A Medical Device Daily

The Centers for Medicare and Medicaid Services (CMS; Washington) has accepted the recommendation received from the American Medical Association’s (AMA; Chicago) Specialty Society Relative Value Update Committee and created a clinical reimbursement code and rate for percutaneous renal cryoablation. The new rate will go into effect Jan. 1.

According to Endocare (Irvine, California), a device company focused on the development of minimally invasive technologies for tissue and tumor ablation, the new code will be paid an adjusted average in the $440 range and is the first time there is a specific code and reimbursement rate for this procedure.

Percutaneous renal cryoablation is a minimally invasive procedure that allows physicians to destroy small tumors in the kidney by inserting a probe directly through the skin and freezing the cancerous tissue.

“This represents a significant milestone for Endocare and for cryoablation as a cancer therapy,” said Craig Davenport, CEO and chairman of Endocare. “Recent data showing the safety and effectiveness of renal cryoablation have made a positive impression on the American Medical Association committee that establishes clinical CPT codes. The new renal cryoablation reimbursement rate, paid at a higher rate than other percutaneous ablation modalities, provides patients and their physicians with a powerful new option when choosing a therapy to treat a dangerous disease.”

FDA urged to revise breast biopsy rules

The National Mammography Quality Assurance Advisory Committee (NMQAAC) has advised the FDA to lift the current exemption of stereotactic breast biopsy from the MQSA regulations.

Nine out of 14 members of the committee voted in favor of regulating stereotactic breast biopsy facilities, citing current variable quality, lack of voluntary participation in existing accreditation programs, and dose concerns. Those voting against the proposal cited access issues, no scientifically documented need, and that MQSA did not intend to address interventional procedures.

After testimony from the American College of Radiology (ACR; Reston, Virginia), the Society of Breast Imaging (SBI; Reston, Virginia), the American College of Surgeons (Chicago), the American Society of Breast Surgeons (Columbia, Maryland), the Medical Imaging and Technology Alliance (Rosslyn, Virginia), radiologists and consumer advocates, the panel openly discussed their views before voting.

All speakers and committee members agreed that regulations should not be written to effectively exclude any specialties. FDA said it would take this advice under consideration as they draft revisions to their mammography regulations.

Members chosen for new FDA committee

FDA has selected 15 voting members to serve on its Risk Communication Advisory Committee. The committee will advise the agency about how best to communicate to the public about the risks and benefits of FDA-regulated products so as to facilitate their optimal use.

FDA announced the committee on June 5 and requested nominations for individuals to serve as members. The agency said it received more than 240 nominations.

The establishment of the advisory committee was one of the recommendations of the Institute of Medicine’s 2006 report, “The Future of Drug Safety: Promoting and Protecting the Health of the Public.”

“Communicating effectively about the safety and effectiveness of drugs and other medical products is one of the central roles of FDA,” said Randall Lutter, PhD, Deputy Commissioner for Policy. “We were in such strong agreement about the value of the Risk Communication Advisory Committee that we expanded its scope to address communication regarding all products regulated by the agency, including our food supply responsibilities.”

The advisory committee’s 15 voting members include independent experts and public members. Experts were chosen from the fields of risk communication, risk perception, decision analysis, communication, social marketing, health literacy, journalism, and other behavioral and social sciences. Public members include those who can provide the perspective of users of FDA-regulated products, such as consumers, patients, caregivers and health care providers. For some meetings, one or more industry representatives may be invited to participate in a nonvoting capacity.

Members have been assigned to serve for periods ranging from one to four years. FDA expects to hold the committee’s first meeting in 1Q08. The list of members is available on FDA’s web site at http://www.fda.gov/oc/advisory/OCRCACRoster.htm.

FDA is currently amending the committee’s charter to incorporate the provisions of the recently passed Food and Drug Administration Amendments Act of 2007.

Palmetto to serve as MAC for CMS

Palmetto GBA (Columbia, South Carolina), a provider of technical and administrative services for the federal government, said it has been selected by the Centers for Medicare and Medicaid Services (CMS) to process fee-for-service Medicare claims and perform related duties for California, Hawaii, Nevada, American Samoa, Guam and the Northern Marina Islands.

CMS awarded Palmetto a contract with a base period of one year and four one-year options to serve as the Medicare Administrative Contractor (MAC) for those states and U.S. territories, known as MAC Jurisdiction 1. The contract has a potential value of about $400 million. As the MAC, Palmetto will process claims for both Parts A and B of the Medicare benefit program.

To support the contract, Palmetto and its two largest subcontractors, TrailBlazer Health Enterprises (Dallas) and First Coast Service Options (Jacksonville, Florida) will add about 750 full-time jobs.

Palmetto said it would begin implementation activities immediately. It will assume full responsibility for claims in Jurisdiction 1 by June.