Cme Shel­ter

Sun­shine Act waiver for med ed pay­ments may prompt mar­ket­ing shift for prod­uct mak­ers

Modern Healthcare - - NEWS - By Jaimy Lee

ACMS rule that ex­empts drug and med­i­cal-de­vice com­pa­nies from hav­ing to dis­close indi­rect pay­ments to physi­cians for ac­cred­ited con­tin­u­ing med­i­cal ed­u­ca­tion could prompt man­u­fac­tur­ers to shift their mar­ket­ing dol­lars to­ward CME and away from di­rect pro­mo­tional pro­grams for their prod­ucts, ex­perts say. If that oc­curs, it would re­verse a years­long trend of man­u­fac­tur­ers pulling back on CME grants.

Drug and de­vice com­pa­nies pay hun­dreds of mil­lions of dol­lars a year to for-profit com­pa­nies and not-for-profit or­ga­ni­za­tions such as aca­demic med­i­cal cen­ters that ed­u­cate physi­cians about new treat­ment op­tions and help them hone their skills as part of ac­cred­ited or cer­ti­fied CME pro­grams. The CME providers then hire and pay doc­tors to lead the ses­sions.

Man­u­fac­tur­ers are ex­empt from re­port­ing these indi­rect CME pay­ments to doc­tors un­der the Physician Pay­ments Sun­shine Act, which gen­er­ally re­quires pub­lic disclosure of in­dus­try pay­ments to physi­cians and teach­ing hos­pi­tals start­ing in Septem­ber. Com­pa­nies will still have to re­port the value of some meals they pro­vide to all physi­cians at CME events.

Some ex­perts worry that the CMS ex­emp­tion

for re­port­ing CME pay­ments will cre­ate a loop­hole for man­u­fac­tur­ers to in­flu­ence doc­tors with­out hav­ing to dis­close their in­volve­ment.

“It’s a lot of money that’s be­ing put into CME by in­dus­try,” said Dr. Daniel Car­lat, direc­tor of the Pre­scrip­tion Project at Pew Char­i­ta­ble Trusts. “There’s a chance to look for op­por­tu­ni­ties where money can­not be dis­closed.” There’s been in­creas­ing con­cern in academia that in­dus­try pay­ments for CME bias these pro­grams, and that bi­ased ses­sions lead the doc­tors at­tend­ing the ses­sions “to un­duly pre­scribe prod­ucts that in­dus­try is push­ing,” he added.

The As­so­ci­a­tion of Amer­i­can Med­i­cal Col­leges, Pew and the Amer­i­can Med­i­cal Stu­dent As­so­ci­a­tion have called for end­ing in­dus­try fund­ing for ac­cred­ited CME.

But CME providers and their ac­cred­it­ing or­ga­ni­za­tions say they have strong vol­un­tary stan­dards in place that pre­vent man­u­fac­tur­ers from shap­ing the con­tent of their CME pro­grams or in­flu­enc­ing the se­lec­tion of the physi­cians who speak at the ses­sions. Those stan­dards were the rea­son why the CMS rule im­ple­ment­ing the Sun­shine Act ex­empted man­u­fac­tur­ers’ pay­ments for ac­cred­ited CME to physi­cians from pub­lic disclosure, they say.

“The rule re­flected stan­dards that were al­ready in our rules,” said Dr. Mur­ray Kopelow, pres­i­dent and CEO of the Ac­cred­i­ta­tion Coun­cil for Con­tin­u­ing Med­i­cal Ed­u­ca­tion, the largest of the five or­ga­ni­za­tions that the CMS lists as an ap­proved ac­cred­i­tor of CME providers un­der the ex­emp­tion. “Ac­cred­ited providers are re­spon­si­ble for en­sur­ing that each in­di­vid­ual ac­tiv­ity meets the ap­pro­pri­ate stan­dards.”

“We are a very strong ad­vo­cate for high eth­i­cal stan­dards,” said An­drew Rosen­berg, se­nior ad­viser for the CME Coali­tion, a trade group rep­re­sent­ing CME or­ga­ni­za­tions and man­u­fac­tur­ers that fund CME. “A com­mer­cial sup­porter has no in­put into who par­tic­i­pates and isn’t able to choose the speak­ers or in any way in­flu­ence the cur­ricu­lum.”

While gifts, travel and con­sult­ing fees are easy con­flicts of in­ter­est to iden­tify, con­flicts re­lated to CME pay­ments are less clear cut.

In­flu­enc­ing CME con­tent

Crit­ics say, how­ever, that man­u­fac­tur­ers still can in­flu­ence CME con­tent in­di­rectly by sup­port­ing CME pro­grams in clin­i­cal ar­eas where they have dom­i­nant prod­ucts.

The Sun­shine Act, which is a sec­tion of the Pa­tient Pro­tec­tion and Af­ford­able Care Act, grew out of wide­spread con­cern that fi­nan­cial re­la­tion­ships be­tween doc­tors and man­u­fac­tur­ers have driven up health­care costs. Crit­ics say doc­tors dis­pro­por­tion­ately use pricey drugs and de­vices made by com­pa­nies that pay them to par­tic­i­pate in their pro­mo­tional and mar­ket­ing pro­grams. Some say in­dus­try-funded CME pro­grams are part of the prob­lem.

Un­der the Sun­shine Act, nearly all “trans­fers of value”— in­clud­ing gifts, con­sult­ing and speak­ing fees, and meals worth more than $10—from in­dus­try to physi­cians and teach­ing hos­pi­tals must be re­ported and will then be dis­closed in a pub­lic data­base. Fund­ing of ac­cred­ited CME pro­grams is ex­empt from that man­date.

Ex­perts say the Sun­shine Act dis­clo­sures and in­creased aware­ness among con­sumers, law­mak­ers, re­searchers and the me­dia about these re­la­tion­ships be­tween doc­tors and in­dus­try likely will change how com­pa­nies mar­ket drugs and de­vices. But while gifts, travel and con­sult­ing fees are easy con­flicts of in­ter­est to iden­tify, con­flicts re­lated to CME pay­ments are less clear-cut.

CME is con­sid­ered an in­te­gral part of med­i­cal ed­u­ca­tion in the U.S. Most states re­quire doc­tors to com­plete a set num­ber of hours of ac­cred­ited CME to main­tain their med­i­cal li­censes.

In ac­cred­ited and cer­ti­fied CME pro­grams, man­u­fac­tur­ers com­monly pro­vide grants to third-party CME providers such as for-profit med­i­cal com­mu­ni­ca­tions firms and not-for-prof­its such as aca­demic med­i­cal cen­ters, med­i­cal schools and dis­ease aware­ness or­ga­ni­za­tions to de­velop CME pro­grams around spe­cific ther­a­peu­tic or dis­ease cat­e­gories. The ac­cred­ited CME providers then hire speak­ers, usu­ally doc­tors, and de­velop the con­tent for live or on­line events at­tended by physi­cians or other health­care pro­fes­sion­als.

Sig­nif­i­cant play­ers in the for-profit med­i­cal com­mu­ni­ca­tions in­dus­try in­clude We­bMD’s Med­scape busi­ness unit, the Post­grad­u­ate In­sti­tute for Medicine, and Re­search to Prac­tice. They each re­ceived at least $10 mil­lion in grants from in­dus­try for CME in 2010, ac­cord­ing to a study pub­lished last year in JAMA. We­bMD de­clined to com­ment for this ar­ti­cle.

The num­ber of ac­cred­ited CME providers in the U.S. fell 13% from 2,300 in 2008 to 2,000 in 2012, and the num­ber of ac­cred­ited CME events dropped about 11% from 150,000 in 2008 to 133,000 in 2012, ac­cord­ing to the ACCME.

But the amount of money spent on CME re­mains very sig­nif­i­cant for man­u­fac­tur­ers, CME providers, and physi­cians. A to­tal of $2.47 bil­lion was spent on ac­cred­ited CME in 2012, ac­cord­ing to ACCME data, and one-quar­ter of that rev­enue came from in­dus­try sup­port. The share of CME costs paid by

man­u­fac­tur­ers is down from pre­vi­ous years, when drug com­pany spend­ing made up half of all CME grants.

The JAMA study found that 14 drug and de­vice com­pa­nies paid $657 mil­lion in grants to CME providers in 2010. For-profit med­i­cal com­mu­ni­ca­tion firms re­ceived about 77% of that to­tal, with the rest go­ing to aca­demic med­i­cal cen­ters and dis­ease-tar­geted or­ga­ni­za­tions.

In to­tal, the phar­ma­ceu­ti­cal in­dus­try spent about $27 bil­lion on drug pro­mo­tion in 2012, with nearly all of that spend­ing go­ing to­ward mar­ket­ing to physi­cians, ac­cord­ing to Pew data. This fig­ure does not in­clude CME, which Pew con­sid­ers indi­rect mar­ket­ing.

CME tra­di­tion­ally has been viewed as one of the in­dus­try’s pri­mary mar­ket­ing tools when launch­ing or pro­mot­ing a drug, said Eric Camp­bell, direc­tor of re­search for the Mon­gan In­sti­tute of Health Pol­icy at Mas­sachusetts Gen­eral Hos­pi­tal.

Some for-profit med­i­cal com­mu­ni­ca­tion com­pa­nies pro­vide ac­cred­ited CME and un­ac­cred­ited pro­mo­tional and mar­ket­ing pro­grams. In the lat­ter types of pro­grams, drug and de­vice com­pa­nies have con­trol over the con­tent and the speak­ers, and pay­ments to physi­cians who speak must be dis­closed un­der the Sun­shine Act. But ac­cred­i­ta­tion stan­dards pro­hibit em­ploy­ees at these com­pa­nies from work­ing on both sides of the busi­ness, and the ac­cred­ited CME and pro­mo­tional arms must be or­ga­nized as sep­a­rate cor­po­ra­tions.

Preventing bias

Ac­cred­ited and cer­ti­fied CME pro­grams are re­quired by CME ac­cred­it­ing or­ga­ni­za­tions to be in­de­pen­dent of in­dus­try in­flu­ence. Un­der ac­cred­i­ta­tion stan­dards, CME providers can­not al­low spon­sor­ing man­u­fac­tur­ers to play any role in se­lect­ing pro­gram speak­ers or shap­ing the con­tent. But some ex­perts say the stan­dards cur­rently in place aren’t suf­fi­cient to pre­vent bias to­ward the spon­sor­ing com­pany’s prod­ucts or ser­vices.

“There’s no real ques­tion in anybody’s mind … that com­pa­nies fo­cus their CME spend­ing on prod­ucts in ther­a­peu­tic ar­eas that will make them money,” Pew Char­i­ta­ble Trusts’ Car­lat said.

Pew and the Amer­i­can Med­i­cal Stu­dent As­so­ci­a­tion have urged aca­demic med­i­cal cen­ters to es­tab­lish “ad­di­tional safe­guards be­yond” what the ACCME re­quires.

Most aca­demic med­i­cal cen­ters and med­i­cal schools con­tinue to re­ceive fund­ing from in­dus­try for the ac­cred­ited CME pro­grams. No­table ex­cep­tions in­clude the Univer­sity of Michi­gan, which ac­cepts no in­dus­try fund­ing for CME, and Stan­ford Univer­sity, which has re­stric­tive poli­cies that have dis­cour­aged in­dus­try sup­port for CME.

There also has been an in­crease in the num­ber of hos­pi­tal sys­tems and aca­demic med­i­cal cen­ters that don’t al­low their af­fil­i­ated physi­cians to par­tic­i­pate in both man­u­fac­turer-paid pro­mo­tional work and teach­ing ac­cred­ited CME pro­grams. The con­cern “is that physi­cians who mar­ket prod­ucts for com­pa­nies are more likely to give bi­ased CME pre­sen­ta­tions, es­pe­cially if the CME is funded by those same com­pa­nies,” Car­lat said.

There have been cases that have raised ques­tions about the in­tegrity of CME. In 2010, As­traZeneca reached a $520 mil­lion set­tle­ment with the U.S. Jus­tice Depart­ment over al­le­ga­tions re­lated to the mar­ket­ing of its block­buster anti-psy­chotic Sero­quel. The set­tle­ment said the British drug­maker “im­prop­erly and un­duly” in­flu-

enced the choice of con­tent and speak­ers for CME pro­grams that it funded.

The new re­port­ing re­quire­ments, in­creas­ing me­dia at­ten­tion to such re­la­tion­ships be­tween doc­tors and in­dus­try, and the de­cline of the tra­di­tional block­buster-drug sales model al­ready have led to shifts in how some drug and de­vice com­pa­nies mar­ket their prod­ucts.

Late last year, drug­maker Glax­oSmithK­line an­nounced it would stop di­rect pay­ments to health­care pro­fes­sion­als for speak­ing en­gage­ments and at­ten­dance at med­i­cal con­fer­ences by the start of 2016. In­stead, the com­pany said, it would in­crease ef­forts to sup­port med­i­cal ed­u­ca­tion, which may in­clude pro­mo­tional and un­branded pro­grams as well as ac­cred­ited CME. Pfizer pre­vi­ously said it would not fund CME cour­ses of­fered by for-profit com­pa­nies. Both drug­mak­ers also said they would no longer pay for meals served to doc­tors at CME events, the value of which must be re­ported to the Open Pay­ments data­base, which the CMS is ex­pected to launch Sept. 30.

“Com­pa­nies are tak­ing mat­ters into their own hands as

“Com­pa­nies are tak­ing mat­ters into their own hands as they see the pub­lic per­cep­tion of some of this fund­ing is be­com­ing sour.”


they see the pub­lic per­cep­tion of some of this fund­ing is be­com­ing sour,” Car­lat said. “As long as CME is a safe har­bor in the Sun­shine Act, it’s pos­si­ble that the in­dus­try will look for more ways to spend money on CME.”

Ef­fect of new re­quire­ments

Ex­perts say that while in­dus­try fund­ing for ac­cred­ited CME has dropped in re­cent years, the new re­port­ing re­quire­ments may prompt them to boost their sup­port. “The non-ac­cred­ited ac­tiv­i­ties (such as) pro­mo­tional ac­tiv­i­ties, I’ve been told, are go­ing to di­min­ish be­cause they don’t have the pro­tec­tions in the ex­emp­tion of the Sun­shine Act,” the ACCME’s Kopelow said.

Kath­leen Mar­ley-Matts, manag­ing direc­tor of CME busi­ness at Quin­tiles, a North Carolina-based provider of ac­cred­ited CME, prod­uct devel­op­ment and mar­ket­ing ser­vices, said her com­pany’s busi­ness hasn’t changed. But she says there is plenty of spec­u­la­tion in her in­dus­try about whether man­u­fac­tur­ers will choose to spend more money on CME be­cause it is ex­empt from re­port­ing re­quire­ments.

Crit­ics say that man­u­fac­tur­ers should not be in­volved at all in fund­ing ac­cred­ited CME, and that physi­cians should shell out for their own con­tin­u­ing ed­u­ca­tion, just as other pro­fes­sion­als do. “Physi­cians should pay for this,” Camp­bell said. “This is an in­vest­ment in their hu­man cap­i­tal that they reap back in the form of a salary.”


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