Claims administrators

Point cf service (POS) An electronic system is used for exchanging information that can handle plan design elements, such as eligibility for product coverage, plan limits, member cost-share amormts, and product information, between the pharmacy and the claims administrator in real time as the pharmacist dispenses the prescription. 

In 2014, General Motors Corporation faced multiple lawsuits arising from the fact that, between 2001 and 2014, millions of GM cars were sold with ignition switches that some GM employees knew for years were defective. As of May 15, 2015, the GM Ignition Compensation Claims Administrator had accepted that defective switches were implicated in 104 fatalities, with 26 death claims still under review. Reflecting on this situation, consumer advocate Ralph Nader made the following suggestion to Mary T. Barra, GM s CEO ... 

Liability typically only provides for restitution of a portion of the losses suffered in an accident. For example, freight customers are only compensated under the Carmack Amendment for the value of their goods that are damaged or destroyed. Shippers are not compensated for costs related to damage such as delays in their production schedules or costs of claim administration. 

If, upon review of the patent, the patentee discovers that the claims contain a formal error, are too narrow, or are too broad in view of the prior art, the patentee may ask the U.S. PTO to correct this error. There are four administrative vehicles for correcting errors in issued patents. The appHcation of each of these mechanisms is dependent on the nature and severity of the error, as weU as the source of its creation. 

Nutrients and diet supplements without claims of therapeutic effects are considered foods, and are thus regulated by the U.S. Food and Dmg Administration. These are further subject to specific food regulations. Specifications for pyridoxine hydrochloride (7) for foods are given in the Food Chemicals Codex (80) and for pharmaceuticals in the US. Pharmacopeia (81). General test methods have been summarized (82). 

Claims for safety and efficacy of therapeutic dentifrices are regulated by the Pood and Dmg Administration. The Council on Dental Therapeutics of the American Dental Association reviews products and grants a Seal of Acceptance to those products deemed worthy. 

Another notable glycoside is amygdalin, which occurs in bitter almonds and in the kernels or pits of cherries, peaches, and apricots. Hydrolysis of this substance and subsequent oxidation yields laetrile, which has been claimed by some to have anticancer properties. There is no scientific evidence for these claims, and the U.S. Food and Drug Administration has never approved laetrile for use in the United States. 

Mitochondria-associated toxicities, such as pancreatitis, are frequently demonstrated in HlV/HCV-coinfected individuals, and may significantly influence treatment options (de Mendoza and Soriano 2005). Yet, no cell culture or animal models have been developed to predict nucleoside-induced pancreatitis. Nevertheless, an association of HCV replication and mitochondrial DNA depletion in primary human lymphocytes obtained from HIV/HCV-coinfected individuals under concomitant administration of HCV and HIV medications was demonstrated by de Mendoza and coworkers (de Mendoza et al. 2007). They claimed that the use of HCV medication together with certain antiretroviral agents seemed to enhance mitochondrial damage due to a synergistic deleterious interaction between the anti-HCV and anti-HIV drugs. In contrast, an improvement in mitochondrial content with effective... 

Since 1999, when the Food and Drug Administration allowed the first health claim for soy-fortified foods in the USA, there has been a large increase in the sales of food products claiming to contain soy isoflavones. At the same time, over-the-counter supplements have become widely available. However, concerns have been raised about the real health benefits of such supplements in the absence of adequate information about bioavailability, pharmacokinetics and safety. To fill this gap, an extensive study on pure isoflavones and commercial soy isoflavone supplements has recently been carried out (Setchell et al, 2001). A selection of 31 commercially available supplements showed a wide variation in isoflavone composition and in the amount provided by one tablet. Furthermore, a lower isoflavone content, with respect to the claimed levels, has been observed in almost 50% of the analysed products. In one case, no isoflavones at all could be detected (Setchell et al, 2001). 

Trumbo, R R. and K. C. Ellwood (2006). Lutein and zeaxanthin intakes and risk of age-related macular degeneration and cataracts An evaluation using the Food and Drug Administration s evidence-based review system for health claims. Am. J. Clin. Nutr. 84(5) 971-974. 

Provide either in vitro or in vivo assay results for representative compounds, describe how the in vitro or in vivo assay protocol is performed, and describe how and why the test results demonstrate that the tested compounds exhibit a useful pharmaceutical property. Ideally, provide and link in vitro assay results to in vivo assay results that in turn demonstrate that the claimed compounds can be used to treat or prevent a disease. Describe how to administer the application s compounds and intended administration recipients (e.g., humans), including dosage amounts and dosage forms (e.g., pills, tablets, capsules), possible ways of administering the dosage... 

The physiologic sequelae of biotin deficiency are almost unexplored. Severe skin lesions, especially seborrheic dermatitis and Leiner s disease (Erythroderma desquamativum or exfoliative dermatitis), were increased in young infants bom of mothers on a restricted diet low in eggs, livers, and other biotin-rich foods. After biotin administration the lesions healed. There are claims that excess biotin produces a fatty liver characterized by heightened cholesterol content. Choline has no effect in the prevention of biotin-fatty livers (G2, M2). In mice with transplanted tumors, both the tumors and the blood levels of biotin are below normal (R8). More recent studies established a protection with avidin, the biotin-binding fraction of egg white, against tumor formation (K4). More data along these lines are still needed for confirmation. 

Focus of the development process for a new pharmaceutical is an essential aspect of success, but is also difficult to maintain. Clinical research units generally desire to pursue as many or as broad claims as possible for a new agent, and frequently also apply pressure for the development of multiple forms for administration by different routes. These forces must be resisted because they vastly increase the work involved in safety assessment, and they may also produce results (in one route) that cloud evaluation [and impede Institutional Review Board (IRB) and regulatory approval] of the route of main interest. 

Although a high level of plasma renin appears to identify a subject likely to respond to (3-blockers the relationship between the reduction in renin level and fall in blood pressure is still obscure. While some investigators claim good correlations between the reduction in renin and blood pressure others find no such correlation (20). In fact, Stokes et al (34) showed that pindolol was able to maintain the fall in blood pressure produced by chronic administration of propranolol without maintaining the reduction in renin. 

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