In This Issue...


ONC to Assess Electronic Transfer of Data from Labs to Physicians

The Office of the National Coordinator (ONC) for Health IT is seeking approval from the Office of Management and Budget (OMB) to develop and implement a National Survey on Health Information Exchange in Clinical Laboratories. The purpose of the study would be to “assess and evaluate the electronic transfer of health information from clinical laboratories to ordering physicians.” ONC would seek information on two measures:
  1. The percentage of laboratories that are sending structured lab results electronically to physicians; and
  2. The percentage of lab results that are currently being sent electronically in coded format to ordering physicians.
ONC will send similar questionnaires to hospitals and commercial laboratories. Please go to the October 19th Federal Register to see a copy of the release by clicking here.

First In-Home Rapid HIV Test Available

The first over-the-counter home use HIV test is now for sale in the United States. The FDA-approved OraQuick In-Home HIV Test developed by OraSure Technologies allows consumers to find out their HIV status within 20-40 minutes. The FDA recommends that all positive test results be confirmed by a CLIA-certified laboratory. According to the Centers for Disease Control and Prevention nearly 250,000 people in the United States are unaware they are HIV-positive. For more information regarding the in-home test, please visit the FDA website and/or OraSure Technologies website.

Congressional Bill Would Punish Medicare Auditors

Representative Sam Graves (R-MO) recently introduced legislation, H.R.6575, the Medicare Audit Improvement Act of 2012, which would increase the accuracy and transparency of the recovery audit contractors (RACs) program. Created under Medicare Modernization Act of 2003, RACs are directed by Congress to identify fraud and abuse within the Medicare program and recoup overpayments. RACs are permitted to keep a portion of the overpayments they recover.

A number of providers have complained that RACs are disruptive to their health care operations and too zealous in their claims denials. The American Hospital Association reports that hospitals are “successfully overturning RAC denials 75 percent of the time.” H.R.6575 would address these complaints by:

  • Placing limits on records requests
  • Making the auditing process more transparent and timely;
  • Imposing financial penalties on RACs when claims denials are overturned; and
  • Requiring physician review of medical necessity claims denials

To see a copy of H.R.6575, please visit the congressional web site, THOMAS, by clicking here. To get a copy of the AHA letter endorsing the bill, please visit the association’s web page.

New Test Reimbursement Bill Introduced

Representative Peter Roskam (R-IL) introduced legislation, H.R.6446, the Improving Diagnostic Innovations Act of 2012, which would create a process for increasing Medicare payments for new laboratory tests. Under the legislation, the Department of Health and Human Services (HHS) would take into consideration a number of factors when using the gap-fill process to set payment rates for new laboratory tests. Among the factors CMS would be required to take into account include:

  • The tests impact on patient care;
  • The resources needed to develop, validate and perform the test;
  • Medicare claims data;
  • Laboratory charges to patients;
  • Private insurance rates; and
  • Other factors specified by HHS.

H.R.6446 would also establish an HHS Independent Advisory Panel to make payment recommendations regarding the test. The 19-member panel would be comprised of a variety of individuals with knowledge of the test and/or interest in its use, including patients, physicians, and laboratorians. The bill would also establish a process for assigning a temporary national HCPCS code to identify the test until a permanent HCPCS code was available.

The most controversial aspect of the bill is the use of the potential cost savings generated by a new test as a means of determining its payment rate. Not only would it be difficult to accurately quantify the savings associated with the test, but increasing payments for new tests could lead to cuts in reimbursement for existing tests if Congress were to make the adjustments in a budget-neutral environment. For a copy of the bill, please visit the congressional web site, THOMAS, by clicking here.