A Medical Device Daily

The Centers for Medicare & Medicaid Services (CMS) reported recently that it will undertake an analysis of whether it should remove language in one of its national coverage determination statements that bars reimbursement for MRI for angiography studies (MRA). According to the Jan. 20 posting at the CMS web site, the move was prompted at least in part by a Dec. 24, 2008, letter from several physician specialty societies after consultation between the doctor groups and CMS in July 2008.

According to the Jan. 20 CMS posting, CMS proposes to patch over the problem "by specifically removing the phrase blood flow measurement' from the nationally non-covered indications" for MRI. The inclusion of the phrase "blood flow measurements" is said to have created confusion when doctors sought to use the procedure as part of a suite of services in a bundled code.

According to the Dec. 24 letter from three specialty societies, "non-coverage of blood flow measurement has been included in the NCD for MRI since 1985," but is in conflict with a separate NCD for MRA. The letter states that the authors of the letter "believe that the reference to blood flow measurement in the NCD for MRI was inadvertently retained when the NCD for MRA was released."

The Dec. 24 letter, which was signed by leaders at the American College of Radiology (ACR; Washington), the American College of Cardiology (ACC; Washington), and the Society for Cardiovascular Magnetic Resonance (Mt. Royal, New Jersey), state further that "Medicare's own contractors also have been confused by the conflicting statements regarding blood flow in the NCDs," leading to problems with reimbursement. "Based on discussions with . . . CMS staff on July 23, 2008, we now understand that the solution to this problem requires a reconsideration of the NCD for MRI."

The CMS announcement states that the open public comment period ends Feb. 19 and that a decision will be published Oct. 18.

HHS adds three HIT standards

The Office of the National Coordinator for Health Information Technology (ONCHIT), an agency at the Department of Health and Human Services, recently published an update on the first three interoperability standards for electronic health records as well as the first publication of three additional standards. According to the announcement, posted in the Jan. 21 edition of the Federal Register, the newly published standards deal with health records used by emergency responders, data sets for healthcare quality, and data for communication with patients "via media."

For those who do not understand why interoperability standards have been so hard to come by, a quick count of the number of components in the emergency responder standard is illuminating. ONCHIT lists 46 components in this standard alone, including multiple standards for "audit trail and node authentication integration profile." The standard also includes a separate provision for both ICD-9 and ICD-10, the latter of which is the latest iteration of the International Classification of Diseases. HHS has tried to nudge healthcare providers in the migration from ICD-9 to ICD-10, but providers nonetheless have until 2013 before their Medicare billing is likely to suffer from continued use of the older standard.

The standard for communicating with patients "via media" echoes one of the first three standards, one that deals with patient access to EHRs "via networks." The update for this standard adds 42 elements to the nine that were already on the list.

The HHS statement also notes that the standard for interoperability will shift over time and that as a consequence, the Department would take the elapsed time into consideration before going after such donations that might otherwise run afoul of Stark and anti-kickback laws. Because the laws in question generally require that the donated software be interoperable at some point in the 12 months prior to the donation, HHS "would consider the prevailing state of technology at the time the items or services were donated."

OIG's fraud recovery nets $2.3B

The Office of Inspector General (OIG) at the Department of Health and Human Services has responsibility for anti-fraud and audit activities for many agency activities at HHS as well as federal health programs such as Medicare and Medicaid, and OIG's latest annual performance report suggests that the rate of return for its work is the stuff of Wall Street dreams.

The report, which is dated January 2009, states that the return on investment for anti-fraud and audit work comes out to more than $14 for each dollar spent for the three-year period ending late last year. However, when the numbers are broken down by federal programs, OIG notes a "Medicare- and Medicaid-specific return on investment . . . of $17:$1."

The report notes that the average rate of recovery for each of the three years 2006-2008 was about $3.4 billion, which OIG says "exceeded all previous reporting periods and exceeded the preceding reporting period by 8.5%. The Office managed to persuade drugmaker Cephalon (Frazer, Pennsylvania) to cough up $425 million in fines for off-label marketing of three drugs, and Staten Island University Hospital (New York) agreed to a fine of almost $89 million last year to answer fraud charges.

Interim chief of CDC named

The Obama administration has appointed an infectious disease and disaster preparedness expert to the position of acting director of the Centers for Disease Control and Prevention. Richard Besser, MD, was named in an e-mail message to CDC employees, but it is not clear whether he will take the permanent position. The previous head of CDC, Julie Gerberding, MD, had the job for six years before resigning the job with the change in administration.

A previous announcement had named William Gimson III, the agency's chief operating officer, to the job (Medical Device Daily, Jan. 14, 2009), but Gimson was seen as an inappropriate choice because he is not a medical doctor.