190.14 - Human Immunodeficiency Virus (HIV) Testing (Diagnosis)
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Medical Review(S) Clinical Review
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 200327 MEDICAL REVIEW(S) CLINICAL REVIEW Application Type NDA Application Number(s) 200327 Priority or Standard Standard Submit Date(s) December 29, 2009 Received Date(s) December 30, 2009 PDUFA Goal Date October 30, 2010 Division / Office Division of Anti-Infective and Ophthalmology Products Office of Antimicrobial Products Reviewer Name(s) Ariel Ramirez Porcalla, MD, MPH Neil Rellosa, MD Review Completion October 29, 2010 Date Established Name Ceftaroline fosamil for injection (Proposed) Trade Name Teflaro Therapeutic Class Cephalosporin; ß-lactams Applicant Cerexa, Inc. Forest Laboratories, Inc. Formulation(s) 400 mg/vial and 600 mg/vial Intravenous Dosing Regimen 600 mg every 12 hours by IV infusion Indication(s) Acute Bacterial Skin and Skin Structure Infection (ABSSSI); Community-acquired Bacterial Pneumonia (CABP) Intended Population(s) Adults ≥ 18 years of age Template Version: March 6, 2009 Reference ID: 2857265 Clinical Review Ariel Ramirez Porcalla, MD, MPH Neil Rellosa, MD NDA 200327: Teflaro (ceftaroline fosamil) Table of Contents 1 RECOMMENDATIONS/RISK BENEFIT ASSESSMENT ......................................... 9 1.1 Recommendation on Regulatory Action ........................................................... 10 1.2 Risk Benefit Assessment.................................................................................. 10 1.3 Recommendations for Postmarketing Risk Evaluation and Mitigation Strategies ........................................................................................................................ -
ICD10 Diagnoses FY2018 AHD.Com
ICD10 Diagnoses FY2018 AHD.com A020 Salmonella enteritis A5217 General paresis B372 Candidiasis of skin and nail A040 Enteropathogenic Escherichia coli A523 Neurosyphilis, unspecified B373 Candidiasis of vulva and vagina infection A528 Late syphilis, latent B3741 Candidal cystitis and urethritis A044 Other intestinal Escherichia coli A530 Latent syphilis, unspecified as early or B3749 Other urogenital candidiasis infections late B376 Candidal endocarditis A045 Campylobacter enteritis A539 Syphilis, unspecified B377 Candidal sepsis A046 Enteritis due to Yersinia enterocolitica A599 Trichomoniasis, unspecified B3781 Candidal esophagitis A047 Enterocolitis due to Clostridium difficile A6000 Herpesviral infection of urogenital B3789 Other sites of candidiasis A048 Other specified bacterial intestinal system, unspecified B379 Candidiasis, unspecified infections A6002 Herpesviral infection of other male B380 Acute pulmonary coccidioidomycosis A049 Bacterial intestinal infection, genital organs B381 Chronic pulmonary coccidioidomycosis unspecified A630 Anogenital (venereal) warts B382 Pulmonary coccidioidomycosis, A059 Bacterial foodborne intoxication, A6920 Lyme disease, unspecified unspecified unspecified A7740 Ehrlichiosis, unspecified B387 Disseminated coccidioidomycosis A080 Rotaviral enteritis A7749 Other ehrlichiosis B389 Coccidioidomycosis, unspecified A0811 Acute gastroenteropathy due to A879 Viral meningitis, unspecified B399 Histoplasmosis, unspecified Norwalk agent A938 Other specified arthropod-borne viral B440 Invasive pulmonary -
Educational Achievement and Economic Self-Sufficiency in Adults After Childhood Bacterial Meningitis
1 Supplementary Online Content Roed C, Omland LH, Skinhoj P, Rothman KJ, Sorensen HT, Obel N. Educational achievement and economic self-sufficiency in adults after childhood bacterial meningitis. JAMA. doi:10.1001/jama.2013.3792 Appendix 1. Description of Registries Appendix 2. Diagnosis Codes for Intrauterine and Birth Asphyxia or Chromosomal Abnormalities Appendix 3. Diagnosis Codes for Meningococcal, Pneumococcal, Or H influenzae Meningitis Appendix 4. Diagnosis Codes for Neuroinfections Other Than Bacterial Meningitis eTable 1. Number of Events in the Study Population and Total Observation Time eTable 2. Estimated Prevalence at Age 35 of Vocational Education, High School, Higher Education, Economic Self‐sufficiency and Disability pension Among Meningitis Patients, Members of the Population Comparison Cohorts, and Their Siblings Without Neonatal Morbidity eFigure 1. Cumulative Incidence of Having Been Economically Self‐sufficient for a Year and of Receiving Disability Pension in the Meningococcal, Pneumococcal and H. influenzae Meningitis Patients (Black), Members of the Population Comparison Cohort (Red), Full Siblings of Patients (Green) and Siblings of Members of the Population Comparison Cohort (Blue) eFigure 2. Cumulative Incidence of Vocational Education, High School and Higher Education for Meningococcal, Pneumococcal and H. influenzae Meningitis Patients (Black), Members of the Population Comparison Cohort (Red), Full Siblings of Patients (Green) and Full Siblings of Members of the Population Comparison Cohort (Blue) Born Before 1980 eFigure 3. Cumulative Incidence of Vocational Education, High School and Higher Education for Meningococcal, Pneumococcal and H. influenzae Meningitis Patients (Black), Members of the Population Comparison Cohort (Red), Full Siblings of Patients (Green) and Full Siblings of Members of the Population Comparison Cohort (Blue) Born After 1980 This supplementary material has been provided by the authors to give readers additional information about their work. -
Neuropsychological Testing
Medical Coverage Policy Effective Date ............................................. 8/15/2021 Next Review Date ....................................... 8/15/2022 Coverage Policy Number .................................. 0258 Neuropsychological Testing Table of Contents Related Coverage Resources Overview .............................................................. 1 Attention-Deficit/Hyperactivity Disorder: Assessment Coverage Policy ................................................... 1 and Treatment General Background ............................................ 2 Autism Spectrum Disorder/Pervasive Developmental Medicare Coverage Determinations .................. 15 Disorders: Assessment and Treatment Coding/Billing Information .................................. 16 Cognitive Rehabilitation Lyme Disease Treatment— Antibiotic Treatment References ........................................................ 28 INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary -
Academy of Medical Sciences of Ukraine L. V. Gromashevskiy
Academy of Medical Sciences of Ukraine L. V. Gromashevskiy Institute of Epidemiology and Infektious Diseases Panasiuk Olena Leonidivna ETHIOPATHOGENETIC THERAPY OF HERPES VIRUS INFECTION WITH THE USE OF PROTEFLAZID 14.01.13 — Infektious Diseases Kyiv — 2007 TABLE OF CONTENTS LIST OF ABBREVIATIONS USED INTRODUCTION CHAPTER 1 PRESSING ISSUES OF TREATMENT OF HERPES VIRUS INFECTIONS 1.2. Main principles of treatment of patients with herpes virus infections CHAPTER 2 MATERIALS AND STUDY METHODS 2.1. Characteristic of examined patients 2.2. Characteristic of study drug and treatment methods 2.3. Study design 2.3.1. Subjects enrollment and discontinuation criteria 2.3.2. Principles and algorithm of subjects grouping 2.3.3. Assessment of therapy efficacy 2.4. Study methods 2.4.1. Clinical method 2.4.2. Special study methods 2.4.3. Statistical method CHAPTER 3 ETHIOPATHOGENETIC THERAPY OF HERPES VIRUS INFECTION WITH THE USE OF PROTEFLAZID 3.1. Clinical efficacy of Proteflazid 3.2. Adverse effects of therapy with Proteflazid 3.3. Interferon inducing and immunomodulatory activity of Proteflazid in subjects with herpes virus infection 3.3.1. Immunomodulatory activity of Proteflazid 3.3.2. Interferon inducing properties of Proteflazid CHAPTER 4 LONG-TERM RESULTS OF TREATMENT OF HERPES VIRUS INFECTION 4.1. Anti-relapse efficacy of Proteflazid CONCLUSIONS PRACTICAL GUIDELINES REFERENCES List of abbreviations used NK (CD16) — natural killer cells NSE — neurospecific enolase ME — meningoencerebritis ANAD — acyclic nucleoside antiviral drugs AB — antibody -
Primary Amoebic Meningoencephalitis Amoebic Meningoencephalitis Is Primary Ś
PØEHLEDOVÉ PRÁCE PØEHLEDOVÉ JE NEGLERIÓZA VEREJNO-ZDRAVOTNÍCKYM PROBLÉMOM? IS PRIMARY AMOEBIC MENINGOENCEPHALITIS (NAEGLERIASIS) A PUBLIC HEALTH PROBLEM? KATARÍNA TRNKOVÁ, LUCIA MAĎAROVÁ, CYRIL KLEMENT Regionálny úrad verejného zdravotníctva so sídlom v Banskej Bystrici, odbor lekárskej mikrobiológie SOUHRN Neglerióza alebo primárna amébová meningoencefalitída (PAM) je zriedkavé ochorenie CNS, pôvodcom ktorého je vo¾ne žijúca meòavka Naegleria fowleri. Medzi stovkami vo¾ne žijúcich meòaviek sú známe i ïalšie rody, ktorých zástupcovia sú schopní infikovaś èloveka a vyvolaś u neho ochorenie. Za patogény sú považovaní zástupcovia rodov Acanthamoeba a Naegleria a druhy Balamuthia mandrillaris a Sappi- nia diploidea. Infekcie spôsobené týmito organizmami vyvolávajú u ¾udí syndrómy v rozsahu od akútnych fatálnych ochorení po chronické, tkanivá napadajúce infekcie s granulomatóznymi prejavmi. Epidemiológia, imunológia, patológia a klinické prejavy týchto infekcií sa vzájomne ve¾mi líšia. Príspevok podáva preh¾ad o pôvodcovi ochorenia PAM, o jeho morfológii, životnom cykle, ekológii ako aj o patogenéze, symptomatike a spôsoboch laboratórnej diagnostiky negleriózy. K¾úèové slová: neglerióza, primárna amébová meningoencefalitída, epidemiológia, laboratórna diagnostika Naegleria fowleri SUMMARY Naegleriasis or primary amoebic meningoencephalitis (PAM) is invariably an acute, often fulminant infection of CNS caused by Naegleria fowleri, a small, free-living amoeba. Pathogenic free-living amoebae can cause serious illnesses in humans. The amoe- HYGIENA bae belonging to the genus Naegleria, Acanthamoeba and Balamuthia mandrillaris and Sappinia diploidea produce syndromes in man ranging from acute fatal disease to chronic tissue invasion with granulomatous manifestation. The purpose of this report is to describe the clinical history, treatment, pathology and methods of laboratory diagnostic of naegleriasis. Key words: primary amoebic meningoencephalitis, naegleriasis, epidemiology, laboratory diagnostics of Naegleria fowleri ÈÍSLO 2 Úvod Obr. -
SNF Mobility Model: ICD-10 HCC Crosswalk, V. 3.0.1
The mapping below corresponds to NQF #2634 and NQF #2636. HCC # ICD-10 Code ICD-10 Code Category This is a filter ceThis is a filter cellThis is a filter cell 3 A0101 Typhoid meningitis 3 A0221 Salmonella meningitis 3 A066 Amebic brain abscess 3 A170 Tuberculous meningitis 3 A171 Meningeal tuberculoma 3 A1781 Tuberculoma of brain and spinal cord 3 A1782 Tuberculous meningoencephalitis 3 A1783 Tuberculous neuritis 3 A1789 Other tuberculosis of nervous system 3 A179 Tuberculosis of nervous system, unspecified 3 A203 Plague meningitis 3 A2781 Aseptic meningitis in leptospirosis 3 A3211 Listerial meningitis 3 A3212 Listerial meningoencephalitis 3 A34 Obstetrical tetanus 3 A35 Other tetanus 3 A390 Meningococcal meningitis 3 A3981 Meningococcal encephalitis 3 A4281 Actinomycotic meningitis 3 A4282 Actinomycotic encephalitis 3 A5040 Late congenital neurosyphilis, unspecified 3 A5041 Late congenital syphilitic meningitis 3 A5042 Late congenital syphilitic encephalitis 3 A5043 Late congenital syphilitic polyneuropathy 3 A5044 Late congenital syphilitic optic nerve atrophy 3 A5045 Juvenile general paresis 3 A5049 Other late congenital neurosyphilis 3 A5141 Secondary syphilitic meningitis 3 A5210 Symptomatic neurosyphilis, unspecified 3 A5211 Tabes dorsalis 3 A5212 Other cerebrospinal syphilis 3 A5213 Late syphilitic meningitis 3 A5214 Late syphilitic encephalitis 3 A5215 Late syphilitic neuropathy 3 A5216 Charcot's arthropathy (tabetic) 3 A5217 General paresis 3 A5219 Other symptomatic neurosyphilis 3 A522 Asymptomatic neurosyphilis 3 A523 Neurosyphilis, -
A Phase Ib Study Evaluating Cobimetinib Plus
Official Title: A Phase Ib Study Evaluating Cobimetinib Plus Atezolizumab in Patients With Advanced BRAF V600 Wild-Type Melanoma Who Have Progressed During or After Treatment With Anti−PD-1 Therapy and Atezolizumab Monotherapy in Patients With Previously Untreated Advanced BRAF V600 Wild-Type Melanoma NCT Number: NCT03178851 Document Date: Protocol Version 5: 26-October-2018 PROTOCOL TITLE: A PHASE IB STUDY EVALUATING COBIMETINIB PLUS ATEZOLIZUMAB IN PATIENTS WITH V600 ADVANCED BRAF WILD-TYPE MELANOMA WHO HAVE PROGRESSED DURING OR AFTER TREATMENT WITH ANTI−PD-1 THERAPY AND ATEZOLIZUMAB MONOTHERAPY IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED V600 BRAF WILD-TYPE MELANOMA PROTOCOL NUMBER: CO39721 VERSION NUMBER: 5 EUDRACT NUMBER: 2016-004402-34 IND NUMBER: 135,717 TEST PRODUCTS: Cobimetinib (RO5514041) Atezolizumab (RO5541267) MEDICAL MONITOR: M.D. SPONSOR: F. Hoffmann-La Roche Ltd DATE FINAL: 14 December 2016 DATES AMENDED: Version 2: 23 June 2017 Version 3: 19 September 2017 Version 4: 3 February 2018 Version 5: See electronic date stamp below. PROTOCOL AMENDMENT APPROVAL Approver's Name Title Date and Time (UTC) Company Signatory 26-Oct-2018 10:19:14 CONFIDENTIAL This clinical study is being sponsored globally by F. Hoffmann-La Roche Ltd of Basel, Switzerland. However, it may be implemented in individual countries by Roche’s local affiliates, including Genentech, Inc. in the United States. The information contained in this document, especially any unpublished data, is the property of F. Hoffmann-La Roche Ltd (or under its control) and therefore is provided to you in confidence as an investigator, potential investigator, or consultant, for review by you, your staff, and an applicable Ethics Committee or Institutional Review Board. -
New Emergency Room Requirement for Hospital and Autopay List of Diagnosis Codes
Provider update New emergency room requirement for hospitals Dell Children’s Health Plan reviewed our emergency room (ER) claims data and identified numerous reimbursements for services with diagnoses that are not indicative of urgent or emergent conditions. As a managed care organization, we promote the provision of services in the most appropriate setting and reinforce the need for members to coordinate care with their PCP unless the injury or sudden onset of illness requires immediate medical attention. Effective on or after August 1, 2020, for nonparticipating hospitals and on or after October 1, 2020, for participating hospitals, Dell Children’s Health Plan will only process an ER claim for a hospital as emergent and reimburse at the applicable contracted rate or valid out‐ of‐network Medicaid fee‐for‐service rate when a diagnosis from a designated auto‐pay list is billed as the primary diagnosis on the claim. If the primary diagnosis is not on the auto‐pay list, the provider must submit medical records with the claim. Upon receipt, the claim and records will be reviewed by a prudent layperson standard to determine if the presenting symptoms qualify the patient’s condition as emergent. If the reviewer confirms the visit was emergent, according to the prudent layperson criteria, the claim will pay at the applicable contracted rate or valid out‐of‐network Medicaid fee‐for‐service rate. If it is determined to be nonemergent, the claim will pay a triage fee. In the event a claim from a hospital is submitted without a diagnosis from the auto‐pay list as the primary diagnosis and no medical records are attached, the claim for the ER visit will automatically pay a triage fee. -
Reptile Clinical Pathology Vickie Joseph, DVM, DABVP (Avian)
Reptile Clinical Pathology Vickie Joseph, DVM, DABVP (Avian) Session #121 Affiliation: From the Bird & Pet Clinic of Roseville, 3985 Foothills Blvd. Roseville, CA 95747, USA and IDEXX Laboratories, 2825 KOVR Drive, West Sacramento, CA 95605, USA. Abstract: Hematology and chemistry values of the reptile may be influenced by extrinsic and intrinsic factors. Proper processing of the blood sample is imperative to preserve cell morphology and limit sample artifacts. Identifying the abnormal changes in the hemogram and biochemistries associated with anemia, hemoparasites, septicemias and neoplastic disorders will aid in the prognostic and therapeutic decisions. Introduction Evaluating the reptile hemogram is challenging. Extrinsic factors (season, temperature, habitat, diet, disease, stress, venipuncture site) and intrinsic factors (species, gender, age, physiologic status) will affect the hemogram numbers, distribution of the leukocytes and the reptile’s response to disease. Certain procedures should be ad- hered to when drawing and processing the blood sample to preserve cell morphology and limit sample artifact. The goal of this paper is to briefly review reptile red blood cell and white blood cell identification, normal cell morphology and terminology. A detailed explanation of abnormal changes seen in the hemogram and biochem- istries in response to anemia, hemoparasites, septicemias and neoplasia will be addressed. Hematology and Chemistries Blood collection and preparation Although it is not the scope of this paper to address sites of blood collection and sample preparation, a few im- portant points need to be explained. For best results to preserve cell morphology and decrease sample artifacts, hematologic testing should be performed as soon as possible following blood collection. -
Issues of the Presence of Parasitic Protozoa in Surface Waters
E3S Web of Conferences 30, 01010 (2018) https://doi.org/10.1051/e3sconf/20183001010 Water, Wastewater and Energy in Smart Cities Issues of the presence of parasitic protozoa in surface waters Eliza Hawrylik1* 1 Department of Chemistry, Biology and Biotechnology, Faculty of Civil and Environmental Engineering, Bialystok University of Technology, Wiejska 45E Street, 15-351 Bialystok, Poland Abstract. Parasitic protozoa are very numerous organisms in the environment that play an important role in the spread of water-borne diseases. Water-borne epidemics caused by parasitic protozoa are noted throughout the world. Within these organisms, intestinal protozoa of the genera Cryptosporidium and Giardia are ones of the most serious health hazards for humans. This paper focuses on the problem of the presence of parasitic protozoa in surface waters. Characteristics of the most frequently recognized pathogens responsible for water-borne outbreaks were described, as well as sources of contamination and surface waters contamination due to protozoa of the genus Cryptosporidium and Giardia were presented. The methods of destroying the cysts and oocysts of parasitic protozoa used nowadays in the world were also presented in a review. 1 Occurrence of parasitic protozoa in surface water Parasitic protozoa are unicellular animal organisms that are very numerously isolated from natural waters, soils, food and media contaminated with animal manure and diseased humans. They are cosmopolitans, and are found in all countries of the world. They play an important role in the spread of water-borne diseases [1,2]. Water is the most common source of infection with protozoa, such as Entamoeba histolytica, Giardia intestinalis, Cryptosporidium sp., Cyclospora cayetanensis, Toxoplasma gondii. -
Diagnosis One To
Diagnosis One-to-One I9cm I9 Long Desc I10cm I10 Long Desc 0010 Cholera due to vibrio cholerae A000 Cholera due to Vibrio cholerae 01, biovar cholerae 0011 Cholera due to vibrio cholerae el tor A001 Cholera due to Vibrio cholerae 01, biovar eltor 0019 Cholera, unspecified A009 Cholera, unspecified 0021 Paratyphoid fever A A011 Paratyphoid fever A 0022 Paratyphoid fever B A012 Paratyphoid fever B 0023 Paratyphoid fever C A013 Paratyphoid fever C 0029 Paratyphoid fever, unspecified A014 Paratyphoid fever, unspecified 0030 Salmonella gastroenteritis A020 Salmonella enteritis 0031 Salmonella septicemia A021 Salmonella sepsis 00320 Localized salmonella infection, unspecified A0220 Localized salmonella infection, unspecified 00321 Salmonella meningitis A0221 Salmonella meningitis 00322 Salmonella pneumonia A0222 Salmonella pneumonia 00323 Salmonella arthritis A0223 Salmonella arthritis 00324 Salmonella osteomyelitis A0224 Salmonella osteomyelitis 0038 Other specified salmonella infections A028 Other specified salmonella infections 0039 Salmonella infection, unspecified A029 Salmonella infection, unspecified 0040 Shigella dysenteriae A030 Shigellosis due to Shigella dysenteriae 0041 Shigella flexneri A031 Shigellosis due to Shigella flexneri 0042 Shigella boydii A032 Shigellosis due to Shigella boydii 0043 Shigella sonnei A033 Shigellosis due to Shigella sonnei 0048 Other specified shigella infections A038 Other shigellosis 0049 Shigellosis, unspecified A039 Shigellosis, unspecified 0050 Staphylococcal food poisoning A050 Foodborne staphylococcal