Assessing Hipaa: How Federal Medical Record Privacy Regulations Can Be Im- Proved
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ASSESSING HIPAA: HOW FEDERAL MEDICAL RECORD PRIVACY REGULATIONS CAN BE IM- PROVED HEARING BEFORE THE SUBCOMMITTEE ON HEALTH OF THE COMMITTEE ON ENERGY AND COMMERCE HOUSE OF REPRESENTATIVES ONE HUNDRED SEVENTH CONGRESS FIRST SESSION MARCH 22, 2001 Serial No. 107–15 Printed for the use of the Committee on Energy and Commerce ( Available via the World Wide Web: http://www.access.gpo.gov/congress/house U.S. GOVERNMENT PRINTING OFFICE 71–494PS WASHINGTON : 2001 For sale by the Superintendent of Documents, U.S. Government Printing Office Internet: bookstore.gpo.gov Phone: (202) 512–1800 Fax: (202) 512–2250 Mail: Stop SSOP, Washington, DC 20402–0001 VerDate 11-MAY-2000 10:53 Jun 29, 2001 Jkt 000000 PO 00000 Frm 00001 Fmt 5011 Sfmt 5011 71494.TXT HCOM2 PsN: HCOM2 VerDate 11-MAY-2000 10:53 Jun 29, 2001 Jkt 000000 PO 00000 Frm 00002 Fmt 5011 Sfmt 5011 71494.TXT HCOM2 PsN: HCOM2 COMMITTEE ON ENERGY AND COMMERCE W.J. ‘‘BILLY’’ TAUZIN, Louisiana, Chairman MICHAEL BILIRAKIS, Florida JOHN D. DINGELL, Michigan JOE BARTON, Texas HENRY A. WAXMAN, California FRED UPTON, Michigan EDWARD J. MARKEY, Massachusetts CLIFF STEARNS, Florida RALPH M. HALL, Texas PAUL E. GILLMOR, Ohio RICK BOUCHER, Virginia JAMES C. GREENWOOD, Pennsylvania EDOLPHUS TOWNS, New York CHRISTOPHER COX, California FRANK PALLONE, Jr., New Jersey NATHAN DEAL, Georgia SHERROD BROWN, Ohio STEVE LARGENT, Oklahoma BART GORDON, Tennessee RICHARD BURR, North Carolina PETER DEUTSCH, Florida ED WHITFIELD, Kentucky BOBBY L. RUSH, Illinois GREG GANSKE, Iowa ANNA G. ESHOO, California CHARLIE NORWOOD, Georgia BART STUPAK, Michigan BARBARA CUBIN, Wyoming ELIOT L. ENGEL, New York JOHN SHIMKUS, Illinois TOM SAWYER, Ohio HEATHER WILSON, New Mexico ALBERT R. WYNN, Maryland JOHN B. SHADEGG, Arizona GENE GREEN, Texas CHARLES ‘‘CHIP’’ PICKERING, Mississippi KAREN MCCARTHY, Missouri VITO FOSSELLA, New York TED STRICKLAND, Ohio ROY BLUNT, Missouri DIANA DEGETTE, Colorado TOM DAVIS, Virginia THOMAS M. BARRETT, Wisconsin ED BRYANT, Tennessee BILL LUTHER, Minnesota ROBERT L. EHRLICH, Jr., Maryland LOIS CAPPS, California STEVE BUYER, Indiana MICHAEL F. DOYLE, Pennsylvania GEORGE RADANOVICH, California CHRISTOPHER JOHN, Louisiana CHARLES F. BASS, New Hampshire JANE HARMAN, California JOSEPH R. PITTS, Pennsylvania MARY BONO, California GREG WALDEN, Oregon LEE TERRY, Nebraska DAVID V. MARVENTANO, Staff Director JAMES D. BARNETTE, General Counsel REID P.F. STUNTZ, Minority Staff Director and Chief Counsel SUBCOMMITTEE ON HEALTH MICHAEL BILIRAKIS, Florida, Chairman JOE BARTON, Texas SHERROD BROWN, Ohio FRED UPTON, Michigan HENRY A. WAXMAN, California JAMES C. GREENWOOD, Pennsylvania TED STRICKLAND, Ohio NATHAN DEAL, Georgia THOMAS M. BARRETT, Wisconsin RICHARD BURR, North Carolina LOIS CAPPS, California ED WHITFIELD, Kentucky RALPH M. HALL, Texas GREG GANSKE, Iowa EDOLPHUS TOWNS, New York CHARLIE NORWOOD, Georgia FRANK PALLONE, Jr., New Jersey Vice Chairman PETER DEUTSCH, Florida BARBARA CUBIN, Wyoming ANNA G. ESHOO, California HEATHER WILSON, New Mexico BART STUPAK, Michigan JOHN B. SHADEGG, Arizona ELIOT L. ENGEL, New York CHARLES ‘‘CHIP’’ PICKERING, Mississippi ALBERT R. WYNN, Maryland ED BRYANT, Tennessee GENE GREEN, Texas ROBERT L. EHRLICH, Jr., Maryland JOHN D. DINGELL, Michigan, STEVE BUYER, Indiana (Ex Officio) JOSEPH R. PITTS, Pennsylvania W.J. ‘‘BILLY’’ TAUZIN, Louisiana (Ex Officio) (II) VerDate 11-MAY-2000 10:53 Jun 29, 2001 Jkt 000000 PO 00000 Frm 00003 Fmt 6011 Sfmt 0486 71494.TXT HCOM2 PsN: HCOM2 C O N T E N T S Page Testimony of: Appelbaum, Paul, Chairman, Department of Psychiatry, University of Massachusetts Medical School ..................................................................... 47 Clough, John D., Director of Health Affairs, Cleveland Clinic Foundation . 34 Foley, Mary E., President, American Nurses Association ............................. 37 Goldman, Janlori, Director, Health Privacy Project, Institute for Health Care Research and Policy, Georgetown University .................................... 57 Heird, Robert, Senior Vice President, Anthem Bluecross Blueshield .......... 69 Melski, John, Medical Director of Informatics, Marshfield Clinic ................ 40 Ortiz, Carlos R., Director of Government Affairs, CVS Pharmacy ............... 53 Material submitted for the record by: American Association of Health Plans, prepared statement of .................... 111 American Association of Occupational Health Nurses, Inc., letter dated March 26, 2001, providing comments for the record ................................. 113 Lower, Robert C., Alston & Bird LLP, prepared statement of ..................... 109 (III) 2 VerDate 11-MAY-2000 10:53 Jun 29, 2001 Jkt 000000 PO 00000 Frm 00004 Fmt 0486 Sfmt 0486 71494.TXT HCOM2 PsN: HCOM2 ASSESSING HIPAA: HOW FEDERAL MEDICAL RECORD PRIVACY REGULATIONS CAN BE IMPROVED THURSDAY, MARCH 22, 2001 HOUSE OF REPRESENTATIVES, COMMITTEE ON ENERGY AND COMMERCE, SUBCOMMITTEE ON HEALTH, Washington, DC. The subcommittee met, pursuant to notice, at 10:05 a.m. In Room 2123, Rayburn House Office Building, Hon. Michael Bilirakis (chairman) presiding. Members present: Representatives Bilirakis, Upton, Greenwood, Whitfield, Ganske, Norwood, Shadegg, Bryant, Buyer, Pitts, Tauzin (ex officio), Brown, Waxman, Barrett, Capps, Stupak, Engel, Wynn, Green, and Dingell (ex officio). Also present: Representative Markey. Staff present: Marc Wheat, majority counsel; Brent Delmonte, majority counsel; Kristi Gillis, legislative clerk; and John Ford, mi- nority counsel. Mr. BILIRAKIS. Can we have order please? Good morning. Today the subcommittee tackles a very complex issue, the medical records privacy rule issued last year by the outgoing administration. This is an issue of great importance to both health care con- sumers and the regulated community, and we will hear the views of expert witnesses about whether the rule adequately balances the interests involved. Americans should feel secure in knowing that their medical records are kept confidential in virtually every instance, unless dis- closure of their record is authorized by the patients themselves. The best way to ensure open and honest communication between providers and patients is to guarantee that the information shared during such exchanges is kept out of the public domain. That being said, I have concerns that the regulation issued late last year which is presently undergoing a comment period may not strike the balance appropriately. For example, some local phar- macists from our districts have said that the rule may prevent from them filling prescriptions unless they have received a signed au- thorization from the patient. While that requirement may sound reasonable, we must think of the elderly shut-in who needs her son or daughter to pick up her prescriptions. Under the rule, she could not get her prescriptions filled without going to the pharmacy to fill out the form and pick up the prescription in person. This may not (1) VerDate 11-MAY-2000 10:53 Jun 29, 2001 Jkt 000000 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 71494.TXT HCOM2 PsN: HCOM2 2 be difficult for most people, but it could be a major problem for a frail elderly individual. Likewise, concerns have been raised about the burdens this may place on small rural hospitals. I am told that the rule requires them to keep written consent for 6 years. This raises several ques- tions: Is it necessary to keep these records? Does this record- keeping requirement help or hurt patients and providers? We should be concerned if money that would otherwise be spent on pa- tient care would be diverted to other efforts to comply with this regulation. Whether that result is likely or possible is a question we must explore today. I would also like to explore why statutory authorization language was dropped from the proposed rule. When the Clinton administra- tion first proposed its regulations, there was no requirement to ob- tain the specific consent of the patient before disclosing information for treatment and payment. In fact, the proposed rule indicated that such a requirement could impair care. Subsequently, however, this provision was replaced by a requirement to obtain specific con- sent. Certainly there are instances when specific consent should be required before medical information is shared with others. How- ever, it may not be necessary in other situations, such as when calling patients, when scheduling appointments, or answering questions about medication interactions when patients call pro- viders. Finally, I want to address one concern up front. We will not hear today from an administration witness. When an initial inquiry was made by us, the Department of Health and Human Services indi- cated that it could not provide a witness to testify on the regulation until the comment period ended. We have since learned that the Department does not face any legal obstacle but, rather, that the regulation issued by the previous administration is currently under review and policy analysis by the new administration. In light of the change in leadership at HHS and the complexity of these issues, I understand the Department’s position. However, I also appreciate very much the concerns raised by a number of our colleagues. I know we will hear those concerns in opening state- ments this morning from members who would like to hear from the current administration on these important issues; and we all want to hear from the current administration regarding these issues. We have asked them to provide their views on this issue at a fu- ture hearing, and we are making every effort