Medicare program; replacement of reasonable charge methodology by fee schedules for parenteral and enteral nutrients, equipment, and supplies. Final rule.
(41/671)
This final rule implements fee schedules for payment of parenteral and enteral nutrition (PEN) items and services furnished under the prosthetic device benefit, defined in section 1861(s)(8) of the Social Security Act. The authority for establishing these fee schedules is provided by the Balanced Budget Act of 1997, which amended the Social Security Act at section 1842(s). Section 1842(s) of the Social Security Act specifies that statewide or other area wide fee schedules may be implemented for the following items and services still subject to the reasonable charge payment methodology: medical supplies; home dialysis supplies and equipment; therapeutic shoes; parenteral and enteral nutrients, equipment, and supplies; electromyogram devices; salivation devices; blood products; and transfusion medicine. This final rule describes changes made to the proposed fee schedule payment methodology for these items and services and provides that the fee schedules for PEN items and services are effective for all covered items and services furnished on or after January 1, 2002. Fee schedules will not be implemented for electromyogram devices and salivation devices at this time since these items are not covered by Medicare. In addition, fee schedules will not be implemented for medical supplies, home dialysis supplies and equipment, therapeutic shoes, blood products, and transfusion medicine at this time since the data required to establish these fee schedules are inadequate. (+info)
Design and implementation of a portal for the medical equipment market: MEDICOM.
(42/671)
BACKGROUND: The MEDICOM (Medical Products Electronic Commerce) Portal provides the electronic means for medical-equipment manufacturers to communicate online with their customers while supporting the Purchasing Process and Post Market Surveillance. The Portal offers a powerful Internet-based search tool for finding medical products and manufacturers. Its main advantage is the fast, reliable and up-to-date retrieval of information while eliminating all unrelated content that a general-purpose search engine would retrieve. The Universal Medical Device Nomenclature System (UMDNS) registers all products. The Portal accepts end-user requests and generates a list of results containing text descriptions of devices, UMDNS attribute values, and links to manufacturer Web pages and online catalogues for access to more-detailed information. Device short descriptions are provided by the corresponding manufacturer. The Portal offers technical support for integration of the manufacturers Web sites with itself. The network of the Portal and the connected manufacturers sites is called the MEDICOM system. OBJECTIVES: To establish an environment hosting all the interactions of consumers (health care organizations and professionals) and providers (manufacturers, distributors, and resellers of medical devices). METHODS: The Portal provides the end-user interface, implements system management, and supports database compatibility. The Portal hosts information about the whole MEDICOM system (Common Database) and summarized descriptions of medical devices (Short Description Database); the manufacturers servers present extended descriptions. The Portal provides end-user profiling and registration, an efficient product-searching mechanism, bulletin boards, links to on-line libraries and standards, on-line information for the MEDICOM system, and special messages or advertisements from manufacturers. Platform independence and interoperability characterize the system design. Relational Database Management Systems are used for the system s databases. The end-user interface is implemented using HTML, Javascript, Java applets, and XML documents. Communication between the Portal and the manufacturers servers is implemented using a CORBA interface. Remote administration of the Portal is enabled by dynamically-generated HTML interfaces based on XML documents. A representative group of users evaluated the system. The aim of the evaluation was validation of the usability of all of MEDICOM s functionality. The evaluation procedure was based on ISO/IEC 9126 Information technology - Software product evaluation - Quality characteristics and guidelines for their use. RESULTS: The overall user evaluation of the MEDICOM system was very positive. The MEDICOM system was characterized as an innovative concept that brings significant added value to medical-equipment commerce. CONCLUSIONS: The eventual benefits of the MEDICOM system are (a) establishment of a worldwide-accessible marketplace between manufacturers and health care professionals that provides up-to-date and high-quality product information in an easy and friendly way and (b) enhancement of the efficiency of marketing procedures and after-sales support. (+info)
Foreign establishment registration and listing. Final rule.
(43/671)
The Food and Drug Administration (FDA) is issuing a final rule to amend its regulations pertaining to the registration of foreign establishments and the listing of human drugs, animal drugs, biological products, and devices. The final rule requires foreign establishments whose products are imported or offered for import into the United States to register with FDA and to identify a United States agent. The final rule implements section 417 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) as it pertains to foreign establishment registration. (+info)
Expression of renal cell protein markers is dependent on initial mechanical culture conditions.
(44/671)
The rotating wall vessel is optimized for suspension culture, with laminar flow and adequate nutrient delivery, but minimal shear. However, higher shears may occur in vivo. During rotating wall vessel cultivation of human renal cells, size and density of glass-coated microcarrier beads were changed to modulate initial shear. Renal-specific proteins were assayed after 2 days. Flow cytometry antibody binding analysis of vitamin D receptor demonstrated peak expression at intermediate shears, with 30% reduction outside this range. Activity of cathepsin C showed the inverse pattern, lowest at midshear, with twofold increases at either extreme. Dipeptidyl-peptidase IV had no shear dependence, suggesting that the other results are specific, not universal, changes in membrane trafficking or protein synthesis. On addition of dextran, which changes medium density and viscosity but not shear, vitamin D receptor assay showed no differences from controls. Neither cell cycle, apoptosis/necrosis indexes, nor lactate dehydrogenase release varied between experiments, confirming that the changes are primary, not secondary to cell cycling or membrane damage. This study provides direct evidence that mechanical culture conditions modulate protein expression in suspension culture. (+info)
Medical devices; device tracking. Final rule.
(45/671)
The Food and Drug Administration (FDA) is amending the medical device tracking regulation. FDA is making substantive changes to revise the scope of the regulation and add certain patient confidentiality requirements, and nonsubstantive changes to remove outdated references and simplify terminology. These revisions are made to conform the regulation to changes made in section 519(e) of the Federal Food, Drug, and Cosmetic Act (the act) by the FDA Modernization Act of 1997 (FDAMA), and to simplify certain requirements. (+info)
Blood extraction from lancet wounds using vacuum combined with skin stretching.
(46/671)
Key factors and practical limits of blood extraction from lancet wounds on body sites other than the finger were determined by testing a large number of conditions. During these tests, the pain associated with lancing alternate body sites was rated as less painful than a fingerstick 98% of the time. Vacuum combined with skin stretching was effective in extracting an adequate volume of blood from the forearm for glucose testing, up to an average of 16 microl in 30 s. The amount of blood extracted increases with the application of heat or vacuum before lancing, the level of vacuum, the depth of lancing, the time of collection, and the amount of skin stretching. Vacuum and skin stretching led to significant increases, up to fivefold in the perfusion of blood in the skin as measured by laser Doppler. Our observations suggest that vacuum combined with skin stretching increases blood extraction at alternate sites by increasing the lancet wound opening, increasing the blood available for extraction by vasodilatation, and reducing the venous return of blood through capillaries. (+info)
The SleepStrip: an apnoea screener for the early detection of sleep apnoea syndrome.
(47/671)
Sleep apnoea svndrome (SAS) is a largely undiagnosed and prevalent disorder. It is associated with cardiovascular morbidity as well as excessive daytime sleepiness and poor quality of life. In the present study the SleepStrip, a novel screening device is introduced, which is low cost and easy to use and is aimed for widespread use. The results of three independent validation studies, which compared the SleepStrip score (Sscore) against "gold standard" polysomnographically-determined apnoea/ hypopnoea index (AHI), are reported both separately and combined. Four hundred and two patients suspected of SAS underwent full polysomnography recordings concomitantly with the use of the SleepStrip. For all samples combined, the correlation between AHI and Sscore was r=0.73, sensitivity and specificity values ranged from 80-86% and 57-86% respectively, and the area under the curve derived from receiver-operating characteristic curves ranged from 0.81-0.92 at varying AHI thresholds. Though not intended as a substitute for polysomnography, the SleepStrip may provide initial screening information, which may be useful in both clinical and experimental settings. (+info)
Effect of Guglielmi detachable coils on intraaneurysmal flow: experimental study in canines.
(48/671)
BACKGROUND AND PURPOSE: Guglielmi detachable coils (GDCs) are effective in preventing rebleeding of ruptured aneurysms. To better understand the mechanism underlying this protective effect, we evaluated blood flow in aneurysms and their parent arteries before and after GDC coil placement. METHODS: An 0.14-inch guidewire containing a combined pressure and thermistor sensor was inserted through a microcatheter into both the parent artery and the dome of surgically created canine aneurysms. Before and after GDC coil placement, intravascular pressures and thermodilution responses where recorded in the parent artery and aneurysmal dome during injections of room-temperature isotonic sodium chloride solution over 4 seconds (5 mL/s) and 2 seconds (20 mL/s) in the parent artery. RESULTS: Before GDC coil placement, similar U-shaped thermodilution curves were present in the parent artery and in the dome of the aneurysm. GDC coil placement reduced intraaneurysmal flow by 61-99.6% (P <.05), prolonged aneurysmal filling and washout (dilution interval increased from 5.16 seconds before coil placement to 26.79 seconds after coil placement, P < 0.05), and caused a dissociation of pressure and flow (shift epsilon was 0.45 seconds before coil placement versus 0.56 seconds after coil placement, P <.05). Flow in the parent artery was not significantly affected by GDC coil placement in the aneurysm. CONCLUSION: In this model, intraaneurysmal blood flow can be evaluated with thermodilution. GDC coil placement significantly reduces blood flow in aneurysms. (+info)