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American Health Information Community

Electronic Health Records Workgroup

Summary of the 15th Web Conference of This Workgroup

Wednesday, April 18, 2007

PURPOSE OF MEETING

The 15th Web conference of the Electronic Health Records Workgroup (EHR WG), chaired by Dr. Jonathan Perlin and Ms. Lillee Gelinas, had two primary objectives: (1) hear testimony related to the legal/regulatory domain of the EHR WG’s broad charge; and (2) finalize the EHR WG’s recommendations to be presented to the Secretary of Health and Human Services (HHS) at the upcoming meeting of the American Health Information Community (AHIC) on Tuesday, April 24, 2007.

INTRODUCTORY REMARKS

Dr. Perlin and Ms. Gelinas began the meeting at 1 p.m. The minutes of the March 20, 2007, EHR WG meeting were approved, and Dr. Karen Bell updated the EHR WG on the status of action items from the March meeting:

Staff Action Item #1: Formulate possible financial recommendation focusing on pay for improvement using structure, process, and outcome measures.

Status: A draft recommendation is to be considered by the EHR WG today.

Staff Action Item #2: WG members should forward questions and requests for clarity regarding Stark and antikickback to ONC.

Status: A panel of people is to present to the EHR WG on these issues today.

Staff Action Item #3: Work on a background resolution concerning encouraging malpractice insurance companies to issue premium credits to physicians as a way to encourage adoption of EHR.

Status: A draft recommendation is to be considered by the EHR WG today.

KEY TOPICS

1. Legal/Regulatory Panel Testimony

A legal/regulatory panel organized by Howard Isenstein gave testimony on questions and concerns related to the new Stark and anti-kickback regulations and hospitals’ health information technology arrangements with physicians. Their presentations are available at http://www.hhs.gov/healthit/ahic/healthrecords/ehr_archive.html. Dr. Bell stated that the testimony would be used by an internal workgroup that HHS is pulling together to begin writing guidelines for the law.

a. Implementation Concerns about Stark and Antikickback Regulations Lawrence Hughes, Regulatory Counsel, American Hospital Association. Because the penalties included in Stark and anti-kickback regulations are very significant, Mr. Hughes explained, it is important for hospitals to be certain that the arrangements they develop comply. Currently, some hospitals have questions and concerns about the lack of specific guidance from Internal Revenue Service with regard to tax exemptions pertaining to health information technology provided to physicians. In addition, some hospitals have concerns about the new regulations’ restrictions on permissible donations of information technology (notably, the exclusion of hardware and security infrastructure); the evolving definition of interoperability and its value as a fraud and abuse concept; 12-month certification requirement and its impact on multiyear rollouts; definition of equivalency; and cost-sharing requirements. From the hospitals’ perspective, in order to encourage the adoption of health information technology it is best if the regulations have limited complexities and great clarity.

b. Stark Regulations Case Study Andreanna Ksidakis, Vice President and Deputy General Counsel, Sutter Health. Ms. Ksidakis discussed the challenges that Sutter Health, a nonprofit, community-based, tax-exempt health care system primarily located in northern California, has had in trying to implement interoperable electronic health records (EHRs) in its diverse system. She noted the following challenges: the no loans to physicians Stark provision and how to handle those physicians that do not pay on time; the 15% cost sharing requirements; and security issues with regards to what comprises the legal medical records and its ownership.

c. How to Improve the EHR Fraud Exceptions Jeffrey Micklos, Senior Vice President and General Counsel, Federation of American Hospitals. Mr. Micklos offered recommendations for addressing several problems identified by Mr. Hughes, either through the Federal regulatory process or via Federal legislation. He suggested that the cost-sharing requirement should be modified to say “at least 15%” and denote what that 15% entails. He also noted the need for more flexibility in definition of interoperability and to adopt an exception similar to Stark for the civil monetary penalties law. He also noted that there are particular states whose fraud and abuse rules are either directly inconsistent or arguably inconsistent with the federal standards.

2. Finalizing the EHR WG’s April 2007 Recommendations to the HHS Secretary and AHIC

For much of the meeting, EHR WG members focused on finalizing recommendations to the AHIC on how to expedite the widespread adoption of interoperable EHRs. The final recommendations from the EHR WG are to be presented to the AHIC at the meeting on April 24, 2007. A draft recommendation letter from the EHR WG proposed recommendations in three specific domains: business case alignment, workflow and culture, and medical-legal concerns. The letter also included an overarching recommendation to advance the adoption of certified EHRs via differential Medicare reimbursement to healthcare providers.

a. Business Case Alignment. EHR WG members agreed to separate the recommendation pertaining to business case alignment in the Workgroup’s final recommendations letter into two recommendations along the lines of the following:

Recommendation 1.0: As the Federal Government develops language in its contracts with health plans and insurers to support the widespread adoption of Health Information Technology Standards Panel interoperability standards, this language should foster the use of pay-for-performance programs for physicians that include structural measures to incent the adoption and effective use of certified EHRs. This emphasis on structural measures may be limited to a specific time frame with the ultimate goal of using process and outcome measures to assess performance.

Recommendation 1.1: These pay-for-performance programs should use reliable, standardized, and validated tools which are currently available to assess structural measures as defined by the Medicare Payment Advisory Commission, such as the National Committee on Quality Assurance’s Physician’s Practice Connections or the Centers for Medicare & Medicaid Services publicly available Office System Survey.

b. Workflow and Culture. EHR WG members agreed to add language to the first paragraph in the workflow and culture section of the Workgroup’s final recommendations letter to note that there are programs other than the Doctors’ Office Quality-Information Technology University that are helping small physician practices address the special challenges of EHR implementation.

c. Medical-legal Concerns. EHR WG members agreed to highlight (by underlining or bold facing) the key sentence in the text of the Workgroup’s final recommendations letter beginning, “Clear, focused, easy-to-find documentation of health information decreases overall cost of claims paid by malpractice coverage entities…,” as well as to highlight similar key sentences in other portions of the letter.

In addition, EHR WG members agreed to separate the recommendation pertaining to medical-legal concerns in the final letter into the following two recommendations:

Recommendation 3.0: HHS should work with the Certification Commission for Healthcare Information Technology to obtain medial-legal counsel to ensure that its functional criteria include documentation approaches that will mitigate malpractice risk.

Recommendation 3.1: HHS should meet with malpractice insurers throughout the country to encourage premium reductions for those physicians who have adopted certified EHRs.

Overarching Recommendation on Medicare Reimbursement. EHR WG members agreed to change the language in the overarching Medicare reimbursement recommendation from “Medicare providers” to “Medicare physicians,” but to emphasize that the EHR WG believes that the recommendation eventually will be applicable to a much broader group of providers. They also agreed to change the introductory material to reflect this change.

Recommendation 4.0: HHS should develop a schedule for implementing differential reimbursement to Medicare physicians for use or nonuse of EHRs. While we would defer to Departmental expertise, we note that this might be achieved bypaying full Medicare rates and market basket updates (and possibly an “EHR premium”) to physicians using certified EHRs, while physicians using paper-based records are paid at discounted rates achieved by nonqualification for full market basket updates or other measures.

Finally, EHR WG members agreed to add a paragraph to the text of the EHR WG’s final recommendations letter explaining why the letter does not include any recommendations in the two key domains related to the Workgroup’s broad charge: privacy/security and technology.

3. Public Comment

Angela Jeansonne, from the American Osteopathic Association, reiterated concerns about helping physicians are in smaller practices, especially those in rural or underserved areas, cope with costs and other challenges of adopting and using EHRs. Nora Notolu, a recent graduate of UNC Chapel Hill, asked a question about incorporating clinical trial data into EHRs, and Howard Isenstein suggested that CDISC was preparing a standard for electronic entry of clinical trial data.

SUMMARY OF ACTION ITEMS

Overarching Staff Action Item: Revise the EHR WG’s recommendations letter for the April 24, 2007 AHIC meeting. Send the new version via email to EHR WG members so that their comments can be incorporated in the final letter by 5 p.m.

Status: COMPLETED

MEETING MATERIALS

Agenda

Presentations

Lawrence Hughes - Health IT Arrangements with Physicians: Implementation Concerns

Jeffrey Micklos - How to Improve the EHR Fraud Exceptions

Draft Recommendation Letter (for April 24 AHIC Meeting)

Electronic Health Records Workgroup

Members and Designees Participating in the Web Conference

Co-chairs

Lillee Smith Gelinas

VHA, Inc.

Jonathan B. Perlin

HCA, Inc.

Office of the National Coordinator for Health Information Technology Staff

Karen Bell

Alicia Bradford

Members and Designees

Carolyn Clancy

HHS/Agency for Healthcare Research and Quality

Jason DuBois (for Alan Mertz)

American Clinical Laboratory Association

Howard Isenstein (for Chip Kahn)

Federation of American Hospitals

Mike Kappel (for Pam Pure)

McKesson

Connie Laubenthal (for John Tooker)

American College of Physicians

Robert Smith

Department of Veterans Affairs

Jim Sorace (for Barry Straube)

Centers for Medicare and Medicaid Services

Presenters

Lawrence Hughes

American Hospital Association

Andreanna Ksidakis

Sutter Health

Jeffrey Micklos

Federation of American Hospitals

Disclaimer: The views expressed in written conference materials or publications and by speakers and moderators at HHS-sponsored conferences do not necessarily reflect the official policies of HHS; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.