A Medical Device Daily

Predictive medicine company PreMD (Toronto) reported that the FDA has upheld its decision regarding the company's appeal of the not substantially equivalent (NSE) letter it received this past January in connection with a premarket submission to expand indication for its skin cholesterol test.

PreMD said that the FDA agreed with it on two of three issues on appeal, but concluded that the clinical trial data was not sufficient to determine that the product is substantially equivalent to other markers of cardiovascular risk.

PreMD submitted the 510(k) application in 2007 with the data from a clinical study based on guidance received from the FDA in 2004.

Brent Norton, president/CEO of PreMD, said, "Our situation now is strictly in the area of a scientific disagreement. There is a well defined process for a scientific dispute resolution, one of the paths we will be exploring immediately."

He said that despite winning agreement on two issues, "including the use of CIMT as a clinical endpoint, we are very disappointed with the decision. We continue to believe that our skin cholesterol test is a beneficial product [because adding] to our understanding of those at cardiovascular risk."

The company said it disagreed with the original decision as expressed in the NSE determination letter and submitted a letter to the FDA and a meeting was held in late March 21, 2008, between PreMD, several medical experts, regulatory consultants, executives from AstraZeneca Pharmaceuticals (London), and various FDA personnel involved in the review process.

PreMD said it presented expert analysis of the data gathered during clinical trials, in particular data relating to the use of carotid intima wall thickness (CIMT), a determinant for those at risk of cardiovascular disease. In addition, PreMD argued for reversal of the FDA's decision.

Additional information regarding the status of FDA clearance efforts and other business updates will be provided as information becomes available.

Ubl lauds home monitoring bill

In a statement from AdvaMed (Washington), Stephen Ubl, president/CEO of the association, praised the recent introduction of the Remote Monitoring Access Act by Rep. Anna Eshoo (D-California).

"What was once only science fiction is now patient care reality. With remote monitoring technologies, a physician can evaluate and manage complex chronic diseases from remote locations and provide real-time care for patients. [But] adoption and widespread diffusion of such innovations have been stymied by antiquated reimbursement systems."

Ubl said that the act means that "physicians may finally be reimbursed for the remote care they provide for elderly, disabled and rural patients, and encourage further use of these lifesaving and life-enhancing technologies that improve patient care and reduce costs."

He said the legislation will require Medicare to cover remote monitoring that will help manage patients with congestive heart failure and cardiac arrhythmia and "work with stakeholders to develop a standard of care for using remote monitoring for those conditions."

He concluded: "We urge Congress to join Rep. Eshoo, Rep. Charles W. Pickering (R-Miss.), Rep. John Tanner (D-Tennessee) and Rep. Kenny Hulshof (R-Missouri) in supporting this important bipartisan legislation and hope it is included in this year's Medicare package."

Federal works get SBI coverage

The White House Office of National Drug Control Policy (ONDCP) reported that about 5.6 million federally insured federal workers will now be covered for a substance abuse prevention and treatment procedure called Screening and Brief Intervention (SBI).

The coverage will reimburse doctors who screen their patients for a "full spectrum" of substance use behaviors: alcohol, illicit drugs and prescription drug abuse/addiction, and provide intervention.

The U.S. Office of Personnel Management asked carriers participating in the Federal Employees Health Benefits (FEHB) program to review new Current Procedural Terminology (CPT) codes – CPT 99408 and CPT 99409 – for screening and short-term intervention for alcohol and substance abuse, which are American Medical Association (AMA; Chicago) codes used to bill health insurance plans for physician services.

OPM said that at least 70% of enrollees participate in FEHB plans which will recognize the codes for their claims processing systems when services are delivered.

The administration said that SBI facilitates "dialogue between doctors and patients about the harms of substance abuse, risks for the disease of addiction, and strategies to help patients achieve sobriety. Through SBI, patients can be referred to an appropriate level of care or specialty treatment."

Dr. Bertha Madras, deputy director for demand reduction at the White House Office of National Drug Control Policy, said, "By opening the lines of communication between doctors and patients, SBI can help identify users and reduce substance use and its associated consequences," said. "This intervention assists an individual engaged in risky substance abuse to change their [addictive] behaviors."

The Centers for Medicare and Medicaid Services adopted SBI codes in January 2007, while the AMA's addition of two CPT codes became effective in January 2008. CMS has also line-itemed SBI in their annual budget, with a $265 million set-aside to match state contributions for Medicaid for states implementing the codes and reimbursing for SBI services.