In This Issue...


Congressional Leaders Announce Six-Month Spending Agreement

Senate Majority Leader Harry Reid (D-NV) and Speaker of the House John Boehner (R-OH) have agreed to a six month extension of the fiscal year (FY) 2012 spending levels through March 30, 2013. This agreement will eliminate the possibility of a government shutdown prior to the election as congressional leaders sort through the ‘thorny’ budget issues that still lay ahead. In addition to passing a budget for next year, Congress needs to:

  • address the $1.2 trillion spending cuts required by the Budget Control Act of 2011 or accept sequestration;
  • decide whether to extend the ‘Bush’ tax cuts; and
  • find money to forestall the upcoming 27 percent cut in physician payments that is due on January 1, 2013.

Congress is likely going to address these issues in a lame duck session after the November elections.

Prostate Cancer Legislation Introduced

Senator Barbara Boxer (D-CA) and Representative Elijah Cummings (D-MD) recently introduced legislation, S.3345 and H.R.6033, respectively, the Prostate Cancer Detection Research and Education Act, which would improve research and detection of prostate cancer and support a national awareness campaign promoting prostate cancer screening. The NIH National Cancer Institute reports that 242,000 men will be diagnosed with prostate cancer in 2012 and 28,000 will die from the disease.

According to Senator Boxer, the measure is needed to “develop a more reliable test for prostate cancer to ensure that patients are getting the right diagnosis and the treatment they need.” Specifically, the bill would establish an Advisory Council of experts to coordinate federal research to develop and validate an accurate test for prostate cancer and create a national campaign to increase the awareness of prostate cancer screening. To date, neither the Senate nor the House has taken action on this legislation. If you would like more information on either S.3345 or H.R.6033, please go to the congressional Web site, THOMAS.

CMS Holds 2013 Coding Meeting; Gets Feedback on New Molecular Codes

On July 16th, the Centers for Medicare and Medicaid Service (CMS) held its annual public forum to get input on the payment rates for the new CPT codes that take effect on January 1, 2013. As part of this meeting the agency sought feedback on where to place the new 101 molecular pathology CPT codes—either the physician fee schedule (PFS) or the clinical laboratory fee schedule (CLFS). This is a key area where CMS is hoping to get guidance.

The agency received public input, but not clarity regarding the placement of the molecular tests. The College of American Pathologists, American Society for Clinical Pathology and Association for Molecular Pathology urged that CMS place all of the new molecular codes on the PFS. Although these new codes would receive regular updates (they are not subject to the annual CPI cuts as tests on the CLFS), they would be subject to a 20 percent copayment. In addition, payment rates are regularly reviewed under the PFS, which means reimbursement rates could be cut over time. There is not a similar mechanism on the CLFS.

On the other hand, AACC and the American Clinical Laboratory Association urged CMS to assign the tests on a case-by-case basis and not uniformly assign all tests to a single fee schedule, as suggested by CMS. In subsequent comments to CMS, AACC recommended that the Agency take into consideration, during the review process, the technology used to perform these molecular tests since some of the newer devices are so advanced that they generate results that require little or no interpretation. In addition, the Association reminded CMS that there may not be enough physicians to interpret the tests if all are placed on the PFS, since PhD professional scientists perform many of the interpretations and they are not permitted to bill for this service on the PFS.

FDA Issues New Guidance

The Food and Drug Administration (FDA) has released new guidance documents to expedite the medical device review process. On July 31st, the agency released , “Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review for Premarket Approval Applications,” regarding the acceptance and filing review time for pre-market applications and similarly “Guidance for Industry and Food and Drug Administration Staff; Refuse to Accept Policy for 510(k)s” on August 13th. In each instance, the FDA stated that it will notify the submitter within 15 calendar days of receiving either a PMA or 510(k) submission whether their document is complete and, if it’s not, what information is needed to make it complete.

AACC’s New Regulatory Affairs for Laboratory Compliance Certificate Program

If you need to understand how the regulatory process works or how the government makes coverage and payment decisions that impact your laboratory, you may want to consider participating in AACC’s New Regulatory Affairs Laboratory Compliance Certificate Program. This five course program, which can earn you 10 CE credits, also covers public and private sector oversight of clinical laboratories, the fraud and abuse rules that affect your facility, and the CLIA’88 requirements. Learn more about this new Certificate program by visiting our Web site.