CLN Article

Regulatory Profiles

In This Issue...

CMS Boosts Reimbursement for BRCA Testing

Correcting a cut of nearly 50% made during Medicare's switch to a new coding scheme in September 2013, the Centers for Medicare and Medicaid Services (CMS) announced that the reimbursement for BRCA genetic testing would swing back up to $2,200.

In September, CMS established the national limitation amount for BRCA testing at $1,440 after receiving information from Noridian, a CMS administrative contractor for much of the Pacific Northwest. According to CMS, the agency did not have complete market data at the time, and over the past several months has collected more data from three other contractors indicating that the price for BRCA testing—CPT code 81211—ranged from $2,000 to $2,500. The new reimbursement amount became effective for claims dated April 1, 2014.

More information is available from the CMS clinical lab fee schedule website,

Doc Fix Bill Could Affect Labs Differently

A bill signed into law patching the flawed physician sustainable growth rate (SGR) formula also contains several provisions that will change how Medicare sets payment rates for laboratory testing. However, hospital and independent labs will likely be affected in different ways as the legislation is implemented over the next 3 years.

Because the bill avoids a 24% cut in physician fees due to the SGR formula, Congress took aim at other healthcare providers to compensate for the $21 million "patch," including clinical labs. Among other provisions, the bill would, for the first time, use market rates to establish test pricing.

According to the American Association for Molecular Pathology (AMP), this provision could seriously harm hospital labs, putting them at a great disadvantage compared to large independent labs.

The Advanced Medical Technology Association (AdvaMed), however, praised the bill due to provisions that would treat new, advanced tests from independent labs in a special way, initially paying the list price for these tests.

CLN will devote a feature story to complete coverage of the reimbursement changes in the June issue. AACC will also host a webinar on the topic on May 7. The bill, H.R. 4302, is available on the Library of Congress website,

A2LA's CLIA Accreditation Program for Clinical Laboratories Achieves CMS Approval

The American Association for Laboratory Accreditation (A2LA) announced approval by the Centers for Medicare and Medicaid Services (CMS) to accredit clinical laboratories worldwide to CLIA requirements, the first new player to join the accreditation field since 1995. A2LA has more than 35 years of accreditation experience working with international standards for laboratories, such as ISO 15189:2012.

A2LA will now be the only U.S. accreditation body with dual recognitions—from the International Laboratory Accreditation Cooperation for the accreditation of clinical laboratories to ISO 15189:2012 and recognition by CMS for the accreditation of clinical laboratories to the CLIA requirements.

CDC Updates Hepatitis Action Plan

Led by the Centers for Disease Control and Prevention (CDC), federal agencies launched an updated Action Plan for the Prevention, Care, and Treatment of Viral Hepatitis (2014–2016), building upon the nation's first comprehensive cross-agency action plan to combat viral hepatitis.

The 3-year renewal of the Action Plan not only builds upon the progress accomplished since 2011 by agencies and offices from across the Department of Health and Human Services, but also sets new goals to address the disease. Between 3.5 and 5.3 million Americans are living with chronic viral hepatitis, and most of them do not know that they are infected. Viral hepatitis is the leading cause of liver cancer and the most common reason for liver transplantation in the United States. In addition, it is a leading infectious cause of death in the U.S., claiming the lives of 12,000–18,000 Americans each year, according to the report.

The goals of the action plan are four-fold: increase the proportion of persons who are aware of their hepatitis B virus infection, from 33% to 66%; increase the proportion of persons who are aware of their hepatitis C virus infection, from 45% to 66%; reduce by 25% the number of new cases of HCV infection; and eliminate mother-to-child transmission of HBV.

The full Action Plan for the Prevention, Care, and Treatment of Viral Hepatitis (2014–2016) is available from