HHS vows to lighten up on regs

Prom­ises of reg­u­la­tory sav­ings met with skep­ti­cism

Modern Healthcare - - Front Page - Joe Carl­son

Fed­eral of­fi­cials say they can save hos­pi­tals $600 mil­lion a year in ad­min­is­tra­tive costs by elim­i­nat­ing ob­so­lete and bur­den­some reg­u­la­tions for par­tic­i­pa­tion in Medi­care, but the an­nounce­ment was greeted with cau­tion and skep­ti­cism.

The pro­posal to re­vamp Medi­care’s con­di­tions of par­tic­i­pa­tion, or COP, came with the largest sin­gle dol­lar-sav­ings in a bul­let­pointed, 44-page re­port re­leased by HHS last week out­lin­ing ar­eas where reg­u­la­tors in the mas­sive fed­eral agency say they can elim­i­nate rules without harm­ing pa­tient care.

Over­all, the plan touched on dozens of pos­si­ble changes in reg­u­la­tions for hos­pi­tals, pay­ers, de­vice­mak­ers, states and Medi­care ben­e­fi­cia­ries. Reg­u­la­tors pledged to make de­vices eas­ier to bring to mar­ket, pri­vacy prac­tices eas­ier to com­mu­ni­cate to pa­tients, and sci­en­tific re­search in­volv­ing hu­man sub­jects more stream­lined, among other top­ics.

The re­port came in re­sponse to a Jan. 18 ex­ec­u­tive or­der from Pres­i­dent Barack Obama that man­dated all fed­eral agen­cies sub­mit a plan to re­view sig­nif­i­cant reg­u­la­tions with an eye to­ward lis­ten­ing to pub­lic com­ment, im­pos­ing the least-bur­den­some rules, and re­duc­ing re­dun­dancy and over­lap for in­dus­tries gov­erned by mul­ti­ple agen­cies.

While the doc­u­ment was short on spe­cific de­tails, some ob­servers cheered the over­ar­ch­ing goals.

“We share the broad goal of the ad­min­is­tra­tion to im­prove bur­den­some or in­ef­fi­cient reg­u­la­tions,” Lisa Grabert, se­nior as­so­ciate di­rec­tor of pol­icy at the Amer­i­can Hos­pi­tal As­so­ci­a­tion, said in an e-mailed state­ment. “As more guid­ance and specifics are pro­vided by HHS, we will re­view them care­fully to en­sure that, as in­tended, reg­u­la­tions are stream­lined and im­proved.”

The plan says HHS in­tends to is­sue the $600 mil­lion con­di­tions-of-par­tic­i­pa­tion pro­posal in Septem­ber as part of an on­go­ing re­view.

But as part of that re­view HHS of­fi­cials have also made it clear they in­tend to im­prove hos­pi­tals’ per­for­mance on qual­ity mea­sures, in­clud­ing re­duc­tions in read­mis­sions and pre­ventable in­fec­tions, said Mar­i­lyn Yager, a for­mer con­gress­woman and White House health­care ad­viser un­der Pres­i­dent Bill Clin­ton.

“I think my clients are wor­ried that they will be get­ting rid of some old ob­so­lete COP re­quire­ments but then adding new ones,” said Yager, who to­day works as a se­nior pol­icy ad­viser to Wash­ing­ton-based law firm Al­ston & Bird. HHS “may have a long list of rules they have stream­lined or got­ten rid of, but in the full vol­ume of what they’ve done, has the bur­den de­creased?”

For ex­am­ple, one way to re­duce read­mis­sions would be to man­date as a con­di­tion of par­tic­i­pa­tion that hos­pi­tals make fol­low-up phone calls to dis­charged pa­tients. While that would likely re­duce read­mis­sions, Yager said, it would also place an ad­di­tional bur­den on hos­pi­tals.

“If you’re re­duc­ing read­mis­sions through re­vamp­ing COP, you’re prob­a­bly not do­ing it with less re­quire­ments. Oth­er­wise, why would you be us­ing COP?” Yea­ger said.

Ken­neth Marcus, a part­ner in health­care law at Detroit-based law firm Honig­man Miller Schwartz and Cohn, said HHS may want to use cau­tion when elim­i­nat­ing any of the con­di­tions that ex­ist to­day.

He noted that the ex­ist­ing con­di­tions of

par­tic­i­pa­tion re­quire hos­pi­tals to “pro­vide a san­i­tary en­vi­ron­ment to avoid sources and trans­mis­sion of in­fec­tions and com­mu­ni­ca­ble dis­eases,” yet thou­sands of pa­tients con­tract hos­pi­tal-ac­quired in­fec­tions at hos­pi­tals that meet the cur­rent stan­dards.

“While the elim­i­na­tion of ‘bur­den­some’ reg­u­la­tions may play well in Peo­ria, as the ex­pres­sion goes, sight should not be lost that ab­sent ap­pro­pri­ate con­di­tions of par­tic­i­pa­tion, the pub­lic is ex­posed to in­creased risk,” Marcus said in an e-mail.

In ad­di­tion to po­ten­tially sweep­ing changes in con­di­tions-of-par­tic­i­pa­tion rules, the HHS re­port in­cluded a vague ref­er­ence that “ap­prox­i­mately 80” other re­forms were be­ing con­sid­ered to im­prove ac­cess to care.

While tak­ing note of sev­eral re­cent changes al­ready un­veiled, the re­port did not specif­i­cally out­line any of the new ac­ces­sim­prove­ment pro­pos­als, say­ing only that “the cu­mu­la­tive ef­fect of re­mov­ing bar­ri­ers to ef­fi­cient and ef­fec­tive pa­tient care will be sub­stan­tial.”

Of the two dozen other ways HHS would elim­i­nate bur­den­some rules, one of the most sig­nif­i­cant for non­hos­pi­tal health­care firms is a pro­posal to ease the pri­vacy bur­dens on health plans by chang­ing the re­quire­ments for how they in­form pa­tients of pri­vacy-pro­tec­tion poli­cies.

The rule change is ex­pected to save the in­sur­ers $120 mil­lion and 2 mil­lion “bur­den hours,” the HHS re­port says.

HHS noted that the Food and Drug Ad­min­is­tra­tion is propos­ing ways to ease bur­dens on de­vice­mak­ers by switch­ing to a pa­per­less ad­verse-events re­port­ing sys­tem and es­tab­lish­ing a vol­un­tary de­vice-ap­proval process that could speed up Medi­care na­tional cov­er­age de­ter­mi­na­tions.

And HHS is team­ing with the White House Of­fice of Science and Tech­nol­ogy Pol­icy for a ma­jor re­vi­sion of the rules pro­tect­ing hu­man sub­jects of re­search, po­ten­tially elim­i­nat­ing un­needed in­sti­tu­tional re­view board eval­u­a­tions and im­prov­ing the speed of in­for­ma­tion col­lec­tion. HHS pub­lished a no­tice pro­posed rule­mak­ing on that point on July 26. <<

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