Courtesy of: Jess Ebert, CIS Compliance Associate
jessicaebert@cis-partners.com
1) More blood pressure worry: It's linked to dementia
http://news.yahoo.com/s/ap/20100126/ap_on_he_me/us_med_healthbeat_dementia_blood_pressure
2) Analysis: Smokers with cancer could quit and double survival
http://www.usatoday.com/news/health/2010-01-22-smoking-lung-cancer_N.htm?csp=34
3) 'Overweight' Adults Age 70 or Older Are Less Likely to Die Over a 10-Year Period
http://www.sciencedaily.com/releases/2010/01/100128091740.htm
4) Discovery Links Genes to Pancreatic Cancer
http://www.nlm.nih.gov/medlineplus/news/fullstory_94492.html
5) Fake Drugs Bought on the Web Pose Big Health Risks
http://www.healthday.com/Article.asp?AID=635386
Friday, January 29, 2010
Thursday, January 28, 2010
Grim Repercussions
By: Sabrina Skari, CIS Business Development Manager
sabrinaskari@cis-partners.com
Anyone who has ever met me knows that I am a pop culture junkie. I have no desire to live that lifestyle, I never planned a move to L.A. and I am appalled by 99% of what I see on the “entertainment news” shows. However, I continue to watch with suspended disbelief as the Hollywood elite, sports champions and billion-heir’s club continue their reign of stupidity. CNN features entertainment stories and offers Kathy Griffin hosting duties for New Year’s Eve. Barbara Walters’ “10 Most Fascinating People of 2009” included SIX from the entertainment industry in a year riddled with war, economic downturn and political regime changes.
So, one must ask why is America (including myself) along for the ride every time we hear another story that takes someone from pedestal to pedestrian? We are fascinated by repercussions. We love seeing people get their just desserts. And who doesn’t crave an “I told you so” every now and then?
When the story of Tiger Woods’ “transgressions” broke, the entire world (including the CIS office) was busy dissecting all of the measures he could have taken to prevent such a public eruption: he didn’t have to get married, he could have limited the texting, he could have limited the women and so on…Our fascination around the demise of his public image centered on the fact that Tiger Woods- the brand- is well recognized as wholesome, family-oriented and driven with purpose. But behind the scenes, Tiger Woods- the person- didn’t live up to the standards set by his brand and chances are that he heard several warnings and chose to ignore the danger signs. In the end, the repercussions of his actions have already cost him billions of dollars in endorsement deals and he has permanently altered his public image.
The same type of behavior can be true for all of us. In our personal lives, each of us has a personalized way in which we engage in “risky behavior.” Perhaps it is waiting until the last day to send in our bills, driving just 5 miles over the speed limit or having the second portion of macaroni and cheese. The repercussions for these dalliances aren’t too costly, but the point is that we know we’re doing something that is against our best interests.
Then, take it to the next level and think about these actions in a professional world…in some industries sending in an expense report late, doing personal stuff on company time or even snagging an extra half hour for lunch is as risky as it gets. However, in the pharmaceutical industry, and particularly the world of compliance, the stakes are high. When it comes to government compliance, the pharmaceutical industry can’t hold a press conference and apologize publicly for our compliance “transgressions.”
In the realm of GP compliance, there are so many crucial calculations and reporting activities that are predicated on historical data. The sheer complexity of these activities provides ample opportunity for human error, even among the most cognoscente analysts. This is the foundation upon which CIS has built its audit and assessment business, as it provides a chance for an outside party to come in with the magnifying glass and evaluate risk areas. However, after following this compliance due diligence, how many manufacturers go down the warning list of actionable items and ensure that each identified risk is mitigated effectively over the recommended timeframe? I would venture to guess that number is not 100%.
Further, let’s say that in the midst of running shadow calculations, you find a flaw or mistake. Do you go back and correct the calculation or do you correct the calculation AND also review the methodology to ensure the mistake doesn’t happen again? Then, if the methodology was incorrect, do you update the appropriate policy and procedures and notify all individuals with a hand in the process? In fact, in your procedure documentation do you have an action plan specifically laid out for instances where mistakes are found or risk areas are identified? The situations may seem circular but this is good because an effective compliance program should be a closed loop process. In the process, you are effectively closing the gap for GP compliance “transgressions.”
The same principle applies in Corporate Compliance. For example, activities are often managed by third party vendors, including Speaker Programs, Sample Accountability and Consultant Meetings. This practice is more than acceptable, there just have to be processes in place to monitor the activities and ensure compliance. Tiger relied on his associates to cover his tracks, and in the same way that it came back to haunt him, relying on others to keep you compliant will come back to haunt you. When you identify that a vendor or representative is not acting in accordance with your policies and procedures, sending a warning and insisting on change isn’t always enough. You have to track the transgressions, appropriately elevate the status for repeat offenses and track disciplinary measures. Once patterns are identified, it is the responsibility of the compliance office to heed the warning signs and identify troublesome individuals, departments or districts, or gaps in the program itself.
In the areas of manufacturing and clinical compliance, one could argue that the cost of a mistake or error has the potential to be the highest. If your company has the unfortunate circumstance of being involved in a recall by the FDA the risk can easily be millions of dollars. It may occur due to something that was not documented correctly in a clinical trial, or a manufacturing issue, but the repercussions are the same. There are fines to deal with from the FDA, not to mention potential law suits from patients who were prescribed the drug in question. In the worst case scenario, if a drug is pulled off the market, the money that was poured into its research and development is lost and there are several instances where that amount nears the $1 billion mark.
Financial losses are devastating but in many of these instances, the cost of disregarding a compliance issue can have personal repercussions as well. It may cost an individual their job and may cost a manufacturer their reputation. When all of these potential risks in different areas are combined, it’s easy to see how quickly ignoring compliance risks can have a domino effect. That said, the major differences between watching Tiger Woods’ reputation crumble in the public eye and the potential downfall of a pharmaceutical company is that the weight falls on the shoulders of many people instead of one lone individual. Also, celebrities are forced to deal with both the highs and lows as they are documented by the mainstream media. Oh, and one final piece of good news is that at least when you’re in the healthcare industry, you don’t have to worry about losing an endorsement deal with Gatorade in the process.
sabrinaskari@cis-partners.com
Anyone who has ever met me knows that I am a pop culture junkie. I have no desire to live that lifestyle, I never planned a move to L.A. and I am appalled by 99% of what I see on the “entertainment news” shows. However, I continue to watch with suspended disbelief as the Hollywood elite, sports champions and billion-heir’s club continue their reign of stupidity. CNN features entertainment stories and offers Kathy Griffin hosting duties for New Year’s Eve. Barbara Walters’ “10 Most Fascinating People of 2009” included SIX from the entertainment industry in a year riddled with war, economic downturn and political regime changes.
So, one must ask why is America (including myself) along for the ride every time we hear another story that takes someone from pedestal to pedestrian? We are fascinated by repercussions. We love seeing people get their just desserts. And who doesn’t crave an “I told you so” every now and then?
When the story of Tiger Woods’ “transgressions” broke, the entire world (including the CIS office) was busy dissecting all of the measures he could have taken to prevent such a public eruption: he didn’t have to get married, he could have limited the texting, he could have limited the women and so on…Our fascination around the demise of his public image centered on the fact that Tiger Woods- the brand- is well recognized as wholesome, family-oriented and driven with purpose. But behind the scenes, Tiger Woods- the person- didn’t live up to the standards set by his brand and chances are that he heard several warnings and chose to ignore the danger signs. In the end, the repercussions of his actions have already cost him billions of dollars in endorsement deals and he has permanently altered his public image.
The same type of behavior can be true for all of us. In our personal lives, each of us has a personalized way in which we engage in “risky behavior.” Perhaps it is waiting until the last day to send in our bills, driving just 5 miles over the speed limit or having the second portion of macaroni and cheese. The repercussions for these dalliances aren’t too costly, but the point is that we know we’re doing something that is against our best interests.
Then, take it to the next level and think about these actions in a professional world…in some industries sending in an expense report late, doing personal stuff on company time or even snagging an extra half hour for lunch is as risky as it gets. However, in the pharmaceutical industry, and particularly the world of compliance, the stakes are high. When it comes to government compliance, the pharmaceutical industry can’t hold a press conference and apologize publicly for our compliance “transgressions.”
In the realm of GP compliance, there are so many crucial calculations and reporting activities that are predicated on historical data. The sheer complexity of these activities provides ample opportunity for human error, even among the most cognoscente analysts. This is the foundation upon which CIS has built its audit and assessment business, as it provides a chance for an outside party to come in with the magnifying glass and evaluate risk areas. However, after following this compliance due diligence, how many manufacturers go down the warning list of actionable items and ensure that each identified risk is mitigated effectively over the recommended timeframe? I would venture to guess that number is not 100%.
Further, let’s say that in the midst of running shadow calculations, you find a flaw or mistake. Do you go back and correct the calculation or do you correct the calculation AND also review the methodology to ensure the mistake doesn’t happen again? Then, if the methodology was incorrect, do you update the appropriate policy and procedures and notify all individuals with a hand in the process? In fact, in your procedure documentation do you have an action plan specifically laid out for instances where mistakes are found or risk areas are identified? The situations may seem circular but this is good because an effective compliance program should be a closed loop process. In the process, you are effectively closing the gap for GP compliance “transgressions.”
The same principle applies in Corporate Compliance. For example, activities are often managed by third party vendors, including Speaker Programs, Sample Accountability and Consultant Meetings. This practice is more than acceptable, there just have to be processes in place to monitor the activities and ensure compliance. Tiger relied on his associates to cover his tracks, and in the same way that it came back to haunt him, relying on others to keep you compliant will come back to haunt you. When you identify that a vendor or representative is not acting in accordance with your policies and procedures, sending a warning and insisting on change isn’t always enough. You have to track the transgressions, appropriately elevate the status for repeat offenses and track disciplinary measures. Once patterns are identified, it is the responsibility of the compliance office to heed the warning signs and identify troublesome individuals, departments or districts, or gaps in the program itself.
In the areas of manufacturing and clinical compliance, one could argue that the cost of a mistake or error has the potential to be the highest. If your company has the unfortunate circumstance of being involved in a recall by the FDA the risk can easily be millions of dollars. It may occur due to something that was not documented correctly in a clinical trial, or a manufacturing issue, but the repercussions are the same. There are fines to deal with from the FDA, not to mention potential law suits from patients who were prescribed the drug in question. In the worst case scenario, if a drug is pulled off the market, the money that was poured into its research and development is lost and there are several instances where that amount nears the $1 billion mark.
Financial losses are devastating but in many of these instances, the cost of disregarding a compliance issue can have personal repercussions as well. It may cost an individual their job and may cost a manufacturer their reputation. When all of these potential risks in different areas are combined, it’s easy to see how quickly ignoring compliance risks can have a domino effect. That said, the major differences between watching Tiger Woods’ reputation crumble in the public eye and the potential downfall of a pharmaceutical company is that the weight falls on the shoulders of many people instead of one lone individual. Also, celebrities are forced to deal with both the highs and lows as they are documented by the mainstream media. Oh, and one final piece of good news is that at least when you’re in the healthcare industry, you don’t have to worry about losing an endorsement deal with Gatorade in the process.
Wednesday, January 27, 2010
Changes to MDRP and PHS 340B Programs Likely After Massachusetts Senate Election
By: Grete Dudek, CIS Compliance Associate
gretedudek@cis-partners.com
Since before President Obama was elected, healthcare reform has been in the spotlight, and there has been much speculation about how it could affect the pharmaceutical industry. Until a few days ago, it seemed as if the Senate version of the Healthcare Reform Bill was going to be pushed through the House of Representatives for President Obama to sign. Since some parts of the bill would have taken effect immediately, and some in a few years, more changes could have been made as different pieces of the bill went into effect.
One of these likely changes is that the Medicaid base rebate amount would increase from 15.1% to 22.1% or 23.1% of AMP for single source (S) and multiple source innovator (I) drugs, and from 11% to 13% of AMP for generic drugs (N). The additional rebates paid by manufacturers under the Medicaid Drug Rebate Program (MDRP) will add up to $23 billion dollars over 10 years, and will be used by the Federal government to help pay for health insurance for those currently without it (1). The MDRP would also be expanded to Medicaid Managed Care Organizations (MCOs) (2) and to more Americans by expanding the low-income eligibility for individuals, children, and pregnant women (5).
The changes to the MDRP will also affect the Public Health Service (PHS) 340B program price. The higher Medicaid unit rebate amount (URA) will lead to a decrease in PHS 340B prices, since the price determination is based on AMP and URA. The expansion of the 340B program to inpatients and new covered entities, including children’s hospitals, freestanding cancer hospitals, critical access hospitals, and more (2) could lead to $2 million saved each year by about 800 safety net hospitals. Hospitals have seen increases in uninsured seeking emergency medical services instead of preventative care due to the recent increase in unemployment and low insurance coverage (3).
Recently, a special Senate election was held in Massachusetts to fill the seat vacated by the death of Democratic Senator Edward Kennedy. Scott Brown, a Republican, was elected, reducing the Democrat’s advantage from 60-40 to 59-41, and giving the Republicans the ability to sustain a filibuster (4). Since the election, healthcare reform plans that seemed like a sure thing before may be no more.
Healthcare reform has quickly turned, and President Obama has indicated that he believes the plan to push the Senate bill through the House of Representatives should be scrapped, and that negotiations should not proceed until Senator-elect Brown takes office. Once he is in, the healthcare reform process will most likely be slowed down (4), and law makers have stated that the bill should be pared down to attract bipartisan support. “I would advise that we try to move quickly to coalesce around those elements of the package that people agree on,” President Obama said (5), and he has two initial goals if an immediate overhaul isn’t possible: an insurance industry regulation banning denying insurance based on pre-existing conditions, and cost containment of health care costs. From there, more discussion could take place about extending healthcare to the people who are currently uninsured. For now, the path forward has taken another unexpected turn, and there will be more anticipation of how the passage of a bill whose contents are yet to be determined will affect the pharmaceutical industry.
Sources:
1) http://www.corporatecomplianceinsights.com/2010/the-baucus-health-bill-%E2%80%93-a-mixed-bag-for-drug-makers
2) http://pssc.aphanet.org/policy/fed340blegislation.htm
3) http://www.healthleadersmedia.com/content/FIN-245095/Senate-Bill-Would-Save-Safety-Net-Hospitals-Billions-in-Inpatient-Pharmacy-Costs
4) http://www.nytimes.com/2010/01/21/health/policy/21health.html?pagewanted=2&hp
5) http://www.kff.org/healthreform/upload/7952.pdf
gretedudek@cis-partners.com
Since before President Obama was elected, healthcare reform has been in the spotlight, and there has been much speculation about how it could affect the pharmaceutical industry. Until a few days ago, it seemed as if the Senate version of the Healthcare Reform Bill was going to be pushed through the House of Representatives for President Obama to sign. Since some parts of the bill would have taken effect immediately, and some in a few years, more changes could have been made as different pieces of the bill went into effect.
One of these likely changes is that the Medicaid base rebate amount would increase from 15.1% to 22.1% or 23.1% of AMP for single source (S) and multiple source innovator (I) drugs, and from 11% to 13% of AMP for generic drugs (N). The additional rebates paid by manufacturers under the Medicaid Drug Rebate Program (MDRP) will add up to $23 billion dollars over 10 years, and will be used by the Federal government to help pay for health insurance for those currently without it (1). The MDRP would also be expanded to Medicaid Managed Care Organizations (MCOs) (2) and to more Americans by expanding the low-income eligibility for individuals, children, and pregnant women (5).
The changes to the MDRP will also affect the Public Health Service (PHS) 340B program price. The higher Medicaid unit rebate amount (URA) will lead to a decrease in PHS 340B prices, since the price determination is based on AMP and URA. The expansion of the 340B program to inpatients and new covered entities, including children’s hospitals, freestanding cancer hospitals, critical access hospitals, and more (2) could lead to $2 million saved each year by about 800 safety net hospitals. Hospitals have seen increases in uninsured seeking emergency medical services instead of preventative care due to the recent increase in unemployment and low insurance coverage (3).
Recently, a special Senate election was held in Massachusetts to fill the seat vacated by the death of Democratic Senator Edward Kennedy. Scott Brown, a Republican, was elected, reducing the Democrat’s advantage from 60-40 to 59-41, and giving the Republicans the ability to sustain a filibuster (4). Since the election, healthcare reform plans that seemed like a sure thing before may be no more.
Healthcare reform has quickly turned, and President Obama has indicated that he believes the plan to push the Senate bill through the House of Representatives should be scrapped, and that negotiations should not proceed until Senator-elect Brown takes office. Once he is in, the healthcare reform process will most likely be slowed down (4), and law makers have stated that the bill should be pared down to attract bipartisan support. “I would advise that we try to move quickly to coalesce around those elements of the package that people agree on,” President Obama said (5), and he has two initial goals if an immediate overhaul isn’t possible: an insurance industry regulation banning denying insurance based on pre-existing conditions, and cost containment of health care costs. From there, more discussion could take place about extending healthcare to the people who are currently uninsured. For now, the path forward has taken another unexpected turn, and there will be more anticipation of how the passage of a bill whose contents are yet to be determined will affect the pharmaceutical industry.
Sources:
1) http://www.corporatecomplianceinsights.com/2010/the-baucus-health-bill-%E2%80%93-a-mixed-bag-for-drug-makers
2) http://pssc.aphanet.org/policy/fed340blegislation.htm
3) http://www.healthleadersmedia.com/content/FIN-245095/Senate-Bill-Would-Save-Safety-Net-Hospitals-Billions-in-Inpatient-Pharmacy-Costs
4) http://www.nytimes.com/2010/01/21/health/policy/21health.html?pagewanted=2&hp
5) http://www.kff.org/healthreform/upload/7952.pdf
Monday, January 25, 2010
Healthcare Reform Legislation and the Senator Brown Effect – What Should GP Professionals Be Thinking Now?
By: Chris Cobourn, VP of Regulatory Affairs
chriscobourn@cis-partners.com
Many in the industry are asking the obvious question, “What does it mean to Healthcare Reform now that Republican Scott Brown won the Senate seat in Massachusetts?” While it certainly appears that major legislative action will change direction, I think it is also important that we keep in mind that change is coming and we must be prepared.
I am of the personal opinion that substantial changes to Government Programs for Pharmaceutical Manufacturers are still coming sooner rather than later. There are large and contentious issues in the political debate around Healthcare Reform in the United States, such as the creation of a Public Option and potential taxes on expensive “Cadillac Plans.” There is little national debate over some substantial changes that would dramatically impact the industry, such as changing the definition of AMP, raising the base Medicaid rebate percentages (percent of AMP), expanding eligibility and changing the 340B program. The pharmaceutical industry itself seems to have accepted that these changes are coming and are bracing for the financial impact, while also focusing on other open issues in the debate, such as the creation of a period of exclusivity for bio-equivalent drugs.
The next important question is, “Which of the financial components, such as raising the base rebate percentage, will be included in the budget process or in other, newer and maybe smaller bills?” I think that it is still prudent to anticipate that changes to core elements such as methodology, processes and systems will have a dramatic impact on the business. Some changes to core elements that, I believe, will be incorporated in the future include:
chriscobourn@cis-partners.com
Many in the industry are asking the obvious question, “What does it mean to Healthcare Reform now that Republican Scott Brown won the Senate seat in Massachusetts?” While it certainly appears that major legislative action will change direction, I think it is also important that we keep in mind that change is coming and we must be prepared.
I am of the personal opinion that substantial changes to Government Programs for Pharmaceutical Manufacturers are still coming sooner rather than later. There are large and contentious issues in the political debate around Healthcare Reform in the United States, such as the creation of a Public Option and potential taxes on expensive “Cadillac Plans.” There is little national debate over some substantial changes that would dramatically impact the industry, such as changing the definition of AMP, raising the base Medicaid rebate percentages (percent of AMP), expanding eligibility and changing the 340B program. The pharmaceutical industry itself seems to have accepted that these changes are coming and are bracing for the financial impact, while also focusing on other open issues in the debate, such as the creation of a period of exclusivity for bio-equivalent drugs.
The next important question is, “Which of the financial components, such as raising the base rebate percentage, will be included in the budget process or in other, newer and maybe smaller bills?” I think that it is still prudent to anticipate that changes to core elements such as methodology, processes and systems will have a dramatic impact on the business. Some changes to core elements that, I believe, will be incorporated in the future include:
- Changes to the definition of AMP resulting in a Higher AMP.
A shift to a more restrictive definition of “community retail pharmacies”, as well as a reduction in the types of rebates that are excluded from AMP can result in a higher-calculated AMP. - An increase in base rebates.
Such as 23.1% for Branded Products, 13% for Generic Products and 17.1% for Pediatric Products. - Higher Medicaid Rebates.
An increase in the base rebate percentages will lead to a higher percentage on a higher AMP. - Medicaid Eligibility will be expanded.
The first two bullets will result in a higher Unit Rebate Amount (URA) and the number of eligible participants will increase based upon expanded eligibility in the states. - Medicaid level rebates will be expanded.
Expand the Medicaid Rebates to Managed Care Organizations (MCO) and to Dual Eligibles in Medicare Part D programs. - Base-line AMP will be applied to new formulations.
The perceived “loophole” of some new formulations setting their own new Base-line AMP will be addressed, with a major financial impact to many manufacturers. - 340B Program participation will expand.
Program enhancements seem to be a certainty, with increased eligibility for additional entity types. Further, the potential impact from the changes in AMP and URA from the Medicaid side should be considered. The expansion will also have an impact on GPO purchasing.
Friday, January 22, 2010
Articles of the Week!
Courtesy of: Scott Hoffman
scotthoffman@cis-partners.com
1) Obama Retreats On Health-Care Bill
http://online.wsj.com/article/SB10001424052748704320104575014982123360418.html
2) Cancer Docs Judge Drugs' Cost-Effectiveness
http://www.fiercepharma.com/story/cancer-docs-judge-drugs-cost-effectiveness/2010-01-21
3) Experts: Sitting Too Much Could Be Deadly
http://news.yahoo.com/s/ap/20100120/ap_on_he_me/eu_med_dangers_of_sitting
4) Ga. Faces $506M Medicaid Gap; Hospital Fee Mulled
http://abcnews.go.com/Business/wireStory?id=9628627
5) First U.S. Stem Cells Transplanted Into Spinal Cord
http://www.cnn.com/2010/HEALTH/01/21/stem.cell.spine/index.html
scotthoffman@cis-partners.com
1) Obama Retreats On Health-Care Bill
http://online.wsj.com/article/SB10001424052748704320104575014982123360418.html
2) Cancer Docs Judge Drugs' Cost-Effectiveness
http://www.fiercepharma.com/story/cancer-docs-judge-drugs-cost-effectiveness/2010-01-21
3) Experts: Sitting Too Much Could Be Deadly
http://news.yahoo.com/s/ap/20100120/ap_on_he_me/eu_med_dangers_of_sitting
4) Ga. Faces $506M Medicaid Gap; Hospital Fee Mulled
http://abcnews.go.com/Business/wireStory?id=9628627
5) First U.S. Stem Cells Transplanted Into Spinal Cord
http://www.cnn.com/2010/HEALTH/01/21/stem.cell.spine/index.html
Thursday, January 21, 2010
CIS will be exhibiting at CBI's 7th Annual Pharmaceutical Compliance Congress!
When: Monday, January 25th – Tuesday, January 26th
Where: The Ritz Carlton, Washington, D.C.
For additional conference information, please click here.
Where: The Ritz Carlton, Washington, D.C.
For additional conference information, please click here.
Robert Vito – Guest Speaker at CIS’ IIR Baltimore Pre-Conference Workshop!
By: Chris Cobourn, VP of Regulatory Affairs
chriscobourn@cis-partners.com
CIS’ Bill Baxter, Director of Medicaid Market and Rebate Management, and I have been coordinating with OIG’s Robert Vito, Regional Inspector, General for Evaluation and Inspections, to speak at the February IIR Government Programs Summit in Baltimore, MD.[1]
For those of you who might not be aware, CIS is hosting an all-day pre-conference workshop for advanced GP staff on Monday, February 8th. This workshop is called “Government Programs 201,” and can be found under Track B2: Agency Town Hall on the IIR Agenda.[2] As described on the Agenda,
GP 201 is an advanced full-day GP Town Hall Forum. It is your unique opportunity for access to top agency officials to discuss topical issues. Now in its third year, this forum has become the “talk of the town” as the place to have a working dialog between your peers in the GP environment, including the agencies, law firms and industry. The unique venue is designed for experienced GP professionals, fostering discussion on operational issues and challenges across the programs.[3]
GP 201, our 3rd annual pre-conference event, runs concurrent to the MDRP 101 session (Track B1) for beginners that day. During the course of the day, CIS will facilitate agency round table discussions with industry leaders and peers, as well as agency officials. The forum was very well received by all involved last year, and was a great opportunity for thoughtful discussion amongst the attendees, including manufacturers, agencies, consultants and law firms.
One area we thought would be a great addition to the day is a discussion about the OIG, including the departments and functions within the OIG, accompanied by explanations of their missions and roles. As Rob has explained before, it is important for manufacturers to understand that if, or when, they get a phone call from the OIG, they should know which department the call is coming from and why. I think that our discussion of this topic will be a great addition to the workshop, and I thank Rob for his participation.
If you have any questions about our pre-conference GP 201 workshop, please feel free to contact me.
Thank you,
Chris Cobourn
[1] http://www.iirusa.com/gp/speakers.xml
[2] http://www.iirusa.com/gp/agenda-at-a-glance.xml
[3] http://www.iirusa.com/gp/agenda-at-a-glance.xml
chriscobourn@cis-partners.com
CIS’ Bill Baxter, Director of Medicaid Market and Rebate Management, and I have been coordinating with OIG’s Robert Vito, Regional Inspector, General for Evaluation and Inspections, to speak at the February IIR Government Programs Summit in Baltimore, MD.[1]
For those of you who might not be aware, CIS is hosting an all-day pre-conference workshop for advanced GP staff on Monday, February 8th. This workshop is called “Government Programs 201,” and can be found under Track B2: Agency Town Hall on the IIR Agenda.[2] As described on the Agenda,
GP 201 is an advanced full-day GP Town Hall Forum. It is your unique opportunity for access to top agency officials to discuss topical issues. Now in its third year, this forum has become the “talk of the town” as the place to have a working dialog between your peers in the GP environment, including the agencies, law firms and industry. The unique venue is designed for experienced GP professionals, fostering discussion on operational issues and challenges across the programs.[3]
GP 201, our 3rd annual pre-conference event, runs concurrent to the MDRP 101 session (Track B1) for beginners that day. During the course of the day, CIS will facilitate agency round table discussions with industry leaders and peers, as well as agency officials. The forum was very well received by all involved last year, and was a great opportunity for thoughtful discussion amongst the attendees, including manufacturers, agencies, consultants and law firms.
One area we thought would be a great addition to the day is a discussion about the OIG, including the departments and functions within the OIG, accompanied by explanations of their missions and roles. As Rob has explained before, it is important for manufacturers to understand that if, or when, they get a phone call from the OIG, they should know which department the call is coming from and why. I think that our discussion of this topic will be a great addition to the workshop, and I thank Rob for his participation.
If you have any questions about our pre-conference GP 201 workshop, please feel free to contact me.
Thank you,
Chris Cobourn
[1] http://www.iirusa.com/gp/speakers.xml
[2] http://www.iirusa.com/gp/agenda-at-a-glance.xml
[3] http://www.iirusa.com/gp/agenda-at-a-glance.xml
Wednesday, January 20, 2010
CMS Issued Release # 80 on January 5th – Updated Guidance on Recalculations
By: Chris Cobourn, VP of Regulatory Affairs
chriscobourn@cis-partners.com
The recent Manufacturer Release # 80 from CMS provided an updated guidance on methodology-related Average Manufacturer Price (AMP) and Best Price (BP) recalculations in the Medicaid Program. As you can see below, there have been various regulations (CFRs, including the Final Rule) and guidance (Release Letters) published to provide manufacturers with information on performing recalculations and restatements. This guidance is designed to help manufacturers understand all the “ins and outs” of these calculations, including what may constitute a methodology change, versus a data-related calculation error. There will be a panel discussion at IIR Government Programs and Pricing Summit in Baltimore this February (during the February 8th pre-conference day) that will focus on recalculations and restatements. CMS will be participating in the panel discussion, and I think it will be a great opportunity to review the relevant regulations and guidance in effect now, as the rules and processes have changed significantly since Release #14 (the Office of Pharmacy Affairs (OPA) will also be present to discuss the impact of recalculations on the PHS program).
With that said, let me provide some thoughts on my reading of Release #80, starting with a summary of previously published regulations and guidance. Please remember that these are my thoughts and opinions, for discussion purposes, not intended to represent the view of CMS, to be legal advice or provide specific recommendations. I welcome any follow up questions. (FYI, I have a quick summary at the end).
First, let’s summarize a few key documents prior to Release #80 (you can also read Debbe Saez’s previous blog entry, “AMP and BP Methodology Changes Are a Go,” for additional information).
Release #14 (January, 1995):
This release provides standard guidance applied to recalculations and restatements, requiring CMS approval prior to a manufacturer making any methodology changes (retroactive or prospective), until Release #78 and the Final Rule made substantive changes to the process.
Release #61 (Sept 2003):
This release references CMS-2175-FC: REGULATION ISSUED AUGUST 29, 2003, which states that manufacturers must report revisions to AMP or BP within a period not to exceed 12 quarters from the quarter in which the data was due (establishing the 12 Quarter rule).
Release #78 (June 26, 2007):
This release states that a manufacturer may implement pending recalculation requests (which were submitted prior to Release # 78, and required CMS approval according to Release #14) on a prospective basis, beginning with the date the manufacturer notified CMS of the recalculation. Release #78 also includes the following provisions:
The AMP Final Rule establishes:
Release #80 appears to reiterate recent guidance on the 12-quarter period and CMS approval.
Manufacturers with pending recalculation requests, made prior to the effective date of regulations that set the 12-quarter time limitation for submission of recalculated data (which I assume is August, 2003), may implement the revised pricing methodology for the specified periods without prior review and approval by CMS.
We can talk about the history of guidance, and where newer guidance may supersede previous guidance, as well as specific times where older guidance may still be in effect if not specifically changed. But, at the end of the day, I think our ultimate goal is to understand the rules that are currently in place. With that said, my initial reading of the status of recalculation requests, as of Release #80, is (again, this is my read of it!):
Thank you, I welcome your questions, and I hope to see you in Baltimore February 8th!
Chris
For all Drug Manufacturer Releases, check out the GP Pharma Compliance Exchange:
http://gp.cis-pcx.com/federal-agencies/centers_for_medicare_and_medicaid_services,8/medicaid_guidance,62/drug_manufacturer_releases,151/
If you are not currently a PCX subscriber, you can sign up for a 30-day free trial!
chriscobourn@cis-partners.com
The recent Manufacturer Release # 80 from CMS provided an updated guidance on methodology-related Average Manufacturer Price (AMP) and Best Price (BP) recalculations in the Medicaid Program. As you can see below, there have been various regulations (CFRs, including the Final Rule) and guidance (Release Letters) published to provide manufacturers with information on performing recalculations and restatements. This guidance is designed to help manufacturers understand all the “ins and outs” of these calculations, including what may constitute a methodology change, versus a data-related calculation error. There will be a panel discussion at IIR Government Programs and Pricing Summit in Baltimore this February (during the February 8th pre-conference day) that will focus on recalculations and restatements. CMS will be participating in the panel discussion, and I think it will be a great opportunity to review the relevant regulations and guidance in effect now, as the rules and processes have changed significantly since Release #14 (the Office of Pharmacy Affairs (OPA) will also be present to discuss the impact of recalculations on the PHS program).
With that said, let me provide some thoughts on my reading of Release #80, starting with a summary of previously published regulations and guidance. Please remember that these are my thoughts and opinions, for discussion purposes, not intended to represent the view of CMS, to be legal advice or provide specific recommendations. I welcome any follow up questions. (FYI, I have a quick summary at the end).
First, let’s summarize a few key documents prior to Release #80 (you can also read Debbe Saez’s previous blog entry, “AMP and BP Methodology Changes Are a Go,” for additional information).
Release #14 (January, 1995):
This release provides standard guidance applied to recalculations and restatements, requiring CMS approval prior to a manufacturer making any methodology changes (retroactive or prospective), until Release #78 and the Final Rule made substantive changes to the process.
Release #61 (Sept 2003):
This release references CMS-2175-FC: REGULATION ISSUED AUGUST 29, 2003, which states that manufacturers must report revisions to AMP or BP within a period not to exceed 12 quarters from the quarter in which the data was due (establishing the 12 Quarter rule).
Release #78 (June 26, 2007):
This release states that a manufacturer may implement pending recalculation requests (which were submitted prior to Release # 78, and required CMS approval according to Release #14) on a prospective basis, beginning with the date the manufacturer notified CMS of the recalculation. Release #78 also includes the following provisions:
- Manufacturers may implement the new methodology prospectively as of the date of the request (where the request pre-dates Release #78);
- New recalculation requests, as of the date of Release #78, may proceed with implementation of the change in methodology without review or approval by CMS;
- Manufacturers must notify CMS and receive authorization in advance of retroactive changes in methodology, and include fiscal magnitude and reasons for the change.
The AMP Final Rule establishes:
- A 3-year window for restatements;
- That revised calculations must be reported for a period not to exceed 12 quarters;
- That manufacturers must report revisions to AMP except where the revision is solely related to lagged price concession data.
- Requests submitted to CMS before the 12-quarter limitation took effect: Retroactive requests for methodology changes may be implemented, without prior review and approval from CMS, for the period specified in the request;
- Requests submitted to CMS after the 12-quarter limitation took effect: Manufacturers may implement changes and recalculate for a period not to exceed 12 quarters.
Release #80 appears to reiterate recent guidance on the 12-quarter period and CMS approval.
Manufacturers with pending recalculation requests, made prior to the effective date of regulations that set the 12-quarter time limitation for submission of recalculated data (which I assume is August, 2003), may implement the revised pricing methodology for the specified periods without prior review and approval by CMS.
- Requests made prior to the guidance establishing the 12-quarter “window” may proceed without prior approval by CMS
- Request for methodology changes received after the establishment of the 12-quarter window may proceed with the change without prior CMS approval (reiterating Release #78), and the period may not exceed 12 quarters (Release #78 did not specifically mention the 12-quarter period).
- A future recalculation may be done without review and approval by CMS, but the manufacturer must notify CMS of the change in methodology, the revised AMP and BP data, the fiscal magnitude and the reason for the change. The change cannot exceed 12 quarters from the date of notification.
We can talk about the history of guidance, and where newer guidance may supersede previous guidance, as well as specific times where older guidance may still be in effect if not specifically changed. But, at the end of the day, I think our ultimate goal is to understand the rules that are currently in place. With that said, my initial reading of the status of recalculation requests, as of Release #80, is (again, this is my read of it!):
- The 12-quarter rule should apply to both methodology related changes and data calculation errors;
- Pending recalculation requests made prior to the implementation of the 12-quarter rule may proceed without review or approval, for the period indicated in the request;
- Pending requests issued after the 12-quarter rule was implemented may proceed without further review or approval, and can go back 12 quarters from the date the request is issued; for methodology changes, rationale and impact must be submitted;
- Future recalculation requests, methodology- or data-related, may proceed without further review or approval, and can go back 12 quarters from the date of the request; for methodology changes, rationale and impact must be submitted.
Thank you, I welcome your questions, and I hope to see you in Baltimore February 8th!
Chris
For all Drug Manufacturer Releases, check out the GP Pharma Compliance Exchange:
http://gp.cis-pcx.com/federal-agencies/centers_for_medicare_and_medicaid_services,8/medicaid_guidance,62/drug_manufacturer_releases,151/
If you are not currently a PCX subscriber, you can sign up for a 30-day free trial!
Monday, January 18, 2010
The Most Important Vote on Healthcare Reform?
By: Jess Ebert, CIS Compliance Associate
jessicaebert@cis-partners.com
On Tuesday, January 19th, voters in Massachusetts will go to the polls in the state’s Senate special election to fill the seat left by Senator Edward Kennedy after his 47 years of service. The special election comes on the same day that the 2nd session of the 111th congress reconvenes in order to, among other items on President Obama’s domestic agenda, vote on the healthcare bill that has been intensely debated over the prior 12 months. Not only is the race symbolically significant considering Sen. Kennedy’s years championing the cause of Healthcare in the Senate, but the outcome of the election has a critical bearing over the voting on and passing of the current healthcare bill, as a Republican victory would deliver a blow to the Democrats’ filibuster-proof majority in the Senate.
After the death of Sen. Edward Kennedy on August 25th of last year, Massachusetts democratic leaders reversed a state law which disallowed the Governor’s appointment of a replacement Senator to fill a seat in the event of it being vacated. On September 25th, Paul Kirk, a long-time Kennedy aide and former Democratic National Committee chairman was seated in the US Senate after being appointed by Massachusetts Governor Deval Patrick. Gov. Patrick also chose January 19th, 2010 as the date of the Senate special election. After the December 8th party primaries, the Republican Party nominated State Senator Scott Brown, and the Democratic Party nominated Attorney General Martha Coakley[i].
Brown has guaranteed that, if seated, he will cast his vote against the Healthcare Reform bill in the Senate. A 41st Republican seat in the Senate, coupled with the loss of the Democrats’ 60th seat would jeopardize not only the Democrats’ Healthcare Reform plans, but would cast doubts about other items on President Obama’s legislative docket at least until this fall’s mid-term Senate elections. But, even greater questions remain there with the imminent retiring of Senators Dodd and Dorgan[ii].
Are current Congressional Democrats and President Obama willing to make yet more concessions in the Healthcare Reform bill, or is Martha Coakley Healthcare Reform’s last great hope?
Sources:
[i] http://en.wikipedia.org/wiki/United_States_Senate_special_election_in_Massachusetts,_2010
[ii] http://www.latimes.com/news/nation-and-world/la-na-senate6-2010jan06,0,7077974.story
jessicaebert@cis-partners.com
On Tuesday, January 19th, voters in Massachusetts will go to the polls in the state’s Senate special election to fill the seat left by Senator Edward Kennedy after his 47 years of service. The special election comes on the same day that the 2nd session of the 111th congress reconvenes in order to, among other items on President Obama’s domestic agenda, vote on the healthcare bill that has been intensely debated over the prior 12 months. Not only is the race symbolically significant considering Sen. Kennedy’s years championing the cause of Healthcare in the Senate, but the outcome of the election has a critical bearing over the voting on and passing of the current healthcare bill, as a Republican victory would deliver a blow to the Democrats’ filibuster-proof majority in the Senate.
After the death of Sen. Edward Kennedy on August 25th of last year, Massachusetts democratic leaders reversed a state law which disallowed the Governor’s appointment of a replacement Senator to fill a seat in the event of it being vacated. On September 25th, Paul Kirk, a long-time Kennedy aide and former Democratic National Committee chairman was seated in the US Senate after being appointed by Massachusetts Governor Deval Patrick. Gov. Patrick also chose January 19th, 2010 as the date of the Senate special election. After the December 8th party primaries, the Republican Party nominated State Senator Scott Brown, and the Democratic Party nominated Attorney General Martha Coakley[i].
Brown has guaranteed that, if seated, he will cast his vote against the Healthcare Reform bill in the Senate. A 41st Republican seat in the Senate, coupled with the loss of the Democrats’ 60th seat would jeopardize not only the Democrats’ Healthcare Reform plans, but would cast doubts about other items on President Obama’s legislative docket at least until this fall’s mid-term Senate elections. But, even greater questions remain there with the imminent retiring of Senators Dodd and Dorgan[ii].
Are current Congressional Democrats and President Obama willing to make yet more concessions in the Healthcare Reform bill, or is Martha Coakley Healthcare Reform’s last great hope?
Sources:
[i] http://en.wikipedia.org/wiki/United_States_Senate_special_election_in_Massachusetts,_2010
[ii] http://www.latimes.com/news/nation-and-world/la-na-senate6-2010jan06,0,7077974.story
Friday, January 15, 2010
Articles of the Week!
Courtesy of: Amanda Zanetti, CIS Compliance Associate
amandazanetti@cis-partners.com
1) Unions Cut Special Deal on Health Taxes
http://online.wsj.com/article/SB10001424052748704281204575003040695279432.html
2) Are Doctors Ready for Virtual Visits?
http://www.nytimes.com/2010/01/07/health/07chen.html?ref=health
3) Medicaid and Children’s Health Insurance Program Provisions in Health Reform Bills: Affordable Health Care for America Act & The Patient Protection and Affordable Care Act
http://www.kff.org/healthreform/7952.cfm
4) Expanding Medicaid: The Real Costs to the States
http://www.heritage.org/Research/HealthCare/wm2757.cfm
5) Feds vs. states: Who should run health market?
http://www.msnbc.msn.com/id/34868472/ns/health-health_care/
amandazanetti@cis-partners.com
1) Unions Cut Special Deal on Health Taxes
http://online.wsj.com/article/SB10001424052748704281204575003040695279432.html
2) Are Doctors Ready for Virtual Visits?
http://www.nytimes.com/2010/01/07/health/07chen.html?ref=health
3) Medicaid and Children’s Health Insurance Program Provisions in Health Reform Bills: Affordable Health Care for America Act & The Patient Protection and Affordable Care Act
http://www.kff.org/healthreform/7952.cfm
4) Expanding Medicaid: The Real Costs to the States
http://www.heritage.org/Research/HealthCare/wm2757.cfm
5) Feds vs. states: Who should run health market?
http://www.msnbc.msn.com/id/34868472/ns/health-health_care/
Thursday, January 14, 2010
New Year, New Resolutions
By: Amy Lotman, CIS Senior Compliance Manager
amylotman@cis-partners.com
Back in March 2009, President Barack Obama said the US food safety system is a "public health hazard" and in need of an overhaul. He sent out the warning as he appointed a new head of the federal Food and Drug Administration (FDA), New York Health Commissioner Dr. Margaret Hamburg.The President said underfunding and understaffing at the FDA had left the agency only able to conduct annual inspections on a fraction of America's 150,000 food processing premises.
And it is all supposed to change under the leadership of Dr. Hamburg.
The past decade was a difficult one for the Agency. The drugs it regulates are now more sophisticated, food importers bring in products from all over the world, and Congress wants the FDA to do more. Now, with new money and new leadership, the FDA seems ready to adapt.
One of the lowest moments for the FDA in recent years came in 2008 at a hearing of a congressional committee. Democratic Representative John Dingell grilled then-FDA chief Andrew von Eschenbach about not inspecting foreign drug manufacturing plants and the failure to prevent outbreaks of food borne illnesses. The FDA inspected just one-fifth of the food manufacturing facilities in 2000 than it did in 1980.
The FDA was taken to task time and again for failing to deal promptly with problems of popular drugs like Vioxx. New challenges cropped up: bio-terrorism, complicated bio-tech drugs, increasingly sophisticated medical devices, and then food safety.
So, the new administration brought in Dr. Hamburg and the President promised to give her the tools to do her job.
FDA Commissioner Hamburg thinks she can bring the Agency back. She is optimistic that she can make the drug review process safe and quick. She is also working with Congress in the hopes of getting new authorities in some key areas, including widely supported food safety legislation that would bring in money from food processors for inspections and give the Agency the power to assess fines. The FDA has already set up offices in China and India and it has got a lot more on its plate for the next few years. It just got the power to regulate tobacco and started monitoring drug information on the Internet. The FDA is likely to be tasked with evaluating generic versions of biotech drugs, and through all of this, Hamburg has promised to make the Agency’s inner workings more transparent.
amylotman@cis-partners.com
Back in March 2009, President Barack Obama said the US food safety system is a "public health hazard" and in need of an overhaul. He sent out the warning as he appointed a new head of the federal Food and Drug Administration (FDA), New York Health Commissioner Dr. Margaret Hamburg.The President said underfunding and understaffing at the FDA had left the agency only able to conduct annual inspections on a fraction of America's 150,000 food processing premises.
And it is all supposed to change under the leadership of Dr. Hamburg.
The past decade was a difficult one for the Agency. The drugs it regulates are now more sophisticated, food importers bring in products from all over the world, and Congress wants the FDA to do more. Now, with new money and new leadership, the FDA seems ready to adapt.
One of the lowest moments for the FDA in recent years came in 2008 at a hearing of a congressional committee. Democratic Representative John Dingell grilled then-FDA chief Andrew von Eschenbach about not inspecting foreign drug manufacturing plants and the failure to prevent outbreaks of food borne illnesses. The FDA inspected just one-fifth of the food manufacturing facilities in 2000 than it did in 1980.
The FDA was taken to task time and again for failing to deal promptly with problems of popular drugs like Vioxx. New challenges cropped up: bio-terrorism, complicated bio-tech drugs, increasingly sophisticated medical devices, and then food safety.
So, the new administration brought in Dr. Hamburg and the President promised to give her the tools to do her job.
FDA Commissioner Hamburg thinks she can bring the Agency back. She is optimistic that she can make the drug review process safe and quick. She is also working with Congress in the hopes of getting new authorities in some key areas, including widely supported food safety legislation that would bring in money from food processors for inspections and give the Agency the power to assess fines. The FDA has already set up offices in China and India and it has got a lot more on its plate for the next few years. It just got the power to regulate tobacco and started monitoring drug information on the Internet. The FDA is likely to be tasked with evaluating generic versions of biotech drugs, and through all of this, Hamburg has promised to make the Agency’s inner workings more transparent.
1) http://www.whitehouse.gov/the_press_office/Weekly-Address-President-Barack-Obama-Announces-Key-FDA-Appointments-and-Tougher-F/
2) http://www.fda.gov/AboutFDA/CommissionersPage/default.htm
3)http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106274.htm
4) http://www.fda.gov/NewsEvents/Testimony/ucm115219.htm
5) http://www.fda.gov/NewsEvents/Speeches/ucm191342.htm
6) http://www.fda.gov/NewsEvents/Testimony/ucm187566.htm
7) http://medicalinnovationsummit.clevelandclinic.org/2009/10/q-with-dr-margaret-hamburg.html
Wednesday, January 13, 2010
3rd Annual CIS Full Day Advanced GP Workshop at IIR’s GP Summit!
If you follow Adam Fein’s interesting, and often amusing blog, http://www.drugchannels.net , you may have noticed mention of the upcoming Government Programs Summit, scheduled for February 8-10 in Baltimore, MD. If you are not aware of Adam’s blog, you may want to give it a visit, as Adam looks in to his crystal ball and shares his informed and thought provoking views of the industry. It is especially relevant now with so many potential changes in the air. It is critical these days to view the potential changes and impact of Healthcare Reform from both a business and compliance perspective. The role of “GP Experts” at a manufacturer will increasingly be to inform the business on the potential financial impact of legislative changes.
Also, if you are interested in more information about the upcoming Government Program Summit, please feel free to contact me. This is the 3rd year of our Advanced GP Full Day Workshop, held on Monday, February 8th (a pre-conference day). The day will feature an “Agency Roundtable” where agency representatives can have an open forum for discussion of topical issues. Last year’s session was very well received by all who participated and attended. CIS and IIR are committed to continuing to make this an integral part of the GP Summit conference, and I welcome your participation. If you have thoughts and ideas for the roundtable, please submit them to me in advance at chriscobourn@cis-partners.com!
Conference Information:
IIR's Gov't Programs and Pricing Summit
Monday, February 8th – Wednesday, February 10th
Baltimore, MD
Hyatt Regency Hotel
http://www.iirusa.com/gp/welcome.xml
Also, if you are interested in more information about the upcoming Government Program Summit, please feel free to contact me. This is the 3rd year of our Advanced GP Full Day Workshop, held on Monday, February 8th (a pre-conference day). The day will feature an “Agency Roundtable” where agency representatives can have an open forum for discussion of topical issues. Last year’s session was very well received by all who participated and attended. CIS and IIR are committed to continuing to make this an integral part of the GP Summit conference, and I welcome your participation. If you have thoughts and ideas for the roundtable, please submit them to me in advance at chriscobourn@cis-partners.com!
Conference Information:
IIR's Gov't Programs and Pricing Summit
Monday, February 8th – Wednesday, February 10th
Baltimore, MD
Hyatt Regency Hotel
http://www.iirusa.com/gp/welcome.xml
Tuesday, January 12, 2010
The Adventures of Steven Moore, Scooter Boy, Part Deux
Due to popular demand, I am passing along another installment of of my adventures in an almost, ‘paint by number’ style. I hope you enjoy!
1. You will see that my Scooter has multiple functions. This picture was taken by my wife during a key internal CIS WebEx meeting last week. You can see the structure slide that is up and, if you could see my face, you’d see the disbelief that I was not in the top box. I digress. You’ll also see that I have my snack in hand (apples, as I am watching my weight while laying motionless for umpteen days) and my Scooter has become the stand for my computer, as well as a holder for my new speaker phone. Who knew that Scooters did more than just alleviate crutches, get you around much better and make you as desirable as George Clooney or Hugh Jackman when you’re out in public? Beware: The Scooterazi.
2. Please notice that the TV is off. As tempting as it may be for some, I hate the TV. I just wanted it to be known that when I work from home, it’s all serious and all work --- all the time. Until, of course, Ellen comes on at 3PM.
3. These are my beloved Bird plates. For those of you who do not know, I am an avid and serious birdwatcher and can name any bird by sight or song east of the Mississippi River. That, in combination with my Scooter, officially makes me cooler than you.
4. This takes some ‘splainin. My Mom (Hi Mom!) got me and my wife a countdown to Xmas calendar that had 25 days. It has a little boot on a string that moved around as you got closer to Xmas. So, I developed (on the white sheet of paper to the left of the calendar) the 25 Achilles “Heal” Milestones (dig the pun?). These include things like: 1) Giving blood without passing out (long story --- thanks Lyme Disease), 2) Getting through surgery, 3) The first time going #1, 4) The first time going #2 (have I revealed too much?). Anyway, the goal is to move the boot (how fitting) around the calendar till we get to #25 --- The First Jog. Novel, I know. I’m currently on #11: “The first pain free night.” In typical ‘sales guy’ fashion, I simply can’t do anything without a goal or number to get after…
5. This is my hospital bracelet. I have kept it on for 12 days now to remind me to stay strong throughout this grueling recovery process. I am currently working with a vendor to replicate these and sell them as “SCOOTERSTRONG” bracelets with the proceeds going to me.
6. Pictures of Jamaica. Taunting me. Constantly. “Hi Scooter Boy. Remember where you were supposed to be during this week…” Die pictures. I know what you’re saying, “Scoots, why don’t you just take it down?” Because I want to feel it. I want to live it. I want to remember to never play pickup basketball again.
7. This is what my wife has coined “The Situation” (for those Jersey Shore fans out there). You see 12 pillows, a heating pad, my leg in a splint and back up sweatshirts and pillows.
8. Windows to the outdoors. Taunting me. Constantly. There are birds out there to watch!
In my next update, I look forward to telling you how I’ve tricked out my Scooter with massive amounts of bling and started a Twitter and Facebook following of fans…
For Your Space,
Steven “Scooter Boy” Moore
1. You will see that my Scooter has multiple functions. This picture was taken by my wife during a key internal CIS WebEx meeting last week. You can see the structure slide that is up and, if you could see my face, you’d see the disbelief that I was not in the top box. I digress. You’ll also see that I have my snack in hand (apples, as I am watching my weight while laying motionless for umpteen days) and my Scooter has become the stand for my computer, as well as a holder for my new speaker phone. Who knew that Scooters did more than just alleviate crutches, get you around much better and make you as desirable as George Clooney or Hugh Jackman when you’re out in public? Beware: The Scooterazi.
2. Please notice that the TV is off. As tempting as it may be for some, I hate the TV. I just wanted it to be known that when I work from home, it’s all serious and all work --- all the time. Until, of course, Ellen comes on at 3PM.
3. These are my beloved Bird plates. For those of you who do not know, I am an avid and serious birdwatcher and can name any bird by sight or song east of the Mississippi River. That, in combination with my Scooter, officially makes me cooler than you.
4. This takes some ‘splainin. My Mom (Hi Mom!) got me and my wife a countdown to Xmas calendar that had 25 days. It has a little boot on a string that moved around as you got closer to Xmas. So, I developed (on the white sheet of paper to the left of the calendar) the 25 Achilles “Heal” Milestones (dig the pun?). These include things like: 1) Giving blood without passing out (long story --- thanks Lyme Disease), 2) Getting through surgery, 3) The first time going #1, 4) The first time going #2 (have I revealed too much?). Anyway, the goal is to move the boot (how fitting) around the calendar till we get to #25 --- The First Jog. Novel, I know. I’m currently on #11: “The first pain free night.” In typical ‘sales guy’ fashion, I simply can’t do anything without a goal or number to get after…
5. This is my hospital bracelet. I have kept it on for 12 days now to remind me to stay strong throughout this grueling recovery process. I am currently working with a vendor to replicate these and sell them as “SCOOTERSTRONG” bracelets with the proceeds going to me.
6. Pictures of Jamaica. Taunting me. Constantly. “Hi Scooter Boy. Remember where you were supposed to be during this week…” Die pictures. I know what you’re saying, “Scoots, why don’t you just take it down?” Because I want to feel it. I want to live it. I want to remember to never play pickup basketball again.
7. This is what my wife has coined “The Situation” (for those Jersey Shore fans out there). You see 12 pillows, a heating pad, my leg in a splint and back up sweatshirts and pillows.
8. Windows to the outdoors. Taunting me. Constantly. There are birds out there to watch!
In my next update, I look forward to telling you how I’ve tricked out my Scooter with massive amounts of bling and started a Twitter and Facebook following of fans…
For Your Space,
Steven “Scooter Boy” Moore
Friday, January 8, 2010
Articles of the Week!
Courtesy of: Jordan Mummau, CIS Compliance Associate
jordanmummau@cis-partners.com
1) Is the FDA Too Easy On Medical Devices?
http://blogs.wsj.com/health/2009/12/30/is-the-fda-too-easy-on-medical-devices/
2) Health Cuts with Little Effect on Care
http://www.nytimes.com/2009/12/30/business/economy/30leonhardt.html
3) In Reconciling Health Bill for All, Revisiting Provisions for a Few
http://www.nytimes.com/2010/01/04/health/policy/04health.html
4) Health Care Spending Appears To Slow In 2008
http://www.npr.org/templates/story/story.php?storyId=122242722&ft=1&f=1027,1030,1066
5) Congress Proposes New Physician Payment System
http://www.npr.org/templates/story/story.php?storyId=122217323
jordanmummau@cis-partners.com
1) Is the FDA Too Easy On Medical Devices?
http://blogs.wsj.com/health/2009/12/30/is-the-fda-too-easy-on-medical-devices/
2) Health Cuts with Little Effect on Care
http://www.nytimes.com/2009/12/30/business/economy/30leonhardt.html
3) In Reconciling Health Bill for All, Revisiting Provisions for a Few
http://www.nytimes.com/2010/01/04/health/policy/04health.html
4) Health Care Spending Appears To Slow In 2008
http://www.npr.org/templates/story/story.php?storyId=122242722&ft=1&f=1027,1030,1066
5) Congress Proposes New Physician Payment System
http://www.npr.org/templates/story/story.php?storyId=122217323
Thursday, January 7, 2010
CIS Will Be Exhibiting At DIA's Contemporary Pharmacovigilance And Risk Management Strategies!
When: Monday, January 11th - Wednesday, January 13th
Where: Renaissance Hotel, Washington, D.C
For additional conference information, please click here.
Where: Renaissance Hotel, Washington, D.C
For additional conference information, please click here.
Senate Rejects Low Cost Imported Drugs
By: John Jordan, CIS Senior Compliance Associate
johnjordan@cis-partners.com
Senator Byron Dorgan, D – North Dakota, proposed an amendment that would allow Americans to import low-cost prescriptions from other countries. This bill was co-sponsored by a number of senators including John McCain, R – Arizona (3). “Senator Dorgan’s plan would have allowed American pharmacies and drug wholesalers to import federally approved drugs from Canada, Europe, Australia, New Zealand and Japan -- placing them within reach of average consumers (2).” Many countries have price controls that allow lower prices than what are normally seen in the United States (2).
Many Democrats were afraid that this amendment would interfere with the agreement that was made with pharmaceutical companies and the government towards the health care bill. Over the summer the pharmaceutical industry agreed to provide $80 billion in savings towards Americans and the United States government. According to Robert Pear’s article, “The industry, represented by the Pharmaceutical Research and Manufacturers of America, or PhRMA, adamantly opposes legalizing additional imports and says the government could not guarantee the safety of imported medicines (1).”
According to Pear’s article, “the Congressional Budget Office has estimated that the federal government would save over $19.4 billion dollars over the next 10 years (1)” if the amendment had passed. In addition, Senator Dorgan felt that the amendment could have saved the American consumer four times that amount. The vote for the amendment came to 51-48 in favor for it. However, 60 votes were required, under a special rule, in order for it to be passed. President Obama originally was in favor of the amendment while running for the presidency. However, many feel that this could interfere with the US Health Care Bill, which is one of the president’s top priorities (2).
Sources:
(1) http://www.nytimes.com/2009/12/11/health/policy/11health.html
(2) http://www.drugs.com/news/senate-rejects-plan-import-low-cost-drugs-21524.html
(3) http://www.law360.com/articles/138440
johnjordan@cis-partners.com
Senator Byron Dorgan, D – North Dakota, proposed an amendment that would allow Americans to import low-cost prescriptions from other countries. This bill was co-sponsored by a number of senators including John McCain, R – Arizona (3). “Senator Dorgan’s plan would have allowed American pharmacies and drug wholesalers to import federally approved drugs from Canada, Europe, Australia, New Zealand and Japan -- placing them within reach of average consumers (2).” Many countries have price controls that allow lower prices than what are normally seen in the United States (2).
Many Democrats were afraid that this amendment would interfere with the agreement that was made with pharmaceutical companies and the government towards the health care bill. Over the summer the pharmaceutical industry agreed to provide $80 billion in savings towards Americans and the United States government. According to Robert Pear’s article, “The industry, represented by the Pharmaceutical Research and Manufacturers of America, or PhRMA, adamantly opposes legalizing additional imports and says the government could not guarantee the safety of imported medicines (1).”
According to Pear’s article, “the Congressional Budget Office has estimated that the federal government would save over $19.4 billion dollars over the next 10 years (1)” if the amendment had passed. In addition, Senator Dorgan felt that the amendment could have saved the American consumer four times that amount. The vote for the amendment came to 51-48 in favor for it. However, 60 votes were required, under a special rule, in order for it to be passed. President Obama originally was in favor of the amendment while running for the presidency. However, many feel that this could interfere with the US Health Care Bill, which is one of the president’s top priorities (2).
Sources:
(1) http://www.nytimes.com/2009/12/11/health/policy/11health.html
(2) http://www.drugs.com/news/senate-rejects-plan-import-low-cost-drugs-21524.html
(3) http://www.law360.com/articles/138440
Wednesday, January 6, 2010
Send Your Ideas – CIS’ ‘Agency Town Hall Forum’, Full Day Workshop
IIR’s Government Programs Summit
Monday, February 8th
Baltimore, MD
Hyatt Regency Hotel
Monday, February 8th
Baltimore, MD
Hyatt Regency Hotel
By: Chris Cobourn, VP, Regulatory Affairs
chriscobourn@cis-partners.com
This will be our 3rd Annual Advanced GP session, with a full day agenda geared towards the experienced GP professional (Monday, February 8th is a pre-conference day, running concurrently to MDRP 101). Our format is an “Agency Town Hall Forum,” where we have the opportunity to discuss topical issues with the agencies across the Medicaid, Medicare, VA and PHS programs. We received great feedback on last year’s conference from the industry participants, as well as the agency representatives, who all enjoyed the opportunity for open dialog.
At CIS, we work closely with the industry on a variety of GP-related topics, as well as discuss issues directly with the agencies. Prior to last year’s conference we provided many of the topics and issues we have worked with throughout the year in order to facilitate a good discussion, and also to inform the audience of certain topics that could not be discussed at that time. As I said, the result was a very open and comprehensive dialogue from all sides.
I invite you to participate this year and encourage you to email me any topic ideas in advance. The source of the topic will be confidential, so no company names will be provided. Please email me at chriscobourn@cis-partners.com.
We look forward to seeing you in Baltimore in February!
For additional conference information, please visit the website:
http://www.iirusa.com/gp/welcome.xml
Tuesday, January 5, 2010
The Adventures of Steven Moore, "Scooter Boy"
By: Steven Moore, CIS Director of Business Development
I thought it would be great to kick off the New Year with a serious article.
So my wife and I had grand plans for a house-hopping, crazy holiday --- visiting family and friends and then celebrating New Year’s Eve and heading to Jamaica on January 1st for an eight day trip (mostly because NOBODY wants to hear from the ‘Sales guy’ the first week back from the holidays).
As the commercial says, life comes at you fast…
On December 15th, with the score tied at 7 in a heated pick-up basketball game to 8, I dove for a loose ball and heard and felt a very loud “POP” in the back of my leg. I went to get up, only to fall down, to try and slug the jerk that kicked me in the back of the leg but, alas, nobody was even within 10 feet of me. Houston, we have a problem. I was no longer 30 going on 18… I was 30 going on 50...
I limped off the court and got in my car and visions of Jamaica and ‘froo froo’ drinks began to sputter. My mind raced and I called my wife:
Wifey: “Hello.”
Me: “Um. Yeah. I got hurt. Bad.”
These are the calls in life you hate to make and the worries that you don’t have because you can’t predict them. I got home and said, “I think I pulled a muscle --- maybe my calf muscle.” I iced the back of my leg and was in excruciating pain --- but still waited two days and a CIS holiday party to go to the doctor’s office. After a Google search and a “Thompson Test” (which is when you squeeze your calf muscle while lying face down --- and notice that your foot doesn’t move --- try it, it’s creepy), followed by an X-ray, MRI and visit, the dreaded but expected prognosis was given by the orthopedic surgeon:
“You have fully ruptured your Achilles tendon. It will heal over time (6
months) on its own, but re-rupture is far more likely if you go that
route. Most people who are active and healthy choose surgery. You
will not be able to put any weight on it for 6 weeks post surgery and likely
won’t walk normally for 3 or 4 months.”
My holiday Cheerios were officially peed in.
Surgery is a scary thing and I don’t have too much pride (heck, that was out the window a long, long time ago) to admit that I was nervous and, well, scared. I didn’t know what to expect or what I was supposed to be afraid of. I chose not to have surgery until 12/28 so that we could still have a semi-normal Christmas celebration and it wouldn’t effect seeing both sides of our families. It was a good move, but at any moment my mind was idle, the devil was at play in his workshop.
So I was called back into the surgery and then came the IV, then waiting and then sedatives (I think I recall saying, “Wow, now I know why the Beatles were such good song writers,” to my nurse anesthetist). The last thing I remember is hearing my surgeon say, “This may sting a little.” After that, I woke up and it was all done. I think I was given Propofol, or “Milk of Amnesia”, and I can honestly say it was the wildest experiences to wake up two hours later with ZERO recollection of what occurred. That hasn’t happened since college… Kidding, of course. You guys know I don’t drink. That often.
So here’s where the ‘Scooter’ part comes in and what is relevant to the Pharma Compliance Blog. Our industry is sweet and more people need to know about the advances that are happening. First and foremost, somebody sliced open my calf and tied my tendon together without me feeling a thing, and then I awoke to some strong pain but was given medicine to deal with it (I actually only used painkillers for about 48 hours) as well as the appropriate antibiotics to guard against wound infection and, here’s the kicker: I researched my injury and decided to rent a knee walker (which we’ll affectionately call “Scooter”) to replace crutches and it’s been a revelation for me.
I can buzz around the house, use the bathroom, take a shower with my leg hanging out and do cool ‘k’ turns with my Scooter without my leg ever touching the ground or being straight up and down as it would be on crutches (and trust me, when the blood flows to the wound, I can feel it!). My uncles and cousins made fun of me and called me ‘Scooter Boy’ during Christmas, but I didn’t care since I’ve read and heard (thanks CIS’ Amy VanDeCar) that those who use the Scooter cut their healing time down and walk sooner. Give me two extra weeks of walking and I’ll take all the derision that comes my way.
In fact, when I’m up to it, I plan to take my Scooter to the mall and do ‘laps’ as exercise and cardio while the High School kids make fun of me. Heck, I might even put one of those ‘bicycle bells’ on it and wear a helmet with cool decals. And when I physically return to work in the next week or so, I’ll buzz around the office in my Scooter and will likely be made fun of as well --- but it’s all good! The truth is, when it comes to medicine and healing, we should all take our pride out of the equation and do what’s best for the recovery process. Those suffering with crutches --- and the accompanying worn out armpits and palms --- need only 5 minutes with my Scooter and I can sell them.
I’m 8 days post-surgery and am feeling great. Sure, I was SUPPOSED to be in Jamaica right now doing the reggae walk and saying ‘yeah mon’ to every offer from the resort staff (well, almost every offer) --- but life doesn’t work that way. I’ve already learned a lot through this and plan to hold onto it. My New Year’s resolution is to not take so many things for granted, like getting dressed, going to the bathroom, showering, getting a drink, making coffee and, oh yeah, walking and exercise. My wife and caretaker has been a savior and we’re very lucky she is a college professor and home these days!
Finally, I send out a big ‘cheers’ to our industry for novel medicines and devices that will help me heal faster than the ancient Greek hero warrior Achilles could himself. I’m convinced that even this great warrior wouldn’t have minded the Romans making fun of him...
Achilles, “Scooter Boy”.
"Gotta dig the holiday beard..."
For Your Space and here’s to a Fantastic 2010!
Steven “Scooter Boy” Moore
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