Cynthia K. Kirkwood, PharmD, BCPP

• Executive Associate Dean for Academic Affairs
• Professor, Department of Pharmacotherapy & Outcomes Science, School of Pharmacy, Virginia Commonwealth University, Richmond, Virginia

https://app.pharmacy.vcu.edu/ckkirkwo

In: Ponticelli C diabetes prevention meal plan generic 100 mg januvia overnight delivery, nephropathy and nephrotic syndrome: outcome in the era of evidence Glassock R (eds) diabetes 30 day cure 100 mg januvia fast delivery. Idiopathic membranous chlorambucil as compared with methylprednisolone alone for the nephropathy: the natural history of untreated patients diabetes specialist januvia 100 mg cheap. Membranous nephropathy: its relative methylprednisolone plus chlorambucil versus methylprednisolone plus benignity in women can diabetes insipidus kill you januvia 100mg with visa. Management of membranous nephropathy: when and what idiopathic membranous nephropathy: a systematic review. Oral cyclophosphamide versus of idiopathic membranous nephropathy: its clinical and research chlorambucil in the treatment of patients with membranous implications. Nephrol Dial Transplant 2004; 19: patients with idiopathic membranous nephropathy. Comparison of the azathioprine in the nephrotic syndrome secondary to idiopathic influence of angiotensin-converting enzyme inhibitor lisinopril and membranous glomerulonephritis. Mechanism of the microglobulin predicts renal outcome in patients with idiopathic antiproteinuric effect of cyclosporine in membranous nephropathy. A controlled trial of comparing methylprednisolone plus a cytotoxic agent versus synthetic cyclosporine in patients with progressive membranous nephropathy. Treatment of idiopathic chlorambucil as compared with prednisolone alone for the treatment of membranous nephropathy unresponsive to methylprednisolone and idiopathic membranous nephropathy. Preserving renal function in therapy for severe idiopathic membranous nephropathy. Remissions and relapses in chlorambucil therapy for idiopathic membranous nephropathy with idiopathic membranous nephropathy. Relapsing membranous treatment of nephrotic idiopathic membranous nephropathy: a nephropathy. Response to therapy of relapses compared to that of the multicenter randomized controlled trial. A controlled study of short-term prednisone treatment in adults with immunosuppressive therapy in patients with membranous nephropathy membranous nephropathy. Collaborative Study of the Adult Idiopathic and persistent or relapsing disease activity. Successful treatment of membranous membranous nephropathy with nephrotic syndrome in Japan. Nephrotic syndrome in children: prediction of histopathology from mofetil in idiopathic membranous nephropathy: a clinical trial with clinical and laboratory characteristics at time of diagnosis. Atlas of mycophenolate mofetil and prednisolone in the treatment of end-stage renal disease. Membranous nephropathy in children: clinical standard therapy for membranous nephropathy and focal segmental presentation and therapeutic approach. Idiopathic membranous circulating B cells to optimize lymphocytolytic therapy in idiopathic glomerulopathy in Canadian children: a clinicopathologic study. Pediatr Nephrol 1992; outcome of idiopathic membranous nephropathy in Japanese children. Idiopathic membranous nephropathy in membranoproliferative glomerulonephritis in children. Response of type I membranoproliferative pediatric patients: presentation, response to therapy, and long-term glomerulonephritis to pulse methylprednisolone and alternate-day outcome. Prophylactic oral anticoagulation in nephrotic membranoproliferative glomerulonephritis. Proceedings of the 8th and normocomplementemic persistent (chronic) glomerulonephritis; International Congress of Nephrology. Nephritis-associated plasmin with idiopathic membranoproliferative glomerulonephritis: a long-term receptor and acute poststreptococcal glomerulonephritis: follow-up. Membranoproliferative Force on the Prevention, Diagnosis, and Treatment of Infective glomerulonephritis. Pulse methylprednisolone therapy in endocarditis: results of a 1-year survey in France. Effect of aspirin and dipyridamole on endocarditis-induced rapidly progressive glomerulonephritis by steroid proteinuria in idiopathic membranoproliferative glomerulonephritis: therapy combined with antibiotics: a case report. Membranoproliferative ribavirin treatment in patients with hepatitis C virus-related systemic glomerulonephritis associated with hepatitis C virus infection. Hepatitis C and renal and ribavirin of hepatitis C virus-associated mixed cryoglobulinemia: disease: an update. Antiviral therapy for hepatitis C virus-related cryoglobulinemic glomerulonephritis. Hepatitis C viral infection is C-associated immune-complex nephritis with cryoprecipitate apheresis associated with fibrillary glomerulonephritis and immunotactoid and antiviral therapy. Diagnosis, management, and (rituximab) treatment for cryoglobulinemic vasculitis: where do we treatment of hepatitis C: an update. Rituximab combined with ribavirin combination therapy in chronic hepatitis C: a randomized study Peg-interferon-ribavirin in refractory hepatitis C virus-associated of treatment duration and ribavirin dose. Peginterferon alfa-2b plus active cryoglobulinaemic membranoproliferative glomerulonephritis ribavirin compared with interferon alfa-2b plus ribavirin for initial associated with hepatitis C virus infection by means of the sequential treatment of chronic hepatitis C: a randomised trial. Interferon alfa-2a therapy in interferon-alpha/ribavirin compared with Peg-interferon-alpha/ribavirin cryoglobulinemia associated with hepatitis C virus. National Institutes of Health therapy in hepatitis C virus-associated nephropathy. Hepatitis B treatment: Lessons for the patients with hepatitis C virus-associated cryoglobulinaemic nephrologist. A risk allele for focal in patients with hepatitis C-associated renal disease and renal segmental glomerulosclerosis in African Americans is located within insufficiency. Immune complex renal disease and human cryoglobulinemic membranoproliferative glomerulonephritis. Int Urol Nephrol seropositive patients with varying degrees of proteinuria in South Africa. Am J Nephrol 1995; 15: Salmonella bacteremia: the role of schistosomal glomerulopathy. Secondary collapsing glomerulo therapy in IgA nephropathy presenting with isolated hematuria.

Diseases

• Thin ribs tubular bones dysmorphism
• Pyrimidinemia familial
• Wolfram syndrome
• Silengo Lerone Pelizzo syndrome
• Isaacs syndrome
• Acute intermittent porphyria
• Generalized anxiety disorder (GAD)
• Encephalocele anterior

Because of their hydrophobic nature and resistance to metabolism diabetes test cost in india generic 100 mg januvia, these chemicals persist and bioaccumulate in the fatty tissues of animals and humans diabetes type 2 hereditary purchase januvia 100 mg with amex. That complicates the human health risk assessment that may be associated with exposures to varied mixtures of dioxin-like chemicals diabetes medications flow chart januvia 100mg visa. This approach has signifcant limitations due to the lack of in vivo human data and the diffculty of extrapolating cell line and rodent data to humans diabetes symptoms on neck buy generic januvia pills. National Toxicology Program upgraded its classifcation to known to be a hu man carcinogen. M ultivariate linear regression was used to study associations between natural log-transformed leukocyte telomere length and persistent organic pollutant quartiles. M ost of these effects were stronger in the non-dioxin-like congeners than in the dioxin-like congeners, which brings into question the direct relevance to the committees charge. This study suggests that telomere length may be infuenced by exposure to dioxin and dioxin-like chemicals, however, the association between telomere length and disease is not well understood. These modifcations are considered epigenetic because they control the function of genes without changing the coding sequence. M ore detailed information about epigenetic mechanisms in general can be found later in this chapter, particularly concerning somatic modifcations in an individual, and again in Chapter 8 with respect to effects that may affect offspring of an exposed organism. Data on the developmental effects of dioxin-like chemicals in humans have begun to emerge over the past 10 years (M ocarelli et al. Human and animal studies have revealed other potential health out comes, including cardiovascular disease, hepatic disease, thyroid dysfunction, lipid disorders, neurotoxicity, and metabolic disorders such as diabetes. M itochondrial oxidative stress has been shown to be induced when calcium is mo bilized (Senft et al. Receptor binding may result in the release of other cytoplasmic proteins that alter the expression or activity of other cell-regulatory proteins. However, they may exceed normal physiologic bound aries or constitute early events in a pathway that leads to damage in sensitive members of the population. In the latter case, the response is toxic and would be expected to cause an adverse health effect. However, there are signifcant quantitative differences between responses in humans and rodents. Evidence from highly exposed human populations is an important means for corroborating biological plausibility. Although animal and cell-culture studies provide important links to understanding the biochemical and molecular mechanisms as sociated with toxicity induced by xenobiotics, many factors must be considered in extrapolating their results to human disease and disease progression. The fol lowing are key factors that might limit the ability of laboratory studies to predict human responses completely and accurately. Animal studies that establish a measurement of body burden over a specifc period provide the best potential for extrapolation to humans. Therefore, the response of some systems (such as the immune or cardiovascular systems) may depend on the timing of exposure relative to the other challenges. Stress (not to be confused with oxidative stress) produced via known or unknown sources is a well-known modifer of human disease responses (for example, immune and cardiovascular responses). Furthermore, stress is an ever-present factor that is diffcult to assess or control for in epide miologic studies because there is substantial individual variation in response to it (Cohen et al. On the other hand, direct cause-and-effect relationships are more easily established in animal studies because of their standardization. The totality of epigenetics marks in each cell, termed the epigenome, creates and maintains the identity and function of the cell type (Christensen and M arsit, 2011; Cortessis et al. Around 2005, the frst mapping of the yeast epigenome was conducted (Pokholok et al. The studies show that epigenetic marks act together in an exquisitely choreographed fashion to control cellular differentiation and the cellular ability to interact with, process, and initiate events and to respond to the signals and needs of the individual and local tissue environment. In mammals it occurs mostly at cytosine nucleotides that are adjacent to guanine nucleotides (CpG sites), but it can also occur at cytosine nucleotides followed by other bases in embryonic cells and brain cells (Lister et al. Chemical modifcations of histones, such as methylation and acetylation, can alter the histone structure and modify gene expression by attracting protein complexes that can stimulate or repress transcription, in part by changing nucleosome spacing (Reid et al. The interaction of all those epigenetic processes creates the epigenome, which has a critical role in regulating gene expression (Christensen and M arsit, 2011; Cortessis et al. That implies that trillions of confgurations of the epigenome are possible, although typically only about half of all genes are ex pressed in any given cell. Environmental epigenetics is the study of how environmental factors such as nutrition, toxicants, and stress alter epigenetic programming. Epigenetics has been shown to have a role in the disease etiology of cancers and a number of other diseases (Christensen and M arsit, 2011; Cortessis et al. In addition, exposure to environmental factors at critical times of development when epigenomes are shifting has the ability to alter epigenetic programming and cause changes in gene expression because these are times when epigenomes are evolving rapidly as stems cells differentiate into more mature cell types (Skinner et al. Hence, immune responses, fetal development, and gamete formation are impor tant examples of physiological processes whose functioning can be affected by environmentally induced epigenetic changes. New investigative tools and a more refned understanding of the epigenetic process have given rise to active research on the nature of the relationship be tween environmental exposure to epigenetically active agents and the occurrence of diverse disease states, including cancers, reproductive-developmental prob lems, immune dysregulation, diabetes, obesity, and psychiatric illnesses (Brookes and Shi, 2014). The committee sought to review data on the potential relationship of the exposures of interest with adverse epigenetic effects in directly exposed veterans in an attempt to fnd evidence linking the exposures to disease processes that might have been mediated epigenetically. The committee also sought to re view relevant data on female veterans and male veterans separately inasmuch as the epigenetic consequences of exposures could be different, particularly in the case of adverse reproductive outcomes. Of note, possibly the greatest limitation to environmental epigenetic studies in human cohorts is access to the target tis sue of interest. Researchers rely on more accessible proxy tissues such as blood leukocytes, saliva, buccal cells, or placenta. M ore generally, studies of the de velopmental origins of health and disease have shown that early-life exposures or environmental infuences can be associated with the onset of disease much later in life (Barker et al. These early developmental alterations in the epigenome provide a molecular mechanism by which environmental exposures of female veterans can have effects on their children into adulthood. There is precedent within the endocrine disrupting chemical literature for epigenetic alterations to have low-dose and non-monotonic effects, which are not necessarily linked to blocking or mimicking hormones, but may occur through other mechanisms such as oxida tive stress or direct interactions with any of the many epigenetic enzymes and co-factors necessary for epigenetic gene regulation (Tapia-Orozco et al. Most epigenetic modifcations occur in somatic cells and are heritable only within the altered cell line, thereby having the potential to generate effects in the exposed individual but not in that individuals offspring. The sparse data include the results of studies of lead, a known developmental and neurologic toxicant. It has been suggested that environmental exposures can result in reduced fertility (Guerrero-Bosagna and Skinner, 2014; Paoloni-Giacobino, 2014). In summary, the ability of epigenetic mechanisms to regulate gene expres sion coupled with the interaction of the epigenome and the environment, includ ing multi and trans-generational effects, might underlie the ability of xenobiotic exposure to contribute to disease development and the potential for offspring to inherit the effects of the disrupted epigenetic processes. Developmental Immunotoxicity A second emerging feld in the biologic sciences that may provide insight into the mechanism of xenobiotic-induced disease is developmental immunotox icity, the study of the disruption of the developing immune system by xenobiotic exposure. The developing immune system is among the most sensitive physi ologic targets of prenatal and childhood environmental insult. The sensitivity is due, in part, to the novel processes of gene rearrangement, somatic-cell selection, and immune-cell distribution that are required to produce a security system that can effectively protect not only the child but also the aging adult from disease. To produce that security system, the immune system, as it matures, must coor dinate steps that result in highly specialized immune cells that are capable of self-versus-non-self recognition and that are tailored to the specialized functional environments of different tissues and organs (such as brain, lungs, skin, liver, gastrointestinal tract, and reproductive tract). A disruption of immune develop ment can place the integrity of the organism at risk. The adverse outcomes of develop mental immunotoxicity may become apparent soon after exposure or can emerge much later in life (Gascon et al.

Whether true or not diabetes symptoms joslin purchase januvia amex, such charges The most reliable way to quantify future pharmaceuti are damaging in that suppliers diabetes mellitus causes order 100mg januvia overnight delivery, health care providers diabetic diet nursing teaching buy januvia 100mg with amex, and cal demand is to start with accurate past-consumption data patients lose confdence in the system diabetic neuropathy foot cream discount januvia 100 mg overnight delivery. Unsuccessful sup from all units being supplied, assuming the supply pipeline pliers may feel that they have no chance to win and conse has been consistently full. Tese data should be tempered quently withdraw from future tenders or submit only token by known or expected changes in morbidity patterns, sea bids. As the pool of potential suppliers decreases to a small sonal factors, service levels, formulary changes or changes to set, price competition decreases and procurement prices prescribing patterns, and patient attendance. In such cases, the morbidity-based and auctions, cite transparency and the potential for reduced adjusted consumption techniques discussed in Chapter 20 tender management costs as primary benefts; however, may be needed to estimate procurement demand. In general, these functions the medicines are for treating commonly encountered should be handled by diferent individuals, units, commit diseases. Suppliers or procurement personnel may are essential to attract the best suppliers and the best prices. An efective procurement program must ensure that the medicines purchased and distributed are of the specifed Regular reporting on procurement performance quality, according to specifed standards, which are clear and recognized. When managing pharmaceutical procurement by generic The Assessment Guide at the end of this chapter suggests name and introducing new suppliers whose products are some procurement indicators. Indicators such as average not familiar in the country, the procurement program must supplier lead time and percentage of key medicines in stock be particularly alert to product quality issues. Some products vary substantially in formulation and bio Tese indicators should not be limited to the public sector availability from supplier to supplier. Figure 18-3 provides actual Even when new products are completely equivalent in indicator data from several countries. Chapter 8 fnancial and procurement audit, which is a formal examina describes fve diferent supply chain systems currently being tion and verifcation of books and records by accountants who used by governments to supply pharmaceuticals to their specialize in fnancial audit procedures. External auditsare conducted which pharmaceuticals are procured and distributed by a by auditors from outside the managing organization and are centralized government unit. Primary distributor system (also known as prime vendor purchasing transactions in pooled procurement programs. Ten, in a centralized one or more primary distributors, who warehouse and purchasing model the central ofce also manages the pur distribute pharmaceuticals to districts and major health chasing transactions on behalf of group members, while in facilities. Many of these countries are now decentralizing considerations are properly addressed and particularly for procurement to the regional, state, or even local facility enforcing transparency and equity in the purchasing pro level, either by choice or because the central system has cess. However, decentralized procurement management has Responsibilities in the procurement process proved challenging in many countries. Problems encoun tered include signifcantly higher prices (if the decentral Efective procurement is a collaborative process between ized managers select their own suppliers), potential product the procurement ofce, which manages many of the steps, quality issues, irrational purchasing patterns based on the and technical and policy committees, which should usually whims of prescribers or local procurement ofces, and make the decisions about which medicines to buy, in what overall erratic supply because of local inefciencies, lack of quantities, and from which suppliers. The procurement ofce, which may be Without political commitment to efciency and active part of the government or independent, collates informa supervision by senior management, the procurement sys tion on medicine needs, develops a proposed procure tem will not function efciently, regardless of its organiza ment list based on clients requirements, manages the tion. The lack of modern fnancial management, accounting tendering process, manages and arranges supply con systems, and supervisory responsibility has doomed many tracts unless there is a separate tender board, and moni pharmaceutical systems to chronic failure. To manage the pharmaceutical supply chain, senior man Staf of the procurement ofce should not have the agers should demand and use regular reports from procure sole deciding voice in determining which products are ment and distribution agencies and from health facilities purchased and which suppliers receive contracts; these on expenditures, purchases, stock levels, order status, lead decisions should be made by committees that include times, and budget status. If a system lacks the capacity to representatives from other administrative sections or produce these reports in a timely manner, introduction stakeholders, including client facilities. Senior of powers helps ensure broad ownership of the system managers should also maintain regular communications and avoids conficts of interest. If the procurement ofce with facilities and staf; systems do not work very well if the is independently operated, it is important that its opera senior managers have never visited any facilities outside the tions be supervised by a board of directors that includes capital. In many countries, tendering and contract In some countries, separate subcommittees develop negotiation are done according to law by a govern product specifcations and investigate suppliers qualif ment tender board, which either reports to the fnance cation for participation in tenders. In such situations, the procurement ofce prepares the list of Procurement office staffing and management systems requirements, and the tender board may monitor the tender process. The prime task of the tender board is The structure of the procurement ofce depends on the to make the award decision; in some cases, this will scope of the program, the availability of funds, and whether be an absolute decision, while in others, the tender the ofce is managed as a government entity or as an inde board will make recommendations to health ofcials. Whichever system is followed, it is essential that the health system provide technical input into the contract Stafng requirements. Ofen the same as the formu technical staf members, with at least one pharmacist or lary committee or pharmacy and therapeutics commit physician to provide sound technical input for the devel tee, the medicine selection committee should comprise opment and refnement of procurement lists. Also quently chairs the committee, and a pharmacist generally needed are one or more clerical managers, one or more serves as organizing secretary. The committee reviews secretaries or clerks, a receptionist or telephone opera requests for additions to the procurement list, com tor, maintenance staf, and, in some systems, a driver and pares the cost efectiveness of medicines on the list, and security staf. The committee also must be well trained and highly motivated, with the determines which therapeutic categories, if any, are suit capability to manage the procurement process efectively. The committee Unfortunately, in many countries, people are transferred needs access to current, unbiased drug information and just as they become competent in a position, and a new members who can synthesize such information to make cycle of training and time lag between appointment and appropriate selection decisions. When procurement ofce ment tender board is in charge of tendering, the health salaries are too low to support an individual or a family, system should establish a procurement committee to or much lower than for equivalent work in the private make fnal decisions or to make the recommendations sector, corrupt practices and neglect of duties are much for such decisions to the tender board on medicine more likely to occur. Tese kinds of problems increase selection, procurement quantity, and supplier selec funding requirements to replace the resulting thef and tion, and approve the exact specifcations for product waste. Paying reasonable salaries in the frst place and description, packaging and labeling, and quality assur implementing tough controls is more cost-efective. The committee should base those deci In some countries, restructuring the procurement sions on recommendations from technical committees ofce as an independent parastatal or privatized unit may and subcommittees. It reviews information on suppliers be the only way to pay adequate salaries to staf. To succeed in the a restricted tender is used, and which suppliers should international market, procurement programs need two receive contracts, unless such decisions are made by sorts of critical information: comparative price and avail a separate tender board. The procurement committee ability data on products in the national and international should include senior ofcials from the highest level of pharmaceutical market and information about suppliers government served by the procurement system as well capacity, reliability, and quality. For example, a federal ment agencies without access to price information or to government program that serves teaching hospitals the performance record of international suppliers oper and regional health systems might include two or three ate in a vacuum and are essentially at the mercy of the representatives of the ministry of health, two or three marketplace. A central repository of international information depend on appropriate sofware (Chapter 50). Key staf on worldwide supplier performance and tender pricing must be familiar with the sofware, and competent data would be useful but has not yet proved feasible. Using written have sufcient budget capability to purchase enough medi policies and procedures that spell out how the procure cines to cover the needs of all patients, without supplement ment process should be managed and how the procure ing the budget with some sort of cost recovery or donor ment system should operate is critical. Tese initiatives provide large-scale Malaria publishes policy guidelines for procurement fnancing for countries to procure medicines and essential through its program (Global Fund 2009). A recently developed procure tiatives, fnancing issues still require the attention of health ment system assessment tool, funded by the World Bank, systems managers. Sources of funds for pharmaceutical procurement When starting a new procurement system or revamp ing a poorly functioning system, outside technical Primary sources of funds for pharmaceuticals include gov assistance may help local managers in design and ernment fnancing, user fees, health insurance, community implementation. Agency for International Development to operate proper procurement systems and to obtain the funds several global and local programs that provide best prices. Other bilateral agencies, such as the and various types of revolving drug funds have been used to U. Department for International Development, the separate pharmaceutical procurement from the annual trea Danish International Development Agency, and oth sury cycle. This separation also ofen requires some form of ers, fund support to focus countries and regions, and cost recovery, which the decentralized mechanism manages. Inventory Programme provide procurement support in some management improves when medicines can be ordered countries (see the Glossary and References and Further when needed rather than at an arbitrary point in the govern Readings sections for more information). When suppliers know that orders will be placed promptly afer tendering and that payment will be made according to contract terms, prices will be much more 18.

For the purpose of this subsection diabetes test orlando trusted januvia 100 mg, "Orally Administered Anti-Cancer Drugs" are Prescription Drugs that: (a) are used to slow or kill the growth of cancerous cells; and (b) are administered orally diabetes in dogs problems order januvia 100mg online. But diabetic diet guidelines patient handout order 100 mg januvia visa, the term does not include: fabric and elastic supports; corsets; arch supports; trusses; elastic hose; canes; crutches; cervical collars; or dental appliances or other similar devices carried in stock and sold by drug stores new diabetes definition trusted 100mg januvia, department stores, corset shops or surgical supply facilities. Surgical procedures include: (a) those after a mastectomy on one or both breasts; (b) reconstructive breast Surgery; and (c) Surgery to achieve symmetry between both breasts. Coverage may be limited each Benefit Period as shown in the Schedule of Covered Services and Supplies. For all Covered Persons 35 years of age or older, a glaucoma eye test every five years. For all Covered Persons 20 years of age and older, a yearly consultation with a Provider to discuss lifestyle behaviors that promote health and well-being, including but not limited to: smoking control; nutrition and diet recommendations; exercise plans; lower back protection; weight control; immunization practices; breast self-exam; testicular self-exam; and seat belt usage in motor vehicles. An ultrasound evaluation; magnetic resonance imaging scan; three-dimensional mammography; or other additional testing of an entire breast or breasts after any baseline mammogram exam, if: a. Pap Smears this Policy provides benefits for charges Incurred in conducting a Pap smear. Prostate Cancer Screening this Program provides benefits for an annual medically recognized diagnostic exam, including, but not limited to: (a) a digital rectal exam; and (b) a prostate-specific antigen test, for male Covered Persons age 50 or over who are asymptomatic; and male Covered Persons age 40 and over with a family history of prostate cancer or other prostate cancer risk factors. Well Child Immunizations and Lead Poisoning Screening and Treatment this Program covers Well Child immunizations and lead poisoning screening. To be covered: (i) childhood immunizations must be as recommended by the Advisory Committee on Immunization Practices of the United States Public Health Service and the Department of Health pursuant to Section 7. Colorectal Cancer Screening this Program covers colorectal cancer screening rendered at regular intervals for: (a) Covered Persons age 50 or over; and (b) Covered Persons of any age who are deemed to be at high risk for this type of cancer. Evidence-based items or services that have in effect a rating of "A" or "B" in the current recommendations of the United States Preventive Services Task Force; 2. Immunizations that have in effect a recommendation from the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention with respect to the Covered Person; 3. Solely for the purposes of this subsection, a Prosthetic Device is an artificial device (not including dental prostheses or largely cosmetic devices (such as, wigs; artificial breasts; eyelashes; or other similar devices)) that: (a) is not surgically implanted; and (b) is used to replace a missing limb, appendage or any other external human body part. Skilled Nursing Facility Charges this Program covers bed and board (including diets, drugs, medicines and dressings and general nursing service) in a Skilled Nursing Facility. This includes coverage for speech-language pathology services rendered by a physician or a licensed speech-pathologist. Speech-Language Pathology Services Speech-language pathology services rendered by a Physician or a licensed speech-language pathologist, where such services are determined to be Medically Necessary and Appropriate and when performed within the scope of practice. Multi-visceral transplant (small bowel and liver with one or more of the following: stomach; duodenum; jejunum; ileum; pancreas; colon); r. This Program also provides benefits for the treatment of cancer by dose-intensive Chemotherapy/ autologous bone marrow transplants and peripheral blood stem cell transplants. When organs/tissues are harvested from a cadaver, this Program will also cover those charges for Surgical, storage and transportation services that: (a) are directly related to donation of the organs/ tissues; and (b) are billed for by the Hospital where the transplant is performed. This Program also covers the following services required for a live donor due to a covered transplant procedure. Blood this Program covers: (a) blood; (b) blood products; (c) blood transfusions; and (d) the cost of testing and processing blood. This Program does not pay for blood that has been donated or replaced on behalf of the Covered Person. Blood transfusions (including the cost of blood plasma and blood plasma expanders) are covered from the first pint. But, this is so only to the extent that the first pint and any additional pints to follow are not donated or replaced without charge through a blood bank or otherwise. A home treatment program will not preclude further or additional treatment or care at an eligible Facility. Diabetes Benefits this Program covers dialysis services that are furnished by a dialysis center. This Program also provides benefits for the following equipment and supplies for the treatment of diabetes, if recommended or prescribed by a physician or nurse practitioner/clinical nurse specialist; a. Benefits for self-management education and education relating to diet shall be limited to Visits that are Medically Necessary and Appropriate upon: 1. Inherited Metabolic Disease this Program provides benefits for the therapeutic treatment of Inherited Metabolic Diseases. Private Duty Nursing Care this Program covers the services of a Nurse for Private Duty Nursing care. Requirement (b)(i), above, will not be deemed to be met if the care actually furnished is mainly Custodial Care or maintenance. Specialized Non-Standard Infant Formulas this Program covers specialized non-standard infant formulas, if these conditions are met: a. The physician has determined that the formula is Medically Necessary and Appropriate; and c. The infant has not responded to trials of standard non-cow milk-based formulas, including soybean and goat milk. If a Covered Person or his/her Provider does not comply with this Utilization Review section, he/she will not be eligible for full benefits under this Program. We must receive the notice and request at least five business days (or as soon as reasonably possible) before the Admission is scheduled to occur. The Covered Person or his/her Provider must ask for a continued stay review whenever it is Medically Necessary and Appropriate to increase the authorized length of an Inpatient Hospital stay. If the treatment or procedure is being performed in a Hospital on an Inpatient basis, only one authorization for both the Inpatient Admission and the treatment or procedure is needed. We will evaluate the appropriateness of the level of patient care given to a Covered Person as well as the setting in which it is received. An Alternate Treatment/Individual Case Management Plan is a specific written document. Anesthesia and consultation services when they are given in connection with Non-Covered Charges. Blood or blood plasma or other blood derivatives or components that are replaced by a Covered Person. This includes the following connected with Cosmetic Services: procedures: treatments; drugs; biological products; and complications of cosmetic Surgery. Custodial Care or domiciliary care, including respite care except as otherwise stated in this Booklet. For the purposes of this Program, orthognathic Surgery will always be deemed a dental treatment. Expenses Incurred after any payment, duration or Visit maximum is or would be reached. Experimental or Investigational treatments; procedures; hospitalizations; drugs; biological products; or medical devices, except as otherwise stated in this Booklet. Housekeeping services, except as an incidental part of Covered Services and Supplies furnished by a Home Health Agency. Local anesthesia charges billed separately by a Practitioner for Surgery performed on an Outpatient basis. Maintenance therapy for: Physical Therapy; Manipulative Therapy; Occupational Therapy; and Speech Therapy. Milieu Therapy: Inpatient services and supplies which are primarily for milieu therapy even though covered treatment may also be provided. Non-medical equipment which may be used chiefly for personal hygiene or for the comfort or convenience of a Covered Person rather than for a medical purpose. This includes: air conditioners; dehumidifiers; purifiers; saunas; hot tubs; televisions; telephones; first aid kits; exercise equipment; heating pads; and similar supplies which are useful to a person in the absence of Illness or Injury. Routine Foot Care, except as may be Medically Necessary and Appropriate for the treatment of certain Illnesses or Injuries. Services involving equipment or Facilities used when the purchase, rental or construction has not been approved in compliance with applicable state laws or regulations.

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