American Association for Clinical Chemistry
Better health through laboratory medicine
October 2009 Clinical Laboratory News: Regulatory Profiles

CLN Banner Logo

October 2009: Volume 35, Number 10

Health Reform Framework Includes Lab Co-pay

The American Clinical Laboratory Association (ACLA) and other lobbying groups are voicing concern about a possible 20% lab co-pay that was included in Senate Finance Committee Chairman Max Baucus’ (D-Mont.) healthcare reform framework proposal. According to ACLA, the co-pay would financially burden both beneficiaries and laboratories and would not accomplish any change in utilization, because laboratory services are ordered by healthcare professionals and not initiated by patients.

The result of this proposed policy would be a $23 billion shift of costs to Medicare beneficiaries. In a letter to Senator Baucus, ACLA notes that for the majority of the top 100 laboratory procedures, beneficiaries would pay less than $2 in copayment, meaning that it could likely cost labs more to go through the paperwork to collect the copayment than the amount they would receive. Labs lack a direct relationship with patients, and under Medicare, labs would be required to make repeated attempts to collect the co-pays, the letter emphasized. More information about the co-pay is available on the ACLA website.

Draft Payment Amounts for New Codes Published

The Centers for Medicare and Medicaid Services (CMS) released payment recommendations for 15 new CPT codes that will take effect on January 1, 2010. The draft includes a new code for myeloperoxidase (MPO), a surprising reversal from last year’s decision when CMS crosswalked the test to a code for “immunoassay, analyte, quantitative; not otherwise specified” with a lower reimbursement rate of $18.91. The new draft recommendations crosswalk MPO to the code for natriuretic peptide with a payment rate of $49.56.

CMS sought the input of stakeholders on July 14 in Baltimore before releasing the 2010 recommendations. The draft recommendations are available on the CMS website.

Comparative Effectiveness Funding Detailed

The Agency for Healthcare Research and Quality (AHRQ) recently released a breakdown of how it will spend $300 million in stimulus money set aside for comparative effectiveness research (CER). The funds will be divided four ways: $148 million for prospective studies and national patient registries; $50 million to enhance ongoing studies; $29.5 million for innovative translation and dissemination grants; and $20 million for CER training and career development.

Each of these areas will focus on 14 conditions established by the Secretary of the Department of Health and Human Services as most relevant to the Medicare, Medicaid, and SCHIP programs, including arthritis, cancer, cardiovascular disease, dementia, infectious disease, diabetes, obesity, and other common diseases and conditions.

The agency will also spend $9.5 million to establish an infrastructure to identify new and/or emerging issues for CE review investments, and $10 million to establish a citizens’ forum. Details on the grants will be published this fall, with funding beginning in 2010. More information is on the AHRQ website.

Newborn Blood Spots Under Review

A draft guidance document from the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) tackles the privacy issues related to retaining newborns’ dried blood spot specimens, noting a lack of standardized consent policies across state programs, the lack of a universal legal definition of specimen ownership, and the lack of public awareness about screening. The panel reports to the U.S. Secretary of Health and Human Services.

The guidance suggests putting in place several new policies to protect privacy and educate the public, including developing a policy addressing the use of blood specimens after the screening is complete; specifying who has access to and use of dried blood specimens; proactively educating all women about newborn screening while they are receiving prenatal care; and obtaining informed consent from parents for uses other than screening purposes.

A copy of the report is available online.

Pay-for-Performance Working for Hospitals

CMS announced positive results for a demonstration project that aimed for improving the quality of inpatient care by awarding bonus payments to hospitals for high quality care in several clinical areas and by reporting extensive quality data on the CMS website. Under the voluntary demonstration project, top performing hospitals received performance-related bonuses based on evidence-based quality measures for inpatients with heart attack, heart failure, pneumonia, coronary artery bypass graft, and hip and knee replacements.

The quality measures in the demonstration have been validated through research and are based on work by the Quality Improvement Organizations, the Joint Commission, the Agency for Healthcare Research and Quality, the National Quality Forum, the Premier Inc. system and other CMS collaborators.

With 230 hospitals currently participating, the total improvement in average composite quality scores over the demonstration project’s first 3 years was 17.2 percentage points. Between the project’s third and fourth years, the average composite quality score increase was 2.2 percentage points.

More information about the demonstration project is on the CMS website.