Civic tech vs. illicit pharmacies - Ibraheem Saleem (Code for Pakistan)mysociety
This was presented at mySociety's TICTeC Show & Tell event, which was held virtually on 23rd March 2021. More details on the event can be found here: https://tictec.mysociety.org/showandtells/2021
ACCC 340B Sherer and Guide Article May 2011Matt Sherer
The document provides information about the 340B Drug Pricing Program. It describes the program as originating from legislation in 1992 that limits drug costs for certain healthcare facilities. Safety-net providers can save 20-50% on drug costs by participating. To qualify, a disproportionate share hospital must meet requirements like having an 11.75% DSH percentage and maintaining separate drug inventories for 340B and non-340B patients. The Affordable Care Act expanded eligibility for the program and increased compliance monitoring.
MA Appeals Overturn 75% Of Claims Denialsbrennaljan
The name of the company that made the redetermination (the company that handled the Medicare claim in Level 1). You can find this information on the Medicare Summary Notice or the redetermination notice.
The medical associations and specialty societies writing this letter have serious concerns about the implementation of the Physician Payments Sunshine Act. Specifically:
1) CMS has proposed changing the reporting exclusion for continuing medical education activities in a way that could significantly and negatively impact CME. The organizations recommend a slight modification to the proposal.
2) CMS's interpretation of the educational materials exclusion is too narrow and should be reconsidered to include medical textbooks and journal articles that directly benefit patients.
3) The condensed timeframe for physician registration does not allow adequate time for registration or review/dispute of reports before publication. The organizations strongly urge postponing publication for six months.
4) The registration process is overly complex
To recap the August 2015 month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 18 has been released with the following content.
News Uptoday
New Guidance
Audit Findings
483 Observations
- 483 of PharMEDium Services, LLC (Outsourcing facility)
- 483 of "Walgreens Home Care, Inc. dba Walgreens Infusion Services
EU Non Compliance Report
- EU Non-Compliance Report: TXCELL - BESANCON, France Warning Letters
- Warning letter : Sipra Labs Limited, Hyderabad
- Warning letter : Mylan Laboratories Limited, India
Health Canada Non Compliance Report
- Procter & Gamble Inc., Canada.
Regulations of the Month
- Sec. 211.28 Personnel responsibilities (b) & (c)
- Sec. 211.42 Design and construction features (a) & (b)
Celebrating Successful completion of one year
"Happy anniversary… Pharma Uptoday"
Thanks a lot to all members & Viewers.
To recap the previous month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 4 has been released with
News Uptoday
New Guidelines
Audit Findings
Regulation of the Month
Translating compliance requirements into action items 340BCompliatric
The document provides guidance on complying with 340B program requirements by taking specific action items, such as keeping HRSA 340B database information accurate and up-to-date, preventing diversion of drugs to ineligible patients, preventing duplicate discounts, and preparing for potential audits by maintaining thorough documentation and policies and procedures. Non-compliance can result in findings during HRSA audits, so covered entities must understand eligibility rules, establish data sharing processes, and conduct regular self-audits to ensure only eligible patients and locations are utilizing 340B discounted drugs.
Pharma Uptoday Monthly Magazine Volume 5, Issue Aug 2014Sathish Vemula
This document provides a summary of news and regulatory information related to the pharmaceutical industry. Key points include:
- The FDA released its strategic priorities document and is seeking public comments on how to ensure drug safety throughout a product's lifecycle.
- Novartis' Japan unit and a former employee were charged for allegedly manipulating data related to their blood pressure drug Diovan.
- The TGA published an updated summary of fees and is working to implement eCTD submissions for drug applications.
- The FDA filed a complaint seeking to permanently enjoin a California company from distributing vaginal drug products without approval.
- Industry groups in India are concerned about dependence on China for drug APIs and are calling for policies to promote
Civic tech vs. illicit pharmacies - Ibraheem Saleem (Code for Pakistan)mysociety
This was presented at mySociety's TICTeC Show & Tell event, which was held virtually on 23rd March 2021. More details on the event can be found here: https://tictec.mysociety.org/showandtells/2021
ACCC 340B Sherer and Guide Article May 2011Matt Sherer
The document provides information about the 340B Drug Pricing Program. It describes the program as originating from legislation in 1992 that limits drug costs for certain healthcare facilities. Safety-net providers can save 20-50% on drug costs by participating. To qualify, a disproportionate share hospital must meet requirements like having an 11.75% DSH percentage and maintaining separate drug inventories for 340B and non-340B patients. The Affordable Care Act expanded eligibility for the program and increased compliance monitoring.
MA Appeals Overturn 75% Of Claims Denialsbrennaljan
The name of the company that made the redetermination (the company that handled the Medicare claim in Level 1). You can find this information on the Medicare Summary Notice or the redetermination notice.
The medical associations and specialty societies writing this letter have serious concerns about the implementation of the Physician Payments Sunshine Act. Specifically:
1) CMS has proposed changing the reporting exclusion for continuing medical education activities in a way that could significantly and negatively impact CME. The organizations recommend a slight modification to the proposal.
2) CMS's interpretation of the educational materials exclusion is too narrow and should be reconsidered to include medical textbooks and journal articles that directly benefit patients.
3) The condensed timeframe for physician registration does not allow adequate time for registration or review/dispute of reports before publication. The organizations strongly urge postponing publication for six months.
4) The registration process is overly complex
To recap the August 2015 month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 18 has been released with the following content.
News Uptoday
New Guidance
Audit Findings
483 Observations
- 483 of PharMEDium Services, LLC (Outsourcing facility)
- 483 of "Walgreens Home Care, Inc. dba Walgreens Infusion Services
EU Non Compliance Report
- EU Non-Compliance Report: TXCELL - BESANCON, France Warning Letters
- Warning letter : Sipra Labs Limited, Hyderabad
- Warning letter : Mylan Laboratories Limited, India
Health Canada Non Compliance Report
- Procter & Gamble Inc., Canada.
Regulations of the Month
- Sec. 211.28 Personnel responsibilities (b) & (c)
- Sec. 211.42 Design and construction features (a) & (b)
Celebrating Successful completion of one year
"Happy anniversary… Pharma Uptoday"
Thanks a lot to all members & Viewers.
To recap the previous month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 4 has been released with
News Uptoday
New Guidelines
Audit Findings
Regulation of the Month
Translating compliance requirements into action items 340BCompliatric
The document provides guidance on complying with 340B program requirements by taking specific action items, such as keeping HRSA 340B database information accurate and up-to-date, preventing diversion of drugs to ineligible patients, preventing duplicate discounts, and preparing for potential audits by maintaining thorough documentation and policies and procedures. Non-compliance can result in findings during HRSA audits, so covered entities must understand eligibility rules, establish data sharing processes, and conduct regular self-audits to ensure only eligible patients and locations are utilizing 340B discounted drugs.
Pharma Uptoday Monthly Magazine Volume 5, Issue Aug 2014Sathish Vemula
This document provides a summary of news and regulatory information related to the pharmaceutical industry. Key points include:
- The FDA released its strategic priorities document and is seeking public comments on how to ensure drug safety throughout a product's lifecycle.
- Novartis' Japan unit and a former employee were charged for allegedly manipulating data related to their blood pressure drug Diovan.
- The TGA published an updated summary of fees and is working to implement eCTD submissions for drug applications.
- The FDA filed a complaint seeking to permanently enjoin a California company from distributing vaginal drug products without approval.
- Industry groups in India are concerned about dependence on China for drug APIs and are calling for policies to promote
This document is the 2016 Provider Manual for Medical Mutual of Ohio and its subsidiaries. It contains 14 sections that provide information to healthcare providers about claims submission, care management programs, appeals processes, reimbursement, and other administrative policies. The manual applies to PPO, POS, HMO and other product lines. It is considered an extension of provider agreements and identifies policies and procedures to enhance the provider-payer relationship. The manual is reviewed regularly and providers are notified of updates through communications. Definitions of terms can be found in Section 14.
This document is a HIPAA-compliant authorization form that allows a patient to authorize the release of their health information for litigation purposes. It provides information about what types of health information may be disclosed, such as alcohol/drug treatment, mental health, and HIV status if the patient initials the corresponding boxes. The patient can authorize a specific provider or entity to disclose their medical records for a certain date range and/or types of information. The recipient of the information and the purpose/reason for disclosure are also specified. The patient signature authorizes the disclosure of the health information pursuant to HIPAA and provides instructions on revoking the authorization.
This document is a form authorizing the release of a patient's health information pursuant to HIPAA regulations. It allows the patient to specify what health information can be released, to whom, and for what timeframe or purpose. The patient can authorize the release of their medical records, including information related to mental health, substance abuse, HIV, and other sensitive health details by initialing the relevant boxes. Signing the form is voluntary and will not affect their treatment or benefits. The recipient of the health information is barred from redisclosing certain sensitive information without additional authorization.
The document provides updates on Aetna's precertification list, drug precertification requirements, billing policies, and clinical coding policies. It also provides reminders on topics like notifying Aetna of observation stays over 24 hours, appropriate lab testing for patients on certain medications, and verifying member eligibility and coverage when patients seek out-of-state care. The document concludes with information on Aetna's disease management programs and improving quality of care for ADHD.
The healthcare industry in the UAE is growing rapidly as the government aims to improve healthcare standards and establish Dubai as a regional medical tourism hub. All medical devices sold in the UAE must be registered with the Ministry of Health. The registration guidelines were developed to prevent unsafe devices while providing access to beneficial technologies, and were modeled after international standards from the EU and US. Registration requires an application including device details, manufacturing and quality certifications, clinical evidence, and post-market monitoring plans. The process aims to ensure medical devices meet safety and efficacy requirements before approval and sale in the UAE market.
This article discusses audit readiness for hospitals participating in the 340B drug pricing program. It outlines several key areas hospitals should focus on to ensure compliance, including: 1) confirming eligibility requirements for the hospital, patients, and prescribers; 2) developing comprehensive oversight strategies and compliance monitoring programs; and 3) incorporating frequent self-audits and preparing for potential audits from the Health Resources and Services Administration. The article provides tips for audit readiness, such as establishing policies and procedures, updating databases, conducting ongoing education and monitoring, and developing a community benefit plan.
Pharma Uptoday Monthly Magazine Volume 21; Issue Dec 2015Sathish Vemula
News Uptoday
New Guidance
Audit Findings
- Diabetes Corporation of America
- Pine Pharmaceuticals
Warning Letters
- Warning letter: American Family Pharmacy
- Warning letter: Dr. Reddy's Laboratories Limited
- Warning letter: Sandoz Private Limited
Article of the Month
- Data Integrity Checklist related to Electronic Records and Electronic Signatures.
Regulations of the Month
- Sec. 211.46 Ventilation, air filtration, air heating and cooling
- Sec. 211.48 Plumbing
To recap the previous month's pharma highlights to members, Monthly magazine Volume 20 has been released with the following content.
News Uptoday
New Guidance
Audit Findings
- Pernix Receives Form 483 for cGMP Violations
- FDA Hits Pfizer Subsidiary With Second Form 483 in Five Years
- Galena Hit With 10-Item Form 483 Over Unresolved Issues
Warning Letters
- Warning letter: Unimark Remedies Ltd., Mumbai, India
- Warning letter: SSM Health Care St. Louis DBA SSM St. Clare Health Center
Health Canada Non Compliance Report
- Non Compliance Report: Unilever Canada Inc.
EMA Non-Compliance Report
- GlaxoSmithKline (Tianjin) Company Limited (Teda), China
- CARGILL FRANCE
Regulations of the Month
- Sec. 211.42 Design and construction features (c)(5) to (c)(10)
- Sec. 211.44 Lighting
To recap the previous month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 3 has been released with
News Uptoday
New Guidelines
Audit Findings
Guest of the Month
Regulation of the Month
Vuksan Bulatovic is registered as a medical examiner on the National Registry of Certified Medical Examiners. He has completed required training and testing on federal physical qualifications and standards for commercial drivers. The certification confirms Dr. Bulatovic has the knowledge and credentials to perform physical examinations for commercial drivers according to federal motor carrier safety regulations.
The FDA has determined that MED-TECH Water Systems Inc.'s Exchangeable Carbon Tanks for Dialysis are substantially equivalent to previously marketed devices and can be marketed subject to general controls. The letter informs MED-TECH that while the device is cleared for marketing, the company must still comply with requirements for registration, labeling, good manufacturing practices, and medical device reporting. MED-TECH is directed to regulatory sections for further details on ongoing compliance.
Case Study "Meeting Meaningful Use Requirements Using HIE"
This presentation will provide an overview of health information exchange in Kansas including a description of how the Kansas Health Information Network (KHIN) is helping Kansas providers meet Stage 1 and Stage 2 Meaningful Use requirements that are necessary to receive Medicare and Medicaid incentive payments. It will include a live demonstration of the health information exchange and a question and answer session.
KHIN provides health information exchange services to all health care providers in Kansas. The KHIN network allows health care providers to share health information at the point of care. Health data includes current diagnosis, medications, allergies, lab results, procedures, immunizations, visit history and summary of care documents.
In August 2012, Via Christi Health Systems and HCA Wesley became the first Kansas health care organizations to share health data. Just 10 months later, 42 Kansas health care systems are live sharing data including all of the largest health systems in Kansas. Nineteen others are actively testing data and 3200 providers have the ability to exchange secure messages. KHIN members can now access information on almost 900,000 Kansas patients, electronically send immunizations to the state registry, electronically send syndromic surveillance data to the CDC and securely communicate with other health care providers through the DIRECT protocols which comply with all HIPAA regulations. Soon, KHIN members will be able to provide a personal health record (PHR) to all of their patients.
Learning Objectives:
∙ Understand the basic principles of health information exchange through a case study of the Kansas Health Information Network (KHIN).
∙ Understand the role of health information exchange in meeting Stage 1 and Stage 2 Meaningful Use requirements.
∙ Describe how health information exchange can facilitate population health and patient engagement.
My Presentation on Mexico Medical Device RegulationsHarshit Thakkar
The document summarizes the key considerations for TrojanCare to register their insulin infusion pump in Mexico. It outlines the disease profile, healthcare landscape, market opportunities and regulatory requirements. To register, TrojanCare must submit a dossier to Mexico's health authority including device details, labeling and quality certificates. They also require a local representative for registration and distribution. Overall, Mexico provides opportunities through its large diabetes population and trade agreements, but public coverage favors lower-cost alternatives.
This document outlines guidelines for filing applications using an Integrated Application Form adopted by the Philippines' Food and Drug Administration (FDA) to streamline the application process. The form was created to comply with laws mandating improved efficiency and accountability in government services. It consolidates requirements for various FDA authorizations like licenses and permits onto a single electronic form. Applicants must submit documentary requirements digitally, pay fees, and provide hard copies of certain documents to complete the application process based on a scheduled intake procedure.
Spurrier Medical - Harwood Design Inc., located in Bristol, Pennsylvania, holds Certificate No. FM 553211 from BSI certifying that its quality management system complies with ISO 13485:2003 standards for medical devices. The certificate is valid until March 24, 2016 and covers contract manufacturing of medical instruments, handheld surgical instruments, medical device components, and implants.
To recap the previous month's pharma highlights to Pharma Uptoday followers, Monthly magazine Volume 17 has been released with the following content.
News Uptoday
New Guidance
Audit Findings
483 Observations
EU Non Compliance Report
- INTEGRA LIFE SCIENCES CORP, United States
- JINAN JINDA PHARMACEUTICAL CHEMISTRY CO., LTD., China
- WUXI JIDA PHARMACEUTICAL CO., LTD, China
- PARABOLIC DRUGS LIMITED, India
Warning Letters
- Mahendra Chemicals, India
Regulations of the Month
- Sec. 211.25 Personnel qualifications
- Sec. 211.28 Personnel responsibilities
The 340B Program and Implications of the Mega GuidanceCompleteRx
As the 340B Drug Pricing Program continues to undergo changes, our team has been following all the recent updates and how they impact hospital pharmacies. This presentation goes through the latest on the long awaited guidance of proposed changes that was posted by the Federal Register on August 28, 2015.
Pharma Uptoday Monthly Magazine Volume 8 issue Nov 2014Sathish Vemula
To recap the previous month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 8 has been released with the following content.
3 News Uptoday
14 New Guidance
30 Audit Findings
483 Observations
- Exemplar Lab, MA
- Genentech Inc
- Celltex Therapeutics Corporation
- APP Pharmaceuticals, LLC
- Reganeron Pharmaceuticals, Inc.
Warning Letters
- Hospira, Austarlia
- Sanjiu Medical and Pharmaceutical Co.,
- Beacon Hill Medical Pharmacy
EMA Non-Compliance Reports
- Wockhardt Limited, Nani Daman
- Fujian South Pharmaceutical, China
40 Regulations of the Month
§211.184 Component, drug product container, closure, and labeling records
§ 211.186 Master production and control records
The document summarizes Dhaivat Bhatt's work at the Srujana innovation center from December 15, 2014 to January 1, 2015. It includes two projects: 1) performing eigen decomposition on a dataset of eye images to extract the principal components, or "eigeneyes" and 2) developing software to apply image processing techniques like smoothing, thresholding, and edge detection on eye images using a graphical user interface. The software allows adjusting parameters for these techniques. The first project helped understand principal component analysis and reduced the eye image data dimensionally. The second project created easy-to-use software for ophthalmologists to process eye images.
Este documento proporciona información sobre APRENDER 2016, el sistema de evaluación nacional de aprendizajes de estudiantes en Argentina. Explica que APRENDER evalúa logros de aprendizaje y condiciones de enseñanza para obtener datos que permitan mejorar la educación. En 2016, evaluará Lengua y Matemática en 3° grado primario y 6° grado primario de forma censal, y también Lengua y Matemática en 2°-3° año secundario de forma muestral. El documento brinda detalles sobre los instrumentos de evalu
This document is the 2016 Provider Manual for Medical Mutual of Ohio and its subsidiaries. It contains 14 sections that provide information to healthcare providers about claims submission, care management programs, appeals processes, reimbursement, and other administrative policies. The manual applies to PPO, POS, HMO and other product lines. It is considered an extension of provider agreements and identifies policies and procedures to enhance the provider-payer relationship. The manual is reviewed regularly and providers are notified of updates through communications. Definitions of terms can be found in Section 14.
This document is a HIPAA-compliant authorization form that allows a patient to authorize the release of their health information for litigation purposes. It provides information about what types of health information may be disclosed, such as alcohol/drug treatment, mental health, and HIV status if the patient initials the corresponding boxes. The patient can authorize a specific provider or entity to disclose their medical records for a certain date range and/or types of information. The recipient of the information and the purpose/reason for disclosure are also specified. The patient signature authorizes the disclosure of the health information pursuant to HIPAA and provides instructions on revoking the authorization.
This document is a form authorizing the release of a patient's health information pursuant to HIPAA regulations. It allows the patient to specify what health information can be released, to whom, and for what timeframe or purpose. The patient can authorize the release of their medical records, including information related to mental health, substance abuse, HIV, and other sensitive health details by initialing the relevant boxes. Signing the form is voluntary and will not affect their treatment or benefits. The recipient of the health information is barred from redisclosing certain sensitive information without additional authorization.
The document provides updates on Aetna's precertification list, drug precertification requirements, billing policies, and clinical coding policies. It also provides reminders on topics like notifying Aetna of observation stays over 24 hours, appropriate lab testing for patients on certain medications, and verifying member eligibility and coverage when patients seek out-of-state care. The document concludes with information on Aetna's disease management programs and improving quality of care for ADHD.
The healthcare industry in the UAE is growing rapidly as the government aims to improve healthcare standards and establish Dubai as a regional medical tourism hub. All medical devices sold in the UAE must be registered with the Ministry of Health. The registration guidelines were developed to prevent unsafe devices while providing access to beneficial technologies, and were modeled after international standards from the EU and US. Registration requires an application including device details, manufacturing and quality certifications, clinical evidence, and post-market monitoring plans. The process aims to ensure medical devices meet safety and efficacy requirements before approval and sale in the UAE market.
This article discusses audit readiness for hospitals participating in the 340B drug pricing program. It outlines several key areas hospitals should focus on to ensure compliance, including: 1) confirming eligibility requirements for the hospital, patients, and prescribers; 2) developing comprehensive oversight strategies and compliance monitoring programs; and 3) incorporating frequent self-audits and preparing for potential audits from the Health Resources and Services Administration. The article provides tips for audit readiness, such as establishing policies and procedures, updating databases, conducting ongoing education and monitoring, and developing a community benefit plan.
Pharma Uptoday Monthly Magazine Volume 21; Issue Dec 2015Sathish Vemula
News Uptoday
New Guidance
Audit Findings
- Diabetes Corporation of America
- Pine Pharmaceuticals
Warning Letters
- Warning letter: American Family Pharmacy
- Warning letter: Dr. Reddy's Laboratories Limited
- Warning letter: Sandoz Private Limited
Article of the Month
- Data Integrity Checklist related to Electronic Records and Electronic Signatures.
Regulations of the Month
- Sec. 211.46 Ventilation, air filtration, air heating and cooling
- Sec. 211.48 Plumbing
To recap the previous month's pharma highlights to members, Monthly magazine Volume 20 has been released with the following content.
News Uptoday
New Guidance
Audit Findings
- Pernix Receives Form 483 for cGMP Violations
- FDA Hits Pfizer Subsidiary With Second Form 483 in Five Years
- Galena Hit With 10-Item Form 483 Over Unresolved Issues
Warning Letters
- Warning letter: Unimark Remedies Ltd., Mumbai, India
- Warning letter: SSM Health Care St. Louis DBA SSM St. Clare Health Center
Health Canada Non Compliance Report
- Non Compliance Report: Unilever Canada Inc.
EMA Non-Compliance Report
- GlaxoSmithKline (Tianjin) Company Limited (Teda), China
- CARGILL FRANCE
Regulations of the Month
- Sec. 211.42 Design and construction features (c)(5) to (c)(10)
- Sec. 211.44 Lighting
To recap the previous month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 3 has been released with
News Uptoday
New Guidelines
Audit Findings
Guest of the Month
Regulation of the Month
Vuksan Bulatovic is registered as a medical examiner on the National Registry of Certified Medical Examiners. He has completed required training and testing on federal physical qualifications and standards for commercial drivers. The certification confirms Dr. Bulatovic has the knowledge and credentials to perform physical examinations for commercial drivers according to federal motor carrier safety regulations.
The FDA has determined that MED-TECH Water Systems Inc.'s Exchangeable Carbon Tanks for Dialysis are substantially equivalent to previously marketed devices and can be marketed subject to general controls. The letter informs MED-TECH that while the device is cleared for marketing, the company must still comply with requirements for registration, labeling, good manufacturing practices, and medical device reporting. MED-TECH is directed to regulatory sections for further details on ongoing compliance.
Case Study "Meeting Meaningful Use Requirements Using HIE"
This presentation will provide an overview of health information exchange in Kansas including a description of how the Kansas Health Information Network (KHIN) is helping Kansas providers meet Stage 1 and Stage 2 Meaningful Use requirements that are necessary to receive Medicare and Medicaid incentive payments. It will include a live demonstration of the health information exchange and a question and answer session.
KHIN provides health information exchange services to all health care providers in Kansas. The KHIN network allows health care providers to share health information at the point of care. Health data includes current diagnosis, medications, allergies, lab results, procedures, immunizations, visit history and summary of care documents.
In August 2012, Via Christi Health Systems and HCA Wesley became the first Kansas health care organizations to share health data. Just 10 months later, 42 Kansas health care systems are live sharing data including all of the largest health systems in Kansas. Nineteen others are actively testing data and 3200 providers have the ability to exchange secure messages. KHIN members can now access information on almost 900,000 Kansas patients, electronically send immunizations to the state registry, electronically send syndromic surveillance data to the CDC and securely communicate with other health care providers through the DIRECT protocols which comply with all HIPAA regulations. Soon, KHIN members will be able to provide a personal health record (PHR) to all of their patients.
Learning Objectives:
∙ Understand the basic principles of health information exchange through a case study of the Kansas Health Information Network (KHIN).
∙ Understand the role of health information exchange in meeting Stage 1 and Stage 2 Meaningful Use requirements.
∙ Describe how health information exchange can facilitate population health and patient engagement.
My Presentation on Mexico Medical Device RegulationsHarshit Thakkar
The document summarizes the key considerations for TrojanCare to register their insulin infusion pump in Mexico. It outlines the disease profile, healthcare landscape, market opportunities and regulatory requirements. To register, TrojanCare must submit a dossier to Mexico's health authority including device details, labeling and quality certificates. They also require a local representative for registration and distribution. Overall, Mexico provides opportunities through its large diabetes population and trade agreements, but public coverage favors lower-cost alternatives.
This document outlines guidelines for filing applications using an Integrated Application Form adopted by the Philippines' Food and Drug Administration (FDA) to streamline the application process. The form was created to comply with laws mandating improved efficiency and accountability in government services. It consolidates requirements for various FDA authorizations like licenses and permits onto a single electronic form. Applicants must submit documentary requirements digitally, pay fees, and provide hard copies of certain documents to complete the application process based on a scheduled intake procedure.
Spurrier Medical - Harwood Design Inc., located in Bristol, Pennsylvania, holds Certificate No. FM 553211 from BSI certifying that its quality management system complies with ISO 13485:2003 standards for medical devices. The certificate is valid until March 24, 2016 and covers contract manufacturing of medical instruments, handheld surgical instruments, medical device components, and implants.
To recap the previous month's pharma highlights to Pharma Uptoday followers, Monthly magazine Volume 17 has been released with the following content.
News Uptoday
New Guidance
Audit Findings
483 Observations
EU Non Compliance Report
- INTEGRA LIFE SCIENCES CORP, United States
- JINAN JINDA PHARMACEUTICAL CHEMISTRY CO., LTD., China
- WUXI JIDA PHARMACEUTICAL CO., LTD, China
- PARABOLIC DRUGS LIMITED, India
Warning Letters
- Mahendra Chemicals, India
Regulations of the Month
- Sec. 211.25 Personnel qualifications
- Sec. 211.28 Personnel responsibilities
The 340B Program and Implications of the Mega GuidanceCompleteRx
As the 340B Drug Pricing Program continues to undergo changes, our team has been following all the recent updates and how they impact hospital pharmacies. This presentation goes through the latest on the long awaited guidance of proposed changes that was posted by the Federal Register on August 28, 2015.
Pharma Uptoday Monthly Magazine Volume 8 issue Nov 2014Sathish Vemula
To recap the previous month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 8 has been released with the following content.
3 News Uptoday
14 New Guidance
30 Audit Findings
483 Observations
- Exemplar Lab, MA
- Genentech Inc
- Celltex Therapeutics Corporation
- APP Pharmaceuticals, LLC
- Reganeron Pharmaceuticals, Inc.
Warning Letters
- Hospira, Austarlia
- Sanjiu Medical and Pharmaceutical Co.,
- Beacon Hill Medical Pharmacy
EMA Non-Compliance Reports
- Wockhardt Limited, Nani Daman
- Fujian South Pharmaceutical, China
40 Regulations of the Month
§211.184 Component, drug product container, closure, and labeling records
§ 211.186 Master production and control records
The document summarizes Dhaivat Bhatt's work at the Srujana innovation center from December 15, 2014 to January 1, 2015. It includes two projects: 1) performing eigen decomposition on a dataset of eye images to extract the principal components, or "eigeneyes" and 2) developing software to apply image processing techniques like smoothing, thresholding, and edge detection on eye images using a graphical user interface. The software allows adjusting parameters for these techniques. The first project helped understand principal component analysis and reduced the eye image data dimensionally. The second project created easy-to-use software for ophthalmologists to process eye images.
Este documento proporciona información sobre APRENDER 2016, el sistema de evaluación nacional de aprendizajes de estudiantes en Argentina. Explica que APRENDER evalúa logros de aprendizaje y condiciones de enseñanza para obtener datos que permitan mejorar la educación. En 2016, evaluará Lengua y Matemática en 3° grado primario y 6° grado primario de forma censal, y también Lengua y Matemática en 2°-3° año secundario de forma muestral. El documento brinda detalles sobre los instrumentos de evalu
The document is an IEEE copyright and consent form that contains 4 sections:
1. The copyright transfer section assigns copyright of the work submitted to IEEE.
2. The consent and release section grants IEEE permission to use, distribute, publish materials related to any conference presentation based on the work.
3. General terms specify that authors retain proprietary rights to processes described in the work and can reproduce for personal/company use.
4. Author responsibilities and information for authors provides guidance on ensuring work meets IEEE requirements and that statements express authors' opinions.
This document summarizes a study that evaluated the effect of irrigation interval and plant density on the yield and yield components of mungbean. The study found that:
1) An irrigation interval of 8 days resulted in taller plants, more pods per plant, heavier 100-seed weight, and longer pods compared to 10 or 12 day intervals.
2) Higher plant density of 25cm row spacing led to more pods per plant, more seeds per pod, and longer pods than densities of 15cm or 20cm.
3) The interaction of 8 day irrigation interval and 25cm row spacing produced the highest 100-seed weight.
4) A density of 15cm row spacing resulted in higher biological yield than
Retail2020 - Forecast for the future of RetailSuhas Dutta
The document discusses the future of retail in 2020 and beyond. It predicts that technology will continue to rapidly disrupt retail through developments like mobile commerce, social media, and convergence of media. Customers will expect more personalized experiences. Retailers will need to focus on sustainability and go beyond physical stores to engage customers online at all times. The retail landscape in India is also expected to change significantly as internet penetration grows, especially in tier 2 and 3 cities, and more international players enter through franchising. Overall, retailers must adapt quickly to new technologies, deeply understand their customers, and think both short-term and long-term to succeed in this changing environment.
This document provides an overview of narrative inquiry as a qualitative research methodology. It defines key terms and concepts in narrative inquiry. Narrative inquiry studies experience as understood narratively, through concepts like temporality, sociality, and place. Research can start from either stories participants tell or from living stories as experiences unfold. Field texts are created from stories and analyzed considering narrative elements. The recursive process involves moving between fieldwork, field texts, interim analyses, and final research texts while thinking narratively about the phenomenon under study. Design considerations include justifying and framing the research puzzle and acknowledging the ongoing nature of experience.
Este documento resume varios procesos psicológicos clave como la inteligencia, la creatividad y la resolución de problemas. Explica la teoría de las inteligencias múltiples de Howard Gardner que propone varios tipos de inteligencia como la lingüística, lógico-matemática, musical, espacial e interpersonal. También describe los pasos para resolver problemas de manera efectiva como definir el problema, buscar soluciones, evaluar consecuencias y tomar una decisión.
Donald Trump has succeeded in the 2016 presidential election due to his use of entertainment and distraction tactics borrowed from reality TV. He dominates media coverage by making outrageous statements and creating drama. While this has helped him gain popularity, his tactics may prevent him from ultimately winning the election, as they do not demonstrate the compromise and leadership needed in the White House. Trump also promotes xenophobic rhetoric that plays on human cognitive biases, but his lead in the polls has begun to decline due to backlash from the Republican establishment. Whether Trump ultimately becomes president remains to be seen.
Dr. Eliza Buyers: Puberty within the Rett Clinic PopulationUrsula Webhofer
This document discusses puberty, menstrual periods, and related topics for individuals with Rett syndrome. It begins by outlining the topics that will be covered, including puberty, menstrual period options, sexual abuse awareness and prevention, HPV vaccination, pap smears, and vulvar care. It then defines puberty and the hormonal processes involved. Menstrual periods and options for managing them if needed using hormonal methods are described. The document stresses increasing awareness and prevention of sexual abuse and the importance of the HPV vaccine. It concludes by providing contact information for the pediatric and adolescent gynecology team at Children's Hospital Colorado for any questions.
Taxation Services
With our team of trained tax professionals, who have extensive experience and knowledge in Malaysia and International Taxation, rest assured for we provided a broad range of corporate taxation services in Malaysia to assist various Multi-National Corporations.
We keep our clients updated on the Malaysia tax regulations (including Budget updates).
-Corporate Tax
-Personal Income Tax
-Expatrait Tax
-Other taxable
-Record Keeping
-Self-Assesment System
Corporate Taxes
-Paid-up share capital of MYR 2.5 million and below:
20% on the first MYR 500,000 (19% from YA 2016), 25% on every ringgit exceeding MYR 500,000 (24% from YA 2016)
Corporate tax rates for companies resident in Malaysia:
25% (24 %from YA 2016)
Companies, limited liability partnerships, trust bodies and cooperative societies that are dormant have not commenced business are required to furnish the ITRF (including Form E)
Personal Income Tax
It is mandatory to make monthly contributions to the Employees’ Provident Fund. In addition, employee earns < MYR 3,000/mth, must make contributions to the Social Security Organization.
-26% , applies to income > than MYR 100,000.
-From YA 2015, 25%, apply to income of MYR 400,000 or >.
-Non-residents are taxed at a flat rate of 26%.
Every individual who is liable to tax is required to declare income to IRBM.
The taxpayer is responsible for obtaining and forwarding Income Tax Return Form (ITRF) have to submit duly completed before 30th April every year to the address:
Information Processing Department
Inland Revenue Board of Malaysia
Ground Floor, Menara Hasil
No. 3, Jalan 9/10
Seksyen 9
43650 Bandar Baru Bangi
Selangor Darul Ehsan
Expatraite Taxes
Types of Income:
- Non-resident Tax rate:
Liable to Malaysian tax when it carries on a business through a permanent establishment and assessable on income accruing in/or derived from Malaysia.
-Special Classes of Income:
10% Rental of movable property
10% Fees for technical or management servies performed in Malaysia
10% Payment for services rendered in Malaysia purchased from a non-resident person
-Real Estate Investment Trust (REIT):
Other than a resident company
Non-resident company
Foreign Investment Institution
*With the introduction of the single tier dividend system effective 1.1.2008, all dividends are tax free in the hands of the shareholders. However companies with section 108 credit under the old imputation system are given a transitional period until 31.12.2013 to frank normal dividends so as to enable them to exhaust their section 108 credit.
Other Taxable
-Property taxes
-Import Duty
-Export Duty
-Excise Duty
-Inheritance /gift tax
Let Paul Hype Page assist you in all your business compliance and taxation in Malaysia.
www.paulhypepage.my
PT BDO Konsultan Indonesia offers business services and outsourcing including payroll services, accounting, bookkeeping, compliance, and back office support. Their dedicated team has experience and fluency in English to serve both domestic and international clients. Their goal is to take on non-core activities for clients so they can focus on their business. They have solutions for payroll processing, tax calculations, reporting, and ensuring accuracy and on-time payments. BDO is one of the largest accounting networks worldwide with a presence in Indonesia since 1992.
Classroom management theory presentation.notes.pptx.pdfIan Glasmann
Classroom management theories based on four leading models of theory: Student-Centered Management Theory, Choice Theory, Kohn's Student Directed Learning, and Positive Behavior Support (PBS).
This document provides directions for a long walk through Dalby Forest to view the Bridestones rock formations. The walk is approximately two hours long and starts from the Bridestones car park in Dalby Forest. It guides hikers through woodland and open moorland to see both the low and high Bridestones. Detailed directions are given throughout the walk to navigate between landmarks like farms, fences, gates, and streams back to the starting point.
Este proyecto versará sobre la relación entre la socialización y la red, con especial ahínco en las redes sociales. Esta relación innata que encontramos entre los dos temas será lo que desarrollaremos a lo largo de este proyecto virtual.
No hay que menospreciar la labor de las redes sociales en la socialización que podemos encontrar dentro de la red, ya que una gran parte de las interacciones sociales online ocurren en estas páginas de internet. De gran importancia son, además, los jóvenes, que de manera masiva ocupan, dan uso y participan de estas redes sociales y por eso tienen un papel importante en este proyecto. Pero al juntarse tanta gente en un mismo lugar, a pesar de ser digital, no es de extrañar que surjan dudas como: ¿Quién lo regula?, ¿Cómo se controla? o ¿Hay algún control en internet?
Part ONE-1 page AMA format-due 917 by 1000 pm EST Evaluate m.docxdanhaley45372
Part ONE-
1 page AMA format-due 9/17 by 10:00 pm EST
Evaluate meaningful use regulations for recovery audit contractors (RACs) and electronic health records (EHRs), as well as the impact on either case management or performance incentives. What is the purpose of these regulations? How effective are they in meeting the purpose? Support your answer with course resources-attached
Part TWO
In response to your peer-provided below, agree or disagree with their assessments of the effectiveness of RAC and EHR meaningful use regulations. Be sure to justify your answer.
Classmate Chiwaula’s post:
Top of Form
MEANINGFUL USE REGULATIONS FOR RECOVERY AUDIT CONTRACTORS & ELECTRONIC HEALTH RECORDS
IMPACT ON CASE MANAGEMENT OR PERFORMANCE INCENTIVES.
In 2015 the Board of Registration in Medicine introduced a set of regulations requiring physicians to demonstrate proficiency in the use of electronic medical records, as well as the skills to achieve the federal Meaningful Use standard. Under the regulations, physicians are considered to have demonstrated proficiency if they meet any one of the following conditions:
· Participating in the Meaningful Use program as an Eligible Professional
· Having a relationship with a hospital that has been certified as a Meaningful Use participant. This relationship would be satisfied by any oneof the following conditions:
. Employed by the hospital
. Credentialed by the hospital to provide patient care
. Having a “contractual agreement” with the hospital
· Completing at least three hours of accredited CME program on electronic health records. Such a program must, at a minimum, discuss the core and menu set objectives, as well as the clinical quality measures for Meaningful Use.1
The Recovery Audit Contractor, or RAC, program was created through the Medicare Modernization Act of 2003 (MMA) to identify and recover improper Medicare payments paid to health care providers under fee-for-service (FFS) Medicare plans. The United States Department of Health and Human Services (DHHS) is required by law to make the program permanent for all states by January 1, 2010, under section 302 of the Tax Relief and Health Care Act of 2006.2 The main goals for RAC include:
• Minimize Provider Burden
• Ensure Accuracy
• Maximize Transparency
RACs are authorized to investigate claims submitted by all physicians, providers, facilities, and suppliers—essentially, everyone who provides Medicare beneficiaries in the fee for service program with procedures, services, and treatments and submits claims to Medicare (and/or their fiscal intermediaries (FI), regional home health intermediaries (RHHI), Part A and Part B Medicare administrative contractors (A/B/MACs), durable medical equipment Medicare administrative contractors (DME MACs), and/or carriers.2
Benefits of Electronic Health Records (EHRs)
Providers who use EHRs report tangible improvements in their ability to make better decisions with more compreh.
Medical Consumer Product Protection LegislationJoseph Curtis
Outlines US and International legislation initiated to minimize risk to consumers of medical products. Presents new FDA requirements for manufacturers of medical products. Covers global Clinical Trial Database systems used to evaluate product safety and post marketing studies.
An abbreviated new drug application (ANDA) is submitted to the FDA to obtain approval for a generic drug version of an already approved brand name drug. The ANDA process allows for generic drugs to be approved without repeating clinical trials, as long as the generic drug is proven to be bioequivalent to the original drug. If approved, a generic drug application allows the applicant to manufacture and market a safe, effective and lower-cost alternative to the original brand name drug. The ANDA review process focuses on demonstrating bioequivalence rather than requiring new clinical trial data.
The document discusses Investigational New Drug (IND) applications, which are submitted to the FDA to obtain approval to begin human clinical trials of an experimental drug. An IND application includes preclinical animal data, clinical trial protocols, and information about manufacturing. The FDA has 30 days to review an IND for safety before trials may begin. Clinical holds may be placed on applications that pose unreasonable risks or are missing required information. Notifications are provided to sponsors regarding review outcomes and any deficiencies that must be addressed.
The document provides guidance on navigating the regulatory requirements for mHealth applications in the United States. It outlines the key steps, including determining if the app meets the definition of a medical device regulated by the FDA, adhering to privacy and security rules, and ensuring a positive user experience. Regulations may vary depending on whether the app uses custom hardware, is intended for health administration or management, or qualifies as a mobile medical device.
The United States has always been and remains to be the leading place
for the conduct of clinical trials. According to Clinicaltrials.gov, the largest
clinical trials registry, 32% of registered clinical trials were conducted in
the U.S. as of May 2022 (1). Factors such as the availability of qualified
healthcare professionals, high-quality infrastructure and facilities,
cutting-edge research, an efficient regulatory system, and a high
standard of ethics and participant protection make the U.S. the leading
country for clinical trials.
Clinical trials follow extensive preclinical research to test the safety and
efficacy of a new drug, medical device, or biological in humans. They are
usually divided into three phases: phases I, II, and III which are designed
to ascertain safety, pharmacokinetics, efficacy, dosage, and adverse
events. Figure 1 shows the typical route from discovery and preclinical
studies to the post-marketing phase (phase IV).Clinical trials represent the longest and most expensive step in bringing
drugs to the market and have the highest attrition rate, only 10% of drugs
that enter phase I trials are granted marketing approval. Therefore,
clinical trials should be conducted by experts that are
well-versed with all the regulations and guidelines in a particular region to
boost the chances of drug approval.
The United States Food and Drug Administration (US FDA) is the
regulatory body that approves and oversees the conduct of clinical trials
for drugs, medical devices, and biologicals that are intended to be
marketed in the U.S and is touted to have the most stringent standards
for drug approval. The primary role of the FDA is to protect public health
by ensuring that medicinal products and devices are safe and efficacious.
Therefore, it is necessary for sponsors/investigators or contract research
organizations (CRO) that are conducting clinical trials to be familiar with
regulations and guidances that govern the conduct of clinical trials.Conducting a clinical trial in the United States requires a deep understanding of the
regulations and guidelines set by the FDA. It is important to know what is needed for a
successful clinical trial, from selecting an appropriate study site to obtaining informed
consent from participants. Additionally, it is essential to understand the requirements for data
collection and analysis, as well as how to develop an effective protocol. Clinical trial services
in USA can provide guidance on all of these aspects and more, helping you ensure that your
clinical trial meets all necessary standards
HIGHLIGHTED: Dissemination of Patient-Specific Information from Devices by De...NextWorks
This is the highlighted version of FDA's Guidance for Industry: Dissemination of Patient-Specific Information from Devices by Device Manufacturers from June 2016.
When these guidances come out, I typically go through them and highlight the most relevant portions for those who need to skim through or refresh their memory.
Pharmaceutical industries invest billions of dollars, Euros in these highly risky health care solutions, for this Intellectual property protection is essential. Innovator company enjoys a period of "data exclusivity" during which their pre-clinical and clinical trials data may not be referenced in the regulatory filings of another company for the same drug substance.
This document provides an overview of key regulatory and legal issues related to health IT, including various acronyms. It summarizes regulations from HIPAA, HITECH, the FTC, FDA, ECPA, SCA, FCC, and CMIA. HIPAA and HITECH establish privacy and security rules for health information. The FTC protects consumer privacy and enforces data breach notification. The FDA regulates medical devices, including some software. ECPA/SCA limit sharing of electronic communications. The FCC regulates communications carriers. CMIA is California's health privacy law.
Health Insurance Portability & Accountability Act (HIPAA)Arpitha Aarushi
This presentation contains all the information about the HIPAA, the Privacy rule and its clinical significance. It also contains the information about the violation of the HIPAA policy.
The document summarizes the process by which the FDA approves new drugs for use and regulates drugs post-approval. It discusses how drugs are tested in clinical trials through an investigational new drug application and new drug application. It then outlines the FDA's role in reviewing applications and ensuring safety and effectiveness. Finally, it describes the FDA's ongoing role in regulating approved drugs, including product quality, labeling, adverse event reporting, and risk management. The House passed legislation that would reauthorize FDA drug user fee programs and make changes to the drug approval process.
Guidi Sherer Everything You Wanted to Know About 340B Oncology Issues 2011Matt Sherer
The document provides information about the 340B Drug Pricing Program. It describes the program as originating from legislation in 1992 that limits drug costs for certain healthcare facilities. Safety-net providers can save 20-50% on drug costs by participating. To qualify, a disproportionate share hospital must meet requirements like having an 11.75% DSH percentage and maintaining separate drug inventories for 340B and non-340B patients. The Affordable Care Act expanded eligibility for the program and increased compliance monitoring.
THE MEDICINE SHOPPE V. LORETTA LYNCH, ETAL. PHARMACISTS A.docxoreo10
THE MEDICINE SHOPPE V. LORETTA LYNCH, ET
AL.: PHARMACISTS AND PRESCRIBING
PHYSICIANS ARE EQUALLY LIABLE
Grass, Jeffrey C, JD, MS, ACLM . The Health Lawyer ; Chicago Vol. 28, Iss. 3, (Feb 2016): 28-37.
ProQuest document link
ABSTRACT
[...]Petitioners challenged the DEA's interpretation of "legitimate medical purpose" under the Controlled Substances
Act ("CSA") and the "corresponding responsibility" standard under DEA Regulation 21 C.F.R. § 1306.04(a) (2014) on
the grounds that these standards exceed the United States Attorney General's and the DEA's statutory authority
under the CSA.7 On December 16, 2015, the Court denied The Medicine Shoppe's petition for review without
comment, thereby leaving open the question of whether or not the United States Attorney General may expand the
professional duty of pharmacists to require they either endorse or overrule the medical judgment of the prescribing
physician.
FULL TEXT
On November 3, 2011, the Dmg Enforcement Administration ("DEA") conducted an inspection of The Medicine
Shoppe, a small family-owned pharmacy in San Antonio, Texas. DEA Diversion Investigators ("Dis") seized
prescriptions filled by patients of a local physician who was under investigation for possible dmg diversion. On
October 7, 2013, the DEA Deputy Administrator issued an Order to Show Cause ("OTSC") to revoke The Medicine
Shoppe's controlled substances Certificate of Registration ("COR") on the grounds that the pharmacy had filled
prescriptions written by the target physician that were not for a "legitimate medical purpose."1 The DEA alleged
that The Medicine Shoppe's pharmacists failed to exercise their "corresponding responsibility," along with the
physician, "to assure that its prescription for controlled substances was issued for a legitimate medical purpose"
and "in the practitioner's usual course of professional practice" under DEA regulation.
The Medicine Shoppe responded that the pharmacists had known the patients and the prescribing physician for
many years and had contacted the prescribing physician's office to verify the prescriptions before filling them.2
The Medicine Shoppe argued that therefore it had complied with the requirements of their pharmacists'
professional licenses and absent clear evidence of diversion, the pharmacists were obliged to fill the
prescriptions.3
On October 2nd, 2014 the DEA revoked The Medicine Shoppe's COR.4 The Medicine Shoppe then filed a Petition for
Review with the United States Court of Appeals for the District of Columbia Circuit, which has original jurisdiction
for appeals of DEA Orders under the Administrative Procedure Act ("APA").5 The Medicine Shoppe appealed on the
grounds that imposing a "corresponding responsibility" on pharmacists to ensure that controlled substances are
prescribed for a "legitimate medical purpose'" requires them to make medical judgments beyond their education
and training.6 Moreover, should the DEA ...
http1500cms.comBECAUSE THIS FORM IS USED BY VARIOUS .docxpooleavelina
http://1500cms.com/
BECAUSE THIS FORM IS USED BY VARIOUS GOVERNMENT AND PRIVATE HEALTH PROGRAMS, SEE SEPARATE INSTRUCTIONS ISSUED BY
APPLICABLE PROGRAMS.
NOTICE: Any person who knowingly files a statement of claim containing any misrepresentation or any false, incomplete or misleading information may
be guilty of a criminal act punishable under law and may be subject to civil penalties.
REFERS TO GOVERNMENT PROGRAMS ONLY
MEDICARE AND CHAMPUS PAYMENTS: A patient’s signature requests that payment be made and authorizes release of any information necessary to process
the claim and certifies that the information provided in Blocks 1 through 12 is true, accurate and complete. In the case of a Medicare claim, the patient’s signature
authorizes any entity to release to Medicare medical and nonmedical information, including employment status, and whether the person has employer group health
insurance, liability, no-fault, worker’s compensation or other insurance which is responsible to pay for the services for which the Medicare claim is made. See 42
CFR 411.24(a). If item 9 is completed, the patient’s signature authorizes release of the information to the health plan or agency shown. In Medicare assigned or
CHAMPUS participation cases, the physician agrees to accept the charge determination of the Medicare carrier or CHAMPUS fiscal intermediary as the full charge,
and the patient is responsible only for the deductible, coinsurance and noncovered services. Coinsurance and the deductible are based upon the charge
determination of the Medicare carrier or CHAMPUS fiscal intermediary if this is less than the charge submitted. CHAMPUS is not a health insurance program but
makes payment for health benefits provided through certain affiliations with the Uniformed Services. Information on the patient’s sponsor should be provided in those
items captioned in “Insured”; i.e., items 1a, 4, 6, 7, 9, and 11.
BLACK LUNG AND FECA CLAIMS
The provider agrees to accept the amount paid by the Government as payment in full. See Black Lung and FECA instructions regarding required procedure and
diagnosis coding systems.
SIGNATURE OF PHYSICIAN OR SUPPLIER (MEDICARE, CHAMPUS, FECA AND BLACK LUNG)
I certify that the services shown on this form were medically indicated and necessary for the health of the patient and were personally furnished by me or were furnished
incident to my professional service by my employee under my immediate personal supervision, except as otherwise expressly permitted by Medicare or CHAMPUS
regulations.
For services to be considered as “incident” to a physician’s professional service, 1) they must be rendered under the physician’s immediate personal supervision
by his/her employee, 2) they must be an integral, although incidental part of a covered physician’s service, 3) they must be of kinds commonly furnished in physician’s
offices, and 4) the services of nonphysicians must be included on the physician’s bills.
For CHA ...
In Good News For Providers, OIG and CMS Propose Extensions And Modifications ...Patton Boggs LLP
The document summarizes a proposed rule from the Department of Health and Human Services Office of Inspector General (OIG) and Centers for Medicare & Medicaid Services (CMS) that aims to extend the sunset dates of existing safe harbor and exception rules related to electronic health record (EHR) systems donations beyond the current end-of-year dates. Specifically:
1) The agencies propose extending the sunset dates to December 31, 2016 or December 31, 2021 to align with incentives program end dates and seek comments on alternative dates.
2) The e-prescribing requirement would be removed due to industry progress and minimal abuse risk.
3) Interoperability provisions would be updated to track evolving certification processes through the
This document discusses several standards related to controlled substances in pharmacy practice, including standards for mailing, destroying, faxing prescriptions for, and reporting loss of controlled substances. It provides details on the requirements for mailing controlled substances, destroying them according to state regulations, faxing prescriptions (which are allowed only in certain situations), standards for prescriptions by nurse practitioners, and requirements for reporting loss or theft of controlled substances to the DEA and state board of pharmacy. The document aims to review some common rules regarding controlled substances but does not present all state and federal regulations.
This document provides an overview of HIPAA and 42 CFR Part 2 regulations regarding protected health information. HIPAA establishes national standards for secure handling of health data, while 42 CFR Part 2 provides additional privacy protections for substance abuse treatment records. Both laws restrict disclosure of personal health information without patient consent, with 42 CFR Part 2 requiring written consent even for common uses like treatment, payment, and healthcare operations. The document defines key terms and outlines permitted uses and disclosures, consent requirements, and exceptions under each regulation.
introduction, classification, regulatory approval process for medical devices (510k) premarket notification, pre market approval (PMA), investigational device exemption (IDE) and invitro diagnostics, quality system requirements 21 CFR PART 820, labeling requirements 21 CFR part 801, UDI
Pharma Uptoday MM: Volume 1 issue April 2014 Sathish Vemula
This document provides information about the Pharma Uptoday newsletter. It was initiated in July 2013 to share knowledge about current happenings in the pharmaceutical industry and help minimize regulatory issues. The newsletter includes updates on warning letters, guidelines, presentations, and other topics related to good manufacturing practices and regulations. It is intended for people in the drugs and pharmaceutical industry. The highlights mentioned include the current number of members and posts. The editor provides a message and the issue includes several news articles and information on new guidelines and audit findings related to regulations.
Human: Thank you for the summary. Summarize the following document in 3 sentences or less:
[DOCUMENT]:
To: Pharma Industry
From: FDA
The document discusses federal regulations regarding the disposal of medicines from the FDA, DEA, and USPS. The FDA recommends mixing most medicines with unpalatable substances and throwing them in the trash or using drug take-back programs. However, some controlled substances should not be thrown in the trash due to the risk of accidental ingestion; these may require approval from the DEA for disposal. The USPS allows returning prescription drugs by mail for recalls, withdrawals, or errors when sent to the manufacturer.
Similar to Prescription Drug Monitoring Program | State of California - Department of Justice (20)
Prescription Drug Monitoring Program | State of California - Department of Justice
1. Prescription Drug Monitoring Program | State of California -
Department of Justice
Controlled Substance Utilization Review and Evaluation System (CURES) CURES 2.0 Soft Launch
and Phased Rollout
June 30, 2015
The Department of Justice (DOJ) and the Department of Consumer Affairs (DCA) are pleased to
announce that the states new Controlled Substance Utilization Review and Evaluation System
commonly referred to as CURES 2.0 will go live on July 1, 2015. This upgraded prescription drug
monitoring program features a variety of performance improvements and added functionality.
In order to ensure a smooth transition from the current system, CURES 2.0 will be rolled out to
users in phases over the next several months, beginning with early adoption by a select group of
users who currently use CURES and meet the CURES 2.0 security standards, including minimum
browser specifications.** DOJ is currently identifying prescribers and dispensers who meet these
criteria and will contact and coordinate their enrollment into CURES 2.0. For all other current users,
access to CURES 1.0 will not change and no action is needed at this time. For users and entities not
currently enrolled in CURES, further notification will be provided in August as to the
enrollment/registration process.
Practitioners and health systems should begin to prepare for universal adoption of the system by
January 2016, at which point all users will be required to meet CURES 2.0s security standards. If
you have any questions please contact cures@doj.ca.gov.
Thank you for your continued support of the CURES program.
**CURES 2.0 users will be required to use Microsoft Internet Explorer Version 11.0 or greater,
Mozilla FireFox, Google Chrome, or Safari when accessing the system.
CURES Contact Information: cures@doj.ca.gov or (916) 227-3843
The Controlled Substance Utilization Review and Evaluation System (CURES) is a database
containing information on Schedule II through IV controlled substances dispensed in California. It is
a valuable investigative, preventive, and educational tool for the healthcare community, regulatory
boards, and law enforcement.
The California Prescription Drug Monitoring Program (PDMP) maintains the CURES database. The
PDMP allows authorized users, including licensed healthcare prescribers eligible to prescribe
controlled substances, pharmacists authorized to dispense controlled substances, law enforcement,
and regulatory boards, to access patient controlled substance history information maintained in
CURES. The PDMP is committed to assisting in the reduction of pharmaceutical drug diversion
without affecting legitimate medical practice or patient care.
2. Through online access to CURES, authorized prescribers and pharmacists can quickly review
information via Patient Activity Reports (PAR) in an effort to identify and deter drug abuse and
diversion through accurate and rapid tracking of Schedule II through IV controlled substances. In
2014, over 3.5 million PAR requests were processed.
To obtain access to CURES, prescribers and pharmacists must: (1) submit an application form
electronically; and (2) mail a notarized copy of their printed and signed Application Confirmation,
along with copies of the following supporting documents: Drug Enforcement Administration
registration certificate (prescribers only), medical or pharmacist license, and a government-issued
photo identification. Applicants can email their complete CURES application packet to
pmp@doj.ca.gov or mail by standard U.S. mail to:
California Department of Justice
PDMP/CURES
P.O. Box 160447
Sacramento, CA 95816
The Department of Justice (DOJ) limits access to and dissemination of CURES information to
licensed prescribers, licensed pharmacists, law enforcement personnel, and regulatory board
personnel strictly for patient care or official investigatory/regulatory purposes. The DOJ pursues
regulatory and/or criminal sanctions for misuse of CURES information.
The Health Insurance Portability and Accountability Act of 1966 (HIPAA) and all confidentiality and
disclosure provisions of California law cover the information contained in CURES. All users must
comply with HIPAA Privacy Rule Requirements when using CURES.
Submission of Controlled Substance Data
California Health & Safety Code Section 11165(d) requires dispensing pharmacies, clinics, or other
dispensers of Schedule II through IV controlled substances to provide specified dispensing
information to the DOJ on a weekly basis in a format approved and accepted by the DOJ. Currently,
the ASAP 2009 Version 4.1 format is accepted.
Direct Dispense Reporting Application
The DOJ, in coordination with Atlantic Associates, Inc. (AAI), allows direct dispense prescribers and
entities, including pharmacies filling less than 25 prescriptions per month, to electronically report
dispensing data to the DOJ. The direct dispense application can be accessed on the Direct Dispense
website located at www.aaicures.com. Also available at this website are instructions on how to apply
for an account and submit dispense data. Please note that the DOJ no longer accepts paper direct
dispense reports.
To access the secured direct dispense site, dispensers must first complete the application at
http://aaicures.com/register.for.access.php. Once an application has been submitted, an email
confirmation from AAI will provide approved users with a username and temporary password. If an
email confirmation is not received within 48 hours of submitting the application, please contact AAI
at CACures@aainh.com or (800) 539-3370.
3. For additional information concerning controlled substance prescription data reporting, please
contact AAI at CACures@aainh.com or (800) 539-3370.
Prescription Forms (For Prescribers)Obtain Security Prescription Forms
California law requires prescribers of any Schedule II through V controlled substance to obtain and
use tamper-resistant prescription forms ordered only from state-approved security printers. To order
tamper-resistant prescription forms, please refer to the Approved List of Security Prescription
Printers for vendors authorized by the DOJ and their contact information.
Report Lost or Stolen Prescription Forms
Reports of lost or stolen prescription forms or pads must be reported to local law enforcement and
the PDMP. Users registered with CURES can href="https://pmp.doj.ca.gov/pdmp/index.do"
target="_blank">electronically report their lost or stolen prescription forms or pads online when
logged into their CURES account. A law enforcement agency report number is required when
submitting a report of lost or stolen prescription forms to the PDMP.
For questions concerning how to report lost or stolen prescription pads or forms, please contact the
Security Prescription Printer Program at SecurityPrinter@doj.ca.gov.