The document discusses key considerations for manufacturers in implementing changes required by the 2016 Medicaid Program Covered Outpatient Drug Final Rule. It identifies areas that may require changes to master data, pricing methodologies, reports, and system configurations. Specific provisions that could significantly impact systems include distinguishing mail order pharmacies, identifying pediatric drugs, implementing a monthly 70/30 test to determine the average manufacturer price methodology, and calculating quarterly average manufacturer price using reported monthly values.
Icd 10 remediation for provider practices – key challenges and mitigation str...Apoorv S
On October 1, 2014, the U.S. healthcare system will transition from the Ninth Edition of the International Classification of Diseases (ICD-9) set of diagnosis and inpatient procedure codes to the Tenth Edition of those code sets (ICD-10). Provider systems are impacted across the value chain due to ICD-10 remediation and significant changes are required across the value chain and provider business functions. This article focuses on the key challenges being faced by providers in their ICD-10 remediation journey and the mitigation approaches that providers can adopt to address them.
Regulatory Affairs Excellence: Staffing and Performance in Medical Device Com...Best Practices
Regulatory affairs group ensure that medical device companies comply with volatile regulatory environment pertaining to developing and marketing medical device products. These specialized groups rely on their own internal effectiveness and efficiencies for enhanced performance under stringent compliance norms. Also, optimal resourcing and staffing helps Regulatory Affairs groups in the medical device industry prioritize roles and responsibilities that will be most beneficial to growth.
Best Practices, LLC conducted this benchmarking study to establish meaningful metrics and insights around the structure, activities, roles and responsibilities of Regulatory Affairs groups at medical device companies. The study also provides recent spend and staffing trends of regulatory affairs in medical device sector, including the use of outsourcing and off-shoring.
Medical device regulatory leaders can use this study to align their staff as per strategies of best in class companies for an increased performance delivery.
Icd 10 remediation for provider practices – key challenges and mitigation str...Apoorv S
On October 1, 2014, the U.S. healthcare system will transition from the Ninth Edition of the International Classification of Diseases (ICD-9) set of diagnosis and inpatient procedure codes to the Tenth Edition of those code sets (ICD-10). Provider systems are impacted across the value chain due to ICD-10 remediation and significant changes are required across the value chain and provider business functions. This article focuses on the key challenges being faced by providers in their ICD-10 remediation journey and the mitigation approaches that providers can adopt to address them.
Regulatory Affairs Excellence: Staffing and Performance in Medical Device Com...Best Practices
Regulatory affairs group ensure that medical device companies comply with volatile regulatory environment pertaining to developing and marketing medical device products. These specialized groups rely on their own internal effectiveness and efficiencies for enhanced performance under stringent compliance norms. Also, optimal resourcing and staffing helps Regulatory Affairs groups in the medical device industry prioritize roles and responsibilities that will be most beneficial to growth.
Best Practices, LLC conducted this benchmarking study to establish meaningful metrics and insights around the structure, activities, roles and responsibilities of Regulatory Affairs groups at medical device companies. The study also provides recent spend and staffing trends of regulatory affairs in medical device sector, including the use of outsourcing and off-shoring.
Medical device regulatory leaders can use this study to align their staff as per strategies of best in class companies for an increased performance delivery.
ISR interviewed 13 experienced Regulatory Affairs professionals at 11 of the Top 50 pharmaceutical companies to better understand the Regulatory Affairs function. ISR has designed this report to be used as a benchmarking tool for companies to compare their Regulatory Affairs functions to those of other organizations. Key takeaways include:
Identify how your company’s approach to Regulatory Affairs may be different from a typical industry approach and the benefits and drawbacks that may result
Gather information on unique Regulatory Affairs structures and best practices employed by other organizations, which may be used to improve or streamline the function
Compare your company’s Regulatory Affairs department size, structure, resources and approach to those of other companies
Learn more: https://goo.gl/
I'm seeking a permanent job or long term contract. It will be nice when Employment Agencies are honest when they write "Contract to Perm"., From my experience this is an outright lie in most cases and I'm not the only person who believes this. At any rate, please be upfront and truthful regarding your agenda (i.e. money, helping others, sleeping with boss, other) when presenting contract or permanent positions.We job-seekers aren't getting paid to look for jobs. I'd rather be walking my dog.Thank yiou
ISR interviewed 13 experienced Regulatory Affairs professionals at 11 of the Top 50 pharmaceutical companies to better understand the Regulatory Affairs function. ISR has designed this report to be used as a benchmarking tool for companies to compare their Regulatory Affairs functions to those of other organizations. Key takeaways include:
Identify how your company’s approach to Regulatory Affairs may be different from a typical industry approach and the benefits and drawbacks that may result
Gather information on unique Regulatory Affairs structures and best practices employed by other organizations, which may be used to improve or streamline the function
Compare your company’s Regulatory Affairs department size, structure, resources and approach to those of other companies
Learn more: https://goo.gl/
I'm seeking a permanent job or long term contract. It will be nice when Employment Agencies are honest when they write "Contract to Perm"., From my experience this is an outright lie in most cases and I'm not the only person who believes this. At any rate, please be upfront and truthful regarding your agenda (i.e. money, helping others, sleeping with boss, other) when presenting contract or permanent positions.We job-seekers aren't getting paid to look for jobs. I'd rather be walking my dog.Thank yiou
ISO standards for identification of medical products (IDMP) are set to require pharmaceuticals companies to comply with medicinal identification standards. We explain how to get started and navigate a smooth IDMP transition.
Solutions to Accelerate Compliance with Affordable Care Act (ACA) Mandates an...Lightwell
The healthcare payer ecosystem in the United States has changed dramatically over the last decade and is expected to evolve at an even faster pace over the next few years. Many world-class companies involved in healthcare payment processing are finding themselves constrained by their existing information technology infrastructure. The silos that they built around Business to Business (B2B) processing are constraining them, making it difficult to achieve governmental mandates and (more importantly) increase processing efficiency and competitive advantage.
The payers’ world today requires adherence to multiple industry standards, government regulations, and industry expectations. It is becoming more technical and payers need to become more agile (Figure 1). The IBM Standards Processing Engine Solution for Healthcare Payers is your answer to B2B enablement in today’s complex HIPAA/ACA (Affordable Care Act) world.
Recommendation for PharmaLedger governance, operating model and ConstitutionPharmaLedger
PharmaLedger is a project under the auspices of the Innovative Medicines Initiative (“IMI”). Like all projects, IMI PharmaLedger has a start and an end. The IMI PharmaLedger project will conclude in December 2022. For the solutions developed in PharmaLedger to continue to operate and evolve into the future, we must define a sustainable “post-PharmaLedger” governance and operating model. For the purpose of this report, we are referring to the current project as “IMI PharmaLedger” and the future, post-IMI business network as “NextGen PharmaLedger.”
This document builds on our previous work in researching governance and operation models (“D4.1 PharmaLedger Governance Options”). We provide a summary of the different governance options that we considered and make a recommendation for NextGen PharmaLedger’s future governance and operating model. In some cases there is not yet enough certainty about the scope, participants and scale of NextGen PharmaLedger to make a final recommendation. In those cases, we have narrowed the options to a smaller preferred set but have left a final recommendation until later in the project.
This report does not detail the implementation of its recommendations as those details will come later. Furthermore, it is assumed that the reader has a general familiarity with the governance of blockchain business networks and we do not provide exhaustive explanations of all details contained in this document.
Scenario A specialty memory chip manufacturer is located in South.docxkenjordan97598
Scenario: A specialty memory chip manufacturer is located in Southern California with manufacturing plants located in the United States, Europe, Singapore, and Japan. Additionally, it has branch sales offices located in major metropolitan areas across the globe. The market for its six key products included original equipment manufacturers of personal computers, cellular telephone manufacturers, electronics distributors, and government organizations. The market environment for its products is extremely volatile with fluctuating demand and rapidly changing prices. The company uses short-term contracts (less than 1 month) and spot pricing for irregular customers. Internally, the operation is capital-intensive with depreciation running approximately $1.2 million per day (depreciation has an impact on revenue streams). The 6 key products had further specialized components, making the possible line mix total 24 distinct products. Further, the manufacturing process required high manufacturing lead times and various product yields. In the high technology memory arena, product life cycles were dramatically shortened because of rapid obsolescence. To coordinate the manufacturing activity, the company has an established process and system that helped optimize resource utilization, improve shop floor efficiencies, and manage customer demand.
The company is experiencing 10–15% growth in revenues and volume, primarily tied to increased worldwide demand, product type, and market variables. Most significantly, the company received a major preorder for a new cellular phone memory chip that is scheduled to come out in 3 months. This preorder is scaled for up to 10 million units, and management is concerned that the existing process and system may not be suitably optimized for this order. Additionally, the forecast in sales figures for all six key product lines is higher than it has been in the past. With the increase in volume, management is concerned about the quality management process as well—can the existing processes maintain the highest degree of quality needed?
As a new member of the production planning management staff, you will be expected to help develop strategies to support the expanded growth plans. Your team faces several fundamental issues. First, are the individual plant layouts conducive to the expanded growth expected by the company? Second, are individual plant layouts optimized for the most efficient performance and lowest cost? Third, is the existing supply chain interaction among all the various components optimized in the same manner individual layouts are expected to be optimized? Finally, your group must consider capacity planning and workflow to ensure the company can meet its contractual obligations with the maximum revenue and profitability. It currently uses information systems developed by the company to conduct production planning. You believe that a fully integrated enterprise resource planning tool or specific production plann.
The Drug Quality and Security Act adds additional requirements that are causing pharmaceutical companies to adjust their serialization strategies and implementation timelines.
This Discussion offers you the opportunity to apply return on in.docxgasciognecaren
This Discussion offers you the opportunity to apply return on investment (ROI) concepts in a real case scenario. As is often the case, technology offerings involve costs that must be justified by virtue of expense reductions for revenue increases in the organization. There are creative opportunities in the Discussion for leaders to facilitate the development of the revenues into the organization and operational changes that reduce expenses.
Scenario:
Dynamic Health System is a 3-hospital, 500-bed system in the Midwest United States. This system employs 100 physicians, both primary care and specialists, in 12 physician practices. Dynamic also runs a center of excellence in orthopedic care for the large geriatric population in the area, including an outpatient rehabilitation facility that is currently profitable. Dynamic offers a full spectrum of medical and surgical services to their population with an emphasis on programs of excellence in orthopedic surgery, diabetes, and women’s care.
Dynamic’s typical patient mix is over 45% Medicare with another 35% private pay patients covered by three large insurance companies. Their Medicaid population is approximately 12%, with the reminder of patients self-pay.
Due to market forces, the three private payers have begun to implement a program of bundled payments for their members in the following areas: hip replacements, knee replacements, and lower back surgeries. In these models, Dynamic hospitals and employed physicians will be paid a fixed amount for an entire episode of care from pre- surgery evaluation, through surgery and post-surgery, physical therapy, and rehabilitation. Medicare is likewise proposing a pilot study for a population of hip replacement beneficiaries to assess the outcomes of care as opposed to procedure costs as a result of Dynamic’s petition to receive increased payments for beneficiaries due to age demographics and for being the only orthopedic geriatric center in 200 miles.
As a result of these factors and the aging HIT infrastructure, the Chief Medical Officer (CMO), Chief Executive Officer (CEO), and Chief Information Officer (CIO) of Dynamic are proposing the purchase of a monolithic Electronic Health Record (EMR) solution that will provide complete online documentation, orders, pharmacy, labs, and patient portal for all hospitals and employed physician offices. Because the (1) physician offices are currently using Epic Corporation’s back office billing system with an outstanding record of accurate coding and short “days in Accounts Receivable” and (2) Epic’s EMR has a high ranking in industry HIT assessments, the executive team is proposing the purchase of Epic’s clinical EMR (documentation, ancillaries, orders, and patient portal).
The CFO is supportive but skeptical, as the Epic bid is approximately $1.5 M to implement the clinical software with a continued $300K per year in software maintenance and support. Current clinical technologies information systems are fra ...
1. Policy Analysis
Introduction
Organizational policy alignment and adherence to laws and regulations is critical for overall corporate compliance and to decrease organizational risks (patient falls, medication errors, cyber hacks and PHI data breaches, infection control, et cetera). In this assignment, you will select, evaluate, and update one health care provider’s policy related to a significant regulatory risk to the health care organization.
Instructions
Select one of two options:
Option A
If you work for a hospital or health care organization you may select a policy that is of interest to you then follow these assignment instructions:
· Imagine you are a health care administrator at your current employer. Analyze the policy you selected, taking into consideration any recent changes. Evaluate what information and where that information would need to be updated. Propose revisions that are based on current identified standards and/or new guidelines that you have researched in the text or identified in other high-quality sources (that is, journals, government websites, and the like). Analyze the significance of the selected policy updates as it relates to potential litigation. (Why did the policy need updating? What threats do these changes help avoid?) Summarize your perspective on the revisions as well as any additional changes that should be considered. Present your work as an executive summary suitable for distribution to your organization’s board members.
Option B
If you do not work in the industry or do not have access to a health care policy, use the Hahnemann Falls Policy to complete this assignment. Then follow these assignment instructions:
· As you can see, this policy was written in 2012. Now, imagine you are a health care administrator working at the health care organization where this policy originates from. Analyze the policy, taking into consideration the changes in HIPAA and PHI since 2012. Evaluate what information and where that information would need to be updated for a current revision of this document. Locate the areas where you would update or add information to this 2012 version. Propose revisions that are based on current identified standards and/or new guidelines that you have researched in the text or identified in other high-quality sources (that is, journals, government websites, and the like). Analyze the significance of the selected policy updates as it relates to potential litigation. (Why did the policy need updating? What threats do these changes help avoid?) Summarize your perspective on the revisions as well as any additional changes that should be considered. Present your work as an executive summary suitable for distribution to your organization’s board members.
Your paper should be 3–5 pages long and should include a title page and references for a total of 5–7 pages.
Strayer Writing Standards
This course requires the use of Strayer Writing Standards. For assistance and information, please refer to t ...
1. Policy Analysis
Introduction
Organizational policy alignment and adherence to laws and regulations is critical for overall corporate compliance and to decrease organizational risks (patient falls, medication errors, cyber hacks and PHI data breaches, infection control, et cetera). In this assignment, you will select, evaluate, and update one health care provider’s policy related to a significant regulatory risk to the health care organization.
Instructions
Select one of two options:
Option A
If you work for a hospital or health care organization you may select a policy that is of interest to you then follow these assignment instructions:
· Imagine you are a health care administrator at your current employer. Analyze the policy you selected, taking into consideration any recent changes. Evaluate what information and where that information would need to be updated. Propose revisions that are based on current identified standards and/or new guidelines that you have researched in the text or identified in other high-quality sources (that is, journals, government websites, and the like). Analyze the significance of the selected policy updates as it relates to potential litigation. (Why did the policy need updating? What threats do these changes help avoid?) Summarize your perspective on the revisions as well as any additional changes that should be considered. Present your work as an executive summary suitable for distribution to your organization’s board members.
Option B
If you do not work in the industry or do not have access to a health care policy, use the Hahnemann Falls Policy to complete this assignment. Then follow these assignment instructions:
· As you can see, this policy was written in 2012. Now, imagine you are a health care administrator working at the health care organization where this policy originates from. Analyze the policy, taking into consideration the changes in HIPAA and PHI since 2012. Evaluate what information and where that information would need to be updated for a current revision of this document. Locate the areas where you would update or add information to this 2012 version. Propose revisions that are based on current identified standards and/or new guidelines that you have researched in the text or identified in other high-quality sources (that is, journals, government websites, and the like). Analyze the significance of the selected policy updates as it relates to potential litigation. (Why did the policy need updating? What threats do these changes help avoid?) Summarize your perspective on the revisions as well as any additional changes that should be considered. Present your work as an executive summary suitable for distribution to your organization’s board members.
Your paper should be 3–5 pages long and should include a title page and references for a total of 5–7 pages.
Strayer Writing Standards
This course requires the use of Strayer Writing Standards. For assistance and information, please refer to t ...
Utilizing crm for medical transparency complianceCharudatta Thute
United States of America (USA) implemented Physician Payment Act, as a part of the healthcare reform bill, in February 2013 commonly known as the Sunshine Act. As per the regulations of this bill, data on payments and gifts made to physicians, teaching hospitals by pharmaceutical
and medical device companies must be made public. Healthcare companies use CRM for sales and service management and medical representatives are the key users to capture HCP (Healthcare professionals) centric data. The paper provides an honest approach to cater to Sunshine act related expense management within CRM. It details concept and approach needed to fulfill Sunshine ACT expense management compliance. The concept is based on study of US medical industry transparency guidelines i.e. Sunshine Act and can be leveraged across geographies with similar medical industry regulations and compliance.
The approach also describes first of its kind unique and distinct feature to track and monitor carbon footprint for expenses incurred by sales representatives. By relating carbon emissions to expenses, it helps set up a practice to approach customers through greener means and reduce organizational carbon footprint,
Pharmaceutical companies and SEO search results complianceMarcos Richardson
This paper looks at two search components (from an optimisation perspective and a pharama compliance perspective) that are publicly visible in search engine results: the ‘Title Tag’ and the ‘Description Tag’.
Search results are important because they are the first piece of information a person sees before clicking and entering a web property and should comply with FDA and PMCPA regulations.
SRS for Online Medicine Ordering SystemUmmeKalsoom11
The purpose of this document is to deliver a detailed depiction of the Online Medicine Ordering System. It will explain the function and characteristics of the system, the boundaries, and purpose of the system, and all the external environment restrictions under which the system must operate and react successfully. Both the investors and the developers of the system will use this document for understanding and approval, respectively.