Di­rect de­liv­ery

Rule would re­move bar­rier be­tween lab, pa­tient

Modern Healthcare - - The Week In Healthcare - Joseph Conn

All pa­tients may some­day be able to re­ceive copies of their lab test re­sults di­rectly from labs rather than from be­ing forced to re­ceive the re­sults only from their physi­cians or other providers who or­dered the tests.

The CMS pro­posed a rule last week that would amend the pa­tient pri­vacy pro­vi­sions of the Clin­i­cal Lab­o­ra­tory Im­prove­ment Amend­ments of 1988, or CLIA, and the Health In­sur­ance Porta­bil­ity and Ac­count­abil­ity Act of 1996.

The rule also would cre­ate a new fork in the grow­ing elec­tronic stream of what’s been es­ti­mated by the CMS at 6.1 bil­lion lab test re­sults a year, although rule mak­ers also es­ti­mate as few as one in 2,000 pa­tients will even­tu­ally want to re­ceive their test re­sults di­rectly from labs.

The CMS said the change would ad­dress pro­vi­sions in state and fed­eral laws while paving the way for in­di­vid­u­al­ized medicine and “an in­di­vid­ual’s ac­tive in­volve­ment in his or her own health­care.”

The com­plain­ing stake­hold­ers in­clude large and medium-sized lab­o­ra­to­ries, some pub­lic health lab­o­ra­to­ries, elec­tronic health-record sys­tem ven­dors, health pol­icy ex­perts, health in­for­ma­tion ex­change or­ga­ni­za­tions and health­care providers “who be­lieve that the in­di­vid­ual’s ac­cess to his or her own records is im­peded, pre­vent­ing pa­tients from a more ac­tive role in their per­sonal health­care de­ci­sions,” the CMS said in the rule.

Un­der cur­rent reg­u­la­tions, CLIA lim­its a lab­o­ra­tory’s dis­clo­sure of test re­sults to: the so­called “au­tho­rized per­son,” the per­son re­spon­si­ble for us­ing the test re­sults for treat­ment and re­fer­ring labs. CLIA de­fines an au­tho­rized per­son as “the in­di­vid­ual au­tho­rized un­der state law to or­der or re­ceive test re­sults, or both.”

The HIPAA pri­vacy rule gen­er­ally grants pa­tients a right of ac­cess to their med­i­cal records, but it carves out an ex­cep­tion to honor a state’s right to re­strict lab re­sults reporting. The pro­posed rule would elim­i­nate that. The test re­sults would con­tinue to flow to the or­der­ing clin­i­cian un­der the pro­posal, but a pa­tient might see test re­sults first, be­fore the doc­tor.

Laws in 13 states re­strict the di­rect flow of lab re­sults only to providers. Seven states per­mit di­rect con­nec­tions with pa­tients, but only with their provider’s ap­proval, and 23 states and three ter­ri­to­ries de­fault to the cur­rent CLIA and HIPAA re­stric­tions, which, in ef­fect, ban di­rect pa­tient con­nec­tions. Just seven states, plus Puerto Rico and the District of Columbia, have laws that per­mit a pa­tient to re­ceive test re­sults di­rectly from a lab. Thus the pro­posed rule would fed­er­ally pre­empt state laws and de facto dis­clo­sure lim­its in 46 states and ter­ri­to­ries.

The Fed­er­a­tion of Amer­i­can Hos­pi­tals de­clined to com­ment on the rule. The Amer­i­can Hos­pi­tal As­so­ci­a­tion was un­able to re­spond to a re­quest for com­ment by dead­line.

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