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Improvement activities (IA) - MIPS 2020 submission is incomplete without it - is easy to submit with the right MIPS consulting firm. Find out more about it.

Improvement activities (IA) - MIPS 2020 submission is incomplete without it - is easy to submit with the right MIPS consulting firm. Find out more about it.

Course "Verification vs. Validation - Product Process Software and QMS" 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 will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer and tougher regulatory stance. This course's aim is to prove "Product Risk Based V&V" by sufficient, targeted and documented risk-based V&V test case elements/scripts. It will teach participants to evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management. This course will evaluate different field-tested, U.S. FDA-reviewed V&V protocols; how to employ equipment/process Requirements Specs / DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, all against a background of limited company resources. It will review a matrix that simplifies "as-product", in-product", process and equipment, et al, software VT&V, to assure key FDA requirements are not overlooked. While considering the QMS and 21 CFR Part 11; this course will make practical application of these same in two hands-on sessions. Why you should attend: This session helps participants: * Understand Verification and Validation, differences and how they work together; * Discuss recent regulatory expectations; * Know how to document a "risk-based" rationale, and use it in a resource-constrained environment; * Determine key "milestones" and "tasks" in a project; * Locate and document key subject "inputs"; * Compile "generic" Master and Individual Validation Plans; * Learn the key element of a Product V&V File/Protocol; * Understand how to develop Process and/or Production/Test Equipment V&V Files/Protocols; * Get a grasp of basic Test Case construction; * Understand sample sizes and their justification; * Learn the key elements of Software V&V expected by the FDA and how to document; * Deal with hardwa

We are dealing with a public health emergency, and CMS has proactively come forward to facilitate clinicians in Quality Payment Program (QPP). This year, the final rule for QPP MIPS data submission required some flexibility to accommodate the pressure.

Here are ten steps of claims submission via medical billing services to speed up the medical billing and coding process. Take notes and improve your revenue cycle management.

Here are ten steps of claims submission via medical billing services to speed up the medical billing and coding process. Take notes and improve your revenue cycle management.

Here are ten steps of claims submission via medical billing services to speed up the medical billing and coding process. Take notes and improve your revenue cycle management.

Course "Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools The attendees must have attended the Basic Validation & 21 CFR 11 Compliance. This is a very hands-on class and the attendees will be expected to use templates provided in the class to create the complete package for the validation of a system The Seminar: This Hands-On course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation as follows: 1. Validation Master Plan 2. Complete Validation for a System 3. Excel Spreadsheet Validation 4. Change Control 5. SOPs 6. Test Tools Validation 7. Project Management for Validation Who Should Attend : * VP of IT * Director of IT * Quality Managers * Project Managers (for CSV / IT) * Validation Specialists * Database Administrators * System Administrators * Directors / Senior Directors of Discovery * Directors /

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: Drug and device research is confusing and difficult on its own but when you start combining drugs with devices the regulatory landscape changes as there are more nuances to deal with. Knowing how drug and device studies are each regulated is important in navigating the challenges posed by studies that wish to use both. It is also important to be aware of current guidance affecting the use of both drugs and devices in a study as well current guidance affecting the classification of devices. Why should you attend: Information on drugs and devices is plentiful. But, it can also be daunting .The webinar will give attendees a foundation and a starting point on which they can build. Learning objectives: Define drug research Define device research Explore the differences between the two Describe requirements when drugs and devices are combined in one study Areas Covered in the Session: Defining Drug Research FDA approved drugs Investigational drugs Compassionate use Defining Device Research FDA approved devices 510 K devices Humanitarian Device Exemptions Invitro Diagnostic Devices Investigational Devices Federal regulations governing drugs and devices Guidance governing drugs and devices Combining devices and drugs into one study What are the requirements? What are the regulations and guidance? How these studies are reviewed Who Will Benefit: Investigators Researchers Research Staff Study Coordinators Auditors Research Administrators Speaker Profile Sarah Fowler-Dixon is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with st

Overview: The trial master file is a hard copy of all documentation relating to a clinical trial. It contains essential documents. When studies are conducted under ICH E6 Good Clinical Practices (GCP), this collection of documents must be present before, during and after the trial. These documents help provide quality assurance and help researchers evaluate their compliance with GCP, federal regulations and applicable laws. Why should you Attend: Anyone responsible for handling trial documentation or quality assurance activities. Areas Covered in the Session: Trial Master File (TMF): what is it? Essential documents required ICH guidelines and Good Clinical Practice (GCP) Food and Drug Administration (FDA) guidance and expectations Paper or electronic trial master files - what is allowable Links to useful resources Who Will Benefit: This webinar will provide valuable assistance to all personnel in: Human Subjects Research Healthcare interested in exploring the field of Clinical Research New Clinical Research Coordinator positions (1-2 years) New Principal Investigator positions Administration in charge of Clinical Research Regulatory Compliance Speaker Profile Sarah Fowler-Dixon is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities. She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research manageme

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

Dealing with Medicare and Medicaid Overpayments : Medicare and Medicaid overpayments are pretty common. If they are not dealt with properly, they invite penalties. Medicare and Medicaid Overpayments happen when a person, provider or supplier receives a payment that is in excess of the amount due to him or her under Medicare statutes and regulations. This overpayment becomes a federal debt that is owed by the individual to the State. So, Centers for Medicare and Medicaid Services (CMS) is required by federal law to recover this amount. Overpayments routinely occur in Medicare and Medicaid. Many a time, these are unintended and are usually a result of oversight, but could also happen due to intent. Some of the most common reasons for which Medicare and Medicaid overpayments occur can be when: Duplicate submissions of the same service or claim are made Excessive or non-covered services are billed or furnished for billing Services that are not necessary medically or are excluded are paid for The wrong payee gets paid. How are Medicare and Medicaid overpayments processed? Obamacare has amended the federal False Claims Act (FCA), which is part of the Fraud Enforcement Recovery Act of 2009 (FERA), to add provisions relating to recovery of Medicare and Medicaid overpayments. This is how the process of Medicare and Medicaid overpayments works: Whenever Medicare comes to know that any overpayment of $10 (raised to $25 from July 2014) or more is made, it directs the Medicare Administrative Contractor (MAC) to initiate the process of recovery of this overpayment. The MAC starts the process by initially mailing a demand letter in which repayment is requested If no action is taken, a second and third demand letters are mailed in a month following the first one. Contents of a demand mail from Medicare/Medicaid: The demand letter sent by the MAC will explain the details of the Medicare and/or overpayment. When repayment is not made in full within 30 days, interest starts get

Course "Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools The attendees must have attended the Basic Validation & 21 CFR 11 Compliance. This is a very hands-on class and the attendees will be expected to use templates provided in the class to create the complete package for the validation of a system The Seminar: This Hands-On course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation as follows: 1. Validation Master Plan 2. Complete Validation for a System 3. Excel Spreadsheet Validation 4. Change Control 5. SOPs 6. Test Tools Validation 7. Project Management for Validation Who Should Attend: * VP of IT * Director of IT * Quality Managers * Project Managers (for CSV / IT) * Validation Specialists * Database Administrators * System Administrators * Directors / Senior Directors of Discovery * Directors / Senior

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

Overview: The Sunshine Act, or Open Payments Program, requires manufacturers of drugs, medical devices, and biologics that participate in U.S. federal health care programs to report certain payments and items of value given to physicians and teaching hospitals. This Act was part of a healthcare reform bill adopted in March 2010. It came about due to requests for increased transparency about the financial relationships between physicians and industry. The Centers for Medicare and Medicaid (CMS) issued the final rules in 2013 which implemented the Sunshine Act. Why should you Attend: Anyone required to adhere to the Sunshine Act standards or anyone interested in knowing what must be reported and made public. Areas Covered in the Session: Purpose of the Sunshine Act Who is required to report under the Sunshine Act? What is reported? Exclusions Tracking Penalties Useful links Who Will Benefit: This webinar will provide valuable assistance to all personnel in: Human Subjects Research Healthcare interested in exploring the field of Clinical Research Clinical Research Coordinators Principal Investigators/Physicians Administration in charge of Clinical Research Regulatory Compliance Speaker Profile Sarah Fowler-Dixon is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities. She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fu

In the business world as well as in the healthcare field growth is good. However, with growth comes a unique challenge; which may or may not be solved. Even though an evolving or growing medical facility services may not change, the internal processes related to claims submission, income cycle, billing and coding and revenue cycle management need a serious overhaul in order to stay efficient and sustainable as they scale up the operation.

The Common Technical Document (CTD) is an international standard for the summary documents relating to quality, safety and efficacy information of medicinal products. The CTD is mandatory for the registration of medicines. International Council for Harmonization (ICH) mandates to obtain regulatory approval of new drug applications of Pharmaceutical companies operating in European Union states. The main aim of CTD is to achieve greater harmonization in new drugs development and registration. The standard encompasses the entire spectrum of documentation to be integrated into a regulatory submission dossier, thereby offering complete guidance to pharmaceutical companies as to how formulation and manufacturing information supporting the quality parameter as well as the results of non-clinical and clinical research needs to be organized and presented.

Scientific Regulatory writing is a complex process due to its dossier size, data complexity, and submission deadlines and it requires specialized domain-specific knowledge, understanding of drug development process, pharmacology, statistical and writing skills to develop superior regulatory documents as per the exact requirements of the regulatory authority. Besides, the scientific writer must be familiar with technical guidelines prevailing in countries like European Union (EU), USA, Japan that includes ICH E3 to write clinical study reports, periodic safety reports (ICH E2C), publication guidelines (e.g. CONSORT, STROBE, PRISMA), the International Committee of Medical Journal Editors (ICMJE) guidelines for manuscripts.

It is about accuracy of data for each performance category that matters the most in MIPS. As a MIPS Qualified Registry for the fourth time in a row is a living proof of our past performances and current status. In this article, we got a chance to reflect on a few MIPS data essentials; and thought they would be useful for clinicians before the submission window closes for good.

There is little time left for MIPS 2020 quality reporting. Some of you might have selected quality measures but with this little time, reconsider your choices and consult a MIPS Qualified Registry for guaranteed MIPS quality measures submission.

Want to know about the top 3 tricks for successful MIPS Quality measures selection? Read this article to get started. For more help in accurate MIPS data submission and the latest updates, contact p3care.