Meaningful Use Stage 2: CMS and ONC Release Final Rule for Meaningful Use and Certification

Posted on August 26, 2012 by Mike Squires

Meaningful Use Stage 2: CMS and ONC Release Final Rule for Meaningful Use and Certification
Excerpted from HealthIT.gov and CMS.gov on August 26, 2012

On August 23, 2013, the Centers for Medicare & Medicaid Services (CMS) released the final rule which establishes Stage 2 of the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs, updates Stage 1, and includes other program modifications. At the same time the Office of National Coordinator for Health IT (ONC) released the 2014 Edition Standards and Certification Criteria (S&CC) final rule which completes ONC’s second full rulemaking cycle to adopt standards, implementation specifications, and certification criteria for EHR technology.

The CMS final rule specifies the Stage 2 criteria that eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) must meet in order to continue to participate in the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs. All providers must achieve meaningful use under the Stage 1 criteria before moving to Stage 2.

The 2014 Edition S&CC final rule reflects ONC’s commitment to reduce regulatory burden; promote patient safety and patient engagement; enhance EHR technology’s interoperability, electronic health information exchange capacity, public health reporting, and security; enable clinical quality measure data capture, calculation, and electronic submission to CMS or states; and introduce greater transparency and efficiency to the certification process.

CMS Final Rule

CMS Resources

ONC Final Rule

ONC Resources

Other Resources

How to Play by the (Final) Rules: An Overview of Meaningful Use Stage 2 and the Standards and Certification Criteria Final Rules: Webinar recording and presentation materials

Stage 2 Timeline
The earliest that the Stage 2 criteria will be effective is in fiscal year 2014 for eligible hospitals and CAHs or calendar year 2014 for EPs. The table below illustrates the progression of meaningful use stages from when a Medicare provider begins participation in the program.

1st Year	Stage of Meaningful Use
1st Year	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021
2011	1	1	1	2	2	3	3	TBD	TBD	TBD	TBD
2012		1	1	2	2	3	3	TBD	TBD	TBD	TBD
2013			1	1	2	2	3	3	TBD	TBD	TBD
2014				1	1	2	2	3	3	TBD	TBD
2015					1	1	2	2	3	3	TBD
2016						1	1	2	2	3	3
2017							1	1	2	2	3

Note that providers who were early demonstrators of meaningful use in 2011 will meet three consecutive years of meaningful use under the Stage 1 criteria before advancing to the Stage 2 criteria in 2014. All other providers would meet two years of meaningful use under the Stage 1 criteria before advancing to the Stage 2 criteria in their third year.

In the first year of participation, providers must demonstrate meaningful use for a 90-day EHR reporting period; in subsequent years, providers will demonstrate meaningful use for a full year EHR reporting period (an entire fiscal year for hospitals or an entire calendar year for EPs) except in 2014, which is described below. Providers who participate in the Medicaid EHR Incentive Programs are not required to demonstrate meaningful use in consecutive years as described by the table above, but their progression through the stages of meaningful use would follow the same overall structure of two years meeting the criteria of each stage, with the first year of meaningful use participation consisting of a 90-day EHR reporting period.

For 2014 only, all providers regardless of their stage of meaningful use are only required to demonstrate meaningful use for a 3-month EHR reporting period. For Medicare providers, this 3-month reporting period is fixed to the quarter of either the fiscal (for eligible hospitals and CAHs) or calendar (for EPs) year in order to align with existing CMS quality measurement programs, such as the Physician Quality Reporting System (PQRS) and Hospital Inpatient Quality Reporting (IQR). The 3-month reporting period is not fixed for Medicaid EPs and hospitals that are only eligible to receive Medicaid EHR incentives, where providers do not have the same alignment needs. CMS is permitting this one-time 3-month reporting period in 2014 only so that all providers who must upgrade to 2014 Certified EHR Technology will have adequate time to implement their new Certified EHR systems.

Core and Menu Objectives
Stage 2 uses a core and menu structure for objectives that providers must to achieve in order to demonstrate meaningful use. Core objectives are objectives that all providers must meet. There is also a predetermined number of menu objectives that providers must select from a list and meet in order to demonstrate meaningful use.
To demonstrate meaningful use under Stage 2 criteria—

EPs must meet 17 core objectives and 3 menu objectives that they select from a total list of 6, or a total of 20 core objectives.
Eligible hospitals and CAHs must meet 16 core objectives and 3 menu objectives that they select from a total list of 6, or a total of 19 core objectives.

Download the Stage 2 Overview Tipsheet for a complete list of the Stage 2 core and menu objectives for both EPs and eligible hospitals and CAHs. Providers can also download a table of the Stage 2 core and menu objectives and measures by clicking on the links below:

Stage 1 vs. Stage 2 Core and Menu Objectives for EPs
Stage 1 vs. Stage 2 Core and Menu Objectives for Eligible Hospitals and CAHs

Clinical Quality Measures for 2014 and Beyond
All providers are required to report on CQMs in order to demonstrate meaningful use. Beginning in 2014, all providers regardless of their stage of meaningful use will report on CQMs in the same way.

EPs must report on 9 out of 64 total CQMs.
Eligible hospitals and CAHs must report on 16 out of 29 total CQMs.

In addition, all providers must select CQMs from at least 3 of the 6 key health care policy domains recommended by the Department of Health and Human Sevices’ National Quality Strategy:

Patient and Family Engagement
Patient Safety
Care Coordination
Population and Public Health
Efficient Use of Healthcare Resources
Clinical Processes/Effectiveness

A complete list of 2014 CQMs and their associated National Quality Strategy domains will be posted on the Clinical Quality Measures tab in the future. CMS will also post a recommended core set of CQMs for EPs that focus on high-priority clinical conditions.
For more detailed information on 2014 CQMs and electronic reporting options, click to download our 2014 Clinical Quality Measures Tipsheet.

ONC Blogs on multi-EHR certification and other issues

Posted on June 11, 2011 by Mike Squires

Perpetually Perplexed by Regulatory Interpretations? Separate the Fact from Fiction
June 10, 2011, 2:45 pm /Posted by Steven Posnack, Director Federal Policy Division, ONC, on ONC’s Health IT Buzz blog and republished by e-Healthcare Marketing here.

If enough people believe something, it has to be true, right? In my travels, I’ve found that regulatory interpretations range from being largely factual to wildly fictitious. The latter often results from misinterpretations of regulatory language, improper combinations of regulatory language from different rules, or accurate interpretations getting lost in translation as they are passed from person-to-person. These inaccurate interpretations, intentional or not, often unsurprisingly lead to confusion. Accordingly, I thought it would be helpful to clear up a few things I’ve heard related to certification.

Statement 1: If an eligible professional or eligible hospital combines multiple certified electronic health record (EHR) Modules together (or a certified EHR Module[s] with a certified Complete EHR), that combination also needs to be separately certified in order for it to meet the definition of Certified EHR Technology – *FICTION*
- Part 2 of the definition of Certified EHR Technology acknowledges that a combination of certified EHR Modules can be used to meet the definition of Certified EHR Technology. At 75 FR 2023, we clarified that as long as each EHR Module which makes up the combination has been certified, the definition could be met. See also FAQ 17.
- Combining certified EHR Modules or certified EHR Modules with a certified Complete EHR (or even two certified Complete EHRs) will not invalidate the certification assigned to the EHR technologies. Each EHR technology retains the certification assigned to it. Our FAQs (such as #7, #14, and #21) identify cases where combining certified Complete EHRs with other certified EHR Modules could occur without any negative effects.
- Note, generating the “CMS EHR Certification ID” on ONC’s Certified HIT Products List (CHPL) for meaningful use attestation purposes is different. Using the CHPL, an eligible professional (EP) or eligible hospital (EH) generates a CMS EHR Certification ID (a unique alpha-numeric string) to report to CMS as part of its attestation. The CMS EHR Certification ID represents the combination of certified EHR Modules or other combination of certified EHR technologies that meet the definition of Certified EHR Technology and were used during the meaningful use reporting period.
Statement 2: The ONC-Authorized Testing and Certification Bodies (ONC-ATCBs) operate under contract with and receive funding from ONC – *FICTION*
- ONC-ATCBs do not receive funding from ONC to perform their ONC-ATCB duties. ONC-ATCBs support their operations through testing and certification fees charged to Complete EHR and EHR Module developers.
- The Temporary Certification Program Final Rule established certain responsibilities and rules for ONC-ATCBs. ONC-ATCBs must fulfill these requirements and adhere to the rules in order to maintain good standing under the program. For example, ISO/IEC Guide 65 requires ONC-ATCBs to make their services accessible to all applicants (e.g., EHR developers) whose activities fall within its declared field of operation (e.g., the temporary certification program), including not having any undue financial or other conditions.
Statement 3: Testing and certification under the Temporary Certification Program does not examine whether two randomly combined EHR Modules will be compatible or work together – *FACT*
- ONC-ATCBs are not required to examine the compatibility of two or more EHR Modules with each other. EHR Module developers, however, are free, and highly encouraged, to work together to ensure that EHR Modules are compatible.
Statement 4: The ONC-ATCBs favor big EHR technology developers – *FICTION*
- The ONC-ATCBs do not favor large developers, and such favoritism is precluded by the international standards to which ONC-ATCBs must adhere.
- As of June 3, 2011, 438 EHR technology developers were represented on the CHPL. Of those, approximately 60 percent are small companies (<51 employees) and approximately 12 percent are large companies (>200 employees).
Statement 5: Certification doesn’t require that an EHR technology designed by one EHR developer make its data accessible or “portable” to another EHR technology designed by a different developer – *FACT*
- We are very interested in exploring future certification requirements to improve data portability.
- If you have any insights on how to improve data portability between EHR technologies, please feel free to leave a comment below.
Statement 6: As an EP or EH, you need to demonstrate meaningful use in the exact way that EHR technology was tested and certified – *FICTION* (mostly)
- See the jointly posted ONC and CMS FAQs (#24 or 10473)
Statement 7: Certifications “expire” every two years – *FICTION*
- A certification represents a “snapshot.” It indicates that EHR technology has met specific certification criteria at a fixed point in time. In other words, an EHR technology would not “lose its certification” after a given time period. If, however, certification requirements change (e.g., new and/or revised certification criteria are adopted), the snapshot the certification represents would no longer accurately reflect that the EHR technology meets the changed requirements.
- In our certification program rules, we indicated that we anticipated adopting new and/or revised certification criteria every two years to coincide with changes to the meaningful use objectives and measures under the Medicare and Medicaid EHR Incentive Programs. We did not, however, set a specific expiration for certifications. Rather, we explained that once the Secretary adopts new and/or revised certification criteria, EHR technology may need to be tested and certified again. In other words, the previously taken snapshot would no longer accurately represent what is required to meet the adopted certification criteria and, thus, would no longer be sufficient to support an EP or EH’s ability to achieve updated meaningful use requirements.
- For more information about the validity of a certification, please refer to the Temporary Certification Program final rule (75 FR 36188) and the Permanent Certification Program final rule (76 FR 1301).

As someone who has played a roll in drafting all of ONC’s regulations, I take pride in making our rules readily understandable and as easy to read as possible. Sometimes, though, no matter how hard we try to convey a regulation’s intent, there is always another believable interpretation. Hopefully, this blog helps clear up a few points and furthers your personal understanding of our rules.
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To post comments directly on ONC’s Health IT Buzz blog post, click here.

ONC and CMS: Blog Post on Resources to Become ‘Meaningful User’

Posted on January 16, 2011 by Mike Squires

Becoming a Meaningful User of EHRs: Resources from ONC and CMS
Wednesday, January 12th, 2011 | Posted by: Julie Franklin CMS and Peter Garrett ONC on ONC’s Health IT Buzz blog and republished here by e-Healthcare Marketing.

The Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS) want to help you on your journey to becoming a meaningful user of certified electronic health record (EHR) technology. Here are resources about meaningful use, Medicare and Medicaid EHR Incentive Programs, and the EHR certification process to help guide you:

Meaningful Use and Medicare and Medicaid EHR Incentive Programs

1) Meaningful Use Overview
https://www.cms.gov/EHRIncentivePrograms/01_Overview.asp

2) Path to Payment
https://www.cms.gov/EHRIncentivePrograms/10_PathtoPayment.asp

3) PowerPoint Presentation: Medicare and Medicaid EHR Incentive Programs Final Rule
https://www.cms.gov/EHRIncentivePrograms/Downloads/EHR_Incentive_Program_Agency_Training_v8-20.pdf

4) Timeline: Medicare and Medicaid EHR Incentive Programs
https://www.cms.gov/EHRIncentivePrograms/Downloads/EHRIncentProgtimeline508.pdf

5) Being a Meaningful User of Electronic Health Records
http://healthit.hhs.gov/meaningfuluse/provider

6) Meaningful Use Specification Sheets
https://www.cms.gov/EHRIncentivePrograms/Downloads/EP-MU-TOC-Core-and-MenuSet-Objectives.pdf

7) Flow Chart – Determine Eligibility for Medicare and Medicaid EHR Incentive Programs
https://www.cms.gov/EHRIncentivePrograms/downloads/eligibility_flow_chart.pdf

Certification

1) Certification Programs Overview
http://healthit.hhs.gov/certification

2) Standards and Certification Criteria Final Rule Fact Sheet
http://healthit.hhs.gov/standardsandcertification/factsheet

3) HITECH Temporary Certification Program for EHR Technology Fact Sheet
http://healthit.hhs.gov/tempcert/factsheet

4) Temporary Certification Program Final Rule Frequently Asked Questions
http://healthit.hhs.gov/tempcert/faqs

5) Permanent Certification Program
http://healthit.hhs.gov/permcert/factsheet

6) Certified Health IT Product List
http://healthit.hhs.gov/chpl

Privacy and Security

1) Building Trust in Health Information Exchange
http://healthit.hhs.gov/buildingtrust

2) Health Information Privacy and Information on HIPAA
http://www.hhs.gov/ocr/privacy/

For additional resources on certification and meaningful use check out ONC’s Meaningful Use resources:
http://healthit.hhs.gov/meaningfuluse/resources.

ONC has also funded 62 Regional Extension Centers, located across the country, to offer customized, on-the-ground assistance for providers who need help adopting and meaningfully using certified EHR technology.

You can also stay up to date on ONC and CMS activities by:

Signing up for ONC’s e-mail updates or
Visiting CMS’ Spotlight and Upcoming Events at: https://www.cms.gov/EHRIncentivePrograms/50_Spotlight.asp

What resources or tools from ONC, CMS, or other organizations have you or your practice used to help you become a meaningful user? What challenges have you faced on your road to meaningful use? We encourage you to start a dialogue and share your comments [on the ONC site].
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Please share your comments directly on the ONC Health IT Buzz blog post.

Surescripts becomes sixth ONC-Authorized Testing & Certification Body

Posted on December 29, 2010 by Mike Squires

Surescripts limited to EHR Modules of E-Prescribing, Privacy and Security
Here’s the listing found on ONC Web site on 12/29/2010 without further explanation. Surescripts is the first ATCB with this focused scope.

Surescripts LLC – Arlington, VA
Date of authorization: December 23, 2010.
Scope of authorization: EHR Modules: E-Prescribing, Privacy and Security

Blumenthal Reviews ONC’s 2010 Accomplishments on ONC Blog

Posted on December 27, 2010 by Mike Squires

2010 ONC Update Meeting: Advancing the Dialogue on Health IT
Monday, December 27th, 2010 | Posted by: Dr. David Blumenthal on ONC’s Health IT Buzz blog and republished here by e-Healthcare Marketing.

Thank you to everyone who participated in the 2010 ONC Update on December 14-15, 2010 where we had the opportunity to discuss ONC’s strategies and programs, hear about your experiences in the field, assess progress to date, and get caught up on HITECH’s implementation. Video-recordings of the webcast are now available through the ONC website at http://healthit.hhs.gov/ONCMeeting2010.

The 2010 ONC Update was held in conjunction with 2010 ONC Grantee Meeting which brought together for the first time the awardees of all of the ONC programs , including the Beacon Communities Program, Regional Extension Center Program, SHARP Program, State Health Information Exchange Program, and the many Workforce Development Programs.

This year, significant strides were made in health information technology. And for us, information technology has always been a means to an end, the end of improving health, improving the health system, making the lives of our fellow Americans better, making our nation’s health professionals and institutions able to live up to their aspirations, empowering Americans to have and take control of their own health and lives. These are the reasons why the Congress and the President enacted the HITECH Act and the reason that the Office of the National Coordinator exists today.

But, of course, there are many organizations and groups that have those high aspirations. Our unique contribution comes from a core insight that good intentions have to be powered by strong capabilities. And science and technology have created for us an enormously powerful new set of tools in the form of health information technology.

We are here to make sure that those tools are used fully to realize our collective aspirations. Information is the lifeblood of medicine. As health professionals and institutions, we are only as good as the information we have about the patients that we care for. Health IT is destined to be the circulatory system for that information in the decades to come.

The last several months have been a whirlwind of activity. And it is easy to forget how much we’ve accomplished. We established the meaningful use framework, one that I think is unprecedented in the history of electronic health information systems. No other country has laid out a similar framework for what can and should be accomplished using health information technology. And on January 3, the Centers for Medicare & Medicaid Services will launch the registration process for those who wish to participate in the Medicare and Medicaid EHR Incentive Programs.

We’ve issued a standards and certification regulation. As of this week, we have five certifying bodies that are available to certify electronic health records. They’ve certified more than 200 records and modules in the several months since they’ve been in existence.

Regional extension centers – 62 of them are working hard to provide hands-on assistance to those providers that need the most help in making this transition. As of this week, 30,000 physicians have already enrolled in these extension programs across the United States.

The State Health Information Exchange Program has provided 56 states and territories with planning grants. More than 20 of these states and territories have approved implementation plans, and new implementation plans are being approved every day.

Seventeen Beacon Communities are now in place. They didn’t exist a year ago. They are paving the way toward real improvements in health and health care in the communities they serve, leveraging health information technology. The SHARP Program is tackling new challenges through research and development.

And ONC’s Workforce Development Programs are preparing a whole new workforce and creating new jobs to support the transformation of our health care system through the use of information technology. To date, we have seen almost 2,300 new enrollees in community college programs and close to 400 in University‑based Training Programs focused on health information technology. And we are well on our way in these very early stages toward meeting that target of 10,000 new health professionals trained annually during the lifetime of the program.

In addition to our grants, we have dozens of contracts that are supporting programs like the Nationwide Health Information Network. And our Health IT Policy Committee and Health IT Standards Committee continue to provide enormously valuable guidance on the many policies and standards that are needed to support execution against our mission.

All of these efforts not only play a critical role in our strategy related to the improvement of health and health care through information technology, but also provide the foundation for health systems change and upcoming reforms in how we deliver and pay for care.

As we look to 2011, there will be many challenges. Driving change is hard. And it takes leadership, commitment and the ability to move forward – despite the many obstacles that each of you will encounter. I hope your sense of contributing something unique to health care and the American people – for most certainly you are – balances the incredibly hard work that you are undertaking. Someday you will look back and realize that you were present at the creation of something big.

Thanks again, and we look forward to our continued collaboration in the new year.
###To comment directly on ONC’s Health IT Buzz Blog, click here.
See Blumenthal Letter #22 on e-Healthcare Marketing.

Blumenthal Letter #22: Ready for Jan 3 EHR Incentives Registration?

Posted on December 27, 2010 by Mike Squires

Registration for EHR Incentive Programs
Starts January 3, 2011: Are You Ready?

Dr. David Blumenthal

A Message from Dr. David Blumenthal, the National Coordinator for Health Information Technology
December 27, 2010
Published by ONC on 12/27/2010 and republished here.

The New Year is just around the corner, and so is another milestone in our nation’s work to improve health care through health information technology. Starting on January 3, 2011, eligible health care professionals, hospitals, and critical access hospitals may register to participate in the Medicare and Medicaid EHR Incentive Programs.

This is an auspicious time. Nearly two years ago, the Health Information Technology for Economic and Clinical Health (HITECH) Act, part of the American Recovery and Reinvestment Act of 2009, was signed into law. Since then Department of Health and Human Services (HHS) agencies like the Office of the National Coordinator for Health Information Technology (ONC), the Centers for Medicare & Medicaid Services (CMS), the Office for Civil Rights (OCR), and others have implemented HITECH policies and programs to help providers adopt and achieve meaningful use of certified electronic health record technology and ensure that electronic health information remains private and secure.

[See Blumenthal's review of 2010, originally posted on ONC's Health IT Buzz blog.]

Why Become a Meaningful User?

Qualify for financial incentives from the federal government
Eligible professionals who demonstrate meaningful use have the opportunity to receive incentive payments through the Medicare and Medicaid EHR Incentive Programs—up to $44,000 from Medicare, or $63,750 from Medicaid. Under both Medicare and Medicaid, eligible hospitals may receive millions of dollars for implementing and meaningfully using certified EHR technology. Providers can get started now with the help of financial incentives from the federal government. If they wait, those incentives may not be available. And financial penalties are scheduled to take effect in five years.

Build a sustainable medical practice
The next generation of health care professionals will expect and demand that their own medical facility home have a state-of-the-art information system. Becoming a meaningful user of electronic health records will allow providers who are building their practices to recruit and retain talented young clinicians.

Improve the safety and quality of health care
The meaningful use of electronic health records will help health care providers and hospitals offer higher quality and safer care. By adopting electronic health records in a meaningful way, providers and hospitals can:

See the whole picture. All of a patient’s health information—medical history, diagnoses, medications, lab and test results—is in one place. Providers don’t have to settle for a snapshot when they can have the entire album.

Coordinate care. Providers involved in a patient’s care can access, enter, and share information in an electronic health record.

Make better decisions. With more comprehensive health information at their fingertips, providers can make better testing, diagnostic, and treatment decisions.

Save time and money. Providers who have implemented electronic health records say they spend less time searching for paper charts, transcribing, calling labs or pharmacies, reporting, and fixing coding errors.

ONC and CMS: Here To Help

Registration for the incentive programs may be close at hand, but so is assistance. If you need help in registering for the Medicare and Medicaid EHR Incentive Programs or selecting a certified EHR system, ONC and CMS have resources and services to help you.

The Medicare and Medicaid EHR Incentive Programs website contains educational resources and fact sheets with information to help eligible professionals and hospitals adopt, implement, and upgrade certified EHR technology and demonstrate meaningful use to receive EHR incentive payments.
Regional Extension Centers, which cover every region of the country, provide on-the-ground technical assistance to health care providers working to adopt and meaningfully use certified EHR technology.
The Health IT Workforce Development Program prepares skilled workers for new jobs in health IT.

Connecting to Your Community
ONC also has other programs in place to help advance the meaningful use of certified EHR technology and health information exchange:

The Beacon Community Program provides funding to selected communities that demonstrate exceptional health IT infrastructure and exchange capability—and that can model best practices in health IT for others.
The State Health Information Exchange (HIE) Cooperative Agreement Program funds states’ efforts to rapidly increase connectivity and enable the flow of patient-centric information across the health care system—within and across states.
The Strategic Health IT Advanced Research Projects (SHARP) Program supports innovative research to address problems that impede the adoption of health IT.

As 2010 comes to a close, we are well on our way as a nation to achieving the benefits of widespread adoption of EHRs. If you haven’t made any preparations to register to receive incentive payments, I encourage you to get started now. Resolve today to become a meaningful user in 2011.

Sincerely,
David Blumenthal, MD, MPP
National Coordinator for Health Information Technology
The Office of the National Coordinator for Health Information Technology (ONC) encourages you to share this information as we work together to enhance the quality, safety and value of care and the health of all Americans through the use of electronic health records and health information technology.

For more information and to receive regular updates from the Office of the National Coordinator for Health Information Technology, please subscribe to our Health IT News list.

Health IT Special Issue of The American Journal of Managed Care: Dec 2010

Posted on December 24, 2010 by Mike Squires

AJMC Publishes Health Information Technology Special Issue Online Dec 20, 2010
“Featuring scholarly articles and perspectives from policymakers, payers, providers, pharmaceutical companies, health IT vendors, health services researchers, patients, and medical educators, this [December 2010 special] issue of The American Journal of Managed Care is a reflection” of “the dramatic growth of interest in the potential for HIT to improve health and healthcare delivery,” writes Sachin H. Jain, MD, MBA and David Blumenthal, MD, MPP in their introductory article titled “Health Information Technology Is Leading Multisector Health System Transformation.” Both Jain and Blumenthal are with the Office of the National Coordinator for Health Information Technology.

Authors of 23 Articles in Special Issue
Sachin H. Jain, MD, MBA; and, David Blumenthal, MD, MPP; Cynthia L. Bero, MPH; and Thomas H. Lee, MD; Aaron McKethan, PhD; and Craig Brammer; John Glaser, PhD; Pete Stark; Newt Gingrich, PhD, MA; and Malik Hasan, MD; James N. Ciriello, MS; and Nalin Kulatilaka, PhD, MS; Seth B. Cohen, MBA, MPA; Kurt D. Grote, MD; Wayne E. Pietraszek, MBA; and Francois Laflamme, MBA; Amol S. Navathe, MD, PhD; and Patrick H. Conway, MD, MSc; Reed V. Tuckson, MD; Denenn Vojta, MD; and Andrew M. Slavitt, MBA; Marc M. Triola, MD; Erica Friedman, MD; Christopher Cimino, MD; Enid M. Geyer, MLS, MBA; Jo Wiederhorn, MSW; and Crystal Mainiero; Nancy L. Davis, PhD; Lloyd Myers, RPh; and Zachary E. Myers; Bryant A. Adibe, BS; and Sachin H. Jain, MD, MBA; Spencer S. Jones, PhD; John L. Adams, PhD; Eric C. Schneider, MD; Jeanne S. Ringel, PhD; and Elizabeth A. McGlynn, PhD; Jeffrey L. Schnipper, MD, MPH; Jeffrey A. Linder, MD, MPH; Matvey B. Palchuk, MD, MS; D. Tony Yu, MD; Kerry E. McColgan, BA; Lynn A. Volk, MHS; Ruslana Tsurikova, MA; Andrea J. Melnikas, BA; Jonathan S. Einbinder, MD, MBA; and Blackford Middleton, MD, MPH, MS;Alexander S. Misono, BA; Sarah L. Cutrona, MD, MPH; Niteesh K. Choudhry, MD, PhD; Michael A. Fischer, MD, MS; Margaret R. Stedman, PhD; Joshua N. Liberman, PhD; Troyen A. Brennan, MD, JD; Sachin H. Jain, MD, MBA; and William H. Shrank, MD, MSHS; Amir Dan Rubin, MBA, MHSA; and Virginia A. McFerran, MA; Fredric E. Blavin, MS; Melinda J. Beeuwkes Buntin, PhD; and Charles P. Friedman, PhD Robert D. Hill, PhD; Marilyn K. Luptak, PhD, MSW; Randall W. Rupper, MD, MPH; Byron Bair, MD; Cherie Peterson, RN, MS; Nancy Dailey, MSN, RN-BC; and Bret L. Hicken, PhD, MSPH; Jeffrey A. Linder, MD, MPH; Jeffrey L. Schnipper, MD, MPH; Ruslana Tsurikova, Msc, MA; D. Tony Yu, MD, MPH; Lynn A. Volk, MHS; Andrea J. Melnikas, MPH; Matvey B. Palchuk, MD, MS; Maya Olsha-Yehiav, MS; and Blackford Middleton, MD, MPH, MSc; Emily Ruth Maxson, BS; Melinda J. Beeuwkes Buntin, PhD; and Farzad Mostashari, MD, ScM; Daniel C. Armijo, MHSA; Eric J. Lammers, MPP; and Dean G. Smith, PhD; Katlyn L. Nemani, BA.

Look for an upcoming post on e-Healthcare Marketing reviewing this special issue of AJMC.

Blumenthal Blogs to Clarify EHR Certification Re: ‘Meaningful Use’

Posted on December 23, 2010 by Mike Squires

Affirming Flexibility…With Certified EHR Systems
Thursday, December 23rd, 2010 | Posted by: Dr. David Blumenthal on ONC Health IT Buzz blog and republished here by e-Healthcare Marketing

Today on our FAQ page, we are posting a revised Question and Answer regarding an issue that has recently caused confusion in our meaningful use regulations: namely, the flexibility that providers have to defer performance on some Stage 1 meaningful use objectives; and how that squares with the requirement that providers must nonetheless possess fully-certified EHR systems.

The new FAQ is meant to clarify this two-part requirement. But we should make it equally clear that our policy has not changed:

As stated in our final regulations, providers are given the flexibility to defer as many as five “menu set” objectives during Stage 1 and still achieve meaningful use. That means providers have flexibility to stage their adoption and implementation of EHRs in sync with their plans to defer certain menu set objectives.
But as also stated in our final regulations, we require EHR systems themselves be certified against all criteria adopted by the Secretary. So even though a provider has the option of deferring some objectives during Stage 1, the EHR system in the provider’s possession must be certified against all functions. Possession means having a legal right to access and use, at the provider’s discretion, all of the Stage 1 functions of a fully-certified system – but it does not imply that the provider must fully implement every one of these functions.

To understand this two-part approach, we need to look back to the development of the meaningful use regulations. From the beginning, this process was aimed at achieving the right balance – a balance between the need to achieve effective and rapid adoption of EHRs throughout the United States; and at the same time to be realistic about the challenges facing providers on the road to meaningful use.

In our final regulations, I believe HHS achieved the needed balance:

We identified the objectives that constituted meaningful use in Stage 1. These objectives are part of a coherent, longer-range plan for EHR adoption and meaningful use. We will build on these objectives as we graduate through Stage 2 and 3 of the transition process.
But at the same time, for these initial years, we recognized the challenge that this transition will pose to providers. For that reason, we gave providers flexibility in their own “staging” choices, permitting them to defer performing on as many as five of the 10 “menu set” objectives. This guarantee of flexibility, provided in our final regulations, has not been changed.

Why did we require that EHRs be certified as capable of meeting all of the certification criteria for meaningful use, even though we allowed flexibility concerning which criteria providers actually had to meet? There were several reasons.

First, our regulation stated that in Stage 2 of Meaningful Use, we will require that providers meet all the requirements laid out in Stage 1, including all 10 of objectives on the options menu. Having records capable of meeting all 10 objectives allows providers to get a head start on Stage 2 of meaningful use.

Second, we expect that some providers may try and fail to meet meaningful use objectives on one or more of the menu criteria. If their records are not capable of meeting the other optional objectives, they may be unable to obtain and implement the capabilities they lack in time to qualify for meaningful use. Thus, the requirement that certified EHRs possess the capability to meet all requirements actually gives providers the flexibility to experiment with multiple approaches to meeting meaningful use– and guarantees that if they fall short, they will not be left high and dry. This flexibility is only possible when the provider has access to certified technology for all Stage 1 functions.

The details of these requirements can be found in the new FAQ , and I invite you to read and comment. I hope it will be clear that these two elements are not in conflict, but rather represent the balance that has characterized the evolution of the meaningful use process. Finally, I hope it will be clear that there has been no change in the guarantee of provider flexibility during Stage 1.

To achieve EHR-based health care, we need to build a strong technology foundation. But at the same time, we need to recognize that providers have varying circumstances and different needs, and we seek to accommodate those differences as we support the transition to EHRs. In that spirit, we are delivering on the promise in our final regulations to give providers the flexibility they require to succeed in adoption and meaningful use of EHRs.

New EHR FAQs Added to ONC/CMS sites on eRx, Clinical Info Exchange

Posted on December 18, 2010 by Mike Squires

CMS and ONC both Add to FAQs related to Health Information Exchange on 12/12/2010
Link to PDF of ONC’s 22 Regulations FAQs. Note FAQ #21 not yet posted.
The following FAQs were excerpted on 12/18/2010.

ONC Question [12-10-022-1]:
Does the certification criterion pertaining to electronic prescribing, which references certain content exchange standards (i.e., NCPDP SCRIPT 8.1 and NCPDP SCRIPT 10.6), require that a Complete EHR or EHR Module be capable of electronically exchanging information with only external recipients (i.e., recipients that are not part of that legal entity) according to the appropriate standard (and implementation specifications) or does it apply more broadly?

Answer:
For the certification criterion pertaining to electronic prescribing (45 CFR 170.304(b)), which references those two content exchange standards adopted at 45 CFR 170.205(b) and the vocabulary standard 170.207(d) (i.e., any source vocabulary that is included in RxNorm), a Complete EHR or EHR Module must be certified as being capable of electronically generating and transmitting prescriptions and prescription-related information to external recipients in accordance with the appropriate adopted standard(s) (and implementation specifications). These standards were adopted for the purpose of enabling a user of Certified EHR Technology to “exchange” electronically certain health information, as indicated in the first sentence of the regulatory section and the section title, and as alluded to in various other parts of the Standards and Certification Criteria Interim Final and Final Rules.

We intended the capability required by this certification criterion and the referenced standards and implementation specifications to apply to the electronic exchange of prescription information between different legal entities (e.g., from an eligible professional’s Certified EHR Technology to a pharmacy that is not part of the eligible professional’s legal entity), to complement how CMS has generally described “exchange” in the context of meaningful use as information “sent between different legal entities with distinct certified EHR technology or other system that can accept the information….” (75 FR 44361-62). In the Standards and Certification Criteria Interim Final Rule and in the Standards and Certification Criteria final rule, we discussed current Medicare Part D electronic prescribing regulatory requirements for using NCPDP SCRIPT 8.1, and the anticipated use of NCPDP SCRIPT 10.6. (75 FR 2031-32, 75 FR 44625-26). In both rules, we also had explained that the purpose of the adopted standards and certification criteria was not to specify how or when Certified EHR Technology must be used, but only what capabilities Certified EHR Technology must include. (75 FR 2022-23, 75 FR 44592-93). We sought to align the adopted standards, implementation specifications, and certification criteria with certain already established regulatory requirements to ensure that Certified EHR Technology would provide a base-level of capabilities to assist users in meeting those other regulatory requirements. (See, for example, 75 FR 44591, and 75 FR 44598.) Then, when discussing electronic prescribing, we referred to the adopted NCPDP SCRIPT standard as a standard required under the Medicare Part D e-prescribing regulations when “an entity sends prescriptions outside the entity (for example, from an HMO to a non-HMO pharmacy)….” (75 FR 2031-32, 75 FR 44592). Consequently, with respect to the capability a Complete EHR or EHR Module must demonstrate in order to be certified to the certification criterion adopted at 170.304(b), a Complete EHR or EHR Module must be capable of electronically transmitting prescriptions and prescription-related information to external recipients according to NCPDP SCRIPT 8.1 or 10.6 in addition to the adopted vocabulary standard for medications at 45 CFR 170.207(d).

This approach is consistent with a principle we established in the Standards and Certification Criteria Interim Final Rule where we sought to ensure that eligible health care providers seeking to meaningfully use Certified EHR Technology and engaging in electronic exchange would be able to do so in a manner that would be compliant with other applicable law. Thus, with respect to electronic prescribing, we adopted NCPDP SCRIPT 8.1 and 10.6 to ensure that when an eligible professional electronically transmits a prescription or prescription-related information for Medicare Part D covered drugs for Medicare Part D eligible individuals to, for example, a pharmacy that is not part of the legal entity of the eligible professional, the eligible professional would be able to do so using Certified EHR Technology and also comply with the Medicare Part D e-prescribing rules.

See CMS FAQ 10284 [ or immediately below] for information about how these transmissions should be counted.

CMS Question 10284 FAQ on EHR Incentive Program
For the meaningful use objective of “generate and transmit prescriptions electronically (eRx)” for the Medicare and Medicaid Electronic Health Record (EHR) Incentive Program, how should the numerator and denominator be calculated? Should electronic prescriptions fulfilled by an internal pharmacy be included in the numerator?
Published 12/17/2010 11:34 AM | Updated 12/17/2010 11:41 AM | Answer ID 10284

ANSWER
The denominator for this objective consists of the number of prescriptions written for drugs requiring a prescription in order to be dispensed, other than controlled substances, during the EHR reporting period. The numerator consists of the number of prescriptions in the denominator generated and transmitted electronically using certified EHR technology. In order to meet the measure of this objective, 40 percent of all permissible prescriptions written by the EP must be generated and transmitted electronically according to the applicable certification criteria and associated standards adopted for certified EHR technology as specified by the Office of the National Coordinator for Health IT (ONC).

ONC has released an FAQ stating that “with respect to the capability a Complete EHR or EHR Module must demonstrate in order to be certified to the certification criterion adopted at 170.304(b), a Complete EHR or EHR Module must be capable of electronically transmitting prescriptions to external recipients according to NCPDP SCRIPT 8.1 or 10.6 in addition to the adopted vocabulary standard for medications (45 CFR 170.207(d)).” Given such FAQ, prescriptions transmitted electronically within an organization (the same legal entity) would not need to use these NCPDP standards. However, an EP’s EHR must meet all applicable certification criteria and be certified as having the capability of meeting the external transmission requirements of §170.304(b). In addition, the EHR that is used to transmit prescriptions within the organization would need to be Certified EHR Technology.

The EP would include in the numerator and denominator both types of electronic transmissions (those within and outside the organization) for the measure of this objective. We further clarify that for purposes of counting prescriptions “generated and transmitted electronically,” we consider the generation and transmission of prescriptions to occur constructively if the prescriber and dispenser are the same person and/or are accessing the same record in an integrated EHR to creating an order in a system that is electronically transmitted to an internal pharmacy.

For more information about the Medicare and Medicaid EHR Incentive Program, please visit http://www.cms.gov/EHRIncentivePrograms.

ONC Question [12-10-023-1]:
Could an interface that transmits lab results in HL7 message format between a hospital laboratory system and a physician’s EHR (presuming that the transmissions were occurring between two different legal entities) satisfy the certification criteria related to the exchange of key clinical information in 45 CFR 170.304(i) and 45 CFR 170.306(f)? If not, please specify the required data types and exchange characteristics that must be part of the required clinical information exchange.

Answer:
As implied in the question, for certification a Complete EHR or an EHR Module must have the capability to electronically receive and display, and transmit certain key clinical information in accordance with one of two separate certification criteria (45 CFR 170.304(i) or 45 CFR 170.306(f)), depending on the setting for which the EHR technology is designed (ambulatory or inpatient, respectively). Generally speaking, these certification criteria require two types of information exchange capabilities – the capability to:

Electronically receive and display a patient’s summary record, from other providers and organizations including, at a minimum, diagnostic tests results, problem list, medication list, and medication allergy list in accordance with the continuity of care document (CCD) standard (and the HITSP/C32¹ implementation specifications) or the continuity of care record (CCR) standard and that upon receipt of a patient summary record formatted according to the alternative standard, display it in human readable format.
Electronically transmit a patient summary record to other providers and organizations including, at a minimum, diagnostic test results, problem list, medication list, and medication allergy list using the CCD standard (and the HITSP/C32 implementation specifications) or the CCR standard while also representing specific named data elements (problems, laboratory test results, and medications) according to adopted standards.

Note: The above uses language from 45 CFR 170.304(i). The certification criterion adopted at 45 CFR 170.306(f) also includes “procedures” as a required, standardized data element within these exchange capabilities.

Therefore, an interface that transmits lab results in HL7 message format between a hospital laboratory system and a physician’s EHR (where the transmission is occurring between two different legal entities) would not qualify as an exchange of key clinical information that complies with the requirements of either of these two certification criteria. The interface would not satisfy the required capabilities included within the adopted certification criteria, and more specifically, the ability to transmit a patient summary record in accordance with the CCD standard (and the HITSP/C32 implementation specifications) or the CCR standard.

¹HITSP Summary Documents Using HL7 Continuity of Care Document (CCD)

Two New EHR Testing and Certification Labs; CHPL List shows Additional Software Required

Posted on December 11, 2010 by Mike Squires

ONC Site Reflects Changes: Additional Test Labs and Additional Software
Two new ONC-Authorized Testing and Certification Bodies (ATCBs) were authorized on December 10, 2010 to test and certify complete EHRs and EHR modules: Mechanicsburg, PA-based ICSA Labs and Denver, CO-based SLI Global Solutions.

Also, the CHPL list or Certified HIT Product List which “provides the authoritative, comprehensive listing of Complete EHRs and EHR Modules that have been tested and certified under the Temporary Certification Program” has been modified to reflect “additional software required.” While most of the additional software required impacts ambulatory systems, it also impacts a number of Inpatient systems. Email software appears to be the most needed software. In many cases additional components by the vendor are required as well. This area of additional software needs to be further reviewed by this blog and purchasers. The latest list is dated December 4, 2010, but was accessed on December 11, 2010.

ONC-Authorized Testing and Certification Bodies
Excerpted from Office of National Coordinator for Health IT site on 12/11/2010
The following organizations have been selected as ONC-Authorized Testing and Certification Bodies (ATCBs):

ICSA Labs – Mechanicsburg PA
Date of authorization: December 10, 2010.
Scope of authorization: Complete EHR and EHR Modules.
SLI Global Solutions – Denver CO
Date of authorization: December 10, 2010.
Scope of authorization: Complete EHR and EHR Modules.
Certification Commission for Health Information Technology (CCHIT) – Chicago, Ill.
Date of authorization: September 3, 2010.
Scope of authorization: Complete EHR and EHR Modules.
Drummond Group, Inc. (DGI) – Austin, Texas.
Date of authorization: September 3, 2010.
Scope of authorization: Complete EHR and EHR Modules.
InfoGard Laboratories, Inc. – San Luis Obispo, CA
Date of authorization: September 24, 2010.
Scope of authorization: Complete EHR and EHR Modules.

The organizations listed above have been authorized to perform Complete EHR and/or EHR Module testing and certification. These ONC-ATCBs are required to test and certify EHRs to the applicable certification criteria adopted by the Secretary under subpart C of Part 170 Part II and Part III as stipulated in the Standards and Certification Criteria Final Rule.

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:

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Health Information Exchange, Electronic Health Records and Personal Health Records

Category Archives: Certification for EHRs