As reported to Dana Zelig, CIS Compliance Specialist
On the twelfth day of CIS, the blog introduced to me...
Founding Partner and VP of Operations Jim Collins,
(Founder Toni Barsh, SCC Raul Reyes, SCC Barb Lutz, VP Chris Cobourn, SCC Alaina Confer Anderson, Meredith Taylor, Esq., SCC Debbe Saez, SCC Chrissy Spicer, SCC Clarissa Crain, SCC Judy Fox, and Steven Moore, Director of BD)
Q: What’s your background?
A: I was born in Brooklyn, NY and moved to South Jersey at age 5 when my father, who was a stock broker on Wall Street, took a job with a small start up firm on the Philadelphia Stock Exchange. I went to Rider College and majored in Accounting and Finance. I received my CPA in 1990 and quickly got out of accounting. I worked for Barnett International, a division of PAREXEL Consulting, as VP of Operations for 14 years prior to co-founding CIS in 2004.
Q: Why did you decide to start CIS?
A: After 14 years of a being part of a large public company and spending the majority of my time on internal politics and BS - I thought it would be a refreshing change to build a company where the culture is based on performance, growing professionally and financially, and helping clients.
Q: What company milestones are you proud of?
A: Our goal in year 1 was to be in business in year 2, so that is a milestone I am very proud of. Now that we are approaching our 5 year anniversary as a company, I am proud to be working with close to 50 of the smartest, most hard working and talented staff in our industry.
Q: If you could give your employees once piece of advice, what would it be?
A: You get out of your career what you put into it– there are no short cuts. By taking it easy you limit your own growth – professionally and financially.
Q: What’s your favorite holiday movie and why?
A: Elf – Buddy is the best!
Q: What are you most thankful for this holiday season?
A: The ability to get up every day and see that I have a healthy family, and I know I have the ability to be in control of my own destiny.
Email Jim any time at jimcollins@cis-partners.com!
There are currently:
2 days until Christmas, and
3 days until Kwanzaa!
*
Tonight is the 3rd night of Chanukah!
The days are now getting longer!
*
(We at CIS are equal opportunity celebrators!)
Tuesday, December 23, 2008
Monday, December 22, 2008
On the Eleventh Day of CIS...
As reported to Dana Zelig, CIS Compliance Specialist
On the eleventh day of CIS, the blog introduced to me...
Founding Partner and VP of Account Management Toni Barsh,
(SCC Raul Reyes, SCC Barb Lutz, VP Chris Cobourn, SCC Alaina Confer Anderson, Meredith Taylor, Esq., SCC Debbe Saez, SCC Chrissy Spicer, SCC Clarissa Crain, SCC Judy Fox, and Steven Moore, Director of BD)
Q: Why did you decide to start CIS?
A: I ran my second consulting company for 5 years, and was burned out being a "single shingle." [CIS Co-Founder] Jim Collins and I collaborated on a new business venture that immediately interested me. We already had a 10 year working relationship, so partnering with Jim was a no brainer. My best professional decision yet!
Q: What projects and product lines do you work with at CIS?
A: I help wherever I am needed. I work primarily in Account Management supporting our managers. I also try to get a bit of Business Development in from time to time.
Q: What do you like about CIS?
A: I love the culture we have created here and the people I work with. I want and need to learn from the people who surround me, and I think we have some of the most talented employees around….people who want to learn, want to grow and want to be challenged!
Q: What’s the best holiday gift you’ve ever gotten (or given)?
A: The best gift I've ever given was a cruise to Bermuda for my parents' 25th wedding anniversary. The best gift I've ever received was the opportunity to adopt a child and become a parent!
On the eleventh day of CIS, the blog introduced to me...
Founding Partner and VP of Account Management Toni Barsh,
(SCC Raul Reyes, SCC Barb Lutz, VP Chris Cobourn, SCC Alaina Confer Anderson, Meredith Taylor, Esq., SCC Debbe Saez, SCC Chrissy Spicer, SCC Clarissa Crain, SCC Judy Fox, and Steven Moore, Director of BD)
Q: What’s your background?
A: I graduated with a BA and went right into pharma working for a pharmaceutical advertising agency where I held many roles, but became an Account Manager for CME programs and promotional events. I went from one agency to another, helping clients with patient education and working with brand managers on product positioning and marketing. After following the Ad Agency route for a while, I took a job at Wyeth in the Sales and Marketing Department. I helped with the launch of Norplant and worked in company positioning (as Wyeth products expired, we would allocate surplus products to indigent countries for donations).
A: I graduated with a BA and went right into pharma working for a pharmaceutical advertising agency where I held many roles, but became an Account Manager for CME programs and promotional events. I went from one agency to another, helping clients with patient education and working with brand managers on product positioning and marketing. After following the Ad Agency route for a while, I took a job at Wyeth in the Sales and Marketing Department. I helped with the launch of Norplant and worked in company positioning (as Wyeth products expired, we would allocate surplus products to indigent countries for donations).
*
Ready for a change, I started a little consulting company in marketing/advertising. I then changed direction and joined a clinical training/education subsidiary of Parexel, where I spent 5 years working as the training manager and transitioning into consulting sales. Due to lack of growth, I started my second business in clinical training and process consulting. After 5 years I teamed up with Jim Collins, and the rest is CIS history!
Q: Why did you decide to start CIS?
A: I ran my second consulting company for 5 years, and was burned out being a "single shingle." [CIS Co-Founder] Jim Collins and I collaborated on a new business venture that immediately interested me. We already had a 10 year working relationship, so partnering with Jim was a no brainer. My best professional decision yet!
Q: What projects and product lines do you work with at CIS?
A: I help wherever I am needed. I work primarily in Account Management supporting our managers. I also try to get a bit of Business Development in from time to time.
Q: What do you like about CIS?
A: I love the culture we have created here and the people I work with. I want and need to learn from the people who surround me, and I think we have some of the most talented employees around….people who want to learn, want to grow and want to be challenged!
Q: What’s the best holiday gift you’ve ever gotten (or given)?
A: The best gift I've ever given was a cruise to Bermuda for my parents' 25th wedding anniversary. The best gift I've ever received was the opportunity to adopt a child and become a parent!
*
Email Toni any time at tonibarsh@cis-partners.com!
*
There are currently:
3 days until Christmas, and
4 days until Kwanzaa!
*
Happy Chanukah!
The days are now getting longer!
*
(We at CIS are equal opportunity celebrators!)
Friday, December 19, 2008
On the Tenth Day of CIS...
As reported to Dana Zelig, CIS Compliance Specialist
On the tenth day of CIS, the blog introduced to me...
Senior Compliance Consultant Raul Reyes,
(SCC Barb Lutz, VP Chris Cobourn, SCC Alaina Confer Anderson, Meredith Taylor, Esq., SCC Debbe Saez, SCC Chrissy Spicer, SCC Clarissa Crain, SCC Judy Fox, and Steven Moore, Director of BD)
Q: What’s your background?
A: After completing my BA in Economics at the University of Delaware, I immediately started work on my MPA, concentrating on Health Policy and International Development. During graduate school I worked for the Delaware Health Care Commission, the Delaware Association for Public Administration and the Delaware Department of Health and Social Services. I focused my last year of research on HIV Education and Health programs for disenfranchised youth.
Upon graduation I took a position with the Delaware Department of Services for Children, Youth and their Families developing their Medicare cost recovery program methodology. After about 2 years, I began my career in the Pharmaceutical Industry. During my 7 years in pharma I handled Medicaid claims, dispute resolution, Supplemental and SPAP contracting, and all types of Government Contracting, including managing my company’s FSS contract and all related activities.
Q: Why did you choose to join CIS?
A: I came to CIS needing a change and wanting a challenge. Two former coworkers had already made the switch, and recommended that I do the same. After meeting with Jim Collins, I was convinced that this was an opportunity that I could not walk away from.
Q: What projects and product lines do you work with for CIS?
A: I basically work across all GP activities with a great mix of clients. FSS Assistance, Medicaid data migration, Government Contracting and Pricing assessments, Medicaid claims and Pricing Calculations are all areas I have been involved in since joining CIS. I have been lucky to work with a wide array of clients and products during my time with CIS.
Q: What do you like about CIS?
A: It’s a good time! Great people, interesting work and a team atmosphere.
Q: What are you looking forward to this holiday season?
A: We just adopted two baby brother kittens, so my house is totally crazy this season. Regardless, I am looking forward to filling our home with lots of friends, visiting our families, and plenty of gaiety all around … oh, and of course, the CIS Holiday Party!
Feel free to email Raul any time at raulreyes@cis-partners.com!
There are currently:
6 days until Christmas,
5 days until Chanukah,
7 days until Kwanzaa, and
2 days until Winter Solstice!
(We at CIS are equal opportunity celebrators!)
On the tenth day of CIS, the blog introduced to me...
Senior Compliance Consultant Raul Reyes,
(SCC Barb Lutz, VP Chris Cobourn, SCC Alaina Confer Anderson, Meredith Taylor, Esq., SCC Debbe Saez, SCC Chrissy Spicer, SCC Clarissa Crain, SCC Judy Fox, and Steven Moore, Director of BD)
Q: What’s your background?
A: After completing my BA in Economics at the University of Delaware, I immediately started work on my MPA, concentrating on Health Policy and International Development. During graduate school I worked for the Delaware Health Care Commission, the Delaware Association for Public Administration and the Delaware Department of Health and Social Services. I focused my last year of research on HIV Education and Health programs for disenfranchised youth.
Upon graduation I took a position with the Delaware Department of Services for Children, Youth and their Families developing their Medicare cost recovery program methodology. After about 2 years, I began my career in the Pharmaceutical Industry. During my 7 years in pharma I handled Medicaid claims, dispute resolution, Supplemental and SPAP contracting, and all types of Government Contracting, including managing my company’s FSS contract and all related activities.
Q: Why did you choose to join CIS?
A: I came to CIS needing a change and wanting a challenge. Two former coworkers had already made the switch, and recommended that I do the same. After meeting with Jim Collins, I was convinced that this was an opportunity that I could not walk away from.
Q: What projects and product lines do you work with for CIS?
A: I basically work across all GP activities with a great mix of clients. FSS Assistance, Medicaid data migration, Government Contracting and Pricing assessments, Medicaid claims and Pricing Calculations are all areas I have been involved in since joining CIS. I have been lucky to work with a wide array of clients and products during my time with CIS.
Q: What do you like about CIS?
A: It’s a good time! Great people, interesting work and a team atmosphere.
Q: What are you looking forward to this holiday season?
A: We just adopted two baby brother kittens, so my house is totally crazy this season. Regardless, I am looking forward to filling our home with lots of friends, visiting our families, and plenty of gaiety all around … oh, and of course, the CIS Holiday Party!
Feel free to email Raul any time at raulreyes@cis-partners.com!
There are currently:
6 days until Christmas,
5 days until Chanukah,
7 days until Kwanzaa, and
2 days until Winter Solstice!
(We at CIS are equal opportunity celebrators!)
Living in the Disclosure Era: Pharmaceuticals and Medical Devices
By: Alaina Confer, CIS Senior Compliance Specialist
alainaconfer@cis-partners.com
Disclosure. Transparancy. These have become buzzwords across many industries, including the pharmaceutical, biotechnology and medical device industries. Throughout November, we frequently heard of Senator Grassley’s investigations of physician payments, as well as the proposed Physician Payments Sunshine Act (FDALegislativeWatch.com, 2008). The bill was introduced in March 2008 and if approved would require pharmaceutical and medical device makers to disclose payments to physicians in excess of $500.
Many believe that the act will be passed, it’s just a matter of time and what details will be approved. Meanwhile, some companies are voluntarily changing their policies and adopting procedures to publicly disclose physician compensation by posting the details on websites (O'Reilly, 2008). And more recently in the news, we hear of medical centers taking the initiative to disclose their physicians’ compensation from the pharmaceutical industry (Grayson, 2008).
What does this mean for your company?
1. Hopefully the act will preempt state law. Some state laws, e.g., Vermont, mandate disclosure of payments and gifts over $25. For the sake of saving some headaches, the over $500 specification seems so much more reasonable. After all, if the disclose is for the sake of the public, wouldn’t the public get discouraged if they had to sift through extraordinary number of listings for $25 to $500? I know I would, and then you’ve lost the purpose of this whole thing.
2. With the voluntary disclosure increasing, you had better not wait to make sure your organization has a straight-forward, clear and consistent policy and procedure for determining physician compensation for the various activities for which you are engaging them. Take a good hard look at your company’s practices and do what is necessary, because it won’t be long until the laundry is hung for the world to see (I’m not saying you’ve got dirty laundry, just that it’s going to be hung regardless).
3. Assess how your payments compare to your competitors. No doubt, the outliers will be questioned. I anticipate we will see shifts in payments until a sort of equilibrium is reached among the industry of what appropriate and fair payments are. If your payments are currently high, the disclosure movement is actually good news; it will equal cost savings as you most certainly need to lower your payments. The physicians will no longer be able to negotiate higher fees because they are just as well aware of this disclosure movement as we are. I can’t tell you where the equilibrium will rest, but know that this adjustment is coming.
One way or another, this is happening. Be ready.
Works Cited:
FDALegislativeWatch.com. (2008, May 20). Retrieved December 05, 2008, from FDA Legislative Watch: http://www.fdalegislativewatch.com/2008/05/grassley-kohl-r.html
Grayson, A. (2008, December 04). abcnews.com. Retrieved December 04, 2008, from ABC News: http://abcnews.go.com/print?id=6385382
O'Reilly, K. B. (2008, November 17). amednews.com. Retrieved December 05, 2008, from American Medical News: http://www.ama-assn.org/amednews/2008/11/17/prsa1117.htm
alainaconfer@cis-partners.com
Disclosure. Transparancy. These have become buzzwords across many industries, including the pharmaceutical, biotechnology and medical device industries. Throughout November, we frequently heard of Senator Grassley’s investigations of physician payments, as well as the proposed Physician Payments Sunshine Act (FDALegislativeWatch.com, 2008). The bill was introduced in March 2008 and if approved would require pharmaceutical and medical device makers to disclose payments to physicians in excess of $500.
Many believe that the act will be passed, it’s just a matter of time and what details will be approved. Meanwhile, some companies are voluntarily changing their policies and adopting procedures to publicly disclose physician compensation by posting the details on websites (O'Reilly, 2008). And more recently in the news, we hear of medical centers taking the initiative to disclose their physicians’ compensation from the pharmaceutical industry (Grayson, 2008).
What does this mean for your company?
1. Hopefully the act will preempt state law. Some state laws, e.g., Vermont, mandate disclosure of payments and gifts over $25. For the sake of saving some headaches, the over $500 specification seems so much more reasonable. After all, if the disclose is for the sake of the public, wouldn’t the public get discouraged if they had to sift through extraordinary number of listings for $25 to $500? I know I would, and then you’ve lost the purpose of this whole thing.
2. With the voluntary disclosure increasing, you had better not wait to make sure your organization has a straight-forward, clear and consistent policy and procedure for determining physician compensation for the various activities for which you are engaging them. Take a good hard look at your company’s practices and do what is necessary, because it won’t be long until the laundry is hung for the world to see (I’m not saying you’ve got dirty laundry, just that it’s going to be hung regardless).
3. Assess how your payments compare to your competitors. No doubt, the outliers will be questioned. I anticipate we will see shifts in payments until a sort of equilibrium is reached among the industry of what appropriate and fair payments are. If your payments are currently high, the disclosure movement is actually good news; it will equal cost savings as you most certainly need to lower your payments. The physicians will no longer be able to negotiate higher fees because they are just as well aware of this disclosure movement as we are. I can’t tell you where the equilibrium will rest, but know that this adjustment is coming.
One way or another, this is happening. Be ready.
Works Cited:
FDALegislativeWatch.com. (2008, May 20). Retrieved December 05, 2008, from FDA Legislative Watch: http://www.fdalegislativewatch.com/2008/05/grassley-kohl-r.html
Grayson, A. (2008, December 04). abcnews.com. Retrieved December 04, 2008, from ABC News: http://abcnews.go.com/print?id=6385382
O'Reilly, K. B. (2008, November 17). amednews.com. Retrieved December 05, 2008, from American Medical News: http://www.ama-assn.org/amednews/2008/11/17/prsa1117.htm
Thursday, December 18, 2008
On the Ninth Day of CIS...
As reported to Matt Hotz, CIS Compliance Specialist
On the ninth day of CIS, the blog introduced to me...
Senior Compliance Consultant Barb Lutz,
(VP Chris Cobourn, SCC Alaina Confer Anderson, Meredith Taylor, Esq., SCC Debbe Saez, SCC Chrissy Spicer, SCC Clarissa Crain, SCC Judy Fox, and Steven Moore, Director of BD)
Q: What’s your background?
A: I received my Bachelor's Degree in Computer Information Systems from Rider University. Prior to joining CIS I spent 8 years working at I-many, assisting with the implementation and support of Medicaid and Government Pricing systems for pharmaceutical manufacturers. During my time with I-many I had the opportunity to present at various Medicaid and GP conferences, and was able to meet many of CIS' clients and current employees, including VP Chris Cobourn who helped bring me on board!
Q: Why did you choose to join CIS?
A: Joining CIS gave me the opportunity to expand my Medicaid and Government Pricing knowledge in other areas besides software. I think the assessments and audits CIS performs are very important for drug manufacturers, and I'm excited to be a part of ensuring that they stay compliant with government regulations.
Q: What projects and product lines do you work with for CIS?
A: I am currently acting as a Project Manager, overseeing various GP and Medicaid assessments for our AWESOME clients!
Q: What do you like about CIS?
A: I really enjoy the people I work with. All my co-workers are extremely knowledgeable in the Government Pricing and Medicaid space. I'm really proud of our product offerings, especially the PCX, which is a very useful and necessary tool. I also enjoy the monthly newsletter!
Q: What’s your favorite holiday movie?
A: It would have to be National Lampoon's Christmas Vacation. That movie makes me laugh out loud every time.
Feel free to email Barb any time at barblutz@cis-partners.com!
There are currently:
7 days until Christmas,
6 days until Chanukah,
8 days until Kwanzaa, and
3 days until Winter Solstice!
(We at CIS are equal opportunity celebrators!)
On the ninth day of CIS, the blog introduced to me...
Senior Compliance Consultant Barb Lutz,
(VP Chris Cobourn, SCC Alaina Confer Anderson, Meredith Taylor, Esq., SCC Debbe Saez, SCC Chrissy Spicer, SCC Clarissa Crain, SCC Judy Fox, and Steven Moore, Director of BD)
Q: What’s your background?
A: I received my Bachelor's Degree in Computer Information Systems from Rider University. Prior to joining CIS I spent 8 years working at I-many, assisting with the implementation and support of Medicaid and Government Pricing systems for pharmaceutical manufacturers. During my time with I-many I had the opportunity to present at various Medicaid and GP conferences, and was able to meet many of CIS' clients and current employees, including VP Chris Cobourn who helped bring me on board!
Q: Why did you choose to join CIS?
A: Joining CIS gave me the opportunity to expand my Medicaid and Government Pricing knowledge in other areas besides software. I think the assessments and audits CIS performs are very important for drug manufacturers, and I'm excited to be a part of ensuring that they stay compliant with government regulations.
Q: What projects and product lines do you work with for CIS?
A: I am currently acting as a Project Manager, overseeing various GP and Medicaid assessments for our AWESOME clients!
Q: What do you like about CIS?
A: I really enjoy the people I work with. All my co-workers are extremely knowledgeable in the Government Pricing and Medicaid space. I'm really proud of our product offerings, especially the PCX, which is a very useful and necessary tool. I also enjoy the monthly newsletter!
Q: What’s your favorite holiday movie?
A: It would have to be National Lampoon's Christmas Vacation. That movie makes me laugh out loud every time.
Feel free to email Barb any time at barblutz@cis-partners.com!
There are currently:
7 days until Christmas,
6 days until Chanukah,
8 days until Kwanzaa, and
3 days until Winter Solstice!
(We at CIS are equal opportunity celebrators!)
Daschle May Lead to Lambrew
By Mike Kurland, CIS Senior Compliance Specialist
mikekurland@cis-partners.com
By now, I am sure you are aware that President-elect Barack Obama has selected Former Senate majority leader Thomas A. Daschle as his choice for Secretary of Health and Human Services (HHS). HHS has over 65,000 employees and a budget of $707.7 billion, accounting for nearly one-quarter of all federal spending, second only to the Defense Department.[1] Mr. Daschle will be expected to do more than simply manage the department, however. President-elect Obama also expects him to push health care reform through Congress, and manage its progress. It is speculated that Mr. Daschle will turn to Jeanne Lambrew, the co-author of Daschle’s book “Critical: What We Can Do About the Health-Care Crises,” for advice. She may soon be involved in important health care policy decisions, so what do we know about Jeanne Lambrew?
Jeanne Lambrew is a Senior Fellow at the Center for American Progress, a think tank founded by former Clinton White House Chief of Staff John Podesta. She is also an Associate Professor of Public Affairs at the Lyndon B. Johnson School of Public Affairs at the University of Texas. Lambrew has conducted vast research and has spoken before congress on the uninsured, and on government programs such as Medicaid, Medicare, and long-term care.
Previously, Lambrew was an Associate Professor with the Department of Health Policy at The George Washington University School of Public Health and Health Services, and she worked on health care policy for the Clinton administration from 1997 to 2001.
In the past, Lambrew has called for “Extending and simplifying Medicaid nationwide (e.g., to 100 to 150 percent of poverty)” and for a plan that would expect people to enroll in an insurance option (private or federal) or pay an income-related assessment to support the care that they will inevitably use; Medicaid would be the default payer for such people[2].
Lambrew has been a strong supporter of public programs, and has testified before congress that they are important public safety nets. Lambrew cautioned that any changes to these programs should be made carefully, to avoid the loss or reduction of health care coverage for those requiring these programs the most.
[1] Washington Post (2008, December 5). Citing electronic sources retrieved October 5, 2008 from:
http://www.washingtonpost.com/wp-dyn/content/article/2008/12/04/AR2008120403716.html?hpid=topnews
[2] Meeting the Challenge of Covering all Americans by 2010 (2005, July 10). Citing electronic sources retrieved December 5, 2008 from:
www.results.org/website/navdispatch.asp?id=1681
mikekurland@cis-partners.com
By now, I am sure you are aware that President-elect Barack Obama has selected Former Senate majority leader Thomas A. Daschle as his choice for Secretary of Health and Human Services (HHS). HHS has over 65,000 employees and a budget of $707.7 billion, accounting for nearly one-quarter of all federal spending, second only to the Defense Department.[1] Mr. Daschle will be expected to do more than simply manage the department, however. President-elect Obama also expects him to push health care reform through Congress, and manage its progress. It is speculated that Mr. Daschle will turn to Jeanne Lambrew, the co-author of Daschle’s book “Critical: What We Can Do About the Health-Care Crises,” for advice. She may soon be involved in important health care policy decisions, so what do we know about Jeanne Lambrew?
Jeanne Lambrew is a Senior Fellow at the Center for American Progress, a think tank founded by former Clinton White House Chief of Staff John Podesta. She is also an Associate Professor of Public Affairs at the Lyndon B. Johnson School of Public Affairs at the University of Texas. Lambrew has conducted vast research and has spoken before congress on the uninsured, and on government programs such as Medicaid, Medicare, and long-term care.
Previously, Lambrew was an Associate Professor with the Department of Health Policy at The George Washington University School of Public Health and Health Services, and she worked on health care policy for the Clinton administration from 1997 to 2001.
In the past, Lambrew has called for “Extending and simplifying Medicaid nationwide (e.g., to 100 to 150 percent of poverty)” and for a plan that would expect people to enroll in an insurance option (private or federal) or pay an income-related assessment to support the care that they will inevitably use; Medicaid would be the default payer for such people[2].
Lambrew has been a strong supporter of public programs, and has testified before congress that they are important public safety nets. Lambrew cautioned that any changes to these programs should be made carefully, to avoid the loss or reduction of health care coverage for those requiring these programs the most.
[1] Washington Post (2008, December 5). Citing electronic sources retrieved October 5, 2008 from:
http://www.washingtonpost.com/wp-dyn/content/article/2008/12/04/AR2008120403716.html?hpid=topnews
[2] Meeting the Challenge of Covering all Americans by 2010 (2005, July 10). Citing electronic sources retrieved December 5, 2008 from:
www.results.org/website/navdispatch.asp?id=1681
Wednesday, December 17, 2008
On the Eighth Day of CIS...
As reported to Dana Zelig, CIS Compliance Specialist
On the eighth day of CIS, the blog introduced to me...
VP of Regulatory Compliance Chris Cobourn,
(SCC Alaina Confer Anderson, Meredith Taylor, Esq., SCC Debbe Saez, SCC Chrissy Spicer, SCC Clarissa Crain, SCC Judy Fox, and Steven Moore, Director of BD)
Q: What’s your background?
A: Prior to coming to CIS, I worked for I-many (hence my living in the fine state of Maine!) and KPMG. I have a Masters of Education, with a focus on technical training, and had done corporate software implementation and training for many years.
I began at a small and growing company called SCC (the precursor to I-many) as a technical trainer and business analyst, where I thoroughly enjoyed the experience of implementing Contracting Systems and getting to know the Pharma industry. Dave Cannell recruited me into the Product Management Department, where I became the Director of Life Sciences. It was in this role that myself and Mark Sabatelli (also now with CIS!) saw where Government Program Compliance was going and identified the need to develop a commercial GP System.
At I-many, I found myself spending more and more time working in a consultative role in the industry, especially in the rapidly evolving GP area, and so I made the switch to pure consulting by joining KPMG’s pharma practice. As a manager at KPMG I worked with the fine people at King Pharmaceuticals, helping them through the long process leading up to their CIA, which I still consider a benchmark case in the GP area. I consider it an honor today to be considered a GP Geek!
Q: Why did you choose to join CIS?
A: I believed in the vision of company founders Jim Collins and Toni Barsh. We believed we could take consulting in a new direction, and felt real opportunity and need in the industry, especially in the GP and Corporate Compliance space. As VP of Regulatory Compliance, my role at CIS is to build these practices. To me that meant building a team of strong industry professionals, and establishing our skill sets in the areas of Subject Matter Expertise, Experience, Thought Leadership, and Audit. My first hires Clarissa Crain, Katie Lapins, and Chrissy Spicer have helped me build that team, which continues to expand and grow!
Our first initiative was the Pharma Compliance Exchange, or PCX, which is a truly innovative service that has changed the way the industry views Authoritative Guidance Libraries. We soon added the monthly PCX Newsletter, the Pharma Compliance Blog, our “GP 101” training presentation, and our CalcPartner offering. So, in addition to the quality of work we were performing in GP and Compliance consulting, it was a unique opportunity to develop and deliver unique and innovative service offerings.
Q: What projects and product lines do you work with for CIS?
A: I work across most of our service offerings, but concentrate mostly on Corporate Compliance, Government Programs and Audit Services (for both commercial and government groups). Clarissa Crain leads our GP Audit Services; Chrissy Spicer and Judy Fox lead audits in the Commercial Compliance areas. Companies large and small are shifting their focus to monitoring and audit, trying to understand what it means to be “audit ready,” and wanting to make sure that they feel prepared in the event of a Government audit. So I am spending a lot of time at conferences and webinars talking about Monitoring and Audit.
Q: What do you like about CIS?
A: I really enjoy, and thrive in, the professional and collaborative environment we have developed. It is difficult to find people with all the skill sets that we are looking for, including strong subject matter expertise, industry experience, project management abilities, and the ability to communicate well with clients. Our staff is exceptional and have an amazing work ethic. It is not unusual to see late night and early morning emails, or to see the staff rolling up their sleeves and working late in the office when the need is there. In the end, this is very important work we are doing for our clients. We have to be completely committed to it. I am very proud of the team we have put together and of the work we do.
Q: How do you celebrate the holidays in Maine? Is it kind of like the North Pole?
A: What can I say, Maine is the best - all seasons of the year! We are hoping for a cold streak and some snow so that we can enjoy some winter hikes, skiing and ice skating! Nothing beats a winter weekend day like having a bonfire, hot chocolate, and all day skating party! (Yes, it is something like the North Pole!)
Feel free to email CIS’ resident elf Chris Cobourn any time at chriscobourn@cis-partners.com!
There are currently:
8 days until Christmas,
7 days until Chanukah,
9 days until Kwanzaa, and
4 days until Winter Solstice!
(We at CIS are equal opportunity celebrators!)
On the eighth day of CIS, the blog introduced to me...
VP of Regulatory Compliance Chris Cobourn,
(SCC Alaina Confer Anderson, Meredith Taylor, Esq., SCC Debbe Saez, SCC Chrissy Spicer, SCC Clarissa Crain, SCC Judy Fox, and Steven Moore, Director of BD)
Q: What’s your background?
A: Prior to coming to CIS, I worked for I-many (hence my living in the fine state of Maine!) and KPMG. I have a Masters of Education, with a focus on technical training, and had done corporate software implementation and training for many years.
I began at a small and growing company called SCC (the precursor to I-many) as a technical trainer and business analyst, where I thoroughly enjoyed the experience of implementing Contracting Systems and getting to know the Pharma industry. Dave Cannell recruited me into the Product Management Department, where I became the Director of Life Sciences. It was in this role that myself and Mark Sabatelli (also now with CIS!) saw where Government Program Compliance was going and identified the need to develop a commercial GP System.
At I-many, I found myself spending more and more time working in a consultative role in the industry, especially in the rapidly evolving GP area, and so I made the switch to pure consulting by joining KPMG’s pharma practice. As a manager at KPMG I worked with the fine people at King Pharmaceuticals, helping them through the long process leading up to their CIA, which I still consider a benchmark case in the GP area. I consider it an honor today to be considered a GP Geek!
Q: Why did you choose to join CIS?
A: I believed in the vision of company founders Jim Collins and Toni Barsh. We believed we could take consulting in a new direction, and felt real opportunity and need in the industry, especially in the GP and Corporate Compliance space. As VP of Regulatory Compliance, my role at CIS is to build these practices. To me that meant building a team of strong industry professionals, and establishing our skill sets in the areas of Subject Matter Expertise, Experience, Thought Leadership, and Audit. My first hires Clarissa Crain, Katie Lapins, and Chrissy Spicer have helped me build that team, which continues to expand and grow!
Our first initiative was the Pharma Compliance Exchange, or PCX, which is a truly innovative service that has changed the way the industry views Authoritative Guidance Libraries. We soon added the monthly PCX Newsletter, the Pharma Compliance Blog, our “GP 101” training presentation, and our CalcPartner offering. So, in addition to the quality of work we were performing in GP and Compliance consulting, it was a unique opportunity to develop and deliver unique and innovative service offerings.
Q: What projects and product lines do you work with for CIS?
A: I work across most of our service offerings, but concentrate mostly on Corporate Compliance, Government Programs and Audit Services (for both commercial and government groups). Clarissa Crain leads our GP Audit Services; Chrissy Spicer and Judy Fox lead audits in the Commercial Compliance areas. Companies large and small are shifting their focus to monitoring and audit, trying to understand what it means to be “audit ready,” and wanting to make sure that they feel prepared in the event of a Government audit. So I am spending a lot of time at conferences and webinars talking about Monitoring and Audit.
Q: What do you like about CIS?
A: I really enjoy, and thrive in, the professional and collaborative environment we have developed. It is difficult to find people with all the skill sets that we are looking for, including strong subject matter expertise, industry experience, project management abilities, and the ability to communicate well with clients. Our staff is exceptional and have an amazing work ethic. It is not unusual to see late night and early morning emails, or to see the staff rolling up their sleeves and working late in the office when the need is there. In the end, this is very important work we are doing for our clients. We have to be completely committed to it. I am very proud of the team we have put together and of the work we do.
Q: How do you celebrate the holidays in Maine? Is it kind of like the North Pole?
A: What can I say, Maine is the best - all seasons of the year! We are hoping for a cold streak and some snow so that we can enjoy some winter hikes, skiing and ice skating! Nothing beats a winter weekend day like having a bonfire, hot chocolate, and all day skating party! (Yes, it is something like the North Pole!)
Feel free to email CIS’ resident elf Chris Cobourn any time at chriscobourn@cis-partners.com!
There are currently:
8 days until Christmas,
7 days until Chanukah,
9 days until Kwanzaa, and
4 days until Winter Solstice!
(We at CIS are equal opportunity celebrators!)
Tuesday, December 16, 2008
On the Seventh Day of CIS...
As reported to Dana Zelig, CIS Compliance Specialist
On the seventh day of CIS, the blog introduced to me...
Senior Compliance Consultant Alaina Confer Anderson,
(Meredith Taylor, Esq., SCC Debbe Saez, SCC Chrissy Spicer, SCC Clarissa Crain, SCC Judy Fox, and Steven Moore, Director of BD)
Q: What’s your background?
A: How far back do you really want me to go?
Educationally, I have a BA in Psychobiology. I always get a raised eyebrow with that one. It’s a mix of psychology and biology, including topics such as animal behavior and evolution. And in just one more semester I’ll have my MBA in Biotechnology and Health Industry Management. I can’t wait to have those two nights a week back, but it was worth it.
Professionally, for four years I worked in a GLP environment at Covance; some of that time I spent as a Lab Technician and the remainder as a QA auditor. The QA position was one of my favorites due to the variety of work from general toxicology to developmental and genetic toxicology, including hosting client visits/audits and FDA inspections. From there I transitioned to Clinical Research via a Data Management position. Over the course of 1 ½ years this provided the opportunity to become acclimated to Clinical Research, the associated challenges and the related regulations.
Q: Why did you choose to join CIS?
A: For the variety of work. Although, I was with Covance for over 5 years I found that in each position I learned quickly, reached a plateau and then started looking for new opportunities. With CIS, I do not have to look for new positions to fulfill my eagerness to learn. I’ve been able to work with clients of all shapes and sizes (small to large, local to international) as well as projects of varying topics, such as Corporate Compliance Programs and Research and Development procedural documents.
Q: What projects and product lines do you work with for CIS?
A: Currently, I am balancing my time between two very different projects.
Email Alaina any time at alainaconfer@cis-partners.com!
There are currently:
9 days until Christmas,
6 days until Chanukah,
10 days until Kwanzaa, and
5 days until Winter Solstice!
(We at CIS are equal opportunity celebrators!)
On the seventh day of CIS, the blog introduced to me...
Senior Compliance Consultant Alaina Confer Anderson,
(Meredith Taylor, Esq., SCC Debbe Saez, SCC Chrissy Spicer, SCC Clarissa Crain, SCC Judy Fox, and Steven Moore, Director of BD)
Q: What’s your background?
A: How far back do you really want me to go?
Educationally, I have a BA in Psychobiology. I always get a raised eyebrow with that one. It’s a mix of psychology and biology, including topics such as animal behavior and evolution. And in just one more semester I’ll have my MBA in Biotechnology and Health Industry Management. I can’t wait to have those two nights a week back, but it was worth it.
Professionally, for four years I worked in a GLP environment at Covance; some of that time I spent as a Lab Technician and the remainder as a QA auditor. The QA position was one of my favorites due to the variety of work from general toxicology to developmental and genetic toxicology, including hosting client visits/audits and FDA inspections. From there I transitioned to Clinical Research via a Data Management position. Over the course of 1 ½ years this provided the opportunity to become acclimated to Clinical Research, the associated challenges and the related regulations.
Q: Why did you choose to join CIS?
A: For the variety of work. Although, I was with Covance for over 5 years I found that in each position I learned quickly, reached a plateau and then started looking for new opportunities. With CIS, I do not have to look for new positions to fulfill my eagerness to learn. I’ve been able to work with clients of all shapes and sizes (small to large, local to international) as well as projects of varying topics, such as Corporate Compliance Programs and Research and Development procedural documents.
Q: What projects and product lines do you work with for CIS?
A: Currently, I am balancing my time between two very different projects.
One is developing and implementing a Corporate Compliance Program for a small Pharmaceutical firm that is approaching the launch of their first product. This company is a pleasure to work with, they are small, flexible and so appreciative of our help.
The other is an internal initiative. As you know, in 2007 CIS launched the Pharma Compliance Exchange (PCX), a library of statutes, regulations, and guidance documents regarding the US Government Programs. I’m working on developing a Clinical portion of the PCX. This is a regulatory library of the statutes, regulations, and guidance documents from the relevant agencies of the United States and European Union covering topics from filing for clinical trial authorization to marketing authorization. We anticipate launching the site in February 2009. We will then continue to update the Clinical R&D PCX as regulatory updates become available, as well as expand the scope to include other international regulations.
Q: What do you like about CIS?
A: I can wear flip flops to work. I also love the collaboration. CIS is made up of people with all different types of backgrounds and strengths, it is so often that we call on each other for assistance. We are all constantly learning from each other.
Q: You recently became Alaina Confer Anderson. How will the holidays be different now that you’re married?
A: It’s busier, busier, busier. To cover both families, we’ll be travelling to Delaware, Central Pennsylvania and North Carolina over the holidays. It was so much easier when I could go where I wanted, when I wanted. But it’s totally worth it, I love sharing my life with my husband.
Email Alaina any time at alainaconfer@cis-partners.com!
There are currently:
9 days until Christmas,
6 days until Chanukah,
10 days until Kwanzaa, and
5 days until Winter Solstice!
(We at CIS are equal opportunity celebrators!)
Shortage of Primary Care Physicians + Healthcare Reform = Disaster
By: Jessica Ebert, CIS Compliance Specialist
jessicaebert@cis-partners.com
As we all know, one of the biggest debatable issues during this year’s presidential election was health care reform. Even though it has only been a month since the election, the new Administration is already developing proposals for change. Suma Kallurkar’s post several weeks ago reported on the Baucus Plan for Health Care Reform, which would provide access to health care for everyone through a national insurance pool. As a recent graduate who went without health insurance for seven months, I know how it feels to be one of more than 40 million uninsured Americans. I personally would love to see a reform that allows everyone to be covered, but I also think it is important to consider the effects that it would have on our health care providers, specifically primary care physicians. Many of them are already operating at maximum capacity, so what will happen if we throw another forty million people at them?
A survey recently released by The Physicians’ Foundation portrays the frustrations and dissatisfaction that primary care physicians are feeling toward their practices, and indicates that almost half of the nation’s primary care physicians said that they would quit the practice of medicine if they were offered an alternative[1]. Well, perhaps some aren’t entirely ready to quit, so instead they are reducing the number of patients they see. As a newly-hired CIS associate, I became eligible for insurance, and in my search for a new primary care physician I have found the preceding statement to be very true. Many of the offices I have contacted are no longer accepting new patients. And as many of you know, even if you’ve been seeing the same physician for years, you have to schedule an appointment several months in advance because the office is so busy. For us, the patients, it’s easy to get frustrated with the process of finding a doctor, making appointments, dealing with wait times and insurance issues, but few people realize that doctors are just as aggravated with the same issues.
So what is going on? Why are primary care physicians ready to throw in the towel? Low reimbursement rates from insurance companies, as well as difficulty and delays in receiving them, are among the biggest complaints. In response, many physicians limit the types of insurance they accept and are even closing their practices to those on Medicare or Medicaid. Another complaint is that physicians have to spend so much time on cumbersome non-clinical paperwork that could otherwise have been devoted to their patients’ needs[2]. Combine these factors with the rising cost of malpractice insurance and tight government regulations, and no one would even want to become a primary care physician, right?
Unfortunately, that is right. Medical students who were once planning on becoming primary care physicians are now switching to a sub-specialty after witnessing the current situations of many practicing physicians. According to a survey published in the Journal of the American Medical Association in September, only 2% of current medical students are preparing to specialize in primary care.Two percent! If that’s not enough to scare you, the AMA is also predicting that by the year 2025, there will be a shortage of 35,000 to 40,000 physicians[2]. You do the math here- we could be headed for a big problem.
So, let’s say our healthcare system changes and everyone becomes eligible for health insurance; the question is will there be enough primary care physicians available to offer them all services? With 49% of physicians reducing their number of patients, or ready to quit, they might be difficult to find.
As members of the incoming Obama Administration begin proposing ideas for health care reform, I think it’s very important that they look to other areas that also need reform. In order to support a nation of newly insured individuals, we need more primary care physicians. And in order to maintain our current physicians, as well as inspire medical students to choose the same path, we need to make some big changes to the insurance industry and lighten up on governmental regulations, making it manageable to be a primary care physician again.
To read more about The Physicians' Foundation and view their complete survey, please visit www.physiciansfoundation.org.
__________________________________
1. http://www.physiciansfoundations.org/news/news_show.htm?doc_id=728872
2. http://www.cnn.com/2008/HEALTH/11/17/primary.care.doctors.study/index.html
jessicaebert@cis-partners.com
As we all know, one of the biggest debatable issues during this year’s presidential election was health care reform. Even though it has only been a month since the election, the new Administration is already developing proposals for change. Suma Kallurkar’s post several weeks ago reported on the Baucus Plan for Health Care Reform, which would provide access to health care for everyone through a national insurance pool. As a recent graduate who went without health insurance for seven months, I know how it feels to be one of more than 40 million uninsured Americans. I personally would love to see a reform that allows everyone to be covered, but I also think it is important to consider the effects that it would have on our health care providers, specifically primary care physicians. Many of them are already operating at maximum capacity, so what will happen if we throw another forty million people at them?
A survey recently released by The Physicians’ Foundation portrays the frustrations and dissatisfaction that primary care physicians are feeling toward their practices, and indicates that almost half of the nation’s primary care physicians said that they would quit the practice of medicine if they were offered an alternative[1]. Well, perhaps some aren’t entirely ready to quit, so instead they are reducing the number of patients they see. As a newly-hired CIS associate, I became eligible for insurance, and in my search for a new primary care physician I have found the preceding statement to be very true. Many of the offices I have contacted are no longer accepting new patients. And as many of you know, even if you’ve been seeing the same physician for years, you have to schedule an appointment several months in advance because the office is so busy. For us, the patients, it’s easy to get frustrated with the process of finding a doctor, making appointments, dealing with wait times and insurance issues, but few people realize that doctors are just as aggravated with the same issues.
So what is going on? Why are primary care physicians ready to throw in the towel? Low reimbursement rates from insurance companies, as well as difficulty and delays in receiving them, are among the biggest complaints. In response, many physicians limit the types of insurance they accept and are even closing their practices to those on Medicare or Medicaid. Another complaint is that physicians have to spend so much time on cumbersome non-clinical paperwork that could otherwise have been devoted to their patients’ needs[2]. Combine these factors with the rising cost of malpractice insurance and tight government regulations, and no one would even want to become a primary care physician, right?
Unfortunately, that is right. Medical students who were once planning on becoming primary care physicians are now switching to a sub-specialty after witnessing the current situations of many practicing physicians. According to a survey published in the Journal of the American Medical Association in September, only 2% of current medical students are preparing to specialize in primary care.Two percent! If that’s not enough to scare you, the AMA is also predicting that by the year 2025, there will be a shortage of 35,000 to 40,000 physicians[2]. You do the math here- we could be headed for a big problem.
So, let’s say our healthcare system changes and everyone becomes eligible for health insurance; the question is will there be enough primary care physicians available to offer them all services? With 49% of physicians reducing their number of patients, or ready to quit, they might be difficult to find.
As members of the incoming Obama Administration begin proposing ideas for health care reform, I think it’s very important that they look to other areas that also need reform. In order to support a nation of newly insured individuals, we need more primary care physicians. And in order to maintain our current physicians, as well as inspire medical students to choose the same path, we need to make some big changes to the insurance industry and lighten up on governmental regulations, making it manageable to be a primary care physician again.
To read more about The Physicians' Foundation and view their complete survey, please visit www.physiciansfoundation.org.
__________________________________
1. http://www.physiciansfoundations.org/news/news_show.htm?doc_id=728872
2. http://www.cnn.com/2008/HEALTH/11/17/primary.care.doctors.study/index.html
Monday, December 15, 2008
On the Sixth Day of CIS...
As reported to Dana Zelig, CIS Compliance Specialist
On the sixth day of CIS, the blog introduced to me...
Meredith Taylor, Esq., Senior Compliance Consultant & PCX Product Manager,
(SCC Debbe Saez, SCC Chrissy Spicer, SCC Clarissa Crain, SCC Judy Fox, and Steven Moore, Director of BD)
Q: What’s your background?
A: Before I came to CIS, I practiced law in Philadelphia for two years for a mid-sized litigation law firm. My practice included workers’ compensation where I represented employers and insurance companies, and personal injury where I represented injured people.
Q: Why did you choose to join CIS?
A: My interest in the healthcare arena and compliance issues led me to CIS. I was no longer interested in the litigation aspect of my job, so I began searching for a job where I could use my law degree and focus on healthcare issues. Pharmaceutical compliance was the perfect area for me to get into, and luckily CIS had an opening. That’s how I ended up here.
Q: What projects and product lines do you work with for CIS?
A: I currently wear many hats at CIS. The subject areas I focus on are Government Programs, corporate, and commercial compliance. The types of projects I have worked on include: drafting policies and procedures, conducting assessments and audits, Class of Trade validation, presenting training sessions on various areas of compliance, and preparing government communications. I am also the Product Manager for the Parma Compliance Exchange (PCX), which is an Internet website that houses GP laws, statutes, and guidance documents. I offer WebEx demonstrations to potential clients to show them how to use the product. Finally, I am the Editor-In-Chief of the CIS newsletter, which is circulated to our PCX clients once a month.
Q: What’s your favorite holiday cartoon on TV?
A: My favorite holiday movie would definitely be “A Christmas Story.” It’s my Dad’s favorite movie, and I have probably seen it over 100 times. My favorite holiday cartoon would probably be “The Grinch. “
Q: What do you like about CIS?
A: My favorite thing about CIS is the variety of things I get to do on a daily basis. My job is different day to day; I never know what to expect. Also, I love interacting with all of my clients, in both large and small pharma companies, and helping them resolve their compliance issues.
Email Meredith any time at meredithtaylor@cis-partners.com!
There are currently:
10 days until Christmas,
7 days until Chanukah,
11 days until Kwanzaa, and
6 days until Winter Solstice!
(We at CIS are equal opportunity celebrators!)
On the sixth day of CIS, the blog introduced to me...
Meredith Taylor, Esq., Senior Compliance Consultant & PCX Product Manager,
(SCC Debbe Saez, SCC Chrissy Spicer, SCC Clarissa Crain, SCC Judy Fox, and Steven Moore, Director of BD)
Q: What’s your background?
A: Before I came to CIS, I practiced law in Philadelphia for two years for a mid-sized litigation law firm. My practice included workers’ compensation where I represented employers and insurance companies, and personal injury where I represented injured people.
Q: Why did you choose to join CIS?
A: My interest in the healthcare arena and compliance issues led me to CIS. I was no longer interested in the litigation aspect of my job, so I began searching for a job where I could use my law degree and focus on healthcare issues. Pharmaceutical compliance was the perfect area for me to get into, and luckily CIS had an opening. That’s how I ended up here.
Q: What projects and product lines do you work with for CIS?
A: I currently wear many hats at CIS. The subject areas I focus on are Government Programs, corporate, and commercial compliance. The types of projects I have worked on include: drafting policies and procedures, conducting assessments and audits, Class of Trade validation, presenting training sessions on various areas of compliance, and preparing government communications. I am also the Product Manager for the Parma Compliance Exchange (PCX), which is an Internet website that houses GP laws, statutes, and guidance documents. I offer WebEx demonstrations to potential clients to show them how to use the product. Finally, I am the Editor-In-Chief of the CIS newsletter, which is circulated to our PCX clients once a month.
Q: What’s your favorite holiday cartoon on TV?
A: My favorite holiday movie would definitely be “A Christmas Story.” It’s my Dad’s favorite movie, and I have probably seen it over 100 times. My favorite holiday cartoon would probably be “The Grinch. “
Q: What do you like about CIS?
A: My favorite thing about CIS is the variety of things I get to do on a daily basis. My job is different day to day; I never know what to expect. Also, I love interacting with all of my clients, in both large and small pharma companies, and helping them resolve their compliance issues.
Email Meredith any time at meredithtaylor@cis-partners.com!
There are currently:
10 days until Christmas,
7 days until Chanukah,
11 days until Kwanzaa, and
6 days until Winter Solstice!
(We at CIS are equal opportunity celebrators!)
CIS is Proud to Announce our Participation in the Upcoming IIR Government Programs & Pricing Compliance Summit
Dear Colleagues & Friends,
Compliance Implementation Services (CIS) (http://www.cis-partners.com/) is delighted to announce our attendance and participation in IIR’s Government Programs & Pricing Compliance Summit from February 11th – 13th in Baltimore, Maryland. CIS will be speaking on two occasions:
On Day 1 of the conference, Chris Cobourn (CIS GP Practice Lead) will explore “Government Program Fundamentals.” During this full day session, CIS will take a thorough look at the key topics involving all Government Programs. The presentation will include Managing the Government Business, Monitoring and Audit, Class of Trade Designation, PHS Eligibility Verification, Restatements and Recalculations, Documentation and Record Retention, and more important GP information!
Clarissa Crain (CIS Senior GP Consultant) will present the topic “Developing an Effective Risk Management Strategy Across Government Programs: Proactive Testing, Monitoring and Audit Practices” on Day 2 of the conference at 2:30PM.
Please take note that this letter entitles you to a 25% discount off of the conference registration by using the priority code ‘CIS’! (Complete registration details are at the bottom of this letter.)
CIS has also introduced GP CalcPartner to our growing list of Government Pricing (GP) services. CIS has the in-house, industry expertise to perform all GP Calculations including AMP, BP, Non-FAMP, FCP, IFF, ASP & PHS, while providing you with an auditable, affordable and reusable calculation toolset. Please stop by our booth for a look at this exciting new product and to learn more about CIS!
We will also be demonstrating our popular Pharma Compliance Exchange (PCX) website (www.cis-pcx.com/register)! Since its inception in 2007, the PCX has experienced explosive growth. The PCX contains important statutes, regulations, and guidance documents necessary to perform and back up the GP calculations. Having all of this valuable information in one centralized location saves time and money by eliminating the need to search for these documents every time they are needed. Furthermore, the PCX is organized with the Pharmaceutical industry in mind; so, it is reliable, easy to use, and acts as an insurance policy in the case of an audit. Additionally, the PCX also offers additional features including: weekly updates, a monthly newsletter, and daily access to the GP compliance experts at CIS!
CIS is a consulting firm specializing in establishing a Culture of Compliance for pharmaceutical companies. We evaluate, promote and execute effective compliance programs by evaluating an organization’s compliance policies, procedures, and systems. CIS prioritizes areas of risk and creates short-term and long-term remediation and monitoring plans. Our goal is to provide an efficient and affordable means of compliance and risk management that is scalable to any size company’s needs and priorities.
CIS sincerely looks forward to seeing you in Baltimore!
Kind Regards,
Steven P. Moore
Director of Business Development
Compliance Implementation Services, LLC
1400 North Providence Road
Building One, Suite 307
Media, PA 19063
Phone: 484.445.7207
Fax: 610.565.7010
stevenmoore@cis-partners.com
P.S. To register, call (888) 670-8200, send an e-mail to “mailto:register@iirusa.com?subject=P1201CRV,” or click here to register online at http://www.iirusa.com/gp/welcome.xml. I urge you to register for this informative event or to pass along a copy of the brochure to a colleague if you’re unable to attend. Please mention priority code CIS when registering to receive the 25% discount.
Compliance Implementation Services (CIS) (http://www.cis-partners.com/) is delighted to announce our attendance and participation in IIR’s Government Programs & Pricing Compliance Summit from February 11th – 13th in Baltimore, Maryland. CIS will be speaking on two occasions:
On Day 1 of the conference, Chris Cobourn (CIS GP Practice Lead) will explore “Government Program Fundamentals.” During this full day session, CIS will take a thorough look at the key topics involving all Government Programs. The presentation will include Managing the Government Business, Monitoring and Audit, Class of Trade Designation, PHS Eligibility Verification, Restatements and Recalculations, Documentation and Record Retention, and more important GP information!
Clarissa Crain (CIS Senior GP Consultant) will present the topic “Developing an Effective Risk Management Strategy Across Government Programs: Proactive Testing, Monitoring and Audit Practices” on Day 2 of the conference at 2:30PM.
Please take note that this letter entitles you to a 25% discount off of the conference registration by using the priority code ‘CIS’! (Complete registration details are at the bottom of this letter.)
CIS has also introduced GP CalcPartner to our growing list of Government Pricing (GP) services. CIS has the in-house, industry expertise to perform all GP Calculations including AMP, BP, Non-FAMP, FCP, IFF, ASP & PHS, while providing you with an auditable, affordable and reusable calculation toolset. Please stop by our booth for a look at this exciting new product and to learn more about CIS!
We will also be demonstrating our popular Pharma Compliance Exchange (PCX) website (www.cis-pcx.com/register)! Since its inception in 2007, the PCX has experienced explosive growth. The PCX contains important statutes, regulations, and guidance documents necessary to perform and back up the GP calculations. Having all of this valuable information in one centralized location saves time and money by eliminating the need to search for these documents every time they are needed. Furthermore, the PCX is organized with the Pharmaceutical industry in mind; so, it is reliable, easy to use, and acts as an insurance policy in the case of an audit. Additionally, the PCX also offers additional features including: weekly updates, a monthly newsletter, and daily access to the GP compliance experts at CIS!
CIS is a consulting firm specializing in establishing a Culture of Compliance for pharmaceutical companies. We evaluate, promote and execute effective compliance programs by evaluating an organization’s compliance policies, procedures, and systems. CIS prioritizes areas of risk and creates short-term and long-term remediation and monitoring plans. Our goal is to provide an efficient and affordable means of compliance and risk management that is scalable to any size company’s needs and priorities.
CIS sincerely looks forward to seeing you in Baltimore!
Kind Regards,
Steven P. Moore
Director of Business Development
Compliance Implementation Services, LLC
1400 North Providence Road
Building One, Suite 307
Media, PA 19063
Phone: 484.445.7207
Fax: 610.565.7010
stevenmoore@cis-partners.com
P.S. To register, call (888) 670-8200, send an e-mail to “mailto:register@iirusa.com?subject=P1201CRV,” or click here to register online at http://www.iirusa.com/gp/welcome.xml. I urge you to register for this informative event or to pass along a copy of the brochure to a colleague if you’re unable to attend. Please mention priority code CIS when registering to receive the 25% discount.
Friday, December 12, 2008
On the Fifth Day of CIS...
As reported to Matt Hotz, CIS Compliance SpecialistOn the fifth day of CIS, the blog introduced to me...
Senior Compliance Consultant Debbe Saez,
(SCC Chrissy Spicer, SCC Clarissa Crain, SCC Judy Fox, and Steven Moore, Director of BD)
Q: What’s your background?
A: After earning my Bachelors in Mathematics from the University of Delaware, I worked for a small Department of Defense contractor in Aberdeen, Maryland for about a year. From there I went to JP Morgan. I had 2 roles at JP Morgan – a Business Analyst, managing a project plan and leading weekly meetings with the project team; and an Accountant, with responsibility for the Stockholder’s Equity section of the balance sheet. During my years at JP Morgan I continued my education by taking several Accounting courses at a local college - building up to earning a Masters in Accounting Information Systems. In 2000, I left JP Morgan and joined the pharma world. After 3 years as an Accountant, I made the move to the world of Government Pricing. My role evolved over the years – I processed Medicaid Claims, calculated pricing (AMP, BP, ASP, NonFAMP, FCP, PHS) and managed a variety of projects. Now, after 8 years in pharma, I have found my way to CIS!!
Q: Why did you choose to join CIS?
A: A former coworker had already come to CIS and raved about his job, the variety of opportunities, the coworkers and the company. I was ready for a change and for new challenges. So, after hearing all about CIS, I couldn’t resist.
Q: What projects and product lines do you work with for CIS?
A: I am currently a Project Manager on 3 projects. In my first role, I am leading a Project Management Project. That may sound redundant, but one of my coworkers is managing a few other projects for the same client. My role is a general project management function, to manage the project plan that incorporates all projects with that client, and to help keep track of all the moving parts. Through the course of these projects I have also taken on an Analyst role, to help with the historical recalculation analysis and lead the preparation of our findings report and presentation.
A: After earning my Bachelors in Mathematics from the University of Delaware, I worked for a small Department of Defense contractor in Aberdeen, Maryland for about a year. From there I went to JP Morgan. I had 2 roles at JP Morgan – a Business Analyst, managing a project plan and leading weekly meetings with the project team; and an Accountant, with responsibility for the Stockholder’s Equity section of the balance sheet. During my years at JP Morgan I continued my education by taking several Accounting courses at a local college - building up to earning a Masters in Accounting Information Systems. In 2000, I left JP Morgan and joined the pharma world. After 3 years as an Accountant, I made the move to the world of Government Pricing. My role evolved over the years – I processed Medicaid Claims, calculated pricing (AMP, BP, ASP, NonFAMP, FCP, PHS) and managed a variety of projects. Now, after 8 years in pharma, I have found my way to CIS!!
Q: Why did you choose to join CIS?
A: A former coworker had already come to CIS and raved about his job, the variety of opportunities, the coworkers and the company. I was ready for a change and for new challenges. So, after hearing all about CIS, I couldn’t resist.
Q: What projects and product lines do you work with for CIS?
A: I am currently a Project Manager on 3 projects. In my first role, I am leading a Project Management Project. That may sound redundant, but one of my coworkers is managing a few other projects for the same client. My role is a general project management function, to manage the project plan that incorporates all projects with that client, and to help keep track of all the moving parts. Through the course of these projects I have also taken on an Analyst role, to help with the historical recalculation analysis and lead the preparation of our findings report and presentation.
I am also managing our CalcPartner and ClaimsPartner service for another client. I was actively involved in the implementation of both services. For the CalcPartner service, I oversee the ongoing pricing calculations and ensure all calculations are compliant with federal regulations and client policies. For Claims Partner, I review Medicaid Claims and ensure timely forwarding to the client for payment.
Q: What do you like about CIS?
A: As far as my career, I enjoy the opportunities, the variety of projects and the ability to work with different size pharma companies, each with different focuses and concerns. On a personal front, the people are great – from interesting personalities to being passionate about their jobs, everyone here is great to work with!!
Q: What do you like about CIS?
A: As far as my career, I enjoy the opportunities, the variety of projects and the ability to work with different size pharma companies, each with different focuses and concerns. On a personal front, the people are great – from interesting personalities to being passionate about their jobs, everyone here is great to work with!!
Q: What’s the best gift you ever received for the holidays?
A: A beautiful hand-crafted menorah, made from many pieces of different colored glass.
(See the picture above!)
Email Debbe any time at debbesaez@cis-partners.com!
There are currently:
13 days until Christmas,
10 days until Chanukah,
14 days until Kwanzaa, and
9 days until Winter Solstice!
(We at CIS are equal opportunity celebrators!)
CIS is Proud to Announce our Participation in the Upcoming ExL Pharma Webinar:
OIG Audit Readiness:
Developing and Implementing a Practical and Meaningful Government Programs Audit Plan.
January 14, 2009 1PM – 3PM
Register before Friday, December 19th to receive discount pricing!
Developing and Implementing a Practical and Meaningful Government Programs Audit Plan.
January 14, 2009 1PM – 3PM
Register before Friday, December 19th to receive discount pricing!
Leaders:
Chris Cobourn, VP of Regulatory Compliance (CIS)
Clarissa Crain, Sr. Compliance Specialist (CIS)
Jim Jaakobs, MBA, CPA, Manager of Government Contracting and Pricing Compliance, Johnson & Johnson
Leverage Your Webinar Investment by Learning How to:
- Understand the importance of OIG Audit Readiness, and how to communicate the risks within your organization.
- Evaluate the soundness of your current policies, procedures and systems if the OIG were to audit you today.
- Proactively identify and mitigate potential issues related to statutory price reporting requirements.
- Demonstrate due diligence in the development, maintenance, and adherence to policies, procedures and systems.
- Determine whether your calculations are accurate and complete, and whether your record retention procedures are appropriate to support the CMS 10-year rule.
Webinar Summary:
The risks are real. In today’s regulatory environment it is no longer a question of if you will be audited by an external party, but rather when you will be audited As fiscal pressures at the Federal and State levels catalyst enforcement agencies into greater audit activity, prudent manufacturers must respond by proactively developing and implementing Government Programs (GP) Auditing and Monitoring Plans. Effective Auditing and Monitoring plans will ensure audit-readiness, and will help to detect and mitigate compliance issues on your own before a government audit. From this has grown a new concept in risk mitigation, OIG Audit Readiness. If in the past your company has flown “under the radar,” it is critical to understand that the OIG is now budgeted to conduct ongoing proactive audits, and has developed more efficient data mining tools. Join the Government Programs Risk and Audit Team of CIS for a webinar focused on understanding, developing, and implementing a practical and meaningful audit program.
Who Should Participate?
This course has been designed to benefit:
- Small to mid-sized pharma, who may not have the budgets or formalized audit functions in-house to adequately prepare for an OIG audit.
- Large pharma, who may have audit programs in place, but want to know that they appropriately understand the risk and the approach, and want to evaluate industry practices related to GP audit preparedness.
Registration Options for Attending The OIG Audit Readiness Webinar:
INDIVIDUAL ACCESS PASS: Log-in allowing one viewer
Register before December 19th for our Early Bird Pricing: $295
Register after December 19th for Standard Pricing: $395
GROUP SITE PASS: Log-in allowing multiple viewers to join the webinar at one location
Flat Rate of: $1295
STATE AND FEDERAL GOVERNMENT RATE: $50 administrative fee only
(Your email address must have a .gov extension to qualify!)
5 EASY WAYS TO REGISTER:
Mail: ExL Events, Inc., 555 8th Ave., Ste. 310, New York, NY 10018
Email: register@exlpharma.com
Phone: 866-207-6528 Fax: 888-221-6750
Online : www.exlpharma.com
For more information please contact Pam Sobotka at psobotka@exlpharma.com!
Thursday, December 11, 2008
On the Fourth Day of CIS...
As reported to Matt Hotz, CIS Compliance Specialist
On the fourth day of CIS, the blog introduced to me...
Senior Compliance Consultant Chrissy Spicer,
(SCC Clarissa Crain, SCC Judy Fox, and Steven Moore, Director of BD)
Q: What’s your background?
A: I graduated from Drexel University with a B.S. in Business Administration with a concentration in Accounting and Management Information Systems. More recently, in May of 2008, I graduated St. Joseph’s University with an MBA in Pharmaceutical Marketing. Prior to joining CIS, I worked as an Operation Analyst in Global Medical Affairs at Wyeth Pharmaceuticals, where I was responsible for managing a database that tracked Phase IV clinical trial data in approximately 22 countries. I worked at Wyeth for 6 years before deciding to make the transition into the consulting arm of the industry, and have since been retained by CIS working in multiple capacities over the past 4 years.
Q: Why did you choose to join CIS?
A: The vision of course - when I started, the company was just getting started. To be part of the vision was the best part of the job offer...
Q: What projects and product lines do you work with for CIS?
A: Frankly, I enjoy working with Corporate Compliance Departments; however, due to my diverse background I tend to dabble in Clinical, Commercial, and GP as well. Although Chris Cobourn is convinced I’d make an excellent resident GP expert, and GP calculations are always a fabulous time, I try to resist to the urge to become a permanent "GP Geek."
Q: What do you like about CIS?
A: The energy and the growth opportunities – Coming from a huge corporation to a small-to-mid size consulting firm, CIS is unique in that everyone determines their own role in the company. Meaning, there is no statistical bell curve for assessing performance, or strict career ladders that inhibit you from working on new projects or moving to a higher level before a predetermined time period. The energy and commitment people people here have in achieving the goals of the company has created a collaborative, educational, and challenging, but rewarding team environment that I am glad to be a part of.
Q: Do you have any holiday disaster stories you’d like to share (i.e. drunk uncle, still-frozen turkey, dog knocks over tree, etc.)?
A: I like to say that when my family gets together it is like the perfect storm – we are Irish and there are a lot of us! To put this in perspective, I have 60 cousins, and Christmas Eve we all try to get together to celebrate. So, based on the examples of disasters you provided, my choice is all of the above.
Email Chrissy any time at chrissyspicer@cis-partners.com!
There are currently:
14 days until Christmas,
11 days until Chanukah,
15 days until Kwanzaa, and
10 days until Winter Solstice!
(We at CIS are equal opportunity celebrators!)
On the fourth day of CIS, the blog introduced to me...
Senior Compliance Consultant Chrissy Spicer,
(SCC Clarissa Crain, SCC Judy Fox, and Steven Moore, Director of BD)
Q: What’s your background?
A: I graduated from Drexel University with a B.S. in Business Administration with a concentration in Accounting and Management Information Systems. More recently, in May of 2008, I graduated St. Joseph’s University with an MBA in Pharmaceutical Marketing. Prior to joining CIS, I worked as an Operation Analyst in Global Medical Affairs at Wyeth Pharmaceuticals, where I was responsible for managing a database that tracked Phase IV clinical trial data in approximately 22 countries. I worked at Wyeth for 6 years before deciding to make the transition into the consulting arm of the industry, and have since been retained by CIS working in multiple capacities over the past 4 years.
Q: Why did you choose to join CIS?
A: The vision of course - when I started, the company was just getting started. To be part of the vision was the best part of the job offer...
Q: What projects and product lines do you work with for CIS?
A: Frankly, I enjoy working with Corporate Compliance Departments; however, due to my diverse background I tend to dabble in Clinical, Commercial, and GP as well. Although Chris Cobourn is convinced I’d make an excellent resident GP expert, and GP calculations are always a fabulous time, I try to resist to the urge to become a permanent "GP Geek."
Q: What do you like about CIS?
A: The energy and the growth opportunities – Coming from a huge corporation to a small-to-mid size consulting firm, CIS is unique in that everyone determines their own role in the company. Meaning, there is no statistical bell curve for assessing performance, or strict career ladders that inhibit you from working on new projects or moving to a higher level before a predetermined time period. The energy and commitment people people here have in achieving the goals of the company has created a collaborative, educational, and challenging, but rewarding team environment that I am glad to be a part of.
Q: Do you have any holiday disaster stories you’d like to share (i.e. drunk uncle, still-frozen turkey, dog knocks over tree, etc.)?
A: I like to say that when my family gets together it is like the perfect storm – we are Irish and there are a lot of us! To put this in perspective, I have 60 cousins, and Christmas Eve we all try to get together to celebrate. So, based on the examples of disasters you provided, my choice is all of the above.
Email Chrissy any time at chrissyspicer@cis-partners.com!
There are currently:
14 days until Christmas,
11 days until Chanukah,
15 days until Kwanzaa, and
10 days until Winter Solstice!
(We at CIS are equal opportunity celebrators!)
Wednesday, December 10, 2008
On the Third Day of CIS...
As reported to Dana Zelig, CIS Compliance Specialist
On the third day of CIS, the blog introduced to me...
Senior Compliance Consultant Clarissa Crain,
(SCC Judy Fox, and Steven Moore, Director of BD)
Q: What is your background?
A: My pharmaceutical industry experience began during my undergraduate work. I conducted 2 years of research on the economic theory of Ramsey Pricing and the effects of price controls on innovation within the pharmaceutical industry. My research culminated in the publication of, “The Effects of Price Regulation on Pharmaceutical R&D and Innovation,” with the Pennsylvania Economics Association and the label of ‘huge nerd,’ amongst my college peers.
During my time in industry, I worked across multiple facets of Commercial Operations. In one of these areas, I was asked to help support a Third Party Vendor Audit, where I met now CIS VP of Regulatory Compliance, Chris Cobourn. Shortly after the conclusion of the Audit I departed the pharmaceutical industry to pursue other opportunities. It is still debated whether or not there was direct correlation between being Audited by Chris Cobourn and my departure from the industry.
Despite my efforts to escape, Chris tracked me down amongst 90,000 others at one of the nation’s largest insurance firms. He presented to me an opportunity to join a growing, specialty consulting firm. A few short weeks later, I joined CIS and have been here ever since!
Q: Why did you choose to join CIS?
A: Two words - Chris Cobourn.
All kidding aside, it was a great opportunity that I couldn’t refuse. The vision of the management team is clear and sets us apart from other firms. I’m proud of what we’ve done at CIS and what we continue to do.
Q: What projects and product lines do you work with for CIS?
A: My primary focus is Risk Management (Monitoring, Testing, and Auditing) in the Commercial Compliance space. I have supported a variety of accounts including top ten manufacturers, generic firms, and single product companies.
Q: What do you like about CIS?
A: Our plush new offices – if you haven’t seen them yet, come on by! We love having visitors! Interior decorator, VP of Account Management, and CIS founding partner Toni Barsh (along with some help from founding partner and VP of Operations, Jim Collins) has created a beautiful new working space for the CIS team. We moved in on Memorial Day, and believe it or not we’re growing so fast that we are opening another office already! CIS’ Raleigh, NC offices will officially open in January. I’m sure they’ll be just as nice!
Q: What's your favorite holiday tradition?
A: My mother is Swedish and so we celebrate Christmas based on Swedish traditions. On Christmas Eve we enjoy a Smorgasbord of Swedish delicacies, and have recently moved from the traditional phone call to Sweden to using Skype and chatting via live video with our family “back home.” We are only able to travel back to Sweden to visit our family once a year, so it is great to get to see them at Christmas, even if it is over the web.
Email Clarissa any time at clarissacrain@cis-partners.com!
There are currently:
15 days until Christmas,
12 days until Chanukah,
16 days until Kwanzaa, and
11 days until Winter Solstice!
(We at CIS are equal opportunity celebrators!)
On the third day of CIS, the blog introduced to me...
Senior Compliance Consultant Clarissa Crain,
(SCC Judy Fox, and Steven Moore, Director of BD)
Q: What is your background?
A: My pharmaceutical industry experience began during my undergraduate work. I conducted 2 years of research on the economic theory of Ramsey Pricing and the effects of price controls on innovation within the pharmaceutical industry. My research culminated in the publication of, “The Effects of Price Regulation on Pharmaceutical R&D and Innovation,” with the Pennsylvania Economics Association and the label of ‘huge nerd,’ amongst my college peers.
During my time in industry, I worked across multiple facets of Commercial Operations. In one of these areas, I was asked to help support a Third Party Vendor Audit, where I met now CIS VP of Regulatory Compliance, Chris Cobourn. Shortly after the conclusion of the Audit I departed the pharmaceutical industry to pursue other opportunities. It is still debated whether or not there was direct correlation between being Audited by Chris Cobourn and my departure from the industry.
Despite my efforts to escape, Chris tracked me down amongst 90,000 others at one of the nation’s largest insurance firms. He presented to me an opportunity to join a growing, specialty consulting firm. A few short weeks later, I joined CIS and have been here ever since!
Q: Why did you choose to join CIS?
A: Two words - Chris Cobourn.
All kidding aside, it was a great opportunity that I couldn’t refuse. The vision of the management team is clear and sets us apart from other firms. I’m proud of what we’ve done at CIS and what we continue to do.
Q: What projects and product lines do you work with for CIS?
A: My primary focus is Risk Management (Monitoring, Testing, and Auditing) in the Commercial Compliance space. I have supported a variety of accounts including top ten manufacturers, generic firms, and single product companies.
Q: What do you like about CIS?
A: Our plush new offices – if you haven’t seen them yet, come on by! We love having visitors! Interior decorator, VP of Account Management, and CIS founding partner Toni Barsh (along with some help from founding partner and VP of Operations, Jim Collins) has created a beautiful new working space for the CIS team. We moved in on Memorial Day, and believe it or not we’re growing so fast that we are opening another office already! CIS’ Raleigh, NC offices will officially open in January. I’m sure they’ll be just as nice!
Q: What's your favorite holiday tradition?
A: My mother is Swedish and so we celebrate Christmas based on Swedish traditions. On Christmas Eve we enjoy a Smorgasbord of Swedish delicacies, and have recently moved from the traditional phone call to Sweden to using Skype and chatting via live video with our family “back home.” We are only able to travel back to Sweden to visit our family once a year, so it is great to get to see them at Christmas, even if it is over the web.
Email Clarissa any time at clarissacrain@cis-partners.com!
There are currently:
15 days until Christmas,
12 days until Chanukah,
16 days until Kwanzaa, and
11 days until Winter Solstice!
(We at CIS are equal opportunity celebrators!)
The Decline of Direct to Consumer Advertising
By: Chrissy Spicer, CIS Sr. Compliance Specialist
chrissyspicer@cis-partners.com
Over the past couple of years, we have all begun to accept the inundation of Direct-to-Consumer advertisements by pharmaceutical companies. In between our favorite shows, listening to the radio, or browsing a magazine, we have all been familiarized with the following statement “Talk to your doctor about…fill in the blank.” Well, in the future we can expect to see less and less of these advertisements, because the trending growth of this exercise by pharmaceutical companies is taking a sharp down-hill turn. As more and more companies look for ways to cut costs in a recessed economy, and in response to research that was recently published challenging the effectiveness of these ads, ad agencies have experienced a loss in this market sector. According to an October 16, 2008 article in USA Today, TNS Media Intelligence has reported the total decline in ad spending for this year is 3.9% to $2.4 billion, while their rival, Nielsen Monitor-Plus, reports a decline at 4.8% to $2.7 billion.[1]
Currently, the U.S. and New Zealand are the only countries that allow drug companies to advertise directly to consumers. Since the U.S. Food and Drug Administration (FDA) eased advertising restrictions on the industry a decade ago, ad outlays by drug makers rose by 330%, the researchers said with approximately $5 billion spent by drug companies on such campaigns in 2006.[2]
The article in USA Today continues by explaining that the brunt of the decline is in radio and magazines. “Magazines and radio stations have seen the most drug ad decline. Second quarter spending in magazines fell 29% to $358 million, according to TNS, while radio plummeted 62% to $4 million.”[1]
The research conducted by Harvard Medical School focused on advertisements of the following products: Enbrel (Rheumatoid Arthritis), Nasonex (nasal allergies), and Zelnorm (irritable bowel syndrome). The research evaluated the trends in script volume over five years and the relationship to the timing of DTC campaigns. The results of research showed that for Nasonex and Enbrel there was almost no effect as a result of the campaigns. In evaluating Zelnorm, the researchers did identify a 40% increase; however, the increase was brief and prescription volume quickly reverted to normal patterns.
The debate over the effectiveness of DTC advertising has been raging for years. Marketers in the pharmaceutical industry have stressed that DTC advertisements carry other important implications in the industry besides the potential to increase sales including: educating patients, building disease awareness and also patient advocacy.
Both sides of this argument are equally convincing; however, based on the fact that fewer new drugs are being launched; new drugs are targeted to niche markets and appeal to fewer customers; and pharmaceutical companies are decreasing their overall spending, it is unlikely that spending on direct to consumer advertising will increase any time soon.
[1] USA Today, October 16, 2008, “Media Owners Ill as Drug Advertising Spending is Seen Less Effective”
[2] http://www.aef.com/industry/news/data/2008/8035
chrissyspicer@cis-partners.com
Over the past couple of years, we have all begun to accept the inundation of Direct-to-Consumer advertisements by pharmaceutical companies. In between our favorite shows, listening to the radio, or browsing a magazine, we have all been familiarized with the following statement “Talk to your doctor about…fill in the blank.” Well, in the future we can expect to see less and less of these advertisements, because the trending growth of this exercise by pharmaceutical companies is taking a sharp down-hill turn. As more and more companies look for ways to cut costs in a recessed economy, and in response to research that was recently published challenging the effectiveness of these ads, ad agencies have experienced a loss in this market sector. According to an October 16, 2008 article in USA Today, TNS Media Intelligence has reported the total decline in ad spending for this year is 3.9% to $2.4 billion, while their rival, Nielsen Monitor-Plus, reports a decline at 4.8% to $2.7 billion.[1]
Currently, the U.S. and New Zealand are the only countries that allow drug companies to advertise directly to consumers. Since the U.S. Food and Drug Administration (FDA) eased advertising restrictions on the industry a decade ago, ad outlays by drug makers rose by 330%, the researchers said with approximately $5 billion spent by drug companies on such campaigns in 2006.[2]
The article in USA Today continues by explaining that the brunt of the decline is in radio and magazines. “Magazines and radio stations have seen the most drug ad decline. Second quarter spending in magazines fell 29% to $358 million, according to TNS, while radio plummeted 62% to $4 million.”[1]
The research conducted by Harvard Medical School focused on advertisements of the following products: Enbrel (Rheumatoid Arthritis), Nasonex (nasal allergies), and Zelnorm (irritable bowel syndrome). The research evaluated the trends in script volume over five years and the relationship to the timing of DTC campaigns. The results of research showed that for Nasonex and Enbrel there was almost no effect as a result of the campaigns. In evaluating Zelnorm, the researchers did identify a 40% increase; however, the increase was brief and prescription volume quickly reverted to normal patterns.
The debate over the effectiveness of DTC advertising has been raging for years. Marketers in the pharmaceutical industry have stressed that DTC advertisements carry other important implications in the industry besides the potential to increase sales including: educating patients, building disease awareness and also patient advocacy.
Both sides of this argument are equally convincing; however, based on the fact that fewer new drugs are being launched; new drugs are targeted to niche markets and appeal to fewer customers; and pharmaceutical companies are decreasing their overall spending, it is unlikely that spending on direct to consumer advertising will increase any time soon.
[1] USA Today, October 16, 2008, “Media Owners Ill as Drug Advertising Spending is Seen Less Effective”
[2] http://www.aef.com/industry/news/data/2008/8035
Tuesday, December 9, 2008
On the Second Day of CIS...
As reported to Matt Hotz, CIS Compliance Specialist
On the second day of CIS, the blog introduced to me...
Senior Compliance Consultant Judy Fox
(and Steven Moore, Director of BD)
Q: What is your background?
A: I started out as a Graphic Designer and worked for 15 years as an illustrator in the retail advertising industry. I decided to make a career change when my children were grown, and I was hired in a very small pharma company (one of 8 employees, including the reps!) in 2000 and learned the industry from the bottom. I took every opportunity to get involved in as many projects and go to as many conferences and trainings as possible, and as a result gained my experience and certifications.
Q: Why did you choose to join CIS?
A: When I joined CIS the company was small, but the passion that people showed in their work, and the commitment of the partners was incredible. On my first project in 2006, the partners were there with us until midnight, printing out our reports and helping us with the presentation. It was contagious.
Q: What projects and product lines do you work with for CIS?
A: Most sample accountability and PDMA based projects end up on my desk, but I am also very involved in various transactional, vendor and GMP audits.
Q: When is the last time you enjoyed a little too much of the “holiday spirit?”
A: Never! NO really – not even in college. I grew up in an Italian family where wine is served with every meal from the time you are 4 and in the same house as my grandparents who rubbed my gums with whiskey to sooth teething. They’d all be thrown in jail today, but I think it took away the mystique of alcohol growing up.
Q: What do you like about CIS?
A: It may sound contrived, but I really like the people here. There is an incredible work ethic and climate here that I have not seen in many places. Consulting is not a 9-5 job, and people here really get that. There is a great commitment to doing a great job for our clients and everyone I’ve worked with has a passion for giving 100% to the task at hand. There is also this incredible respect for a family/work balance, so as a result everyone is willing to help each other out to ensure that we put out a quality product every time.
Email Judy any time at judyfox@cis-partners.com!
There are currently:
16 days until Christmas,
13 days until Chanukah,
17 days until Kwanzaa, and
12 days until Winter Solstice!
(We at CIS are equal opportunity celebrators!)
On the second day of CIS, the blog introduced to me...
Senior Compliance Consultant Judy Fox
(and Steven Moore, Director of BD)
Q: What is your background?
A: I started out as a Graphic Designer and worked for 15 years as an illustrator in the retail advertising industry. I decided to make a career change when my children were grown, and I was hired in a very small pharma company (one of 8 employees, including the reps!) in 2000 and learned the industry from the bottom. I took every opportunity to get involved in as many projects and go to as many conferences and trainings as possible, and as a result gained my experience and certifications.
Q: Why did you choose to join CIS?
A: When I joined CIS the company was small, but the passion that people showed in their work, and the commitment of the partners was incredible. On my first project in 2006, the partners were there with us until midnight, printing out our reports and helping us with the presentation. It was contagious.
Q: What projects and product lines do you work with for CIS?
A: Most sample accountability and PDMA based projects end up on my desk, but I am also very involved in various transactional, vendor and GMP audits.
Q: When is the last time you enjoyed a little too much of the “holiday spirit?”
A: Never! NO really – not even in college. I grew up in an Italian family where wine is served with every meal from the time you are 4 and in the same house as my grandparents who rubbed my gums with whiskey to sooth teething. They’d all be thrown in jail today, but I think it took away the mystique of alcohol growing up.
Q: What do you like about CIS?
A: It may sound contrived, but I really like the people here. There is an incredible work ethic and climate here that I have not seen in many places. Consulting is not a 9-5 job, and people here really get that. There is a great commitment to doing a great job for our clients and everyone I’ve worked with has a passion for giving 100% to the task at hand. There is also this incredible respect for a family/work balance, so as a result everyone is willing to help each other out to ensure that we put out a quality product every time.
Email Judy any time at judyfox@cis-partners.com!
There are currently:
16 days until Christmas,
13 days until Chanukah,
17 days until Kwanzaa, and
12 days until Winter Solstice!
(We at CIS are equal opportunity celebrators!)
The 2009 OIG Work Plan
By: Katie Lapins, CIS Sr. Compliance Specialist and Chris Cobourn, CIS GP Practice Lead
katielapins@cis-partners.com and chriscobourn@cis-partners.com
We encourage GP professionals to be familiar with the Office of Inspector General (OIG) Work Plan, and to help give senior management in their company an understanding of the OIG’s increasing focus on proactive audits in the GP area. A quick comparison between the 2008 Work Plan and the 2009 Work Plan will demonstrate the direction the OIG is taking with regards to GP Audits. The 2008 Work Plan included a very brief section on GP Audits, which merely stated that the OIG would perform selective audits. The 2009 Work Plan is much more broad, and details specific audit activity the OIG plans to perform.
One of the OIG’s objectives is to maintain the integrity of Federal Government Pharmaceutical Programs; this objective is fulfilled through investigations and audits. Historically, investigations were the result of a complaint or allegation made by a “whistleblower,” but in the 2008 Work Plan, the OIG was provided funding to conduct proactive audits or investigations; the 2009 Work Plan also provides this funding. We at CIS expect this trend to continue and, one day, we envision OIG audits related to GP participation to be routine, similar to those conducted by the FDA.
Highlights of the OIG 2009 Work Plan include:
1. Did manufacturers submit Average Manufacturer Price (AMP) by the deadline required for each time period? (It is also worth noting that the impact on PHS price is an additional reason noted for the importance of timely reporting.)
2. For purposes of calculating Federal Upper Limits (FULs), were outlier AMPs calculated correctly by manufacturers?
3. Was the methodology used by manufacturers to calculate AMP and Best Price (BP) correct, especially in light of changes by the Deficit Reduction Act and related Final Rule?
4. Were Medicaid claims made by States accurate, and were rebate payments made by manufacturers correct?
5. Were Medicaid claims submitted, and subsequently paid, for drugs dispensed to children that were not approved by the FDA for use in children?
6. Were Medicaid claims submitted and subsequently paid for non-FDA approved drugs?
7. Are States properly submitting Medicaid claims for drugs with a Unit Rebate Amount (URA) of $0 and are manufacturers paying these invoices correctly?
8. Is the additional Medicaid rebate amount related to inflation, and based on the Consumer Price Index, being paid correctly by manufacturers?
9. Have manufacturers assigned the correct classification of their drugs so that URA is calculated correctly?
From a compliance consultant’s perspective, one of the more interesting sections in the Work Plan is the following, found on Page 68:
This sounds to me like the OIG has recognized that the Medicaid program is complex, and is acknowledging that to be able to audit all of the various program components requires more knowledge and training on the part of their investigators. It’s nice to see that there are people who appreciate the complexity of our segment of this industry. And as those of us who work in this field understand, just when you think you understand the rules, you either find an exception to them, or they completely change the rules!
The OIG’s 2009 Work Plan can be viewed in its entirety at: http://oig.hhs.gov/publications.html
If your company is concerned about how it would withstand an OIG audit, let CIS work with you to conduct an audit or assessment, and ensure you are OIG ready.
katielapins@cis-partners.com and chriscobourn@cis-partners.com
We encourage GP professionals to be familiar with the Office of Inspector General (OIG) Work Plan, and to help give senior management in their company an understanding of the OIG’s increasing focus on proactive audits in the GP area. A quick comparison between the 2008 Work Plan and the 2009 Work Plan will demonstrate the direction the OIG is taking with regards to GP Audits. The 2008 Work Plan included a very brief section on GP Audits, which merely stated that the OIG would perform selective audits. The 2009 Work Plan is much more broad, and details specific audit activity the OIG plans to perform.
One of the OIG’s objectives is to maintain the integrity of Federal Government Pharmaceutical Programs; this objective is fulfilled through investigations and audits. Historically, investigations were the result of a complaint or allegation made by a “whistleblower,” but in the 2008 Work Plan, the OIG was provided funding to conduct proactive audits or investigations; the 2009 Work Plan also provides this funding. We at CIS expect this trend to continue and, one day, we envision OIG audits related to GP participation to be routine, similar to those conducted by the FDA.
Highlights of the OIG 2009 Work Plan include:
1. Did manufacturers submit Average Manufacturer Price (AMP) by the deadline required for each time period? (It is also worth noting that the impact on PHS price is an additional reason noted for the importance of timely reporting.)
2. For purposes of calculating Federal Upper Limits (FULs), were outlier AMPs calculated correctly by manufacturers?
3. Was the methodology used by manufacturers to calculate AMP and Best Price (BP) correct, especially in light of changes by the Deficit Reduction Act and related Final Rule?
4. Were Medicaid claims made by States accurate, and were rebate payments made by manufacturers correct?
5. Were Medicaid claims submitted, and subsequently paid, for drugs dispensed to children that were not approved by the FDA for use in children?
6. Were Medicaid claims submitted and subsequently paid for non-FDA approved drugs?
7. Are States properly submitting Medicaid claims for drugs with a Unit Rebate Amount (URA) of $0 and are manufacturers paying these invoices correctly?
8. Is the additional Medicaid rebate amount related to inflation, and based on the Consumer Price Index, being paid correctly by manufacturers?
9. Have manufacturers assigned the correct classification of their drugs so that URA is calculated correctly?
From a compliance consultant’s perspective, one of the more interesting sections in the Work Plan is the following, found on Page 68:
“We will continue to conduct investigations related to false claims submitted to
Medicaid for services not rendered, claims that manipulate payment codes in an
effort to inflate reimbursement amounts ... We will use a portion of this
funding to provide customized training to our special agents and our Federal,
State, and local partners.
“This customized training and education
will enable us to better identify Medicaid program vulnerabilities, coordinate
investigative activities and efforts, highlight successful Medicaid
investigative accomplishments, illustrate new approaches to working cases, and
hold information-sharing sessions to increase the efficiency and effectiveness
of our efforts to protect the Medicaid program.”
This sounds to me like the OIG has recognized that the Medicaid program is complex, and is acknowledging that to be able to audit all of the various program components requires more knowledge and training on the part of their investigators. It’s nice to see that there are people who appreciate the complexity of our segment of this industry. And as those of us who work in this field understand, just when you think you understand the rules, you either find an exception to them, or they completely change the rules!
The OIG’s 2009 Work Plan can be viewed in its entirety at: http://oig.hhs.gov/publications.html
If your company is concerned about how it would withstand an OIG audit, let CIS work with you to conduct an audit or assessment, and ensure you are OIG ready.
Monday, December 8, 2008
On the First Day of CIS...
Dear Readers,
The Holiday Season is now upon us, so we here at the PCB thought we would take this opportunity to introduce you to some of the talented employees who have made CIS an industry-leading provider of pharmaceutical compliance services.
For those of you who know us, you may just learn a thing or two about who we are and what makes us tick. For those of you who have not had the great pleasure of meeting us, we hope you like what you read!
Thanks, and Happy Holidays!
Dana Zelig, CIS Compliance Specialist and PCB Editor
Now without further ado:
On the first day of CIS, the blog introduced to me...
Steven Moore, Director of BD (Business Development)
Q: What is your background?
A: I graduated with a Communications & Business Administration degree from Muhlenberg College in Allentown, PA in 2001. During my four years I played golf, was a member of the TKE fraternity, wrote for the school paper and had a some really cool internships, including one in the Sports Information Department. Since graduation, I’ve predominately worked in Sales & Marketing. At CIS specifically, I started by heading up the marketing department (which really meant heading up myself) and then worked on several projects within Corporate Compliance, Government Pricing and Clinical Training. I also started the Pharma Compliance Blog last year and have really handed it off into the capable hands of Dana Zelig and our expert consultants. I made the switch into the Business Development department earlier this year and am so happy I do jumping jacks every morning when I get out of bed.
Q: Why did you choose to join CIS?
A: Chicks dig Compliance. OK, seriously? The entrepreneurial work environment and the belief in the energy, vision and mission of its founders.
Q: What projects and product lines do you work with for CIS?
A: I’m in Business Development, so I have familiarity with all of our service areas, but couldn’t hold a candle to what our consultants can do! I particularly enjoy U.S. Corporate Compliance and spend most of my Friday and Saturday nights reading up on this area if I’m not trying to calculate AMPs, BPs and their respective URAs for fun. It’s kind of like my own form of Sudoku.
Q: What’s the best gift you ever gave someone for the holidays?
A: I gave my wife a new laptop computer for Christmas last year, so she would have her own to complete her dissertation.
Q: What do you like about CIS?
A: The coffee could be better, but it’s all about the people. On any given night, you might see a team of our consultants burning the midnight oil (or in the case of Clarissa Crain --- not going home) to deliver the finest work product this industry has ever seen. Collectively, CIS’s people are smart, energetic, dedicated and an awful lot of fun. Don’t believe me? Come hang out with as at one of the conferences! We put our heads down and get the job done at all times, but also know when it’s time to kick back, relax and be real, genuine people.
There are currently:
17 days until Christmas,
14 days until Chanukah,
18 days until Kwanzaa, and
13 days until Winter Solstice!
(We at CIS are equal opportunity celebrators!)
The Holiday Season is now upon us, so we here at the PCB thought we would take this opportunity to introduce you to some of the talented employees who have made CIS an industry-leading provider of pharmaceutical compliance services.
For those of you who know us, you may just learn a thing or two about who we are and what makes us tick. For those of you who have not had the great pleasure of meeting us, we hope you like what you read!
Thanks, and Happy Holidays!
Dana Zelig, CIS Compliance Specialist and PCB Editor
Now without further ado:
On the first day of CIS, the blog introduced to me...
Steven Moore, Director of BD (Business Development)
Q: What is your background?
A: I graduated with a Communications & Business Administration degree from Muhlenberg College in Allentown, PA in 2001. During my four years I played golf, was a member of the TKE fraternity, wrote for the school paper and had a some really cool internships, including one in the Sports Information Department. Since graduation, I’ve predominately worked in Sales & Marketing. At CIS specifically, I started by heading up the marketing department (which really meant heading up myself) and then worked on several projects within Corporate Compliance, Government Pricing and Clinical Training. I also started the Pharma Compliance Blog last year and have really handed it off into the capable hands of Dana Zelig and our expert consultants. I made the switch into the Business Development department earlier this year and am so happy I do jumping jacks every morning when I get out of bed.
Q: Why did you choose to join CIS?
A: Chicks dig Compliance. OK, seriously? The entrepreneurial work environment and the belief in the energy, vision and mission of its founders.
Q: What projects and product lines do you work with for CIS?
A: I’m in Business Development, so I have familiarity with all of our service areas, but couldn’t hold a candle to what our consultants can do! I particularly enjoy U.S. Corporate Compliance and spend most of my Friday and Saturday nights reading up on this area if I’m not trying to calculate AMPs, BPs and their respective URAs for fun. It’s kind of like my own form of Sudoku.
Q: What’s the best gift you ever gave someone for the holidays?
A: I gave my wife a new laptop computer for Christmas last year, so she would have her own to complete her dissertation.
Q: What do you like about CIS?
A: The coffee could be better, but it’s all about the people. On any given night, you might see a team of our consultants burning the midnight oil (or in the case of Clarissa Crain --- not going home) to deliver the finest work product this industry has ever seen. Collectively, CIS’s people are smart, energetic, dedicated and an awful lot of fun. Don’t believe me? Come hang out with as at one of the conferences! We put our heads down and get the job done at all times, but also know when it’s time to kick back, relax and be real, genuine people.
There are currently:
17 days until Christmas,
14 days until Chanukah,
18 days until Kwanzaa, and
13 days until Winter Solstice!
(We at CIS are equal opportunity celebrators!)
Healthcare: A Little Less Conversation, A Little More Action
By: America Castro, CIS Compliance Specialist
americacastro@cis-partners.com
Admittedly, President-elect Obama has a lot of issues on his plate, but amid bailout discussions and the plunging market, many of us in the pharma industry are wondering, “What’s next for healthcare?” We have been hearing this plan, and that plan, “I will do this,” and “I will change that,” for months now. Thus, the question in everyone’s mind is, “Shall we get started?” Given the overall dissatisfaction of the American public in regards to our current healthcare system, the new President needs to get to business ASAP (or faster). Healthcare was indeed a crucial component of Obama’s campaign, and it is every American’s hope to really see a solution for this problem that seems to get worse and worse every new presidential term. Americans are ready for a change, and the President-elect is aware of this fact.
When healthcare has gotten to such a point that people are willing to sacrifice quality to cost, you know there is something wrong with the system. According to a survey conducted by QualityHealth.com, 83% of Americans are dissatisfied with the current state of the US healthcare system, and about 82% are concerned about their ability to cover future costs[1]. Additionally, according to a poll conducted by Picis, 63% of respondents believe that the systems has either declined or stagnated[2]. This is quite a number of “angry” citizens the new president will have to deal with. So what should he do to fix this broken system?
There has always been the impression from outsiders that this system (or that of an industrialized country) runs and works just perfectly. However, respondents from the US, UK and France feel very negative about their respective health care systems. Spain, on the other hand, is one example of a healthcare system citizens believe in; it ranks number one in overall public satisfaction across the European Union (EU).[3] In fact, if you are traveling across the EU and you have the misfortune of getting sick, the one country in which you may want to find yourself is Spain, as you are covered even as a tourist. Satisfaction of the system is shared not only by the Spanish people, but by foreigners living in the country as well. It is fairly common for foreigners working in Spain to move to the country without the offering of private healthcare, as the public healthcare is just “extremely good”. The Spanish government has successfully run its healthcare system because the country invests in areas that offer the greater returns, such as technology and infrastructure. Coincidentally, these are two areas that Obama highlighted as necessary to improve healthcare during his campaign. Maybe he’s on the right track.
With skyrocketing unemployment rates, mass layoffs, and more and more small businesses closing their doors, it is critically important that Obama puts his money where his mouth is. When Americans lose their jobs, they also lose their healthcare, and with unemployment up 36% since January, something must be done. “Expanding access to health insurance, with federal subsidies, was a priority for President-elect Barack Obama and the new Democratic Congress,” reports the New York Times. “The increase in the ranks of the uninsured, including middle-class families with strong ties to the work force, adds urgency to their efforts. ‘This shows why — no matter how bad the condition of the economy — we can’t delay pursuing comprehensive health care,’ said Senator Sherrod Brown, Democrat of Ohio. ‘There are too many victims who are innocent of anything but working at the wrong place at the wrong time.’”[4]
In November the American people made their decision, and they voted overwhelmingly for change. Now it is time to supply the change the country demands. From an indigent child, to a retired veteran, a factory worker to a successful white collar executive, it is every citizen’s right to be offered the best healthcare available. It is not going to be an easy job for the President-elect, but the American people will not accept any more apologies. So Mr. President, the American people are shouting, “A little less conversation, a little more action!”
[1] Drugs.com “Americans Dissatisfied with Healthcare, Want Lower Costs Even if it Means Sacrificing Quality According to New Quality Health.com Survey”
[2] Genengnews.com “Patient Satisfaction with Healthcare Systems: Do Different Funding Models Lead to Different Results”
[3] Genengnews.com “Patient Satisfaction with Healthcare Systems: Do Different Funding Models Lead to Different Results”
[4] New York Times “When a Job Disappears, So Does the Health Care”
americacastro@cis-partners.com
Admittedly, President-elect Obama has a lot of issues on his plate, but amid bailout discussions and the plunging market, many of us in the pharma industry are wondering, “What’s next for healthcare?” We have been hearing this plan, and that plan, “I will do this,” and “I will change that,” for months now. Thus, the question in everyone’s mind is, “Shall we get started?” Given the overall dissatisfaction of the American public in regards to our current healthcare system, the new President needs to get to business ASAP (or faster). Healthcare was indeed a crucial component of Obama’s campaign, and it is every American’s hope to really see a solution for this problem that seems to get worse and worse every new presidential term. Americans are ready for a change, and the President-elect is aware of this fact.
When healthcare has gotten to such a point that people are willing to sacrifice quality to cost, you know there is something wrong with the system. According to a survey conducted by QualityHealth.com, 83% of Americans are dissatisfied with the current state of the US healthcare system, and about 82% are concerned about their ability to cover future costs[1]. Additionally, according to a poll conducted by Picis, 63% of respondents believe that the systems has either declined or stagnated[2]. This is quite a number of “angry” citizens the new president will have to deal with. So what should he do to fix this broken system?
There has always been the impression from outsiders that this system (or that of an industrialized country) runs and works just perfectly. However, respondents from the US, UK and France feel very negative about their respective health care systems. Spain, on the other hand, is one example of a healthcare system citizens believe in; it ranks number one in overall public satisfaction across the European Union (EU).[3] In fact, if you are traveling across the EU and you have the misfortune of getting sick, the one country in which you may want to find yourself is Spain, as you are covered even as a tourist. Satisfaction of the system is shared not only by the Spanish people, but by foreigners living in the country as well. It is fairly common for foreigners working in Spain to move to the country without the offering of private healthcare, as the public healthcare is just “extremely good”. The Spanish government has successfully run its healthcare system because the country invests in areas that offer the greater returns, such as technology and infrastructure. Coincidentally, these are two areas that Obama highlighted as necessary to improve healthcare during his campaign. Maybe he’s on the right track.
With skyrocketing unemployment rates, mass layoffs, and more and more small businesses closing their doors, it is critically important that Obama puts his money where his mouth is. When Americans lose their jobs, they also lose their healthcare, and with unemployment up 36% since January, something must be done. “Expanding access to health insurance, with federal subsidies, was a priority for President-elect Barack Obama and the new Democratic Congress,” reports the New York Times. “The increase in the ranks of the uninsured, including middle-class families with strong ties to the work force, adds urgency to their efforts. ‘This shows why — no matter how bad the condition of the economy — we can’t delay pursuing comprehensive health care,’ said Senator Sherrod Brown, Democrat of Ohio. ‘There are too many victims who are innocent of anything but working at the wrong place at the wrong time.’”[4]
In November the American people made their decision, and they voted overwhelmingly for change. Now it is time to supply the change the country demands. From an indigent child, to a retired veteran, a factory worker to a successful white collar executive, it is every citizen’s right to be offered the best healthcare available. It is not going to be an easy job for the President-elect, but the American people will not accept any more apologies. So Mr. President, the American people are shouting, “A little less conversation, a little more action!”
[1] Drugs.com “Americans Dissatisfied with Healthcare, Want Lower Costs Even if it Means Sacrificing Quality According to New Quality Health.com Survey”
[2] Genengnews.com “Patient Satisfaction with Healthcare Systems: Do Different Funding Models Lead to Different Results”
[3] Genengnews.com “Patient Satisfaction with Healthcare Systems: Do Different Funding Models Lead to Different Results”
[4] New York Times “When a Job Disappears, So Does the Health Care”
Friday, December 5, 2008
Articles of the Week!
Here's a taste of what happened in pharma this week!
Courtesy of: Jacqueline O'Connor, CIS Marketing Associate
jacquelineoconnor@cis-partners.com
Measles Deaths Drop Worldwide, Report Estimates
http://www.nytimes.com/aponline/health/AP-MED-Global-Measles.html?ref=health
Perrigo, Schering-Plough Settle Clarinex Suit
http://www.forbes.com/feeds/ap/2008/12/04/ap5780615.html
Medicare Drug Criticized as Unclear
http://www.usatoday.com/news/health/2008-12-02-drug-penalties_N.htm
Brain-injured Troops Face Unclear Long Term Effects
http://health.yahoo.com/news/ap/med_brain_injury.html
Cervical Cancer Vaccine Well Tolerated
http://health.msn.com/health-topics/sexual-health/cervical-cancer/articlepage.aspx?cp-documentid=100228027
Have a great weekend!
Courtesy of: Jacqueline O'Connor, CIS Marketing Associate
jacquelineoconnor@cis-partners.com
Measles Deaths Drop Worldwide, Report Estimates
http://www.nytimes.com/aponline/health/AP-MED-Global-Measles.html?ref=health
Perrigo, Schering-Plough Settle Clarinex Suit
http://www.forbes.com/feeds/ap/2008/12/04/ap5780615.html
Medicare Drug Criticized as Unclear
http://www.usatoday.com/news/health/2008-12-02-drug-penalties_N.htm
Brain-injured Troops Face Unclear Long Term Effects
http://health.yahoo.com/news/ap/med_brain_injury.html
Cervical Cancer Vaccine Well Tolerated
http://health.msn.com/health-topics/sexual-health/cervical-cancer/articlepage.aspx?cp-documentid=100228027
Have a great weekend!
Wednesday, December 3, 2008
Google Search Trends Reveal Flu Outbreaks
By: Amy Lotman, CIS Compliance Consultant
amylotman@cis-partners.com
With flu season fast approaching, people who feel themselves getting sick are turning to the web to self-diagnose, so search engine giant Google launched a new tool that will help U.S. federal health experts track the annual flu epidemic.
“Google Flu Trends” uses search terms that people put into the Web-based search engine to figure out where influenza is heating up, and then notify the U.S. Centers for Disease Control and Prevention (CDC) in real time. So, you can now track the annual flu epidemic on a national level and even drill down to your specific region.
This tool was developed after Google discovered that certain search terms are good indicators of flu activity. It seems that when people are sick, they tend to look up their symptoms.
“Google Flu Trends” takes Google search terms of influenza-like illness and influenza and emulates a signal that tells the CDC how much influenza activity there was. Google is keeping the search terms it uses private, but influenza-like illnesses include symptoms such as fever, muscle aches and cough.
Currently, the CDC relies on centers that report on people coming to their doctors with flu-like symptoms, and lab tests that confirm whether a patient has influenza. But many people with flu never visit a doctor and most doctors treat based on symptoms, rarely giving a flu test. Either way, the CDC's surveillance data has been about two weeks behind.
On a day-to-day basis, “Google Flu Trends” data can tell the relative direction of flu activity for a given area. It turns out Google is about a week ahead of the CDC system.
Now, “Google Flu Trends” can be used as an early warning signal for flu activity. The CDC can get the word out to hospitals, clinics and doctors offices so they can stock up on flu tests, antiviral drugs and antibiotics for people who get what are known as co-infections — bacterial infections that worsen a bout of flu. Two weeks warning also allows people to get vaccinated before flu reaches their community.
Google is not charging for its “Flu Trands” service. Currently, the service covers only the United States, but Google is hoping to eventually use the same technique to help track influenza and other diseases worldwide.
NOTE: A paper on the methodology of “Google Flu Trends” is expected to be published in the journal Nature.
Source:
http://www.google.org/flutrends/
amylotman@cis-partners.com
With flu season fast approaching, people who feel themselves getting sick are turning to the web to self-diagnose, so search engine giant Google launched a new tool that will help U.S. federal health experts track the annual flu epidemic.
“Google Flu Trends” uses search terms that people put into the Web-based search engine to figure out where influenza is heating up, and then notify the U.S. Centers for Disease Control and Prevention (CDC) in real time. So, you can now track the annual flu epidemic on a national level and even drill down to your specific region.
This tool was developed after Google discovered that certain search terms are good indicators of flu activity. It seems that when people are sick, they tend to look up their symptoms.
“Google Flu Trends” takes Google search terms of influenza-like illness and influenza and emulates a signal that tells the CDC how much influenza activity there was. Google is keeping the search terms it uses private, but influenza-like illnesses include symptoms such as fever, muscle aches and cough.
Currently, the CDC relies on centers that report on people coming to their doctors with flu-like symptoms, and lab tests that confirm whether a patient has influenza. But many people with flu never visit a doctor and most doctors treat based on symptoms, rarely giving a flu test. Either way, the CDC's surveillance data has been about two weeks behind.
On a day-to-day basis, “Google Flu Trends” data can tell the relative direction of flu activity for a given area. It turns out Google is about a week ahead of the CDC system.
Now, “Google Flu Trends” can be used as an early warning signal for flu activity. The CDC can get the word out to hospitals, clinics and doctors offices so they can stock up on flu tests, antiviral drugs and antibiotics for people who get what are known as co-infections — bacterial infections that worsen a bout of flu. Two weeks warning also allows people to get vaccinated before flu reaches their community.
Google is not charging for its “Flu Trands” service. Currently, the service covers only the United States, but Google is hoping to eventually use the same technique to help track influenza and other diseases worldwide.
NOTE: A paper on the methodology of “Google Flu Trends” is expected to be published in the journal Nature.
Source:
http://www.google.org/flutrends/
Monday, December 1, 2008
Development in the AMP Lawsuit – An Amended Complaint was Filed
By: Meredith Taylor, Esq., CIS Sr. Compliance Specialist & PCX Product Manager
meredithtaylor@cis-partners.com
On November 7, 2007, two pharmacy trade associations initiated a lawsuit in federal court challenging the AMP Final Rule. The National Association of Chain Drug Stores along with the National Community Pharmacists Association (“the Associations”) filed a Complaint against the United States Department of Health and Human Services; the Secretary of Health and Human Services, Michael O. Leavitt; Centers for Medicare and Medicaid Services; and Acting Administrator of the Centers for Medicare and Medicaid Services, Kerry Weems (“the Government”). The Associations challenged the AMP Final Rule on the basis that it “unlawfully changes the methodology by which pharmacies are reimbursed for dispensing prescription drugs to Medicaid patients.”
The Associations alleged that the Government ignored the plain language of the Social Security Act (“the Act”) when it enacted the AMP Final Rule, in order to save billions of dollars in reimbursements payable to pharmacies. Prior to the AMP Final Rule, retail pharmacies that participated in the Medicaid Drug Rebate Program were eligible for higher reimbursements. Under AMP Final Rule, the Associations alleged that reimbursement rates would fall well below the rates allowed by Congress, pursuant to the Social Security Act.
Ultimately, the Associations sought three things: to stop the Government from implementing the AMP Final Rule, to stop the Government from posting AMP data on a public website, and to have the Court declare that the Final Rule failed to comply with the Social Security Act.
Earlier this year, the Associations were successful in obtaining a preliminary injunction to stop the Government from forcing manufacturers to publish AMP, at least until the end of the lawsuit.
A number of motions and answers have been filed, and orders have been issued, but there has not been much movement over the past eight months, with the exception of the two Amended Complaints filed on behalf of the Associations.
Both Amended Complaints correspond to the publication of the Multiple Source Drug (MSD) Interim Final Rule (published March 2008) and the MSD Final Rule (published October 2008) (“The MSD Rules”). In the original Complaint, the Associations argued that AMP Final Rule does not comply with the definition of MSD contained in the Social Security Act. The Social Security Act allows the establishment of Federal Upper Limits (FUL) on reimbursement for a drug only if the drug qualifies as a multiple source drug. The Act defines a multiple source drug as one that has two or more equivalent drug products sold or marked in the state which are generally available to the public. The Associations argue that the DRA and the AMP Final Rule violate the Act’s statutory requirements in three ways:
(1) The AMP Final Rule ignores the Act’s requirement that equivalent drug products must be “sold or marketed in the state,” and replaced it with a requirement that the drug must be “sold or marketing in the United States.”
(2) The AMP Final Rule fails to ensure that FULs will be established for a drug, only if an equivalent drug product “appears in a published national listing of average wholesale prices selected by the Secretary.”
(3) The AMP Final Rule fails to ensure that FULs are applied in each state, only to the MSD products that are “generally available to the public through retail pharmacies in that state.”
The Government attempted to revise the definition of MSD in the MSD Rules in order to comply with the Act’s state availability standard, but the same language is repeated (as appears in the AMP Final Rule). The Associations argue there was no meaningful revision because the Government states, in the preambles to the MSD Rules, that it will continue to assume all drug products are available nationwide. The Associations also allege that, procedurally, the Government failed to follow proper notice and comment rulemaking requirements of the Administrative Procedure Act when the MSD Rules were issued.
Stay tuned for more updates!
meredithtaylor@cis-partners.com
On November 7, 2007, two pharmacy trade associations initiated a lawsuit in federal court challenging the AMP Final Rule. The National Association of Chain Drug Stores along with the National Community Pharmacists Association (“the Associations”) filed a Complaint against the United States Department of Health and Human Services; the Secretary of Health and Human Services, Michael O. Leavitt; Centers for Medicare and Medicaid Services; and Acting Administrator of the Centers for Medicare and Medicaid Services, Kerry Weems (“the Government”). The Associations challenged the AMP Final Rule on the basis that it “unlawfully changes the methodology by which pharmacies are reimbursed for dispensing prescription drugs to Medicaid patients.”
The Associations alleged that the Government ignored the plain language of the Social Security Act (“the Act”) when it enacted the AMP Final Rule, in order to save billions of dollars in reimbursements payable to pharmacies. Prior to the AMP Final Rule, retail pharmacies that participated in the Medicaid Drug Rebate Program were eligible for higher reimbursements. Under AMP Final Rule, the Associations alleged that reimbursement rates would fall well below the rates allowed by Congress, pursuant to the Social Security Act.
Ultimately, the Associations sought three things: to stop the Government from implementing the AMP Final Rule, to stop the Government from posting AMP data on a public website, and to have the Court declare that the Final Rule failed to comply with the Social Security Act.
Earlier this year, the Associations were successful in obtaining a preliminary injunction to stop the Government from forcing manufacturers to publish AMP, at least until the end of the lawsuit.
A number of motions and answers have been filed, and orders have been issued, but there has not been much movement over the past eight months, with the exception of the two Amended Complaints filed on behalf of the Associations.
Both Amended Complaints correspond to the publication of the Multiple Source Drug (MSD) Interim Final Rule (published March 2008) and the MSD Final Rule (published October 2008) (“The MSD Rules”). In the original Complaint, the Associations argued that AMP Final Rule does not comply with the definition of MSD contained in the Social Security Act. The Social Security Act allows the establishment of Federal Upper Limits (FUL) on reimbursement for a drug only if the drug qualifies as a multiple source drug. The Act defines a multiple source drug as one that has two or more equivalent drug products sold or marked in the state which are generally available to the public. The Associations argue that the DRA and the AMP Final Rule violate the Act’s statutory requirements in three ways:
(1) The AMP Final Rule ignores the Act’s requirement that equivalent drug products must be “sold or marketed in the state,” and replaced it with a requirement that the drug must be “sold or marketing in the United States.”
(2) The AMP Final Rule fails to ensure that FULs will be established for a drug, only if an equivalent drug product “appears in a published national listing of average wholesale prices selected by the Secretary.”
(3) The AMP Final Rule fails to ensure that FULs are applied in each state, only to the MSD products that are “generally available to the public through retail pharmacies in that state.”
The Government attempted to revise the definition of MSD in the MSD Rules in order to comply with the Act’s state availability standard, but the same language is repeated (as appears in the AMP Final Rule). The Associations argue there was no meaningful revision because the Government states, in the preambles to the MSD Rules, that it will continue to assume all drug products are available nationwide. The Associations also allege that, procedurally, the Government failed to follow proper notice and comment rulemaking requirements of the Administrative Procedure Act when the MSD Rules were issued.
Stay tuned for more updates!
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