December 2009 Clinical Laboratory News: Regulatory Profiles

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December 2009: Volume 35, Number 12

Joint Commission Changing ID Rules for Phlebotomy

Sparking an outcry from the phlebotomy community, the Joint Commission will no longer require patient involvement when identifying patients before a phlebotomist collects a lab sample, according to a pre-publication draft of the Joint Commission’s 2010 National Patient Safety Goals (NPSG). The requirement for patient involvement, which included asking the patient’s name, first became part of the lab NPSG in 2009.

The 2010 NPSGs require using at least two patient identifiers, but would allow both identifiers to come from the patient’s ID bracelet. “By permitting those two identifiers to come from the same identification bracelet without requiring active patient involvement to confirm the bracelet was attached to the right person, patients could be misidentified without any deviation from the Joint Commission’s requirements…to remove that critical provision is dangerous and ill-advised,” wrote Dennis Ernst, MT(ASCP), director of the Center for Phlebotomy Education, in a letter to the Joint Commission.

The Joint Commission defended the change, pointing out that the intent was not to discourage patient involvement, but that requiring it would be difficult to en-force and could raise problems with patients not able to interact. More information about the NPSGs is available on the Joint Commission’s website. The Center for Phlebotomy Education letter is posted online.

GINA Provisions Take Effect

Beginning December 7, elements of the 2008 Genetic Information Nondiscrimination Act (GINA) go into effect, barring insurers from denying coverage based on genetic information. The Department of Health and Human Services published an interim final rule in the Federal Register that limits how insurers use and access a person’s genetic information. The rule permits insurers “to obtain and use the results of a genetic test to make a determination regarding payment.” However, plans and insurers must request the minimum amount of information needed to make such a determination. The interim final rule is available on the Federal Register website. Search for pages 51664–51697.

House Health Bill Covers Testing but Reduces Payment

On November 7, the House of Representatives narrowly passed its version of a healthcare reform bill that would extend lab testing to the newly insured. The bill also promotes preventive care and comparative effectiveness research. However, similar to the Senate version, the House bill spells bad news for reimbursement. The change in payment to labs would take the form of a reduction in the laboratory consumer price index (CPI) update. Starting in 2010, the bill would reduce the update by a “productivity factor,” typically ranging from 1%–1.4% a year, potentially reducing payments to labs by $5 billion over the next 5 years.

For diagnostics manufacturers, the bill would levy a 2.5% tax at the point of sale for medical devices, or about $20 billion over 7 years. The Senate version of the healthcare reform bill taxes manufacturers $40 billion over 10 years, based on the business’s market share.

To increase the number of insured in the U.S., the bill would, among other things: ban insurance companies from denying coverage to anyone with a pre-existing condition or charging higher premiums based on sex or medical history; create a national Health Insurance Exchange as well as a government-run insurance plan that provides the means to negotiate rates with providers; expand Medicaid to all families up to 150% of the federal poverty level; mandate that employers purchase insurance for their employees or be subject to an 8% payroll tax; mandate that all individuals obtain health insurance or be subject to a 2.5% fine of their adjusted gross income; and levy a 5.4% surtax on individuals earning more than $500,000 annually or married couples earning more than $1 million. According to the Congressional Budget Office, the bill would guarantee coverage for 96% of Americans.

The next step is for the Senate to pass its version of a healthcare reform bill, after which the two bills will be reconciled for differences and sent to both houses of Congress for final approval before heading to the President’s desk. At CLN press time, the timeline for these events extended into 2010.

Senate Bill Includes Workaround for 14-Day Rule

Offered by Senators Ron Wyden (D-Wash.) and Tom Carper (D-Del.), an amendment to the Senate Finance Committee healthcare reform plan would allow independent labs to bill Medicare directly for certain esoteric genetic tests even when the specimen is collected at a hospital. Under current Medicare regulation, the date of service for a test ordered less than 14 days after a patient’s discharge from a hospital is considered the date on which the specimen was collected, and must be covered under the hospital diagnostic-related group (DRG) payment for that stay. Essentially, the rule treats tests ordered less than 14 days after a patient is discharged as having been performed when the patient was actually in the hospital, even if the testing takes place somewhere else.

The amendment would allow clinical laboratories to bill Medicare directly at a higher reimbursement rate if the test is not furnished by the hospital where the sample was collected, and if the test is performed only by the laboratory offering the test. The amendment is similar to legislation introduced by Jason Altmire (D-Pa.), H.R. 1699. The amendment is available on the Senate Finance Committee website.

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