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Implementing the 21St Century Cures Act: an Update from the Office of the Na- Tional Coordinator

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Implementing the 21St Century Cures Act: an Update from the Office of the Na- Tional Coordinator IMPLEMENTING THE 21ST CENTURY CURES ACT: AN UPDATE FROM THE OFFICE OF THE NA- TIONAL COORDINATOR HEARING BEFORE THE SUBCOMMITTEE ON HEALTH OF THE COMMITTEE ON ENERGY AND COMMERCE HOUSE OF REPRESENTATIVES ONE HUNDRED FIFTEENTH CONGRESS SECOND SESSION DECEMBER 11, 2018 Serial No. 115–173 ( Printed for the use of the Committee on Energy and Commerce energycommerce.house.gov U.S. GOVERNMENT PUBLISHING OFFICE 36–819 PDF WASHINGTON : 2019 VerDate Mar 15 2010 13:13 Aug 05, 2019 Jkt 037690 PO 00000 Frm 00001 Fmt 5011 Sfmt 5011 P:\115THCONGRESS\115X173X21CCURESONC\115X173X21CCURESONCWORKING W CED-24 with DISTILLER COMMITTEE ON ENERGY AND COMMERCE GREG WALDEN, Oregon Chairman JOE BARTON, Texas FRANK PALLONE, JR., New Jersey Vice Chairman Ranking Member FRED UPTON, Michigan BOBBY L. RUSH, Illinois JOHN SHIMKUS, Illinois ANNA G. ESHOO, California MICHAEL C. BURGESS, Texas ELIOT L. ENGEL, New York MARSHA BLACKBURN, Tennessee GENE GREEN, Texas STEVE SCALISE, Louisiana DIANA DEGETTE, Colorado ROBERT E. LATTA, Ohio MICHAEL F. DOYLE, Pennsylvania CATHY MCMORRIS RODGERS, Washington JANICE D. SCHAKOWSKY, Illinois GREGG HARPER, Mississippi G.K. BUTTERFIELD, North Carolina LEONARD LANCE, New Jersey DORIS O. MATSUI, California BRETT GUTHRIE, Kentucky KATHY CASTOR, Florida PETE OLSON, Texas JOHN P. SARBANES, Maryland DAVID B. MCKINLEY, West Virginia JERRY MCNERNEY, California ADAM KINZINGER, Illinois PETER WELCH, Vermont H. MORGAN GRIFFITH, Virginia BEN RAY LUJA´ N, New Mexico GUS M. BILIRAKIS, Florida PAUL TONKO, New York BILL JOHNSON, Ohio YVETTE D. CLARKE, New York BILLY LONG, Missouri DAVID LOEBSACK, Iowa LARRY BUCSHON, Indiana KURT SCHRADER, Oregon BILL FLORES, Texas JOSEPH P. KENNEDY, III, Massachusetts SUSAN W. BROOKS, Indiana TONY CA´ RDENAS, California MARKWAYNE MULLIN, Oklahoma RAUL RUIZ, California RICHARD HUDSON, North Carolina SCOTT H. PETERS, California KEVIN CRAMER, North Dakota DEBBIE DINGELL, Michigan TIM WALBERG, Michigan MIMI WALTERS, California RYAN A. COSTELLO, Pennsylvania EARL L. ‘‘BUDDY’’ CARTER, Georgia JEFF DUNCAN, South Carolina SUBCOMMITTEE ON HEALTH MICHAEL C. BURGESS, Texas Chairman BRETT GUTHRIE, Kentucky GENE GREEN, Texas Vice Chairman Ranking Member JOE BARTON, Texas ELIOT L. ENGEL, New York FRED UPTON, Michigan JANICE D. SCHAKOWSKY, Illinois JOHN SHIMKUS, Illinois G.K. BUTTERFIELD, North Carolina MARSHA BLACKBURN, Tennessee DORIS O. MATSUI, California ROBERT E. LATTA, Ohio KATHY CASTOR, Florida CATHY MCMORRIS RODGERS, Washington JOHN P. SARBANES, Maryland LEONARD LANCE, New Jersey BEN RAY LUJA´ N, New Mexico H. MORGAN GRIFFITH, Virginia KURT SCHRADER, Oregon GUS M. BILIRAKIS, Florida JOSEPH P. KENNEDY, III, Massachusetts BILLY LONG, Missouri TONY CA´ RDENAS, California LARRY BUCSHON, Indiana ANNA G. ESHOO, California SUSAN W. BROOKS, Indiana DIANA DEGETTE, Colorado MARKWAYNE MULLIN, Oklahoma FRANK PALLONE, JR., New Jersey (ex RICHARD HUDSON, North Carolina officio) EARL L. ‘‘BUDDY’’ CARTER, Georgia GREG WALDEN, Oregon (ex officio) (II) VerDate Mar 15 2010 13:13 Aug 05, 2019 Jkt 037690 PO 00000 Frm 00002 Fmt 0486 Sfmt 5904 P:\115THCONGRESS\115X173X21CCURESONC\115X173X21CCURESONCWORKING W CED-24 with DISTILLER CONTENTS Page Hon. Michael C. Burgess, a Representative in Congress from the State of Texas, opening statement .................................................................................... 1 Prepared statement .......................................................................................... 3 Hon. Gene Green, a Representative in Congress from the State of Texas, opening statement ................................................................................................ 4 Prepared statement .......................................................................................... 5 Hon. Marsha Blackburn, a Representative in Congress from the State of Tennessee, opening statement ............................................................................ 6 Hon. Greg Walden, a Representative in Congress from the State of Oregon, prepared statement .............................................................................................. 41 Hon. Frank Pallone, Jr., a Representative in Congress from the State of New Jersey, prepared statement ........................................................................ 41 WITNESS Donald Rucker, M.D., National Coordinator for Health Information Tech- nology, Department of Health and Human Services ......................................... 7 Prepared statement .......................................................................................... 9 SUBMITTED MATERIAL Statement of the College of Healthcare Information Management Executives, December 11, 2018, submitted by Mr. Burgess ................................................. 43 Letter of December 11, 2018, from Clifford Hudis, Chief Executive Officer, American Society of Clinical Onocology, to Mr. Burgess and Mr. Green, submitted by Mr. Burgess ................................................................................... 48 (III) VerDate Mar 15 2010 13:13 Aug 05, 2019 Jkt 037690 PO 00000 Frm 00003 Fmt 5904 Sfmt 5904 P:\115THCONGRESS\115X173X21CCURESONC\115X173X21CCURESONCWORKING W CED-24 with DISTILLER VerDate Mar 15 2010 13:13 Aug 05, 2019 Jkt 037690 PO 00000 Frm 00004 Fmt 5904 Sfmt 5904 P:\115THCONGRESS\115X173X21CCURESONC\115X173X21CCURESONCWORKING W CED-24 with DISTILLER IMPLEMENTING THE 21ST CENTURY CURES ACT: AN UPDATE FROM THE OFFICE OF THE NATIONAL COORDINATOR TUESDAY, DECEMBER 11, 2018 HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON HEALTH, COMMITTEE ON ENERGY AND COMMERCE, Washington, DC. The subcommittee met, pursuant to call, at 10:15 a.m., in room 2322, Rayburn House Office Building, Hon. Michael Burgess (chair- man of the subcommittee) presiding. Members present: Representatives Burgess, Guthrie, Upton, Blackburn, Latta, Griffith, Bilirakis, Long, Bucshon, Brooks, Mullin, Hudson, Carter, Green, Engel, Matsui, Castor, Kennedy, Ca´rdenas, Eshoo, and DeGette. Staff present: Adam Buckalew, Professional Staff Member, Health; Daniel Butler, Legislative Clerk, Health; Adam Fromm, Di- rector of Outreach and Coalitions; Caleb Graff, Professional Staff Member, Health; Ed Kim, Policy Coordinator, Health; J.P. Paluskiewicz, Professional Staff Member, Health; Brannon Rains, Staff Assistant; Austin Stonebraker, Press Assistant; Tiffany Guarascio, Minority Deputy Staff Director and Chief Health Advi- sor; Samantha Satchell, Minority Senior Policy Analyst; and C.J. Young, Minority Press Secretary. OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS Mr. BURGESS. The subcommittee on Health will come to order, and I will recognize myself 5 minutes for the purpose of an opening statement, and I want to thank everyone for joining us for this im- portant and long-awaited hearing in 2018. In 2018 we have held two Cures implementation hearings, in- cluding focusing on biomedical research and innovation at the Na- tional Institute of Health and the Food and Drug Administration and the hearing on the mental health title. Today’s hearing com- pletes the 21st Century Cures trifecta covering the last remaining title, Health Information Technology. Our society, our economy have become increasingly driven by technology, and healthcare, of course, is no exception. Electronic health records, patient data, the move to open application program- ming interfaces, and other developments have brought healthcare into the 21st century. Law lagged behind such advances which led to various pieces of legislation to address the aforementioned issues (1) VerDate Mar 15 2010 13:13 Aug 05, 2019 Jkt 037690 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 P:\115THCONGRESS\115X173X21CCURESONC\115X173X21CCURESONCWORKING W CED-24 with DISTILLER 2 including the HITECH Act in 2009 and 21st Century Cures Act in 2016. Cures built on top of the foundation laid by the HITECH Act which passed in 2009 and encouraged adoption and the use of elec- tronic health records through payment incentives and penalties. For the record, I opposed that. This law also established the Office of National Coordinator for Health Information Technology in stat- ute. Previously it had been via executive order, but the HITECH Act established that in statute, signifying the importance of health IT in the future of healthcare data and delivery. Some argue that HITECH was well intentioned. Stakeholders have reported concerns during implementation related to the inter- operability and functionality of this technology. While we have seen widespread adoption of electronic health records, there does con- tinue to be significant fragmentation of the healthcare system, making it difficult to ensure continuity of evidence-based care for patients. The 21st Century Cures Act has set us on a path toward achieving this nationwide interoperable healthcare information sys- tem, and the idea is to put the needs of patients and providers first. The first health IT provision in Cures was aimed at assisting doctors and hospitals in improving the quality of care for patients. One goal of this provision was to reduce the burden on physicians regarding electronic health records. As the Office of National Coor- dinator moves forward, it is of utmost importance that it take into account the impact of policies on both patients and physicians. Section 4003 of the Cures act expedites interoperability and secu- rity among electronic health records through a voluntary model framework and a common agreement among vendors. The Office of National
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