I will be giving a web presentation on July 30, 2009 at 1 pm CST to discuss my experiences and recommendations for the utilization of Contract Research Organizations (CROs) by pharmacuetical, biologics and medical device companys who engage in clinical research. Please join us by registering at http://www.q1productions.com/store/product_info.php/cPath/30_42/products_id/80
Thanks. Hope to "see" you there. If you have any specific issues of concern that you would like me to cover, please contact me.
Steve Schurr
Friday, June 19, 2009
Saturday, April 18, 2009
e-conference May 6, 2009; Working with CROs
On May 6, 2009, I will be presenting an e-conference over the web in conjuction with Clinical Device Group of Chicago, IL on how to work effectively with Contract Research Organizations (CROs) on a clinical research project. For more information on the e-conference, use the link below:
https://www.clinicaldevice.com/mall/eConferences.asp
I welcome any questions or issues in advance from the audience. Please feel free to contact me if you have a question or issue you would like to have discussed. Please see below for more information about the upcoming e-conference.
Thanks.
Steve Schurr
Common Mistakes with CROsOver and over again sponsors make the same mistake when choosing a Contract Research Organization. They base the choice on cost rather than reputation, capability, demonstrated knowledge, contribution to the industry, and a match in size, philosophy, and attitude. Then, after having chosen poorly, they fail to manage the CRO or stay in close contact.
Learning ObjectiveYou will learn the regulatory, legal and financial pitfalls in the use of a CRO for a research project and how to protect your organization from such pitfalls.
Step by StepSteven Schurr, Esq. will walk you through the process of hiring a CRO for medical device research. He will cover:[x] The risks involved in utilizing a CRO versus hiring in-house employees to perform the tasks. [x] The best ways for a sponsor to solicit and evaluate potential CRO vendors. [x] Once the sponsor chooses a CRO vendor, how to structure the budget and contract.[x] How to monitor and evaluate the performance of the CRO during the project.[x] What happens if the project needs to be expanded beyond its original scope after the original contract is finalized. [x] What the sponsor should do if they choose to terminate the contract with the CRO while the project is ongoing.
Case StudiesMr. Schurr will use case studies of precarious situations to demonstrate what can go wrong, explanations of what caused the situations, and recommendations on how to avoid them.
Are You A CRO?For the CROs in the audience, Mr. Schurr will have a few words about choosing a client. Vendors should go through a selection process too, as was vividly demonstrated in the recent GAO sting operation against independent IRBs. You should ask questions like:[x] Is the client honest?[x] Do they want an ethical research study with data that have proven integrity?[x] Can they pay you?
https://www.clinicaldevice.com/mall/eConferences.asp
I welcome any questions or issues in advance from the audience. Please feel free to contact me if you have a question or issue you would like to have discussed. Please see below for more information about the upcoming e-conference.
Thanks.
Steve Schurr
Common Mistakes with CROsOver and over again sponsors make the same mistake when choosing a Contract Research Organization. They base the choice on cost rather than reputation, capability, demonstrated knowledge, contribution to the industry, and a match in size, philosophy, and attitude. Then, after having chosen poorly, they fail to manage the CRO or stay in close contact.
Learning ObjectiveYou will learn the regulatory, legal and financial pitfalls in the use of a CRO for a research project and how to protect your organization from such pitfalls.
Step by StepSteven Schurr, Esq. will walk you through the process of hiring a CRO for medical device research. He will cover:[x] The risks involved in utilizing a CRO versus hiring in-house employees to perform the tasks. [x] The best ways for a sponsor to solicit and evaluate potential CRO vendors. [x] Once the sponsor chooses a CRO vendor, how to structure the budget and contract.[x] How to monitor and evaluate the performance of the CRO during the project.[x] What happens if the project needs to be expanded beyond its original scope after the original contract is finalized. [x] What the sponsor should do if they choose to terminate the contract with the CRO while the project is ongoing.
Case StudiesMr. Schurr will use case studies of precarious situations to demonstrate what can go wrong, explanations of what caused the situations, and recommendations on how to avoid them.
Are You A CRO?For the CROs in the audience, Mr. Schurr will have a few words about choosing a client. Vendors should go through a selection process too, as was vividly demonstrated in the recent GAO sting operation against independent IRBs. You should ask questions like:[x] Is the client honest?[x] Do they want an ethical research study with data that have proven integrity?[x] Can they pay you?
2009 Clinical Research Educational Conference
I will be presenting at the 2009 Clinical Research Educational Conference on Friday, May 15, 2009 at Northwestern University in Chicago. I will be giving two one hour presentations on what I believe to be the "10 Most Important Documents in Implementing a Clinical Trial". I will be speaking from a legal, regulatory and practical perspective. It is my hope that this topic will generate much debate and opinion from the audience.
Please join us in the discussion. You may learn more about the conference at the following link:
http://www.nucats.northwestern.edu/education/CRPT/CREC/index.html
Thanks and I hope to see you there.
Steve
Please join us in the discussion. You may learn more about the conference at the following link:
http://www.nucats.northwestern.edu/education/CRPT/CREC/index.html
Thanks and I hope to see you there.
Steve
Saturday, November 15, 2008
Enrollment for Medicare Drug Plan Begins November 15, 2008
Starting today, seniors can enroll in a new or different Medicare drug plan for 2009.
Even if you are already enrolled, please review your options since several popular plans are raising monthly premiums or changing benefits. Do not assume that your plan will be the same in the following year. By now, you should have received an "annual notice of change" package of materials telling you the changes in your plan that go into effect in the next year.
To be on safe side, the Medicare Rights Center advises seniors to call their plans and check if their medications are covered. Be sure to make a list of all your drugs and the dosages prescribed in advance.
Also, you'll want to ask about drug co-payments, the pharmacies in the plan network, and if the plan has placed any restrictions on the medications you use.
For an overview of the Medicare drug benefit, the different types of plans available and questions you might want to consider, go to http://www.medicareinteractive.org/. You can compare how your plan stacks up against others by going to the Medicare Drug Plan finder at http://www.medicare.gov/ or calling 1-800-Medicare (1-800-633-4227).
Remember, if you don't have much money, you might qualify for financial subsidies from the government to cover drug expenses.
Please contact me if I can help or if you have any questions.
Steve
Even if you are already enrolled, please review your options since several popular plans are raising monthly premiums or changing benefits. Do not assume that your plan will be the same in the following year. By now, you should have received an "annual notice of change" package of materials telling you the changes in your plan that go into effect in the next year.
To be on safe side, the Medicare Rights Center advises seniors to call their plans and check if their medications are covered. Be sure to make a list of all your drugs and the dosages prescribed in advance.
Also, you'll want to ask about drug co-payments, the pharmacies in the plan network, and if the plan has placed any restrictions on the medications you use.
For an overview of the Medicare drug benefit, the different types of plans available and questions you might want to consider, go to http://www.medicareinteractive.org/. You can compare how your plan stacks up against others by going to the Medicare Drug Plan finder at http://www.medicare.gov/ or calling 1-800-Medicare (1-800-633-4227).
Remember, if you don't have much money, you might qualify for financial subsidies from the government to cover drug expenses.
Please contact me if I can help or if you have any questions.
Steve
Thursday, October 23, 2008
Update on Enforcement of HIPAA Privacy Rule
CCH has published a summary of enforcement data for privacy violations under HIPAA since enforcement of the law began in April 2003:
http://www.hr.cch.com/news/benefits/092208.asp
There is no individual private cause of action for HIPAA violations. A complaint must be filed with the Office of Civil Rights in the case of an alleged violation.
Steve
http://www.hr.cch.com/news/benefits/092208.asp
There is no individual private cause of action for HIPAA violations. A complaint must be filed with the Office of Civil Rights in the case of an alleged violation.
Steve
New Mental Health Parity Law
At least one good thing came out of the recent financial troubles that our country has been experiencing. After more than 10 years of trying, Congress has passed a law that requires employer-sponsored health care plans to treat mental health disorders to the same level and degree as they do physical ailments.
The new requirements are included in the Emergency Economic Stabilization Act (H.R. 1424), which is the "economic bailout" bill that that President Bush signed into law on October 3, 2008. For years, plans have generally been less generous in their coverage of treatment for mental illness. The new law becomes effective in 2010 and generally applies to employers with more than 50 workers, with certain exceptions.
Under the new law, plan participants cannot be required to pay more in deductibles, copayments, coinsurance and out-of-pocket expenses for mental health and substance use disorder benefits that they are required to pay for the plan's most common or frequent types of medical/surgical benefit.
The new law prevents plans from limiting the frequency of treatment, the number of visits, the days of coverage, etc. for mental health/substance use treatment moreso than they do for medical/surgical benefits.
In addition, "out-of-network" mental health services must be covered under the law if they are covered for medical/surgical benefits.
A plan must provide a legally acceptable definition of "mental health" and "substance use disorder" and is permitted to use utilization review and/or pre-authorization to determine medical necessity and appropriateness. The plan administrator must disclose any medical necessity determination criteria to any participant upon request. Also, the reason for any denial of reimbursement or payment also must be provided.
The law provides a penalty of up to $100/day for non-compliance and allows plan participants to file civil lawsuits to obtain inappropriately denied benefits.
Steve
The new requirements are included in the Emergency Economic Stabilization Act (H.R. 1424), which is the "economic bailout" bill that that President Bush signed into law on October 3, 2008. For years, plans have generally been less generous in their coverage of treatment for mental illness. The new law becomes effective in 2010 and generally applies to employers with more than 50 workers, with certain exceptions.
Under the new law, plan participants cannot be required to pay more in deductibles, copayments, coinsurance and out-of-pocket expenses for mental health and substance use disorder benefits that they are required to pay for the plan's most common or frequent types of medical/surgical benefit.
The new law prevents plans from limiting the frequency of treatment, the number of visits, the days of coverage, etc. for mental health/substance use treatment moreso than they do for medical/surgical benefits.
In addition, "out-of-network" mental health services must be covered under the law if they are covered for medical/surgical benefits.
A plan must provide a legally acceptable definition of "mental health" and "substance use disorder" and is permitted to use utilization review and/or pre-authorization to determine medical necessity and appropriateness. The plan administrator must disclose any medical necessity determination criteria to any participant upon request. Also, the reason for any denial of reimbursement or payment also must be provided.
The law provides a penalty of up to $100/day for non-compliance and allows plan participants to file civil lawsuits to obtain inappropriately denied benefits.
Steve
Thursday, August 28, 2008
Importation of Medicines via the Internet
Is it legal to order prescription pharmaceuticals over the internet? If not, your shipment could be seized at the border by US Customs and you could receive an alarming letter.
In the United States, the FDA has given guidelines for review of the personal importation of pharmacuetical products. They will generally be allowed on a doctor's prescription being for personal use only and no more than a 3 months supply.
FDA personnel are responsible for monitoring mail importations. If a customs officer examines a parcel, he/she is to set is aside if it appears to contain a drug, biologic, or device that the FDA has specifically requested to be held.
Additional issues arise when the pharmaceutical in question is a controlled substance, such as Valium, and falls under the jurisdiction of the US Drug Enforcement Administration.
Can an individual legally order drugs using the internet without seeing a doctor? No.
Federal law requires that "A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice" (21 CFR 1306.04(a)). In other words, there must be a bona fide doctor/patient relationship.
Four elements indicate a legitimate doctor/patient relationship: 1.) patient has a medical complaint; 2.) medical history has been taken; 3.) physical examination has been performed; and 4.) some logical connection exists between the medical complaint, the medical history, the physical examination and the drug prescribed.
A patient completing a questionnaire that is then reviewed by a physician hired by or working on behalf of an internet pharmacy does not establish a doctor/patient relationship.
In addition, providing false material information to obtain controlled substances could be considered obtaining a controlled substance by fraud and deceit, which is subject to Federal and State penalties. Illegal importation of controlled substances is a felony that may result in imprisonment and fines (21 U.S.C. 960).
In the United States, the FDA has given guidelines for review of the personal importation of pharmacuetical products. They will generally be allowed on a doctor's prescription being for personal use only and no more than a 3 months supply.
FDA personnel are responsible for monitoring mail importations. If a customs officer examines a parcel, he/she is to set is aside if it appears to contain a drug, biologic, or device that the FDA has specifically requested to be held.
Additional issues arise when the pharmaceutical in question is a controlled substance, such as Valium, and falls under the jurisdiction of the US Drug Enforcement Administration.
Can an individual legally order drugs using the internet without seeing a doctor? No.
Federal law requires that "A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice" (21 CFR 1306.04(a)). In other words, there must be a bona fide doctor/patient relationship.
Four elements indicate a legitimate doctor/patient relationship: 1.) patient has a medical complaint; 2.) medical history has been taken; 3.) physical examination has been performed; and 4.) some logical connection exists between the medical complaint, the medical history, the physical examination and the drug prescribed.
A patient completing a questionnaire that is then reviewed by a physician hired by or working on behalf of an internet pharmacy does not establish a doctor/patient relationship.
In addition, providing false material information to obtain controlled substances could be considered obtaining a controlled substance by fraud and deceit, which is subject to Federal and State penalties. Illegal importation of controlled substances is a felony that may result in imprisonment and fines (21 U.S.C. 960).
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