health IT in innovative ways.  We look forward to engaging and helping these communities through a broader nationwide effort.”

In the near term, HHS’ Office of the National Coordinator for Health IT will work closely with other federal partners and the private sector to identify and share promising health IT health care solutions among communities across America.  

“Although we could only select two additional Beacon communities, we are incredibly impressed by the creativity and focus exhibited by communities over the course of this competition,” said Blumenthal. “Local leadership is an essential ingredient to improving health care. The Beacon Community application process provides strong evidence that communities throughout the country are mobilizing for positive change, using health IT as a critical foundation for improving health care.”

Like other Beacon communities, today’s awardees will coordinate community efforts toward specific goals: 

The Greater Cincinnati HealthBridge, Inc. – $13.8 million over three years – HealthBridge will serve a 16-county area spanning three states surrounding greater Cincinnati. Under the Beacon program, HealthBridge and its partners will use its advanced health information exchange program to develop new quality improvement and care coordination initiatives focusing on patients with pediatric asthma, adult diabetes, and encouraging smoking cessation. For example, not only will physicians and other providers receive more timely and accurate information about when their patients experience a medical complication or are hospitalized, they will have new support from care managers to use this information effectively to intervene early and assist patients in managing their health and avoiding further complications. This program will provide better clinical information and IT “decision support” tools to physicians, health systems, federally qualified health centers, and critical access hospitals. As part of the Beacon program, this health IT community collaboration will also provide patients and their families with timely access to data, knowledge, and tools to make informed decisions and manage their own health and health care.  

The Southeastern Michigan Health Association (SEMHA) – $16.2 million over three years – The SEMHA and its partners in the greater Detroit area will use health IT tools and strategies to prevent and better manage diabetes, which today affects a large percentage of residents of the city of Detroit. This community collaboration will leverage existing and new technologies across health care settings to improve the availability of patient information at the point of care, regardless of where the patient is in the health system. Furthermore, the community will provide practical support to physician practices to help clinicians, nurses, and others make the best use of electronic health data to catch potential health complications before they arise.  The city’s clinical community will have the capacity to track clinical outcomes with the overarching goal of making long-term, sustainable improvements in the quality and efficiency of diabetes care in Detroit, Hamtramck, Highland Park, Dearborn and Dearborn Heights. 

The Beacon program is one of several new programs created by the Health Information Technology Economic and Clinical Health (HITECH) Act last year.  HITECH included $2 billion for technical assistance, training and demonstration programs supporting the adoption of heath information technology, including electronic health records (EHRs).  Total funding for the Beacon program initiatives is $250 million plus an additional $15 million for technical assistance and evaluation.  In addition, HITECH authorized incentive payments to health care professionals and hospitals to reward adoption and meaningful use of EHRs.  The incentive payments, provided through Medicare and Medicaid, could total as much as $27 billion over 10 years.  These incentive payments are part of the broader efforts in Medicare and Medicaid under the Affordable Care Act to transform payments to reward better quality care. 

More information about Beacon Communities can be found at:  http://Healthit.hhs.gov/Programs/Beacon

For information about the Affordable Care Act and other efforts to promote improved care delivery, see:
http://www.healthcare.gov

For information about other HHS Recovery Act programs, see:
http://www.hhs.gov/recovery
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CCHIT and Drummond Group Press Releases on EHR Certification Testing

Aug 30, 2010 Press Releases from Drummond Group and CCHIT in Full
CCHIT announced September  20, 2010 Town Hall meeting and will start accepting applications for certification immediately after the meeting. Drummond Group promised more details and pricing by August 31, 2010. See ONC announcement.

Certification Commission Among First To Be Approved As ONC-ATCB
CCHIT is Authorized by HHS as Testing and Certification Body for Electronic Health Records
CCHIT Press Release
CHICAGO – August 30, 2010 – Certification Commission for Health Information Technology (CCHIT®) announced today that it has been recognized by the Office of the National Coordinator for Health Information Technology (ONC), U.S. Department of Health and Human Services (HHS) as an Authorized Testing and Certification Body (ONC-ATCB) under the initial certification program created to certify that electronic health records (EHRs) are capable of meeting the criteria to support meaningful use and qualify  eligible providers and hospitals for funding under the American Recovery and Reinvestment Act (ARRA). 

“We are gratified to be among the first organizations authorized to certify EHRs by ONC,” said Karen M. Bell, M.D., M.M.S., chair of CCHIT.  “As the originator of EHR certification, CCHIT has tested and certified hundreds of EHRs. Our experience has enabled us to promptly adapt our processes to accommodate the certification and standards adopted by HHS to support the meaningful use of EHRs by healthcare providers.”

CCHIT is authorized to offer HHS certification for complete EHRs that meet all of the Stage 1, 2011/2012 HHS/ONC criteria, as well as certification for modular EHR products that meet one or more – but not all – of the criteria.

CCHIT plans to launch its authorized HHS certification program on September 20 at 1:00 PM Eastern time with a Town Call Web-cast describing its application and testing process. CCHIT will take new health IT developer applications immediately after at http://cchit.org/ and the first group of HHS certified complete EHRs and EHR modules will be announced within weeks of that launch. More information about the Town Call will be available at http://www.cchit.org/towncalls. The call will be recorded for later viewing.

In addition to HHS certification, CCHIT will continue to offer its CCHIT Certified® program for Ambulatory and Inpatient EHR products that exceed the HHS/ONC criteria and are designed for hospitals and physician practices that are looking for assurance of more robust, integrated EHR products to support the unique needs of its clinicians and patients.   Many of these products will also be HHS certified. 

CCHIT also offers CCHIT Certified® programs for EHRs used in Cardiovascular Medicine, Child Health, Emergency Departments, Behavioral Health, Dermatology and Long-Term and Post-Acute Care. In addition, a certification program for EHRs used in Clinical Research will be available in fall 2010, and programs in Women’s Health and Oncology are in development for launch in spring 2011.

About CCHIT
The Certification Commission for Health Information Technology (CCHIT®) is an independent, 501(c)3 nonprofit organization with the public mission of accelerating the adoption of robust, interoperable health information technology.  The Commission has been certifying electronic health record technology since 2006 and is recognized by the Office of the National Coordinator for Health Information Technology (ONC), U.S. Department of Health and Human Services (HHS) as an Authorized Testing and Certification Body (ONC-ATCB).  More information on CCHIT, CCHIT Certified® products and HHS certified electronic health record technology is available at http://cchit.org/ and http://ehrdecisions.com/

“CCHIT®” and “CCHIT Certified®” are registered trademarks of the Certification Commission for Health Information Technology.
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Drummond Group Approved by HHS to Certify EHR
Drummond Group Press Release
August 30, 2010, Austin Texas. Drummond Group Inc., the trusted software testing lab, is one of the first to be approved by the Health and Human Services, Office of the National Coordinator for Health IT (ONC) to be an ONC-Authorized Testing and Certification Body (ONC-ATCB) to certify Complete EHRs and all EHR Modules for both ambulatory and inpatient settings. Eligible professionals (EPs), eligible hospitals and critical access hospitals (CAHs) participating in Medicare and Medicaid programs to collect incentive payments through meaningful use of electronic health record (EHR) technology must use EHR technology certified by an ONC-ATCB.

“Drummond Group has been working diligently for many months to meet the stringent criteria set forth by ONC to become certified as an ONC-ATCB, and we are very pleased that ONC has recognized our efforts and our competency to be an approved testing and certification body,” says Rik Drummond, CEO Drummond Group Inc. “We are pleased to offer over ten years of software testing and certification experience in other industries to Healthcare. After executing several pilots on existing EHR products and working with industry consultants, our organization is more than prepared to test and certify healthcare products.”

“The ONC accreditation is an acknowledgement that Drummond Group is fully qualified to meet the needs of EHR meaningful use stage one testing and certification. We highly commend the work of ONC and their accreditation process which tested the details of our testing and certification process and our industry knowledge. Having started new tests with other industries, we found this approval process to be the most demanding and the most thorough we have encountered. With our approval as an ONC-ATCB, EHR vendors and implementers can have full confidence in our testing and certification services, and we look forward to beginning testing with the many EHR software companies that have contacted us.”

To learn more about Drummond Group’s EHR testing and certification program including test registration and related pricing, please visit: http://www.drummondgroup.com/

[More information including pricing and registration instructions will be available by August 31, 2010.]

For more information on ONC’s ATCB program, please visit: http://healthit.hhs.gov/

About Drummond Group Inc.

Drummond Group Inc. (DGI) is the trusted interoperability test lab which works with standards groups, software/firmware vendors and industry groups to drive adoption of standards by offering global interoperability, conformance testing and certification. DGI facilitates these testing services under association-branded certification programs and its own Drummond Certified(R) program. Founded in 1999, DGI also represents best-of-breed in strategic interoperability consulting recognizing the challenges of interoperability for industry over the product life cycle.

  • DGI provides interoperability certification for M2M or business-to-business (B2B) standards which are used for the Fortune 500 financial information flow, representing billions of dollars per year. Cyber security of data transfer is critically tested.
  • DGI manages the KANTARA INITIATIVE Global Interoperability Test Program for Identity information exchange for the US government and the other global leaders in identity.
  • DGI facilitates software audits of the Controlled Substance Ordering System (CSOS) software managed in compliance with the DEA regulations.
  • Drummond Certified(R) software and firmware is required in RFP’s around the globe to ensure seamless, secure, interoperable products which make implementation easy, thereby significantly reducing costs.
  • DGI was recently awarded two Department of Energy stimulus funded Smart Grid demonstration projects. DGI’s role in both projects relates to the interoperability and certification of Smart Grid technology.

For more information, visit http://www.drummondgroup.com/.
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Initial EHR Certification Bodies Named: CCHIT and Drummond Group

CCHIT and Drummond Group Named as First 
ONC-Authorized Testing and Certification Bodies (ONC-ATCBs)
Key step in national initiative toward adoption of electronic health records
Excerpted from HHS Press Release emailed 8/30/2010  More from ONC site in Next Section
The Certification Commission for Health Information Technology (CCHIT), Chicago, Ill. and the Drummond Group Inc. (DGI), Austin, Texas, were named today by the Office of the National Coordinator for Health Information Technology (ONC) as the first technology review bodies that have been authorized to test and certify electronic health record (EHR) systems for compliance with the standards and certification criteria that were issued by the U.S. Department of Health and Human Services earlier this year.

Announcement of these ONC-Authorized Testing and Certification Bodies
(ONC-ATCBs) means that EHR vendors can now begin to have their products certified as meeting criteria to support meaningful use, a key step in the national initiative to encourage adoption and effective use of EHRs by America’s health care providers.

“Less than two months following the issuance of final meaningful use rules, we have approved our initial ONC-ATCB certifiers.  EHR vendors can begin immediately to get their products certified.” said David Blumenthal, M.D., national coordinator for Health Information Technology.  This is a crucial step because it ensures that certified EHR products will be available to support the achievement of the required meaningful use objectives, that these products will be aligned with one another on key standards, and that doctors and hospitals can invest with confidence in these certified systems.”

Applications for additional ONC-ATCBs are also under review. 

Certification of EHRs is part of a broad initiative undertaken by Congress and President Obama under the Health Information Technology for Economic and Clinical Health (HITECH) Act, which was part of the American Recovery and Reinvestment Act (ARRA) of 2009.  HITECH created new incentive payment programs to help health providers as they transition from paper-based medical records to EHRs.  Incentive payments totaling as much as $27 billion may be made under the program.

Individual physicians and other eligible professionals can receive up to $44,000 through Medicare and almost $64,000 through Medicaid.  Hospitals can receive millions.

To qualify for the incentive payments, providers must not only adopt, but also demonstrate meaningful use of, certified EHR systems.  The law envisions that defined meaningful use requirements will help ensure that the patient and provider benefits of EHRs are realized.  Initial meaningful use criteria were defined in a final rule issued by the Centers for Medicare & Medicaid Services (CMS) on July 28.

In addition to the CMS rule, ONC also issued standards and certification criteria for EHRs on July 28, aimed at ensuring that EHR systems will support the specific tasks required under meaningful use.  Also, through regulations issued on June 24, ONC created a system by which technology review organizations could also qualify as ONC- ATCBs that will certify EHR products as meeting the requirements necessary for meaningful use. 

With the initial two ONC-ATCBs now named, EHR vendors can apply to them for certification of their products.  By purchasing certified products, providers will have assurance that the products will support achievement of the meaningful use objectives.

“Multiple steps are underway to carry out the intent of Congress in supporting rapid and effective adoption of EHRs throughout our health care system,” Dr. Blumenthal said.  “The naming of initial ONC-ATCBs is one important step.  Actual certification of multiple vendors’ systems by the ONC-ATCBs is an important next step.  CMS is also working to create an online system for providers to register and attest for the EHR incentive programs. The first incentive payments are targeted to be made in May 2011.  Meanwhile, ONC is also carrying out new programs of technical assistance and training, especially for smaller hospitals and physician practices.”

Dr. Blumenthal said the Health IT initiative “is on an aggressive schedule to meet the urgent targets set by Congress and the President toward realizing the quality and safety improvements that we can achieve through health information technology.”

To learn more about the ONC-ATCBs named today visit http://www.cchit.org  and http://www.drummondgroup.com/.  

For more information about the ONC certification programs visit http://healthit.hhs.gov/certification.

For more information about other HHS Recovery Act Health Information Technology funding and programs, visit

http://www.hhs.gov/recovery/programs/index.html#Health.    

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ONC-Authorized Testing and Certification Bodies
Excerpted from ONC site on 8/30/2010

The following organizations have been selected as ONC-Authorized Testing and Certification Bodies (ATCBs):

Certification by an ATCB will signify to eligible professionals, hospitals, and critical access hospitals that an EHR technology has the capabilities necessary to support their efforts to meet the goals and objectives of meaningful use.

Learn more about ONC-ATCBs:

ONC Site Map Updated in Conjunction with New Health IT Unified Theme

“Connecting America for Better Health” – ONC for HIT
Web Site Map for Office of the National Coordinator for Health IT
On August 27, 2010, the Office of National Coordinator (ONC) for Health IT announced a new “unified identity for Health IT”  which includes a “new theme and visual identity” for the ONC Web site and ONC and can be seen at the top of ONC Web pages.

The site map below for  ONC’s Web site is pulled primarily from the left navigation bar on the ONC site with some additional links to key areas. [Please send any corrections or comments to e-Healthcare Marketing. This is an update to a previous site map posted on February 16, 2010 on e-Healthcare Marketing, including new workgroups.]

While the visible structure of the Web site remains mainly the same, the home page and much of the underlying architecture appears to have been updated to simplify access to users, highlight new and important content, and simplify the addition of new information anticipated to come soon, such as announcements of the  Authorized Testing and Certification Bodies (ATCB) and Certified EHRs and EHR Modules.

The new theme and identity ”really captures the spirit of these combined efforts to boost national adoption of electronic health records and ensure success. The insignia will also help people easily identify and connect with official HITECH information, resources, programs, and partners,” wrote Communucations Director Peter Garrett on the Health IT Buzz blog on August 27, 2010. Now to the site map.

DERIVED SITE MAP FOR  http://healthit.hhs.gov

FEATURED AREAS
          Meaningful Use
          Certification Program
          Privacy and Security
          HITECH Programs
          On the Frontlines of Health Information Technology
               NEJM Articles: Dr. Blumenthal
                                             Dr. Benjamin
          Federal Advisory Committees

Top Banner Links
          Get email updates from ONC
          Follow ONC on Twitter

HITECH & FUNDING Opportunities
          Contract Opportunities
          Learn about HITECH
          HIT Extension Program — Regional Extension Centers Program
          Beacon Community Program

HITECH PROGRAMS
     State Health Information Exchange Cooperative Agreement Program
     Health Information Technology Extension Program
     Strategic Health IT Advanced Research Projects (SHARP) Program
     Community College Consortia to Educate HIT Professionals Program
     Curriculum Development Centers Program
     Program of Assistance for University-Based Training
     Competency Examination Program
     Beacon Community Program

FEDERAL ADVISORY COMMITTEES
                  (Meeting Calendar At-A-Glance)

HEALTH IT POLICY COMMITTEE
HIT Policy Committee Meetings
          Meeting Webcast & Participation
         
Upcoming Meetings
         
Past Meetings
HIT Policy Committee Recommendations
HIT Policy Committee Workgroups
          Meaningful Use
          Certification/Adoption
          Information Exchange
          Nationwide Health Information Network (NHIN)
          Strategic Planning
          Privacy & Security Policy
          Enrollment
          Privacy & Security Tiger Team
          Governance
          Quality Measures

HEALTH IT STANDARDS COMMITTEE
Health IT Standards Committee Meetings
          Meeting Webcast & Participation
         
Upcoming Meetings
         
Past Meetings
HIT Standards Committee Recommendations
HIT Standards Committee Workgroups
          Clinical Operations
          Clinical Quality
          Privacy & Security
          Implementation
          Vocabulary Task Force
          

REGULATIONS & GUIDANCE     
           Meaningful Use
           Privacy and Security
           Standards and Certification
            
ONC INITIATIVES
          State-Level Health Initiatives 
          Nationwide Health Information Network
          Federal Health Architecture
          Adoption
          Clinical Decision Support & the CDS Collaboratory
         
          Events
                 FACA Meeting Calendar
          Fact Sheets
          Reports
          Federal Health IT Programs
          Technical Expert Workshops
          Acronyms
          Glossary

OUTREACH, EVENTS, & RESOURCES
         News Releases (2007 – Present)
         Events
         FACA Meeting Calendar
         Fact Sheets
         Reports 
         Federal Health IT Programs
         Technical Expert Workshops
         Acronyms 
         Glossary

ABOUT ONC
          Coordinator’s Corner: Updates from Dr. Blumenthal
          Organization               
          Budget & Performance
          Contact ONC and Job Openings
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For a review of the new look and feel of the ONC site, see an earlier post on e-Healthcare Marketing.

ONC’s Mohla Blogs on Community College Classes for Health IT Workforce Transformation

Health IT: Coming Soon to a Class Near You
Wednesday, August 25th, 2010 | Posted by: Chitra Mohla, Director of the Community College Workforce Program, Office of the National Coordinator for Health IT on ONC’s Health IT Buzz blog and republished here by e-Healthcare Marketing.

The HITECH Act is about more than putting computers on the desks of physicians nationwide. It’s about using health information technology (IT) to improve the safety, quality, and effectiveness of our health care system. That takes more than computers. It takes qualified, trained people who are willing to work together toward that goal.

In fact, one of the barriers to the widespread adoption of health IT has been a shortage of qualified workers who can help the nation’s health care providers make the transition.  The current push for greater adoption of health IT will create even more jobs that need to be filled by qualified workers.

To address the workforce shortage, the HITECH Act authorized the creation of a program to assist in the establishment and/or expansion of programs to train a skilled workforce to facilitate the adoption and meaningful use of electronic health records (EHRs).  The Community College Consortia to Educate Health Information Professionals is designed to train “health IT practitioners” who can meet the needs of hospitals and physicians as they move to an electronic health care system.  EHR vendors and public health facilities will also have jobs that these professionals can fill.

Five community college consortia were funded to implement the training programs. The goal of the programs is to train 10,500 people a year in six workforce roles. The five consortia include 84 community colleges.  Each regional consortium is led by a lead community college that is responsible for the coordination of the program in the region.

The community colleges will offer six-month non-degree programs for people already involved in the health care or information technology fields so they can quickly learn the skills necessary to ensure the rapid and effective adoption of health IT. Courses will be available both at the colleges and through distance learning. Each student will receive an institutional certificate or equivalent for successfully completing the program. In some cases, financial assistance may be available to enable students to take advantage of this opportunity. In six months or less, qualified applicants can be ready for jobs in the growing area of health IT. The colleges will help students who complete the program find jobs in their new fields.

I’m pleased to announce that, just in time for the coming school year, the curricula are developed, and community colleges across the country are staffing up and recruiting students for the first wave of classes. We expect classes to start by September 30 in most of the colleges. That means the time to apply is now.

The six workforce roles for which students can train are:

  • Practice workflow and information management redesign specialists: The goal of health IT is to improve processes, not just computerize them. An essential part of the transition will be to assess workflows in a practice, suggest changes to increase the quality and efficiency of care and facilitate reporting, and work with providers to implement these changes. These jobs are well-suited for people with experience in practice management or IT in a clinical setting.
  • Clinician/practitioner consultants: The colleges will offer programs for licensed health professionals so that they can apply their specialized clinical knowledge to selecting hardware/software, working with vendors, and ensuring that clinical goals are met.
  • Implementation support specialists: Specialists will be needed to install and test health IT systems in clinical settings to ensure that the systems are easy and effective to use. The Community College Consortia will provide training for those who have IT or information management experience but not necessarily in the health care arena.
  • Implementation managers: Those who have administrative or managerial experience in health or IT environments may seek additional training to oversee and manage the transition to health IT for providers.
  • Technical/software support: Providers will need ongoing support to diagnose IT problems, develop solutions, and keep systems running smoothly and securely. Those with IT or information management experience may want to train for these positions.
  • Trainers: The need for skilled trainers will be ongoing. Practice staff will have to be trained on new systems and upgrades. And new staff will have to be trained as they come onboard. IT specialists with training experience can receive instruction in the design and delivery of training programs.

We at ONC are excited about the potential of the Community College Consortia – for the students who will train for promising new careers, for the health care providers who will have qualified staff to guide them through the transition to health IT, and for all the patients who stand to benefit from the increased quality, safety and effectiveness of care made possible by digital information technology.

To learn more, contact the consortium leader for your geographical area.
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To comment on the ONC Health IT Buzz log post directly, click here.

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Privacy and Security Tiger Team’s Recommendations in Full Text

Health IT Policy Committee Approves Tiger Team Recommendations
Mary Mosquera reported in Government HealthIT reported on August 20, 2010
“The Health & Human Services Department Health IT Policy Committee endorsed a set of recommendations on when health care providers must obtain consent before exchanging patient heath records electronically with other clinicians, testing labs or health information exchange (HIE) networks.”

Here’s the full-text version of the Tiger Team’s recommendations to the Health IT Policy Committee, which the committee approved and sent on to the Office of the National Coordinator (ONC) for Health IT.
PDF Version
HTML Version below:

August 19, 2010

David Blumenthal, MD, MPP
Chair, HIT Policy Committee
U.S. Department of Health and Human Services
Washington, D.C. 20201

Dear Mr. Chairman:

An important strategic goal of the Office of the National Coordinator (ONC) is to build public trust and participation in health information technology (IT) and electronic health information exchange by incorporating effective privacy and security into every phase of health IT development, adoption, and use.

A Privacy and Security “Tiger Team,” formed under the auspices of the HIT Policy Committee, has met regularly and intensely since June to consider how to achieve important aspects of this goal.

The Tiger Team has focused on a set of targeted questions raised by the ONC regarding the exchange of personally identifiable health information required for doctors and hospitals to qualify for incentive payments under Stage I of the Electronic Health Records Incentives Program.

This letter details the Tiger Teamʼs initial set of draft recommendations for the HIT Policy Committeeʼs review and approval.

Throughout the process, the HIT Policy Committee has supported  the overall direction of the Tiger Teamʼs evolving recommendations, which have been discussed in presentations during regular Policy Committee meetings this summer. There has always been an understanding, however, that the Tiger Team would refine its work and compile a set of formal recommendations at the end of summer for the HIT Policy Committeeʼs final review and approval.

It bears repeating: The following recommendations apply to electronic exchange of patient identifiable health information among known entities to meet Stage I of “meaningful use — the requirements by which health care providers and hospitals will be eligible for financial incentives for using health information technology. This includes the exchange of information for treatment and care coordination, certain quality reporting to the Centers for Medicare & Medicaid Services (CMS), and certain public health reporting.

Additional work is needed to apply even this set of initial recommendations specifically to other exchange circumstances, such as exchanging data with patients and sharing information for research. We hope we will be able to address these and other key questions in the months to come.

Most importantly, the Tiger Team recommends an ongoing approach to privacy and security that is comprehensive and firmly guided by fair information practices, a well-established rubric in law and policy. We understand the need to address ad hoc questions within compressed implementation time frames, given the statutory deadlines of the EHR Incentives Program. However, ONC must apply the full set of fair information practices as an overarching framework to reach its goal of increasing public participation and trust in health IT.

I. FAIR INFORMATION PRACTICES AS THE FOUNDATION
Core Tiger Team Recommendation:
All entities involved in health information exchange – including providers (1)
and third party service providers like Health Information Organizations (HIOs) and other intermediaries – should follow the full complement of fair information practices when handling personally identifiable health information.

Fair information practices, or FIPs, form the basis of information laws and policies in the United States and globally. This overarching set of principles, when taken together, constitute good data stewardship and form a foundation of public trust in the collection, access, use, and disclosure of personal information.

We used the formulation of FIPs endorsed by the HIT Policy Committee and adopted by ONC in the Nationwide Privacy and Security Framework for Electronic Exchange of Individually Identifiable Health Information. (2)  The principles in the Nationwide Framework are:
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(1) Our recommendations are intended to broadly apply to both individual and institutional providers.
(2) http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_
0_10731_848088_0_0_18/NationwidePS_Framework-5.pdf

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            • Individual Access – Individuals should be provided with a simple and timely means to access and obtain their individually identifiable health information in a readable form and format.           

            • Correction – Individuals should be provided with a timely means to dispute the  accuracy or integrity of their individually identifiable health information, and to have  erroneous information corrected or to have a dispute documented if their requests are denied.           

            • Openness and Transparency – There should be openness and transparency    about policies, procedures, and technologies that directly affect individuals and/or their individually identifiable health information.           

            • Individual Choice – Individuals should be provided a reasonable opportunity and  capability to make informed decisions about the collection, use, and disclosure of  their individually identifiable health information. (This is commonly referred to as the individualʼs right to consent to identifiable health information exchange.)          

            • Collection, Use, and Disclosure Limitation – Individually identifiable health      information should be collected, used, and/or disclosed only to the extent necessary         to accomplish a specified purpose(s) and never to discriminate inappropriately.           

            • Data Quality and Integrity – Persons and entities should take reasonable steps to         ensure that individually identifiable health information is complete, accurate, and up-    to-date to the extent necessary for the personʼs or entityʼs intended purposes and     has not been altered or destroyed in an unauthorized manner.          

            • Safeguards – Individually identifiable health information should be protected with           reasonable administrative, technical, and physical safeguards to ensure its  confidentiality, integrity, and availability and to prevent unauthorized or inappropriate   access, use, or disclosure.           

            • Accountability – These principles should be implemented, and adherence  assured, through appropriate monitoring and other means and methods should be in   place to report and mitigate non-adherence and breaches.

The concept of remedies or redress — policies formulated in advance to address situations where information is breached, used, or disclosed improperly — is not expressly set forth in this list (although it is implicit in the principle of accountability). As our work evolves toward a full complement of privacy policies and practices, we believe it will be important to further spell out remedies as an added component of FIPs.

We also note that in a digital environment, robust privacy and security policies should be bolstered by innovative technological solutions that can enhance our ability to protect information. This includes requiring that electronic record systems adopt adequate security protections (like encryption, audit trails, and access controls), but it also extends to decisions about infrastructure and how health information exchange will occur, as well as how consumer consents will be represented and implemented. The Tiger Teamʼs future work will need to address the role of technology in protecting privacy and security.

 II. CORE VALUES  

In addition to a firm embrace of FIPs, the Tiger Team offers the following set of Core Values to guide ONCʼs work to promote health information technology:

             • The relationship between the patient and his or her health care  provider isthe foundation for trust in health information exchange, particularly with  respect to protecting the confidentiality of personal health information.           

             • As key agents of trust for patients, providers are responsible for  maintaining the privacy and security of their patientsʼ records.           

              • We must consider patient needs and expectations. Patients should not  be surprised about or harmed by collections, uses, or disclosures of  their  information.Ultimately, to be successful in the use of health information exchange  to  improve health and health care, we need to earn the trust of both consumers    and physicians.

III. SPECIFIC RECOMMENDATIONS REQUESTED

ONC has asked the Tiger Team for specific recommendations in the following areas:

            • Use of intermediaries or third party service providers in identifiable health  information exchange;

            • Trust framework to allow exchange among providers for purpose of treating  patients;

            • Ability of the patient to consent to participation in identifiable health information  exchange at a general level (i.e., yes or no), and how consent should be  implemented;

            • The ability of technology to support more granular patient consents (i.e., authorizing  exchange of specific pieces of information while excluding other records); and

            • Additional recommendations with respect to exchange for Stage I of Meaningful Use – treatment, quality reporting, and public health reporting.

All of our recommendations and deliberations have assumed that participating individuals and entities are in compliance with applicable federal and state privacy and security laws.

We evaluated these questions in light of FIPs and the core values discussed above.

1.    Policies Regarding the Use of Intermediaries/Third Party Service Providers/ Health Information Organizations (HIOs)

In the original deliberations of the Privacy and Security Work Group of the HIT Policy Committee, we concluded that directed exchange among a patientʼs treating providers – the sending of personally identifiable health information from “provider A to provider B” – is generally consistent with patient expectations and raises fewer privacy concerns, assuming that the information is sent securely.

However, the Tiger Team recognized that a number of exchange models currently in use are known to involve the use of intermediaries or third party organizations that offer valuable services to providers that often facilitate the effective exchange of identifiable health information (“third party service organizations”). A common example of a third party service organization is a Health Information Organization (HIO) (as distinguished from the term “health information exchange” (HIE), which can be used to refer to information exchange as a verb or a noun.) The exposure of a patientʼs personally identifiable health information to third party service organization raises risk of disclosure and misuse, particularly in the absence of clear policies regarding that organizationʼs right to store, use, manipulate, re-use or re-disclose information.

Our recommendations below regarding third party service organizations aim to address the following fair information practices:           

             Individual Access
            Correction
✔        Openness and Transparency 
            Individual Choice
✔        Collection, Use, and Disclosure Limitation
             
Data Quality and Integrity Safeguards
✔        Accountability

Tiger Team Recommendation 1: With respect to third-party service organizations:

                    Collection, Use and Disclosure Limitation: Third party service organizations   may not collect, use or disclose personally identifiable health information for   any purpose other than to provide the services specified in the business   associate or service agreement with the data provider, and necessary  administrative functions, or as required by law.

                      Time limitation: Third party service organizations may retain personally identifiable health information only for as long as reasonably necessary to  perform the functions specified in the business associate or service agreement  with the data provider, and necessary administrative functions.

                        Retention policies for personally identifiable health information must be established,   clearly disclosed to customers, and overseen. Such data must besecurely returned or destroyed at the end of the specified retention period, according to established NIST standards and conditions set forth in the business associate or service agreement.

                      Openness and transparency: Third party service organizations should be obligated to disclose in their business associate or service agreements with  their customers how they use and disclose information, including without   limitation their use and disclosure of de-identified data, their retention policies   and procedures, and their data security practices.(3)

            • Accountability: When such third party service organizations have access to  personally identifiable health information, they must execute and be bound by  business associate agreements under the Health Insurance Portability and   Accountability Act regulations (HIPAA). (4) However, itʼs not clear that those agreements have historically been sufficiently effective in limiting a third-partyʼs use or disclosure of identifiable information, or in providing the required transparency.

               • While significant strides have been made to clarify how business associates  may access, use and disclose information received from a covered entity, business associate agreements, by themselves, do  not address the full complement of governance issues, including oversight,
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(3) This is the sole recommendation in this letter that also applies to data that qualifies as de-identified under HIPAA. The “Tiger Team” intends to take up de-identified data in a more comprehensive way in subsequent months.
(4)  45 CFR 164.504(e).
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accountability, and enforcement. We recommend that the HIT Policy  Committee oversee further work on these governance issues.

2. Trust Framework For Exchange Among Providers for Treatment

The issue of provider identity and authentication is at the heart of even the most basic exchange of personally identifiable health information among providers for purposes of a patientʼs treatment. To an acceptable level of accuracy, Provider A must be assured that the information intended for provider B is in fact being sent to provider B; that providers on both ends of the transaction have a treatment relationship with the subject of the information; and that both ends are complying with baseline privacy and security policies, including applicable law.

Our recommendations below regarding trusted credentialing aim to address the following fair information practices:
           
Individual Access Correction
✔        Openness and Transparency 
            Individual Choice Collection, Use, and Disclosure Limitation
✔        Data Quality and Integrity 
            Safeguards    
✔        Accountability

 Tiger Team Recommendation 2.1:

            • Accountability: The responsibility for maintaining the privacy and security of        a patientʼs record rests with the patientʼs providers, who may delegate    functions such as issuing digital credentials or verifying provider identity, as  long as such delegation maintains this trust.  

                        o To provide physicians, hospitals, and the public with an acceptable  level of accuracy and assurance that this credentialing responsibility is  being delegated to a “trustworthy” organization, the federal government   (ONC) has a role in establishing and enforcing clear requirements about     the credentialing process, which must include a requirement to validate   the identity of the organization or individual requesting a credential.

                         o State governments can, at their option, also provide additional rules  for credentialing service providers so long as they meet minimum  federal requirements.  

We believe further work is necessary to develop policies defining the appropriate level of assurance for credentialing functions, and we hope to turn to this work in the fall. A trust framework for provider-to-provider exchange also must provide guidance on acceptable levels of accuracy for determining whether both the sending and receiving provider each have a treatment relationship with the person who is the subject of the information being exchanged. Further, the trust framework should require transparency as to whether both senders and recipients are subject to baseline privacy and security policies. We offer the following recommendations on these points:

Tiger Team Recommendation 2.2:  

Openness and transparency: The requesting provider, at a minimum, should provide attestation of his or her treatment relationship with the individual who is subject of the health information exchange.  

Accountability: Providers who exchange personally identifiable health information should comply with applicable state and federal privacy and security rules. If a provider is not a HIPAA-covered entity or business associate, mechanisms to secure enforcement and accountability may include:  

o Meaningful user criteria that require agreement to comply with the HIPAA Privacy and Security Rules;  

o NHIN conditions of participation;  

o Federal funding conditions for other ONC and CMS programs; and  

o Contracts/Business Associate agreements that hold all participants to HIPAA, state laws, and any other policy requirements (such as those that might be established as the terms of participation).

Openness and transparency: Requesting providers who are not covered by HIPAA should disclose this to the disclosing provider before patient information is exchanged.  

3.    Right of the patient or provider to consent to identifiable health information       exchange at a general level — and how are such consents implemented

The Tiger Team was asked to examine the role that one of the fair information practices – individual choice or patient consent – should play in health information exchange. The recommendations cover the role of consent in directed exchange, triggers for when patient consent should be required (beyond what may already be required by law), the form of consent, and how consent is implemented. We also set forth recommendations on whether providers should be required to participate in certain forms of exchange. We must emphasize that looking at one element of FIPs in isolation is not optimal and our deliberations have assumed strong policies and practices in the other elements of FIPs required to support the role of individual consent in protecting privacy. 

            Our recommendations below regarding patient consent aim to address the following fair information practices:

            Individual Access 
  
          Correction            
            Openness and Transparency
✔        Individual Choice
          
Collection, Use, and Disclosure Limitation
         
 Data Quality and Integrity  
           Safeguards 
           Accountability

 A.   Consent and Directed Exchange

 Tiger Team Recommendation 3.1:

            • Assuming FIPs are followed, directed exchange for treatment does not  require patient consent beyond what is required in current law or what has been customary practice.

 Our recommendation about directed exchange is not intended to change the patient-provider relationship or the importance of the providerʼs judgment in evaluating which parts of the patient record are appropriate to exchange for a given purpose. The same considerations and customary practices that apply to paper or fax exchange of patient health information should apply to direct electronic exchange. As always, providers should be prepared and willing to discuss with patients how their information is disclosed; to take into account patientsʼ concerns for privacy; and also ensure the patient understands the information the receiving provider or clinician will likely need in order to provide safe, effective care.

B. Trigger for Additional Patient Consent
     Tiger Team Recommendation 3.2: 
 

      •     When the decision to disclose or exchange the patientʼs identifiable health  information from the providerʼs record is not in the control of the provider or  that providerʼs organized health care arrangement (“OHCA”), (5) patients   should be able to exercise meaningful consent to their participation. ONC    should promote this policy through all of its levers.  

            •   Examples of this include:  

                        o A health information organization operates as a centralized model, which retains identifiable patient data and makes that information available to other parties.  

                        o A health information organization operates as a federated model and                                 exercises control over the ability to access individual patient data.            

                        o Information is aggregated outside the auspices of the provider or OHCA and comingled with information about the patient from other    sources.
___________________________
(5)
Organized health care arrangement (45 CFR 160.103) means: (1) A clinically integrated care setting in which individuals typically receive health care from more than one health care provider; (2) An organized system of health care in which more than one covered entity participates and in which the participating covered entities: (i) Hold themselves out to the public as participating in a joint arrangement; and (ii) Participate in joint activities that include at least one of the following: (A) Utilization review, in which health care decisions by participating covered entities are reviewed by other participating covered entities or by a third party on their behalf; (B) Quality assessment and improvement activities, in which treatment provided by participating covered entities is assessed by other participating covered entities or by a third party on their behalf; or (C) Payment activities, if the financial risk for delivering health care is shared, in part or in whole, by participating covered entities through the joint arrangement and if protected health information created or received by a covered entity is reviewed by other participating covered entities or by a third party on their behalf for the purpose of administering the sharing of financial risk. [provisions applicable to health plans omitted]
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             • As we have noted previously, the above recommendation on consent applies  to Stage 1 Meaningful Use (thus, if consent applies, it applies to exchange for    treatment). We will need to consider potential additional triggers when we start  to discuss exchange beyond Stage One of Meaningful Use.  

            An important feature of meaningful consent criteria, outlined further below, is  that the patient be provided with an opportunity to give meaningful consent    before the provider releases control over exchange decisions. If the patient does not consent to participate in an HIO model that “triggers” consent, the   provider should, alternatively, exchange information through directed    exchange. There are some HIOs that offer multiple services. The provider may still contract with an HIO to facilitate directed exchange as long as the      arrangement meets the requirements of recommendation 1 of this letter.

C. Form of Consent

Consent in our discussions refers to the process of obtaining permission from an individual to collect, use or disclose her personal information for specified purposes. It is also an opportunity to educate consumers about the decision, its potential benefits, its boundaries, and its risks.

While the debate about consent often devolves into a singularly faceted discussion of opt-in or opt-out, we have come to the conclusion that both opt-in and opt-out can be implemented in ways that fail to permit the patient to give meaningful consent. For example, consider the case in which patients are provided with opt-in consent, but the exercise of consent and education about it are limited – the registration desk provides the patient with a form that broadly describes all HIO uses and disclosures and the patient is asked to check a box and consent to all of it. As another example, consider the case in which patients have a right to opt-out – but the patient is not provided with time to make the decision and information about the right or how to exercise it can only be found in a poster in the providerʼs waiting room or on a page of the HIOʼs website. It would jeopardize the consumer trust necessary for HIOs to succeed to simply provide guidance to use “opt-in” or “opt-out” without providing additional guidance to assure that the consent is meaningful.

Tiger Team Recommendation 3.3: Meaningful Consent Guidance When Trigger Appliesʼs consent is “triggered,” such consent must be meaningful (6) in that it:

In a circumstance where patient

            Allows the individual advanced knowledge/time to make a decision. (e.g., outside of the urgent need for care.)          

            • Is not compelled, or is not used for discriminatory purposes. (e.g., consent to participate in a centralized HIO model or a federated HIO model is not a  condition of receiving necessary medical services.)

            • Provides full transparency and education. (i.e., the individual gets a clear   explanation of the choice and its consequences, in consumer-friendly language that is conspicuous at the decision-making moment.)

            • Is commensurate with the circumstances. (I.e., the more sensitive, personally  exposing, or inscrutable the activity, the more specific the consent   mechanism. Activities that depart significantly from patient reasonable    expectations require greater degree of education, time to make decision,  opportunity to discuss with provider, etc.)

            • Must be consistent with reasonable patient expectations for privacy, health, and safety; and

            • Must be revocable. (i.e., patients should have the ability to change their consent preferences at any time. It should be clearly explained whether such    changes can apply retroactively to data copies already exchanged, or whether  they apply only “going forward.”)

 D. Consent Implementation Guidance

Further considerations for implementation includes the following guidance:

Tiger Team Recommendation 3.4 :

            • Based on our core values, the person who has the direct, treating    relationship with the individual, in most cases the patientʼs provider, holds the    trust relationship and is responsible for educating and discussing with
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(6)
http://www.connectingforhealth.org/phti/reports/cp3.html
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 patients about how information is shared and with whom.            • Such education should include the elements required for meaningful choice, as well as understanding of the “trigger” for consent (i.e., how information is being accessed, used and disclosed).            • The federal government has a significant role to play and a responsibility to educate providers and the public (exercised through policy levers).            • ONC, regional extension centers, and health information organizations  should provide resources to providers, model consent language, and educational materials to demonstrate and implement meaningful choice. HIOs  should also be transparent about their functions/operations to both providers  and patients.            • The provider/provider entity is responsible for obtaining and keeping track of  patient consent (with respect to contribution of information from their records.) However, the provider may delegate the management/administrative functions to a third party (such as an HIO), with appropriate oversight.The Tiger Team was asked whether providers should have a choice about participating in exchange models.

E. Provider Consent to Participate in Exchange

Tiger Team Recommendation 3.5: Yes! Based on the context of Stage I Meaningful Use, which is a voluntary program, ONC is not requiring providers to participate in any particular health information exchange.Our recommendations below regarding granular consent aim to address the           following fair information practices:Individual Access                  
                        Correction
                        Openness and Transparency
           
✔        Individual Choice
                       
Collection, Use, and Disclosure Limitation
                        Data Quality and Integrity
                        Safeguards
                        Accountability
In making recommendations about granular consent and sensitive data, we have the following observations:

4. The current ability of technology to support more granular patient consents.

            • All health information is sensitive, and what patients deem to be sensitive is likely to be dependent on their own circumstances.

            • However, the law recognizes some categories of data as being more sensitive than others.            

            • Unless otherwise required by law and consistent with our previous recommendation 3.1, with respect to directed exchange for treatment, the presence of sensitive data  in the information being exchanged does not trigger an additional requirement to  obtain the patientʼs consent in the course of treating a patient.

            • Our recommendations on consent do not make any assumptions about the capacity for an individual to exercise granular control over their information. But since this capability is emerging and its certainly fulfills the aspiration of individual control, we  sought to understand the issue in greater depth.

            • The Tiger Team considered previous NVHS letters and received a presentation of  current NCVHS efforts on sensitive data. We also held a hearing on this topic to try to understand whether and how current EHR technology supports the ability for patients to make more granular decisions on consent – in particular, to give consent to the providers to transmit only certain parts of their medical record.

            • We learned that many EHR systems have the capability to suppress psychotherapy notes (narrative). We also learned that some vendors offer the individual the ability to suppress specific codes. We believe this is promising. With greater use and demand, this approach could possibly drive further innovations.

            • We also note, however, that the majority of witnesses with direct experience in    offering patients the opportunity for more granular control indicated that most patients (7) agreed to the use of their information generally and did not exercise   granular consent options when offered the opportunity to do so. The Tiger Team also learned that the filtering methodologies are still evolving and improving, but that challenges remain,
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(7) Witnesses offered estimates of greater than 90%.
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 particularly in creating filters that can remove any associated or related information  not traditionally codified in standard or structured ways.

            • While it is common for filtering to be applied to some classes of information by commercial applications based on contractual or legal requirements, we understand that most of the commercial EHR systems today do not provide this filtering capability at the individual patient level. There are some that have the capability to allow the user to set access controls by episode of care/encounter/location of  encounter, but assuring the suppression of all information generated from a particular episode (such as prescription information) is challenging.

            • Preventing what may be a downstream clinical inference is clearly a remaining   challenge and beyond the state of the art today. Even with the best filtering it is hard to guarantee against “leaks.”

            • The Tiger Team believes that methodologies and technologies that provide filtering capability are important in advancing trust and should be further explored. There are several efforts currently being piloted in various stages of development. We believe   communicating with patients about these capabilities today still requires a degree of  caution and should not be over sold as fail-proof, particularly in light of the reality of             downstream inferences and the current state of the art with respect to free text.    Further, communicating to patients the potential implications of fine-grained filtering  on care quality remains a challenge.

            • We acknowledge that even in the absence of these technologies, in very sensitive cases there are instances where a completely separate record may be maintained and not released (abortion, substance abuse treatment, for example). It is likely that  these practices will continue in ways that meet the expectations and needs of  providers and patients.

            • In our ongoing deliberations, we discussed the notion of consent being bound to the data such that it follows the information as it flows across entities. We know of no    successful large-scale implementation of this concept in any other sector (in that it achieved the desired objective), including in the case of digital rights management   (DRM) for music. Nonetheless, we understand that work is being done in this emerging area of technology, including by standards organizations.

            • While popular social networking sites are exploring allowing users more granular control (such as Facebook), the ability of individuals to exercise this capability as     intended is still unclear.(8) In addition, the data that
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(8) See http://www.nytimes.com/2010/05/13/technology/personaltech/13basics.html  and http://www.nytimes.com/interactive/2010/05/12/business/facebook-privacy.html .
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                        populates a Facebook account is under the userʼs control and the user has unilateral access to it. Health data is generated and stored by myriad of entities in addition to the patient.

            • Even the best models of PHRs or medical record banks provide individuals with control over copies of the individualʼs information. They do not provide control over the copy of the information under the providerʼs control or that is generated as a part of providing care to the patient. They also do not control the flow of information once    the patient has released it or allowed another entity to have access to it.

            • Discussions about possible or potential future solutions were plentiful in our deliberations. But the Tiger Team believes that solutions must be generated out of  further innovation and, critically, testing of implementation experience.

            • The Tiger Team also considered previous NCVHS letters and received a presentation of current NCVHS efforts on sensitive data.

            • The Tiger Team therefore asked whether and what actions ONC might take to stimulate innovation and generate more experience about how best to enable patients to make more granular  consent decisions.

Tiger Team Recommendation 4: Granular ConsentThe technology for supporting more granular patient consent is promising  but is still in the early stages of development and adoption. Furthering   experience and stimulating innovation for granular consent are needed.This is an area that should be a priority for ONC to explore further, with a wide vision for possible approaches to providing patients more granular  control over the exchange and use of their identifiable health information, while also considering implications for quality of care and patient safety, patient educational needs, and operational implications.The goal in any related endeavor that ONC undertakes should not be a search for possible or theoretical solutions but rather to find evidence (such as through pilots) for models that have been implemented successfully and in   ways that can be demonstrated to be used by patients and fulfill their expectations. ONC and its policy advising bodies should be tracking this issue in an ongoing way and seeking lessons learned from the field as health information exchange matures.

            • In the interim, and in situations where these technical capabilities are being developed and not uniformly applied, patient education is  paramount: Patients must understand the implications of their decisions and the extent to which their requests can be honored, and we  encourage setting realistic expectations. This education has implications for providers but also for HIOs and government.                       Our additional recommendations below regarding Stage 1 of Meaningful Use aim to address the following fair information practices:
                       
Individual Access
                        Correction
                        Openness and Transparency
           
✔        Individual Choice
           
✔        Collection, Use, and Disclosure Limitation
                         
Data Quality and Integrity
                        Safeguards
                        Accountability
Tiger Team Recommendation 5:

5. Exchange for Stage 1 of Meaningful Use – Treatment, Quality reporting, Public health reporting

                      • Individual Consent: The exchange of identifiable health information for “treatment” should be limited to treatment of the individual who is the subject of the information, unless the provider has the consent of the subject individual to access, use, exchange or disclose his or her  information to treat others. (We note that this recommendation may  need to be further refined to ensure the appropriate care of infants or  children when a parentʼs or other family members information is needed to provide treatment and it is not possible or practical to obtain even a general oral assent to use a parentʼs information.)Collection, Use and Disclosure Limitation: Public health reporting by providers (or HIOs acting on their behalf) should take place using the least amount of identifiable data necessary to fulfill the lawful public  health purpose for which the information is being sought. Providers   should account for disclosure per existing law. More sensitive identifiable data should be subject to higher levels of protection.  
                        o In cases where the law requires the reporting of identifiable data (or where identifiable data is needed to accomplish the  lawful public health purpose for which the information is sought),                                    identifiable data may be sent. Techniques that avoid identification, including pseudonymization, should be considered, as appropriate.

            • Collection, use and Disclosure Limitation: Quality data reporting by providers (or HIOs acting on their behalf) should take place using the least amount of identifiable data necessary to fulfill the purpose for which the information is being sought. Providers should account for disclosure. More  sensitive identifiable data should be subject to higher levels of protection.

            • The provider is responsible for disclosures from records under its control, but    may delegate lawful quality or public health reporting to an HIO (pursuant to a business associate agreement) to perform on the  providerʼs behalf; such delegation may be on a “per request” basis or  may be a more general delegation to respond to all lawful requests.

IV. CONCLUSION

The foregoing recommendations were targeted to address set of questions raised by ONC. They should not be taken as the definitive or final word on privacy and security and health IT/health information exchange; they are instead a set of concrete steps that the Tiger Team believes are critical to establishing and maintaining trust. As we have said from the outset, these recommendations can only deliver the trust necessary when they are combined with the full implementation of all the FIPs. Only a systemic and comprehensive approach to privacy and security can achieve confidence among the public. In particular, our recommendations do not address directly the need to also establish individual access, correction and safeguards capabilities, and we recommend these be considered closely in the very near future, in conjunction with a further detailed assessment of how the other FIPs are being implemented.

We look forward to continuing to work on these issues.

Sincerely,
Deven McGraw Chair
Paul Egerman Co-Chair

Appendix A—Tiger Team Members
Deven McGraw, Chair, Center for Democracy & Technology
Paul Egerman, Co-Chair
Dixie Baker, SAIC
Rachel Block, NYS Department of Health
Carol Diamond, Markle Foundation
Judy Faulkner, EPIC Systems Corp.
Gayle Harrell, Consumer Representative/Florida
John Houston, University of Pittsburgh Medical Center; NCVHS
David Lansky, Pacific Business Group on Health
David McCallie, Cerner Corp.
Wes Rishel, Gartner
Latanya Sweeney, Carnegie Mellon University
Micky Tripathi, Massachusetts eHealth Collaborative

ONC Launches SHARP Web site for Strategic Health IT Advanced Research Projects

ONC Launches SHARP Web site for Research Programs
The Office of National Coordinator for Health IT launched its new Web site area on August 20, 2010 for the four research initiatives within the Strategic Health IT Advanced Research Projects Program  overseen by Wil Yu, Special Assistant of Innovations and Research, who  serves as Senior Project Officer for SHARP program.

SHARP Overview

SHARP Overview

Excerpted from ONC Site on August 21, 2010:

“SHARP awardees are currently conducting research along the following areas:

“AREA ONE: Security and Health Information Technology – The University of Illinois at Urbana-Champaign is helping develop technologies and policy recommendations that reduce privacy and security risks and increase public trust.

“AREA TWO: Patient-Centered Cognitive Support – Innovative cognitive research is being led by the University of Texas, Houston to harness the power of health IT to integrate and support physician reasoning and decision-making as providers care for patients.

“AREA THREE: Health Care Application and Network Design – Harvard University is leading platform based research to create new and improved system designs that facilitate information exchange while ensuring the accuracy, privacy, and security of electronic health information.

“AREA FOUR: Secondary Use of EHR Information – Mayo Clinic of Medicine is developing strategies to improve the overall quality of healthcare by leveraging existing EHR data to generate new, environmentally appropriate, best practice suggestions.”

SHARP Project Officer:
Wil Yu, Special Assistant, Innovations
ONC, Office of the Chief Scientist

Resources:
Facts-At-A-Glance
Frequently Asked Questions
Original Funding Announcement

Direct Links to Programs
Security and Health Information Technology:  http://sharps.org
Patient-Centered Cognitive Support: http://sharpc.org
Health Care Application and Network Design: .http://www.smartplatforms.org
Secondary Use of EHR Information: http://sharpn.org/
#                     #                  #

For more on project officer Wil Yu, see e-Healthcare Marketing blog.

Previous e-Healthcare Marketing posts on SHARP Program:
June 7, 2010: Updates on ONC’s SHARP — Strategic Healthcare IT Advanced Research Projects
April 7, 2010: Blumenthal Letter #11: Research and Innovation that Translates to Practice–SHARP Grants  includes Health IT Buzz Blog Post from Dr. Charles Friedman, Chief Scientific Officer, ONC: “SHARP: Confronting IT Challenges Head-on and Investing in the Future of Health Care”

CMS: 52 FAQs on Electronic Health Record Incentive Program

CMS Health IT Incentives: 52 Frequently Asked Questions

Please be advised that these FAQs were generated and excerpted from a database that is updated frequently by the Centers for Medicare and Medicaid Services (CMS).
For the most up-to-date official CMS information, please visit http://questions.cms.hhs.gov or click here to get the latest CMS FAQs on the Electronic Health Records Incentive Program. To get the latest answer on a specific question below, go to either of the links in the previous sentence, use the search box labelled “Find the answer to  your question” located just above the FAQs, type in the four digits only of the “Answer #”, and click “Search”. The general CMS search box does not work the same way.

The url to get the complete list of CMS FAQs on EHR Incentive Program:
http://questions.cms.hhs.gov/app/answers/list/p/21,26,1058
Accessed Date: 8/19/2010

Most of the EHR Incentive FAQs on CMS site included either or both of these links: 
For more information, please visit the Office of the National Coordinator’s website at http://healthit.hhs.gov/certification.
For more information about the Medicare and Medicaid EHR Incentive Program, please visit:  http://www.cms.gov/EHRIncentivePrograms

FAQs on EHR Incentive Program
Question #9814: How will eligible professionals (EPs) and eligible hospitals apply for incentives under the Medicare and Medicaid Electronic Health Record (EHR) Incentive Program?

Answer: Information on registration for EHR incentive programs will be available toward the end of 2010 on our website at http://www.cms.gov/EHRIncentivePrograms . Registration for the Medicare EHR Incentive Program will begin in January 2011 and will be available online. Registration for the Medicaid EHR Incentive Program may also begin in January 2011, but the timing will vary by State.   

Question #9967: Who is responsible for demonstrating meaningful use of certified electronic health record (EHR) technology, the provider or the vendor?

Answer: To receive an EHR incentive payment, the provider (eligible professional (EP), eligible hospital or critical access hospital (CAH)) is responsible for demonstrating meaningful use of certified EHR technology under both the Medicare and Medicaid EHR incentive programs.  

Question #9809: My electronic health record (EHR) system is CCHIT certified, does that mean  it is certified for the Medicare and Medicaid EHR Incentive Programs?

Answer: No. All EHR systems and technology must be certified specifically for this program. Currently, there are no certified EHR products that meet the certification requirements for this program in order to receive an incentive. The Medicare and Medicaid EHR Incentive Programs require the use of certified EHR technology, as established by a new set of standards and certification criteria. Existing EHR technology needs to be certified by an ONC-Authorized Testing and Certification Body (ONC-ATCB) to meet these new criteria in order to qualify for the incentive payments. Through the temporary certification program, new certification bodies will be established to test and certify EHR technology. Upon the “opening” of the certifying bodies, vendors can submit their EHR products to be tested and certified. Hospitals and practices who have developed their own EHR systems or products can also seek to have their existing systems or products tested and certified. Complete EHRs may be certified as well as EHR modules that meet at least one of the certification criteria. Once a product is certified, the name of the product will be published on the ONC web site. It is expected that the first EHRs will be certified and listed on the ONC web site in fall 2010.  

Question #9807: When will CMS begin to pay Medicare and Medicaid EHR incentives to EPs and hospitals (for) the demonstration of meaningful use of certified EHR technology?

Answer: CMS expects that Medicare incentive will begin to be paid in May 2011. Medicaid incentives will be paid by the States and will also begin in 2011 but the timing will vary by State. Under the Medicaid EHR Incentive Program, incentives can also be paid for the adoption, implementation, or upgrade of certified EHR technology.  

Question #9812: What if my electronic health record (EHR) system costs much more than the incentive the government will pay? May I request additional funds?

Answer: The Medicare and Medicaid EHR Incentive Programs provide incentives for the meaningful use of certified EHR technology. Under the Medicaid program, there is also an incentive for the adoption, implementation, or upgrade of certified EHR technology in the first year of participation. The incentives are not a reimbursement of costs, and maximum payments have been set.

Question #9810: What is the maximum incentive an eligible professional (EP) can receive under the Medicaid Electronic Health Record (EHR) Incentive Program?

Answer: EPs who adopt, implement, upgrade, and meaningfully use EHRs can receive a maximum of $63,750 in incentive payments from Medicaid over a six year period (Note: There are special eligibility and payment rules for pediatricians). EPs must begin receiving incentive payments by calendar year 2016.  

Question #9843: Will long term care providers such as nursing homes be eligible for incentive payments under the Medicare and Medicaid Electronic Health Record (EHR) Incentive Program?

Answer: Nursing homes, per se, are not eligible. The following types of institutional providers are eligible for EHR incentive payments under Medicare and/or Medicaid, provided they meet the applicable criteria. Under Medicare, institutional providers eligible for the EHR incentive payments include “subsection (d) hospitals,” as defined under section 1886(d) of the Social Security Act, and critical access hospitals (CAHs). Under Medicaid, institutional providers eligible for the EHR incentive payments are acute care hospitals (which include CAHs and cancer hospitals) and children’s hospitals. However, under Medicare, eligible professionals (EPs) may choose to assign their incentive payments to their employer or entity with which the EP has a contractual arrangement. Under Medicaid, EPs also can choose to assign their incentive payments to their employer or to other state-designated entities. 

Question #9846: If an eligible professional (EPs) is currently receiving an incentive payment for e-prescribing under MIPPA, are they also eligible to receive incentive payments under the Medicare and Medicaid EHR Incentive Program?

Answer: The American Recovery and Reinvestment Act of 2009 specifically states that under the Medicare EHR Incentive Program, EPs cannot receive a payment under both the MIPPA E-Prescribing Incentive Program and the Medicare EHR Incentive Program for the same year. However, EPs may receive payments from both the MIPPA E-Prescribing Incentive Program and the Medicaid EHR Incentive Program for the same year.  

Question #9844: Are physicians who practice in hospital-based ambulatory clinics eligible to receive Medicare or Medicaid EHR incentive payments?

Answer: A hospital-based eligible professional (EP) is defined as an EP who furnishes 90% or more of their services in either inpatient or emergency department of a hospital. Hospital-based EPs do not qualify for Medicare or Medicaid EHR incentive payments.  

Question #9808: Can EPs receive EHR incentive payments from both the Medicare and Medicaid programs?

Answer: Not for the same year. If an EP meets the requirements of both programs, they must choose to receive an EHR incentive payment under either the Medicare program or the Medicaid program. After a payment has been made, the EP may only switch programs once before 2015.

Question #9961: What is the reporting period for EPs participating in the EHR incentive programs?

Answer: For demonstrating meaningful use through both the Medicare and Medicaid EHR Incentive Programs, the EHR reporting period for an EP’s first year is any continuous 90-day period within the calendar year. In subsequent years, the EHR reporting period for EPs is the entire calendar year. Under the Medicaid program, there is also an incentive for the adoption, implementation, or upgrade of certified EHR technology, which does not have a reporting period.  

Question #9811: What is the maximum EHR incentive an EP can earn under Medicare?

Answer: EPs who successfully demonstrate meaningful use certified EHR technology as early as 2011 or 2012 may be eligible for up to $44,000 in Medicare incentive payments spread out over five years. EPs who predominantly furnish services in a Health Professional Shortage Area (HPSA) are eligible for a 10 percent increase in the maximum incentive amount.

Question #9845: Will ambulatory surgical centers be eligible for incentive payments under the Medicare and Medicaid EHR Incentive Program?

Answer: Ambulatory surgical centers are not eligible for EHR incentive payments. The following types of institutional providers are eligible for EHR incentive payments under Medicare and/or Medicaid, provided they meet the applicable criteria. Under Medicare, institutional providers eligible for the EHR incentive payments include “subsection (d) hospitals,” as defined under section 1886(d) of the Social Security Act, and critical access hospitals. Under Medicaid, institutional providers eligible for the EHR incentive payments are acute care hospitals (which include critical access hospitals and cancer hospitals) and children’s hospitals.  

Question #9813: What is the earliest date the payment adjustments will start to be imposed on Medicare EPs and eligible hospitals that do not demonstrate meaningful use of certified electronic health record (EHR) technology?

Answer: Medicare payment adjustments will begin in 2015 for EPs and eligible hospitals that do not demonstrate meaningful use of certified EHR technology. There are no payment adjustments associated with the Medicaid provisions under Section 4201 of the American Recovery and Reinvestment Act of 2009.

Question #9815: How will the public know who has received EHR incentive payments?

Answer: As required by the American Recovery and Reinvestment Act of 2009, CMS will post the names, business addresses, and business phone numbers of all Medicare eligible professionals and hospitals who receive EHR incentive payments. There is no such requirement for CMS to publish information on eligible professionals and hospitals receiving Medicaid EHR incentive payments, though individual States may opt to do so.  

Question #9957:  If an EP meets the criteria for both the Medicare and Medicaid EHR incentive programs, can they choose which program to participate in?

Answer: EPs   Yes. EPs who meet the eligibility requirements for both the Medicare and Medicaid incentive programs must elect the program in which they wish to participate when they register. After the initial designation, EPs can only change their program selection once after they have received payment before 2015.   

Question #9959: What safeguards are in place to ensure that Medicaid EHR incentive payments are used for their intended purpose?

Answer: Like the Medicare EHR incentive program, neither the statute nor the CMS final rule dictate how a Medicaid provider must use their EHR incentive payment. The incentives are not a reimbursement and are at the providers’ discretion, similar to a bonus payment.

Question #9958: Are Medicaid EPs and eligible hospitals subject to payment adjustments or penalties if they do not adopt electronic health record (EHR) technology or fail to demonstrate meaningful use?

Answer: There are no payment adjustments or penalties for Medicaid providers who fail to demonstrate meaningful use.

Question #9962: What is the reporting period for eligible hospitals participating in the Medicare and Medicaid EHR Incentive Program?

Answer: For an eligible hospital or critical access hospital’s first payment year, the EHR reporting period is a continuous 90-day period within a Federal fiscal year. In subsequent years, the EHR reporting period for eligible hospitals and critical access hospitals (CAHs) is the entire Federal fiscal year.

Question #10071: Is the physician the only person who can enter information in the EHR in order to qualify for the Medicare and Medicaid EHR Incentive Programs?

Answer: No. The Final Rule for the Medicare and Medicaid EHR incentive programs, specifies that in order to meet the meaningful use objective for computerized provider order entry (CPOE) for medication orders, any licensed healthcare professional can enter orders into the medical record per state, local, and professional guidelines. The remaining meaningful use objectives do not specify any requirement for who must enter information.

Question #9963: Can hospitals in the U.S. Territories qualify for the Medicare and Medicaid EHR Incentive Program?

Answer: Hospitals in the U.S. Territories cannot receive incentive payments under the Medicare EHR Incentive Program. For the purposes of the Medicare EHR Incentive Program, the Social Security Act defines an eligible hospital as a “subsection (d) hospital” that is located in “one of the fifty States or the District of Columbia.” This does not include hospitals located in the U.S. territories. Therefore, hospitals in the U.S. territories do not qualify for the Medicare EHR Incentive Program. However, under the Medicaid EHR Incentive Program, hospitals located in the U.S. Territories are eligible to participate in the Medicaid incentive program as long as they meet all other eligibility requirements.

Question #10095: What do the numerators and denominators mean in measures that are required to demonstrate meaningful use for the Medicare and Medicaid Electronic Health Record (EHR) Incentive Program?

Answer: There are 16 measures for EPs and 14 measures for eligible hospitals that require the collection of data to calculate a percentage, which will be the basis for determining if the Meaningful Use objective was met according to a minimum threshold for that objective. Objectives requiring a numerator and denominator to generate this calculation are divided into two groups: one where the denominator is based on patients seen or admitted during the EHR reporting period, regardless of whether their records are maintained using certified EHR technology; and a second group where the objective is not relevant to all patients either due to limitations (e.g., recording tobacco use for all patients 13 and older) or because the action related to the objective is not relevant (e.g., transmitting prescriptions electronically). For these objectives, the denominator is based on actions related to patients whose records are maintained using certified EHR technology. This grouping is designed to reduce the burden on providers. Table 3 in the Medicare and Medicaid EHR Incentive programs final rule (FR 75 44376 – 44380) lists measures sorted by the method of measure calculation. To view the final rule, please visit: http://edocket.access.gpo.gov/2010/pdf/2010-17207.pdf .

Question #10084: What is meaningful use, and how does it apply to the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs?

Answer: Under the Health Information Technology for Economic and Clinical Health (HITECH Act), which was enacted under the American Recovery and Reinvestment Act of 2009 (Recovery Act), incentive payments are available to eligible professionals (EPs), critical access hospitals, and eligible hospitals that successfully demonstrate are meaningful use of certified EHR technology. The Recovery Act specifies three main components of meaningful use: The use of a certified EHR in a meaningful manner (e.g.: e-Prescribing); The use of certified EHR technology for electronic exchange of health information to improve quality of health care; The use of certified EHR technology to submit clinical quality and other measures. In the final rule Medicare and Medicaid EHR Incentive Program, CMS has defined stage one of meaningful use. To view the final rule, please visit: http://edocket.access.gpo.gov/2010/pdf/2010-17207.pdf .   

Question #10081: When can I register and where do I register for the Medicare and Medicaid EHR Incentive Programs?

Answer: Hospitals and eligible professionals (EPs) are expected to be able to register for the program in January 2011. The registration process will be the same for the Medicare and Medicaid programs. You will be able to find registration and other program information at http://www.cms.gov/EHRIncentivePrograms  when it becomes available.    

Question #10094: How do I know if my electronic health record (EHR) system is certified? How can I get my EHR system certified?

Answer: Currently, there are no certified EHR products that meet the certification requirements for the Medicare and Medicaid EHR incentive programs..The Medicare and Medicaid EHR Incentive Programs require the use of certified EHR technology, as established by a new set of standards and certification criteria. Existing EHR technology needs to be certified by an ONC-Authorized Testing and Certification Body (ONC-ATCB) to meet these new criteria in order to qualify for the incentive payments. Through the temporary certification program, new certification bodies will be established to test and certify EHR technology. Upon the “opening” of the certifying bodies, vendors can submit their EHR products to be tested and certified. Hospitals and practices who have developed their own EHR systems or products can also seek to have their existing systems or products tested and certified. Complete EHRs may be certified as well as EHR modules that meet at least one of the certification criteria. Once a product is certified, the name of the product will be published on the ONC web site. It is expected that the first EHRs will be certified and listed on the ONC web site in fall 2010.

Question #10083: Do I need to have an EHR system in order to register for the Medicare and Medicaid EHR Incentive Programs?

Answer: You do not need to have a certified EHR in order to register for the Medicare and Medicaid EHR Incentive Programs. However, to receive an incentive payment under the Medicare program, you must attest that you have demonstrated meaningful use of certified EHR technology during the EHR reporting period. For the first year of payment, the EHR reporting period is 90 consecutive days within the calendar year for eligible professionals (EPs) or within the Federal fiscal year for eligible hospitals and critical access hospitals (CAHs). With regard to the Medicaid EHR Incentive program, for the first year of payment, EPs and hospitals must have adopted, implemented, upgraded certified EHR technology before they can receive an EHR incentive payment from the State. As an alternative to demonstrating that they have adopted, implemented or upgraded certified EHR technology, for the first year of payment, the EP or hospital may demonstrate that they are meaningful users of certified EHR technology for the 90-day EHR reporting period.

Question #10076:  In a group practice, will each provider need to demonstrate meaningful use  in order to get Medicare and Medicaid electronic health record (EHR) incentive payments or can meaningful use be calculated or averaged at the group level?

Answer: Yes. Medicare and Medicaid incentive payments are made on a per EP basis, not by practice. Each EP will need to demonstrate the full requirements of meaningful use in order to qualify for the EHR incentive payments. We made this clear in the preamble to the final rule when we declined to adopt alternative means for demonstrating meaningful use on a group-practice level (75 FR 44437). To view the final rule for the Medicare and Medicaid EHR incentive programs, please visit: http://edocket.access.gpo.gov/2010/pdf/2010-17207.pdf .

Question #10068: For EPs who practice in multiple settings, where should EPs base their denominators for meaningful use objectives on the number of unique patients?

Answer: In this case, EPs should base both the numerators and denominators for meaningful use objectives on the number of unique patients in the clinic setting, since this setting is where they are eligible to receive payments from the Medicare and Medicaid EHR Incentive Programs.

Question #10069: Are eligible professionals (EPs) who practice in State Mental Health and Long Term Care Facilities eligible for Medicaid EHR incentive payments  if they meet the eligibility criteria (e.g., patient volume, non-hospital based, certified EHR)?

Answer: The setting in which a physician, nurse practitioner, certified nurse-midwife, or dentist practices is generally irrelevant to determining eligibility for the Medicaid EHR Incentive Program (except for purposes of determining whether an EP can qualify through “needy individual” patient volume). Setting is relevant for physician assistants (PA), as they are eligible only when they are practicing at a Federally Qualified Health Center (FQHC) that is led by a PA or a Rural Health Center (RHC) that is so led. All providers must meet all program requirements prior to receiving an incentive payment (e.g. adopt, implement or meaningfully use certified EHR technology, patient volume, etc.).

Question #10086: Can an EP implement an EHR system and satisfy meaningful use requirements at any time within the calendar year  for the Medicare and Medicaid EHR Incentive Program?

Answer: For a Medicare EP’s first payment year, the EHR reporting period is a continuous 90-day period within a calendar year, so an EP must satisfy the meaningful use requirements for 90 consecutive days within their first year of participating in the program to qualify for an EHR incentive payment. In subsequent years, the EHR reporting period for EPs will be the entire calendar year. With regard to the Medicaid EHR Incentive program, EPs must have adopted, implemented, upgraded, or meaningfully used certified EHR technology during the first calendar year. If the Medicaid EP adopts, implements or upgrades in the first year of payment, and demonstrates meaningful use in the second year of payment, then the EHR reporting period in the second year is a continuous 90-day period within the calendar year; subsequent to that, the EHR reporting period is then the entire calendar year.

Question #10067: Do controlled substances qualify as “permissible prescriptions” for meeting the eRx meaningful use objective under the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs?

Answer: The term “permissible prescriptions” refers to the restrictions that were established by the Department of Justice (DOJ) on electronic prescribing (eRx) for controlled substances in Schedule II. (The substances in Schedule II can be found at http://www.deadiversion.usdoj.gov/schedules/orangebook/e_cs_sched.pdf ). Any prescription not subject to these restrictions would be a permissible prescription. Although DOJ recently published an Interim Final Rule that allows the electronic prescribing of these substances, we were unable to incorporate these recent guidelines into the Final Rule for the Medicare and Medicaid EHR Incentive Programs. Therefore, the determination of whether a prescription is a ”permissible prescription” for purposes of the eRx meaningful use objective should be made based on the guidelines for prescribing Schedule II controlled substances in effect on or before January 13, 2010, when the notice of proposed rulemaking for the Medicare and Medicaid EHR Incentive Program was published in the Federal Register.   

Question #10072:  Do I need to report on the CQMs for the Medicare and Medicaid EHR Incentive Program for which I do not have any data?

Answer: EPs are not excluded from reporting clinical quality measures, but zero is an acceptable value for the CQM denominator. If there were no patients who met the denominator population for a CQM, then the EP would report a zero for the denominator and a zero for the numerator. For the core measures, if the EP reports a zero for the core measure denominator, then the EP must report results for up to three alternate core measures (potentially reporting on all 6 core/alternate core measures). For the menu-set measures, we expect the EP to report on measures which do not have a denominator of zero. If none of the measures in the menu set applies to the EP, then the EP must report on three of such measures, reporting a denominator of zero, and then attest that the remainder of the menu-set measures have a value of zero in the denominator. As we stated in the final rule (75 FR 44409-10): “The expectation is that the EHR will automatically report on each core clinical quality measure, and when one or more of the core measures has a denominator of zero then the alternate core measure(s) will be reported. If all six of the clinical quality measures in Table 7 have zeros for the denominators (this would imply that the EPs patient population is not addressed by these measures), then the EP is still required to report on three additional clinical measures of their choosing from Table 6 in this final rule. In regard to the three additional clinical quality measures, if the EP reports zero values, then for the remaining clinical quality measures in Table 6 (other than the core and alternate core measures) the EP will have to attest that all of the other clinical quality measures calculated by the certified EHR technology have a value of zero in the denominator, if the EP is to be exempt from reporting any of the additional clinical quality measures (other than the core and alternate core measures) in Table 6.”  To view the final rule, please visit:  http://edocket.access.gpo.gov/2010/pdf/2010-17207.pdf

Question #10077: Can the drug-drug and drug-allergy interaction alerts of my EHR also be used to meet the meaningful use objective for implementing one clinical decision support rule for the Medicare and Medicaid EHR Incentive Programs?

Answer: No. The drug-drug and drug-allergy checks and the implementation of one clinical decision support rule are separate core meaningful use objectives. EPs and eligible hospitals must implement one clinical decision support rule in addition to drug-drug and drug-allergy interaction checks. We would not have listed these core requirements as separate measures, nor required that EPs and hospitals meet all core objectives and measures listed in the regulation, had we intended for them to be met simultaneously.   

Question #10088: If I am receiving payments under the CMS Electronic Prescribing (eRx) Incentive Program, can I also receive Medicare and Medicaid Electronic Health Record (EHR) incentive payments?

Answer: If the eligible professional (EP) chooses to participate in the Medicare EHR Incentive Program, they cannot participate in the eRx Incentive Program in the same program year. If the EP chooses to participate in the Medicaid EHR Incentive Program, they can participate in the Medicare eRx Incentive Program simultaneously.   

Question #10075: Can EPs use clinical quality measures from the alternate core set to meet the requirement of reporting three additional measures for the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs?

Answer: No, if EPs report data on all three clinical quality measures from the core set, they would not report on any from the alternate core set. The three additional clinical quality measures must come from Table 6 of the final rule (75 FR 44398-44408), excluding those clinical quality measures included in either the core set or the alternate core set. To view the final rule for the Medicare and Medicaid EHR incentive programs, please visit: http://edocket.access.gpo.gov/2010/pdf/2010-17207.pdf .

Question #10078: What is the difference between the Electronic Health Records (EHR) Demonstration and the Medicare and Medicaid EHR Incentive Programs?

Answer: The EHR Demonstration is a five-year demonstration project designed to encourage small to medium-sized primary care physician practices to adopt and use EHRs to improve the quality of patient care. Practices participating in the EHR Demonstration that meet specified requirements are eligible to receive two types of incentive payments: one for the adoption and use of an EHR and one for the reporting of and performance on 26 clinical quality measures related to the care of diabetes mellitus (DM), congestive heart failure (CHF), coronary artery disease (CAD) and preventive care services. The demonstration was implemented on June 1, 2009 in the following 4 sites: Louisiana, Southwest Pennsylvania, South Dakota (and some counties in bordering states), and Maryland and the District of Columbia. After careful consideration, plans to add 8 additional sites to the demonstration one year later were discontinued due to the creation of the Medicare and Medicaid EHR incentive programs. The EHR Demonstration will continue through May 31, 2014. CMS has no plans to add sites or additional primary care physician practices to the EHR Demonstration. The Medicare and Medicaid EHR Incentive Programs was established under the Health Information Technology for Economic and Clinical Health Act, or the “HITECH Act,” which is part of the Recovery Act. The EHR Incentive Programs under Medicare and Medicaid will provide incentive payments for the “meaningful use” of certified EHR technology. The Medicare and Medicaid EHR Incentive Programs will provide incentive payments to eligible professionals (EPs), critical access hospitals, and eligible hospitals as they adopt, implement, upgrade or demonstrate meaningful use of certified EHR technology. The programs will begin in 2011. For more information about the EHR Demonstration, please visit: http://www.cms.gov/demoprojectsevalrpts/md/itemdetail.asp?itemid=cms1204776 .

Question #10074: Are physicians who work in hospitals eligible to receive Medicare or Medicaid EHR incentive payments?

Answer: Physicians who furnish substantially all, defined as 90% or more, of their covered professional services in either an inpatient (POS 21) or emergency department (POS 23) of a hospital are not eligible for incentive payments under the Medicare and Medicaid EHR Incentive Programs.  

Question #10091: Can I receive the maximum allowable electronic health record (EHR) incentive payments if they total more than the purchase cost of my EHR system?

Answer: Yes. As long as an eligible professional (EP) or eligible hospital meets all necessary requirements for qualifying for incentive payments, they will receive the maximum incentive payment amount, regardless of the purchase or implementation costs of their EHR system. For Medicaid, there is a requirement that an EP is responsible for at least 15% of net average allowable costs in each year. In the first year, this means the EP is responsible for expenditures of at least $3,750. The final rule for the Medicare and Medicaid EHR incentive programs provides additional explanation of what it means for the EP to be “responsible” for such amount, including allowing an employer of the EP to incur the $3,750 on the EP employee’s behalf. However, theoretically, there could be a situation where neither the EP, nor his or her employer expends more than $3,750 in total costs on the certified EHR technology. To view the final rule, please visit: http://edocket.access.gpo.gov/2010/pdf/2010-17207.pdf .

Question #10093: What is the purpose of certified electronic health record (EHR) technology?

Answer: Certification of EHR technology will provide assurance to purchasers and other users that an EHR system or product offers the necessary technological capability, functionality, and security to help them satisfy the meaningful use objectives for the Medicare and Medicaid EHR Incentive Programs. Providers and patients must also be confident that the electronic health information technology (IT) products and systems they use are secure, can maintain data confidentially, and can work with other systems to share information. Confidence in health IT systems is an important part of advancing health IT system adoption and realizing the benefits of improved patient care.

Question #10070: If a patient is dually eligible for both Medicare and Medicaid, can they be counted twice by hospitals in their calculations

Answer: For purposes of calculating the Medicaid share, a patient cannot be counted in the numerator if they would count for purposes of calculating the Medicare share. Thus, in this respect the inpatient bed day of a dually eligible patient could not be counted in the Medicaid share numerator. (See 1903(t)(5)(C), stating that the numerator of the Medicaid share does not include individuals “described in section 1886(n)(2)(D)(i).”) In other respects; however, the patient would count twice. For example, in both cases, the individual would count in the total discharges of the hospital. To view the final rule for the Medicare and Medicaid EHR incentive programs, please visit: http://edocket.access.gpo.gov/2010/pdf/2010-17207.pdf .

Question #10090: Are there any special incentives for rural providers in the EHR Incentive Programs?

Answer: Under the Medicare EHR Incentive Program, the annual incentive payment limit for each payment year will be increased by 10 percent for eligible professionals (EPs) who predominantly furnish services in a Health Professional Shortage Area (HPSA). Critical access hospitals (CAHs) can receive an incentive payment amount equal to the product of its reasonable costs incurred for the purchase of certified EHR technology and the Medicare share percentage. Under Medicaid, there are no additional incentives for rural providers, beyond the incentives already available.

Question #10087: Can an eligible hospital implement an EHR system and satisfy meaningful use requirements at any time

Answer: For an eligible hospital’s first payment year, the EHR reporting period is a continuous 90-day period within a Federal Fiscal Year, so an eligible hospital must satisfy the meaningful use requirements for 90 consecutive days within their first Federal Fiscal Year of participating in the program to qualify for an EHR incentive payment. In subsequent years, the EHR reporting period for eligible hospitals will be the entire Federal Fiscal Year. With regard to the Medicaid EHR Incentive program, eligible hospitals must have adopted, implemented, upgraded, or meaningfully used certified EHR technology during the first Federal Fiscal Year. If the Medicaid eligible hospital adopts, implements or upgrades in the first year of payment, and demonstrates meaningful use in the second year of payment, then the EHR reporting period in the second year is a continuous 90-day period within the Federal fiscal year; subsequent to that, the EHR reporting period is then the entire Federal fiscal year. 

Question #10080: When do the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs start?

Answer: Participation in the Medicare EHR Incentive Program can begin as early as 2011; The incentive program ends in 2016. Registration for the Medicare EHR Incentive Program is expected to begin in January 2011, with attestation beginning in April 2011.The earliest incentive payments to eligible professionals (EPs) and eligible hospitals are expected to be made in May 2011. Medicaid EHR Incentive Program is voluntarily offered by individual states and may begin as early as 2011 and will end in 2021. Registration for the Medicaid incentive program is expected to begin in January 2011. Participants in the Medicaid EHR Incentive Program should consult their State for specific information regarding attestation and payment.

Question #10085:  The meaningful use standards for the EHR Incentive Program require interoperability. Who will pay for ensuring connectivity between physician practices and hospitals? Will there be federal guidance, or will this be hashed out at a local/community level?

Answer: The Office of the National Coordinator for Health Information Technology (ONC) has awarded funds to 56 states, eligible territories, and qualified State Designated Entities (SDEs) under the Health Information Exchange Cooperative Agreement Program to help fund efforts to rapidly build capacity for exchanging health information across the health care system both within and between states. These exchanges will play a critical role in facilitating the exchange capacity of doctors and hospitals to help them meet interoperability requirements which will be part of meaningful use. More information on ONC’s Health Information Exchange grantees is available at: http://healthit.hhs.gov/ .

Question #10073: Do recipients of Medicare or Medicaid EHR incentive payments need to file reports under Section 1512

Answer: No. The Medicare and Medicaid EHR incentive payments made to providers are not subject to Recovery Act 1512 reporting because they are not made available from appropriations made under the Act; however, the Health Information Technology for Clinical and Economic Health (HITECH) Act does require that information about eligible professionals (EPs), eligible hospitals and CAHs participating in the Medicare fee-for-service (FFS) or Medicare Advantage (MA) EHR incentive programs be posted on our website.

Question #10079: If I am participating in the Medicare EHR Demonstration Program, can I also participate in the Medicare and Medicaid EHR Incentive Programs?

Answer: Yes, if the eligible professional (EP) is eligible they may simultaneously participate in the Medicare EHR Demonstration and the Medicare or Medicaid EHR Incentive Program. For more information about the EHR Demonstration, please visit: http://www.cms.gov/demoprojectsevalrpts/md/
itemdetail.asp?itemid=cms1204776
.

Question #10082: Are mental health practitioners eligible to participate in the Medicare and Medicaid EHR Incentive Programs?

Answer: Mental health providers would only be eligible for incentive payments if they meet the criteria of a Medicare or Medicaid eligible professionals (EPs).  For more complete information about eligibility requirements, please refer to the Eligibility section of the CMS website at http://www.cms.gov/EHRIncentivePrograms/20_Eligibility.asp#TopOfPage .

Question #9965: Can EPs in the U.S. Territories qualify for EHR incentive payments?

Answer: Yes, EPs in the U.S. Territories can receive EHR incentive payments under both the Medicare and Medicaid EHR Incentive Programs as long as they meet the applicable requirements. EPs must choose whether to participate in the Medicare or Medicaid EHR Incentive Program.  

Question #10089: How much are the Medicare and Medicaid Electronic Health Record (EHR) incentive payments to EPs?

Answer: Under the Medicare EHR Incentive Program, EPs who demonstrate meaningful use of certified EHR technology can receive up to a total of $44,000 over 5 consecutive years. Additional incentives are available for Medicare EPs who practice in a Health Provider Shortage Area (HPSA). Under the Medicaid EHR Incentive Program, EPs can receive up to a total $63,750 over the 6 years that they choose to participate in program. EPs may switch once between programs after a payment has been made and only before 2015.

Question #10092: Where can I get answers to my privacy and security questions about electronic health records (EHRs)?

Answer: The Office for Civil Rights (OCR) is responsible for enforcing the Privacy and Security rules related to the HITECH program. More information is available at OCR’s website at http://www.hhs.gov/ocr/ .

Question #9966: Can EPs in Washington, D.C., receive electronic EHR incentive payments?

Answer: Yes, EPs in the District of Columbia can receive EHR incentive payments under the Medicare or Medicaid program as long as they meet the program’s requirements. EPs in D.C. are subject to the same requirements as EPs in the 50 States and thus may not concurrently receive payments from both the Medicare and Medicaid EHR Incentive Programs.  

Question #9964: Can hospitals in Washington, D.C. receive the EHR incentive payments?

Answer: Yes, hospitals in the District of Columbia can receive the Medicare and/or Medicaid EHR incentive payments as long as the hospitals meet the requirements for each program.
#                    #                   # 

Please be advised that the above FAQs were generated and excerpted from a database that is updated frequently by the Centers for Medicare and Medicaid Services (CMS).

For the most up-to-date official CMS information, please visit http://questions.cms.hhs.gov or click here to get the latest CMS FAQs on the Electronic Health Records Incentive Program. To get the latest answer on a specific question above, go to either of the links in the previous sentence, use the search box labelled “Find the answer to  your question” located just above the FAQs, type in the four digits only of the “Answer #”, and click “Search”. The general CMS search box does not work the same way.

The url to get the complete list of CMS FAQs on EHR Incentive Program:
http://questions.cms.hhs.gov/app/answers/list/p/21,26,1058

State Medicaid Directors Letters on Health IT from CMS

State Medicaid Directors Letters from CMS on Health IT Programs
2010 and 2009 Letters
This post includes both the latest letter from 2010 in PDF and html formats, that was issued this week; and a link to letter from about one year ago in 2009 in PDF format only .
August 17, 2010 Letter: 
          Federal Funding for Medicaid HIT Activities 
          ARRA of 2009 Section 4201
          PDF Version  (Excerpted below in html)

September 1, 2009 Letter: 
          Federal Funding for Medicaid HIT Activities 
          ARRA of 2009 Section 4201
          PDF Version
 

August 17, 2010 CMS Letter to State Directors on Health IT:
DEPARTMENT OF HEALTH & HUMAN SERVICES
Centers for Medicare & Medicaid Services
Baltimore, Maryland
Center for Medicaid, CHIP and Survey & Certification  
SMD# 10-016

August 17, 2010
Re: Federal Funding for Medicaid HIT Activities

Dear State Medicaid Director:

This letter provides guidance to State Medicaid agencies regarding implementation of section 4201 of the American Recovery and Reinvestment Act of 2009 (the Recovery Act), Pub. L. 111-5, and our recently published regulations at 42 CFR Part 495, Subpart D. Section 4201, as well as our final regulations, will allow the payment of incentives to eligible professionals (EPs) and eligible hospitals to promote the adoption and meaningful use of certified electronic health record (EHR) technology.

The Recovery Act provides 100 percent Federal financial participation (FFP) to States for incentive payments to eligible Medicaid providers to adopt, implement, upgrade, and meaningfully use certified EHR technology, and 90 percent FFP for State administrative expenses related to the program.

The Centers for Medicare & Medicaid Services (CMS) issued a State Medicaid Director (SMD) letter on September 1, 2009, that provided guidance to States on allowable expenses for activities supporting the administration of incentive payments to providers. CMS has now promulgated final regulations that also govern State administrative expenses related to administering the program. Both the SMD letter and our regulations at 42 CFR section 495.318 explain that, in order to qualify for the 90 percent FFP administrative match, a State must, at a minimum, demonstrate to the satisfaction of the Secretary compliance with three requirements:

•           Administration of Medicaid incentive payments to Medicaid EPs and eligible hospitals;

•           Oversight of the Medicaid EHR Incentive Program, including routine tracking of meaningful use attestations and reporting mechanisms; and

•           Pursuit of initiatives that encourage the adoption of certified EHR technology for the promotion of health care quality and the electronic exchange of health information.

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This letter and the accompanying enclosures provide more detailed guidance from CMS on the expectations relating to the activities and potential uses of the 90/10 matching funds.

I.          Administration of the Medicaid EHR Incentive Program

Title IV, Division B of the Recovery Act established the Medicare and Medicaid EHR incentives programs, as one component of the Health Information Technology for Economic and Clinical Health (HITECH) Act. This initiative supports the goals of health reform by helping to improve

Americans’ health, and increase safety and efficiency in health care through expanded use of EHRs. Accordingly, States’ administration of the Medicaid EHR Incentive Program, and their role in fostering adoption and meaningful use of certified EHR technology, are essential components of broader reforms. States can receive the enhanced FFP for approved design, development, and implementation of systems and processes that are necessary to effectively administer the Medicaid EHR Incentive Program. When developing their implementation timelines, States should consider the critical role the Medicaid EHR Incentive Program plays in the success of related HITECH programs. In order for States to benefit most from available Federal resources, including time-limited funding and technical assistance, timely initiation of their Medicaid EHR Incentive Programs (i.e., as soon as possible in 2011) is important.

Enclosure A outlines CMS’ expectations and provides examples of potentially allowable activities and reasonable costs related to State administration of the program.

II.        Oversight of the Medicaid EHR Incentive Program

Under section 1903(t)(9)(B) of the Social Security Act and our recently published regulations at 42 CFR Part 495, Subpart D, States are required to conduct adequate oversight of the Medicaid EHR Incentive Program. Although the provider incentive payments are paid by the States, they are 100 percent reimbursable under Medicaid. States must ensure that the program meets all statutory and regulatory requirements and is implemented in a manner that minimizes the potential for fraud, waste and abuse. The 90 percent matching rate for FFP is available to States for approved processes, systems, and activities necessary to ensure that the incentive payments are being properly made to the appropriate providers, in the appropriate circumstances, and in an auditable and defensible manner. We emphasize that an effective and efficient oversight strategy is one that is timely, targeted, and balances risk with available auditing resources.

Enclosure B provides additional information about CMS’ initial expectations for States’ auditing and oversight of their Medicaid EHR Incentive Program.

III.       Pursuing Initiatives to Encourage the Adoption of Certified EHR Technology and Health Information Exchange

CMS expects that State Medicaid agencies will have a role in the promotion of EHR adoption and health information exchange. HITECH provided several funding sources, including various grant programs through the Office of the National Coordinator for HIT (ONC) for States to achieve improved health care outcomes through health information technology (HIT). Medicaid plays an important role as both a payer and a collaborator with these other HIT initiatives to produce the desired impact on the health care system. Where possible, CMS encourages State Medicaid agencies to collaborate on HIT initiatives with Federal programs and other partners in

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the States, such as public health departments, county governments, and local governments. Costs will be distributed equitably across all payers following fair share and cost allocation principles, per section 495.358.

Enclosure C outlines the CMS guiding principles for the availability of the 90 percent FFP administrative matching funds for basic administration and oversight of the Medicaid EHR Incentive Program, as well as efforts to promote its success among eligible Medicaid providers.

IV.       State Medicaid Health Information Technology Plan (SMHP) and HIT Implementation Advance Planning Document (HIT IAPD)

The SMHP (the product of the initial HITECH planning funds awarded to States) should outline the State’s current (“As-Is”) and future (“To-Be”) HIT landscape and plan for the administration and oversight of its Medicaid EHR Incentive Program in compliance with our regulations. As States establish the broad vision for their Medicaid EHR Incentive Programs in the SMHP, however, not all activities will necessarily be eligible for FFP under HITECH. States must use the HIT Implementation Advance Planning Document (IAPD) to request FFP and receive approval before implementing proposed State Medicaid HIT plan activities and services or acquire equipment. There may be activities that are more appropriately reimbursed as Medicaid Management Information Systems (MMIS) or general program administration expenditures, or may not be eligible for any CMS funding at all.

Enclosure D outlines the CMS process for reviewing the SMHP and associated funding request documents (HITECH and MMIS).

CMS expects that States will take an incremental approach to the initial implementation of their Medicaid EHR Incentive Programs. For example States may begin by focusing on provider outreach and registration, then on provider attestation and verification of eligibility, next on provider payments, and finally on capturing meaningful use data. Toward that end, we have identified elements of an SMHP that are considered critical for the initial submission and those that may be deferred for future updates. States must outline their timeline, noting critical benchmarks and dependencies. An updated template for the SMHP for States to use as a guide is available on the CMS Web site for download at: http://www.cms.gov/EHRIncentivePrograms/91_Information_for_States.asp#TopOfPage .

CMS will seek ONC input as we review SMHPs to ensure a coordinated approach for the State EHR Incentive Program and health information exchange (HIE) efforts. While the SMHP focuses on the Medicaid strategy for moving toward meaningful use of certified EHR technology, it should be consistent with and complementary to the overall State HIT strategy developed under section 3013 of the Public Health Service Act (PHS). CMS and ONC will work together in the review of both strategies to prevent duplicative efforts of statewide HIT/HIE activities, provider outreach activities, and Medicaid HIT activities.

We encourage States to use the resources, tools, Frequently Asked Questions, and information available at the Federal level, particularly through the CMS EHR Incentive Program Web site: http://www.cms.gov/EHRIncentivePrograms/  and the ONC Web site: http://www.healthit.gov. We look forward to collaborating with State Medicaid agencies and learning from your experiences as we provide technical assistance, policy guidance, and Federal resources to ensure successful development and implementation of Medicaid EHR Incentive Programs. CMS believes that health information technology can be a transformative tool, improving the quality,

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efficacy, timeliness, and safety of patient care. With the States, as our partners, we can leverage the momentum provided by the Recovery Act’s EHR incentive programs to ensure that the innovations enabled by technology can support the framework of health care reform.

For further information or clarification on this State Medicaid Director letter, please contact Mr. Rick Friedman at CMS…

Enclosures:
A) Administering the Medicaid EHR Incentive Program
B) Oversight of the Medicaid EHR Incentive Program
C) Guiding Principles for the Use of the 90 Percent FFP for EHR Promotion
D) SMHP/IAPD Review Process

cc:
CMS Regional Administrators

CMS Associate Regional Administrators
Division of Medicaid and Children’s Health Operations

Ann C. Kohler
NASMD Executive Director
American Public Human Services Association

Joy Wilson
Director, Health Committee
National Conference of State Legislatures

Matt Salo
Director of Health Legislation
National Governors Association

Debra Miller
Director for Health Policy
Council of State Governments

Christine Evans, M.P.H.
Director, Government Relations
Association of State and Territorial Health Officials

Sincerely,
/s/
Cindy Mann Director

Page 5 – State Medicaid Director

Alan R. Weil, J.D., M.P.P.
Executive Director
National Academy for State Health Policy

David Blumenthal, M.D.
National Coordinator
Office of the National Coordinator for HIT

Page 6 – State Medicaid Director

Enclosure A
Administering the Medicaid EHR Incentive Program

Under the Recovery Act, States have the option to participate in the Medicaid EHR incentive program. States may receive 90 percent FFP for reasonable administrative expenditures incurred in planning and implementing the program.

States will undertake a number of activities relative to the administration of the Medicaid EHR Incentive program. As indicated in the CMS Electronic Health Record Incentive Program Final Rule at § 495.332, States will be expected to describe in detail in the State Medicaid HIT Plan (SMHP) a number of activities that CMS considers vital to the effective administration of the EHR Incentive Program. In order for States to claim the 90 percent FFP match, they must submit both a State Medicaid HIT Plan and an HIT Implementation Advance Planning Document (HIT IAPD). We recognize that not all States will administer the program using the same systems and processes; therefore we will assess each State’s SMHP to determine which activities would most appropriately be funded with the HITECH enhanced match and which might be better applicable to MMIS or regular program administration funding, or which may not be eligible for any CMS funding at all. In order to be eligible for the HITECH 90 percent FFP, activities must be directly related to the success of the Medicaid EHR Incentive Program, as described further in Enclosure C. In addition, please see Enclosure D for additional details about submitting SMHPs with HIT IAPD’s for both HITECH and MMIS funding.

States may potentially receive 90 percent FFP for the following program administration activities (not an exhaustive list), subject to CMS prior approval. (Note, as required by § 495.358, all costs are subject to cost allocation rules in 45 CFR Part 95.):

  • System and resource costs associated with the National Level Repository (NLR)
  • Interface System and resource costs associated with State interfaces of a Health Information Exchange (HIE)–(e.g., laboratories, immunization registries, public health databases, other HIEs, etc.)
  • Creation or enhancement of a Data Warehouse/Repository (should be cost allocated)
  • Development of a Master Patient Index (should be cost allocated)
  • Communications/Materials Development about the EHR Incentive Program and/or EHR Adoption/meaningful use
  • Provider Outreach Activities (workshops, webinars, meetings, presentations, etc).
  • Provider Help-Line/Dedicated E-mail Address/Call Center (hardware, software, staffing)
  • Web site for Provider Enrollment/FAQs
  • Hosting Conferences/Convening Stakeholder Meetings
  • Business Process Modeling
  • System and resource costs associated with the collection and verification of meaningful use data from providers’ EHRs
  • System and resource costs to develop, capture, and audit provider attestations
  • Evaluation of the EHR Incentive Program (Independent Verification (IV) & Validations (V) and program’s impact on costs/quality outcomes)
  • Data Analysis, Oversight/Auditing and Reporting on EHR Adoption and Meaningful Use
  • Environmental Scans/Gap Analyses SMHP updates/reporting; IAPD updates
  • Developing Data Sharing & Business Associate Agreements (legal support, staff)

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  • Ongoing costs for Quality Assurance activities
  • Multi-State Collaborative for Health IT annual dues
  • Staff/contractual costs related to the development of State-Specific meaningful use and patient volume criteria
  • Medicaid Staff Training/Prof. Development (consultants, registration fees, etc.)

CMS strongly encourages States to collaborate with other State-level and local partners in the design, development, and even procurement of systems needed to administer their EHR Incentive Programs. Doing so would make more effective use of both CMS’ and States’ share of the cost and would shorten the timeline for actually dispersing incentive payments to eligible providers. CMS is available to provide technical assistance to States interested in exploring collaborative approaches, and will disseminate information on approved and successful models.

CMS also strongly encourages States to consider the activities they plan to undertake to administer their EHR Incentive Program and to identify any that may overlap with other Federally-funded activities, such as provider outreach, development of a Master Patient Index, external inquiry management, etc. Where possible, these activities should be accomplished collaboratively, in which case costs are allocated across partners.

Budgeting for the 90 Percent FFP

States will be responsible for estimating the expenditures for the Medicaid EHR Incentive Program on the State’s quarterly budget estimate reports via Form CMS-37. These reports are used as the basis for Medicaid quarterly grant awards that would be advanced to the State for the Medicaid EHR incentive program. These forms are submitted electronically to CMS via the Medicaid and State CHIP Budget and Expenditure System (MBES/CBES). On Form CMS-37, States should include any projections of administration related expenditures for the implementation costs. On Form CMS-64, a State submits on a quarterly basis actual expenses incurred, which is used to reconcile the Medicaid funding advanced to States for the quarter made on the basis of the Form CMS-37. (Refer to Enclosure D and its section on State Reporting of Estimates, Expenditures, and Timing of the Grant Award Letter.)

To assist States in properly reporting expenditures using the MBES/CBES, the CMS-37 and CMS-64 reports will include a new category for reporting the 90 percent FFP match for State administrative expenses associated with the Medicaid EHR Incentive Program. The new category will be called “Health Information Technology Administration.” This reporting category is located on the 64.10 base page lines 24A and 24B for Administration. Implementation expenditures are included on lines 24C and 24D.

CMS will monitor State agency compliance through systems performance reviews, focused reviews, and audits of the processes documented in the SMHP, and other planning documents. CMS may review States’ EHR Incentive Programs using a variety of audit/review tools, including, but not limited to, financial audits, State Program Integrity Reviews, and payment data analysis. CMS is allowed to suspend payments if the State fails to provide access to information, per our final regulations, § 495.330.

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In order to track progress made towards the nationwide implementation of the Medicaid EHR Incentive Programs, CMS requests that States indicate to us through their State Medicaid HIT Plans, the target date by which they plan to launch their program. For consistency’s sake, we will consider a State’s Medicaid EHR Incentive Program ready to launch when a State has met all of the following criteria:

The State has an approved SMHP and an approved IAPD. The State has initiated outreach and communications about the Medicaid EHR Incentive Program, including posting information on its Web site. The State has an effective and tested interface to accept provider registration information from the CMS NLR (i.e., has successfully tested with the NLR). The State is now capable, or will be capable within 3 months, of accepting provider attestations. The State is now capable, or will be capable within 5 months, of making provider incentive payments. The State has sufficient controls in place to ensure that the right incentive payments are made to the right providers before initiating provider incentive payments.

Prior to the release of the 100 percent FFP provider incentive funding, CMS will require that States provide a brief written update regarding the launch criteria above.

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Enclosure B
Oversight of the Medicaid EHR Incentive Program

Under Section 1903(t)(9)(B) of the Social Security Act, States are required to conduct adequate oversight of the Medicaid incentive program. Our regulations, including §§ 495.318(b), 495.332, 495.366, and 495.368, also require States to conduct oversight to monitor, among other things, provider eligibility, payments, fraud, waste, and abuse.

In addition, CMS is developing a joint Medicare/Medicaid audit strategy. In the interim, this enclosure provides initial CMS expectations regarding State responsibilities for oversight and audit in the early stage of EHR incentive program implementation. CMS will expand and build upon these requirements after the joint strategy is finalized and States begin implementing their programs.

CMS expects States to implement a risk-based auditing approach to prevent making improper Medicaid EHR Incentive payments and to monitor the program for potential fraud, waste, and abuse. For 2011, CMS expects that, at a minimum, States will focus their auditing resources on the following specific items:

Provider eligibility: for example, an identified means to verify that providers are credentialed, not-sanctioned, not hospital-based, practicing predominately, and are one of the types of eligible professionals or institutions under the EHR incentive program. Patient volume: for example, an identified means to audit or verify the attestation data, including use of proxy data (such as claims) where appropriate to identify risk. Adopt, implement, or upgrade (AIU): for example, have an identified means to audit or verify that providers have actually adopted, implemented, or upgraded certified EHR technology. (Note: CMS does not anticipate that States will audit meaningful use in 2011 as all eligible Medicaid providers can receive an EHR incentive payment for AIU in their first participation year.) Certified EHR technology: for example, States should collect the certified EHR technology code (see below) as part of provider attestation for AIU, and should verify that the code is on the Office of the National Coordinator (ONC) list of certified EHR technology prior to issuing an incentive payment to that provider.

Prior to January 2011, ONC will make available through a public Web service (URL is still to- be-determined), a list of all certified EHR technology, including the name of the vendor and product, the product’s unique certification code, and the meaningful use criteria for which the product was certified. After January 2011, the ONC Web service is expected to have additional functionality related to combinations of certified EHR modules. For combinations of separate certified EHR technology that collectively could achieve meaningful use (e.g., modules), the ONC Web service would allow providers to enter the codes from the different certified modules and request a unique certification code that represents that specific combination. The Web service would then store and reflect for other providers that particular combination of certified EHR technology and the unique code associated with it. States should utilize the ONC Web service to automate the pre-payment verification of providers’ attestations regarding use of certified EHR technology. States should plan to test this process prior to accepting provider attestations. CMS will provide further details as soon as they become available.

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Using either their attestation system or other means, States must notify providers that it is the provider’s responsibility to ensure that its certified EHR technology code is listed on the ONC Web service before attesting to the State. Otherwise, the State’s verification system might produce a false negative result (e.g., the EHR technology was certified but there was a delay before it was added to the ONC Web service).

States may receive enhanced matching funds for the following audit/oversight activities, subject to CMS prior approval:

Auditing contractor(s)/Auditing In-House Activities Systems costs for interfaces to verify provider identity/eligibility (e.g., provider enrollment, license verification, sanctions, patient volume) System and Resource Costs associated with Provider Appeals for EHR Incentive Payments Staff and resources for data analysis and reporting requirements for the CMS EHR Incentive Program Privacy/Security Controls

We strongly recommend that States consider the data sources and partners (such as Regional Extension Centers and HIEs, etc.) that are available to support their auditing and oversight responsibilities- including using them as tools for conducting risk assessments for fraud, waste and abuse. For example, where appropriate, States should utilize reliable third-party data sources rather than conduct resource-intense individual on-site reviews. As noted above, we will be issuing further guidance related to oversight and auditing of meaningful use in the Medicare and Medicaid EHR Incentive Programs. At that time, CMS will share with States its auditing plans for the Medicare EHR Incentive Program. We will look for opportunities where appropriate to leverage Federal efforts on behalf of the States, including, but not limited to our auditing strategy for hospitals that are eligible for both Medicare and Medicaid EHR incentive payments. Further details regarding potential State and CMS collaboration on the auditing of meaningful use for hospitals that are eligible for both incentive payments is forthcoming. States should recognize that it is their sole responsibility to audit hospitals that are Medicaid-only (e.g., children’s and cancer hospitals).

The primary means for CMS and States to avoid duplicate payments to eligible professionals is through joint use of the National Level Repository (NLR). States must interface with the NLR not just to receive provider registration data and to ensure that there are no duplicative payments prior to issuing provider incentives, but also to notify the NLR when they have made an incentive payment. CMS expects that States will notify the NLR that an incentive payment has been made within 5 business days. Similarly, if a State has determined that the provider is ineligible for a payment, CMS expects that the State will notify the NLR within 5 business days. Finally, in accordance with our regulations, § 495.332, the State must make a payment within 45 days of completing all eligibility verification checks. In the case of providers registering at the end of a calendar year, a payment for that year must be made no later than 60 days into the next calendar year for EPs, or fiscal year, for hospitals. The full requirements document and interface control document developed for States’ interface with the NLR was made available to States through the CMS regional offices, with the July 13, 2010, release of the CMS final rule.

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CMS will monitor State agency compliance with audit and oversight requirements through systems performance reviews, focused reviews, and audits of the processes documented in the SMHP, and other planning documents. CMS may review States’ EHR Incentive Programs using a variety of audit/review tools, including, but not limited to, financial audits, State Program Integrity Reviews, and payment data analysis. CMS is allowed to suspend payments if the State fails to provide access to information, per our final regulations, § 495.330.

In accordance with the CMS final rule, Medicaid agencies must implement a provider appeals process.     See § 495.370 of our final regulations for details regarding provider appeals, as well as the SMHP template, which is located on the CMS Web site at: http://www.cms.gov/EHRIncentivePrograms/91_Information_for_States.asp#TopOfPage. Enclosure E also discusses information regarding provider appeals in the context of the SMHP contents.

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Enclosure C
Guiding Principles for Use of the CMS 90 Percent Administrative Matching Funds for the Medicaid EHR Incentive Program

State Medicaid agencies can receive enhanced matching funds at a 90-percent rate for their administration and oversight of the Medicaid EHR incentive program. CMS also expects that States will request the enhanced matching funds for reasonable administrative expenses related to their efforts to promote the adoption of certified EHR technology and health information exchange (HIE).

We recognize that not all States will implement their programs in the same manner, and each State may face unique barriers to adoption and meaningful use. The principles below provide an overarching framework by which CMS will consider State requests for 90 percent FFP. Each proposal will be examined by CMS (with input from ONC) to ensure funds provide direct support to the success of the Medicaid EHR incentive program, are coordinated with other State HIT-related activities, do not duplicate other funding sources, and are implemented in the most efficient and effective manner. In addition, we strongly encourage States to collaborate with other States and local partners in the design, development, and procurement of any new systems.

CMS will consider approval for 90 percent FFP for EHR/HIE promotion initiatives that will meet all of the following criteria:

  • Serve as a direct accelerant to the success of the State’s Medicaid EHR Incentive Program and facilitate the adoption and meaningful use of certified EHR technology. Expenses that do not directly correlate to the EHR Incentive Program will not be approved. Examples that may correlate include:
                      – Expenditures related to provider needs assessments, provider outreach about adoption and meaningful use of certified EHR technology, staff training, identification and development of tools to connect to health information exchanges, record locater services, secure messaging gateways, provider directories, development of privacy and governance policies and procedures, master patient indexes, interfaces for data (e.g., laboratory) that is important to Medicaid providers to be fully successful in an HIE environment, and procuring technical assistance for Medicaid providers to achieve meaningful use.
  • Are consistent with the ONC long-term vision for health information exchange, and are supportive of the activities prioritized by ONC cooperative agreement funding, namely secure messaging, the electronic reporting of structured laboratory data and enabling e- prescribing.
  • Are not duplicating meaningful use technical assistance efforts conducted by the ONC- funded Regional Extension Centers, Workforce Grantees, Beacon Grantees or other Federally-funded projects whose target population is the same, as well as ONC cooperative agreement grant funding for the development of HIE.

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  • Will, to the extent possible, be normalized and integrated into the Medicaid business enterprise. Examples include:          
                    -Expenditures related to technical bridges between Medicaid and health information exchanges or all-payer clinical/claims data warehouses or technologies to authenticate providers and beneficiaries (e.g., master provider or patient indices).
  • Cannot otherwise be funded by the MMIS matching funds. MMIS will be examined as a more appropriate funding source before HITECH because HITECH funds should be targeted toward scenarios that contribute to the transformation of the MMIS into a clinical- and claims-based engine that supports Medicaid’s broader health care reform goals. Examples of expenditures that relate to the Medicaid EHR Incentive Program but that might more appropriately be funded through the enhanced MMIS match include:
                   -  Expenditures related to the design, development, and testing of a standard continuity of care record (CCR) or continuity of care document (CCD) based upon Medicaid claims; or building a portal between the MMIS and a clinical data repository or an immunization registry.
  • Are designed to be well-defined, developmental, and time-limited projects, with specific goals that would enable eligible Medicaid providers who qualify for the Medicaid EHR Incentive Program to achieve meaningful use of certified EHR technology.
                   – Providers’ transactional and on-going expenses derived from participation in health information exchange would not be eligible for the 90 percent HITECH Medicaid administrative match. Instead, CMS believes such costs are more appropriately addressed through State reimbursement to providers. CMS will entertain State plan amendments that speak to payment policies designed to incentivize providers to report data, such as the medical home per-member/per- month model.
  • Are not intended to be permanent initiatives but will lead within a reasonably short timeframe to sustainable outcomes.
                    - Sustainability refers to the responsibility for on-going costs for operations and maintenance of systems initially developed or enhanced using HITECH funding. After a defined milestone, funding sources other than HITECH must be used.
                   – Personnel costs for those who work directly on the Medicaid EHR Incentive Program are permissible expenditures for the enhanced match over the short term; however, States must plan to absorb or bear those costs in the future.
  • Are developed in accordance with Medicaid Information Technology Architecture (MITA) principles, as required by §495.332.
  • Are distributed equitably across all payers following the fair share principle. CMS recognizes that Medicaid is often one of the largest insurers in a State and, as such, stands to benefit from efficiencies associated with health information exchange and meaningful use of EHRs. However, Medicaid’s contribution to health information technology should be weighted and allocated based on contributions by other payers, and not be the sole or primary source of start-up or operational funding.

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  • Are cost-allocated per Office of Management and Budget (OMB) Circular A-87. CMS will work with States on an individual basis to determine the most appropriate cost allocation methodology.
                   -  HITECH cost allocation formulas should be based on the direct benefit to the Medicaid EHR incentive program, taking into account State projections of eligible Medicaid provider participation in the incentive program.
                   -  Cost allocation must account for other available Federal funding sources, the division of resources and activities across relevant payers, and the relative benefit to the State Medicaid program, among other factors.
                   -  Cost allocations should involve the timely and ensured financial participation of all parties so that Medicaid funds are neither the sole contributor at the onset nor the primary source of funding. Other payers who stand to benefit must contribute their share from the beginning. The absence of other payers is not sufficient cause for Medicaid to be the primary payer.

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Enclosure D
State Medicaid HIT Plan and Implementation Advance Planning Process

This Enclosure provides guidance on the following topics regarding the State’s Medicaid HIT Plan (SMHP) and the State’s HIT Implementation Advance Planning Document (HIT IAPD):

  • HIT IAPD Preparation and On-Going Planning Activities
  • Budget Preparation Tips
  • State Submission and CMS Review and Approval Process for the SMHP and the HIT IAPD
  • State Reporting of Estimates, Expenditures, and Timing of the Grant Award Letter
  • Retroactive Requests for Planning Activities Funded at 90/10 Federal Financial Participation (FFP)

HIT IAPD Preparation and On-Going Planning Activities

Since the publication of the State Medicaid Director’s Letter on September 1, 2009, nearly every State and Territorial Medicaid agency has been approved to conduct HIT planning activities through the HIT Planning Advance Planning Document process (HIT PAPD), with the remaining agencies expected to submit funding requests in the coming months. A required deliverable of the HIT PAPD is the completion of a State Medicaid HIT Plan (SMHP), which must include the elements contained at §495.332 of the Medicare and Medicaid Programs’ EHR Incentive Program Final Rule. Once approved, the SMHP and the results of the planning activities must be included in the States’ HIT Implementation Advance Planning Document (HIT IAPD). The HIT IAPD is a plan of action that requests FFP and approval to acquire and implement the proposed State Medicaid HIT Plan activities, services or equipment. The end result of implementation will be the ability for the State Medicaid agency to successfully operate its EHR Incentive Program. States will then be able to make provider incentive payments with 100 percent FFP for State expenditures.

To the extent possible, the HIT IAPD must include the list of the HIT IAPD required elements that are contained in the Final Rule at: §495.338. In addition, the State should consider incorporating the optional SMHP elements included in the revised SMHP template located on the CMS Web site at: http://www.cms.gov/EHRIncentivePrograms/91_Information_for_States.asp#TopOfPage . It is possible that some planning activities may be on-going. In these instances, the State should continue to describe on-going planning activities using the As-Needed HIT Advance Planning Document Update (HIT APDU) process to request funding approval for project continuation, scope, and schedule changes, for incremental funding authority and project continuation when approval is being granted by phases.

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Budget Preparation Tips

We believe the provisions of the HITECH Act provide the necessary assistance and technical support to providers, enable coordination and alignment within and among States, establish connectivity to the public health community in case of emergencies, and ensure that the workforce is properly trained and equipped to be meaningful users of certified EHR technology. It is therefore important that the HIT IAPD include information about any grants, State or local funds, or other funding sources that are available to the State and that will contribute to the costs of activities for which the State is requesting HITECH matching funds. This information is not meant to duplicate what is in the SMHP but rather to provide CMS with adequate information to determine if the proposed cost allocation and/or division of labor and responsibilities among the various State partners are appropriate to existing rules and regulations and CMS expectations. For example, if a State wishes to build System X, it should indicate all other sources of funding that will contribute to System X, including other Federal HIT grant funding.

Example:

Grant/Funding Source:    

Share of the Cost Allocation    

Timing of the Funding Contribution (e.g., current, FY11, TBD)    

Lead Agency    

Contact Information    

State HIE Cooperative Agreement Program    

$5,000,000    

State Office of E-Health    

NamePhone numberE-mail  

ONC Regional Extension Center Cooperative Agreement Program    

$3,500,000    

State University of XYZ    

NamePhone numberE-mail  

Follow this link for a full description of each grant, listed in the bullets below:

.
 
 

 

.

State Health Information Exchange Cooperative Agreement Program Health Information Technology Extension Program Strategic Health IT Advanced Research Projects (SHARP) Program Beacon Community Program

Community College Consortia to Educate Health Information Technology Professionals Program Curriculum Development Centers Program Program of Assistance for University-Based Training

Competency Examination for Individuals Completing Non-Degree Training Program

The HIT IAPD proposed budget should follow the requirements at § 495.338 in the Final Rule and include the source of all funds which will be utilized by the State Medicaid agency for the

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specific activities outlined in the IAPD. This includes the following grants to the Medicaid agency:

CHIPRA Quality Demonstration Grant, if HIT related Medicaid Transformation Grant Primary Care Stabilization Grant

Enhancements to the State’s MMIS, such as building an interface to a source of HIT data, or shared reporting between the multiple projects, which will be cost allocated between the different projects, should be described in a separate MMIS APD. The separate MMIS APD may be included in the submission of the State’s HIT IAPD and, as an example, may be titled Part 1 – HIT, Part 2 – MMIS. Recovery funds must be tracked separately. That is the reason for separating the two documents. Funding requests for the MMIS APD should follow MMIS-specific guidance about the matching levels and permitted expenditures.

State Submission and CMS Review and Approval Process for the SMHP and the HIT IAPD

The State may simultaneously submit to CMS for approval both the SMHP and the HIT IAPD; or the State may choose to submit the SMHP first, receive CMS approval, and then submit the HIT IAPD to CMS. Either way, implementation activities cannot begin until the SMHP and the HIT IAPD have both been approved by CMS. As with the HIT Planning Advance Planning Document (PAPD), prior approval is required for States requesting FFP before conducting implementation activities. Exceptions will be made for States that have previously conducted planning activities and are requesting retroactive approval for 90 percent FFP for activities that occurred on or after February 18, 2009. Instructions for submitting these requests are described below under the heading, “Retroactive Approval of FFP with an Effective Date of February 18, 2009.”

CMS will determine which activities will be eligible for a 90 percent FFP match for State expenses for administration of the incentive payments and for promoting EHR adoption implementation activities. States should contact their CMS regional office representatives regarding funding questions. Enclosures A, B, and C contain examples of partial lists of implementation expenditures/activities that may be considered eligible for 90 percent FFP for administrative expenses to implement the activities contained in the State’s SMHP and HIT IAPD.

CMS will be using a joint Central Office/Regional Office review approach. In addition, CMS will share the States’ SMHPs with the Office of the National Coordinator for HIT (ONC) to ensure a coordinated approach for the State EHR Incentive Program and HIE efforts. While the SMHP focuses on the Medicaid strategy for moving toward meaningful use of certified EHR technology, it should be consistent with and complementary to the overall State HIT strategy developed under section 3013 of the Public Health Service Act (PHS). CMS and ONC will work together in the review of both strategies to prevent duplicative efforts of statewide HIT/HIE activities, provider outreach activities, and Medicaid HIT activities.

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State Reporting of Estimates, Expenditures and Timing of the Grant Award Letter

For the purposes of this guidance, CMS is using the term “grant award” when approving Federal funding for allowable Medicaid expenditures. This should not be confused with competitive grant awards (e.g., Transformation Grants, CHIPRA grants, etc.) made by CMS or other Federal agencies, such as ONC, for HITECH activities. Once CMS has officially approved the SMHP and HIT IAPD, a CMS HIT approval letter will be issued notifying the State of the approved funding to conduct implementation activities. Only then may a State request to receive the grant award on a quarterly basis. On the Forms CMS-37.9 and CMS-37.10, the new line items listed below have been added to reflect provisions under section 4201 of the Recovery Act:

Line 24A – HIT: Planning: Cost of In-house Activities Planning Activities for administrative expenses to oversee incentive payments made to providers: Cost of In- house Activities

Line 24B – HIT: Planning: Cost of Private Contractors Planning Activities for administrative expenses to oversee incentive payments made to providers: Cost of Private Sector Contractors

Line 24C – HIT: Implementation and Operation: Cost of In-house Activities Implementation Activities for administrative expenses to oversee incentive payments made to providers: Cost of In-house Activities

Line 24D – HIT: Implementation and Operation: Cost of Private Contractors Implementation Activities for administrative expenses to oversee incentive payments made to providers: Cost of Private Sector Contractors

In addition, the CMS 64.10 report includes expenditure reporting for the following line items:

Line 24A – HIT Planning: Cost of In-house Activities Line 24B – HIT Planning: Cost of Private Contractors Line 24C – HIT Implementation and Operation: Cost of In-house Activities Line 24D – HIT Implementation and Operation: Cost of Private Contractors

For both the CMS 37.9, 37.10 and 64.10 reports, estimates and expenditures only pertain to HITECH and not to MMIS reporting for the line items listed above. In that regard, do not include any projections or expenditures of provider incentive payment for this provision for either FY 2010 or FY 2011 on the CMS-37.9, CMS-37.10, or 64.10 reports. When State staff are preparing the budget for the HIT IAPD, it is critical that both program and financial staff communicate with each other to ensure consistent State reporting to CMS’ Financial Management Group in order to eliminate discrepancies in both the APD estimates and the information being reported by the State fiscal staff pertaining to Form CMS-37.9 and Form CMS-37.10.

On the quarterly CMS-37 budget submission, a State may request to receive its HIT IAPD CMS grant award by including an estimated HIT IAPD expenditure in the CMS-37.10 Form. This estimated expenditure will result in a grant award to cover those expenses specified for that quarter. Therefore, it is imperative to accurately estimate the HIT IAPD expenditures by quarter.

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CMS will finalize the HIT IAPD grant award against the 64 HIT IAPD expenditures. The HIT IAPD grant award will be issued separately with a specified Payment Management System subaccount code.

If a State has not received its HIT IAPD approval letter, the State may still include a footnote in the Form CMS-37.12 of anticipated HIT IAPD expenditures, broken out by quarter.

Retroactive Approval of 90/10 FFP with an Effective Date of February 18, 2009

For administrative activities performed by a State, prior to having an approved HIT PAPD, which are in support of administrative expenditures for planning activities for incentive payments to providers, a State may request consideration of retrospective FFP by including a request in a HIT advance planning document or implementation advance planning document update.  In considering such a request, the agency takes into consideration overall Federal interests which may include any of the following:

(a) The acquisition must not be before February 18, 2009.

(b) The acquisition must be reasonable, useful, and necessary.

(c) The acquisition must be attributable to payments for reasonable administrative expenses per our regulations in §495.362.

The activities must be related to planning, and can be requested in the HIT APD that is active at the time of the request. As an example, if the HIT PAPD has ended and the State is preparing the HIT IAPD, then this request can be included in a separate section titled: “Request for Retroactive HIT Planning Funding” and must follow the criteria above. It can also be included in an Update or in the Annual APD report due 60 days from the approved APD anniversary date.