February—2008 will be the year for you, but retire before 2009 if you can. That new drug that R&D has just developed and gotten approved will be a blockbuster in 2008. The longer-term effects of the drug, however, won’t come to light until 2009: temporary insanity, blindness, uncontrollable flatulence, photosensitivity, an outbreak of Bubonic Plague, and Bell’s Palsy. You will also realize, albeit too late, that you sent some free samples to your cousin, Marty. Ah well, you never liked him much anyway.
P.S. Many, many thanks to everyone for helping us push past 12,000 visitors on the Pharma Compliance Blog as of late this evening!
Thursday, January 31, 2008
The Fine Art of Canoodling
With IIR's MDRP 201 and DRA Conference around the corner next week --- I was reminded that it would be a good time to-repost this article. The team of myself, Chris Cobourn, Clarissa Crain, Meredith Taylor and America Castro all promise to be genuine canoodlers next week! And we promise to have some fun and laughs while learning a whole lot too! We hope to see you all next week and, if you are attending, shoot me an email or call --- we're anxious to see you!
For Your Space,
Steven. 610-565-8007; stevenmoore@cis-partners.com
Fresh off of another tiring and fun IIR MDRP conference, I thought I’d pick an interesting topic. We all know that these conferences are great places for us all to learn a bit more from our colleagues and various other organizations. However, the focus of my article will be the ‘other’ reason that we’re all there and, of course, a big reason we at CIS are there.
Like someone with their fly down, the fine art of canoodling is visible to all but hard to openly bring up in conversation. The definition of ‘canoodle’ that I will focus on is not the one that involves two teenagers meeting at that famous ‘spot’ at the top of the hill in the neighborhood. Rather I am talking about the one that reads, more or less, “…To win over or convince by cajoling or flattering.” If you’re like me, you’ll also need the definition of ‘cajoling’ because the definition couldn’t be “to win over or convince by canoodling,” which would be breaking the golden rule of definitions as my colleague Brian O’Rourke would remind me: Thou shalt not define a word with the word in the definition.
I’ll be right back, I have a headache.
Okay --- so where was I --- oh yes, the definition of ‘cajole’. Cajole is to persuade by flattery or promises; wheedle; coax. Oh and the definition of wheedle is to endeavor to influence (a person) by smooth, flattering, or beguiling words or acts. The definition of beguiling is to influence by trickery, flattery, etc.; mislead; delude. Whoa --- now it’s gone completely negative! I will help you clarify when someone is beguiling in a bit.
Now that we’re all smarter and have some new 50 cent (great rapper) words to say at our next Conference Cocktail Hour (thanks I-Many!), let’s talk about canoodling.
I believe there are three categories, rather classes, of canoodlers. They are, in order of most annoying to least annoying:
The “Get Out of my Face” Canoodler: You all know him or her. This is the person that stalks you like a lioness on the hunt --- never ceasing until they get the opportunity to tell you why their awesomeness exceeds the awesomeness of all the other awesome companies doing the same awesome things. They get business via annoying people to the point where a signature acts as the final act of shutting them up. He or she does not drink because their intoxication comes purely from deceiving you and getting your dollars. They are in all industries, but if you’re in need of a Chevy Nova that is 20 years old and only has 3,654 miles on it --- you’ll be sure to meet him or her.
The “Sheepish Grin” Canoodler: Oh, they know what they’re doing. They really, really do. But their grin is one that seems to say, “I hate to do this --- but I have to tell you how awesome we are.” He or she drinks wine at a pace that rivals the evaporation of water on a 33 degree day, but knows that having a drink in their hand (a fine glass of boxed cocktail hour wine) makes them look cool and painfully approachable. These folks will never celebrate in front of you --- but rather close their office door and dance like Dwight Schrute would on ‘The Office’ upon execution of any agreement.
The “Genuine” Canoodler: This is the man or woman doing their job --- and I like them! Let’s face it, we’re all in a business and we all have numbers to make and people to impress. The genuine canoodler is honest with you and tells you why they think they’re product or services are the ones you should go with. They live and breathe on fun relationships with their co-workers, clients and potential clients. Of course they’re thrilled to win your business, but they understand if you choose a different direction. Should they lose your business, they will follow up and ask you what they could have done better. By definition, there is a bit of canoodling going on, but it’s because they genuinely like people and want to work with you. Sure they flatter you --- but mean it if they say they like your suit. Their awesomeness comes from backing up what they tell you.
So there you have it. We’ve successfully defined canoodling and 567 other words that made me feel dumber.
Where does CIS fit in? I try my best not to sell our services on this blog, so I will drop back and punt that one to you.
However, if you’ll allow me just a little bit of latitude, I do think we’re pretty cool. (See: Definition for “Genuine Canoodler”)
For Your Space,
Steven.
For Your Space,
Steven. 610-565-8007; stevenmoore@cis-partners.com
Fresh off of another tiring and fun IIR MDRP conference, I thought I’d pick an interesting topic. We all know that these conferences are great places for us all to learn a bit more from our colleagues and various other organizations. However, the focus of my article will be the ‘other’ reason that we’re all there and, of course, a big reason we at CIS are there.
Like someone with their fly down, the fine art of canoodling is visible to all but hard to openly bring up in conversation. The definition of ‘canoodle’ that I will focus on is not the one that involves two teenagers meeting at that famous ‘spot’ at the top of the hill in the neighborhood. Rather I am talking about the one that reads, more or less, “…To win over or convince by cajoling or flattering.” If you’re like me, you’ll also need the definition of ‘cajoling’ because the definition couldn’t be “to win over or convince by canoodling,” which would be breaking the golden rule of definitions as my colleague Brian O’Rourke would remind me: Thou shalt not define a word with the word in the definition.
I’ll be right back, I have a headache.
Okay --- so where was I --- oh yes, the definition of ‘cajole’. Cajole is to persuade by flattery or promises; wheedle; coax. Oh and the definition of wheedle is to endeavor to influence (a person) by smooth, flattering, or beguiling words or acts. The definition of beguiling is to influence by trickery, flattery, etc.; mislead; delude. Whoa --- now it’s gone completely negative! I will help you clarify when someone is beguiling in a bit.
Now that we’re all smarter and have some new 50 cent (great rapper) words to say at our next Conference Cocktail Hour (thanks I-Many!), let’s talk about canoodling.
I believe there are three categories, rather classes, of canoodlers. They are, in order of most annoying to least annoying:
The “Get Out of my Face” Canoodler: You all know him or her. This is the person that stalks you like a lioness on the hunt --- never ceasing until they get the opportunity to tell you why their awesomeness exceeds the awesomeness of all the other awesome companies doing the same awesome things. They get business via annoying people to the point where a signature acts as the final act of shutting them up. He or she does not drink because their intoxication comes purely from deceiving you and getting your dollars. They are in all industries, but if you’re in need of a Chevy Nova that is 20 years old and only has 3,654 miles on it --- you’ll be sure to meet him or her.
The “Sheepish Grin” Canoodler: Oh, they know what they’re doing. They really, really do. But their grin is one that seems to say, “I hate to do this --- but I have to tell you how awesome we are.” He or she drinks wine at a pace that rivals the evaporation of water on a 33 degree day, but knows that having a drink in their hand (a fine glass of boxed cocktail hour wine) makes them look cool and painfully approachable. These folks will never celebrate in front of you --- but rather close their office door and dance like Dwight Schrute would on ‘The Office’ upon execution of any agreement.
The “Genuine” Canoodler: This is the man or woman doing their job --- and I like them! Let’s face it, we’re all in a business and we all have numbers to make and people to impress. The genuine canoodler is honest with you and tells you why they think they’re product or services are the ones you should go with. They live and breathe on fun relationships with their co-workers, clients and potential clients. Of course they’re thrilled to win your business, but they understand if you choose a different direction. Should they lose your business, they will follow up and ask you what they could have done better. By definition, there is a bit of canoodling going on, but it’s because they genuinely like people and want to work with you. Sure they flatter you --- but mean it if they say they like your suit. Their awesomeness comes from backing up what they tell you.
So there you have it. We’ve successfully defined canoodling and 567 other words that made me feel dumber.
Where does CIS fit in? I try my best not to sell our services on this blog, so I will drop back and punt that one to you.
However, if you’ll allow me just a little bit of latitude, I do think we’re pretty cool. (See: Definition for “Genuine Canoodler”)
For Your Space,
Steven.
Wednesday, January 30, 2008
New SafeRX Law Promotes Sales Rep Compliance
In an article by George Koroneos in the PharmaExec Direct Marketing Edition, I stumbled upon the following --- paying most attention to the quotation:
“Pharmaceutical sales representatives must be licensed in order to work, according to a new law titled SafeRx, which was approved by the Council of the District of Columbia 7-6 last week. According to the bill, reps will now need a bachelor's degree and must adhere to a code of ethics that includes strict rules against gift giving.
Reactions have been mixed. Some industry experts feel that the law is simply business as usual and won't change how pharma reps do business, while others expressed concern that the legislation is unnecessary and a misuse of money.
"The perceptive value of this bill is greater than the actual value—I don't think the legislation will change what pharma is doing and mandating within its own organizations," said Rick Keefer, chief operating officer at Publicis, a company that provides sales representatives to pharma companies. "The pharma companies already take compliance, governance, and appropriate promotional policies very seriously. If a rep violates any of those things, he or she is terminated immediately.""
I must say that struggle with Mr. Keefer’s quote on several levels. First and foremost, if all pharma companies take compliance, governance and appropriate promotional policies very seriously, than how is it that billions and billions of dollars in fines continue to happen? How is it that off-label has continued to be an issue? How is it that compliance violations in the pharmaceutical industry abound to this very day? Do all violations by sales representatives result in immediate termination? Is this an overarching pharmaceutical policy that I am unaware of being in compliance work?
Of course it’s not everyone. Of course the vast majority of pharmaceutical companies and their sales representatives are upstanding individuals who are always seeking to do the right thing. But human nature and psychology tells us that there will always be individuals who bend and break the rules. There will always be individuals who can read grey in things that we see as black and white.
So let’s think about the other issue here: The cost of this type of law. What is the cost? While the article didn’t mention it, it would seem to me that any cost would not be too steep. I think you have to look at the potential result to get the cost. When we implement compliance programs or companies, those in the higher positions with ‘business minds’ always as us: What will my return on investment (ROI) be? I usually answer, “You don’t want to know and, if you really do, visit taf.org to see the most recent settlement in the pharmaceutical industry pertaining to compliance violations.”
In this case, it would seem that the ROI could be even higher. One rogue salesperson could, through verbal or financial means, push an indication that could be very dangerous and even deadly to a patient. What would the cost of another life be?
As an ethical person, I think any movement that helps promote compliance is a worthy one. Most importantly, this quote comes from a gentleman who owns a company that supplies sales representatives to the industry. It might mean a smaller pool of employees --- but it might very well lead to a more ethical group of employees.
A result like this can only benefit our industry and society.
For Your Space,
Steven.
“Pharmaceutical sales representatives must be licensed in order to work, according to a new law titled SafeRx, which was approved by the Council of the District of Columbia 7-6 last week. According to the bill, reps will now need a bachelor's degree and must adhere to a code of ethics that includes strict rules against gift giving.
Reactions have been mixed. Some industry experts feel that the law is simply business as usual and won't change how pharma reps do business, while others expressed concern that the legislation is unnecessary and a misuse of money.
"The perceptive value of this bill is greater than the actual value—I don't think the legislation will change what pharma is doing and mandating within its own organizations," said Rick Keefer, chief operating officer at Publicis, a company that provides sales representatives to pharma companies. "The pharma companies already take compliance, governance, and appropriate promotional policies very seriously. If a rep violates any of those things, he or she is terminated immediately.""
I must say that struggle with Mr. Keefer’s quote on several levels. First and foremost, if all pharma companies take compliance, governance and appropriate promotional policies very seriously, than how is it that billions and billions of dollars in fines continue to happen? How is it that off-label has continued to be an issue? How is it that compliance violations in the pharmaceutical industry abound to this very day? Do all violations by sales representatives result in immediate termination? Is this an overarching pharmaceutical policy that I am unaware of being in compliance work?
Of course it’s not everyone. Of course the vast majority of pharmaceutical companies and their sales representatives are upstanding individuals who are always seeking to do the right thing. But human nature and psychology tells us that there will always be individuals who bend and break the rules. There will always be individuals who can read grey in things that we see as black and white.
So let’s think about the other issue here: The cost of this type of law. What is the cost? While the article didn’t mention it, it would seem to me that any cost would not be too steep. I think you have to look at the potential result to get the cost. When we implement compliance programs or companies, those in the higher positions with ‘business minds’ always as us: What will my return on investment (ROI) be? I usually answer, “You don’t want to know and, if you really do, visit taf.org to see the most recent settlement in the pharmaceutical industry pertaining to compliance violations.”
In this case, it would seem that the ROI could be even higher. One rogue salesperson could, through verbal or financial means, push an indication that could be very dangerous and even deadly to a patient. What would the cost of another life be?
As an ethical person, I think any movement that helps promote compliance is a worthy one. Most importantly, this quote comes from a gentleman who owns a company that supplies sales representatives to the industry. It might mean a smaller pool of employees --- but it might very well lead to a more ethical group of employees.
A result like this can only benefit our industry and society.
For Your Space,
Steven.
Monday, January 28, 2008
A Wicked Problem
This article will appear again in this week's PCX Newsletter for those of you who subscribe. However, I loved it so much I wanted to get it out to the public sooner. For those of you who are not aware of the PCX or the PCX Newsletter, I encourage you to go to www.cis-pcx.com/register to sign up for a free trial to learn what so many in the industry have already learned. The PCX is THE source for Government Program documentation.
For Your Space,
Steven
A Wicked Problem
By Katie Lapins, CIS Senior Compliance Specialist
katielapins@cis-partners.com
Health care is cited as one of the top five concerns of Americans when being asked about the problems this country is facing. According to a survey released earlier this month by the Commonwealth Fund, approximately “68% of US adults support a requirement that all residents obtain health insurance with government subsidies for those who cannot afford coverage.”1
One of the concerns is that the costs of health care and health insurance continue to rise at a higher rate than inflation. The US automobile industry is an example of how these costs are hurting the US economy. “‘Health care raises the price of each GM car by $1,500,’ complains CEO Rick Wagoner.”2 This is a result of the life time insurance benefits promised to retirees by GM. Before a car is even built, the company has to cover $1,500 in expenses. Competing with Japanese imports becomes increasingly more difficult as these costs continue to rise.
I believe the US is at a crossroads for a very difficult problem. A Wicked Problem.
The concept of a “Wicked Problem” was first introduced by Horst Rittel and Melvin Webber in 19733. They assert that there are problems in this world, often associated with social policy, that cannot be resolved in the same way or as easily as other problems. Robert Horn developed a list of defining characteristics for “Wicked Problems:”
1. No unique “correct” view of the problem;
2. Different views of the problem and contradictory solutions;
3. The problem is connected to other problems;
4. Data are often uncertain or missing;
5. Multiple conflicts of values;
6. Ideological and/or cultural constraints;
7. Political constraints;
8. Economic constraints;
9. Often a-logical, illogical or multi-valued thinking;
10. Numerous possible intervention points;
11. Consequences difficult to imagine;
12. Considerable uncertainty and ambiguity;
13. Great resistance to change; and
14. Problem solver(s) out of contact with the problems and potential solutions.4
When considering the characteristics above, providing universal health care in the US definitely qualifies as a “Wicked Problem,” at least in my opinion. Can a Wicked Problem be successfully resolved? If so, how is “success” defined and by whom? Those implementing the solution? The recipients or beneficiaries of the solution? Or even those paying for the solution?
As health care coverage has become a topic of greater importance, many states and even some cities have developed their own solutions. I applaud the efforts by many of these to do something. However, this topic may ultimately be resolved, at least to some degree, by the US Supreme Court. Maybe this is appropriate for a Wicked Problem. As different solutions are being implemented in the various jurisdictions, appeals courts are ruling differently on similar programs5:
Maryland: The 4th US Circuit Court of Appeals ruled that a state law violated federal law that would charge very large employers a fee if they do not spend at least 8% of their payroll on health care. (This law currently only affects Wal-Mart, a company often criticized for its allegedly restrictive health care benefits.)
California: In San Francisco, an appeals court upheld a program that charges employers a fee for universal coverage for all workers within the city.
Massachusetts: A new law became effective January 1, 2008, that charges employers $295 annually per worker for employers who do not offer health insurance. It has not faced a legal challenge and many credit the relatively low fee and the early support from businesses for avoiding such a situation.
If different jurisdictions are enacting their own policies regarding universal health insurance, how will this affect their respective budgets? How will this influence decisions by businesses and individuals about where to locate or relocate? If allowed to continue, the economic impact of different policies will be interesting to track.
Clearly, universal health insurance is becoming increasingly important and an issue that could have a long-term impact on our country’s overall medical health, on the economics associated with providing, or withholding, access and on the overall financial situation in an increasingly global economy. What solutions for health coverage will be realistic and effective, especially when this is a presidential election year?
The Kaiser Family Foundation (KFF) has an excellent tool that allows side-by-side comparisons of all 2008 presidential candidates’ health care proposals. (http://www.health08.org/sidebyside.cfm) Regardless of where you stand on this issue, I strongly recommend that you look at the tool provided by KFF and vote in your state’s primary election, if it hasn’t already taken place, and in the presidential election. I believe this is one of the most important long-term issues, both from an economical and moral perspective, that our country will be forced to address.
For now, I believe my opinion is based on a quote that is attributed to Laurence J. Peter: “Some problems are so complex that you have to be highly intelligent and well informed just to be undecided about them.”
1 – “Most U.S. Adults Support Health Insurance Mandate With Government Subsidies for Some,” (http://www.kaisernetwork.org/daily_reports/health2008dr.cfm?DR_ID=49835)
2 – “Globalization Forces a Health-Check of US Auto Industry,” YaleGlobal, Susan Froetschel, February 19, 2007 (http://yaleglobal.yale.edu/display.article?id=8785)
3 – Rittel, Horst, and Melvin Webber; "Dilemmas in a General Theory of Planning," pp. 155-169, Policy Sciences, Vol. 4, Elsevier Scientific Publishing Company, Inc., Amsterdam, 1973. [Reprinted in N. Cross (ed.), Developments in Design Methodology, J. Wiley & Sons, Chichester, 1984, pp. 135-144.]
4 – Horn, Robert E., "Knowledge Mapping for Complex Social Messes: A presentation to the Foundations in the Knowledge Economy conference at the David and Lucile Packard Foundation, July 16, 2001," 2001
5 – USA Today, “Health plans up against U.S. law,” January 17, 2008
For Your Space,
Steven
A Wicked Problem
By Katie Lapins, CIS Senior Compliance Specialist
katielapins@cis-partners.com
Health care is cited as one of the top five concerns of Americans when being asked about the problems this country is facing. According to a survey released earlier this month by the Commonwealth Fund, approximately “68% of US adults support a requirement that all residents obtain health insurance with government subsidies for those who cannot afford coverage.”1
One of the concerns is that the costs of health care and health insurance continue to rise at a higher rate than inflation. The US automobile industry is an example of how these costs are hurting the US economy. “‘Health care raises the price of each GM car by $1,500,’ complains CEO Rick Wagoner.”2 This is a result of the life time insurance benefits promised to retirees by GM. Before a car is even built, the company has to cover $1,500 in expenses. Competing with Japanese imports becomes increasingly more difficult as these costs continue to rise.
I believe the US is at a crossroads for a very difficult problem. A Wicked Problem.
The concept of a “Wicked Problem” was first introduced by Horst Rittel and Melvin Webber in 19733. They assert that there are problems in this world, often associated with social policy, that cannot be resolved in the same way or as easily as other problems. Robert Horn developed a list of defining characteristics for “Wicked Problems:”
1. No unique “correct” view of the problem;
2. Different views of the problem and contradictory solutions;
3. The problem is connected to other problems;
4. Data are often uncertain or missing;
5. Multiple conflicts of values;
6. Ideological and/or cultural constraints;
7. Political constraints;
8. Economic constraints;
9. Often a-logical, illogical or multi-valued thinking;
10. Numerous possible intervention points;
11. Consequences difficult to imagine;
12. Considerable uncertainty and ambiguity;
13. Great resistance to change; and
14. Problem solver(s) out of contact with the problems and potential solutions.4
When considering the characteristics above, providing universal health care in the US definitely qualifies as a “Wicked Problem,” at least in my opinion. Can a Wicked Problem be successfully resolved? If so, how is “success” defined and by whom? Those implementing the solution? The recipients or beneficiaries of the solution? Or even those paying for the solution?
As health care coverage has become a topic of greater importance, many states and even some cities have developed their own solutions. I applaud the efforts by many of these to do something. However, this topic may ultimately be resolved, at least to some degree, by the US Supreme Court. Maybe this is appropriate for a Wicked Problem. As different solutions are being implemented in the various jurisdictions, appeals courts are ruling differently on similar programs5:
Maryland: The 4th US Circuit Court of Appeals ruled that a state law violated federal law that would charge very large employers a fee if they do not spend at least 8% of their payroll on health care. (This law currently only affects Wal-Mart, a company often criticized for its allegedly restrictive health care benefits.)
California: In San Francisco, an appeals court upheld a program that charges employers a fee for universal coverage for all workers within the city.
Massachusetts: A new law became effective January 1, 2008, that charges employers $295 annually per worker for employers who do not offer health insurance. It has not faced a legal challenge and many credit the relatively low fee and the early support from businesses for avoiding such a situation.
If different jurisdictions are enacting their own policies regarding universal health insurance, how will this affect their respective budgets? How will this influence decisions by businesses and individuals about where to locate or relocate? If allowed to continue, the economic impact of different policies will be interesting to track.
Clearly, universal health insurance is becoming increasingly important and an issue that could have a long-term impact on our country’s overall medical health, on the economics associated with providing, or withholding, access and on the overall financial situation in an increasingly global economy. What solutions for health coverage will be realistic and effective, especially when this is a presidential election year?
The Kaiser Family Foundation (KFF) has an excellent tool that allows side-by-side comparisons of all 2008 presidential candidates’ health care proposals. (http://www.health08.org/sidebyside.cfm) Regardless of where you stand on this issue, I strongly recommend that you look at the tool provided by KFF and vote in your state’s primary election, if it hasn’t already taken place, and in the presidential election. I believe this is one of the most important long-term issues, both from an economical and moral perspective, that our country will be forced to address.
For now, I believe my opinion is based on a quote that is attributed to Laurence J. Peter: “Some problems are so complex that you have to be highly intelligent and well informed just to be undecided about them.”
1 – “Most U.S. Adults Support Health Insurance Mandate With Government Subsidies for Some,” (http://www.kaisernetwork.org/daily_reports/health2008dr.cfm?DR_ID=49835)
2 – “Globalization Forces a Health-Check of US Auto Industry,” YaleGlobal, Susan Froetschel, February 19, 2007 (http://yaleglobal.yale.edu/display.article?id=8785)
3 – Rittel, Horst, and Melvin Webber; "Dilemmas in a General Theory of Planning," pp. 155-169, Policy Sciences, Vol. 4, Elsevier Scientific Publishing Company, Inc., Amsterdam, 1973. [Reprinted in N. Cross (ed.), Developments in Design Methodology, J. Wiley & Sons, Chichester, 1984, pp. 135-144.]
4 – Horn, Robert E., "Knowledge Mapping for Complex Social Messes: A presentation to the Foundations in the Knowledge Economy conference at the David and Lucile Packard Foundation, July 16, 2001," 2001
5 – USA Today, “Health plans up against U.S. law,” January 17, 2008
More Grey Areas, For Your Consideration
By Brian O'Rourke, PCX Product Manager & GP Compliance Specialist
brianorourke@cis-partners.com
Dear GP and Compliance Professionals:
Because I am a consultant, I love to find the grey areas lurking within putatively harmless statutory or regulatory references. I know that by specifically looking for something I am violating probably several principles of scientific scrutiny--because by looking for it, I am all the more likely to find it. But I can't help it. And you cannot blame me for being that way—without grey areas, I, all other consultants, and all other lawyers would be out of jobs. In fact, if such were the case, our government could exist without the judiciary branch at all.
Back to the matter at hand. In our work with various clients, we recently spotted two grey areas in the world of GP: negative and zero AMP values and the AMP smoothing methodology. We beg for your forgiveness for further complicating an already inscrutable field of endeavor. If one reads enough material, especially legal material, one ineluctably finds these things. And in keeping with what we tell all of our clients, the Government does not permit us to be “willfully blind” when it comes to meeting statutory and regulatory requirements. Once we become aware of something, or once we have an inkling there might be something to be aware of, we must come to some sort of understanding of it.
Therefore, we feel it is our duty to bring these issues to your attention. At least, that is how I’m going to justify the writing of this article, and hopefully you the reading of it.
Negative and Zero AMP Values, In General
In the Comments Section of the Final Rule, the following appears:
“Comment: A few commenters asked for guidance on how to handle zero or negative monthly AMPs. The commenters noted that for quarterly reports, CMS has instructed manufacturers to use the last quarter’s positive value when the current quarter is a zero or negative value.
Response: Manufacturers should report the most recent positive AMP value.”
This seems fairly straightforward. Taking this statement to its logical conclusion, the most recent positive AMP value could, depending upon the timing of the current submission, be either a quarterly or monthly AMP.
However, compare the above statement to the question and answer below, found within the DRA Policy Inquiries document on CMS’s website:
“Question: Further, if one of the monthly AMPs is negative, does the manufacturer use the negative monthly AMP or the previous quarter’s reported AMP?
Response: In general, with respect to a negative monthly AMP reporting, the manufacturer reports the most recent prior month’s positive AMP. However, the actual calculated monthly AMP should be used to calculate the quarterly AMP. If this quarterly AMP is negative, report the prior quarter’s AMP.”
On its face, this question and answer appear innocuous enough. What bothers me, though, is the phrase “In general.” CMS could very well have employed the exact same language to answer this question as it did to answer the comment in the Final Rule: manufacturers should report the most recent positive AMP value. So why did CMS choose to answer this question by positing “In general…the manufacturer reports the most recent prior month’s positive AMP”?
Thinking back to law school (something I try not to do), I recall that a basic principle of legal interpretation is that we should attempt to reconcile these two answers wherever possible, to derive a meaning that is consistent with the plain language first and the underlying intent second. In other words, manufacturers will “generally” report the most recent prior month’s positive AMP, because it is generally the prior month that manufacturers will look back to in the special case of a negative or zero monthly AMP.
It sounds reasonable enough to assume that the two statements mean the same thing, but the overly analytical part of me is not satisfied with this answer—CMS could have avoided any and all confusion had it simply used the exact same language to answer both questions. It did not.
The strict constructionist in me says that we must assume that a law-maker (in this case CMS) had a reason for choosing the language it did, and that that language bespeaks the underlying message intended to be conveyed. In other words, we must assume that CMS used that language because that language most accurately captures CMS's meaning. Not a word from you deconstructionists, either.
Beware, also, the exception that swallows the rule: "If this quarterly AMP is negative, report the prior quarter’s AMP." The Final Rule tells us to report the most recent positive AMP value where the current monthly AMP is zero or negative, which theoretically could be a prior monthly OR quarterly AMP. With respect to negative or zero quarterly AMPs, however, the DRA Policy document directs us to report the prior quarter's AMP, which might not be the most recent positive value of AMP. Why would it be acceptable to use a quarterly AMP in place of a negative or zero monthly AMP, but not vice versa? And, what if the prior quarterly AMP was a pre-Final Rule methodology-based AMP?
If we are forced to choose between these two sources--a Comment and Response in the Final Rule or a Question and Answer from the DRA Policy Inquiry document--for a higher level of legal authority, I would favor the answer found in the Comments Section of the Final Rule, as it is a bit more formal in nature than something posted on a web site. However, an answer found within the Final Rule's Comments Section is far from binding.
Fear not—I have contacted CMS and have been told that further clarification on the treatment of negative and zero AMP shall be forthcoming.
Split Smoothing Methodology Disorder
Along very similar lines, I have some concerns with respect to CMS’s smoothing methodology under the Final Rule. Quite naturally, we assume that we can use the same set of rules for the AMP calculation as we do for the ASP calculation. After all, we’re talking about CMS here—the same Federal Agency administers both the Medicaid and the Medicare Programs.
The problem, gentle reader, is that CMS did not use the exact same language to describe both methodologies. So we run into some of the same problems we had above.
For ASP, see 42 CFR 414.804(a)(3)(i)(A): “For each National Drug Code with at least 12 months of sales….after adjusting for exempted sales, the manufacturer calculates a percentage equal to the sum of the price concessions for the most recent 12-month period available associated with sales subject to the average sales price reporting requirement divided by the total in dollars for the sales subject to the average sales price reporting requirement for the same 12-month period.”
For AMP, see 42 CFR 447.510(d)(2): “In calculating monthly AMP, a manufacturer must estimate the impact of its lagged price concessions using a 12-month rolling average to estimate the value of those discounts.”
Both provisions sound similar, and we know the purpose behind smoothing data is to avoid fluctuations in calculations over time. So, if the provisions are similar and have been put into place for the same reason, it would make sense to use the same methodology for each.
But as Galileo might have said (I think scholars disagree on this), “And yet it moves.” Yet, the two provisions are different. If CMS wanted manufacturers to employ the same methodology, it could have easily—VERY EASILY—used the same verbiage. But it did not. Again, operating under the principle of a "purposeful author," we must assume that CMS chose its wording for a reason. And let us not forget that the Final Rule was not scrapped together hastily on a Friday afternoon to beat a five o'clock deadline before a long weekend. The Final Rule was the product of months and months of deliberation (arguably, years of deliberation). So when CMS put pen to paper, it did so with a clear purpose in mind and chose its words for a reason.
I know what you’re all probably saying: “It’s the same Federal Agency, so we should use the same methodology.”
To which, I would reply, “Yes, it is the same Agency. But we all know that CMS has different departments. In point of fact, entirely different departments within CMS are responsible for promulgating regulations with respect to Medicare Part B and Medicaid. In other words, we are talking about two different authors, who purposely chose to use similar, but ultimately different language.” Or, to argue the point using the converse: nothing prevented CMS from using exactly the same language to describe the AMP smoothing methodology as it did for the ASP smoothing methodology. As much as I would like to be able to read these two provisions together, to satisfy my in pari materia yearnings, I can't do so with 100 percent certainty--they were written by "different" authors at different times.
The short answer to this dilemma, and one we always like to give, is that you must run these issues by your Legal Department or outside counsel. Without sidestepping the issue entirely and allowing my column to degenerate into pure sophistry, I will state with (almost) certainty that using the same methodology makes the most sense from a theoretical and practical standpoint. But don't take my word for it--your decision on this issue requires some sort of legal blessing.
As we all know, there is no shortage of grey areas in the GP world. Being able to identify the grey is the crucial first step in a long process of interpretation, research, and informed decision-making. Only through thoughtful consideration of the requirements can you achieve a true measure of compliance. As Galileo said, “I wish they would go back to using Average Wholesale Price. Where’s my telescope?”
brianorourke@cis-partners.com
Dear GP and Compliance Professionals:
Because I am a consultant, I love to find the grey areas lurking within putatively harmless statutory or regulatory references. I know that by specifically looking for something I am violating probably several principles of scientific scrutiny--because by looking for it, I am all the more likely to find it. But I can't help it. And you cannot blame me for being that way—without grey areas, I, all other consultants, and all other lawyers would be out of jobs. In fact, if such were the case, our government could exist without the judiciary branch at all.
Back to the matter at hand. In our work with various clients, we recently spotted two grey areas in the world of GP: negative and zero AMP values and the AMP smoothing methodology. We beg for your forgiveness for further complicating an already inscrutable field of endeavor. If one reads enough material, especially legal material, one ineluctably finds these things. And in keeping with what we tell all of our clients, the Government does not permit us to be “willfully blind” when it comes to meeting statutory and regulatory requirements. Once we become aware of something, or once we have an inkling there might be something to be aware of, we must come to some sort of understanding of it.
Therefore, we feel it is our duty to bring these issues to your attention. At least, that is how I’m going to justify the writing of this article, and hopefully you the reading of it.
Negative and Zero AMP Values, In General
In the Comments Section of the Final Rule, the following appears:
“Comment: A few commenters asked for guidance on how to handle zero or negative monthly AMPs. The commenters noted that for quarterly reports, CMS has instructed manufacturers to use the last quarter’s positive value when the current quarter is a zero or negative value.
Response: Manufacturers should report the most recent positive AMP value.”
This seems fairly straightforward. Taking this statement to its logical conclusion, the most recent positive AMP value could, depending upon the timing of the current submission, be either a quarterly or monthly AMP.
However, compare the above statement to the question and answer below, found within the DRA Policy Inquiries document on CMS’s website:
“Question: Further, if one of the monthly AMPs is negative, does the manufacturer use the negative monthly AMP or the previous quarter’s reported AMP?
Response: In general, with respect to a negative monthly AMP reporting, the manufacturer reports the most recent prior month’s positive AMP. However, the actual calculated monthly AMP should be used to calculate the quarterly AMP. If this quarterly AMP is negative, report the prior quarter’s AMP.”
On its face, this question and answer appear innocuous enough. What bothers me, though, is the phrase “In general.” CMS could very well have employed the exact same language to answer this question as it did to answer the comment in the Final Rule: manufacturers should report the most recent positive AMP value. So why did CMS choose to answer this question by positing “In general…the manufacturer reports the most recent prior month’s positive AMP”?
Thinking back to law school (something I try not to do), I recall that a basic principle of legal interpretation is that we should attempt to reconcile these two answers wherever possible, to derive a meaning that is consistent with the plain language first and the underlying intent second. In other words, manufacturers will “generally” report the most recent prior month’s positive AMP, because it is generally the prior month that manufacturers will look back to in the special case of a negative or zero monthly AMP.
It sounds reasonable enough to assume that the two statements mean the same thing, but the overly analytical part of me is not satisfied with this answer—CMS could have avoided any and all confusion had it simply used the exact same language to answer both questions. It did not.
The strict constructionist in me says that we must assume that a law-maker (in this case CMS) had a reason for choosing the language it did, and that that language bespeaks the underlying message intended to be conveyed. In other words, we must assume that CMS used that language because that language most accurately captures CMS's meaning. Not a word from you deconstructionists, either.
Beware, also, the exception that swallows the rule: "If this quarterly AMP is negative, report the prior quarter’s AMP." The Final Rule tells us to report the most recent positive AMP value where the current monthly AMP is zero or negative, which theoretically could be a prior monthly OR quarterly AMP. With respect to negative or zero quarterly AMPs, however, the DRA Policy document directs us to report the prior quarter's AMP, which might not be the most recent positive value of AMP. Why would it be acceptable to use a quarterly AMP in place of a negative or zero monthly AMP, but not vice versa? And, what if the prior quarterly AMP was a pre-Final Rule methodology-based AMP?
If we are forced to choose between these two sources--a Comment and Response in the Final Rule or a Question and Answer from the DRA Policy Inquiry document--for a higher level of legal authority, I would favor the answer found in the Comments Section of the Final Rule, as it is a bit more formal in nature than something posted on a web site. However, an answer found within the Final Rule's Comments Section is far from binding.
Fear not—I have contacted CMS and have been told that further clarification on the treatment of negative and zero AMP shall be forthcoming.
Split Smoothing Methodology Disorder
Along very similar lines, I have some concerns with respect to CMS’s smoothing methodology under the Final Rule. Quite naturally, we assume that we can use the same set of rules for the AMP calculation as we do for the ASP calculation. After all, we’re talking about CMS here—the same Federal Agency administers both the Medicaid and the Medicare Programs.
The problem, gentle reader, is that CMS did not use the exact same language to describe both methodologies. So we run into some of the same problems we had above.
For ASP, see 42 CFR 414.804(a)(3)(i)(A): “For each National Drug Code with at least 12 months of sales….after adjusting for exempted sales, the manufacturer calculates a percentage equal to the sum of the price concessions for the most recent 12-month period available associated with sales subject to the average sales price reporting requirement divided by the total in dollars for the sales subject to the average sales price reporting requirement for the same 12-month period.”
For AMP, see 42 CFR 447.510(d)(2): “In calculating monthly AMP, a manufacturer must estimate the impact of its lagged price concessions using a 12-month rolling average to estimate the value of those discounts.”
Both provisions sound similar, and we know the purpose behind smoothing data is to avoid fluctuations in calculations over time. So, if the provisions are similar and have been put into place for the same reason, it would make sense to use the same methodology for each.
But as Galileo might have said (I think scholars disagree on this), “And yet it moves.” Yet, the two provisions are different. If CMS wanted manufacturers to employ the same methodology, it could have easily—VERY EASILY—used the same verbiage. But it did not. Again, operating under the principle of a "purposeful author," we must assume that CMS chose its wording for a reason. And let us not forget that the Final Rule was not scrapped together hastily on a Friday afternoon to beat a five o'clock deadline before a long weekend. The Final Rule was the product of months and months of deliberation (arguably, years of deliberation). So when CMS put pen to paper, it did so with a clear purpose in mind and chose its words for a reason.
I know what you’re all probably saying: “It’s the same Federal Agency, so we should use the same methodology.”
To which, I would reply, “Yes, it is the same Agency. But we all know that CMS has different departments. In point of fact, entirely different departments within CMS are responsible for promulgating regulations with respect to Medicare Part B and Medicaid. In other words, we are talking about two different authors, who purposely chose to use similar, but ultimately different language.” Or, to argue the point using the converse: nothing prevented CMS from using exactly the same language to describe the AMP smoothing methodology as it did for the ASP smoothing methodology. As much as I would like to be able to read these two provisions together, to satisfy my in pari materia yearnings, I can't do so with 100 percent certainty--they were written by "different" authors at different times.
The short answer to this dilemma, and one we always like to give, is that you must run these issues by your Legal Department or outside counsel. Without sidestepping the issue entirely and allowing my column to degenerate into pure sophistry, I will state with (almost) certainty that using the same methodology makes the most sense from a theoretical and practical standpoint. But don't take my word for it--your decision on this issue requires some sort of legal blessing.
As we all know, there is no shortage of grey areas in the GP world. Being able to identify the grey is the crucial first step in a long process of interpretation, research, and informed decision-making. Only through thoughtful consideration of the requirements can you achieve a true measure of compliance. As Galileo said, “I wish they would go back to using Average Wholesale Price. Where’s my telescope?”
Friday, January 25, 2008
Presidential Candidates' Platforms Reflect Differences in Perspectives of Democratic, Republican Primary Voters on Health Care Issues, Survey Analysis
From Kaisernetwork.org
[Jan 24, 2008]
A newly published article in the New England Journal of Medicine finds that the contrasting health care platforms of the leading Democratic and Republican presidential candidates reflect underlying differences in the views of their primary voters, the AP/Seattle Post-Intelligencer reports.
The article is based in part on a new telephone survey conducted by the Kaiser Family Foundation and the Harvard School of Public Health, including responses from 674 likely Democratic voters and 508 likely Republican voters in 35 states -- and Washington, D.C. -- with January or February presidential primaries or caucuses (Reuters, 1/24). The survey, conducted in November 2007, had a margin of error of plus or minus four percentage points for Democratic voters and plus or minus five percentage points for Republican voters (Freking, AP/Seattle Post-Intelligencer, 1/24).
Survey Results
According to the survey, 65% of Democratic voters say they would like presidential candidates to propose plans that would expand health insurance to all residents, regardless of whether such plans would increase government spending. Among Republican voters, 23% would like to hear about proposals that would expand health insurance to all residents, compared with 42% who prefer more limited proposals and 27% who would like to see no changes to the current system, the survey found.
In addition, Democratic voters are divided between a focus on expanding insurance coverage and controlling costs, while cost issues dominate among Republican voters, the Kaiser/Harvard survey found (Emery, Reuters, 1/24).
According to the article -- based on the new survey and an analysis of 10 other recent surveys -- the health care proposals from the presidential candidates reflect the views of Democratic and Republican voters. The analysis concluded that the "prospects for actual health care reform are tempered by two factors: the wide difference in the two parties' view of what health care reform should look like and the current level of satisfaction that majorities of both parties have with their own health care situations" (AP/Seattle Post-Intelligencer, 1/24).
Comments
Robert Blendon, a professor of health care and political analysis at the Harvard School of Public Health and an author of the article, said, "There are huge differences between Republicans and Democrats on what should be done to improve health care" (Reuters, 1/24).
Kaiser Family Foundation President and CEO Drew Altman, also an author of the article, said, "In the primaries, we're seeing the presidential candidates adopt health plans that, to some extent, mirror the concerns of their party's core voters -- with leading Democrats aiming for universal coverage by building on the employer-based system and Republicans offering tax-based incentives to encourage more people to buy coverage on their own." He added, "Finding a way to bridge these differences will be important to winning independents in the general election and to fashioning a legislative compromise in the new Congress in 2009" (Kaiser Family Foundation/ Harvard School of Public Health release, 1/23).
[Jan 24, 2008]
A newly published article in the New England Journal of Medicine finds that the contrasting health care platforms of the leading Democratic and Republican presidential candidates reflect underlying differences in the views of their primary voters, the AP/Seattle Post-Intelligencer reports.
The article is based in part on a new telephone survey conducted by the Kaiser Family Foundation and the Harvard School of Public Health, including responses from 674 likely Democratic voters and 508 likely Republican voters in 35 states -- and Washington, D.C. -- with January or February presidential primaries or caucuses (Reuters, 1/24). The survey, conducted in November 2007, had a margin of error of plus or minus four percentage points for Democratic voters and plus or minus five percentage points for Republican voters (Freking, AP/Seattle Post-Intelligencer, 1/24).
Survey Results
According to the survey, 65% of Democratic voters say they would like presidential candidates to propose plans that would expand health insurance to all residents, regardless of whether such plans would increase government spending. Among Republican voters, 23% would like to hear about proposals that would expand health insurance to all residents, compared with 42% who prefer more limited proposals and 27% who would like to see no changes to the current system, the survey found.
In addition, Democratic voters are divided between a focus on expanding insurance coverage and controlling costs, while cost issues dominate among Republican voters, the Kaiser/Harvard survey found (Emery, Reuters, 1/24).
According to the article -- based on the new survey and an analysis of 10 other recent surveys -- the health care proposals from the presidential candidates reflect the views of Democratic and Republican voters. The analysis concluded that the "prospects for actual health care reform are tempered by two factors: the wide difference in the two parties' view of what health care reform should look like and the current level of satisfaction that majorities of both parties have with their own health care situations" (AP/Seattle Post-Intelligencer, 1/24).
Comments
Robert Blendon, a professor of health care and political analysis at the Harvard School of Public Health and an author of the article, said, "There are huge differences between Republicans and Democrats on what should be done to improve health care" (Reuters, 1/24).
Kaiser Family Foundation President and CEO Drew Altman, also an author of the article, said, "In the primaries, we're seeing the presidential candidates adopt health plans that, to some extent, mirror the concerns of their party's core voters -- with leading Democrats aiming for universal coverage by building on the employer-based system and Republicans offering tax-based incentives to encourage more people to buy coverage on their own." He added, "Finding a way to bridge these differences will be important to winning independents in the general election and to fashioning a legislative compromise in the new Congress in 2009" (Kaiser Family Foundation/ Harvard School of Public Health release, 1/23).
Thursday, January 24, 2008
New Study: GP Experts Depressed
I hate to be the bearer of bad news, but I came across this study late last night. I caution you to read this at your own risk—this article won’t make you feel warm and bubbly:
For Your Space,
Steven.
New York, NY (AP) – A new study has shown that individuals working within the pharmaceutical industry, especially those with responsibilities related to reporting rebating or pricing data to the government, are at the most risk for depression and drug dependency compared to similarly-situated individuals in all other fields.
Nearly 90% of all subjects tested showed either early signs or symptoms of depression. In typical scientific fashion, Dr. R.U. Sirius, head researcher on the study, was quick to dismiss any claims of causality. “I want to stress that the study does not necessarily show that these people are depressed because of their jobs. All we can say at this point is there’s a correlation. It’s the classic ‘chicken or the egg’ scenario. Are depressed, masochistic types drawn to this type of work? Does the work cause these feelings? Or is there some strange combination of factors at play?” Sirius expounded.
The new study is a landmark not only for its findings, but in its very methodology. Sirius tested over 1000 professionals in what is commonly referred to as the GP space. GP refers to either Government Pricing or Government Programs. As an aside, it is very common within—and quite illustrative of—the pharmaceutical industry to use acronyms that stand for more than one phrase.
Sirius took the classic indicators of depression: significantly reduced level of interest or pleasure in most or all activities; considerable loss or gain of weight; difficulty falling asleep or staying asleep, or sleeping more than usual; thoughts of worthlessness or extreme guilt; ability to think, concentrate, or make decisions reduced. Then, using a Lickert Scale (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree), he then measured those in light of the Affect Theory, one of the more famous job satisfaction models. Generally speaking, the Affect Theory propounds that satisfaction is determined by a discrepancy between what one wants in a job and what one has in a job.
The results were stark. 89% of “GPers,” as they are sometimes referred to, met the criteria for depression. Perhaps even more unsettling is the fact that of the remaining 11%, 7.9% showed at least three indicators of depression (according to current psychological thinking, an individual must exhibit five of the nine indicators to qualify as suffering from a major depressive episode).
One anonymous GP professional (whom I’ll refer to as “C.C.”), who has nearly twenty years of consulting experience, had this to say about the study’s findings: “I’m not surprised. GP people are typically underappreciated. Nobody knows what they do, or how important it is to the organization. Even worse, nearly every other single aspect of a company’s operations affects what they do, and yet, they have little say or voice when it comes to commercial strategization.”
All of which leads back to one of the study’s findings. Job satisfaction theory has led many researchers to believe that employees need to have autonomy, or at least, feel like they have autonomy. They need to feel like they have some measure of control over their destinies, including how they do their job.
Compared to the national average of alcoholic use disorder in adults, which is 30%, the average of incidence among GP professionals is also markedly higher—52%. Again, Sirius was quick to shy away from any definitive claims of causality: “It’s the same problem as before. Are inebriants drawn to this type of work, or does this type of work drive people to drink?”
Sirius based his findings also partly on a parallel survey conducted by the public interest group UPayWePlay.org. The survey found that, on average, GPers were underpaid by as much as 43%.
I.M. Outamymind, lead researcher at the company, explained how they were able to derive a percentage. “Basically, we compared salary paid to job importance. We defined job importance to include all of the traditional factors, but also some of the more non-traditional. So we made sure to not just look at a job’s relation to profitability but also to risk exposure, level of esoteric knowledge, and frustration.”
UPayWePlay.org ultimately concluded that, based upon the survey’s findings, GPers were significantly more important to an organization than most of the organization’s executives realized, chiefly because the job role requires a highly-specialized knowledge base, financial background, and an abnormal collection of skill sets. Additionally, the risk of exposure factor was also paramount in deriving meaning from the study; in other words, a GPer must do his job “correctly,” lest the organization face exorbitant fines, settlements and legal fees, often reaching the hundreds of millions. According to Outamymind, comparing the average GP salary to the company’s risk of exposure “[p]robably skewed the numbers a little, but not to a statistically significant degree.”
Just kidding --- except for the whole hard work you do and underappreciated part --- we at CIS have a tremendous amount of respect for what you do!!!
By Brian O'Rourke, PCX Editor & GP Compliance Specialist
For Your Space,
Steven.
New York, NY (AP) – A new study has shown that individuals working within the pharmaceutical industry, especially those with responsibilities related to reporting rebating or pricing data to the government, are at the most risk for depression and drug dependency compared to similarly-situated individuals in all other fields.
Nearly 90% of all subjects tested showed either early signs or symptoms of depression. In typical scientific fashion, Dr. R.U. Sirius, head researcher on the study, was quick to dismiss any claims of causality. “I want to stress that the study does not necessarily show that these people are depressed because of their jobs. All we can say at this point is there’s a correlation. It’s the classic ‘chicken or the egg’ scenario. Are depressed, masochistic types drawn to this type of work? Does the work cause these feelings? Or is there some strange combination of factors at play?” Sirius expounded.
The new study is a landmark not only for its findings, but in its very methodology. Sirius tested over 1000 professionals in what is commonly referred to as the GP space. GP refers to either Government Pricing or Government Programs. As an aside, it is very common within—and quite illustrative of—the pharmaceutical industry to use acronyms that stand for more than one phrase.
Sirius took the classic indicators of depression: significantly reduced level of interest or pleasure in most or all activities; considerable loss or gain of weight; difficulty falling asleep or staying asleep, or sleeping more than usual; thoughts of worthlessness or extreme guilt; ability to think, concentrate, or make decisions reduced. Then, using a Lickert Scale (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree), he then measured those in light of the Affect Theory, one of the more famous job satisfaction models. Generally speaking, the Affect Theory propounds that satisfaction is determined by a discrepancy between what one wants in a job and what one has in a job.
The results were stark. 89% of “GPers,” as they are sometimes referred to, met the criteria for depression. Perhaps even more unsettling is the fact that of the remaining 11%, 7.9% showed at least three indicators of depression (according to current psychological thinking, an individual must exhibit five of the nine indicators to qualify as suffering from a major depressive episode).
One anonymous GP professional (whom I’ll refer to as “C.C.”), who has nearly twenty years of consulting experience, had this to say about the study’s findings: “I’m not surprised. GP people are typically underappreciated. Nobody knows what they do, or how important it is to the organization. Even worse, nearly every other single aspect of a company’s operations affects what they do, and yet, they have little say or voice when it comes to commercial strategization.”
All of which leads back to one of the study’s findings. Job satisfaction theory has led many researchers to believe that employees need to have autonomy, or at least, feel like they have autonomy. They need to feel like they have some measure of control over their destinies, including how they do their job.
Compared to the national average of alcoholic use disorder in adults, which is 30%, the average of incidence among GP professionals is also markedly higher—52%. Again, Sirius was quick to shy away from any definitive claims of causality: “It’s the same problem as before. Are inebriants drawn to this type of work, or does this type of work drive people to drink?”
Sirius based his findings also partly on a parallel survey conducted by the public interest group UPayWePlay.org. The survey found that, on average, GPers were underpaid by as much as 43%.
I.M. Outamymind, lead researcher at the company, explained how they were able to derive a percentage. “Basically, we compared salary paid to job importance. We defined job importance to include all of the traditional factors, but also some of the more non-traditional. So we made sure to not just look at a job’s relation to profitability but also to risk exposure, level of esoteric knowledge, and frustration.”
UPayWePlay.org ultimately concluded that, based upon the survey’s findings, GPers were significantly more important to an organization than most of the organization’s executives realized, chiefly because the job role requires a highly-specialized knowledge base, financial background, and an abnormal collection of skill sets. Additionally, the risk of exposure factor was also paramount in deriving meaning from the study; in other words, a GPer must do his job “correctly,” lest the organization face exorbitant fines, settlements and legal fees, often reaching the hundreds of millions. According to Outamymind, comparing the average GP salary to the company’s risk of exposure “[p]robably skewed the numbers a little, but not to a statistically significant degree.”
Just kidding --- except for the whole hard work you do and underappreciated part --- we at CIS have a tremendous amount of respect for what you do!!!
By Brian O'Rourke, PCX Editor & GP Compliance Specialist
Wednesday, January 23, 2008
The Ten Commandments of Sample Accountability: Commandment #10
By Judy Fox
Commandment #10 – Thou Shalt Conduct Inventory and Reconciliations
The PDMA states, “…a manufacturer or authorized distributor of record that distributes drug samples shall establish, maintain, and adhere to written policies and procedures describing its administrative systems for…conducting the annual physical inventory and preparation of the reconciliation report…”
While inventories and reconciliations are established in written processes and procedures, the two entities deserve their own commandment.
The PDMA requires that at a minimum an annual inventory and reconciliation must be conducted. The best way to determine if more frequent inventories and reconciliations are warranted, a pharmaceutical company should determine how they will use the information that is collected, what other methods are utilized to determine compliance, if the volume of sampling activity would warrant more frequent monitoring and reconciliations. The physical inventory and reconciliation must be conducted by someone other than the sales representative.
A reconciliation report takes into consideration all activities surrounding samples, such as shipments, transfers, theft and loss, and of course, disbursements. Some pharmaceutical companies conduct only the required annual physical inventory and reconciliation, others find it helpful to conduct them throughout the year and use the results to monitor their sampling program.
Reconciliation reports, regardless of the frequency, should all be disbursed at the same time, with everyone receiving a report regardless of the reconciliation status. Those that are below the acceptable threshold (or considered “reconciled”) should receive a report and those that are above the acceptable threshold should receive the initial report and updated reports as they work through the reconciliation process. Everyone should be instructed to keep all reports with their other documents for a minimum of three (3) years.
Significant loss thresholds should be determined through several factors including, but not limited to the potential for diversion of the drug, the volume of sampling and the cost of the drug. Many companies find it helpful to establish a corporate threshold to bridge the gap between an acceptable reconciled variance and a reportable variance level.
A corporate threshold will serve to identify employees with a potential for reportability or those who may repeatedly “fly under the radar” of reportability, but warrant further corporate surveillance.
Thresholds can be determined by using variance percentages, quantities or a combination of both, as long as the threshold remains privileged information and is not shared with the corporate sampling community.
In addition to fulfilling the PDMA requirements, Pharmaceutical companies often have a wealth of information in the data collected for reconciliation reports and don’t do anything with it.
The information in reconciliation reports can serve as a business tool and is often used to determine and evaluate sampling trends for the sales and marketing team, “red flag” areas that may require additional surveillance and monitoring and/or identify areas of non-compliance such as failure to turn in documentation.
Commandment #10 – Thou Shalt Conduct Inventory and Reconciliations
The PDMA states, “…a manufacturer or authorized distributor of record that distributes drug samples shall establish, maintain, and adhere to written policies and procedures describing its administrative systems for…conducting the annual physical inventory and preparation of the reconciliation report…”
While inventories and reconciliations are established in written processes and procedures, the two entities deserve their own commandment.
The PDMA requires that at a minimum an annual inventory and reconciliation must be conducted. The best way to determine if more frequent inventories and reconciliations are warranted, a pharmaceutical company should determine how they will use the information that is collected, what other methods are utilized to determine compliance, if the volume of sampling activity would warrant more frequent monitoring and reconciliations. The physical inventory and reconciliation must be conducted by someone other than the sales representative.
A reconciliation report takes into consideration all activities surrounding samples, such as shipments, transfers, theft and loss, and of course, disbursements. Some pharmaceutical companies conduct only the required annual physical inventory and reconciliation, others find it helpful to conduct them throughout the year and use the results to monitor their sampling program.
Reconciliation reports, regardless of the frequency, should all be disbursed at the same time, with everyone receiving a report regardless of the reconciliation status. Those that are below the acceptable threshold (or considered “reconciled”) should receive a report and those that are above the acceptable threshold should receive the initial report and updated reports as they work through the reconciliation process. Everyone should be instructed to keep all reports with their other documents for a minimum of three (3) years.
Significant loss thresholds should be determined through several factors including, but not limited to the potential for diversion of the drug, the volume of sampling and the cost of the drug. Many companies find it helpful to establish a corporate threshold to bridge the gap between an acceptable reconciled variance and a reportable variance level.
A corporate threshold will serve to identify employees with a potential for reportability or those who may repeatedly “fly under the radar” of reportability, but warrant further corporate surveillance.
Thresholds can be determined by using variance percentages, quantities or a combination of both, as long as the threshold remains privileged information and is not shared with the corporate sampling community.
In addition to fulfilling the PDMA requirements, Pharmaceutical companies often have a wealth of information in the data collected for reconciliation reports and don’t do anything with it.
The information in reconciliation reports can serve as a business tool and is often used to determine and evaluate sampling trends for the sales and marketing team, “red flag” areas that may require additional surveillance and monitoring and/or identify areas of non-compliance such as failure to turn in documentation.
Sunday, January 20, 2008
HAPPY Tuesday!
I noticed that a lot of people were off yesterday to celebrate Dr. King's day. I thought it would be good to try and give those who had a day off the same start to the week we offered up everyone yesterday. Also, if you read it yesterday but did not check out the YouTube clip --- I highly recommend it!
Enjoy your day and note that the final installment of the "10 Commandments of Sample Accountability" will be shown tomorrow followed by some late week humor...
Emjoy!
I stumbled upon this gem of information from Time.com tonight while doing my weekly blog preparations:
"There's a lot to feel down about this month: the subprime mortgage crisis, stormy, unpredictable weather, rising gas prices, presidential primary free-for-alls. So, it would be easy to believe the theory set forth by Dr. Cliff Arnall, a researcher from Cardiff University, that the third Monday of the month (Jan. 21, this year) — a day he calls Blue Monday — will be our most depressing day of the year. Arnall bases his yearly prediction on a formula he developed, which factors in the weather, consumer debt from holiday spending and failed New Year's resolutions and arrives at that conclusion that we'll hit rock bottom on Monday the 21st."
Yikes --- talk about a 'Debbie Downer' (I mean no offense to any Debbies reading this). Sure, it's cold out (watching the Green Bay Packers/New York Giants game with temperatures below zero reinforced this), the housing market is in shambles, a gallon of gas costs about as much as a haircut, my beloved Dolphins were 1-15 while the New England Patriots haven't lost since gas was under a dollar a gallon, and the polar ice caps are melting faster than ice cream in the Sahara.
But there's a lot to be happy about too these days, so I want to counter Dr. Arnall with some happy points:
- Today is Martin Luther King, Jr. Day. We should be happy in remembering all that he did for us and celebrate his amazing legacy.
- Every single day we are gaining more daylight than the day before.
- More people are being saved by medical devices and drugs than ever before.
- Less people are dying from the historically most horrible and terrifying diseases in our world.
- The Pharma Compliance Blog is still going strong.
- Your family.
- Your friends.
- You have heat.
- If you're reading this, you can read --- which is more than 42 million Americans can say.
- And...you have access to the internet, which is more than billions can say.
I could go on and on, but you get the point. I know there is a lot that's gone wrong and will go wrong --- but if you sit back and think about your life right now, I hope things aren't too depressing. And, if for some reason that's still the case, check out this YouTube clip. I guarantee that you can't get through it without smiling! (Copy and paste link)
http://www.youtube.com/watch?v=5P6UU6m3cqk&mode=related&search=
HAPPY Monday (and Tuesday!)!
For Your Space,
Steven.
Enjoy your day and note that the final installment of the "10 Commandments of Sample Accountability" will be shown tomorrow followed by some late week humor...
Emjoy!
I stumbled upon this gem of information from Time.com tonight while doing my weekly blog preparations:
"There's a lot to feel down about this month: the subprime mortgage crisis, stormy, unpredictable weather, rising gas prices, presidential primary free-for-alls. So, it would be easy to believe the theory set forth by Dr. Cliff Arnall, a researcher from Cardiff University, that the third Monday of the month (Jan. 21, this year) — a day he calls Blue Monday — will be our most depressing day of the year. Arnall bases his yearly prediction on a formula he developed, which factors in the weather, consumer debt from holiday spending and failed New Year's resolutions and arrives at that conclusion that we'll hit rock bottom on Monday the 21st."
Yikes --- talk about a 'Debbie Downer' (I mean no offense to any Debbies reading this). Sure, it's cold out (watching the Green Bay Packers/New York Giants game with temperatures below zero reinforced this), the housing market is in shambles, a gallon of gas costs about as much as a haircut, my beloved Dolphins were 1-15 while the New England Patriots haven't lost since gas was under a dollar a gallon, and the polar ice caps are melting faster than ice cream in the Sahara.
But there's a lot to be happy about too these days, so I want to counter Dr. Arnall with some happy points:
- Today is Martin Luther King, Jr. Day. We should be happy in remembering all that he did for us and celebrate his amazing legacy.
- Every single day we are gaining more daylight than the day before.
- More people are being saved by medical devices and drugs than ever before.
- Less people are dying from the historically most horrible and terrifying diseases in our world.
- The Pharma Compliance Blog is still going strong.
- Your family.
- Your friends.
- You have heat.
- If you're reading this, you can read --- which is more than 42 million Americans can say.
- And...you have access to the internet, which is more than billions can say.
I could go on and on, but you get the point. I know there is a lot that's gone wrong and will go wrong --- but if you sit back and think about your life right now, I hope things aren't too depressing. And, if for some reason that's still the case, check out this YouTube clip. I guarantee that you can't get through it without smiling! (Copy and paste link)
http://www.youtube.com/watch?v=5P6UU6m3cqk&mode=related&search=
HAPPY Monday (and Tuesday!)!
For Your Space,
Steven.
Friday, January 18, 2008
Columnist Examines Predictions for Health Care Industry in 2008
[Jan 16, 2008]
The Kansas City Star columnist Julius Karash on Monday examined PricewaterhouseCoopers Health Research Institute's predictions for the top eight issues that will affect the health care industry in 2008. Summaries of the issues appear below.
- Medicare: A new Medicare reimbursement system designed to better recognize the severity of patient illnesses could result in decreased revenue for specialty hospitals and other facilities that see fewer acutely ill patients, while urban hospitals that treat sicker patients could benefit.
- FDA: Increased oversight might improve the public's trust in prescription drug safety, but it also could increase the regulatory burden on pharmaceutical companies. The agency now can require drug companies to conduct additional trials after a drug has reached the market.
- Individual coverage: The market for individual coverage "could get much broader" if states and the federal government impose coverage mandates similar to the Massachusetts health insurance law, according to Karash. Individual coverage also could get a "boost" from Republican proposals to provide tax incentives to help consumers purchase individual policies.
- Retail health clinics: The "surge" in the number of retail health clinics "will force states, payers and policymakers to consider the best ways to deliver primary care," Karash writes. Hospitals could benefit if the clinics draw in the uninsured, and pharmaceutical companies might need to increase marketing to nurse practitioners who run the clinics.
- Retirees: "Retirees are playing a greater role in funding their health care coverage," as employers increasingly are shifting the costs to retirees, Karash writes.
- Pharmaceutical companies: Large pharmaceutical companies will continue to purchase and collaborate with life-science companies to improve their product pipelines, but biogenerics could affect drug company revenues.
- Not-for-profit hospitals: New Internal Revenue Service rules will require not-for-profit hospitals to disclose more details about the community benefits they provide, as well as executive salaries and benefits to justify their tax-exempt status.
- Asia: "Asia is poised to become the world's largest pharmaceutical consumer and producer," according to Karash. U.S. drug companies have increased marketing and clinical trials there because of the size of the market, increasing wealth and a "growing awareness of health related issues," Karash writes. In addition, because of inexpensive labor, several Asian drug companies "aim to become worldwide pharmaceutical powerhouses, not just contract manufacturers," according to Karash
(Karash, Kansas City Star, 1/14).
The Kansas City Star columnist Julius Karash on Monday examined PricewaterhouseCoopers Health Research Institute's predictions for the top eight issues that will affect the health care industry in 2008. Summaries of the issues appear below.
- Medicare: A new Medicare reimbursement system designed to better recognize the severity of patient illnesses could result in decreased revenue for specialty hospitals and other facilities that see fewer acutely ill patients, while urban hospitals that treat sicker patients could benefit.
- FDA: Increased oversight might improve the public's trust in prescription drug safety, but it also could increase the regulatory burden on pharmaceutical companies. The agency now can require drug companies to conduct additional trials after a drug has reached the market.
- Individual coverage: The market for individual coverage "could get much broader" if states and the federal government impose coverage mandates similar to the Massachusetts health insurance law, according to Karash. Individual coverage also could get a "boost" from Republican proposals to provide tax incentives to help consumers purchase individual policies.
- Retail health clinics: The "surge" in the number of retail health clinics "will force states, payers and policymakers to consider the best ways to deliver primary care," Karash writes. Hospitals could benefit if the clinics draw in the uninsured, and pharmaceutical companies might need to increase marketing to nurse practitioners who run the clinics.
- Retirees: "Retirees are playing a greater role in funding their health care coverage," as employers increasingly are shifting the costs to retirees, Karash writes.
- Pharmaceutical companies: Large pharmaceutical companies will continue to purchase and collaborate with life-science companies to improve their product pipelines, but biogenerics could affect drug company revenues.
- Not-for-profit hospitals: New Internal Revenue Service rules will require not-for-profit hospitals to disclose more details about the community benefits they provide, as well as executive salaries and benefits to justify their tax-exempt status.
- Asia: "Asia is poised to become the world's largest pharmaceutical consumer and producer," according to Karash. U.S. drug companies have increased marketing and clinical trials there because of the size of the market, increasing wealth and a "growing awareness of health related issues," Karash writes. In addition, because of inexpensive labor, several Asian drug companies "aim to become worldwide pharmaceutical powerhouses, not just contract manufacturers," according to Karash
(Karash, Kansas City Star, 1/14).
Thursday, January 17, 2008
BREAKING NEWS: FDA Issues Public Health Advisory on Cold Remedies for Tots
"Parents should not give sniffling babies and toddlers over-the-counter cough and cold medicines -- they're too risky for tots so small, the government will declare Thursday.
Makers pulled 14 over-the-counter cold and cough medicines from sale in October.
The Food and Drug Administration still hasn't decided if the remedies are appropriate for older children to continue using, officials told The Associated Press.
Expect a decision on that by spring, the deadline necessary to notify manufacturers before they begin production for next fall's cold season.
For now, the FDA is issuing a public health advisory on Thursday to warn parents to avoid these drugs for children under age 2 "because serious and potentially life-threatening side effects can occur."
It's not the first warning about cold remedies and tots: Drug companies last October quit selling dozens of versions targeted specifically to babies and toddlers. That same month, the FDA's own scientific advisers voted that the drugs don't even work in small children and shouldn't be used in preschoolers, either -- anyone under age."
More thoughts to come from the Pharma Compliance Blog...
Makers pulled 14 over-the-counter cold and cough medicines from sale in October.
The Food and Drug Administration still hasn't decided if the remedies are appropriate for older children to continue using, officials told The Associated Press.
Expect a decision on that by spring, the deadline necessary to notify manufacturers before they begin production for next fall's cold season.
For now, the FDA is issuing a public health advisory on Thursday to warn parents to avoid these drugs for children under age 2 "because serious and potentially life-threatening side effects can occur."
It's not the first warning about cold remedies and tots: Drug companies last October quit selling dozens of versions targeted specifically to babies and toddlers. That same month, the FDA's own scientific advisers voted that the drugs don't even work in small children and shouldn't be used in preschoolers, either -- anyone under age."
More thoughts to come from the Pharma Compliance Blog...
Wednesday, January 16, 2008
The Ten Commandments of Sample Accountability: Commandment #9
Commandment #9 – Thou Shalt Take Corrective and Disciplinary Actions
By Judy Fox
The PDMA states, “…a manufacturer or authorized distributor of record that distributes drug samples shall establish, maintain, and adhere to written policies and procedures describing its administrative system for identifying any significant loss of drug samples and notifying FDA of the loss…”
In order to fully commit to a sample accountability program, a pharmaceutical company must have processes in place that address how non-compliance activities will be addressed. The best method includes tracking non-compliance by listing specific activities that will be monitored and attaching corrective or disciplinary actions to each non-compliance offense.
By establishing specific corrective and disciplinary actions, a pharmaceutical message send a message to its employees that compliance is a top priority and is taken very seriously. A clear message of consequences can often help ensure adherence to the program.
Corrective or discipline actions should be incremental and appropriate to offenses. For example, a first offense of neglecting to turn in a monthly inventory may require a corporate warning, a more serious offense such as neglecting to acknowledge a sample shipment may result in a suspension of sample shipments and an even more serious offense such as reportable significant losses may include an audit of the representative and may require a suspension of sampling privileges until additional training can take place. Since repeated offenses are common with difficult employees, it is important that additional monitoring be attached to all non-compliance offenses.
By applying incremental corrective actions against offenses, a pharmaceutical company is also able to effectively discipline repeat offenders. The compliance monitoring program will not only track the date that an offense was noted, but the date that the disciplinary action was enforced and if the issue requires a corrective action, it will include the date the issue was considered closed. Applying incremental disciplinary measure also allow a pharmaceutical company to apply a more severe disciplinary action if an individual continues with the same or similar offenses. This can be important documentation if the offenses of an individual result in termination.
Corrective and disciplinary actions often include, but are not limited to corporate warnings, for-cause audits and inspections, suspension of sample shipments, suspension of sampling privileges, reporting to the FDA, remedial training and terminated when appropriate.
By Judy Fox
The PDMA states, “…a manufacturer or authorized distributor of record that distributes drug samples shall establish, maintain, and adhere to written policies and procedures describing its administrative system for identifying any significant loss of drug samples and notifying FDA of the loss…”
In order to fully commit to a sample accountability program, a pharmaceutical company must have processes in place that address how non-compliance activities will be addressed. The best method includes tracking non-compliance by listing specific activities that will be monitored and attaching corrective or disciplinary actions to each non-compliance offense.
By establishing specific corrective and disciplinary actions, a pharmaceutical message send a message to its employees that compliance is a top priority and is taken very seriously. A clear message of consequences can often help ensure adherence to the program.
Corrective or discipline actions should be incremental and appropriate to offenses. For example, a first offense of neglecting to turn in a monthly inventory may require a corporate warning, a more serious offense such as neglecting to acknowledge a sample shipment may result in a suspension of sample shipments and an even more serious offense such as reportable significant losses may include an audit of the representative and may require a suspension of sampling privileges until additional training can take place. Since repeated offenses are common with difficult employees, it is important that additional monitoring be attached to all non-compliance offenses.
By applying incremental corrective actions against offenses, a pharmaceutical company is also able to effectively discipline repeat offenders. The compliance monitoring program will not only track the date that an offense was noted, but the date that the disciplinary action was enforced and if the issue requires a corrective action, it will include the date the issue was considered closed. Applying incremental disciplinary measure also allow a pharmaceutical company to apply a more severe disciplinary action if an individual continues with the same or similar offenses. This can be important documentation if the offenses of an individual result in termination.
Corrective and disciplinary actions often include, but are not limited to corporate warnings, for-cause audits and inspections, suspension of sample shipments, suspension of sampling privileges, reporting to the FDA, remedial training and terminated when appropriate.
Monday, January 14, 2008
CIS's Chris Cobourn to Present at IIR's Inaugural MDRP 201 Symposium!
“Building a Culture of Compliance”
Dear Colleagues & Friends,
Compliance Implementation Services (CIS) (www.cis-partners.com) is thrilled to announce our attendance and participation in IIR’s inaugural MDRP 201 symposium in Baltimore, MD on February 5th, 2007 (accompanying the MDRP 101 and DRA events). Please mention priority code XP1308SPKR when registering to receive a 20% discount courtesy of Compliance Implementation Services.
The world of Government Programs (GP), and more specifically Medicaid, is extremely important and complicated. On the heels of MDRP 101, the inaugural MDRP 201 symposium digs deeper into some of the more common areas of concern and confusion that you have and/or will face while performing your daily responsibilities. During this session, you will find topics such as:
• The Key Players: Who are they and why are they important to you?
• Breaking Down the Internal Silos: The importance that the Government Pricing Department has in the internal company operations and how important it is for all commercial departments to work closely and communicate with the GP folks. Issues such as price changes, legislative changes and contracting strategies will be discussed.
• Integrity and Validity of Data & Reconciliation: Walks through the key steps and processes that will help strengthen the integrity of your data and make reconciling your records to the General Ledger a more streamlined process.
• Review, Approval & Certification: Examines the increased importance of CEO/CFO certification and how your company can accurately set up a review and approval process that will save time and reduce risk.
• The Extreme Importance of Class of Trade: Will look closely at how accurately assigning & maintaining your COT Schema as soon as possible can save you a multitude of headaches down the road.
State Medicaid Invoices and Dispute Resolution: Will explore what to look for on the invoice and on the line-item detail to identify problems and how and when to dispute.
• SPAPs & State Supplemental Programs: What are they? When is participation mandatory? Who are the “big” players? When do you include or exclude from your calculations?
• Auditing & Monitoring: This session focuses on defining Monitoring and Auditing. The goal is to provide what a short and long term Audit Strategy should be. Included is an overview of a risk based
“Strategic Management Alignment” on Audit, as well as a summary of a specific Medicaid related Audit Methodology.
• Advanced Topics of the DRA: We will examine how the rule has affected areas such as bundling, smoothing, lagged price concessions, weighted averages, PBMs and more.
Symposium Moderator and Presenter:
Christopher Cobourn, Vice President, Regulatory, COMPLIANCE IMPLEMENTATION SERVICES (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 the beautiful city of Baltimore!
Kind Regards,
Steven P. Moore
Marketing Director & Compliance Specialist
Compliance Implementation Services, LLC
1400 North Providence Road
Building One, Suite 307
Media, PA 19063
Phone: 610.565.8007
Fax: 610.565.7010
stevenmoore@cis-partners.com
www.cis-partners.com / www.cis-pcx.com / www.pharmacomplianceblog.blogspot.com
P.S. To register, call (888) 670-8200, send an e-mail to “register@iirusa.com,” or click here to register online at www.iirusa.com/dra 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. Again, please mention priority code XP1308SPKR when registering to receive the 20% discount courtesy of Compliance Implementation Services.
U.S. Health Care Spending Reaches $2.1T In 2006, Increasing 6.7%
From medicalnewstoday.com & Kaiser Network:
U.S. health care spending in 2006 increased by 6.7% to $2.1 trillion, or $7,026 per capita, according to a CMS report published on Tuesday in the journal Health Affairs, the Washington Post reports (Lee, Washington Post, 1/8). According to the report, health care spending in 2006 accounted for 16% of gross domestic product, an increase of 0.1% from 2005 (Reichard, CQ HealthBeat, 1/8).
Prescription drug spending in 2006 increased to $216.7 billion, an 8.5% increase from 2005, the report found. Public programs -- such as Medicare, Medicaid, those operated by the Department of Defense and the Department of Veterans Affairs, and state and local hospital subsidies -- accounted for 34% of prescription drug spending, compared with 28% in 2005, before the Medicare prescription drug benefit took effect, the report found. The increase in prescription drug spending in large part resulted from the use of more medications, not higher prices, according to the report (Washington Post, 1/8).
Medicare beneficiaries who previously purchased medications out of pocket at list prices in 2006 began to receive coverage under the prescription drug benefit, and, as a result, they used more treatments, the report found (Alonso-Zaldivar, Los Angeles Times, 1/8). "Implementation of the Medicare drug benefit shifted the funding of retail drug purchases and impacted the rate of overall drug spending growth," Aaron Catlin, lead author of the report and an economist at HHS, said (Lopes, Washington Times, 1/8). Private Medicare prescription drug plans also received lower discounts on medications than state Medicaid programs, which previously provided coverage to dually eligible beneficiaries, the report found.
The report also cited the use of medications for new purposes and the increased use of biotechnology treatments (Pear, New York Times, 1/8). In addition, the report cited increased use of insomnia medications -- such as Ambien CR, manufactured by Sanofi-Aventis, and Lunesta, manufactured by Sepracor (Zhang, Wall Street Journal, 1/8).
The report found that prescription drug spending would have increased more without the use of more generic medications and the launch of programs that provide discounts on such treatments by Wal-Mart and other retail stores. Generic medications in 2006 accounted for 63% of prescriptions, compared with 56% in 2005, according to the report (New York Times, 1/8).
Medicare
Medicare spending in 2006 increased to $401.3 billion from $338 billion in 2005, and the prescription drug benefit accounted for $41 billion in Medicare spending in 2006, the report found (Washington Post, 1/8). In 2006, Medicare accounted for 18% of retail prescription drug spending, compared with 2% in 2005 (Los Angeles Times, 1/8).
CMS Chief Actuary Richard Foster said, "The source of payment for prescription drugs has changed a lot" because of the Medicare prescription drug benefit, adding, "Those are big changes. But the overall cost of prescription drugs in the U.S. has changed very little as a result of" the benefit. In addition, Foster said that Medicare spending on the prescription drug benefit remains lower than previously estimated (Washington Post, 1/8). According to the Los Angeles Times, the report "did not provide a final verdict on whether the Medicare prescription benefit is a good deal for taxpayers" (Los Angeles Times, 1/8).
Medicare spending on managed care plans in 2006 increased by 48%, in large part because of a 25% increase in enrollment and higher reimbursements for health insurers that operate the plans, according to the report (Wall Street Journal, 1/8). CMS officials said that Medicare spending for beneficiaries in traditional Medicare averaged $9,538 in 2006, compared with an average of $10,133 for those in private Medicare Advantage plans. However, according to Foster, the report does not indicate that MA plans have increased Medicare spending (CQ HealthBeat, 1/8).
Medicaid
Medicaid spending in 2006 decreased by nearly 1% to $310.6 billion, the first decline in spending since the program began in 1965, according to the report. Medicaid in 2006 accounted for 9% of retail prescription drug spending, compared with 19% in 2005, the report found.
Most of the decrease in Medicaid prescription spending resulted from a shift in coverage for many beneficiaries to the Medicare prescription drug benefit, according to Catlin. The report also cited increased state restrictions on Medicaid eligibility and frozen or reduced reimbursements for health care providers that participate in Medicaid.
In 2006, Medicaid enrollment increased by only two-tenths of 1%, the smallest rate of increase since 1998, the report found (New York Times, 1/8).
Additional Results
The report also found:
Consumer out-of-pocket health care spending increased by 3.8% in 2006 (Washington Post, 1/8);
Employer health care spending in 2006 increased by 5.7% to $496.8 billion (New York Times, 1/8);
Private health insurers in 2006 reduced prescription drug spending and increased premiums by 5.5%, the smallest rate of increase since 1997, in part because of a shift in retiree medication costs from employers that provide benefits to Medicare (Washington Times, 1/8);
Spending on physician services in 2006 increased by 5.9% to $447.6 billion, the smallest rate of increase since 1999;
Spending on nursing homes in 2006 increased by 3.5% to $124.9 billion, the smallest rate of increase since 1999 (New York Times, 1/8);
Spending on wheelchairs, walkers, artificial limbs and other medical equipment in 2006 increased by 2.3% (Freking, AP/San Francisco Chronicle, 1/7);
Spending on hospital care in 2006 increased by 7% to $648 billion;
Spending on home health care in 2006 increased by 9.9% to $52.7 billion (CQ HealthBeat, 1/8); and
Spending on health care administrative costs in 2006 increased by 8.8%, in large part because of the launch of the Medicare prescription drug benefit (Washington Post, 1/8).
U.S. health care spending in 2006 increased by 6.7% to $2.1 trillion, or $7,026 per capita, according to a CMS report published on Tuesday in the journal Health Affairs, the Washington Post reports (Lee, Washington Post, 1/8). According to the report, health care spending in 2006 accounted for 16% of gross domestic product, an increase of 0.1% from 2005 (Reichard, CQ HealthBeat, 1/8).
Prescription drug spending in 2006 increased to $216.7 billion, an 8.5% increase from 2005, the report found. Public programs -- such as Medicare, Medicaid, those operated by the Department of Defense and the Department of Veterans Affairs, and state and local hospital subsidies -- accounted for 34% of prescription drug spending, compared with 28% in 2005, before the Medicare prescription drug benefit took effect, the report found. The increase in prescription drug spending in large part resulted from the use of more medications, not higher prices, according to the report (Washington Post, 1/8).
Medicare beneficiaries who previously purchased medications out of pocket at list prices in 2006 began to receive coverage under the prescription drug benefit, and, as a result, they used more treatments, the report found (Alonso-Zaldivar, Los Angeles Times, 1/8). "Implementation of the Medicare drug benefit shifted the funding of retail drug purchases and impacted the rate of overall drug spending growth," Aaron Catlin, lead author of the report and an economist at HHS, said (Lopes, Washington Times, 1/8). Private Medicare prescription drug plans also received lower discounts on medications than state Medicaid programs, which previously provided coverage to dually eligible beneficiaries, the report found.
The report also cited the use of medications for new purposes and the increased use of biotechnology treatments (Pear, New York Times, 1/8). In addition, the report cited increased use of insomnia medications -- such as Ambien CR, manufactured by Sanofi-Aventis, and Lunesta, manufactured by Sepracor (Zhang, Wall Street Journal, 1/8).
The report found that prescription drug spending would have increased more without the use of more generic medications and the launch of programs that provide discounts on such treatments by Wal-Mart and other retail stores. Generic medications in 2006 accounted for 63% of prescriptions, compared with 56% in 2005, according to the report (New York Times, 1/8).
Medicare
Medicare spending in 2006 increased to $401.3 billion from $338 billion in 2005, and the prescription drug benefit accounted for $41 billion in Medicare spending in 2006, the report found (Washington Post, 1/8). In 2006, Medicare accounted for 18% of retail prescription drug spending, compared with 2% in 2005 (Los Angeles Times, 1/8).
CMS Chief Actuary Richard Foster said, "The source of payment for prescription drugs has changed a lot" because of the Medicare prescription drug benefit, adding, "Those are big changes. But the overall cost of prescription drugs in the U.S. has changed very little as a result of" the benefit. In addition, Foster said that Medicare spending on the prescription drug benefit remains lower than previously estimated (Washington Post, 1/8). According to the Los Angeles Times, the report "did not provide a final verdict on whether the Medicare prescription benefit is a good deal for taxpayers" (Los Angeles Times, 1/8).
Medicare spending on managed care plans in 2006 increased by 48%, in large part because of a 25% increase in enrollment and higher reimbursements for health insurers that operate the plans, according to the report (Wall Street Journal, 1/8). CMS officials said that Medicare spending for beneficiaries in traditional Medicare averaged $9,538 in 2006, compared with an average of $10,133 for those in private Medicare Advantage plans. However, according to Foster, the report does not indicate that MA plans have increased Medicare spending (CQ HealthBeat, 1/8).
Medicaid
Medicaid spending in 2006 decreased by nearly 1% to $310.6 billion, the first decline in spending since the program began in 1965, according to the report. Medicaid in 2006 accounted for 9% of retail prescription drug spending, compared with 19% in 2005, the report found.
Most of the decrease in Medicaid prescription spending resulted from a shift in coverage for many beneficiaries to the Medicare prescription drug benefit, according to Catlin. The report also cited increased state restrictions on Medicaid eligibility and frozen or reduced reimbursements for health care providers that participate in Medicaid.
In 2006, Medicaid enrollment increased by only two-tenths of 1%, the smallest rate of increase since 1998, the report found (New York Times, 1/8).
Additional Results
The report also found:
Consumer out-of-pocket health care spending increased by 3.8% in 2006 (Washington Post, 1/8);
Employer health care spending in 2006 increased by 5.7% to $496.8 billion (New York Times, 1/8);
Private health insurers in 2006 reduced prescription drug spending and increased premiums by 5.5%, the smallest rate of increase since 1997, in part because of a shift in retiree medication costs from employers that provide benefits to Medicare (Washington Times, 1/8);
Spending on physician services in 2006 increased by 5.9% to $447.6 billion, the smallest rate of increase since 1999;
Spending on nursing homes in 2006 increased by 3.5% to $124.9 billion, the smallest rate of increase since 1999 (New York Times, 1/8);
Spending on wheelchairs, walkers, artificial limbs and other medical equipment in 2006 increased by 2.3% (Freking, AP/San Francisco Chronicle, 1/7);
Spending on hospital care in 2006 increased by 7% to $648 billion;
Spending on home health care in 2006 increased by 9.9% to $52.7 billion (CQ HealthBeat, 1/8); and
Spending on health care administrative costs in 2006 increased by 8.8%, in large part because of the launch of the Medicare prescription drug benefit (Washington Post, 1/8).
Thursday, January 10, 2008
FDA Approved Only 19 New Medications in 2007
Some interesting news that I read on line this evening. How is your company focusing their efforts? Is it:
- New NDAs?
- Increased indications for existing drugs?
- Purchase drugs from other companies?
- Generics? Authorized Generics?
Have a great weekend!
For Your Space,
Steven.
FDA in 2007 approved 19 new medications, a decrease from 22 in 2006 and the lowest number since 1983, when the agency approved 14 new treatments, according to Ira Loss of Washington Analysis, Bloomberg/Arizona Daily Star reports. According to Loss, FDA in 2007 approved 17 "new molecular entities" and two biotechnology medications. FDA spokesperson Christopher DiFrancesco said that the agency has not totaled the number of new medications approved in 2007 and could not confirm the number cited by Loss.
Kenneth Kaitlin, director of the Center for the Study of Drug Development at Tufts University, attributed the decrease to a shift in focus by pharmaceutical companies to the development of new uses for medications currently on the market, rather than new treatments. "They got away from their core mission, which was to bring new medicines and new treatments to market," he said. However, Kaitlin said that pharmaceutical companies have resumed efforts to develop new prescription drugs and that the number of new medications approved by FDA should increase in future years.
Raymond Woosley -- president of the Critical Path Institute, which has partnered with FDA to improve the prescription drug approval process -- attributed the decrease to a shift in focus by pharmaceutical companies to the development of medications for the causes of diseases, rather than the symptoms, a process that is "just much more complex." He added that many such medications fail in clinical trials and "don't get to the FDA."
Increased Standards?
Some pharmaceutical companies, such as GlaxoSmithKline, attribute the decrease to increased FDA standards for approval of new medications. However, FDA Deputy Commissioner Janet Woodcock denied the claim and attributed the decrease to fewer applications for approval of new medications and improved efforts by the agency to identify safety concerns (Blum, Bloomberg/Arizona Daily Star, 1/10).
According to the Newark Star-Ledger, the decrease indicates "what company executives and bureaucrats already know: The research pipeline that regularly pumped out billion-dollar drugs like Lipitor and Plavix is running dry as regulators are exacting more demands on drug makers." As a result, "drug makers are pouring money into finding new uses for specialized biotech drugs that may be effective against multiple diseases," rather than for a single condition, the Star-Ledger reports (Jordan, Newark Star-Ledger, 1/9).
http://www.kaisernetwork.org/daily_reports/rep_hpolicy.cfm#49767
- New NDAs?
- Increased indications for existing drugs?
- Purchase drugs from other companies?
- Generics? Authorized Generics?
Have a great weekend!
For Your Space,
Steven.
FDA in 2007 approved 19 new medications, a decrease from 22 in 2006 and the lowest number since 1983, when the agency approved 14 new treatments, according to Ira Loss of Washington Analysis, Bloomberg/Arizona Daily Star reports. According to Loss, FDA in 2007 approved 17 "new molecular entities" and two biotechnology medications. FDA spokesperson Christopher DiFrancesco said that the agency has not totaled the number of new medications approved in 2007 and could not confirm the number cited by Loss.
Kenneth Kaitlin, director of the Center for the Study of Drug Development at Tufts University, attributed the decrease to a shift in focus by pharmaceutical companies to the development of new uses for medications currently on the market, rather than new treatments. "They got away from their core mission, which was to bring new medicines and new treatments to market," he said. However, Kaitlin said that pharmaceutical companies have resumed efforts to develop new prescription drugs and that the number of new medications approved by FDA should increase in future years.
Raymond Woosley -- president of the Critical Path Institute, which has partnered with FDA to improve the prescription drug approval process -- attributed the decrease to a shift in focus by pharmaceutical companies to the development of medications for the causes of diseases, rather than the symptoms, a process that is "just much more complex." He added that many such medications fail in clinical trials and "don't get to the FDA."
Increased Standards?
Some pharmaceutical companies, such as GlaxoSmithKline, attribute the decrease to increased FDA standards for approval of new medications. However, FDA Deputy Commissioner Janet Woodcock denied the claim and attributed the decrease to fewer applications for approval of new medications and improved efforts by the agency to identify safety concerns (Blum, Bloomberg/Arizona Daily Star, 1/10).
According to the Newark Star-Ledger, the decrease indicates "what company executives and bureaucrats already know: The research pipeline that regularly pumped out billion-dollar drugs like Lipitor and Plavix is running dry as regulators are exacting more demands on drug makers." As a result, "drug makers are pouring money into finding new uses for specialized biotech drugs that may be effective against multiple diseases," rather than for a single condition, the Star-Ledger reports (Jordan, Newark Star-Ledger, 1/9).
http://www.kaisernetwork.org/daily_reports/rep_hpolicy.cfm#49767
Now this is really, really cool: Musicians on Call
For those of you who have followed the blog the past 8 months or so, you'll know that I love music and I'm constantly tying to find ways to incorporate music into our industry. My lovely bride was listening to XPN 88.5 here in the Philadelphia area (University of Pennsylvania's radio station) and they were discussing the CD Pharmacy charity, which is a program where people can donate their gently used (must be original) CDs for use in healthcare facilties. The idea is to use these donated CDs to promote the healing power of music for patients in need. The CD Pharmacy is a program within a larger organization called Musicians on Call (MOC). To learn more, you can visit www.musiciansoncall.org.
Did you ever feel like you had the idea to end all ideas --- only to find it was already invented? This is that thing for me! I wanted to find a way to incorporate my love of music and its emotional and healing power into the pharmaceutical industry.
As you read the interview below, you'll see that this has been done --- and been around for quite some time. I'm truly cool with this because it means thousands have been helped by the greatest musicians in the world and the charitable donations of other music lovers and volunteers. The list of musicians who have contributed is literally a 'who's who' of the industry!
Kudos to this program! I'm sure that I'll write more on this as I uncover more, but wanted to share this with all of you as soon as possible. We do work in a great industry!
For Your Space,
Steven.
(This article/interview was from the site: http://www.tunedinmusic.com/Musicians%20On%20Call.htm)
Musicians On Call
By: Nicole Roberge
Musicians On Call is an organization that provides music for patients in hospitals. From maintaining a CD Pharmacy to bringing live music to bedsides, Musicians On Call is filled with wonderful volunteers who understand what an integral part music plays in the healing process. MOC has brought in musicians ranging from Ozzy Osbourne to Avril Lavigne, and everywhere in between. This month, they will also be holding a fundraiser where several guitars and memorabilia will be auctioned off, as well as a special performance by John Mayer. But you don’t have to be a musician to help out. You can contact the organization to volunteer, or send in your old CD’s to be added to the CD Pharmacy. Dr. Leslie Faerstein, executive director of Musicians On Call, shares with us here the purpose of Musicians On Call, how it has changed people, and what you can do to help:
Tuned In Music: What is the primary purpose of Musicians On Call?
Dr. Leslie Faerstein: Musicians On Call is a nonprofit organization that brings live and recorded music to the bedsides of people in healthcare facilities. Unlike some organizations that only work with specific illnesses, we facilitate healing from all types of sickness through the power of music. We have already touched over 44,000 individuals through our volunteer performances (this includes patients, family members and caregivers).
TI: How did it begin?
LF: Musicians On Call (MOC) was founded in New York City in 1999 by Michael Solomon and Vivek Tiwary with the assistance of the Kristen Ann Carr Fund. After bringing the first musician on call, Kenli Mattus, to Memorial Sloan-Kettering Cancer Center to play in the general recreation area, the staff asked them if they would play in the rooms of patients too sick to leave their beds. In that moment, watching the reactions of the patients and their families, they knew they had to start a nonprofit that brought live and recorded music right to the bedsides of patients! Musicians On Call was born!
Thanks to the support from rock legend Bruce Springsteen, his managers and The Kristen Ann Carr Fund, Musicians On Call was able to raise the funds to start the organization. MOC officially began in September 1999 and continues to grow in delivering the healing power of both live and recorded music to patients in healthcare facilities.
TI: What are the bedside performances and what impact do you think that they have?
LF: The Bedside Performance Program are given by artists who give in-room performances for patients undergoing treatment or who are unable to leave their hospital beds. All musicians are accompanied by a volunteer guide who has been trained to work in the specific facility. The guide collects our statistics, is the liaison with hospital staff, introduces the musician to the patient and asks first whether the patient wants to hear some music and remains with the musician in the room during the performance. Occasionally, artists who are on tour visit and entertain at hospitals around the country under our sponsorship. Both volunteer musicians and guides go through training programs. The guides’ training is more extensive and involves both experiential and didactic. The guides also make a greater commitment to MOC and guide at least twice a month. Musicians’ commitment is a minimum of ten performances a year. That said, many do much more and one of our musicians, Kenli Mattus, did 55 last year as well as the Project Playback we did with a teen group at the Children’s Hospital At Montefiore.
On average, over 20,000 patients receive inpatient care on a daily basis in New York City hospitals. With such high numbers of people in healthcare facilities, opportunities for enhancing the quality of patient care, such as the Performance Program, are extremely beneficial. It has been demonstrated that live music can lower blood pressure, alleviate pain and reduce depression and anxiety in hospital patients. Since the beginning of the last century, the medical field has recognized that music helped veterans from the First and Second World Wars recover from both emotional and physical traumas. We now know that the one-on-one interaction between the musician and patient has a powerful effect. For a brief time, the patient can transcend being in a healthcare facility.
The impact can be profound. We have people who have had no sign of reacting while in the hospital smile or move their foot to the music. Recently, we were at a New York City hospital and a nurse asked the musician to go into a room where the patient was actively dying. She played and sang “What a Wonderful World” and the patient’s daughters sang along. The patient died minutes later. What an amazing way to leave this world. We also know that sound is the last sense to go when someone is dying (and the first to come when we are born). We have hundreds of stories about how patients AND the volunteers have been affected by the performance.
TI: In addition to these performances, you also distribute CD’s, concert tickets, and have a program where patients can record their own music. What are their reactions to these programs?
LF: We currently have 60 CD Pharmacies in facilities in the tri-state area, Philadelphia and Massachusetts. And we have a waiting list from many more facilities. We sent several hundred CDs with CD Discmen so that patients can listen to music in their beds, waiting for procedures, etc. We all know how music affects us – can make us happy, sad, reflect our moods and having familiar music in the hospital eases a patient’s experience. We always need donations of CDs and would love donations of gently used CDs as well as new discmen.
Concert tickets are great fun and we receive letters, particularly from the children who get them, that this was the first concert they ever attended. Many are from NYC urban areas which is to whom we tend to distribute the tickets and for those who can get to a show it can be one of the most exciting experiences!
Project Playback is a program that gives patients the chance to see their music recorded and produced. Special software enables patients to use a customized program to compose their own songs and work with professionals who will provide guidance. Thus far, we have produced 4 CDs with the Teen Cancer Group at Memorial who love working with a professional musician and having the finished product. We always have a CD Release party where the kids are the rock or hip hop stars, autograph their CDs, perform the song live, etc. Because we need funding to do this, it is not a regular ongoing program. We have, however, managed to do an average of one a year. Sloan-Kettering Cancer Center and 1 with the teens at Children’s Hospital At Montefiore. We have received letters from parents, particularly after their child has passed away, thanking us for giving the child a creative experience that helped him or her transcend their treatments, pain and being in a hospital as well as having a recording of his or her voice. The kids, obviously, love this project.
TI: What different musicians have you worked with?
LF: Our programs are staffed by local volunteer musicians both here in NYC as well as in Philadelphia where we have partnered with WXPN, the nonprofit public radio station of the University of Pennsylvania. We are known in Philly as WXPN Musicians On Call. One of our early volunteers, before she made it big, was Norah Jones. The caliber of our volunteers is very high.
Many artists have made hospital visits and these include: Nils Lofgren, John Mayer, Kelly Rowland of Destiny’s Child, Jason Mraz, Marc Broussard, Ryan Cabrera, Vanessa Carlton, Nick Lachey, Avril Lavigne (twice), Mario Winans, Marc Roberge of O.A.R. and many others have supported us with donations of tickets, guitars, etc.
Some of the artists who have already helped with our mission include: Bruce Springsteen and The E Street Band, Nils Lofgren, The Who, Def Leppard, The Allman Brothers, Sting, Levon Helm, Hanson, Donald Fagen of Steely Dan, Britney Spears, The Goo Goo Dolls, Alice Cooper, Ozzy Osbourne, Dido, The Clarks, David Gray, Barenaked Ladies, Dave Koz, Billy Joel, Peter Frampton and Journey, Bon Jovi, Paul Simon, Tony Bennett, Matchbox Twenty, R.E.M., John Mellencamp, Melissa Etheridge, Kelly Rowland, Destiny’s Child, The Counting Crows, Tim McGraw & Faith Hill, Aerosmith, Elvis Costello, O.A.R., Jessica Simpson, Nich Lachey, Michelle Branch, Jason Mraz, James Taylor, Avril Lavigne, John Mayer and Eric Clapton.
TI: What are your “angel artists?”
LF: With the Angel Artists program, we are building a roster of up and coming recording artists interested in philanthropy who are willing to make Musicians On Call the beneficiaries of their charitable efforts. Activities include fundraising concerts, ticket donations and/or auctions, and awareness campaigns through their websites and email lists. The first Angel Artist act is O.A.R. New artists joining Angel Artists are recent Columbia Records signing Ari Hest and acclaimed folk-rock act Ollabelle, who toured the U.S. extensively last year as the opening act for Norah Jones, Diana Krall and Ryan Adams. As an example of what Angel Artists can do, O.A.R. mounted a successful email campaign among their fans to donate portable CD players that MOC distributed as part of its CD Pharmacy program to several New York City hospitals. In return, O.A.R. sent fans signed tee shirts and other exclusive merchandise.
TI: On January 31, you are having a guitar auction and performance by John Mayer to raise money for Musicians On Call. What are your expectations for this and do you have many similar events throughout the year?
LF: We have great expectations for this both in terms of fundraising to keep our programs going as well as exposure so that Musicians On Call becomes a commonly known organization. We have never done this before. It is our FIRST benefit. We have had small fundraisers but they have either been thrown by our wonderful volunteers (e.g., karaoke nights), Board members (intimate cocktail parties in their home). We have received enormous support from Z100 here in NYC and for three years in a row (2002, 2003, 2004) Musicians On Call has been their official charity, which has raised significant funds for us. We are very pleased that Q104.3 is the radio sponsor for this event.
We are very grateful to John Mayer for donating his time as well as to Cynthia Nixon who will be a special guest at the event.
TI: What overall effect have you seen, not only in patients, but also in artists, after the various forms of music have been exchanged?
LF: As I described earlier, the effects can go from having a nice few moments to something more profound – for both of them. Family members will often ask musicians to play for their sick loved one even if the patient hasn’t requested it directly before hand. Recently, a woman with terminal cancer married her fiancé in the hospital. The following day Musicians On Call was there for our weekly performance and played “Sea of Love” for the couple. They were so joyous since the wife came from Italy and there it is very important to be serenaded on your wedding. As soon as the musician left the room she called her family in Italy who called everyone and by the end of the musician’s time on that floor the husband found him to express such great gratitude on behalf of them as well as the whole Italian family! The musician was honored that he could make this gift in such a paradoxical situation – both great joy and great sadness.
TI: What has been the most rewarding experience for you with Musicians On Call?
LF: As a healthcare professional, for the past 30 years I can see how immediate and direct the experience is for both the patient and the musician. As a psychotherapist, it can take a long time before I see changes. Whenever I go to the hospital and see the reactions of patients I remember why I have to do things that may not be as much fun but that are crucial to keeping our programs going. One program is in a nursing home for people with AIDS. The patients there have almost no visitors and they know that they will not be going home from there. They are so happy to have our program that often they are waiting in their wheelchairs in the lobby to ensure that we’ll visit their rooms. THAT is the most rewarding experience for me. And working with so many young, talented and generous people is incredibly rewarding. For many of our volunteers, this is the first time they have made this kind of charitable contribution of their time. It has been such a gift for them that they recruit musicians for us as well. I love what we do at MOC and want to continue to expand to other cities and eventually internationally so that when someone goes into a healthcare facility, they know that music is part of their healing!
TI: How can people help and become involved?
LF: We always need more musicians and guides as we expand our programs. We need help with fundraising as well. People can log on to our Web site, www.musiciansoncall.org where they can fill out a volunteer application and email it to us. They can also call us here at 212-741-2709.
People can also send us their gently used CDs for our CD Pharmacy (must all be originals) and if they can send a new, still packaged CD Discman to go with the pharmacies that would be wonderful!
Wednesday, January 9, 2008
PhRMA Defends Distribution of Pharmaceutical Samples
New Study Fatally Flawed, 2003 Figures Outdated
Washington, D.C. (January 3, 2008) — Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson issued the following statement regarding the Jan. 2 American Journal of Public Health study on distribution of free pharmaceutical samples:
“Distribution of free samples by technically-trained pharmaceutical research company representatives – many of whom are healthcare professionals themselves – plays a critical role in improving patient care and fostering the appropriate use of medicines. Providing physicians with free samples of pharmaceuticals clearly benefits patients and advances healthcare throughout the United States.
“Instead of second-guessing motives, Harvard researchers would better serve patients by examining health outcomes. Clearly, free samples often lead to improved quality of life for millions of Americans, regardless of their income.
“Free pharmaceutical samples can give physicians valuable first-hand experience with new treatment options. And free samples can help patients begin treatment sooner, find the right medicine, and offer an option for those who have difficulty affording their medicines.
“As the study authors note, when patients were seen by practitioners in their offices, uninsured patients ‘appear more likely to receive a free sample than do insured persons.’
“According to the study authors, this suggests that office-based practitioners make a ‘sincere effort’ to use free samples to help needy patients.
“Likewise, insured patients who lacked prescription drug coverage also were more likely to receive a free sample.
“Indeed, a recent Henry J. Kaiser Family Foundation survey found that 75 percent of physicians frequently or sometimes give free samples to assist patients with their out-of-pocket costs. An earlier survey examining key factors influencing physicians’ decisions to distribute free samples found the ‘patient’s financial situation’ was a considerable or strong influence 86 percent of the time.
"That said, the study released Jan. 2, which was conducted by Harvard Medical School and Cambridge Health Alliance researchers, was fatally flawed.
“The study, which relies on 2003 data, ignores significant outreach efforts in recent years, including the 2005 launch of the Partnership for Prescription Assistance (PPA), a program sponsored by America’s pharmaceutical research companies to help uninsured and underinsured patients.
“Our member companies recognize that, unfortunately, many uninsured and underinsured patients do not receive their medical care from office-based practitioners.
“And, as important as free pharmaceutical samples are in improving healthcare, they represent one – not the only – option for patients in need.
“As a consequence, over and above the billions of dollars in free samples that pharmaceutical research companies distribute to physicians, our companies have provided medicines worth more than $10 billion, in wholesale value, to nearly 5 million struggling Americans since PPA was launched.
“Additionally, we have hand-delivered information about accessing free or nearly free medicines to clinics and hospitals nationwide that serve low-income Americans. And we have connected more than 200,000 patients with clinics and healthcare providers in their communities.
“PPA is a clearinghouse for more than 475 public and private patient assistance programs. More than 2,500 brand-name and generic prescription medicines are available through the participating programs.Patients who need help should call the PPA’s toll-free phone number (1-888-4PPA-NOW), where trained operators field calls in more than 150 languages, or should visit the easy-to-use website www.pparx.org.”
--------------------------------------------------------------------------------
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $43 billion in 2006 in discovering and developing new medicines. Industry-wide research and investment reached a record $55.2 billion in 2006.
Washington, D.C. (January 3, 2008) — Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson issued the following statement regarding the Jan. 2 American Journal of Public Health study on distribution of free pharmaceutical samples:
“Distribution of free samples by technically-trained pharmaceutical research company representatives – many of whom are healthcare professionals themselves – plays a critical role in improving patient care and fostering the appropriate use of medicines. Providing physicians with free samples of pharmaceuticals clearly benefits patients and advances healthcare throughout the United States.
“Instead of second-guessing motives, Harvard researchers would better serve patients by examining health outcomes. Clearly, free samples often lead to improved quality of life for millions of Americans, regardless of their income.
“Free pharmaceutical samples can give physicians valuable first-hand experience with new treatment options. And free samples can help patients begin treatment sooner, find the right medicine, and offer an option for those who have difficulty affording their medicines.
“As the study authors note, when patients were seen by practitioners in their offices, uninsured patients ‘appear more likely to receive a free sample than do insured persons.’
“According to the study authors, this suggests that office-based practitioners make a ‘sincere effort’ to use free samples to help needy patients.
“Likewise, insured patients who lacked prescription drug coverage also were more likely to receive a free sample.
“Indeed, a recent Henry J. Kaiser Family Foundation survey found that 75 percent of physicians frequently or sometimes give free samples to assist patients with their out-of-pocket costs. An earlier survey examining key factors influencing physicians’ decisions to distribute free samples found the ‘patient’s financial situation’ was a considerable or strong influence 86 percent of the time.
"That said, the study released Jan. 2, which was conducted by Harvard Medical School and Cambridge Health Alliance researchers, was fatally flawed.
“The study, which relies on 2003 data, ignores significant outreach efforts in recent years, including the 2005 launch of the Partnership for Prescription Assistance (PPA), a program sponsored by America’s pharmaceutical research companies to help uninsured and underinsured patients.
“Our member companies recognize that, unfortunately, many uninsured and underinsured patients do not receive their medical care from office-based practitioners.
“And, as important as free pharmaceutical samples are in improving healthcare, they represent one – not the only – option for patients in need.
“As a consequence, over and above the billions of dollars in free samples that pharmaceutical research companies distribute to physicians, our companies have provided medicines worth more than $10 billion, in wholesale value, to nearly 5 million struggling Americans since PPA was launched.
“Additionally, we have hand-delivered information about accessing free or nearly free medicines to clinics and hospitals nationwide that serve low-income Americans. And we have connected more than 200,000 patients with clinics and healthcare providers in their communities.
“PPA is a clearinghouse for more than 475 public and private patient assistance programs. More than 2,500 brand-name and generic prescription medicines are available through the participating programs.Patients who need help should call the PPA’s toll-free phone number (1-888-4PPA-NOW), where trained operators field calls in more than 150 languages, or should visit the easy-to-use website www.pparx.org.”
--------------------------------------------------------------------------------
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $43 billion in 2006 in discovering and developing new medicines. Industry-wide research and investment reached a record $55.2 billion in 2006.
Tuesday, January 8, 2008
The Ten Commandments of Sample Accountability: Commandment #8
Commandment #8 – Thou Shalt Monitor Compliance
By Judy Fox
The PDMA states, “…a manufacturer or authorized distributor of record that distributes drug samples shall establish, maintain, and adhere to written policies and procedures describing its administrative systems for…auditing and detecting falsified or incomplete drug sample records…storing drug samples by representatives.”
Pharmaceutical companies are responsible for the actions of their employees when is comes to all federal, state and industry laws and guidelines. Compliance is always a challenge when employees include field sales and other employees who are not in an office on a regular basis, however, non-compliance still needs to be monitored, documented and tracked.
Compliance tracking usually involves a listing of all non-compliance activities tracked. It can start with failure to submit documentation in the required time parameters, storing sample improperly, all the way up to falsification of documents or suspected sample diversion. Each activity should have a disciplinary action or consequence attached to it.
Due to the fact that compliance tracking can provide important insight into compliance areas that need improvement or updates, a good tracking program can serve not only as a tool for disciplinary action, but also as a business tool to monitor and assess the entire sampling program. Compliance tracking often relies on a well defined communication track with a sample accountability vendor.
A compliance tracking program or system allows a pharmaceutical company to readily identify any patterns of non-compliance over the entire company. A trend over a large portion of the company may indicate that there is an administrative area that may need further emphasis in the training program. Trends in a district or region may indicate a lack of management and trends with an individual may indicate a need for additional or remedial training.
Compliance tracking documents any offenses by an individual along with the corrective or disciplinary action attached to the offense. By documenting all of the steps taken to ensure adherence to the corporate policies and procedures, compliance tracking not only readily identifies repeat offenders, but serves as a business tool, especially if termination is inevitable.
Included in a compliance tracking program should be a schedule for annual, random and for-cause audits of practitioners as well as sales representatives and managers.
By Judy Fox
The PDMA states, “…a manufacturer or authorized distributor of record that distributes drug samples shall establish, maintain, and adhere to written policies and procedures describing its administrative systems for…auditing and detecting falsified or incomplete drug sample records…storing drug samples by representatives.”
Pharmaceutical companies are responsible for the actions of their employees when is comes to all federal, state and industry laws and guidelines. Compliance is always a challenge when employees include field sales and other employees who are not in an office on a regular basis, however, non-compliance still needs to be monitored, documented and tracked.
Compliance tracking usually involves a listing of all non-compliance activities tracked. It can start with failure to submit documentation in the required time parameters, storing sample improperly, all the way up to falsification of documents or suspected sample diversion. Each activity should have a disciplinary action or consequence attached to it.
Due to the fact that compliance tracking can provide important insight into compliance areas that need improvement or updates, a good tracking program can serve not only as a tool for disciplinary action, but also as a business tool to monitor and assess the entire sampling program. Compliance tracking often relies on a well defined communication track with a sample accountability vendor.
A compliance tracking program or system allows a pharmaceutical company to readily identify any patterns of non-compliance over the entire company. A trend over a large portion of the company may indicate that there is an administrative area that may need further emphasis in the training program. Trends in a district or region may indicate a lack of management and trends with an individual may indicate a need for additional or remedial training.
Compliance tracking documents any offenses by an individual along with the corrective or disciplinary action attached to the offense. By documenting all of the steps taken to ensure adherence to the corporate policies and procedures, compliance tracking not only readily identifies repeat offenders, but serves as a business tool, especially if termination is inevitable.
Included in a compliance tracking program should be a schedule for annual, random and for-cause audits of practitioners as well as sales representatives and managers.
Monday, January 7, 2008
Unit of Measure: To "Each" His Own
Clarissa Crain, CIS Compliance and GP Specialist
clarissacrain@cis-partners.com
In November, the OIG released “Unit of Measure Inconsistencies in the Medicaid Prescription Drug Program,” a report which documented the OIG's findings related to the use of National Council for Prescription Drug Program’s (NCPDP) unit of measure (UOM) designations versus the use of CMS unit of measure standards for reimbursement and rebating related to the Medicaid Pogram. The OIG’s investigation was undertaken for two purposes: to estimate inappropriate Medicaid rebate claims and to determine how often states convert Medicaid Utilization data to correct for UOM inconsistencies.
Medicaid consists of reimbursements and rebates. Reimbursement is paid by the state to the pharmacy, while rebates are paid by the manufacturer to the State. UOM for reimbursement purposes is based on NCPDP standards while UOM for rebates is based on CMS UOM standards. While NCPDP defines UOM as three unit types, CMS provides eight unit types (five of which are additional to NCPDP). Where CMS and NCPDP reference the same UOM type, they employ different definitions, and so the result is that some drugs are inconsistently classified. When States submit their rebate claims based on the reimbursement payments they have made, they need to convert UOM from the NCPDP standard to the CMS standard. However, the OIG found that States convert less than half of their utilization data. This leads to inappropriate payments and disputes between manufacturers and States.
In its study, the OIG compared NCPDP and CMS UOM standards for drugs reimbursed during the first two quarters of 2006. They found that $8.1 million dollars in over claimed and $3.7 million in under claimed rebates existed in that time period. The “each” unit type represented the largest discrepancies as the guidance from NCPDP and CMS differ with respect to the definition of an each. While the OIG acknowledged that these rebate claims represent on 1% of total rebate claims, the OIG stressed that the impact of these inconsistencies could become more significant as AMP data has been recommended for use in Medicaid reimbursement.
CMS disagreed with the OIG report in two ways. CMS argued that there is sufficient guidance with regards to UOM and that broad guidance issued by CMS related to UOM would be ineffective. Further, CMS argued that the OIG has oversimplified the UOM issue and overstated the inconsistencies. In the end, CMS put a level of responsibility for appropriate guidance on the manufacturer. In its response to the OIG, CMS stated that it “extends the opportunity to manufacturers to put information in regard to their NDCs on the Dispute Resolution Program’s (DRP) Web site.” This suggests that CMS expects manufacturers to be proactive and communicative with respect to identifying UOM inconsistencies. As UOM becomes a more sensitive topic, and if the OIG should conduct any follow up research or get the attention of legislators, it is important that manufacturers be able to show that they have performed the due diligence necessary to limit inconsistency issues.
clarissacrain@cis-partners.com
In November, the OIG released “Unit of Measure Inconsistencies in the Medicaid Prescription Drug Program,” a report which documented the OIG's findings related to the use of National Council for Prescription Drug Program’s (NCPDP) unit of measure (UOM) designations versus the use of CMS unit of measure standards for reimbursement and rebating related to the Medicaid Pogram. The OIG’s investigation was undertaken for two purposes: to estimate inappropriate Medicaid rebate claims and to determine how often states convert Medicaid Utilization data to correct for UOM inconsistencies.
Medicaid consists of reimbursements and rebates. Reimbursement is paid by the state to the pharmacy, while rebates are paid by the manufacturer to the State. UOM for reimbursement purposes is based on NCPDP standards while UOM for rebates is based on CMS UOM standards. While NCPDP defines UOM as three unit types, CMS provides eight unit types (five of which are additional to NCPDP). Where CMS and NCPDP reference the same UOM type, they employ different definitions, and so the result is that some drugs are inconsistently classified. When States submit their rebate claims based on the reimbursement payments they have made, they need to convert UOM from the NCPDP standard to the CMS standard. However, the OIG found that States convert less than half of their utilization data. This leads to inappropriate payments and disputes between manufacturers and States.
In its study, the OIG compared NCPDP and CMS UOM standards for drugs reimbursed during the first two quarters of 2006. They found that $8.1 million dollars in over claimed and $3.7 million in under claimed rebates existed in that time period. The “each” unit type represented the largest discrepancies as the guidance from NCPDP and CMS differ with respect to the definition of an each. While the OIG acknowledged that these rebate claims represent on 1% of total rebate claims, the OIG stressed that the impact of these inconsistencies could become more significant as AMP data has been recommended for use in Medicaid reimbursement.
CMS disagreed with the OIG report in two ways. CMS argued that there is sufficient guidance with regards to UOM and that broad guidance issued by CMS related to UOM would be ineffective. Further, CMS argued that the OIG has oversimplified the UOM issue and overstated the inconsistencies. In the end, CMS put a level of responsibility for appropriate guidance on the manufacturer. In its response to the OIG, CMS stated that it “extends the opportunity to manufacturers to put information in regard to their NDCs on the Dispute Resolution Program’s (DRP) Web site.” This suggests that CMS expects manufacturers to be proactive and communicative with respect to identifying UOM inconsistencies. As UOM becomes a more sensitive topic, and if the OIG should conduct any follow up research or get the attention of legislators, it is important that manufacturers be able to show that they have performed the due diligence necessary to limit inconsistency issues.
Thursday, January 3, 2008
The VA's Position on IMAs
Chrissy Spicer, CIS Compliance and GP Specialist
chrissyspicer@cis-partners.com
The Department of Veteran Affairs letter dated October 18, 2006 posed the following question and answer.
"1. Are IMA Fees Paid to Wholesalers Excluded From non-FAMP?
Since October 2004, VA’s P.L. 102-585, Section 603, Policy Group (the Policy Group) has said that wholesaler fees associated with inventory management agreements, fees charged by general wholesalers (pharmaceutical prime vendors) to manufacturers generally. Product discounts or rebates granted by manufacturers to wholesalers in order to make their drugs more attractive in the market place cannot be excludable fees."
From this, generally speaking, manufacturers have decided that if the fee for service paid to the wholesaler meets certain predefined requirements, then this fee could be excluded from the non-FAMP calculation, even if the fee paid was based upon sales volume.
Subsequently, the VA issued another letter dated October 26, 2007 that references the October 18, 2006 VA letter and provides further clarification regarding the treatment of IMA Fees.
"4. In its Oct. 18, 2006 Dear Manufacturer Letter, VA OGC stated that certain described inventory management agreement (IMA) fees charged to covered drug manufacturers by general wholesalers are excludable from Non-FAMP.
Q: Does VA agree that exclusion from non-FAMP is also proper for percent-of-sales fees offered to wholesalers by manufacturers as incentives for wholesalers to adopt certain beneficial practices or meet certain standards of efficiency?
A: No. VA’s P.L. 102-585, Sec. 603, Policy Group view percent-of-sales incentive fees offered to wholesalers, in order to achieve business goals of the manufacturer, as not being IMA fees that are excludable from non-FAMP. Specific fee situations that may not clearly fit into the IMA or incentive fee categories should be discussed with auditors from the VA’s Office of Inspector General (55)."
The VA did not define what it meant by business goals, and based upon the language above, any IMA fee that is paid as a percent-of-sales could be construed as a price incentive. The reason being is that a fee that increases as sales increase would incentivize the wholesaler to achieve the business goals of the manufacturer.
In summary, the further clarification provided by the VA hones in on fees that are imposed on the manufacturer for a “true” service that the wholesaler provides that the manufacture could not otherwise perform versus an incentive provided to the wholesaler in order to assist the manufacture in achieving specific business objectives. In the pharmaceutical industry, the term IMA fees is used broadly to mean fees paid to wholesalers for meeting certain requirements. These requirements and the fees paid for providing these requirements vary from company to company. As such, it is difficult to make a blanket statement saying whether to include or exclude these fees.
Determining how to treat these is not a simple decision and involves careful consideration. An inventory of all service fees, rebates paid, and documented assumptions related to the treatment of these price concessions must be maintained. One possible approach for determining the treatment of such fees is outlined below:
- Create an inventory of all price concessions.
- List the criteria needed in order for the price concession to be excluded. In my opinion, all fees across all calculations at the very least need to meet the bona fide fee for service requirements to be excluded. It is wise to consult with your --- Legal Department or outside counsel when establishing the criteria.
- Walk through the exercise with counsel in determining if the service fees meet the established criteria for inclusion and exclusion of the calculations.
- Maintain this inventory and ensure that it is kept up-to-date.
A matrix approach to tracking and maintaining calculation inclusions and exclusions as part of the supporting documentation is crucial. It is much easier to satisfy an audit, when a manufacturer can explain and demonstrate its interpretation of the regulations and its logic used for determining the treatment of fees and price concessions, as opposed to when a manufacturer tries to explain and justify a history of ad hoc decisions made with little or without any supporting documentation.
chrissyspicer@cis-partners.com
The Department of Veteran Affairs letter dated October 18, 2006 posed the following question and answer.
"1. Are IMA Fees Paid to Wholesalers Excluded From non-FAMP?
Since October 2004, VA’s P.L. 102-585, Section 603, Policy Group (the Policy Group) has said that wholesaler fees associated with inventory management agreements, fees charged by general wholesalers (pharmaceutical prime vendors) to manufacturers generally. Product discounts or rebates granted by manufacturers to wholesalers in order to make their drugs more attractive in the market place cannot be excludable fees."
From this, generally speaking, manufacturers have decided that if the fee for service paid to the wholesaler meets certain predefined requirements, then this fee could be excluded from the non-FAMP calculation, even if the fee paid was based upon sales volume.
Subsequently, the VA issued another letter dated October 26, 2007 that references the October 18, 2006 VA letter and provides further clarification regarding the treatment of IMA Fees.
"4. In its Oct. 18, 2006 Dear Manufacturer Letter, VA OGC stated that certain described inventory management agreement (IMA) fees charged to covered drug manufacturers by general wholesalers are excludable from Non-FAMP.
Q: Does VA agree that exclusion from non-FAMP is also proper for percent-of-sales fees offered to wholesalers by manufacturers as incentives for wholesalers to adopt certain beneficial practices or meet certain standards of efficiency?
A: No. VA’s P.L. 102-585, Sec. 603, Policy Group view percent-of-sales incentive fees offered to wholesalers, in order to achieve business goals of the manufacturer, as not being IMA fees that are excludable from non-FAMP. Specific fee situations that may not clearly fit into the IMA or incentive fee categories should be discussed with auditors from the VA’s Office of Inspector General (55)."
The VA did not define what it meant by business goals, and based upon the language above, any IMA fee that is paid as a percent-of-sales could be construed as a price incentive. The reason being is that a fee that increases as sales increase would incentivize the wholesaler to achieve the business goals of the manufacturer.
In summary, the further clarification provided by the VA hones in on fees that are imposed on the manufacturer for a “true” service that the wholesaler provides that the manufacture could not otherwise perform versus an incentive provided to the wholesaler in order to assist the manufacture in achieving specific business objectives. In the pharmaceutical industry, the term IMA fees is used broadly to mean fees paid to wholesalers for meeting certain requirements. These requirements and the fees paid for providing these requirements vary from company to company. As such, it is difficult to make a blanket statement saying whether to include or exclude these fees.
Determining how to treat these is not a simple decision and involves careful consideration. An inventory of all service fees, rebates paid, and documented assumptions related to the treatment of these price concessions must be maintained. One possible approach for determining the treatment of such fees is outlined below:
- Create an inventory of all price concessions.
- List the criteria needed in order for the price concession to be excluded. In my opinion, all fees across all calculations at the very least need to meet the bona fide fee for service requirements to be excluded. It is wise to consult with your --- Legal Department or outside counsel when establishing the criteria.
- Walk through the exercise with counsel in determining if the service fees meet the established criteria for inclusion and exclusion of the calculations.
- Maintain this inventory and ensure that it is kept up-to-date.
A matrix approach to tracking and maintaining calculation inclusions and exclusions as part of the supporting documentation is crucial. It is much easier to satisfy an audit, when a manufacturer can explain and demonstrate its interpretation of the regulations and its logic used for determining the treatment of fees and price concessions, as opposed to when a manufacturer tries to explain and justify a history of ad hoc decisions made with little or without any supporting documentation.
Wednesday, January 2, 2008
CIS Marketing Recap 2007: It’s just the way we like to do business.
2007 was quite the year for CIS! From the launch of the PCX and the Pharma Compliance Blog to growing our list of services and increasing our number of talented employees with strong industry experience, CIS has truly made some extraordinary strides. Most importantly, we had a lot of fun along the way!
Earlier in the year, in keeping with our commitment to provide unique and innovative consulting products and services, we began exploring ways in which we could offer clients an anonymous forum to discuss their GP and Compliance issues with their industry counterparts. We soon realized the need for a dynamic ‘information exchange’ between the members of these groups.
With this on mind, on April 30th, we launched the Pharma Compliance Blog: Your Space. For Your Space. I would put the little ™ next to that, but quite honestly, it’s not trademarked. Just in my own head. The PCB is a dynamic forum in which the GP and Compliance communities can exchange information and discuss issues in a professional and anonymous environment each and every day. With 170 or so posts, over 10,500 visitors from hundreds of companies and hundreds of comments, we are so thankful for your support and hope that we are addressing your needs.
We at CIS are committed to providing the pharmaceutical community with a forum where users can discuss issues, pose questions, get the latest news and information, and request information from their counterparts anonymously. The PCB has been, and will always be, free of advertisements and pop-ups. We believe that the free flow of information has better enabled users to make informed decisions regarding business operations and compliance issues. We continue to urge you all to post on your own and to send in possible topics or forums for discussion as we move into 2008. Also, if you spot or learn anything outside of the blog that we should be sharing --- let us know! We at CIS encourage creativity --- rather, we crave creativity!
Also, during the summer after months of development, we launched our brand new web site located at: www.cis-partners.com. The site was the culmination of great deal of work and input from the team at CIS and we hope you that you’ve found the new look and format very pleasing and accommodating. With our company growing and expanding, it is necessary for us to utilize our web site to clearly communicate who we are and what we do. Throughout the course of 2007, our monthly web traffic has more than tripled. Again, we thank you all for your support.
We felt and feel that the new look and feel captures the essence and vision of CIS: We specialize in establishing a Culture of Compliance that provides our clients with industry-specific, innovative compliance solutions.
In 2007, CIS also greatly increased its presence at conferences. In May, we attended and spoke at the CBI Medicaid Rebates Conference in Orlando, FL. We were also the proud hosts of the main conference Cocktail Hour where we publicly launched the PCX. In a room filled with blue “PCXTinis” we enjoyed our time with those of you who attended and look forward to 2008 --- where CIS will again be hosting the cocktail hour. Who out there is ready for Blogtinis this go around? Also, in September, we attended IIR’s Medicaid conference in Chicago, IL. CIS spoke on 3 separate occasions as we did our best to help with some of the confusion surrounding CMS’s Final Rule. We hope we helped! CIS also plans on attending and speaking at IIR’s conference in 2008.
Again, we thank you for our support as we continue to grow and expand our ever-growing list of products and services. Most importantly, we’ve enjoyed getting to know you all and look forward to continued work together in our space. CIS attempts to differentiate itself by hiring the best and the brightest people we can find. Besides me, I think we succeeded in 2007.
CIS wishes you and your company the very best of luck in your respective 2008 endeavors. It will continue be our pleasure to help you grow and protect your business in any and all ways possible by providing the industry’s most innovative compliance solutions. As was the case in 2007, never hesitate to contact myself or anyone on the CIS team directly with any and all questions and issues. If we cannot help you immediately, we will do everything we possibly can to get your answers as soon as possible.
Oh yeah --- we’ll also be as friendly as possible as well. It’s just the way we like to do business.
For Your Space,
Steven.
Earlier in the year, in keeping with our commitment to provide unique and innovative consulting products and services, we began exploring ways in which we could offer clients an anonymous forum to discuss their GP and Compliance issues with their industry counterparts. We soon realized the need for a dynamic ‘information exchange’ between the members of these groups.
With this on mind, on April 30th, we launched the Pharma Compliance Blog: Your Space. For Your Space. I would put the little ™ next to that, but quite honestly, it’s not trademarked. Just in my own head. The PCB is a dynamic forum in which the GP and Compliance communities can exchange information and discuss issues in a professional and anonymous environment each and every day. With 170 or so posts, over 10,500 visitors from hundreds of companies and hundreds of comments, we are so thankful for your support and hope that we are addressing your needs.
We at CIS are committed to providing the pharmaceutical community with a forum where users can discuss issues, pose questions, get the latest news and information, and request information from their counterparts anonymously. The PCB has been, and will always be, free of advertisements and pop-ups. We believe that the free flow of information has better enabled users to make informed decisions regarding business operations and compliance issues. We continue to urge you all to post on your own and to send in possible topics or forums for discussion as we move into 2008. Also, if you spot or learn anything outside of the blog that we should be sharing --- let us know! We at CIS encourage creativity --- rather, we crave creativity!
Also, during the summer after months of development, we launched our brand new web site located at: www.cis-partners.com. The site was the culmination of great deal of work and input from the team at CIS and we hope you that you’ve found the new look and format very pleasing and accommodating. With our company growing and expanding, it is necessary for us to utilize our web site to clearly communicate who we are and what we do. Throughout the course of 2007, our monthly web traffic has more than tripled. Again, we thank you all for your support.
We felt and feel that the new look and feel captures the essence and vision of CIS: We specialize in establishing a Culture of Compliance that provides our clients with industry-specific, innovative compliance solutions.
In 2007, CIS also greatly increased its presence at conferences. In May, we attended and spoke at the CBI Medicaid Rebates Conference in Orlando, FL. We were also the proud hosts of the main conference Cocktail Hour where we publicly launched the PCX. In a room filled with blue “PCXTinis” we enjoyed our time with those of you who attended and look forward to 2008 --- where CIS will again be hosting the cocktail hour. Who out there is ready for Blogtinis this go around? Also, in September, we attended IIR’s Medicaid conference in Chicago, IL. CIS spoke on 3 separate occasions as we did our best to help with some of the confusion surrounding CMS’s Final Rule. We hope we helped! CIS also plans on attending and speaking at IIR’s conference in 2008.
Again, we thank you for our support as we continue to grow and expand our ever-growing list of products and services. Most importantly, we’ve enjoyed getting to know you all and look forward to continued work together in our space. CIS attempts to differentiate itself by hiring the best and the brightest people we can find. Besides me, I think we succeeded in 2007.
CIS wishes you and your company the very best of luck in your respective 2008 endeavors. It will continue be our pleasure to help you grow and protect your business in any and all ways possible by providing the industry’s most innovative compliance solutions. As was the case in 2007, never hesitate to contact myself or anyone on the CIS team directly with any and all questions and issues. If we cannot help you immediately, we will do everything we possibly can to get your answers as soon as possible.
Oh yeah --- we’ll also be as friendly as possible as well. It’s just the way we like to do business.
For Your Space,
Steven.
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