News: November 20, 2007
NIH Aims to Reconcile Clinical Trial Registry Requirements. The National Institutes of Health (“NIH”) is in the process of reconciling the clinical trial registry requirements for medical devices under the newly enacted Food and Drug Administration Amendments Act (“FDAAA”) with the preexisting policy of medical journal editors. Although prior to FDAAA medical device companies were not required by law to register clinical trials on a public database, the International Committee of Medical Journal Editors (“ICMJE”) requires public registration at the inception of any study as a prerequisite for publication. Under FDAAA, NIH may not make information for trials registered on its clinical trials database publicly available before the device is cleared or approved. Although the device industry lobbied for this language, the provision is making implementation difficult since some companies want their trial information to be made public sooner to satisfy journal editors. The NIH is trying to decide whether to allow companies to choose between having their information kept secret or having that information made publicly available on the database web site. NIH expects to issue a fact sheet in the coming weeks clarifying which data fields will be required and how the posting of device trial submissions will be handled. Additional information is available at www.thegraysheet.com (paid subscription service).
Physician Specialty Societies Influential in Device Reimbursement. According to insiders, manufacturers should develop a strategy to communicate with specialty societies, which are becoming increasingly influential in device reimbursement decisions. These societies, which create evidence-based guidelines and appropriateness criteria for medical treatments, are not exclusively focused on the quality of physician care. For example, the American Medical Association (“AMA”) oversees the creation of current procedure terminology (“CPT”) codes used to identify services and procedures for reimbursement and most of the AMA advisory board members are physicians who represent specialty societies. For device manufacturers, the coding process is a crucial first step toward reimbursement. Manufacturers wishing to build relationships with specialty societies should also pay attention to what competitors are doing in the marketplace. New codes could be made at the expense of a company’s product if competitors are pursuing new coding through specialty societies while the company remains invisible. The key may not be to gain an advocate in the specialty society, but merely to gain visibility and avoid opposition. Additional information is available at www.thegraysheet.com (paid subscription service).
Updated ICD Guidance Expected in 2008. The Food and Drug Administration (“FDA”) expects to release a new premarket approval (“PMA”) guidance for pacemaker and implantable defibrillator leads in 2008. The document will give device manufacturers more guidance on bench testing and address premarket development of pacemaker leads. The document recommends more electrical and mechanical bench testing, as well as clinical or animal testing in special circumstances. Additional information is available at www.thegraysheet.com (paid subscription service).
New Advisory Committee Voting Procedures Proposed by FDA. The latest in a series of proposed reforms to the FDA advisory committee replaces the current sequential voting scheme to one in which all votes are cast simultaneously. Additionally, before the panel will be allowed vote on a question not originally posted by FDA, the committee chair must check with the designated FDA official to ensure the question is appropriate for the meeting, is consistent with the topics discussed, and will not be affected by conflict-of-interest screenings. Additional information is available at www.thegraysheet.com (paid subscription service).
Congressional Budget Office Cites New Technology as a Major Factor in Rising Health Costs. According to the Congressional Budget Office (“CBO”), unsustainable growth in healthcare spending can be reduced by eliminating the inappropriate use of new medical technologies. According to the CBO, new technology, which is often used without adequate supporting evidence, is a major contributor to rising costs. The current payment system facilitates the use of technology in situations where the overall benefit is small, at best. The fee-for-service system pays for a service rendered whether that service provides any patient benefit or not. According to the CBO, the widespread use of expensive technologies has the potential to increase costs without a coinciding increase in the quality of care. Although in terms of objective cost effective measures, major medical advances have paid off, the CBO insists that more evidence should be required to support payment for new technologies and is suggesting that legislators consider making statutory changes allowing Medicare to tie its provider payment to comparative effectiveness outcomes, despite device industry opposition. Additional information is available at www.thegraysheet.com (paid subscription service).
Medicare Panel Releases Top Research Priorities. The Medicare Evidence Development and Coverage Advisory Committee (“the committee”), which convened on October 22, 2007, recently released its list of top Medicare research priorities. The committee hopes that the list will provide a framework for the scientific community to design research studies that will affect the health and medical coverage of Medicare beneficiaries. The number one area in need of research as identified by the committee is the appropriate use of erythropoiesis stimulating agent drugs for treatment of cancer. But several of the top ten priorities involve medical devices, including research on treatment of carotid artery disease and intracranial disease, for which stents are widely available, and research on new technologies, such as proton beam radiation and intensity modulated radiation therapy. Additional information available at www.thegraysheet.com (paid subscription service).
Reimbursement Increase for Outpatient Uterine Fibroid Treatments. The Centers for Medicare and Medicaid Services’ (“CMS”) 2008 hospital outpatient rule increases reimbursement for uterine fibroid embolization (“UFE”) treatments from $2,642.00 in 2007 to $5,639 effective January 1, 2008. This increase has fueled industry expectations for increases in the market for device-based alternatives to surgery, such as UFE. The procedure involves the transcatheter implantation of embolic microspheres, which stop the supply of blood to uterine fibroids. The procedure is less invasive than alternative surgical treatments, such as hysterectomy and myomectomy, which remove all or part of the uterine tissue. Although most women undergoing UFE are not eligible for Medicare based on age, CMS expects the increased reimbursement to influence private payers. Additional information is available at www.thegraysheet.com (paid subscription service).
Guidance on Medical Device Tracking Requirements under the FDA Amendments Act Released. The medical device tracking requirements under the recently enacted FDA Amendments Act (“FDAAA”) subject medical device makers to fewer tracking requirements than the prior law. Previously, device manufacturers were required to track certain devices whether the Food and Drug Administration (“FDA” or “the agency”) issued a specific tracking order or not. Under FDAAA, manufacturers will only be required to track devices for which FDA issues a tracking order. The agency’s guidance document, Guidance for Industry—Medical Device Tracking, released November 2, 2007, clarifies that FDA may require tracking for class II or class III devices: 1) that are intended to be implanted into the human body for more than one year; 2) that are life-sustaining or life-supporting devices used outside a device user facility; and 3) whose failure would be reasonably likely to have serious adverse health consequences. Additional information available at www.fdanews.com and http://www.fda.gov/cdrh/comp/guidance/169.html.
FDA Panel to Consider PMA for Permanent Birth Control Device Next Month. An FDA advisory panel will consider Hologic’s premarket approval (PMA) application for the Adiana permanent female birth control product on December 13, 2007. The alternative to tubal ligation consists of a radiofrequency generator, an implantable polymer matrix, and a single-use delivery catheter. The procedure, which is performed in a doctor’s office without general anesthesia, involves inserting the catheter into the uterus, aided by a hysteroscope. Radiofrequency (“RF”) energy is then used to remove a small layer of cells inside the fallopian tube. The polymer matrix is then implanted at the site of the RF lesion to promote healthy tissue growth that will block the fallopian tubes. Additional information available at www.thegraysheet.com (paid subscription service).
CMS Advised to Monitor Growth in Imaging Services. On November 7, 2007, the Office of Inspector General (“OIG”) of the Department of Health and Human Services (“HHS”) advised CMS to monitor the rapid growth in advanced imaging services at freestanding facilities; however, no formal recommendations of action to curb such growth were made. The recommendation is apparently in response to a four-fold increase in the number of magnetic resonance, computer tomography, and positron emission tomography imaging services paid for by Medicare’s physician fee schedule from 1995 to 2005. In addition, OIG cited the $3.5 billion increase in the overall charges for such services. OIG’s sole recommendation is for CMS to monitor the growth of advanced imaging performed in ambulatory settings and to consider conducting site visits to independent diagnostic testing facilities. CMS says it will increase its oversight of such facilities, but does not have the resources to conduct unannounced inspections. Additional information available at www.thegraysheet.com (paid subscription service).