“Un­nec­es­sary” use of stents can be dif­fi­cult to prove

‘Un­nec­es­sary’ use of stents can be hard to prove

Modern Healthcare - - NEWS - Joe Carl­son

Plac­ing an un­nec­es­sary stent in­side a pa­tient’s heart is “a crime of un­think­able pro­por­tions,” ac­cord­ing to one of the government’s top Medi­care watch­dogs, Ni­cholas DiGi­ulio, spe­cial agent in charge of HHS’ in­spec­tor gen­eral’s of­fice for the Philadel­phia re­gion.

But the doc­tors and hos­pi­tals who are tar­gets in th­ese high-stakes car­diac­care in­ves­ti­ga­tions com­plain that it’s not clear what “un­nec­es­sary” means— a cru­cial def­i­ni­tion given the lengthy jail terms and out­size po­ten­tial fines in car­diac overuse cases. Physi­cians say the government is wad­ing into dan­ger­ous ter­ri­tory by sec­ond-guess­ing clin­i­cal de­ci­sions on which rea­son­able peo­ple may have le­git­i­mate dis­agree­ments.

“No spe­cific Medi­care or Med­i­caid reg­u­la­tion de­fines ‘med­i­cal ne­ces­sity’ as to the use of stents or as to re­quired symp­toms re­quir­ing com­pli­ance,” Jack­son, Tenn.-based car­di­ol­o­gist Dr. Elie Kor­ban wrote in a le­gal fil­ing last Septem­ber, re­spond­ing to a whistle­blower com­plaint filed against him by the U.S. Jus­tice De­part­ment al­leg­ing overuse of an­gio­plasty pro­ce­dures.

The stents, metal mesh tubes, hold open clogged ar­ter­ies fol­low­ing an­gio­plasty pro­ce­dures that use pre­cisely in­flated bal­loons to un­block coronary ves­sels. Each year, Amer­i­cans re­ceive more than 600,000 of them, and the in­ter­ven­tions cost about $12 bil­lion a year, ac­cord­ing to a July 2011 study in the Jour­nal of the Amer­i­can Med­i­cal As­so­ci­a­tion.

That study found that 49% of stents in­serted on an elec­tive, non­emer­gency ba­sis in 2009 and 2010 were ei­ther “in­ap­pro­pri­ate” or used for “un­cer­tain” rea­sons. (The study found that 98% of stents used af­ter heart at­tacks or chest pains were ap­pro­pri­ate.)

Dr. Ralph Brindis, an in­ter­ven­tional car­di­ol­o­gist and medicine pro­fes­sor at the Univer­sity of Cal­i­for­nia, San Fran­cisco, with ex­per­tise in ap­pro­pri­ate­ness re­search, said he has es­ti­mated that elim­i­nat­ing in­ap­pro­pri­ate an­gio­plas­ties could save about 200 lives a year in the U.S.

“So it’s not just about the money,” Brindis said.

How­ever, doc­tors who are ac­tu­ally ac­cused of overuse say the government is med­dling in mat­ters of med­i­cal dis­cre­tion.

“The pros­e­cu­tion of Dr. (John) McLean comes down to a de­bate be­tween his treat­ment de­ci­sions re­gard­ing his pa­tients and the lat­ter-day judg­ments of the government’s med­i­cal ex­perts,” McLean’s lawyers wrote in a brief to the 4th U.S. Cir­cuit Court of Ap­peals in Rich­mond, Va. “This can­not be a con­sti­tu­tion­ally ac­cept­able stan­dard upon which to im­pose crim­i­nal li­a­bil­ity.”

McLean, 59, of Sal­is­bury, Md., is slated to have oral ar­gu­ments be­fore the court this month in his at­tempt to over­turn an eight-year prison sen­tence. The case fol­lows a de­ci­sion last year by the 11th U.S. Cir­cuit Court of Ap­peals in At­lanta to re­ject the vague­ness ar­gu­ment and up­hold a 10-year jail term for car­di­ol­o­gist Dr. Mehmood Pa­tel, 67, of Lafayette, La., for sim­i­larly un­needed heart care.

Yet le­gal ex­perts say cases of car­diac overuse are tough to prove in court, be­cause ju­ries are re­luc­tant to con­vict doc­tors in cases where med­i­cal ex­perts dis­agree over the ini­tial treat­ing physi­cian’s judg­ment. Doc­tors might dis- agree over how to in­ter­pret test re­sults for ar­te­rial block­ages, or on ex­ten­u­at­ing cir­cum­stances that could over­ride one com­mon in­dus­try guide­line that a 70% block­age is needed to jus­tify stent­ing.

That’s why many of the cases that are filed tend to in­volve some al­leged ev­i­dence of wrong­ful in­tent. McLean and Pa­tel were ac­cused of not only im­plant­ing un­needed stents, but fal­si­fy­ing med­i­cal records af­ter the fact to make it ap­pear that ar­te­rial block­ages jus­ti­fied the pro­ce­dures. Jesse Wit­ten, a part­ner with Drinker Bid­dle & Reath and former co-chair­man of a Jus­tice De­part­ment health­care fraud task force, said the al­le­ga­tions that lead to for­mal cases usu­ally in­volve writ­ten ev­i­dence that pur­ports to show bad in­tent.

“If the doc­tor was cre­at­ing a false record, it un­der­mines the claim that he truly was ex­er­cis­ing med­i­cal judg­ment,” Wit­ten said. “I think it’s so ob­vi­ous to the DOJ that th­ese are dif­fi­cult cases to bring that they are not go­ing to file a case un­less there is some­thing really egre­gious that has oc­curred.”

The scru­tiny, though, is hav­ing ef­fects on both doc­tors and the hos­pi­tals they work in.

At least four hos­pi­tals in the past two years have come to mul­ti­mil­lion-dol­lar set­tle­ments over al­le­ga­tions of un­needed car­diac pro­ce­dures. For-profit hospi­tal chain HCA dis­closed in se­cu­ri­ties fil­ings last year that in­ter­ven­tional car­di­ol­ogy was be­ing in­ves­ti­gated at a dozen of its Florida hos­pi­tals. EMH Health­care in Elyria, Ohio, an­nounced this month that it would pay $3.8 mil­lion to set­tle overuse al­le­ga­tions with­out ad­mit­ting wrong­do­ing—even though the car­di­ol­o­gists in­volved were in­de­pen­dent physi­cians who sim­ply used the hospi­tal fa­cil­i­ties for treat­ment.

Health­care lawyers say the les­son that health sys­tem ex­ec­u­tives ought to take away from such cases is that government of­fi­cials have come to be­lieve hos­pi­tals bear some level of cul­pa­bil­ity for med­i­cal de­ci­sions of non­staff physi­cians.

“Hos­pi­tals should proac­tively be min­ing their own data on th­ese types of pro­ce­dures, to see, hos­pi­tal­wide or from par­tic­u­lar physi­cians, if there are any aber­rant trends,” said Brian Roark, head of the health­care fraud task force at Bass Berry Sims in Nashville. “If there is a doc­tor on staff who is per­form­ing a whole lot more stents than sim­i­lar doc­tors, hos­pi­tals need to know that so that they can ask some ques­tions.”

REPRINTED WITH PER­MIS­SION OF THE BALTIMORE SUN ME­DIA GROUP. ALL RIGHTS RE­SERVED.

Dr. John McLean, seen ap­proach­ing the court­house in Baltimore, will at­tempt to over­turn an eight-year prison sen­tence.

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