Reimbursement Strategies and CPT Codes for Device Development

Reimbursement refers to the complicated process by which physicians and hospitals deliver products and services and then receive payment from third-party payers. Reimbursement consists of three factors: coding, coverage, and payment. The Current Procedural Terminology (CPT) codes include category I, II, and III codes, each with a different purpose and criteria. Requesting a new CPT code for a new device is a complicated and lengthy process, so an early understanding of the process is important to identifying the necessary resources. Working with CPT code consultants and a medical specialty society can help a startup obtain new CPT codes to ensure reimbursement for new medical devices, or determine if the new device fits within an existing CPT code

Management of Acute and Recurrent Gout: A Clinical Practice Guideline From the American College of Physicians

Description: The American College of Physicians (ACP) developed this guideline to present the evidence and provide clinical recommendations on the management of gout. Methods: Using the ACP grading system, the committee based these recommendations on a systematic review of randomized, controlled trials; systematic reviews; and large observational studies published between January 2010 and March 2016. Clinical outcomes evaluated included pain, joint swelling and tenderness, activities of daily living, patient global assessment, recurrence, intermediate outcomes of serum urate levels, and harms. Target Audience and Patient Population: The target audience for this guideline includes all clinicians, and the target patient population includes adults with acute or recurrent gout. Recommendation 1: ACP recommends that clinicians choose corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or colchicine to treat patients with acute gout. (Grade: strong recommendation, high-quality evidence). Recommendation 2: ACP recommends that clinicians use low-dose colchicine when using colchicine to treat acute gout. (Grade: strong recommendation, moderate-quality evidence). Recommendation 3: ACP recommends against initiating long-term urate-lowering therapy in most patients after a first gout attack or in patients with infrequent attacks. (Grade: strong recommendation, moderate-quality evidence). Recommendation 4: ACP recommends that clinicians discuss benefits, harms, costs, and individual preferences with patients before initiating urate-lowering therapy, including concomitant prophylaxis, in patients with recurrent gout attacks. (Grade: strong recommendation, moderate-quality evidence)

Plate interaction in the NE Caribbean subduction zone from continuous GPS observations

This paper is not subject to U.S. copyright. The definitive version was published in Geophysical Research Letters 39 (2012): L10304, doi:10.1029/2012GL051485.Kinematic similarities between the Sumatra and Puerto Rico Trenches highlight the potential for a mega-earthquake along the Puerto Rico Trench and the generation of local and trans-Atlantic tsunamis. We used the horizontal components of continuous GPS (cGPS) measurements from 10 sites on NE Caribbean islands to evaluate strain accumulation along the North American (NA) – Caribbean (CA) plate boundary. These sites move westward and slightly northward relative to CA interior at rates ≤2.5 mm/y. Provided this motion originates in the subduction interface, the northward motion suggests little or no trench-perpendicular thrust accumulation and may in fact indicate divergence north of Puerto Rico, where abnormal subsidence, bathymetry, and gravity are observed. The Puerto Rico Trench, thus, appears unable to generate mega-earthquakes, but damaging smaller earthquakes cannot be discounted. The westward motion, characterized by decreasing rate with distance from the trench, is probably due to eastward motion of CA plate impeded at the plate boundary by the Bahamas platform. Two additional cGPS sites in Mona Passage and SW Puerto Rico move to the SW similar to Hispaniola and unlike the other 10 sites. That motion relative to the rest of Puerto Rico may have given rise to seismicity and normal faults in Mona Rift, Mona Passage, and SW Puerto Rico

Geodetic Constraints on San Francisco Bay Area Fault Slip Rates and Potential Seismogenic Asperities on the Partially Creeping Hayward Fault

The Hayward fault in the San Francisco Bay Area (SFBA) is sometimes considered unusual among continental faults for exhibiting significant aseismic creep during the interseismic phase of the seismic cycle while also generating sufficient elastic strain to produce major earthquakes. Imaging the spatial variation in interseismic fault creep on the Hayward fault is complicated because of the interseismic strain accumulation associated with nearby faults in the SFBA, where the relative motion between the Pacific plate and the Sierra block is partitioned across closely spaced subparallel faults. To estimate spatially variable creep on the Hayward fault, we interpret geodetic observations with a three-dimensional kinematically consistent block model of the SFBA fault system. Resolution tests reveal that creep rate variations with a length scale of \u3c15 km are poorly resolved below 7 km depth. In addition, creep at depth may be sensitive to assumptions about the kinematic consistency of fault slip rate models. Differential microplate motions result in a slip rate of 6.7 ± 0.8 mm/yr on the Hayward fault, and we image along-strike variations in slip deficit rate at ∼15 km length scales shallower than 7 km depth. Similar to previous studies, we identify a strongly coupled asperity with a slip deficit rate of up to 4 mm/yr on the central Hayward fault that is spatially correlated with the mapped surface trace of the 1868 MW = 6.9–7.0 Hayward earthquake and adjacent to gabbroic fault surfaces

Antigen recognized by monoclonal antibodies to mesencephalic neural crest and to ciliary ganglion neurons is involved in the high affinity choline uptake mechanism in these cells

High-affinity choline uptake mechanisms are among the characteristics of cholinergic neurons such as the ciliary and choroid subpopulations in the ciliary ganglion (Barald and Berg, 1979). We have produced three monoclonal antibodies (Mabs), two of which were made to 8-day embryonic chick ciliary ganglion (CG) neurons (CG-1, CG-4) (Barald, 1982) and one of which was made to cultured mesencephalic neural crest (NC) cells (CG-14) removed from the embryo 31 hr after incubation. We have shown that all three Mabs label a common 75 kD antigen present on the cell surface of both CG neurons and NC cells (Barald, 1988). Here we report that the CG-1 and CG-4 antibodies, used in the same ratios in which they are synergistically cytotoxic for both the CG and NC cells (Barald, 1988), and Mab CG-14 alone, have specific effects on the high-affinity choline uptake mechanism (HACU) of CG neurons and isolated antigen-positive NC cells in the absence of complement. CG-1 and CG-4 in ratios of 8/1 (the same ratios that are used to kill the CG and the NC subpopulation), but neither singly, inhibit the HACU of CG neurons by 40% and that of isolated antigen-positive NC cells by 75%. However, CG-14 alone, at 1 Μg/ml, inhibits the HACU of both CG neurons and isolated NC cells by 95%. None of the antibodies had an effect on numbers of ouabain binding sites (a measure of the Na + /K + ATPase) or cell surface acetylcholinesterase (AChE) of CG neurons or NC cells isolated by “no-flow” fluorescence cytometry with a Meridian Instruments ACAS470 cytometer. CG or NC cells grown in the presence of the antibodies without complement grow and remain healthy for many weeks. They exhibit no difference in morphology, protein content, lactate dehydrogenase activity (LDH), or division time from untreated sister cultures. Therefore, the antigen recognized by all three Mabs may be involved in a high-affinity choline uptake mechanism, a common characteristic of cholinergic neurons. The Mabs themselves may possibly label some element of the high-affinity transporter or a proximal membrane component. This implies that such a high-affinity uptake mechanism is present in the subpopulation of NC cells at early times in development. If these cells in fact are destined to contribute to the avian CG, these characteristics are present in the subpopulation before the NC cells take on a neuronal morphology.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/50220/1/490210205_ftp.pd

Cortical choline transporter function measured in vivo using choline-sensitive microelectrodes: clearance of endogenous and exogenous choline and effects of removal of cholinergic terminals

The capacity of the high-affinity choline transporter (CHT) to import choline into presynaptic terminals is essential for acetylcholine synthesis. Ceramic-based microelectrodes, coated at recording sites with choline oxidase to detect extracellular choline concentration changes, were attached to multibarrel glass micropipettes and implanted into the rat frontoparietal cortex. Pressure ejections of hemicholinium-3 (HC-3), a selective CHT blocker, dose-dependently reduced the uptake rate of exogenous choline as well as that of choline generated in response to terminal depolarization. Following the removal of CHTs, choline signal recordings confirmed that the demonstration of potassium-induced choline signals and HC-3-induced decreases in choline clearance require the presence of cholinergic terminals. The results obtained from lesioned animals also confirmed the selectivity of the effects of HC-3 on choline clearance in intact animals. Residual cortical choline clearance correlated significantly with CHT-immunoreactivity in lesioned and intact animals. Finally, synaptosomal choline uptake assays were conducted under conditions reflecting in vivo basal extracellular choline concentrations. Results from these assays confirmed the capacity of CHTs measured in vivo and indicated that diffusion of substrate away from the electrode did not confound the in vivo findings. Collectively, these results indicate that increases in extracellular choline concentrations, irrespective of source, are rapidly cleared by CHTs.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/65847/1/j.1471-4159.2006.03766.x.pd

Morphotectonics of the central Muertos thrust belt and Muertos Trough (northeastern Caribbean)

Multibeam bathymetry data acquired during the 2005 Spanish R/V Hespérides cruise and reprocessed multichannel seismic profiles provide the basis for the analysis of the morphology and deformation in the central Muertos Trough and Muertos thrust belt. The Muertos Trough is an elongated basin developed where the Venezuelan Basin crust is thrusted under the Muertos fold-and-thrust belt. Structural variations along the Muertos Trough are suggested to be a consequence of the overburden of the asymmetrical thrust belt and by the variable nature of the Venezuelan Basin crust along the margin. The insular slope can be divided into three east–west trending slope provinces with high lateral variability which correspond to different accretion stages: 1) The lower slope is composed of an active sequence of imbricate thrust slices and closed fold axes, which form short and narrow accretionary ridges and elongated slope basins; 2) The middle slope shows a less active imbricate structure resulting in lower superficial deformation and bigger slope basins; 3) The upper slope comprises the talus region and extended terraces burying an island arc basement and an inactive imbricate structure. The talus region is characterized by a dense drainage network that transports turbidite flows from the islands and their surrounding carbonate platform areas to the slope basins and sometimes to the trough. In the survey area the accommodation of the ongoing east–west differential motion between the Hispaniola and the Puerto Rico–Virgin Islands blocks takes place by means of diffuse deformation. The asymmetrical development of the thrust belt is not related to the geological conditions in the foreland, but rather may be caused by variations in the geometry and movement of the backstop. The map-view curves of the thrust belt and the symmetry of the recesses suggest a main north–south convergence along the Muertos margin. The western end of the Investigator Fault Zone comprises a broad band of active normal faults which result in high instability of the upper insular slope