Add-ons en­sure Cures Act easy lame-duck pas­sage

Modern Healthcare - - NEWS - By Shan­non Much­more

It started as a Food and Drug Ad­min­is­tra­tion re­form bill. But by the time the 21st Cen­tury Cures Act cleared the House of Rep­re­sen­ta­tives by an over­whelm­ing 392-26 mar­gin last week, the leg­is­la­tion was re­ceiv­ing cheers from vir­tu­ally every seg­ment of the health­care in­dus­try. The bill ap­pears headed for quick Se­nate pas­sage and sig­na­ture into law by Pres­i­dent Barack Obama.

The leg­is­la­tion, which ini­tially aimed to ex­pe­dite fed­eral ap­proval of new drugs and de­vices, in­cludes a bevy of Easter eggs for nearly all sec­tors of the health­care in­dus­try, which lob­bied heav­ily for the bill. It will cost $6.3 bil­lion over the next decade.

A cen­ter­piece that helped win broad sup­port was the $4.8 bil­lion in­crease in fund­ing over 10 years for the Na­tional In­sti­tutes of Health, whose cur­rent bud­get stands at $33 bil­lion a year. The pres­i­dent’s Pre­ci­sion Medicine Ini­tia­tive and Vice Pres­i­dent Joe Bi­den’s Cancer Moon­shot re­search project are in­cluded in the bill.

But far more sig­nif­i­cant in the long run may be the pro­vi­sions drawn from Rep. Tim Mur­phy’s (R-Pa.) Help­ing Fam­i­lies in Men­tal Health Cri­sis Act (See story, p. 12). They in­clude a re­vamp of the Sub­stance Abuse and Men­tal Health Ser­vices Ad­min­is­tra­tion and fund­ing to fight the opi­oid epi­demic.

The leg­is­la­tion also aims to im­prove electronic health record in­ter­op­er­abil­ity and clar­i­fies that the FDA will not be al­lowed to reg­u­late a num­ber of con­sumer-fac­ing ap­pli­ca­tions, in­clud­ing those for “main­tain­ing and en­cour­ag­ing a healthy life­style.”

The FDA is slated to re­ceive an ad­di­tional $500 mil­lion a year, sub­ject to con­gres­sional au­tho­riza­tion, to hire more staff to ex­pe­dite ap­proval pro­cesses for the drug and de­vice in­dus­tries.

While many dis­ease-fo­cused pa­tient ad­vo­cacy groups sup­port the Cures Act, safety ad­vo­cates warn many of the FDA changes in the bill could lead to mar­ket­ing of drugs and de­vices that are ei­ther dan­ger­ous or not ef­fec­tive (See story, p. 11). The is­sue is likely to come up dur­ing the Se­nate de­bate.

In a fiery speech last week, Sen. El­iz­a­beth War­ren (D-Mass.) said the bill had been hi­jacked by spe­cial in­ter­ests. “Does the Se­nate work for big pharma that hires the lob­by­ists and makes the cam­paign con­tri­bu­tions” she asked, “or does the Se­nate work for Amer­i­can peo­ple who ac­tu­ally sent us here?”

More than 1,400 lob­by­ists worked on the leg­is­la­tion, ac­cord­ing to Se­nate dis­clo­sure records. But they didn’t win on every is­sue.

One pro­vi­sion in­cluded in an earlier ver­sion of the bill would have ex­empted drug and de­vice com­pa­nies from pro­vi­sions of the Physi­cian Pay­ment Sun­shine Act that re­quire re­port­ing some of the pay­ments they make to physi­cians who give talks about their prod­ucts. But when Sen. Chuck Grass­ley (R-Iowa)— who had worked to in­clude the Sun­shine Act in the Af­ford­able Care Act be­fore op­pos­ing the lat­ter’s fi­nal pas­sage—threat­ened to op­pose the bill, the House ar­chi­tects of the Cures Act stripped that pro­vi­sion.

The Cures Act first passed the House in July 2015 but it was stalled in the Se­nate over fund­ing dis­agree­ments. It was di­vided into mul­ti­ple bills that all passed com­mit­tee but never got a full vote. As the lame-duck ses­sion be­gan, lead­ers of both par­ties worked to­gether to come to an agree­ment. The act bal­looned to in­clude other bi­par­ti­san pro­vi­sions, such as the men­tal health leg­is­la­tion.

It also ex­panded to in­clude sweet­en­ers aimed at win­ning sup­port from hos­pi­tals and other health­care in­ter­ests. For in­stance, it re­quires the CMS to in­clude a mea­sure of pa­tient so­cio-eco­nomic sta­tus when it cal­cu­lates penal­ties un­der the Medi­care Hospi­tal Read­mis­sions Re­duc­tion Pro­gram, and it gives more hos­pi­tals in­pa­tient pay­ment rates at their re­cently built or ac­quired out­pa­tient fa­cil­i­ties.

AP PHOTO

House Ma­jor­ity Leader Kevin McCarthy of Cal­i­for­nia, left, shakes hands with Rep. Tim Mur­phy, (R-Pa.), center, and Rep. Fred Up­ton (R-Mich.) dur­ing a news con­fer­ence on Capi­tol Hill Wed­nes­day.

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