CIMIT: May 2008 Regulatory Affairs Newsletter

May 2008 Regulatory Affairs NewsletterPrint this page

• FDA Launches Electronic MDRs
• Gainsharing Reported to Reduce the Price of Medical Devices
• FDA and CMS Team Up for Sentinel Initiative
• CMS to Consider National Coverage for Virtual Colonoscopy
• Patient Safety Coalition Pushes for Unique Device Identifiers
• Opposition Voiced Against Proposed Additional FDA Inspections and Fees
• Task Force Issues Standards Guidance
• $275 Million for FDA Cleared by Senate Panel
• FDA Commissioner Asks Congress for Additional $275 Million
• Import Safety Bill Under Consideration in Congress
• FDA to Examine Toxicity of BPA
• CMS Proposes to Grant Five New Codes for Durable Medical Equipment
• CMS Grants National Coverage for Replacement Heart
• CDRH to Hire 116 New Staffers in Fiscal Year 2008
• Molecular Diagnostics Firm Submits Two HPV PMAs

FDA Launches Electronic MDRs
According to a May 8, 2008, memorandum from FDA’s Office of Surveillance and Biometrics, which was posted online on May 20, 2008, FDA is ready to begin accepting electronic medical device reporting submissions (“eMDRs”). All company filers can immediately begin filing eMDRs detailing adverse events; however, device firms should contact FDA before beginning electronic submissions. The filing of eMDRs will soon be made mandatory for all device firms. Details on eMDRs are available at www.fda.gov/cdrh/emdr. Additional information is available at www.thegraysheet.com (paid subscription service).

Gainsharing Reported to Reduce the Price of Medical Devices
According to a recent study, which was published in the May/June issue of Health Affairs, gainsharing arrangements drive down the prices of medical devices. Gainsharing programs give physicians incentives to reduce hospital costs by having the hospital pay part of the savings it receives to the physicians who help generate those savings. According to the study, from 2001 to 2006, hospitals with gainsharing programs reduced their costs for treating coronary stent patients by 7.4%, or $315 per patient, when compared to non-gainsharing hospitals. Ninety-one percent of this savings was attributable to reduced spending on drugs and medical devices. The study concludes that gainsharing could shift revenues from device firms to physicians and hospitals, or from one manufacturer to another. Widespread adoption of such programs could even influence device firms’ decisions regarding which products to develop and how to market those products. Additional information is available at www.thegraysheet.com (paid subscription service).

FDA and CMS Team Up for Sentinel Initiative
According to Health and Human Services (“HHS”) Secretary Mike Levitt, FDA and the Centers for Medicare and Medicaid Services (“CMS”) are undertaking a joint effort to develop a new electronic system that would enable FDA to query a broad array of information to identify possible post-market adverse events. The so-called Sentinel Initiative will be created through public-private partnerships and will take advantage of existing electronic claims and medical records data maintained by private and government entities. Congress called for such a program in the Food and Drug Administration Amendments Act of 2007 (“FDAAA”), which requires that HHS develop methods to obtain access to disparate data sources and establish a post-market risk identification and analysis system that can link and analyze healthcare data from multiple sources. Additional information is available at http://www.devicelink.com/newsedge/index.php.

CMS to Consider National Coverage for Virtual Colonoscopy
On May 19, 2008, CMS indicated it will consider providing national coverage for computer tomography (“CT”) colonography for cancer screening. Although CMS currently offers some coverage for CT colonography, cancer screening is not covered. Preliminary data, which may be used to support such a national coverage decision, is expected to be published in the New England Journal of Medicine this summer. Additional information is available at www.thegraysheet.com (paid subscription service).

Patient Safety Coalition Pushes for Unique Device Identifiers
In late March 2008, the Advancing Patient Safety Coalition (“APSC”) sent a letter to FDA Commissioner Andrew von Eschenbach urging him to set a timeline to implement the unique device identification (“UDI”) system mandated by the Food and Drug Amendments Act of 2007 (“FDAAA”). According to APSC, such a system would improve patient safety, reduce medical errors, improve adverse event reporting, facilitate device recalls, and improve postmarket surveillance measures. Despite such claims, the medical device industry has had reservations about UDI based on the challenge in developing a system that works for the range of devices on the market today. Additional information is available at www.devicelink.com.

Opposition Voiced Against Proposed Additional FDA Inspections and Fees
On May 14, 2008, the House Energy and Commerce Health Subcommittee held a hearing to obtain feedback regarding the device and cosmetic sections of the draft FDA Globalization Act. At the meeting, industry leaders told lawmakers that additional FDA user fees and expansion of the agency’s pre-approval inspection authority to include Class II devices should not be included in the proposed bill. Insiders speculate that a premarket inspection requirement for such devices would be a logistical nightmare and would cause significant delays in getting products to market. Advocacy groups also argued that because inspections are a core function of FDA, they should be funded through the appropriations process, not industry fees. Additional information is available at www.thegraysheet.com (paid subscription service).

Task Force Issues Standards Guidance
FDA’s Global Harmonization Task Force has issued a new guidance that explains how device manufacturers should use international standards to demonstrate essential device safety and performance principles. The guidance specifies the documentation required for device manufacturers to verify product conformity to recognized standards and advises firms on demonstrating conformity to safety and performance principles when standards change. Specifically, manufacturers may choose to use a superseded version of a standard, but must justify such a decision with a documented risk assessment and must take appropriate risk-mitigating actions. Additional information is available at www.fdanews.com.

$275 Million for FDA Cleared by Senate Panel
On May 15, 2008, the Senate Appropriations Committee approved a supplemental appropriations measure that included $275 million in additional funds for FDA. However, the bill’s future in the House of Representatives and White House are less certain. On that same day, the House passed a FY 2008 supplemental funding measure that did not included the $275 million for FDA and the president has threatened to veto a bill that limits the administration’s authority for the Iraq war or contains unrelated domestic spending increases. Additional information is available at www.thegraysheet.com (paid subscription service).

FDA Commissioner Asks Congress for Additional $275 Million
In a May 5, 2008, letter to Senator Arlen Specter, FDA Commissioner Andrew von Eschenbach requested an extra $275 million to help ensure the safety of food, drugs, and medical devices. The Commissioner’s request parallels legislation that is expected to move forward this week. The Senate Appropriations Committee is expected to approve an emergency spending bill for the wars in Iraq and Afghanistan that would include $275 million for FDA on May 15, 2008. Von Eschenbach’s request is the first of its kind in at least 30 years. According to the Senate bill, the funding initiative would provide $125 million for food safety, $100 million for medical products and drug safety, and $40 million to modernize FDA’s science and work force. The remaining $10 million would be set aside to upgrade FDA’s existing facilities and laboratories. These numbers include approximately $20 million to boost the agency’s overseas presence. Additional information is available at www.nasdaq.com or http://www.nytimes.com/2008/05/14/washington/14fda.html.

Import Safety Bill Under Consideration in Congress
As the House Energy and Commerce Health Subcommittee prepares for its May 14, 2008, hearing on the medical device and cosmetic aspects of the draft FDA Globalization Act (released April 17, 2008), the Senate is drafting a similar version of the bill. The draft legislation is aimed at strengthening FDA’s oversight of products manufactured overseas. Although the Senate approach appears to give FDA and industry more flexibility, both would result in the assessment of new industry-wide fees to help support FDA inspection activities. Additional information is available at www.thegraysheet.com (paid subscription service).

FDA to Examine Toxicity of BPA
In response to a brief published on April 15, 2008, by the National Institutes of Health (“NIH”), FDA will be examining the toxicity of bisphenol A (“BPA”). BPA is a chemical used in some plastics—including those in medical devices—which has the potential to leach from products. The NIH brief cited some concern regarding the potential for neural and behavioral effects in fetuses, infants, and children resulting from exposure to BPA. These concerns are predominantly based on animal studies, which suggest that BPA can also cause changes to the prostate and mammary glands and may lead to early onset of puberty in females. Although both children and adults are routinely exposed to BPA, studies suggest that adults metabolize the substance more efficiently than children, so concerns over adult exposure are considered negligible. Additional information is available at www.thegraysheet.com (paid subscription service).

CMS Proposes to Grant Five New Codes for Durable Medical Equipment
On May 2, 2008, the Centers for Medicare and Medicaid Services (“CMS”) proposed to grant five of 40 requests for new reimbursement codes for durable medical equipment. Four of the five new codes, which will become effective January 1, 2009, are for accessories to Sequal Technologies’ Eclipse portable oxygen concentrators including a wheeled cart, batter packs, chargers, and a DC power supply. The final code will be for Hanger Orthopedic Group/Innovative Neurotronics’ WalkAid system, which is an electrical neurostimulation prosthesis for patients with a foot drop. Despite criticism from industry that its threshold for new codes is too demanding, CMS is cautious about coding requests. The agency often seeks FDA’s input to compare claims made in coding applications, which seek to set a device apart from similar devices, with claims made in 510(k) submissions, which seek to prove substantial equivalence. Additional information is available at www.thegraysheet.com (paid subscription service).

CMS Grants National Coverage for Replacement Heart
Abiomed recently announced that it has receive a positive national coverage determination from the Centers for Medicare and Medicaid Services (“CMS”) that allows for coverage of the AbioCor Total Replacement Heart. This device is the only implantable replacement heart without wires that pierce through the patient’s skin, which reduces the likelihood of infection and allows patients to continue a mobile and productive lifestyle. CMS has agreed to reimburse hospitals for the cost of the AbioCor replacement heart and for the cost of implanting the device. The agency is expected to publish the final coverage decision in August. Additional information is available at www.fdanews.com.

CDRH to Hire 116 New Staffers in Fiscal Year 2008
As part of an agency-wide recruitment effort announced on April 30, 2008, FDA’s Center for Devices and Radiological Health (“CDRH”) aims to hire 116 new staffers by September 30, 2008. The Office of Personnel Management has granted FDA the authority to bypass certain Health and Human Services (“HHS”) hiring procedures when assessing job applicants in an effort to bring candidates on board more quickly. Specifically, the agency may now avoid HHS rating and ranking procedures, allowing FDA to bring in qualified candidates in as little as three weeks, as opposed to the current timeline, which can take up to six months. The majority of the new positions will be funded by user fees collected by the agency. According to FDA, the hiring efforts are focused on medical and consumer safety officers, chemists, biologists, nurses, microbiologists, statisticians, epidemiologists, pharmacologists, pharmacists, veterinary medical officers, and health, regulatory, and general health scientists. Additional information is available at www.thegraysheet.com (paid subscription service).

Molecular Diagnostics Firm Submits Two HPV PMAs
On April 28, 2008, Third Wave Technologies announced that it has submitted premarket approval (“PMA”) applications for two human papillomavirus (“HPV”) tests and continues to develop a testing instrument for use with the assays. One test, which detects 14 high-risk strains of HPV, is intended to be used in combination with a Pap test for women who are at least 30 years old and in patients with abnormal Pap results to determine whether further evaluation is necessary. The second test detects HPV types 16 and 18, which cause approximately 70% of cervical disease. Additional information is available at www.thegraysheet.com (paid subscription service).