Feds pro­pose tougher look at whether EHRs work

Modern Healthcare - - NEWS - By Dar­ius Tahir

The fed­eral health in­for­ma­tion tech­nol­ogy co­or­di­na­tor’s pro­posed cer­ti­fi­ca­tion rule sig­nals that the agency wants to bet­ter en­sure that elec­tronic health-record sys­tems per­form as promised.

Last week, HHS’ Of­fice of the Na­tional Co­or­di­na­tor for Health IT pro­posed a two-pronged ap­proach to achieve that goal. It will in­crease trans­parency for EHR sys­tems mar­keted to providers and en­cour­age EHR cer­ti­fy­ing bod­ies to raise their min­i­mum stan­dards.

“This will cre­ate an­other level of ac­count­abil­ity,” said Cletis Earle, chief in­for­ma­tion of­fi­cer at St. Luke’s Corn­wall Hos­pi­tal, New­burgh, N.Y. “We’re all chal­lenged by lack of func­tion­al­ity to hit th­ese (mean­ing­ful-use) mea­sures,” he said. “It’s be­cause th­ese sys­tems are not truly ready.”

Providers say it’s com­mon for them to pur­chase a “com­plete” EHR, cer­ti­fied as com­ply­ing with the mean­ing­ful-use pro­gram, only to find that they have to pay ex­tra to achieve the pro­gram’s goals.

The cer­ti­fi­ca­tion pro­gram is sup­posed to give clients as­sur­ance that what they’re buy­ing can per­form the tasks re­quired by the fed­eral mean­ing­ful-use pro­gram. Cer­ti­fy­ing groups in­spect EHRs in a con­trolled en­vi­ron­ment, then check to see if they work in the field.

But some buy­ers say the cer­ti­fied EHRs of­ten do not per­form as promised, and ac­tion is needed to en­sure that they do. Earle said that when the sec­ond stage of the mean­ing­ful-use in­cen­tive pro­gram rolled out, St. Luke’s Corn­wall was us­ing Meditech Magic, ver­sion 5.66. Ac­cord­ing to the gov­ern­ment’s EHR list, the pro­gram is cer­ti­fied for the “view, down­load and trans­mit” func­tion, which al­lows pa­tients to ac­cess their data and trans­port it else­where.

Earle said, how­ever, that the soft­ware didn’t ac­tu­ally have that ca­pa­bil­ity. So he ei­ther had to buy a mod­ule from Meditech or a third party, or build one. Earle chose to buy one, which cost “tens of thou­sands of dol­lars.” Meditech did not re­spond to a re­quest for com­ment.

“Time and time again, I’m go­ing back to my ven­dors, and say­ing, ‘Look, th­ese are the reg­u­la­tory re­quire­ments, and you’re not nec­es­sar­ily mak­ing sure we fit those ini­tia­tives,’ ” he said.

Charles Chris­tian, CIO of St. Fran­cis Hos­pi­tal in Colum­bus, Ga., said he’s had sim­i­lar ex­pe­ri­ences with his hos­pi­tal’s EHR and di­rect mes­sag­ing us­ing the C-CDA stan­dard, which al­lows hos­pi­tals to ex­change pa­tient data. His ven­dor at­tempted to sell the ca­pa­bil­ity as an ex­tra, de­spite claim­ing the EHR was com­plete. “Af­ter ex­press­ing my dis­ap­point­ment that they would use this as a rev­enue op­por­tu­nity, I was suc­cess­ful in get­ting the ser­vices turned on with­out ad­di­tional costs,” he said.

Dr. Farzad Mostashari, who for­merly headed the ONC and now is CEO of the health IT firm Aledade, said such prob­lems likely spurred the ONC to act. “I don’t think that ev­ery ven­dor did this, or ev­ery cer­ti­fi­ca­tion re­quire­ment was treated this way,” he said. “But enough ven­dors are do­ing it in enough cer­ti­fi­ca­tion cri­te­ria.”

To win cer­ti­fi­ca­tion, the ONC now wants EHR ven­dors to dis­close more in­for­ma­tion about the use of their sys­tems, in­clud­ing how much it would cost to make the EHR per­form as cer­ti­fied. The other prong of the agency’s pro­posal is to in­crease sur­veil­lance re­quire­ments. The agency hopes that higher min­i­mum re­quire­ments will stim­u­late more thor­ough sur­veil­lance by cer­ti­fy­ing bod­ies. The in­tent is for the cer­ti­fy­ing bod­ies to in­ves­ti­gate whether the EHR sys­tems are per­form­ing in the field as they do in the lab.

That will be ac­com­plished through two meth­ods: re­ac­tive sur­veil­lance, in which a cer­ti­fy­ing body re­sponds to com­plaints from cus­tomers in the field; and ran­dom­ized sur­veil­lance, in which a cer­ti­fy­ing body proac­tively in­spects EHRs used by clin­i­cians.

With ran­dom­ized sur­veil­lance, the agency pro­poses that each cer­ti­fy­ing body must se­lect 10% of its cer­ti­fied prod­ucts per year to in­spect for com­pli­ance.

Strength­en­ing the in­spec­tion re­quire­ments is crit­i­cal, Mostashari said. Up to now, he said, ven­dors “de­velop the func­tion­al­ity in or­der to pass the (cer­ti­fi­ca­tion) test. They don’t bother re­work­ing the whole prod­uct to make that func­tion or fea­ture a core part of their pro­duc­tion en­vi­ron­ment.”

But Earle wor­ries that the au­di­tors testing the sys­tems might not be up to the job, say­ing they need to have clin­i­cal ex­pe­ri­ence to un­der­stand why cer­tain func­tion­al­i­ties might fail.

As a part of the pro­posed rule, the ONC is con­sid­er­ing how to go about strip­ping an EHR’s cer­ti­fi­ca­tion. But de­cer­ti­fy­ing a prod­uct means it can­not be used to at­test for mean­ing­ful use— which af­fects all the providers us­ing that prod­uct, Mostashari warned. They might have to switch sys­tems or hope the prod­uct can re­gain cer­ti­fi­ca­tion. “There has to be a lot of thought given to the process, to the due process, and how to min­i­mize the po­ten­tial im­pact to the in­no­cent by­standers,” he said.

“This will cre­ate an­other level of ac­count­abil­ity. We’re all chal­lenged by lack of func­tion­al­ity to hit th­ese (mean­ing­ful-use) mea­sures. It’s be­cause th­ese sys­tems are not truly ready.” Cletis Earle Chief in­for­ma­tion of­fi­cer St. Luke’s Corn­wall Hos­pi­tal

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