Un­der scru­tiny

Car­di­ol­o­gists feel­ing pres­sure over 70% cri­te­rion

Modern Healthcare - - THE WEEK IN HEALTHCARE - Joe Carl­son

In an era of ris­ing scru­tiny of car­diac care, physi­cians are learn­ing that their le­gal fates may hinge on one num­ber—70%. That’s how much block­age in a coro­nary artery the govern­ment says should be doc­u­mented to jus­tify the place­ment of a car­diac stent, the wire mesh de­vice that can keep a clogged blood ves­sel open.

Stent surg­eries are more prof­itable for hos­pi­tals’ car­diac-care de­part­ments, com­pared with less-in­ten­sive ther­a­pies that in many cases work just as well for pa­tients. Stud­ies show stents are overused in elec­tive surg­eries, and car­di­ol­o­gists vary widely from re­gion to re­gion in how of­ten they im­plant them.

Closely fol­low­ing the re­search show­ing overuse are a grow­ing num­ber of crim­i­nal and civil cases al­leg­ing in­ter­ven­tional cardi- ol­o­gists know­ingly im­planted stents in pa­tients who had lit­tle if any block­age, need­lessly ex­pos­ing them to the risks of in­va­sive pro­ce­dures. At least four hos­pi­tals have set­tled civil cases in the past two years, and three car­di­ol­o­gists have been con­victed of crim­i­nal fraud re­lated to stent overuse. Many more civil cases against doc­tors are pend­ing.

This has led to much dis­cus­sion of the fed­eral govern­ment’s po­si­tion that a coro­nary artery must be at least 70% blocked to jus­tify us­ing a stent. In cases where that cri­te­rion has been chal­lenged, fed­eral judges are agree­ing with the govern­ment—even though physi­cians and their lawyers con­tinue to stress the dan­ger of lim­it­ing physi­cians’ dis­cre­tion in di­ag­nos­ing and treat­ing car­diac prob­lems.

Dr. Tom Stys, med­i­cal di­rec­tor and in­ter­ven­tional car­di­ol­o­gist at San­ford Heart Hos­pi­tal in Sioux Falls, S.D., said there is heavy scru­tiny of car­di­ol­ogy be­cause it ac­counts for a large share of to­tal health­care spend­ing, and it tends to em­brace rapid in­no­va­tions faster than other fields.

He agreed that the over­sight re­sults in a “cer­tain de­gree of a loss of au­ton­omy” for in­di­vid­ual doc­tors. But, he ar­gued, they still should be fol­low­ing widely ac­cepted clin­i­cal guide­lines such as the 70% cri­te­rion, even though ob­servers agree that two doc­tors may see dif­fer­ent lev­els of block­age in the same test re­sults.

“There is def­i­nitely room for some variation in in­ter­pre­ta­tion,” Stys said. “Keep­ing that in mind, a le­sion that is less than 70% usu­ally should not be re­sult­ing in any ad­verse clin­i­cal con­se­quences for the pa­tient, and we do not in­ter­vene on those cases.”

Other doc­tors say the is­sue is murkier than that.

Al­ready this year, the 4th U.S. Cir­cuit Court of Ap­peals up­held an eight-year prison sen­tence for in­ter­ven­tional car­di­ol­o­gist Dr. John McLean of Sal­is­bury, Md., who was con­victed of Medi­care fraud for al­ter­ing pa­tient med­i­cal records to meet the 70% thresh­old.

The 70% cri­te­rion was de­scribed by a pros­e­cu­tion wit­ness as “gen­er­ally ac­cepted in the med­i­cal com­mu­nity.” But McLean ar­gued that was un­con­sti­tu­tion­ally vague as a guide­line to define crim­i­nal fraud. McLean pre­sented an ex­pert wit­ness who tes­ti­fied that at least un­til 2006, 50% block­age was con­sid­ered suf­fi­cient to jus­tify stent­ing when com­bined with ev­i­dence of heart stress from other tests.

The court dis­agreed, find­ing the ev­i­dence that McLean changed pa­tient records proved he knew he was en­gaged in fraud. The de­ci­sion came about a year af­ter the 5th

U.S. Cir­cuit Court of Ap­peals re­jected an al­most iden­ti­cal ar­gu­ment from Dr. Mehmood Pa­tel, a car­di­ol­o­gist in Lafayette, La., who also lost a bid to over­turn his Medi­care fraud con­vic­tion.

Last month, in Lon­don, Ky., Dr. San­desh Patil ac­cepted a plea agree­ment send­ing him to prison for at least two years af­ter he was charged with im­plant­ing one un­needed stent in a pa­tient whose med­i­cal record he later al­tered to show a 70% block­age. Patil was the third crim­i­nal tar­get in a stent case na­tion­ally.

Ex­perts in the field say physi­cians should pay close at­ten­tion to ap­pro­pri­ate-use cri­te­ria first pub­lished by the Amer­i­can Col­lege of Car­di­ol­ogy and other groups in 2009, and up­dated in 2012. The guide­lines es­chew blunt def­i­ni­tions of med­i­cal ne­ces­sity used by pros­e­cu­tors in fa­vor of a 1-10 ap­pro­pri­ate­ness scale for stent­ing that in­cor­po­rates med­i­cal his­tory and test re­sults.

Dr. John Harold, a car­di­ol­o­gist with the Cedars-Si­nai Heart In­sti­tute in Los An­ge­les and pres­i­dent of the Amer­i­can Col­lege of Car­di­ol­ogy, said physi­cians who fol­low the cri­te­ria and doc­u­ment their ac­tions and de­ci­sion­mak­ing pro­cesses should be able to avoid le­gal prob­lems in most cases.

“The ex­treme out­liers, who put pa­tients at risk for overuse for per­sonal gain, should face the con­se­quences,” Harold said. “The over­whelm­ing ma­jor­ity do the right thing, and it is un­for­tu­nate that a few out­liers like this will con­tinue to gen­er­ate pub­lic­ity.”

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