Providers, busi­ness groups spar on need for flex­i­bil­ity in es­sen­tial ben­e­fits

Flex­i­bil­ity at is­sue in es­sen­tial ben­e­fits

Modern Healthcare - - NEWS - Jes­sica Zig­mond

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Ahead of HHS’ fi­nal word on es­sen­tial health ben­e­fits, ten­sion is emerg­ing be­tween provider groups that say giv­ing states and health plans too much flex­i­bil­ity could ren­der the cov­er­age mean­ing­less, and busi­ness groups that ar­gue more flex­i­bil­ity is needed to make cov­er­age af­ford­able. In­dus­try ex­perts ex­pect HHS to re­lease its fi­nal reg­u­la­tion on the crit­i­cal piece of the health­care re­form law this quar­ter, with one source

The re­sults were so strik­ing that the trial was halted be­cause of con­cerns that it was un­eth­i­cal to pre­vent pa­tients in the con­trol group from re­ceiv­ing fe­cal trans­plants.

“That study will def­i­nitely trig­ger a lot of in­quiries,” said Dr. Robert Orenstein, an in­fec­tious disease spe­cial­ist at the 244-bed Mayo Clinic Hospi­tal, Phoenix.

Orenstein and a few of his col­leagues be­gan do­ing fe­cal trans­plants in early 2011, af­ter a pa­tient with a se­vere, re­cur­rent case of C. diff begged for the pro­ce­dure. “We were in awe of the re­sults,” he said. “The pa­tient was near death and was prob­a­bly go­ing to have to have most of his colon re­moved. Twenty-four hours later, he was walking out of the hospi­tal.”

Gal­va­nized by that first case, they be­gan work­ing out the de­tails of a long-term pro­gram. Like Boca Ra­ton Re­gional Hospi­tal, the Mayo Clinic Hospi­tal re­lies on colono­scopies, cov­ered by in­sur­ers, to ad­min­is­ter the do­nated sam­ples. The hospi­tal bills the donor about $1,000 for the screen­ings that aren’t cov­ered, and then bills the pa­tient about $600 for the cost of pro­cess­ing the stool.

Like many who per­form the pro­ce­dure, Orenstein pre­dicts it won’t be long un­til in­sur­ers be­gin re­im­burs­ing di­rectly for fe­cal trans­plants, es­pe­cially now that promis­ing data from a ran­dom­ized trial is avail­able. “It is so ef­fec­tive, it makes you won­der why we do any­thing else,” he said, adding that the hospi­tal has done be­tween 35 and 40 trans­plants. Still, he ac­knowl­edged that ev­i­dence-based guide­lines for donor se­lec­tion, in­fec­tion con­trol, han­dling and ad­min­is­tra­tion are sorely needed. Such guide­lines are likely to be clearer af­ter fu­ture tri­als, he said.

In the mean­time, providers are de­sign­ing widely vary­ing ap­proaches to per­form­ing the pro­ce­dure. At 301-bed Meriter Hospi­tal, Madi-

“We were in awe of the re­sults. The pa­tient was near death and was prob­a­bly go­ing to have to have most of his colon re­moved. Twenty-four hours later, he was walking out of the hospi­tal.”

—Dr. Robert Orenstein Mayo Clinic Hospi­tal, Phoenix

son, Wis., Dr. Gary Griglione, the gas­troen­terol­ogy di­vi­sion chief, has per­formed 33 fe­cal trans­plants since launch­ing Meriter’s pro­gram less than a year ago. But un­like many other physi­cians who per­form the pro­ce­dure, he uses en­e­mas in­stead of colono­scopies, a de­ci­sion he says saves money with­out sac­ri­fic­ing ef­fec­tive­ness. “If we don’t get pa­tients cured with an enema, which costs $1.99, then we do a colonoscopy,” said Griglione, who’s been per­form­ing fe­cal trans­plants for more than 25 years.

Meriter charges donors roughly $1,300 for lab tests, most of which is cov­ered by in­sur­ers, he said. Pa­tients pay a $140 fee for pro­cess­ing the sam­ple, plus a $60 of­fice-visit fee. “I lose money, the hospi­tal loses money, but look what the pa­tient saves,” Griglione said.

Dr. Colleen Kelly, a clin­i­cal as­sis­tant pro­fes- sor of medicine at Brown Univer­sity’s Alpert Med­i­cal School and a leader in the field of fe­cal trans­plan­ta­tion, said the next cross­roads will be reg­u­la­tory. The U.S. Food and Drug Ad­min­is­tra­tion has ex­pressed an in­ter­est in over­see­ing the pro­ce­dure and en­sur­ing it’s done safely, said Kelly, who is lead­ing an­other ran­dom­ized trial of fe­cal trans­plan­ta­tion. She fears government over­sight will in­clude “overly bur­den­some reg­u­la­tions.”

An­other ob­sta­cle is one of per­cep­tion, said Dr. Clif­ford McDon­ald, a med­i­cal epi­demi­ol­o­gist and C. diff ex­pert at the CDC. He wor­ries the “eww” fac­tor could hin­der the progress of a promis­ing treat­ment that he says could prove ef­fec­tive for treat­ing other dru­gre­sis­tant or­gan­isms. One so­lu­tion? A name change. The term “fe­cal trans­plant” places too much em­pha­sis on the do­nated ma­te­rial, he says. A new term—his sug­ges­tions in­clude “in­testi­nal mi­cro­biota restora­tion”—could help peo­ple to bet­ter ac­cept the pro­ce­dure.

“We need to get over the fact that th­ese good bac­te­ria live in our bod­ies and are nec­es­sary,” McDon­ald said.


Dental trade groups are con­cerned HHS will re­quire that in­sur­ers of­fer pe­di­atric dental cov­er­age with­out mak­ing en­rollees buy.

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