On reg­u­la­tion

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MH: The 21st Cen­tury Cures Act has a whole sec­tion on EHRs that states, “pro­mote in­ter­op­er­abil­ity; pro­mote us­abil­ity; pro­mote pa­tient-cen­tric care.” It’s all very gen­eral. What does this ad­min­is­tra­tion need to do to lower the reg­u­la­tory bur­den yet achieve the prom­ise of EHRs?

Halamka: I met with CMS of­fi­cials this morn­ing. This does not rep­re­sent any of­fi­cial gov­ern­ment pol­icy. But what did the CMS say? Value-based pur­chas­ing is here to stay. They’ll be less pre­scrip­tive of how you achieve that value and that out­come. Qual­ity mea­sures need rad­i­cal re­vi­sion be­cause many of them are not rel­e­vant to work­flow and are too com­plex. I think you’ll see the pri­vate sec­tor have an op­por­tu­nity to in­no­vate be­cause the reg­u­la­tions will not say, “Buy a DVD player that’s pur­ple with two green but­tons.” The reg­u­la­tions will say, “Play movies.” That’s what the CMS is think­ing.

Probst: Hav­ing worked with (HHS Sec­re­tary Dr. Tom) Price’s of­fice prior to his ap­point­ment, the sen­ti­ment is we have too much reg­u­la­tion. His staff wasn’t very sup­port­ive of mean­ing­ful use. Hav­ing been on the orig­i­nal com­mit­tees that worked on mean­ing­ful use, it’s be­come a very neg­a­tive in­flu­ence on health­care.

Cham­bers: I may be a bit of a cynic. Right now, one of our in­pa­tient EHRs has to have an up­grade of sev­eral mil­lion dol­lars for new hard­ware just to avoid the stick. We’re past the car­rot. Now we’re try­ing to avoid the stick of some­thing like $12 mil­lion for mean­ing­ful use Stage 3 vi­o­la­tions. We’re spend­ing a lot of money to avoid los­ing a lot of money. It’s not in­cred­i­bly pro­duc­tive.

MH: Does any­one hold out hope for the more pre­scrip­tive reg­u­la­tions in the 21st Cen­tury Cures Act?

Halamka: I was talk­ing to two very no­table sen­a­tors and I asked them, “What is in­ter­op­er­abil­ity?” They said every data el­e­ment in the elec­tronic health record can be shared with every per­son for every pur­pose in real time, at no cost. If that is your def­i­ni­tion of in­ter­op­er­abil­ity, we should just go home. Be­cause, for­get it—not go­ing to hap­pen.

My def­i­ni­tion of in­ter­op­er­abil­ity is the min­i­mum in­for­ma­tion you need for rea­son­able qual­ity care, avail­able with rea­son­ably low ef­fort, at rea­son­ably low cost. In Bos­ton, we are at best an af­fil­i­ated group of friends and fam­ily with six dif­fer­ent EHRs in our health sys­tem. There­fore, what do we do? Some­times we push data to a cen­tral repos­i­tory to mea­sure qual­ity and out­comes. Some­times we pull data for real-time clin­i­cal care co­or­di­na­tion. And some­times we do the quick and dirty, like when I’m in one EHR and I can view an­other EHR be­cause all I want to see is what meds the pa­tient is tak­ing and that sort of thing.

But there are a cou­ple of other things we need. We do not have a good way to match pa­tient iden­tity. Al­though we do name, gen­der, date of birth and other com­bi­na­tions, it doesn’t work, es­pe­cially in ar­eas like south Bos­ton where the Ir­ish-Amer­i­cans named Mau­reen Kelly may have the same birth­day on the same street. Hav­ing mixed med­i­cal records is dan­ger­ous. We need a pa­tient iden­ti­fier, or bio­met­rics, or some­thing.

We don’t have a doc­tor directory for the coun­try. If I wanted to send data to Utah, I wouldn’t have the first clue how to do it. Let’s make sure our pri­vacy poli­cies are ra­tio­nal. I live in New Eng­land. The near­est state is just 20 miles away. Yet I can­not send data across that bor­der be­cause the poli­cies are so het­ero­ge­neous.

Probst: We’re not go­ing to be in­ter­op­er­a­ble at any level un­less we get stan­dards that are ac­cept­able across the whole in­dus­try. There are 157 ways to rep­re­sent blood pres­sure. That’s not a stan­dard. That means we’re send­ing data that you might be able to in­ter­pret if you bring it up on the screen and you’re a physi­cian. But if you want the computer to do any­thing with it to make it more ef­fi­cient, it doesn’t have enough speci­ficity.

This must be a na­tional pri­or­ity for our na­tional safety. Hundreds of thou­sands of peo­ple are dy­ing every year need­lessly be­cause we don’t in­ter­op­er­ate well. Hundreds of bil­lions of dol­lars every year are be­ing wasted be­cause we don’t in­ter­op­er­ate.

I am about as con­ser­va­tive a guy as you’re go­ing to find. Yet I think the fed­eral gov­ern­ment has to take a very dis­tinct and force­ful role in en­sur­ing that we get the stan­dards over the next 10 years.

We’re not go­ing to be in­ter­op­er­a­ble at any level un­less we get stan­dards that are ac­cept­able across the whole in­dus­try. There are 157 ways to rep­re­sent blood pres­sure. That’s not a stan­dard.

Marc Probst

MH: How will a gov­ern­ment-en­forced com­mon stan­dard on med­i­cal data play down in Texas?

Cham­bers: I agree that it’s go­ing to take a fed­eral man­date. They do have to get en­gaged. Hous­ton is much like your Bos­ton sit­u­a­tion. There are 258 Maria Sanchez’s with the ex­act same date of birth in their sys­tem. There’s a lot of pa­tient misiden­ti­fi­ca­tion po­ten­tial there. A na­tional pa­tient iden­ti­fier is needed.

MH: I’m hear­ing two dif­fer­ent views of reg­u­la­tion. In one case you want pre­scrip­tion— a pa­tient iden­ti­fier. But in an­other case, you just want a gen­eral over­view and say, “Let us fig­ure out how to do it.”

Probst: I’m OK if they tell you to drive on the right side of the road. I don’t want them to tell you how to build every car that’s on the road.

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