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Orthopaedic Device
Forum Present:
Members of the Orthopaedic Device Forum introduced themselves and disclosed conflicts of interest. Approval of January 27-28, 2002 Summation Report Members reviewed, amended and approved the summation report from the January 2002 meeting of the Orthopaedic Device Forum. New members and guests were introduced to the Forum. Disclosure statements were updated. |
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| Center for Medicare and Medicaid Services (CMS) Discussion
Technological Change and the Medicare Payment Policy:
CMS typically writes payment policies for acute care in excess of $150 billion per year. In May 2002, CMS will publish a proposed rule on the prospective payment schedule. New technologies are generally paid for through the following process:
Discussion Members of the Forum explained that a public health problem is being created due to the lack of a different payment schedule for orthopaedic revision surgeries. Members report that some hospitals are refusing to do revision hip surgeries, since they are reimbursed as a primary surgery. The hospitals that accommodate revision surgeries are taking a greater share of that market with a substantial loss incurred by the participating hospital. Members also noted that there are CPT codes for revision total knee and total knee operations however none exist for ACL revision surgery or for total shoulder surgeries. CMS pays for some investigational services and may pay for off label use if the device is used in an inpatient setting. Members noted that new technologies such as metal/metal and ceramic/ceramic hip prostheses are not recognized by DRG codes. CMS intended to shift the responsibility to the hospital so that they would question if the clinical decision was worth the expense. A manufacturer may meet with CMS about covering new technologies however; CMS admits that they have a vigorous set of tests that manufacturers must meet to be successful. Members noted that Medicare drives all of the other private insurance payment schedules.Standards
Future meetings/symposia at ASTM
Suggestions for future symposia National Institute of Standards and Technology (NIST), American Standards for Testing and Materials (ASTM), and National Science Foundation (NSF) members will hold a planning session at the May 2002 ASTM meeting on the cleanliness of implants. Forum members suggested possible future symposia topics including biofilm, antibiotic bone cement, reprocessing of instruments, ceramic heads, cartilage repair, kinematics and wear on total joint replacements. Since NIH published a program announcement (PA) on Wear during the last year, members suggested that an ASTM symposium would be timelier after the study was completed.ISO AAOS and FDA members questioned the value of participating in the International Standards Organization (ISO) since ASTM is positioning itself as a global standards organization. The Food and Drug Administration Modernization Act (FDAMA) enacts that CDRH will accept consensus standards. CDRH has accepted standards from multiple standards organizations- national and international.TEMPS The Tissue Engineered Medical Products (TEMPS) division of ASTM is becoming active in European countries. Although the U.S. is the leader in technology, European contingents are becoming very aggressive in developing tissue standards. Europeans object to the use of the term “tissue engineering.” If European and U.S. groups cannot agree on basic terms, two different standards will be developed. Additionally, Europeans use animal products much more readily than their U.S. counterparts. Admittedly, each group derives revenue from selling their standards. Germany has decided that they will not recognize ASTM standards. Members stated that they would like to see the best products recognized and that global harmonization is a very worthy goal.Quality Standards Change Orthopaedic device manufacturers want to alert hospitals to a change in ISO standards. ISO standard #9001 (adopted in 1994) has been changed to ISO standard #13485. The content of the standard has not been altered. Previously, auditors have verified that manufacturers are in compliance with ISO standard #9001 every year. Consequently, hospital contracts were based on certification with that standard. Failure to make note of the change in the standard number may invalidate some contracts for U.S. hospitals. Manufacturers discussed methods to disseminate the information to hospitals. Educational Initiatives
The new technologies subcommittee has proposed two types of educational initiatives:
Criteria for Success Members noted that FDA and industry have some differences in their expectations for the threshold for the initiation of clinical studies and for the success criteria to allow for the evaluation of safety and efficacy for the purposes of approving for marketing applications. FDA identified that for an Investigational Device Exemption (IDE) to be initiated, the sponsor needs to demonstrate the relative safety of a device for the initiation of human clinical studies for the proposed indication use. FDA identified that the criteria for success to evaluate the safety and effectiveness is proposed by the sponsor and negotiated as part of the approval process of the IDE after relative safety for the proposed indication for use has been established. Members stated that it might be beneficial to provide criteria for determining whether clinical study guidances or a seminar on clinical study designs for various implants would be beneficial for FDA staff.Minimum Data Sets
FDA indicated that they are currently assessing appropriate end points for hip and knee malfunctions. Members of the Forum have agreed to participate in a similar effort and will work in tandem with the Orthopaedic Surgical Manufacturers Association (OSMA). Initially, the work group will focus on setting parameters for hip failures. Failures are either a near term or long term (generally five to seven years) issue.
FDA orthopaedic guidances traditionally address:
SUD Device manufacturers reported discussion of contaminated products at the May 2002 OSMA meeting. Original equipment manufacturers continue to object to the lack of identification labeling on reprocessed devices. Additionally, they indicate that biofilm is anticipated to be a greater concern for reprocessed devices. AAOS contends that some devices can be reprocessed safely and pose no risk to the patient. Other devices such as cannulas may be more difficult to reprocess. The FDA maintains a list of commonly reprocessed devices (see Appendix A). Undoubtedly, the cost of patient care will increase due to increased costs of reprocessed or new devices. Hospitals have generally contracted with one of three national reprocessing firms. In 2002, Congress is considering an amendment on a bill to outlaw reprocessing in its entirety. Regulatory Reform The HHS Secretary’s Regulatory Reform Committee’s final report is due in October 2002. AAOS requested participation in the FDA Approval Processes of New Medical Technologies panel during the June 10-11 meeting in Minneapolis. Tommy Thompson, Secretary of HHS, frequently attends regional hearings. AAOS will identify onerous regulations and processes that initiated the current regulatory framework. Surgeons contend that as technology progresses, safety is easier to assess. AAOS advocated that an additional category of devices be devised in their previous comment to the HHS Regulatory Reform Panel. However, this change to the U.S. system would require a legislative initiative. FDA noted that a 510(k) with clinical data might satisfy some applications in such a proposed new regulatory framework should such legislation be approved. Industry has repeatedly stated that spinal implants take between 5-7 years to be granted U.S. market approval. Some members admonished that cardiac devices are generally approved in less time than orthopaedic devices. Additionally, manufacturers suggested that the deNovo pathway to market is under utilized (see Section 513(f)(2)). Orthopaedic and Rehabilitative Devices Panel Forum members are reminded that the conflict of interest policy is in effect throughout federal agencies. FDA holds panel members to the standard of “the appearance of conflict.” Panel members are very helpful to discussions if they have more than one area of expertise. Members stated the need for more geographic distribution and diversity among Panel members. Panel members need to schedule Panel dates several months in advance. Additionally, potential future Panel members should be aware of the fewer pages of text sent to Panel members than in prior years. Registry AAOS will plan an organizational conference call for staff and chairmen of the joint registry oversight panel and project teams. Two subcommittees, the governance team and pilot project team, report to the oversight panel. Forum members urged that all joint registry panel members read the NIH Technology Assessment on Improving Medical Implant Performance Through Retrieval Information: Challenges and Opportunities. A link to the summary is provided. FDA Update Reclassification of the Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis final rule was published in the April 30, 2002 Federal Register. Manufacturers may claim substantial equivalence to this device in 510(k) applications. The PMMA bone cement reclassification order is available on the CDRH website. CDRH has granted a Humanitarian Device Exemption (HDE) to the Ascension PIP for use in arthroplasty of the proximal interphalangeal joint. FDA has recently received several calls from IRBs claiming that products identified as cement restrictors are being used off-label for intervertebral body fusion devices. One warning letter has been issued. The Food and Drug Administration Modernization Act (FDAMA) restricts FDA’s statutory authority on labeling claims. Tissue On March 15, 2002, the Centers for Disease Control (CDC) published a Morbidity and Mortality Weekly Report (MMWR) on infections they believe are attributed to allograft tissue. In the report, they cite 26 cases of infection and state that the investigation is continuing. On May 15, 2002, the CDC reported that their continued investigation has netted 42 cases of infection. The Center for Biologics Evaluation and Research issued the Validation of Procedures for Processing of Human Tissues Intended for Transplantation final guidance in March 2002. This guidance is apparently having a significant effect on industry. In the guidance, CBER states that validation procedures must demonstrate that a process consistently produces a result or product and must meet its predetermined specifications. The AAOS Tissue Banking Work Group will convene another conference call and will solicit personnel from the CDC. 60 Minutes aired a report on profit vs. not for profit tissue banks/processors. Some tissue banks are reporting bone shortages. The demand for bone has increased and adverse publicity may have an affect on donation rates. Members stated that the public needs to be informed about the benefits of bone transplantation. Additionally, OSMA is encouraged to communicate the benefits of manufacturers’ processing of tissues and bone. Demineralized Bone Matrix (DBM) In March 2002, the FDA Office of Compliance in CDRH sent a letter to manufacturers of demineralized bone matrix (DBM). The letter stated that demineralized bone products that have additive ingredients for purposes other than sterilization, preservation, or storage are not regulated under section 361 of the Public Health Service Act but instead are regulated products. These regulated products will be considered under the medical device premarket notification provisions of the Food and Drug Cosmetic Act. The final rule on Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing was published on January 19, 2001. FDA suggests that demineralized bone products should be compared to the gold standard of autograft tissue, allograft alone, or other marketed calcium salts (bone void fillers) in marketing applications for the DBM+addivitive(s) products. Manufacturers of DBM+addivitive(s) products must now show at a minimum equivalence to other marketed calcium salts (bone void fillers). Forum members questioned what storage agents are acceptable to FDA. The Forum agreed to revisit this topic at their next meeting. OSMA
The Orthopaedic Surgical Manufacturers Association (OSMA) has 35 member companies, to date, and may possibly add two more. In brief, they report areas of interest from their last meeting:
Combination Products AdvaMed is attempting to set up a meeting with Mark Kramer, Director of Combination Products in the FDA Commissioner’s office. In the past, some companies prepared for product reviews with the expectation that the lead reviewer was from CDRH and were assigned a lead reviewer from CBER. The creation of this office may lead to more predictable reviews for products. AAOS BOD Report The President of the United States, George W. Bush, has officially signed a proclamation declaring 2002-2011 the Bone and Joint Decade. The AAOS Board of Directors hired a consulting firm to assess the overall structure of the Academy. The consultant’s report is due in May 2002. Additionally, the AAOS Board of Directors held a workshop on AAOS advocacy efforts in April 2002. AAOS is working with ORS and OREF to define a coordinated research agenda. Currently, AAOS is considering whether to have a separate Research day on Capitol Hill or combine efforts with the National Orthopaedic Leadership Conference (NOLC). Approximately 60 surgeons attended Research day in 2002, however the number could increase to 100. Approximately 300 orthopaedic surgeons attend the NOLC. CMS Jeffrey Kang, MD, MPH resigned from CMS; Robert Streimer is the Acting Deputy Director of Clinical Standards and Quality. CMS is expected to issue their proposed rule for Medicare Program changes to the hospital inpatient prospective payment system for fiscal year 2003, imminently. NIH Elias Zerhouni, MD is expected to be confirmed as the Director of the National Institutes of Health (NIH). Dr. Zerhouni was recently executive vice dean of Johns Hopkins University School of Medicine, chair of the Russell H. Morgan department of radiology and radiological science and Martin Donner professor of radiology and professor of biomedical engineering. Biomedical Engineering Committee The AAOS Biomedical Engineering committee is revising the Use of Lasers in Orthopaedic Surgery Advisory statement to include uses of thermal technologies. Also, committee members are drafting point/counterpoint Bulletin articles on the use of kyphoplasty and vertebroplasty and the use of polyethylenes in knee replacement devices. Biological Implants Committee The AAOS Biological Implants committee presented a comprehensive program on bone graft substitutes that included a symposium, an instructional course lecture and a scientific exhibit at the 69th AAOS Annual Meeting. An article on allograft safety for the Bulletin is being reworked due to recent developments detailed in the March 15, 2002 Morbidity and Mortality Weekly Report (MMWR) by the Centers for Disease Control (CDC). The committee voted to strike the Thermography Advisory Statement from the AAOS official policy statements. Additionally, a symposium application on the safety of biological substances has been submitted for consideration for the 2003 AAOS Annual Meeting program. Next Agenda Topics
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