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Overview: The idea of providing health care treatments and insurance coverage according to "medical necessity" determinations seems eminently reasonable. Its obvious ethical thrust is to discourage unnecessary, wasteful or fraudulent practices. As practically implemented, however, "medical necessity" regulations and determinations have proven remarkably controversial and elusive. First of all, the language connected with medical necessity is inherently vague. Language to the effect that a treatment is medically necessary if it is "likely to achieve a significant practical improvement," is "realistic," or "reasonable" will predictably cause disputes between payors and providers of care. Second, the persistence of these disputes calls into question whether evidence based practices have evolved to a point where they are all that reliable and useful. Third, medical necessity determinations incur problems as to who should ultimately make them: payors, health providers or the courts. Obviously, whoever controls the definition of medical necessity controls the flow of health care dollars. While ethical theory can offer important insights about our moral obligations, it remains unable to reliably translate its theoretical principles and rules bearing on harms, benefits and justice into informing medical necessity determinations. Thus, resolving disputes over medical necessity have taken a procedural approach that looks to the interpretation of contractual language in insurance policies, often at the bench of an administrative law judge. This presentation will advance a reasonable set of strategies whereby a convincing case can be made for certain care interventions qualifying as "reasonable and necessary." Why should you Attend: Despite their central importance as a locus for determining reimbursement, "medical necessity" regulations and determinations have proven remarkably controversial and vexing for at least the last 20 years. Yet, whoever controls the definition

Overview: Remember spaghetti code? The HIPAA breach area is now almost as convoluted and overlapping and confusing as spaghetti code. Sometimes you think you are both coming and going at the same time when you think through an event to determine if your organization has had a breach. For example: Is a security incident always a beach? Is an ePHI breach a security incident as well? Is a cybersecurity event always a breach? What if it does not steal any clinical information, diagnoses or procedures information, or any payment information? A security incident? Or both? Are all the necessary kinds of notice in the Breach rule? What is Cybersecurity Insurance? Is it really the finger in the dike or itself full of Swiss cheese? Can the loss of patient or member data be a HIPAA breach and identity theft plus a fraud issue? Why should you Attend: HIPAA breaches now number in the multiple thousands, if not multiple millions. Your organization needs to be prepared for the initial sense of panic, a complete investigation, and the federal, state and reputational costs of a mega breach. A breach now costs in money approximately $225/record. And this does not include any fine of any type. The loss and theft of 1000 records may cost you organization from a quarter to $1 M, or more, and 6 months to a year to resolve. You need to know the basics of what PHI and ePHI really are; what puts the event into the breach safe harbor, what breach exceptions keeps the event out of OCR's hands, what the 4 factors are and how they are used. You need to know that your organization's breach plan and your policies and procedures include the need to notify when necessary the police, the FBI and other state and federal organizations beyond the Office for Civil Rights. Your organization needs to know how to protect itself after the fact by considering Cybersecurity Insurance. Areas Covered in the Session: Definition and reporting of a Security Incident Definition of a breach Breach Guidance Br

Course "Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story. The term SOP is very obvious. We have seen "clearly written description of how specific tasks are to be done." Another satisfactory definition would be "detailed written instructions that achieve the uniformity of the performance of a specific function." Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? If you are medical device or a pharmaceutical manufacturer, these definitions come as no surprise because when it comes to FDA regulations and guidance documents "establish" means to define, to document (in writing or electronically) and to implement. The goal and emphasis with FDA is simple. Proof of "Establish" is the foundation. Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? Are the procedures being followed and enforced by company personnel? SOPs are needed in regulated industries to give step-by-step instructions for performing a particular job or task. This session will provide a step-by-step overview and a snapshot of the procedure description, the process and format. The subject matter of a SOP may range from how to operate a piece of machinery to how to log into a particular software program. SOPs ensure consistency and reliability because they require training of all affected parties. This session will address recent enforcement actions for SOP related violations but no surprise. Most of our enforcement actions are documentation related, i.e., SOP or other procedural documents. We will review examples from

Overview: FDA 7348.811 section 1 states, "Regardless of the type of system used by the clinical site, the regulatory requirements for clinical data do not change whether clinical data are captured on paper, electronically, or using a hybrid system." What type of system is best for your program and investigator capabilities? The wrong choice yields inspectional non compliance. The right choice of electronic data capture, direct data entry, and data management depends on a sponsor assessment of the systems and procedures at the investigator site as compliant with FDA inspectional requirements. Additional source documentation procedures (origination, authorization, and signature) are required at the investigator site to address the electronic data capture process. It is these three FDA mandated inspectional criteria, applicable to every electronic data element, that generate most of the significant inspectional noncompliant findings. Some data elements are more likely to be associated with the findings of noncompliance than others. It is in fact difficult to determine which data requires or does not require original source documentation and what defines "original source documentation". Why should you attend: Investigators commonly assume that the new guidance and regulations reduce the need for source documentation in clinical trials. In fact, there are new procedural documents relevant to the electronic source documents and direct data entry that are required to comply with the current inspectional standards and the final guidance. Sponsor due diligence in choosing, training, and monitoring investigator sites to enable the use of compliant electronic data capture is required. Basic knowledge of part 11 and GCP requirements will be helpful in attending this advanced webinar. The focus will be on the additional FDA inspectional requirements for electronic data capture, and the impact of using electronic data capture on the seven FDA inspectional priority objectives

Introduction and some definitions of good personal health. Everyone wants to be healthy but they don't know what is criteria for good personal health. In this article, we discussed signs of good health. Just compare yourself with these signs and you will know you have good personal health or not.

As a matter of interest, many people know nothing about their health, but they only say "We Are Sick", and many people are not healthy and they say "We Are Healthy".

HIPAA Breach Notification Rules and its new version : Let us begin at the beginning: What is breach notification? The term is pretty simple to understand. It means notifying the authorities whenever there is a breach of Protected Health Information (PHI). Covered Entities (CE's) and Business Associates (BA's), who are closely associated with PHI, and individuals whose PHI data are breached, are required to bring such data breaches to the notice of the authorities, whenever there is one. A breach notification is a mechanism that is aimed at ensuring that BA's and CE's meet requirements in the HITECH Act in the American Recovery and Reinvestment Act of 2009 (ARRA). To whom should the affected individuals and CE's and BA's complain? Whenever there is a breach of PHI by a CE or a BA, or if there is violation of the Privacy, Security, or Breach Notification Rules, the affected individual can complain to the Office for Civil Rights (OCR), which will initiate investigation into these complaints. Whenever a CE or a BA detects a breach, it can complain to the Secretary of Health and Human Services (HHS). In addition, the HIPAA breach notification rules have clear guidelines on how to report breaches in the following classifications: HIPAA's definition of a breach A breach of PHI is said to have taken place when any unpermitted use or disclosure that compromises the security of the data in the PHI takes place. Any such action, resulting in the breach of any kind of data contained in a PHI, big or small, is considered a breach, unless the CE or BA can explain that the data that got breached into was not serious enough, from its risk assessment point of view, to warrant immediate intervention. The new HIPAA breach notification rules The HHS embarked on a new HIPAA breach notification program, the HIPAA Privacy, Security, and Breach Notification Audit Program, with which it seeks to bring a few changes into the existing HIPAA breach notification rules. This new Audit Pr

Course "Marketing Products without Getting Hammered by FDA" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: With this seminar you will learn how to navigate FDA's legal requirements and its interpretations for enforcement purposes. The agency now applies the principles of cognitive psychology to aid in its determination of what a message really conveys. This becomes a new factor in trying to stay within FDA's legal corral. This conference will provide insight on how to manage your marketing activity and gauge what regulatory risks your business is willing to accept. You will learn how corporate management requires cooperation between marketing, regulatory affairs, legal counsel, manufacturing, engineering and finance departments. You will understand that a weak link in any department leaves the entire corporation vulnerable to FDA enforcement. Most importantly, you will understand the boundaries that FDA uses and how easy it is to cross them. With information from this course, you can step back and rationally evaluate your firm's regulatory profile for advertising and promotion. Why should you attend: If you go "off label" with advertising and promotion, you become embroiled in FDA's advertising and promotion requirements. For devices, the law is weak and lacks legal clarity. For drugs, FDA's law and regulations are extensive and have violated Constitutional protections. Depending on your point of FDA's promotion and advertising requirements can help you or hurt you? There is an inherent conflict in interests. In any case, you need to identify practical criteria to make marketing decisions. That begs the question of whether or not marketing managers and regulatory affairs managers will even try to agree on an issue. FDA's Center for Devices and Radiological Health (CDRH) has never issued a comprehensive guidance on advertising and promotion. You are on your own. CDER has esta

Patient quality and safety in healthcare: Patient quality and safety are core aspects of healthcare. They need to be administered and assessed in the backdrop of a variety of factors. Many healthcare professionals see patient quality and safety in healthcare as being part of the broad canopy of healthcare. There is some disagreement and confusion as to the exact meaning of the terms patient quality and safety, but that is only when it comes to semantics. In broad terms, one can understand patient quality and safety in healthcare as efforts and steps and processes meant to improve the quality care given to patients. Patient quality and safety in healthcare relates chiefly to: Improving the safety of patients and augmenting the quality of health care in the various areas of health Bringing about a reduction in infections that are sometimes a byproduct of provision of health care Reduction in the incidence of adverse drug events Quality healthcare, of which patient quality and safety in healthcare are an integral part, is defined as "…doing the right thing, at the right time, for the right person, and having the best possible result" by The Agency for Healthcare Research and Quality (AHRQ). The AHRQ also describes patient safety as "the act of doing no harm", and which "…underlies all aspects of quality health care." Measuring patient quality and safety: Measuring patient quality and safety in healthcare is of utmost importance because no system or practice is meaningful unless it is capable of being measured. The level and success of patient quality and safety in healthcare is measured against the following parameters: How many patients who underwent surgery experienced infections? How many patients were required to be admitted for a second or subsequent time following discharge from hospital because of complications such as infections or recurrence of the problems for which the patient was admitted? To what extent did the healthcare

Course "Risk Analysis and Design of Experiments (DOE) in Process Validation and Development" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course is designed to help scientists and engineers plan and conduct experiments and analyze the data to develop predictive models used to optimize processes and products and solve complex problems. DOE is an extremely efficient method to understand which variables (and interactions) affect key outcomes and allows the development of mathematical models used to optimize process and product performance. The models also provide an understanding of the impact of variability in controllable and uncontrollable factors on important responses. The concepts behind DOE are covered along with some effective types of screening experiments. Case studies will also be presented to illustrate the use of the methods. This highly interactive course will allow participants the opportunity to practice applying DOE techniques with various data sets. The objective is to provide participants with the key tools and knowledge to be able to apply the methods effectively in their process and product development efforts. Why should you attend: · Plan and conduct experiments in an effective and efficient manner · Apply good experimental practices when conducting studies · Determine statistical significance of main and interaction effects · Interpret significant main and interaction effects · Develop predictive models to explain and optimize process/product behavior · Check models for validity · Utilize models for one or more responses to find optimal solutions · Apply very efficient fractional factorial designs in screening experiments · Apply response surface designs for

Course "Fundamentals of Statistical Process Control: Implementation and Assurance of SPC" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This 2-day seminar provides the information you need to use one of the most powerful tools in quality, statistical process control. It will help people in design, quality, and production understand the concepts and effectively implement them. The examples and issues in the seminar come primarily from the medical device industry, but the material is applicable to any production environment. Production process must be controlled to help ensure they are stable. While there are many control methods, the most powerful and often used is statistical process control, SPC. It uses data from the process itself to detect changes - changes that could result from an unstable process. SPC helps determine if a process continues to operate the way it was set up. If not, SPC produces a signal that calls attention to the problem. One very important application is process capability analysis. With a stable process, SPC data can help determine if the process is capable of meeting the product specifications. These are often expressed as process capability indices. Continuous improvement programs can use the information generated by SPC to monitor process variation and identify its causes. These methods can reduce cost, improve product, and enhance customer satisfaction. Why should you attend: Manufacturing companies, especially medical device manufacturers, must control process. Not only is this a regulatory requirement, but is a good business practice. Without a solid understanding of SPC, you put yourself and your company at a disadvantage. On a personal basis, the material in this seminar will help improve your skills; it aligns with the ASQ Body of Knowledge for the Certified Quality Engineer, Green Belt, and Black Belt. These are areas you should master

Overview:   Institute for Healthcare Improvement (IHI) defines reliability as "failure-free performance over time2". This is simple enough to be understood by anyone. The aim is to have no failures over an extended time period in spite of variability in the patient environment. spite of variability in the patient environment.  This is in line with the technical definition of reliability as the probability of successful performance of intended functions for a specified length of time under a specified user (patient) environment. In a system where the severity of consequences is high, such as in hospitals, the goal is to achieve reliability as close to 100% as possible. This is called failure-free performance. Some hospitals have achieved this goal for specific medical procedures for several quarters. Can they extend this performance over years instead of quarters? That is the challenge we need to face and find elegant solutions zero mistakes or find a way to protect patients if a mistake cannot be prevented.  Why should you Attend: The failures of the U.S. healthcare system are enormous considering the severity of failures. As much as 400,000 patients die each year from hospital mistakes. Another 2.1 are harmed from nosocomial infections (infections acquired during hospital stay). The cost is in billions. Discussions with doctors show that there is reluctance to apply reliability principles to healthcare systems because the variability in healthcare is enormous compared to the aviation and industrial fields. Each customer (patient) is different and each illness is unique in its own way. Then there are interconnecting systems such as cardiology, gynecology, gastroenterology, emergency medicine, oncology, and patient data from various doctors, pagers, computers, vendor software, and intensive care, each operating independently most of the time. But good approaches to improving the system reliability have been tried and tested in many industries. There is a

Overview:   Review 6 points of high quality evidence based clinical documentation Review of 7 criteria that all entries in a patient record should include Impact of documentation on coding and claims Impact on audits and ability to defend an audit When an audit is initiated, the completeness of documentation becomes critical in the ability to support what you have reported. Let's take a look at areas in which weaknesses are often found.  Why should you Attend:  The granularity and accuracy of the ICD-10 code set is supported by quality clinical documentation. It is anticipated that payers will increasingly become less flexible in allowing non-specific codes. The use of unspecified codes will likely lead to rejected claims if it is possible to report the more definitive condition. In most cases, unspecified should not be reported unless there is clear evidence to support the inability to report the detailed option.  Is your E & M level supported in the documentation? If you have never experienced scrutiny of your billing patterns by payers and other entities, you may not be aware of weaknesses that lead to recovery of funds or other costly consequences. Your documentation will be key in supporting diagnoses, service codes and acuity of the patient. It is not just payers who engage in audits. Others include State medical boards, Qui Tam and possible reporting of questionable practices by patients. Do your billing patterns and documentation stand up under reporting scrutiny? This presentation will review areas in which you may not be as strong as you think!  Areas Covered in the Session: Significance of abnormal lab results Measurement of lesions, when taken and inclusion of margins Start & stop times & methodology for infusions & discrepancies in billing Diagnostic testing and medications should be supported in a diagnosis Depth of wounds and cause should be clear Severity of illness Diagnosis present on admission? Who Will Benefit: Coders Billers Rev

Siemens Healthineers has signed a definitive agreement to acquire all fully diluted shares of US-based Corindus Vascular Robotics. The deal is valued at $4.28 per share in cash or $1.1bn in total. Corindus develops, produces and sells robotic systems for minimally invasive procedures, while Siemens' products use quality imaging before and during medical interventions to make minimally invasive treatment possible.

Primary biliary cholangitis, also known as primary biliary cirrhosis, is an autoimmune disease of the liver. The auto-immune disorder can have a number of symptoms such as abdominal pain, fever, nausea, vomiting, abdominal bloating, diarrhea, liver tenderness or enlargement, jaundice, and ascites. In most of these symptoms, the patient may be experiencing inflammation at an early stage of the illness, although in some cases, symptoms do not appear until the disease has advanced to a more serious state. A definitive diagnosis can only be made by performing blood tests and ultrasound studies in order to determine the progression of the illness and its effects on the body. At an early stage, most patients who experience mild to moderate symptoms of primary biliary cholangitis exhibit no symptoms, whereas in some cases, symptoms manifest very quickly and rapidly worsen. In both conditions, the majority of affected individuals undergo treatment that is aimed at relieving pain and treating any complications that might occur. High prevalence of primary biliary cholangitis is expected to propel growth of the primary biliary cirrhosis drugs market. For instance, according to the study, 'Epidemiology and clinical course of primary biliary cholangitis in the Asia-Pacific region: a systematic review and meta-analysis', published in Hepatology International in September 2019, the overall prevalence of primary biliary cholangitis was 118.75 cases per million in the Asia Pacific region, with the high, medium and low prevalence being in Japan and China (191.18 cases per million), New Zealand (99.16 cases per million) and South Korea and Australia (39.09 cases per million), respectively. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/01/high-prevalence-of-primary-biliary.html

Biostimulants are natural or synthetic substances that aid in reducing the dependency on fertilizers. These substances are applied to seeds, plants, and soil in order to increase plant growth, resistance to water and abiotic stresses. Increasing global population has led to focus on boosting crop yield. According to projections by Population Reference Bureau (PRB) included in the 2018 World Population Data Sheet, the world population is expected to reach 9.9 billion by 2050, up 2.3 billion or 29% from an estimated 7.6 billion people in 2018. Moreover, according to according to Food and Agriculture Organization, worldwide food demand is expected to increase by 70% by 2050. Decrease in arable land in various regions has led to has led to various challenges in the agricultural sector. According to the study 'Will Limited Land, Water, and Energy Control Human Population Numbers in the Future', published in the journal Human Ecology, the amount of arable land available per person will decrease to 1500m² by 2050 from 4000m² in 1961. In July 2020, the government of India was expected to announce guidelines to regulate the biostimulants market in the country. Earlier, in July 2019, Europe witnessed several changes regarding definition and classification of these substances. Read More @ https://coherentmarketinsights-cmi.blogspot.com/2020/11/increasing-global-population-and-focus.html

Dive into the world of medical coding audit services and discover how to maximize revenue, ensure compliance, and streamline billing processes! Our comprehensive guide covers everything from the audit process to common challenges, with insights from industry leader Instapay Healthcare Services. Don't miss out - optimize your billing today! Fax:- 9179607960