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Course "Effective and Efficient Internal and Supplier Quality System Auditing for Medical Devices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Do you want to understand how to do efficient and effective internal and supplier audits that meet all the requirements of your external auditors, but also add value to your company? Are you confused by all the requirements and guidance documents for medical device quality management systems and are tired of wading through all the regulatory language they contain. This course is for those who will do internal or supplier audits, manage an audit process for these or other company audits. This course will provide you with an easy to understand presentation on the auditing process as well as the requirements you will need to audit under ISO 13485 and the FDA Quality System Regulation (cGMP) Both FDA Quality System Regulation (QSR) and ISO 13485 require that companies do internal audits. However, because the FDA does not look at the content of internal audits, some companies do not get feedback on the true effectiveness of their internal audit system from the FDA during FDA Inspections. ISO 13485 auditors do look at internal audits, but are most concerned that you define a process that meets the requirements of the standard and are following your process. Both require that you define Auditor training is required, but this sometimes just requires reading the company's procedure, although most external auditors will look for more than this. Do you need to train new auditors for yours medical device quality management system or to audit your suppliers? Or do you need to improve the training of your internal and supplier auditors so that they add value to these audits? If you need to do either of these, this seminar will provide this training. In addition to auditing skills and hands-on auditing exercises, this seminar will provide an ove

Overview: This webinar will focus on the major fraud and abuse laws, including the Stark Law, the Anti-Kickback Statute, and the False Claims Act. In this webinar Mr. Wolfe will provide an overview of the health care regulatory issues related to implementing value-based physician compensation models. Why should you Attend: Given the substantial awards and settlements in recent Stark Law enforcement actions, Stark Law compliance has become more than just a compliance issue: it is an enterprise risk management issue. As medical groups, hospitals, and health systems transition to value-based physician compensation arrangements, they will need to make sure their arrangements continue to be compliant with the Stark Law. Areas Covered in the Session: Provide a general overview of the Stark Law, Anti-Kickback Statute and the False Claims Act. Explain the requirements for compliance with key regulatory exceptions and safe harbors. Compensation and valuation issues unique to the group practice model Discuss best practices when implementing value-based physician compensation models. Summarize the recent changes to the Stark Law for 2016. Who Will Benefit: In-House Counsel Health Care Compliance Officers Health Care Human Resources Health Care CFOs Health Care executives Speaker Profile Joseph Wolfe is an attorney with Hall, Render, Killian, Heath & Lyman, P.C., the largest health care focused law firm in the country. Mr. Wolfe provides advice and counsel to some of the nation's largest health systems, hospitals and medical groups on a variety of health care issues. He regularly counsels clients on a national basis regarding compliance-focused physician compensation and alignment strategies. He is a frequent speaker on issues related to the physician self-referral statute (Stark Law), hospital-physician transactions, physician compensation governance and health care valuation issues. Before attending law school at the University of Wisconsin, he served as a combat engi

Overview: This webinar is designed for medical practice leaders to gain a working knowledge of the Value-Based Modifier program and how your cost and quality metrics will be used to determine your Medicare payments in future years. Why should you Attend: Your future Medicare payments are at risk. 2018 payment rates may be cut up to 6% if you fail to report quality measures to CMS for the 2016 calendar year. Your practice can also see cuts of 1-4% if you are an outlier on costs or quality. On the other hand, practices that show they are significantly better than average on costs and/or quality can receive an increase over the standard Medicare payment rates. You'll want to understand how this program works, what the potential impact for your practice is, and what steps you need to take now to ensure success in 2018. Areas Covered in the Session: What types of medical practices are impacted by the VBM program and how much is at risk for practices of different sizes. What cost and quality metrics are used and how are they combined to yield your practice's future payments What are the timelines for submitting data and reviewing your status What actions you can take now to ensure the highest possible Medicare payments in future years Who Will Benefit: Practice Administrators Physicians, Podiatrists, Physician Assistants, Nurse Practitioners, CRNAs Quality Officers Nurse leaders Finance Directors Speaker Profile Jeanne J. Chamberlin Jeanne Chamberlin is currently a Practice Management Consultant with MSOC Health. During her 30 years in the healthcare industry, Jeanne has worked in independent medical practices, health systems, state government, and software development. She holds a Masters Degree in Public Policy from Duke University and is a fellow in the American College of Medical Practice Executives. She has been a leader in both state and local MGMA chapters. As practice administrator of a 10-physician multi-specialty practice, Jeanne first began

Course "Supplier Management for Medical Device Manufacturers" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment. How well do you understand the requirements for supplier management? Could you pass a regulatory audit or inspection without any issues? This course delivers the tools, templates, and methods to help participants implement an effective and efficient supplier management program. This two-day hands-on course provides a clear understanding of the underlying principles of supplier management. The course uses exercises to solidify understanding. In addition, the course uses FDA Warning Letters to illustrate the points and help you learn from others. As part of the practical implementation, the course includes receiving acceptance activities, outsourced processes, process validation at the suppliers' location, supplier auditing techniques, and supplier issues in management review. The course uses the Global Harmonization Task Force (GHTF) framework, but expands it to cover other issues and techniques important in effective implementation. Why should you attend: Since FDA regulations do not allow them to audit your suppliers unless they make finished medical devices, they require that you have sufficient control over them. But from time to time the FDA makes a reinterpretation of what this means. This happened within the last f 5 years, so if you supplier management program is older than that, you need to make major changes in you supp

Overview: This webinar will cover the changes to the PQRS program in 2016 and will provide tips and strategies to help you select the best measures and reporting approach for your practice. Why should you Attend: Your future Medicare payments are at risk. Failing to report quality measures to CMS for Calendar Year 2016 will result in a reduction of up to 6% in your 2018 Medicare payments. The PQRS program carries a potential 2% penalty for each provider who does not report quality measures to CMS - physicians, mid-level providers, therapists, psychologists, social workers, even dieticians. In addition, if your practice has physicians and mid-levels, at least half the physicians must meet the PQRS requirements or the group will face an additional 2-4% penalty from the Value Based Modifier program. Areas Covered in the Session: Understand the difference between a reporting rate and a performance rate? Get access to useful tools to help you identify measures applicable to your specialty. Learn how to choose among the various reporting approaches - what are the pros and cons of each. Understand how CMS will evaluate your submission if you report less than 9 measures. Who Will Benefit: Practice Administrators All providers who bill to Medicare including Physicians (All specialties), Podiatrists, Physician Assistants, Nurse Practitioners, Psychologists, LCSW, Physical and Occupational Therapists, Speech/Language Pathologists, etc. Quality Officers Nurse leaders Finance Directors Speaker Profile Jeanne J. Chamberlin Jeanne Chamberlin is currently a Practice Management Consultant with MSOC Health. During her 30 years in the healthcare industry, Jeanne has worked in independent medical practices, health systems, state government, and software development. She holds a Masters Degree in Public Policy from Duke University and is a fellow in the American College of Medical Practice Executives. She has been a leader in both state and local MGMA chapters. As practice ad

Course "Tougher Import Rules for FDA Imports in 2016" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: FDA's and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of information and adherence to government procedures. Firm's that fail to understand and properly execute an import and export program find that their shipment is delayed, detained or refused. In 2016 entries must use the Automated Commercial Environment (ACE) entry filing system or face entry refusals and monetary penalties up to $10,000 per offense. A number of other factors can derail the expectation of a seamless import process. The course covers detailed information about the roles and responsibilities of the various parties with an import operation and how to correct the weakest link(s) in the commercial chain. The course will include tips on how to understand FDA's thinking and offer anecdotal examples of FDA's import program curiosities. Why should you attend: What happens when your product is detained? FDA will begin a legal process that can become an expensive business debacle. You must respond fully within short timeframes. This is not the time for you to be on a learning curve. You need to have a plan in place and know what you are doing. The FDA is steadily increasing the legal and prior notice information requirements. If you do not know what those requirements are and you initiate a shipment, your product is figuratively dead in the water. You must be accurate with the import coding information and understand the automated and human review process. If not, you can expect detained shipments. CBP is implemented a new "Automated Commercial Environment" computer program that changes import logistics and information reporting for FDA regulated products. Your shipment may be stopped before it is even loaded at the foreign port. What

Overview: This webinar is designed for medical practice leaders to gain a working knowledge of the Value-Based Modifier program and how your cost and quality metrics will be used to determine your Medicare payments in future years. Why should you Attend: Your future Medicare payments are at risk. 2018 payment rates may be cut up to 6% if you fail to report quality measures to CMS for the 2016 calendar year. Your practice can also see cuts of 1-4% if you are an outlier on costs or quality. On the other hand, practices that show they are significantly better than average on costs and/or quality can receive an increase over the standard Medicare payment rates. You'll want to understand how this program works, what the potential impact for your practice is, and what steps you need to take now to ensure success in 2018. Areas Covered in the Session: What types of medical practices are impacted by the VBM program and how much is at risk for practices of different sizes. What cost and quality metrics are used and how are they combined to yield your practice's future payments What are the timelines for submitting data and reviewing your status What actions you can take now to ensure the highest possible Medicare payments in future years Who Will Benefit: Practice Administrators Physicians, Podiatrists, Physician Assistants, Nurse Practitioners, CRNAs Quality Officers Nurse leaders Finance Directors Speaker Profile Jeanne J. Chamberlin Jeanne Chamberlin is currently a Practice Management Consultant with MSOC Health. During her 30 years in the healthcare industry, Jeanne has worked in independent medical practices, health systems, state government, and software development. She holds a Masters Degree in Public Policy from Duke University and is a fellow in the American College of Medical Practice Executives. She has been a leader in both state and local MGMA chapters. As practice administrator of a 10-physician multi-specialty practice, Jeanne first began working wi

Overview: As the healthcare industry moves toward a value based reimbursement model rather than fee for service, it is crucial that the provider and ancillary staff understand how ineffective reporting can lead to dollars lost. We will review the 3 critical areas that require skilled management. Understand that patients are more educated about their healthcare and are increasingly responsible for more out of pocket costs. High dollar deductibles may result in self pay realities and bad debt increases. Learn areas that increase your chances for an audit. Are you ready for the challenge? Why should you Attend: Revenue is dependent upon proficiency in multiple areas. In today's environment, it is risky to maintain the status quo and increasingly important to obtain and maintain skilled business staff. The granularity of the ICD-10 code set requires understanding of the official coding conventions and guidelines, the ability to apply those guidelines, and the ability to recognize when reporting may lead to revenue delay, reduction or loss. Additionally, other factors affect your revenue stream. This includes patients with high deductible plans, collection of much more than a small co-pay, and staff understanding of regulations that govern telephone collection activity. Don't leave money on the table or invite an audit into your practice. Audits are often the result of weak billing and coding skills. This program will review several areas that will cost you money if poorly handled. Areas Covered in the Session: Required specificity in coding Documentation necessary for ICD-10 reporting Why coders must frequently query for clarification How ambiguous diagnosis reporting affects you r bottom line Internal collections versus outsourcing. What should you consider Staff effective in handling problem claims? Developing appeals? Who Will Benefit: Coders Billers Revenue cycle Physicians Mid-level providers Nurses Claims follow-up Managers Managers Speaker Profil

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

Overview: Safe hospital care in neither a science nor an art. It is a practice just like the practice by a doctor who combines hindsight of experience and foresight of imagination to come up with an outsight of the best interventions and best protocols. Over time the doctor standardizes the process but is vigilant to any unique requirements of each patient. Such an approach in patient safety is called hazard analysis and mitigation process. This webinar goes a big step farther. It covers innovation strategies to assure that the safety improvements result in a high return on investment and high value to the hospital, and protects the patients. Why should you Attend: About 400,000 patients die each year from hospital mistakes according to a senate hearing. Evidence based methods to reduce adverse, sentinel, and never events are available and successful in aerospace, nuclear, and chemical industries. Why not use them? We need a paradigm shift. We need it in a hurry! You cannot cross the sea merely by standing and staring at the water. Do not be afraid to take a big step if one is indicated. No noble thing can be done without risks Areas Covered in the Session: The Etiologies of Unsafe Care Sufficient Understanding is a Pre-requisite to Safe Care Preventing "Indifferencity" to Enhance Patient Safety Continuous innovation is better than Continuous Improvement Innovations Should Start with Incidence Reports Hazard Analysis Fault Tree Analysis-the Best Tool for Harm Prevention Doing More with Less is Innovation Re-Invent Quality Management Human Errors may be Unpreventable, Preventing Harm is an Innovation Managing Safety: Lessons from Aerospace Protect Patients from Dangers in Medical Devices The Paradigm Pioneers Aequanimitas,The Best Known Strategy for Safe Care Who Will Benefit: Hospital senior management Hospital administrators Doctors Nursing staff Clinical engineers Radiology staff Infection control staff Patient advocates Speaker Profile Dev Raheja

Outline Value Based Healthcare System - How it is seen today Healthcare Challenge & IoT as a Solution IoT - Big Data Structure Recent Trends in IoT Big Data Analytics Challenges & Our Future In-depth Knowledge of What causes the most premature death? Distribution of Disease burden from 1990 - 2020 Challenges in Healthcare Future Healthcare IoT Machine Talking to Machine Prediction of IoT Usage About PEPGRA HEALTHCARE, A leading healthcare communication firm with years of excellence serving clients with a dedicated team of Medical, Regulatory and Scientific writers specialized in all therapeutic areas. Contact us at : UK: +44-1143520021 US/Canada: +1-972-502-9262 India: +91-8754446690 info@pepgra.com www.pepgra.com

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.

This program has combined previous quality reporting programs such as Physician Quality Reporting System (PQRS), Value-based Payment Modifier (VM), and the Electronic Health Records (EHR) Incentive program (Meaningful Use) under one platform.

This program has combined previous quality reporting programs such as Physician Quality Reporting System (PQRS), Value-based Payment Modifier (VM), and the Electronic Health Records (EHR) Incentive program (Meaningful Use) under one platform.

Currently, the healthcare system is going through a critical phase that involves shifting paradigms, from the volume-based model to the value-based reimbursement system. All of this is intended to minimize healthcare costs and raise the quality of care.

The solid state battery market was valued at USD 51.6 Million in 2014 and is expected to grow at a CAGR of 72.33% during the forecast period. The base year used for this study is 2014 and the forecast period is between 2015 and 2020.

Medical billing services are more of a conundrum in present times because the process has gotten complicated with time. The government has set value-based criteria for the providers to follow, for ensuring a productive health system while cutting costs.