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Overview:   We will review the various elements of the physician employment agreement, focusing on the pitfalls and the problems that can develop when the agreement does not clearly define the relationship, and/or when the parties do not fully understand what is being agreed to. Such items as term and termination, termination for cause, duties of the physician, call, non-compete, and compensation are all items that should be clearly set out in the agreement and fully understood by the parties. Why should you attend: Formal written contracts establish the legal relationship between the parties; they state the terms and conditions of that relationship and the rights and obligations of each party. They confirm the intentions and relationships of the parties as they enter into this relationship, and they eliminate uncertainties regarding mutual rights, obligations, and relationships. If everything remained as it is at the time the agreement is signed, there would be little need for formal documents. However, the agreement serves to protect against future disputes. Therefore, it should include as precise language as possible. Ambiguous terms in agreements are of little effect when disputes occur over the meaning of a party's rights or obligations. You should attend to gain an understanding of what should and what should not be in a physician employment agreement. Areas Covered in the Session: Corporate practice of medicine Term and termination Termination for Cause Severance pay Provision allowing physician to terminate for cause Severance pay Duties of the physician Standards for the provision of professional services Referral to hospital Continuing medical education Who Will Benefit: Physicians Healthcare executives Physician practice managers Speaker Profile William Mack Copeland MS, JD, PhD, LFACHE, practices health care law in Cincinnati at the firm of Copeland Law, LLC. He is also president of Executive & Managerial Development Group, a consu

Overview: Learn how to improve your healthcare compliance program by using requirements found in corporate integrity agreements (CIAs) issued by the OIG. By proactively incorporating various features of CIAs, healthcare providers of all types can be better assured of meeting compliance standards. While there are many different types of healthcare compliance issues, probably the area of most concern is that of properly filing claims and receiving appropriate reimbursement. The OIG has issued various types of guidance including Federal Register entries, fraud alerts, and issues as listed in the OIG Work Plans. By providing such guidance, the OIG has given healthcare providers notice so that there can be no defense of not knowing about an issue. By organizing your compliance program to detect and then correcting various types of issues is a major objective of having a compliance program. Understanding systematic processes for improving your healthcare compliance program using CIA requirements can forestall possible criminal and civil monetary penalties. The hundreds of CIAs that have been developed when the OIG detects fraudulent activities can be used as a guide for developing and improving healthcare compliance programs for all types of healthcare providers. The process of statistical extrapolation is used by the OIG when conducting studies in order to determine recoupment amounts. Statistical extrapolation can also be used by healthcare providers when determining possible overpayments. However, the proper use of statistical extrapolation is a formal and complex mathematical process that must be properly applied. The OIG CIAs provide another resource for healthcare providers to study, understand, and then apply as appropriate. Why should you Attend: What are the OIG Corporate Integrity Agreements (CIAs)? Why does the OIG issue CIAs? Can I use general requirements from CIA to avoid monetary penalties or even avoid going to jail? Can any healthcare provider use

Overview: Today's health care delivery occurs in a diverse, fast-changing, multidisciplinary health care environment. This often presents challenges to the health care professional that are not easy to navigate. Medical records and their confidentiality have long been the exclusive province of state law, but has now been recognized for some time in the federal HIPAA statutes and federal regulations. Differing and even conflicting sources of requirements at the state level still exist for the retention and disposition of medical records. These sources may vary based upon the specific health care practitioner - whether physicians, dentists, psychologists, or other health care providers, including mental health practitioners. As to the specific, individual health care practitioner, state laws mandate their confidentiality, retention, and even their specific content with regards to patient, clinical records. In addition to these clinical requirements, additional state laws set forth the content and retention of other types of records kept by the professional, such as supervisory agreements with other professionals subordinate to them as well as their own unique record content requirements. With the majority of medical records moving to an electronic format, special rules now exist with regard to the confidentiality, security, retention, and disposition of electronic medical records. This is particularly important as state laws continue to allow for and regulate the provision of telemedicine by various health care practitioners. For example, while psychotherapy and mental health services are ideal treatments to offer over the internet, that is, by simultaneous audio-visual transmission between the doctor and the patient, the risks of breaches of confidentiality also vastly increase. And when the successful doctor-patient relationship is over, how does the health care practitioner providing a mental health service dispose of these electronic records? In addition to

Overview: Today's health care delivery occurs in a diverse, fast-changing, multidisciplinary health care environment. This often presents challenges to the health care professional that are not easy to navigate. Medical records and their confidentiality have long been the exclusive province of state law, but has now been recognized for some time in the federal HIPAA statutes and federal regulations. Differing and even conflicting sources of requirements at the state level still exist for the retention and disposition of medical records. These sources may vary based upon the specific health care practitioner - whether physicians, dentists, psychologists, or other health care providers, including mental health practitioners. As to the specific, individual health care practitioner, state laws mandate their confidentiality, retention, and even their specific content with regards to patient, clinical records. In addition to these clinical requirements, additional state laws set forth the content and retention of other types of records kept by the professional, such as supervisory agreements with other professionals subordinate to them as well as their own unique record content requirements. With the majority of medical records moving to an electronic format, special rules now exist with regard to the confidentiality, security, retention, and disposition of electronic medical records. This is particularly important as state laws continue to allow for and regulate the provision of telemedicine by various health care practitioners. For example, while psychotherapy and mental health services are ideal treatments to offer over the internet, that is, by simultaneous audio-visual transmission between the doctor and the patient, the risks of breaches of confidentiality also vastly increase. And when the successful doctor-patient relationship is over, how does the health care practitioner providing a mental health service dispose of these electronic records? In addit

"Bacterial Partnering Terms and Agreements"provides a detailed understanding and analysis of how and why companies enter bacterial partnering deals. The majority of deals are discovery or development stage whereby the licensee obtains a right or an option right to license the licensors bacterial technology.

The majority of deals are development stage whereby the licensee obtains a right or an option right to license the licensors monoclonal antibody technology. These deals tend to be multicomponent, starting with collaborative R&D, and commercialization of outcomes.

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: New changes modifying the HIPAA Privacy and Security Regulations are going into place to meet the privacy and security mandates within the HITECH Act in the American Recovery and Reinvestment Act of 2009. The changes include establishing new rights for individuals as well as changes to the limitations on uses and disclosures. New requirements for patient access to records and requirements to notify individuals in the event of a breach are only two of the many areas affected in the new law, including new requirements for restriction and accounting of disclosures and increased enforcement activity. Covered entities that use electronic health records (EHRs) will need to meet new access and disclosure rules and all kinds of business associates and their subcontractors will need to establish compliance programs. And if you are required to have a HIPAA Notice of Privacy Practices, you will need to update that to show all the new rights that patients will have, such as electronic copies, new rights to restrict disclosures, and much more. Business associates are now directly covered by the HIPAA privacy and security regulations and are liable for fines and penalties if they do not comply. If a business associate supplies services that interact with the new changes to the rules, the BA will need to be aware of the new requirements. We will explain what a Business Associate needs to do differently under the new regulations. Electronic records have new demands placed on them, in both providing access and in accounting for all disclosures of health information - the electronic age in health care brings new obligations to serve individuals as well as manage health information for healthcare professionals. We will discuss how disclosures must be tracked in an EHR and review the various ways patient records can be supplied electronically. The new regulations will be reviewed and their effects on usual practices will be discussed, as will what policies need to be chang

HIPAA Survival Guide: The HIPAA Survival Guide is a set of practical help guides that seek to make compliance with HIPAA and HITECH easy for providers. This kit is some kind of checklist on what to keep in mind and implement to survive a HIPAA audit. The HIPAA Survival Guide was created as a need to comply with the HIPAA audit requirements. It evolved as a response to simplifying the HIPAA Privacy Rule and HIPAA Security Rule without its legal complexity. In other words, the framers of this Guide have developed this concept strictly as a guide, rather than as a legally enforceable set of rules. "Forest from the trees" approach: The HIPAA Survival Guide came into being in order to help users understand HIPAA and HITECH better. The approach the developers of this Guide adapted was what was called the "forest from the trees" way, because the aim was to help users navigate and wade through the complex text. It was aimed at helping them chaff and finesse the parts that required their compliance into simple terms. HIPAA Survival Guide is thus not a strict, legislative Act that lays down rules for conformity. No wonder, it was developed by the joint efforts of a Registered Nurse and an Attorney, who wanted to facilitate a greater understanding of the legislation's audit requirements. The basis on which this Guide came into existence was the HIPAA and HITECH background. It concerns itself with only the part of HIPAA and HITECH relating to a part of Covered Entities, namely providers. This is deliberate, since the aim of this Guide is to help small providers with guidelines aimed at simplifying their task. Important steps for HIPAA survival: The fundamental goal of the HIPAA Survival Guide is to equip providers with the knowledge of what needs to be kept in order and fine-tuned if they have to meet regulatory requirements. These are the thumb rules for the HIPAA Survival Guide: Documenting the provider's privacy, security and breach policies and revie

Overview: The objectives of this course will be to go over the specific risks associated with business associates as it relates to HIPAA compliance. I will uncover myths versus reality as it relates to this very enigmatic law based on over 600 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors. Times have changed and unfortunately many businesses are losing clients or unable to get new clients due to problems with their compliance program or lack of a compliance program. I will demonstrate from real life audits conducted by the Federal government what your highest risks are for being fined (some of the risk factors may surprise you). In addition this course will cover the highest risk factors for being sued for wrongful disclosures of PHI and the manner in which patients are now using state laws to sue for wrongful disclosures. States are being encouraged by the Federal government to implement new laws to remedy their citizens. Why should you Attend: Protect your business! Business associates are now required to comply directly with the HIPAA legislation! Many businesses are losing clients or unable to get clients because of compliance issues. We will be discussing the changes taking place in Washington DC with the Health and Human Services in relating to new risks business associates face under HIPAA. I will also be discussing factors might cause an unwanted visit or letter from the Office of Civil Rights and how to prepare for the audit and deal with the Feds Areas Covered in the Session: Updates for 2016 What to do if a client requires more than just a signed business associate agreement Fines Policy and Procedure Who Will Benefit: Any business associates who work with medical practices or hospitals (i.e. billing companies, transcription companies, IT companies, answering services, home health, coders, attorneys, etc) Speaker Profile Brian Tuttle is a Certified Professional in H

Basics of the Anti-Kickback Statute : The Anti-Kickback Statute is aimed at curbing abuse and fraud in the Medicare and Medicaid systems by professionals who offer services and benefit in direct or indirect ways. In order to protect Medicare and Medicaid patients, as well as federal health care programs from abuse and fraud; the Anti-Kickback Statute was enacted. The core act that the Anti-Kickback Statute considered as fraud and abuse is the unlawful acceptance or diversion of money into influencing medical decision-making. The Anti-Kickback Statute is very clear on this. It states that anyone in the healthcare industry, who consciously and deliberately accepts a fee or remuneration of any kind or offers the same with the intention of manipulating the course of a medical decision-making, is liable to punishment. What acts attract penalties? Acts of various kinds attract penalties under the Anti-Kickback Statute. Some of these include: Carrying out advertising or marketing activities for promoting the brand of health care providers Participating in affiliate programs or pay per click commissions Working out promotion agreements with multiple companies Taking part in sponsorships Working out strategic alliances with healthcare providers Licensing content or technology Selling a healthcare provider's brands of products or services Taking a cut in the advertising revenue The nature of penalties under the Anti-Kickback Statute The Anti-Kickback Statute states major penalties for acts it prohibits. The Anti-Kickback Statute prescribes these major penalties: Up to five years in prison This has the potential to attract additional monetary fines of up to $25,000 Administrative civil money penalties that can go up to $50,000 In addition, the Office of Inspector General (OIG) could initiate administrative proceedings and take steps aimed at prohibiting anyone convicted of an Anti-Kickback violation from participating in State and federal programs. The OIG could also impose

Overview: Become knowledgeable and understand the False Claims Act, Anti-Kickback Statute, Physician Self-Referral Law, Excluded Individuals and additional criminal/civil laws that may worsen the punishment if these laws are violated. Understand the criteria of each law, exceptions and how to identify an issue that requires mitigation. Why should you Attend: Are you able to distinguish with certainty an agreement, contract or activity that is permissible versus one that is not under our current healthcare laws and regulations? Do you have a contract organization system where reviews are done regularly and retained centrally? Do you conduct auditing and monitoring of potential high risk compliance areas related to fraud, waste and abuse? If you are uncertain or need additional guidance on recognizing potential violations of healthcare fraud, waste and abuse regulations and how to audit and monitor for non-compliance, this training is for you. Areas Covered in the Session: Define and describe elements of the Anti-kickback Statute, False Claims Act, Exclusionary Rule, Physician Self-Referral Law and potential penalties for violations Discuss exceptions and related criteria to the Physician Self-Referral Law and the Anti-Kickback Statute Identify common potential issues that may result in violations and how to avoid or mitigate them Provide examples on how to comply with the regulations Describe areas to audit, monitor and implement policies/procedures for compliance Who Will Benefit: Health care providers Revenue cycle management employees Coders, Billers Compliance officers Contract management Compliance and Internal Audit professionals Healthcare administrators Speaker Profile Gail Madison Brown is a registered nurse and an attorney with over 25 years of experience in health care. For the last 15 years she has focused on health care compliance and revenue cycle management operations. Gail's experience ranges from starting new compliance programs and making impr

US-based medical diagnostics maker T2 Biosystems has signed six new agreements for the exclusive distribution of its diagnostic technologies in Estonia, Greece, Ireland, Saudi Arabia, and South Africa.

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.

Overview: The webinar will concentrate on topics that HHS has announced will be the focus of the first round of "desk audits". They reflect significant areas of non-compliance revealed in the 2012 pilot audits and HHS HIPAA violation investigations concluded by Resolution Agreements and Corrective Action Plans. They include: HIPAA Risk Analysis Risk Management based on Risk Analysis Breach Notification Notice of Privacy Practices (for Covered Entities) Minimum Necessary Standard Access of Individuals to their PHI Authorizations Workforce Training This webinar is vital because, in focusing on preparation for a HIPAA Compliance Audit, Covered Entities and Business Associates may review, prioritize and structure their HIPAA Compliance programs. If you have HIPAA Compliance documentation ready to submit on two weeks notice to HHS you are implementing an effective HIPAA Compliance program. In addition, every Covered Entity or Business Associate may face an HHS HIPAA Compliance investigation at any time due to a complaint or a Breach. If you are "audit ready" you will be ready for an investigation - and better able to avoid complaints and prevent breaches. Why should you attend: Every Covered Entity and Business Associate is liable - without prior notice - to be audited for HIPAA Compliance by HHS You will have only 2 weeks after receiving your HIPAA Compliance Audit notification and data request to upload all requested documents to an HHS HIPAA Compliance Audit Portal The HIPAA Compliance Audit data request you receive will specify content and file organization, file names and any other document submission requirements Auditors will not contact an audited entity for clarifications or ask for additional information - it is essential that submitted documents are current, accurately reflect the entity's HIPAA Compliance program and demonstrate HIPAA Compliance Only data submitted on time will be assessed Failure to respond on time may be referred to the HHS regional

Focal Segmental Glomerulosclerosis is presently considered as a set of clinical syndromes sharing a very similar common histopathologic lesion namely, focal scarring in the glomerulus followed by fibrosis, fibrous nodules, and fibric infiltrate. Although various causes may be involved in the pathogenesis of this condition, the most common mechanoreceptor sites of action are the interneurons in the optic nerve and the choroid. The choroid can be damaged due to injuries or diseases like leukemia, lymphoma, myelodysplasia, and so on. Since these choroid sites contain many cell types, a wide variety of cell-damage mechanisms have been proposed to underlie Focal Segmental Glomerulosclerosis. Focal Segmental Glomerulosclerosis is also known as nephrotic syndrome and can be effectively addressed through surgical and non-surgical treatment options. The increasing prevalence of focal segmental glomerulosclerosis is expected to drive growth of the global focal segmental glomerulosclerosis market during the forecast period. According to the National Organization for Rare Disorders (NORD), in the U.S., focal segmental glomerulosclerosis is expected to affect around 7 people per million people in the general population. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/focal-segmental-glomerulosclerosis.html