By: Sabrina Skari, CIS Business Development Manager
sabrinaskari@cis-partners.com
As one of the most recent additions to the CIS team, my perspective on the healthcare industry is different from many of my new peers. I spent the last three years as a Sales Representative calling on family practitioners and internists, and attempting to use my artillery of clinical studies and efficacy measures to sway their prescribing habits. During this time my knowledge of Government Programs was based on the paradigm governing prescribers; I understood these programs as a valuable means to disseminate medicine – often the only means for certain patients to acquire treatment for their ailments.
As I have transitioned into my role as a Business Development Manager at CIS, the paradigm has changed. I can see now that although patients are the ones who directly benefit from the healthcare industry’s breakthroughs, it is the federal and state governments who are often the “customer” that manufacturers must aim to please. This breakthrough, which has been a steady progression over the last month, culminated with my attendance at IIR’s Medicaid Drug Rebate Program Conference in Chicago last week. The conference was overwhelming to say the least. Just a quick peek at the schedule for the three day summit was like taking a peek at a map of a foreign country; a country with an unfamiliar landscape and where the inhabitants spoke another language; however, as time passed I made significant progress.
First, and this was key, I realized that I was not the only person there who wasn’t fluent in “GP.” The session speakers, moderators and chairs exhibited an extreme knowledge and passion for their respective topics, but many spent time sitting in on the other discussions. Furthermore, I learned that many of the manufacturer representatives were sent as ambassadors and not necessarily experts; in fact, many people had backgrounds similar to mine. These attendees came from other functional areas, and as the need for compliance expertise evolved with changes in the healthcare system, their careers evolved as well.
I spent three days absorbed in sessions. During “Best Practices and Considerations to Complement your GP Solution” led by CIS’ own Chris Cobourn and Chrissy Spicer, I learned that the phrase “best practices” is actually passé (use “industry standard” instead). I also learned that the key to maintaining a compliant systems environment is to make like a Boy Scout and “always be prepared” for an internal or external audit. During “Evaluating the Current GP Environment,” led by CIS gurus Chris Cobourn and Katie Lapins, it was made apparent that while not all GP complexities are created equal; they do apply to manufacturers of all shapes and sizes.
It was the speech made by Senator Tom Daschle, “Solving the Healthcare Crisis from the Architect of Obama’s Healthcare Reform,” that helped to bridge my past life in sales with my new responsibilities in GP compliance. Senator Daschle provided perspective when he spoke of transformative moments in history, including the Civil Rights Movement of the 1960’s and the events of September 11th. Regardless of their causes, these events shaped our current perspective of our country, and the healthcare evolution will probably do the same.
It doesn’t matter what side of the fence you’re on in the healthcare industry, politically OR functionally. The fact of the matter is that the healthcare industry accounted for 16.5% of the US Gross Domestic Product in 2008, and is trending to reach 20% by 2016. This is a higher percentage of health care spending than in any other industrialized nation and, as a direct result, the US government is heavily involved in our industry [1]. As government programs aim to improve the welfare of citizens, and manufacturers aim to improve the science of welfare, everyone will be intrinsically connected and GP compliance will provide a basis for fair play.
The difference is that I am now aware that regardless of your position in the industry, the end goal is always the same- to improve health care in our country. I will look back on my attendance at my first IIR MDRP conference as a transformative moment in my GP career. As Senator Daschle commented, “everything is impossible until it is done;” so while it might seem farfetched now that this sales person will ever present at a GP conference, I encourage you to look for me in the coming years.
Source:
[1] http://www.plunkettresearch.com/Industries/HealthCare/HealthCareTrends/tabid/294/Default.aspx
Tuesday, September 29, 2009
Thursday, September 24, 2009
My IIR MDRP 2009 Recap: “30 is the new 74…”
By: Steven Moore, CIS Director of Business Development
stevenmoore@cis-partners.com
Sunday, 1:46PM: Headed to the airport with my wife driving and realizing that leaving on a Sunday during football time on a 75 degree sunny day is the equivalent of a root canal with no Novocain.
Sunday, 2:09PM: Go through security; get virtually naked, some ladies scream, blah, blah, blah. This travel thing does get old sometimes…
Sunday, 2:13PM: I spot Clarissa Crain and realize that my feelings about leaving on a Sunday are bettered by her feelings. The look on her face made me certain that only allowing butter knives on the other side of security is, in fact, a good thing for more than just the obvious reasons.
Sunday, 3:20PM: “Because I’m leavin’ on a jet plane…”
Sunday, 4:17PM: Arrive in Chicago and text and call my wife, check all the football scores and my fantasy team (which stinks), prove the Pythagorean Theorem and look up some good restaurants in Chicago --- all before we get to the gate. Say what you will, technology is amazing.
Sunday, 4:46PM: Pass Soldier Field and can see that it’s packed for the Bears – Steelers game. I realize that my aforementioned root canal continues as it is one heck of a game shaping up. I’m in Chicago --- so Go Bears! Oh wait, my boss is a Steelers fan.
Go Bears!
Sunday, 5:21PM: Unpack as fast as I’ve ever unpacked and sprint to the bar to watch the end of a great football game (of course after reviewing my emails and studying the new HR 3200 bill). The GP Homecoming begins and I enjoy some football with some good friends. The drill is out of the dentist’s hands…
Sunday, 10:00PM: After dinner diet sodas with some clients...
Sunday, 11:20PM: Some clients/competitors go out and I decide that 30 is the new 74 and call it an early night. I am subsequently mocked --- and then receive multiple text messages that question my manhood. I would much prefer to watch the end of the Giants – Cowboys game with GP Practice Lead Chris Cobourn in our room.
I applaud CIS for room sharing, but I’m not sure about the lone King Bed.
Monday, 1:00PM: (Yes, nothing really happened before that). Booth set up. Insert {expletive} here.
Monday, 6:00PM: Dinner with a big group. I proceed to explain the ‘waves’ to our table and realize that, at age 30 and after last night’s performance, that I might be slowly be becoming a 2nd waiver (this doesn’t last --- trust me).
Monday, 7:54PM: I finish my steak and then help finish one of my favorite client’s and my ‘twin’s’ steak. “CIS: we’ll even eat your leftovers.”
Monday, 9:34PM: Watching my favorite team, the Miami Dolphins, play the Indianapolis Colts on Monday Night Football --- with friends from Indianapolis.
Monday, 11:11PM (make a wish): One of my friends from Indianapolis quietly leaves the table, returns with a Peyton Manning jersey and the Dolphins proceed to blow the game.
Monday 11:12PM: I cry for the first time since watching “Ghost.” (Shout out to Patrick Swayze.) Hootie’s line, “I’m such a baby, yeah, the Dolphin’s make me cry” encapsulates me. Okay, for the record, I just really wanted to show up and use the word ‘encapsulate’ in a sentence. For those of you who don’t know who Hootie is or what I’m talking about, you haven’t lived.
Tuesday, 8:15AM: Tom Daschle, keynote speaker for the conference is on. I have a client call.
Tuesday, 9:30AM: Alice Valder Curran from Hogan & Hartson speaks. I have a client call.
For those of you outside the industry and our space, let me make a comparison of what just happened to me in a couple of ways:
Missing Tom & Alice speak is like missing Phil Mickelson and Tiger Woods tee off in succession.
…or missing Mickey and Minnie at Disney World.
Tuesday, 10:15AM (Networking Break): “Hi, are you familiar with CIS and our services.” “Hi, are you familiar with CIS and our services.” “Hi, are you familiar with CIS and our services.” “Hi, are you familiar with CIS and our services.” “Hi, are you familiar with CIS and our services.” “Hi, are you familiar with CIS and our services.” “Hi, are you familiar with CIS and our services.” “Hi, are you familiar with CIS and our services.”
Tuesday, 12:15PM: Lunch and it’s not ‘Conference Chicken’. For those of you unfamiliar with ‘Conference Chicken’, consider yourselves lucky. It’s not chicken, it’s flavored polyethylene.
Tuesday, 5:00PM: The Cocktail Hour begins. It might just be me, but it seems the wine is really flowing for a couple of folks…
Tuesday, 6:30PM: Dinner at Volare --- and it’s dang good! By the end, our table is playing ‘stack the wine corks’ and Chris Cobourn breaks the record with a total of 5 stacked one upon the other. I know what you’re thinking and you’re wrong. Much like the waiting room of a Pediatrician’s office, Chris asked for something to play with as we waited in between appetizers, dinner, desserts, etc. and they supplied us with 6 or so wine corks.
If you believe this, I have some air to sell you…
Tuesday, 8:45PM – 1:30AM: Drinks at the hotel bar followed by the 3rd waivers conspiring to go out. I gladly oblige and head to the rest room as I am told, “We’ll wait for you by the cab.” I return to the lobby and nobody I was leaving with is inside or outside, so I take the cab out to the agreed upon destination. I get to said destination and nobody I know is there. I finally reach CIS’ Chrissy Spicer via phone and nobody ever left the hotel. Sweet.
Tuesday, 12:21AM: During my cab ride, I learn that my driver is from Afghanistan and can’t stop talking about how much he loves America even though he lost 4 family members in a bombing prior to coming here. Let’s take a moment and think about our brave troops and what they’re doing and trying to preserve --- and, no matter how you slice it, how awesome our country and freedom truly are.
(Seriousness ‘off’)
Wednesday, 12:40PM: Clarissa Crain, Chrissy Spicer and I survive the most amazing cab ride to Midway as the cab driver drove over the curb TWICE to get us there and during the second time screamed, “Yeah Baby” while honking his horn. Upon arrival at the terminal he seriously (God as my witness) almost took out a TSA agent…and continued laughing as if we were on Space Mountain in Disney World. I turn to Clarissa and Chrissy and say, “Do you think that my wife will believe the reason I look so tired and worn out was actually the cab ride and not nights out dancing and drinking diet soda?”
Wednesday, 12:41PM: I clean out my shorts.
Wednesday, 1:01PM: I get two gigantic slices of Chicago style pizza to fulfill this aching need to eat grease. I’m only able to finish 1 and a half and realize that it might not have been the smartest move with 2 and half our plane ride ahead.
Wednesday, 2:15PM: Our Southwest Flight Attendant says, during his pre-takeoff gig (paraphrased):
Smoking is not allowed on the plane at any time, but should you choose to do so, I can guarantee the following three things:
1. I will be forced to use the “F” word, as in “Felony”.
2. The FBI will come on the plane and drag you out while we all point and laugh.
3. You will be sent to prison in an orange jumpsuit and put in a cell with a man named Bubba who will definitely think you’re pretty.
Wednesday, 2:17PM: Southwest gets a second nod here as the Flight Attendant says: “Please start by affixing your mask first followed by the child whom you believe has the best chance of putting you in a good retirement home. I know someone who didn’t pick the right child once and they ended up in Jersey.”
Wednesday, 2:17PM: And a 3rd nod as he comes on and says, “We’re currently in a holding pattern for about 20 minutes or so, which shouldn’t be too bad considering once we land in Philadelphia, it should take about 6-8 days to taxi to the gate.” Not sure which reputation is worse: Philadelphia’s Eagle fans or her Airport?
Wednesday, 5:43PM: I see my wife and all in my world is right.
To all my friends new and old, thank you for another great conference!
For Your Space,
Steven
stevenmoore@cis-partners.com
Sunday, 1:46PM: Headed to the airport with my wife driving and realizing that leaving on a Sunday during football time on a 75 degree sunny day is the equivalent of a root canal with no Novocain.
Sunday, 2:09PM: Go through security; get virtually naked, some ladies scream, blah, blah, blah. This travel thing does get old sometimes…
Sunday, 2:13PM: I spot Clarissa Crain and realize that my feelings about leaving on a Sunday are bettered by her feelings. The look on her face made me certain that only allowing butter knives on the other side of security is, in fact, a good thing for more than just the obvious reasons.
Sunday, 3:20PM: “Because I’m leavin’ on a jet plane…”
Sunday, 4:17PM: Arrive in Chicago and text and call my wife, check all the football scores and my fantasy team (which stinks), prove the Pythagorean Theorem and look up some good restaurants in Chicago --- all before we get to the gate. Say what you will, technology is amazing.
Sunday, 4:46PM: Pass Soldier Field and can see that it’s packed for the Bears – Steelers game. I realize that my aforementioned root canal continues as it is one heck of a game shaping up. I’m in Chicago --- so Go Bears! Oh wait, my boss is a Steelers fan.
Go Bears!
Sunday, 5:21PM: Unpack as fast as I’ve ever unpacked and sprint to the bar to watch the end of a great football game (of course after reviewing my emails and studying the new HR 3200 bill). The GP Homecoming begins and I enjoy some football with some good friends. The drill is out of the dentist’s hands…
Sunday, 10:00PM: After dinner diet sodas with some clients...
Sunday, 11:20PM: Some clients/competitors go out and I decide that 30 is the new 74 and call it an early night. I am subsequently mocked --- and then receive multiple text messages that question my manhood. I would much prefer to watch the end of the Giants – Cowboys game with GP Practice Lead Chris Cobourn in our room.
I applaud CIS for room sharing, but I’m not sure about the lone King Bed.
Monday, 1:00PM: (Yes, nothing really happened before that). Booth set up. Insert {expletive} here.
Monday, 6:00PM: Dinner with a big group. I proceed to explain the ‘waves’ to our table and realize that, at age 30 and after last night’s performance, that I might be slowly be becoming a 2nd waiver (this doesn’t last --- trust me).
Monday, 7:54PM: I finish my steak and then help finish one of my favorite client’s and my ‘twin’s’ steak. “CIS: we’ll even eat your leftovers.”
Monday, 9:34PM: Watching my favorite team, the Miami Dolphins, play the Indianapolis Colts on Monday Night Football --- with friends from Indianapolis.
Monday, 11:11PM (make a wish): One of my friends from Indianapolis quietly leaves the table, returns with a Peyton Manning jersey and the Dolphins proceed to blow the game.
Monday 11:12PM: I cry for the first time since watching “Ghost.” (Shout out to Patrick Swayze.) Hootie’s line, “I’m such a baby, yeah, the Dolphin’s make me cry” encapsulates me. Okay, for the record, I just really wanted to show up and use the word ‘encapsulate’ in a sentence. For those of you who don’t know who Hootie is or what I’m talking about, you haven’t lived.
Tuesday, 8:15AM: Tom Daschle, keynote speaker for the conference is on. I have a client call.
Tuesday, 9:30AM: Alice Valder Curran from Hogan & Hartson speaks. I have a client call.
For those of you outside the industry and our space, let me make a comparison of what just happened to me in a couple of ways:
Missing Tom & Alice speak is like missing Phil Mickelson and Tiger Woods tee off in succession.
…or missing Mickey and Minnie at Disney World.
Tuesday, 10:15AM (Networking Break): “Hi, are you familiar with CIS and our services.” “Hi, are you familiar with CIS and our services.” “Hi, are you familiar with CIS and our services.” “Hi, are you familiar with CIS and our services.” “Hi, are you familiar with CIS and our services.” “Hi, are you familiar with CIS and our services.” “Hi, are you familiar with CIS and our services.” “Hi, are you familiar with CIS and our services.”
Tuesday, 12:15PM: Lunch and it’s not ‘Conference Chicken’. For those of you unfamiliar with ‘Conference Chicken’, consider yourselves lucky. It’s not chicken, it’s flavored polyethylene.
Tuesday, 5:00PM: The Cocktail Hour begins. It might just be me, but it seems the wine is really flowing for a couple of folks…
Tuesday, 6:30PM: Dinner at Volare --- and it’s dang good! By the end, our table is playing ‘stack the wine corks’ and Chris Cobourn breaks the record with a total of 5 stacked one upon the other. I know what you’re thinking and you’re wrong. Much like the waiting room of a Pediatrician’s office, Chris asked for something to play with as we waited in between appetizers, dinner, desserts, etc. and they supplied us with 6 or so wine corks.
If you believe this, I have some air to sell you…
Tuesday, 8:45PM – 1:30AM: Drinks at the hotel bar followed by the 3rd waivers conspiring to go out. I gladly oblige and head to the rest room as I am told, “We’ll wait for you by the cab.” I return to the lobby and nobody I was leaving with is inside or outside, so I take the cab out to the agreed upon destination. I get to said destination and nobody I know is there. I finally reach CIS’ Chrissy Spicer via phone and nobody ever left the hotel. Sweet.
Tuesday, 12:21AM: During my cab ride, I learn that my driver is from Afghanistan and can’t stop talking about how much he loves America even though he lost 4 family members in a bombing prior to coming here. Let’s take a moment and think about our brave troops and what they’re doing and trying to preserve --- and, no matter how you slice it, how awesome our country and freedom truly are.
(Seriousness ‘off’)
Wednesday, 12:40PM: Clarissa Crain, Chrissy Spicer and I survive the most amazing cab ride to Midway as the cab driver drove over the curb TWICE to get us there and during the second time screamed, “Yeah Baby” while honking his horn. Upon arrival at the terminal he seriously (God as my witness) almost took out a TSA agent…and continued laughing as if we were on Space Mountain in Disney World. I turn to Clarissa and Chrissy and say, “Do you think that my wife will believe the reason I look so tired and worn out was actually the cab ride and not nights out dancing and drinking diet soda?”
Wednesday, 12:41PM: I clean out my shorts.
Wednesday, 1:01PM: I get two gigantic slices of Chicago style pizza to fulfill this aching need to eat grease. I’m only able to finish 1 and a half and realize that it might not have been the smartest move with 2 and half our plane ride ahead.
Wednesday, 2:15PM: Our Southwest Flight Attendant says, during his pre-takeoff gig (paraphrased):
Smoking is not allowed on the plane at any time, but should you choose to do so, I can guarantee the following three things:
1. I will be forced to use the “F” word, as in “Felony”.
2. The FBI will come on the plane and drag you out while we all point and laugh.
3. You will be sent to prison in an orange jumpsuit and put in a cell with a man named Bubba who will definitely think you’re pretty.
Wednesday, 2:17PM: Southwest gets a second nod here as the Flight Attendant says: “Please start by affixing your mask first followed by the child whom you believe has the best chance of putting you in a good retirement home. I know someone who didn’t pick the right child once and they ended up in Jersey.”
Wednesday, 2:17PM: And a 3rd nod as he comes on and says, “We’re currently in a holding pattern for about 20 minutes or so, which shouldn’t be too bad considering once we land in Philadelphia, it should take about 6-8 days to taxi to the gate.” Not sure which reputation is worse: Philadelphia’s Eagle fans or her Airport?
Wednesday, 5:43PM: I see my wife and all in my world is right.
To all my friends new and old, thank you for another great conference!
For Your Space,
Steven
Wednesday, September 23, 2009
Public Hearing on Promotion via the Internet
Christian Didizian, CIS Compliance Manager
chrisdidizian@cis-partners.com
Back on June 4th I posted a blog article entitled New Draft Guidance on Presentation of Risk Information, highlighting the FDA draft guidance Presenting Risk Information in Prescription Drug and Medical Device Promotion. To summarize that entry, I acknowledge that while the guidance was long overdue, it neglected to address issues surrounding promotion through the internet. On September 21st, the FDA announced that these issues would be discussed in a public hearing regarding the promotion of regulated products through the Internet and other methods of DTC advertising/promotion. The hearing will be held on November 12th and 13th from 8 AM to 5 PM. Registration for this hearing is due by October 9, 2009.
This meeting will aid the FDA in forming policy on promoting these products to ensure that all concerns and issues are addressed. The Agency is particularly interested in how “Web 2.0” can be used to promote products in a truthful, non-misleading, and balanced manner to both consumers and health care professionals (Federal Register 74:181). Web 2.0 includes new web development and design that facilitates interactive information sharing. Additionally, the FDA is particularly interested in “emerging technologies such as blogs, microblogs, podcasts, social networks and online communities, video sharing, widgets, and wikis” (Federal Register 74:181). I encourage anyone interested in this hearing to read the full announcement by clicking here.
chrisdidizian@cis-partners.com
Back on June 4th I posted a blog article entitled New Draft Guidance on Presentation of Risk Information, highlighting the FDA draft guidance Presenting Risk Information in Prescription Drug and Medical Device Promotion. To summarize that entry, I acknowledge that while the guidance was long overdue, it neglected to address issues surrounding promotion through the internet. On September 21st, the FDA announced that these issues would be discussed in a public hearing regarding the promotion of regulated products through the Internet and other methods of DTC advertising/promotion. The hearing will be held on November 12th and 13th from 8 AM to 5 PM. Registration for this hearing is due by October 9, 2009.
This meeting will aid the FDA in forming policy on promoting these products to ensure that all concerns and issues are addressed. The Agency is particularly interested in how “Web 2.0” can be used to promote products in a truthful, non-misleading, and balanced manner to both consumers and health care professionals (Federal Register 74:181). Web 2.0 includes new web development and design that facilitates interactive information sharing. Additionally, the FDA is particularly interested in “emerging technologies such as blogs, microblogs, podcasts, social networks and online communities, video sharing, widgets, and wikis” (Federal Register 74:181). I encourage anyone interested in this hearing to read the full announcement by clicking here.
Tuesday, September 22, 2009
The Risks of Showering
By: Suma Kallurkar, CIS Senior Compliance Manager
sumakallurkar@cis-partners.com
Heavy concerns about swine flu this season have led to increased germophobia world-wide. I have never been a germophobe myself, but I undoubtedly have greater concerns now that I am a new mom with an infant in daycare. As if the current fears around the spread of swine flu were not enough, we heard news earlier this week that our showerheads and shower-sprayed water contain significant amounts of bacteria. This news, of course, is disconcerting for anyone. After all, we take showers daily for the purpose of cleansing ourselves, and it is so ironic that quite the opposite could be occurring.
It is really difficult for many to not stress out about the fact that millions of bacteria are hitting your body and face as you shower, and being inhaled into your lungs. But how much of a threat are these shower germs? Scientists at the University of Colorado who conducted this specific study of showerhead microbes found that a variety of complex microbes exist in showerheads that are potentially pathogenic (i.e. can lead to disease). However, the scientists concluded that the actual health risks posed by these organisms requires further investigation, especially in individuals whose immune function is compromised.
So it appears that there is no need to stress too much about the bacteria in our showers. For those who are more concerned, you may be able to minimize the bacteria that come in contact with you by running the shower for 30 seconds prior to getting in, as the amount of bacteria appears to be highest when the shower is first turned on. Additionally, metal showerheads appear to house fewer bacteria than plastic showerheads.
We also need to remind ourselves that millions of microorganisms exist on practically all surfaces and environments that we come in contact with on a daily basis. Obviously, a majority of these germs are harmless, otherwise we would constantly be sick. Swine flu is a legitimate major concern that we do need to pay attention to and take action to prevent the spread of the virus. However, when it comes to showerhead germs, people should relax and continue enjoying their daily showers!
Sources:
http://www.pnas.org/content/early/2009/09/11/0908446106.abstract
http://blogs.forbes.com/sciencebizblog/2009/09/dont-be-afraid-of-the-germs-in-your-shower/
http://www.nytimes.com/2009/09/15/health/15shower.html?_r=2
sumakallurkar@cis-partners.com
Heavy concerns about swine flu this season have led to increased germophobia world-wide. I have never been a germophobe myself, but I undoubtedly have greater concerns now that I am a new mom with an infant in daycare. As if the current fears around the spread of swine flu were not enough, we heard news earlier this week that our showerheads and shower-sprayed water contain significant amounts of bacteria. This news, of course, is disconcerting for anyone. After all, we take showers daily for the purpose of cleansing ourselves, and it is so ironic that quite the opposite could be occurring.
It is really difficult for many to not stress out about the fact that millions of bacteria are hitting your body and face as you shower, and being inhaled into your lungs. But how much of a threat are these shower germs? Scientists at the University of Colorado who conducted this specific study of showerhead microbes found that a variety of complex microbes exist in showerheads that are potentially pathogenic (i.e. can lead to disease). However, the scientists concluded that the actual health risks posed by these organisms requires further investigation, especially in individuals whose immune function is compromised.
So it appears that there is no need to stress too much about the bacteria in our showers. For those who are more concerned, you may be able to minimize the bacteria that come in contact with you by running the shower for 30 seconds prior to getting in, as the amount of bacteria appears to be highest when the shower is first turned on. Additionally, metal showerheads appear to house fewer bacteria than plastic showerheads.
We also need to remind ourselves that millions of microorganisms exist on practically all surfaces and environments that we come in contact with on a daily basis. Obviously, a majority of these germs are harmless, otherwise we would constantly be sick. Swine flu is a legitimate major concern that we do need to pay attention to and take action to prevent the spread of the virus. However, when it comes to showerhead germs, people should relax and continue enjoying their daily showers!
Sources:
http://www.pnas.org/content/early/2009/09/11/0908446106.abstract
http://blogs.forbes.com/sciencebizblog/2009/09/dont-be-afraid-of-the-germs-in-your-shower/
http://www.nytimes.com/2009/09/15/health/15shower.html?_r=2
Thursday, September 17, 2009
IIR's Medicaid Drug Rebate Program Conference
Dear Colleagues and Friends,
CIS will be exhibiting and presenting at IIR’s Medicaid Drug Rebate Program Conference next week, from September 21st – 23rd in Chicago, IL.
CIS’ subject matter experts will be presenting on the following topics:
Best Practices and Considerations to Complement Your GP Solution
Chris Cobourn, VP, Regulatory Compliance
Chrissy Spicer, CIS Senior Compliance Manager
Topics Include:
• Discussing the fundamental elements of establishing a compliant foundation
• Identifying key stakeholders, roles and responsibilities
• Understanding the operational challenges related to source systems and data
• Best practices for aligning your supporting documentation to your GP Solution
• Developing a holistic approach to support the integrity and accuracy of your GP calculations
• Prevailing practices for a sustainable GP Solution
Evaluating the Current GP Environment
Chris Cobourn, VP, Regulatory Compliance
Katie Lapins, CIS Director, Small and Mid-Market Manufacturers
Panelists:
Catrina Hirschauer, Xanodyne Pharmaceuticals
Todd LeDuc, Solvay Pharmaceuticals
Randy Colvin, Allos Therapeutics
All manufacturers, large and small, face similar requirements and challenges in performing their GP Calculations:
• Staying current on regulations, statutes, and guidance
• Ensuring your systems and tools to reflect current methodology
• Ensuring the accuracy of statutory pricing calculations, and having confidence in your certifications
• Making sure that systems and procedures are auditable and meet the requirements of the 10-Year rule
Manufacturers have various options in today’s environment, including performing calculations internally using spreadsheets and databases, outsourcing them to a third party, or implementing a commercial GP system. In this session, we discuss basic requirements of GP systems and tools, and considerations for companies that may be evaluating their options, or want to know how to evaluate the accuracy and overall compliance of their current toolsets. The presentation will include industry case-studies on various approaches to system evaluation.
Track A: Medicaid Payment Process Improvement – Avoid Pitfalls and Duplicate Discounts
Bill Baxter, CIS Strategic Advisor, Government Affairs (Moderator)
Learn to identify and handle these major pitfalls:
• Medicaid as secondary insurance
• Unit of Measure
• Generic substitution
• Incorrect NDC reporting
• Units vs. reimbursed $
• Double dipping
• Adjustments to prior quarter(s)
Hear the fundamentals of Medicaid payment processing and learn to overcome common challenges facing manufacturers today.
Track A: Vigilant Auditing and Monitoring Practices and Procedures
Clarissa Crain (Moderator), CIS Compliance Director
Panelists:
Lisa Kiniklis, Biogen IDEC
Brian McCartney, Ortho-McNeil Janssen
Lorraine Moccio, Johnson & Johnson Health Care Systems
Improve your current procedures to ensure complete auditing & monitoring of your operational areas. Overcome the difficulty of bringing your company’s Internal Audit group up to speed on current MDRP issues. Take part in this session to discuss current DRA auditing practices, and the internal controls necessary to create sufficient analytical and compliance tools.
Track D: A Strategic and Operational View of the Government as a Customer
Chris Cobourn, VP, Regulatory Compliance
In this session we evaluate the current regulatory environment, as well as new and potential changes to Federal and State programs in 2009 and 2010. We discuss how companies can develop a broader view of managing the government as a customer, evaluating potential shifts in publically funded programs, and key components for a manufacturer to consider, such as managing the government customer from a business perspective, operational considerations, and compliance.
Please click here for more conference information!
CIS will be exhibiting and presenting at IIR’s Medicaid Drug Rebate Program Conference next week, from September 21st – 23rd in Chicago, IL.
CIS’ subject matter experts will be presenting on the following topics:
Best Practices and Considerations to Complement Your GP Solution
Chris Cobourn, VP, Regulatory Compliance
Chrissy Spicer, CIS Senior Compliance Manager
Topics Include:
• Discussing the fundamental elements of establishing a compliant foundation
• Identifying key stakeholders, roles and responsibilities
• Understanding the operational challenges related to source systems and data
• Best practices for aligning your supporting documentation to your GP Solution
• Developing a holistic approach to support the integrity and accuracy of your GP calculations
• Prevailing practices for a sustainable GP Solution
Evaluating the Current GP Environment
Chris Cobourn, VP, Regulatory Compliance
Katie Lapins, CIS Director, Small and Mid-Market Manufacturers
Panelists:
Catrina Hirschauer, Xanodyne Pharmaceuticals
Todd LeDuc, Solvay Pharmaceuticals
Randy Colvin, Allos Therapeutics
All manufacturers, large and small, face similar requirements and challenges in performing their GP Calculations:
• Staying current on regulations, statutes, and guidance
• Ensuring your systems and tools to reflect current methodology
• Ensuring the accuracy of statutory pricing calculations, and having confidence in your certifications
• Making sure that systems and procedures are auditable and meet the requirements of the 10-Year rule
Manufacturers have various options in today’s environment, including performing calculations internally using spreadsheets and databases, outsourcing them to a third party, or implementing a commercial GP system. In this session, we discuss basic requirements of GP systems and tools, and considerations for companies that may be evaluating their options, or want to know how to evaluate the accuracy and overall compliance of their current toolsets. The presentation will include industry case-studies on various approaches to system evaluation.
Track A: Medicaid Payment Process Improvement – Avoid Pitfalls and Duplicate Discounts
Bill Baxter, CIS Strategic Advisor, Government Affairs (Moderator)
Learn to identify and handle these major pitfalls:
• Medicaid as secondary insurance
• Unit of Measure
• Generic substitution
• Incorrect NDC reporting
• Units vs. reimbursed $
• Double dipping
• Adjustments to prior quarter(s)
Hear the fundamentals of Medicaid payment processing and learn to overcome common challenges facing manufacturers today.
Track A: Vigilant Auditing and Monitoring Practices and Procedures
Clarissa Crain (Moderator), CIS Compliance Director
Panelists:
Lisa Kiniklis, Biogen IDEC
Brian McCartney, Ortho-McNeil Janssen
Lorraine Moccio, Johnson & Johnson Health Care Systems
Improve your current procedures to ensure complete auditing & monitoring of your operational areas. Overcome the difficulty of bringing your company’s Internal Audit group up to speed on current MDRP issues. Take part in this session to discuss current DRA auditing practices, and the internal controls necessary to create sufficient analytical and compliance tools.
Track D: A Strategic and Operational View of the Government as a Customer
Chris Cobourn, VP, Regulatory Compliance
In this session we evaluate the current regulatory environment, as well as new and potential changes to Federal and State programs in 2009 and 2010. We discuss how companies can develop a broader view of managing the government as a customer, evaluating potential shifts in publically funded programs, and key components for a manufacturer to consider, such as managing the government customer from a business perspective, operational considerations, and compliance.
Please click here for more conference information!
Initial Thought on Committee “Chairman’s Mark”
By: Clarissa Crain, CIS Compliance Director
clarissacrain@cis-partners.com
On Wednesday, September 16th Senator Baucus, Chairman of the Senate Finance Committee, issued his Chairman’s Mark on America’s Health Future Act of 2009. The document outlines the Chairman’s proposals for reform. The plan is estimated to extend coverage to approximately 29 million uninsured Americans over a 10 year period, and cost approximately $856 billion. While the price tag is high, a factor in the lack of Republican support for the outlined reform, it is estimated to trim deficits by $49 million.[i]
The Chairman’s Mark is yet another piece in the ever evolving debate of healthcare reform. While Chairman Baucus and the Senate Finance Committee sought to present a unified, bipartisan position, support for the proposals is lacking. On Wednesday Baucus stood alone presenting the proposals, while Republican members of the Senate Finance Committee opposed the ‘costly and intrusive’ nature of reform, Democrats argued the proposals did not go far enough in ensuring access to affordable healthcare.
For those specifically interested in the impact of the proposals on Government pharmaceutical access programs, “Section V: Medicaid Prescription Drug Coverage,” presents proposals for reform to the Medicaid Drug Rebate Program (MDRP). Section V outlines the following proposals:
Sources:
Werner, Erica. Deep divisions over long-awaited health care plan. http://news.yahoo.com/s/ap/20090917/ap_on_go_co/us_health_care_overhaul. Accessed September 17, 2009.
H.R. 3200: America's Affordable Health Choices Act of 2009. http://www.govtrack.us/congress/billtext.xpd?bill=h111-3200
Chairman’s Mark. America’s Healthy Future Act of 2009. http://finance.senate.gov/sitepages/leg/LEG%202009/091609%20Americas_Healthy_Future_Act.pdf
Committee of Finance News Release. Baucus Introduces Landmark Plan to Lower Health Care Costs, Provide Quality, Affordable Coverage. September 16, 2009. http://finance.senate.gov/press/Bpress/2009press/prb091609a.pdf
clarissacrain@cis-partners.com
On Wednesday, September 16th Senator Baucus, Chairman of the Senate Finance Committee, issued his Chairman’s Mark on America’s Health Future Act of 2009. The document outlines the Chairman’s proposals for reform. The plan is estimated to extend coverage to approximately 29 million uninsured Americans over a 10 year period, and cost approximately $856 billion. While the price tag is high, a factor in the lack of Republican support for the outlined reform, it is estimated to trim deficits by $49 million.[i]
The Chairman’s Mark is yet another piece in the ever evolving debate of healthcare reform. While Chairman Baucus and the Senate Finance Committee sought to present a unified, bipartisan position, support for the proposals is lacking. On Wednesday Baucus stood alone presenting the proposals, while Republican members of the Senate Finance Committee opposed the ‘costly and intrusive’ nature of reform, Democrats argued the proposals did not go far enough in ensuring access to affordable healthcare.
For those specifically interested in the impact of the proposals on Government pharmaceutical access programs, “Section V: Medicaid Prescription Drug Coverage,” presents proposals for reform to the Medicaid Drug Rebate Program (MDRP). Section V outlines the following proposals:
- Prescription drug coverage would become a mandatory benefit within State Medicaid Programs. Today, states may elect whether or not to include this benefit. While all states in the Program currently do offer the benefit, the proposal would make such coverage a mandatory requirement for both categorically and medically needy persons covered by Medicaid.
- The proposals would remove smoking cessation drugs, barbiturates, and benzodiazepines from the list of covered drugs. This would go into effect as of January 1, 2014.
- Similar to the H.R.3200[ii], the current bill in the House, the Chairman’s proposals outline increases in manufacturer rebate liabilities. Single source (S) and innovator multisource (I) drugs would see an increase of the AMP basic rebate percentage from 15.1% to 23.1% for all drugs except those exclusively approved for pediatric use. Those with pediatric exclusivity would have a basic rebate percentage of 17.1%. While rebates would be increased, the total rebate liability for an S or I drug would be limited to 100% of AMP. (note: Best Price (BP) provisions are proposed to remain unchanged.)
- The rebate on non-innovator or generic drugs (N) would be increased from 11% of AMP to 13% of AMP.
- The rebate program would be expanded to make rebates payments for Medicaid managed care organizations (MCOs) utilization a requirement for manufacturers. The rebate payments would be made directly to states.
- Line-extensions or other formulation changes of existing products would no longer be treated as new drugs for purposes of the MDRP. New versions of existing drugs would no longer be able to be associated with new baseline AMPs. Under the proposal, the original formulation’s baseline AMP would follow through to line-extensions. The only exemption to this would be line-extensions of orphan drugs.
- Under the proposal of the Chairman, the Federal Upper Payment Limits (FULs) would be revised from the 250 percent as proposed by the DRA, to 175 percent (see Adam Fein’s Drug Channels Blog on this topic at www.drugchannels.net). Of interest to manufacturers, the utilization of FUL for pharmacy reimbursement is also associated with clarification on the inclusion of transactions, discounts, and other price adjustments in AMP and the disclosure of AMPs. Should this proposal be accepted, look for more changes in AMP calculations.
- The plan refers to the 50% discount manufacturers have agreed to provide to the Medicare Part D program. The discount would be passed on the enrollees purchasing drugs in the “donut hole.”
- Branded pharmaceutical manufacturers with sales of $5 million or more would incur a flat fee of $2.3 billion across the sector beginning in 2010. This non-deductible fee would be distributed across the industry according to market share.
- Medical device manufacturers with sales of $5 million or more would incur a flat fee of $4 billion across the sector beginning in 2010. This non-deductible fee would be distributed across the industry according to market share. The only exemption to this payment would be sales of Class I products.
- Drug manufacturers and distributors would be required to report information related to the number and type of drug samples provided to physicians, through “physician payment sunshine” type legislation.
Sources:
Werner, Erica. Deep divisions over long-awaited health care plan. http://news.yahoo.com/s/ap/20090917/ap_on_go_co/us_health_care_overhaul. Accessed September 17, 2009.
H.R. 3200: America's Affordable Health Choices Act of 2009. http://www.govtrack.us/congress/billtext.xpd?bill=h111-3200
Chairman’s Mark. America’s Healthy Future Act of 2009. http://finance.senate.gov/sitepages/leg/LEG%202009/091609%20Americas_Healthy_Future_Act.pdf
Committee of Finance News Release. Baucus Introduces Landmark Plan to Lower Health Care Costs, Provide Quality, Affordable Coverage. September 16, 2009. http://finance.senate.gov/press/Bpress/2009press/prb091609a.pdf
Tuesday, September 15, 2009
AMP and BP Methodology Changes are a GO!!
By: Debbe Saez, CIS Senior Compliance Manager
debbesaez@cis-partners.com
Do you remember when there was no limit on how many quarters a manufacturer could recalculate AMP or BP? That was more than 6 years ago. On August 29, 2003, CMS issued a final rule, CMS-2175-FC[1], which implemented the limitation on AMP and BP recalculations to a period not to exceed 12 quarters from the quarter in which the data is due. As clear as that rule is, there were still open questions about AMP and BP recalculations. Does the manufacturer always need CMS’ approval to recalculate? What methodology changes, if any, don’t require prior approval? What about pending requests for approval of methodology changes?
To clarify some of these questions, CMS issued guidance in Drug Manufacturer Release #78[2] on July 26, 2007. More recently, on August 26, 2009, CMS posted changes to this guidance in the form of a Spotlight on the Policy & Reimbursement section of CMS’ website[3]. The topics below highlight the key points from Release 78 and the Guidance in the Spotlight.
Topic:
Treatment of pending recalculation requests due to methodology change…
Release 78(July 26, 2007):
Implement methodology changes prospectively.
Spotlight(August 26, 2009):
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.(Contact Tamara Bruce at MDROperations@cms.hhs.gov for instructions about the data submission process.)
Topic:
New recalculation requests, after the date of the respective guidance, due to methodology changes…
Release 78(July 26, 2007):
Implement the change on a prospective basis without review by CMS.
Wait for approval from CMS before making retroactive changes.
Spotlight(August 26, 2009):
Both prospective and retroactive changes can made without prior approval by CMS.
Manufacturers are requested to notify CMS of the methodology change.
Retroactive changes are still subject to the 12-quarter limitation.
Topic:
Additional notes…
Release 78(July 26, 2007):
None
Spotlight(August 26, 2009):
CMS suggests that manufacturers work with States to prevent undue burden of rebate overpayment recovery.
CMS also suggests limiting the recovery of overpayments to 25% of the rebate payable in quarter.
Until now, manufacturers could not make retroactive methodology changes to their AMP and BP calculations without approval. The downside to this was that with the passing of each quarter, another quarter would fall out of the period available to implement the changes. Now that this is no longer an issue… let the recalculations begin!!
Sources:
[1] http://edocket.access.gpo.gov/2003/pdf/03-21548.pdf
[2] http://www.cms.hhs.gov/MedicaidDrugRebateProgram/03_DrugMfrReleases.asp
[3] http://www.cms.hhs.gov/Reimbursement/02_Spotlight.asp
debbesaez@cis-partners.com
Do you remember when there was no limit on how many quarters a manufacturer could recalculate AMP or BP? That was more than 6 years ago. On August 29, 2003, CMS issued a final rule, CMS-2175-FC[1], which implemented the limitation on AMP and BP recalculations to a period not to exceed 12 quarters from the quarter in which the data is due. As clear as that rule is, there were still open questions about AMP and BP recalculations. Does the manufacturer always need CMS’ approval to recalculate? What methodology changes, if any, don’t require prior approval? What about pending requests for approval of methodology changes?
To clarify some of these questions, CMS issued guidance in Drug Manufacturer Release #78[2] on July 26, 2007. More recently, on August 26, 2009, CMS posted changes to this guidance in the form of a Spotlight on the Policy & Reimbursement section of CMS’ website[3]. The topics below highlight the key points from Release 78 and the Guidance in the Spotlight.
Topic:
Treatment of pending recalculation requests due to methodology change…
Release 78(July 26, 2007):
Implement methodology changes prospectively.
Spotlight(August 26, 2009):
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.(Contact Tamara Bruce at MDROperations@cms.hhs.gov for instructions about the data submission process.)
Topic:
New recalculation requests, after the date of the respective guidance, due to methodology changes…
Release 78(July 26, 2007):
Implement the change on a prospective basis without review by CMS.
Wait for approval from CMS before making retroactive changes.
Spotlight(August 26, 2009):
Both prospective and retroactive changes can made without prior approval by CMS.
Manufacturers are requested to notify CMS of the methodology change.
Retroactive changes are still subject to the 12-quarter limitation.
Topic:
Additional notes…
Release 78(July 26, 2007):
None
Spotlight(August 26, 2009):
CMS suggests that manufacturers work with States to prevent undue burden of rebate overpayment recovery.
CMS also suggests limiting the recovery of overpayments to 25% of the rebate payable in quarter.
Until now, manufacturers could not make retroactive methodology changes to their AMP and BP calculations without approval. The downside to this was that with the passing of each quarter, another quarter would fall out of the period available to implement the changes. Now that this is no longer an issue… let the recalculations begin!!
Sources:
[1] http://edocket.access.gpo.gov/2003/pdf/03-21548.pdf
[2] http://www.cms.hhs.gov/MedicaidDrugRebateProgram/03_DrugMfrReleases.asp
[3] http://www.cms.hhs.gov/Reimbursement/02_Spotlight.asp
Monday, September 14, 2009
Tricky Base AMP Calculations
By: Chris Cobourn, VP of Regulatory Compliance
chriscobourn@cis-partners.com
In working with many of our clients, we have encountered the tricky question of Lagged Rebate Price Concessions and how they figure into the calculation of Base AMP.
Technically speaking, Base AMP is set in the first full quarter of sales. So, if a product was initially sold in November, which occurs in the middle of the 4th Quarter, Base AMP would be set in 1st Quarter, the first full quarter of sales. The problem is that manufacturers sometimes establish initial stocking allowances and other incentives to create market share for new products. These types of discounts have historically been offered prior to the first full quarter of sales.
Prior to the requirement that lagged rebate price concessions be included in AMP, these initial stocking allowances would not be included in the Base AMP calculation, and Base AMP would be set solely on the first full quarter of sales. However, due to the requirement to include lagged or smoothed price concessions, these incentives can now be part of the Base AMP calculation if they can in any way be considered a lagged discount. This can have an unfortunate impact on the manufacturer. The idea of using only the first full quarter of sales to calculate Base AMP seems fair, as doing so creates a Base AMP more aligned with the “normal” quarterly AMP the manufacturer would witness going forward. Including incentives and initial stocking allowances in the calculation can set an artificially low Base AMP, which could set the manufacturer up for increased CPI-U penalties over the course of the product’s life.
This change is important food for thought, as manufacturers consider strategy decisions such as providing initial stocking allowances. Make sure that you are aware of which discounts are lagged, and which are not. In addition, it may be worth modeling various pricing strategies to evaluate the potential impact these decisions will have on the Base AMP, especially relative to the potential sales that may be achieved as a result of those incentives.
chriscobourn@cis-partners.com
In working with many of our clients, we have encountered the tricky question of Lagged Rebate Price Concessions and how they figure into the calculation of Base AMP.
Technically speaking, Base AMP is set in the first full quarter of sales. So, if a product was initially sold in November, which occurs in the middle of the 4th Quarter, Base AMP would be set in 1st Quarter, the first full quarter of sales. The problem is that manufacturers sometimes establish initial stocking allowances and other incentives to create market share for new products. These types of discounts have historically been offered prior to the first full quarter of sales.
Prior to the requirement that lagged rebate price concessions be included in AMP, these initial stocking allowances would not be included in the Base AMP calculation, and Base AMP would be set solely on the first full quarter of sales. However, due to the requirement to include lagged or smoothed price concessions, these incentives can now be part of the Base AMP calculation if they can in any way be considered a lagged discount. This can have an unfortunate impact on the manufacturer. The idea of using only the first full quarter of sales to calculate Base AMP seems fair, as doing so creates a Base AMP more aligned with the “normal” quarterly AMP the manufacturer would witness going forward. Including incentives and initial stocking allowances in the calculation can set an artificially low Base AMP, which could set the manufacturer up for increased CPI-U penalties over the course of the product’s life.
This change is important food for thought, as manufacturers consider strategy decisions such as providing initial stocking allowances. Make sure that you are aware of which discounts are lagged, and which are not. In addition, it may be worth modeling various pricing strategies to evaluate the potential impact these decisions will have on the Base AMP, especially relative to the potential sales that may be achieved as a result of those incentives.
Wednesday, September 9, 2009
Risk & Reward; FDA Expands Access to Investigational Drugs
By: Jordan Mummau, CIS Compliance Associate
jordanmummau@cis-partners.com
On August 12, 2009 the FDA issued two rules that are meant to bring clarity to the ways in which seriously ill patients can gain access to investigational drugs and biologics in cases where there may not be any other satisfactory treatments available. [1]
Unfortunately, some patients are faced with a serious illness that does not react positively to current treatment. Under these circumstances, a drug that shows promise and is under development can be very appealing to patients who have little other choice. The FDA had become aware of this in 1987 when it developed rules that would “allow patients to have access to investigational drugs under certain circumstances, even though the safety and effectiveness of the drug has not been fully established.” [2]
As previously stated, on August 12th the FDA instituted changes to the rules that were originally developed in 1987 so that the rules would apply to a broader population of people who have not had success with approved treatments, and who could have been previously denied access to investigational drugs and biologics. Furthermore, the FDA hopes these new rules will bring more clarity to physicians who are administering investigational drugs and the manufacturers who are developing them. This particular change was described in the Federal Register as a “change to the charging rule to explain when a drug manufacturer can charge a patient for an investigational drug, in a clinical trial or expanded access program, and what costs a manufacturer can recover when charging.” [3]
This could be a tremendous benefit to a sick patient who has run out of all other options. However, the FDA has referred to expanded access to investigational drugs as a “balancing act.” While the FDA understands a promising drug under development could potentially help someone in need, they also notice the risk associated with administering a drug that has not been fully tested. With that said, these new rulings ultimately give patients a choice that may not have been available to them before. The bottom line, per the FDA, is that the potential benefit must outweigh the potential risk. [4]
New Rules at a Glance
•Expanded Access Rule – to permit treatment of a patient with an investigational drug under an expanded access program
oPotential benefit justifies potential risk
•Charging Rule – permits drug manufacturers to charge patients for an investigational drug in clinical trials or that’s being made available for expanded access. Charging in clinical trials will be allowed under very limited circumstances, but will be permitted for most expanded access uses.
oMake process of obtaining authorization to charge more transparent
oSpecify what costs can be recovered by drug manufacturers [5]
Sources:
1) "FDA Issues Final Rules to Help Patients Gain Access to Investigational Drugs." FDA US Food and Drug Administration. 12 Aug. 2009. Web. 1 Sept. 2009. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm176526.htm
2) "FDA Expands Access to Investigational Drugs." FDA US Food and Drug Administration. 12 Aug. 2009. Web. 1 Sept. 2009. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm176845.htm
3) "FDA Expands Access to Investigational Drugs." FDA US Food and Drug Administration. 12 Aug. 2009. Web. 1 Sept. 2009. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm176845.htm
4) "Final Rules for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs." FDA US Food and Drug Administration. 12 Aug. 2009. Web. 1 Sept. 2009. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm172492.htm
5) "FDA Expands Access to Investigational Drugs." FDA US Food and Drug Administration. 12 Aug. 2009. Web. 1 Sept. 2009. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm176845.htm
jordanmummau@cis-partners.com
On August 12, 2009 the FDA issued two rules that are meant to bring clarity to the ways in which seriously ill patients can gain access to investigational drugs and biologics in cases where there may not be any other satisfactory treatments available. [1]
Unfortunately, some patients are faced with a serious illness that does not react positively to current treatment. Under these circumstances, a drug that shows promise and is under development can be very appealing to patients who have little other choice. The FDA had become aware of this in 1987 when it developed rules that would “allow patients to have access to investigational drugs under certain circumstances, even though the safety and effectiveness of the drug has not been fully established.” [2]
As previously stated, on August 12th the FDA instituted changes to the rules that were originally developed in 1987 so that the rules would apply to a broader population of people who have not had success with approved treatments, and who could have been previously denied access to investigational drugs and biologics. Furthermore, the FDA hopes these new rules will bring more clarity to physicians who are administering investigational drugs and the manufacturers who are developing them. This particular change was described in the Federal Register as a “change to the charging rule to explain when a drug manufacturer can charge a patient for an investigational drug, in a clinical trial or expanded access program, and what costs a manufacturer can recover when charging.” [3]
This could be a tremendous benefit to a sick patient who has run out of all other options. However, the FDA has referred to expanded access to investigational drugs as a “balancing act.” While the FDA understands a promising drug under development could potentially help someone in need, they also notice the risk associated with administering a drug that has not been fully tested. With that said, these new rulings ultimately give patients a choice that may not have been available to them before. The bottom line, per the FDA, is that the potential benefit must outweigh the potential risk. [4]
New Rules at a Glance
•Expanded Access Rule – to permit treatment of a patient with an investigational drug under an expanded access program
oPotential benefit justifies potential risk
•Charging Rule – permits drug manufacturers to charge patients for an investigational drug in clinical trials or that’s being made available for expanded access. Charging in clinical trials will be allowed under very limited circumstances, but will be permitted for most expanded access uses.
oMake process of obtaining authorization to charge more transparent
oSpecify what costs can be recovered by drug manufacturers [5]
Sources:
1) "FDA Issues Final Rules to Help Patients Gain Access to Investigational Drugs." FDA US Food and Drug Administration. 12 Aug. 2009. Web. 1 Sept. 2009. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm176526.htm
2) "FDA Expands Access to Investigational Drugs." FDA US Food and Drug Administration. 12 Aug. 2009. Web. 1 Sept. 2009. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm176845.htm
3) "FDA Expands Access to Investigational Drugs." FDA US Food and Drug Administration. 12 Aug. 2009. Web. 1 Sept. 2009. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm176845.htm
4) "Final Rules for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs." FDA US Food and Drug Administration. 12 Aug. 2009. Web. 1 Sept. 2009. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm172492.htm
5) "FDA Expands Access to Investigational Drugs." FDA US Food and Drug Administration. 12 Aug. 2009. Web. 1 Sept. 2009. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm176845.htm
Tuesday, September 8, 2009
DTC Advertising
By: Grete Dudek, CIS Compliance Associate
gretedudek@cis-partners.com
Although the current healthcare reform discussion has been in the spotlight recently, there is also a less visible battle taking place for restrictions on direct to consumer drug (DTC) advertising. Currently, there are a number of different proposed ideas and methods to restrict DTC ads, but since a number of similar bills have stalled in the past, there is uncertainty regarding whether or not any legislation will be passed. One idea (as discussed in Judy Fox’s article, The Definition of Indecent Could Become Ridiculous), from Representative James P. Moran, a Democrat from Virginia, is to ban prescription drug ads for erectile dysfunction during prime time hours on decency grounds.[1] Representative Henry Waxman, a Democrat from California, would like to see a ban on prescription drug advertising for the first few years the drug is on the market. He said,
The drug Vioxx is one example of a drug with risks that weren’t immediately clear. In long-term studies undertaken after the drug’s approval, an increased risk of cardiovascular events was seen after taking the drug for 18 months. The pain drug was removed from the market over these safety concerns, but had extensive usage and patient exposure due to DTC advertising campaigns.[5] Meanwhile, Representative Jerrold Nadler, a Democrat from New York, has introduced a bill to the House that would deny tax deductions for direct to consumer advertising.[4]
Critics of these restrictions have the right to free speech on their side, which is one reason similar bills have stalled in the past. Studies have found that DTC advertising can make consumers aware that their conditions have effective treatment, and that ads “can help people who do need treatment to start taking, and stay on, appropriate drugs.”[3] The ads can lead to increased patient visits to doctors that detect treatable diseases, and increase the quality of discussions between patients and doctors.[6]
It is also interesting to note that the US and New Zealand are the only two developed countries that allow direct to consumer drug advertisements. However, that almost changed a few years ago, when lawmakers in New Zealand tried and failed to ban DTC advertising. What does the future hold for DTC advertising in the U.S? We will have to wait and see.
Sources:
1. http://thomas.loc.gov/cgi-bin/query/z?c111:H.R.2175:
2. http://www.prescriptionproject.org/tools/conference_remarks/files/0003.pdf
3. http://www.nytimes.com/2009/07/27/business/media/27drugads.html
4. http://thomas.loc.gov/cgi-bin/query/z?c111:H.R.2966:
5. http://www.merck.com/newsroom/vioxx/pdf/vioxx_press_release_final.pdf
6. http://roomfordebate.blogs.nytimes.com/2009/08/04/should-prescription-drug-ads-be-reined-in/
gretedudek@cis-partners.com
Although the current healthcare reform discussion has been in the spotlight recently, there is also a less visible battle taking place for restrictions on direct to consumer drug (DTC) advertising. Currently, there are a number of different proposed ideas and methods to restrict DTC ads, but since a number of similar bills have stalled in the past, there is uncertainty regarding whether or not any legislation will be passed. One idea (as discussed in Judy Fox’s article, The Definition of Indecent Could Become Ridiculous), from Representative James P. Moran, a Democrat from Virginia, is to ban prescription drug ads for erectile dysfunction during prime time hours on decency grounds.[1] Representative Henry Waxman, a Democrat from California, would like to see a ban on prescription drug advertising for the first few years the drug is on the market. He said,
“It is in these first few years of a drug’s life that drug companies often aggressively market their products and engage in direct-to-consumer advertising. This increases the number of consumers exposed to safety risks of new products, long before those risks are truly understood.... That is why I have supported legislation that would grant FDA the authority to restrict direct-to-consumer advertising for an initial period for new drugs on a case-by-case basis.”[2]
The drug Vioxx is one example of a drug with risks that weren’t immediately clear. In long-term studies undertaken after the drug’s approval, an increased risk of cardiovascular events was seen after taking the drug for 18 months. The pain drug was removed from the market over these safety concerns, but had extensive usage and patient exposure due to DTC advertising campaigns.[5] Meanwhile, Representative Jerrold Nadler, a Democrat from New York, has introduced a bill to the House that would deny tax deductions for direct to consumer advertising.[4]
Critics of these restrictions have the right to free speech on their side, which is one reason similar bills have stalled in the past. Studies have found that DTC advertising can make consumers aware that their conditions have effective treatment, and that ads “can help people who do need treatment to start taking, and stay on, appropriate drugs.”[3] The ads can lead to increased patient visits to doctors that detect treatable diseases, and increase the quality of discussions between patients and doctors.[6]
It is also interesting to note that the US and New Zealand are the only two developed countries that allow direct to consumer drug advertisements. However, that almost changed a few years ago, when lawmakers in New Zealand tried and failed to ban DTC advertising. What does the future hold for DTC advertising in the U.S? We will have to wait and see.
Sources:
1. http://thomas.loc.gov/cgi-bin/query/z?c111:H.R.2175:
2. http://www.prescriptionproject.org/tools/conference_remarks/files/0003.pdf
3. http://www.nytimes.com/2009/07/27/business/media/27drugads.html
4. http://thomas.loc.gov/cgi-bin/query/z?c111:H.R.2966:
5. http://www.merck.com/newsroom/vioxx/pdf/vioxx_press_release_final.pdf
6. http://roomfordebate.blogs.nytimes.com/2009/08/04/should-prescription-drug-ads-be-reined-in/
Thursday, September 3, 2009
Healthcare for All Americans, Part Two - Con
By: Scott Hoffman, CIS Senior Associate
scotthoffman@cis-partners.com
Disclaimer: This is Part Two of a two part article on Healthcare Reform. This article represents a position against healthcare reform, yesterday’s article presented a position for universal healthcare. We would love to hear your (constructive) feedback, so feel free to post a comment responding to either position, or both.
I would also like to start this article with a disclaimer for the readers. Healthcare reform is a very complex issue that impacts a wide spectrum of individuals, ranging from manufacturers to insurers to the general public. The information I am going to present in this article is only a high level summary of a few arguments opposing healthcare reform. The reasons I am opposed to government-backed healthcare reform are the failure of the Massachusetts reform, the shortcomings of Medicaid and Medicare and, lastly, the prospective cost to taxpayers.
The first issue I would like to highlight is the failure of the healthcare reform enacted in Massachusetts in 2006. To provide a brief background, on April 12, 2006, Massachusetts passed bipartisan legislature requiring all adults to purchase health insurance. If the individuals did not purchase a plan, fines of up to 50 percent of the cost of a health insurance plan would be levied [1]. Additionally, employers employing 11 or more individuals were required to provide health insurance coverage for their employees, or pay a contribution of up to $295 annually per employee [1]. The other key component of the plan was the provision of government-funded subsidies to low-income individuals to assist with the purchase of health insurance [1].
Three years after the passing of the plan, the healthcare situation in Massachusetts has not improved. First, universal healthcare is still not universal (although roughly half of those previously uninsured have subsequently become insured), and more importantly, surveys show that individuals have “substantial problems in access to care” in the state [2]. The state plan has failed to ensure the availability of comprehensive plans at affordable prices and has actually negatively impacted some individuals by requiring high co-pays that the low income individuals subscribing to the plan cannot afford. [2].
The second issue is that the legislation does nothing to control administrative costs and wasteful spending (it has actually increased healthcare costs), and does nothing to address the key drivers of high health care costs, the overuse of high-technology care and the underdevelopment of primary care [2]. In addition (and in support of my third argument), the plan has cost more than originally estimated, resulting in charges to taxpayers of $1.1 billion and $1.3 billion in 2008 and 2009 respectively, resulting in cuts to other state sponsored programs [2]. To summarize, healthcare costs continue to increase, co-payments are still high and Massachusetts’ budget is a mess, which, to me, represents a clear failure.
After reading the above argument some will say that the government now has a blueprint of what areas it should focus on to make healthcare reform successful; as well as a guide of what not to do. My next point is meant to illustrate that whenever the government gets involved, all you get is a very expensive, poorly forecasted, inefficient program full of “bureaucratic politics.” To illustrate, you only have to look at the government’s last foray into healthcare for the public; Medicare and Medicaid. Since most people reading this are familiar with these two programs, I am going to take a stance on why they are not effective. My main point in bringing up Medicare and Medicaid is not that the programs aren’t beneficial, because I believe they do help their intended targets. However, I feel that the government has not properly forecasted the cost and growth of the programs and, on top of that, they have mismanaged them, resulting in huge deficits.
To illustrate the above point, Medicaid currently represents 7% of the federal budget, and is projected to account for roughly 8.5% by 2013. Total Medicaid expenditures on benefits were $329.4 billion in 2007, and according to the Office of the Actuary, they are predicted to increase at an average of 8% to 9% per year for the next 10 years, reaching $735.2 billion by 2017 [3]. The effects of these cost increases on states already experiencing budget deficits could be significant. Plus, the federal government won’t be able to bail them out because according to the Congressional Budget Office (CBO), the government is currently projected to have a deficit of $7.1 trillion by 2019 [4]. Take a second to consider that amount of money, and then assess whether the government understands how to effectively manage and budget money. Personally, I think the answer is pretty clear.
I will keep my final argument brief because this is only a personal argument opposing government healthcare reform. The government has a deficit of approximately $7.1 trillion dollars and is planning on spending roughly $1 trillion on healthcare reform. Where is the money going to come from? The costs are almost assuredly going to be passed to you and I: the taxpayers. I know there was an agreement with the Pharma industry for $80 billion, but when was the last time any industry just gave away $80 billion (and sponsored a $150 million advertising campaign)? In my research and experience, this has never happened. That means Pharma is planning on not only recouping the $80 billion, but also turning some semblance of a profit (after all, profit is the fundamental principle of business), which means eventually the tax payer is going to be on the hook. I don’t know how you personally feel, but I would like to keep the money I work hard to make, and not give it away to the government.
In closing, I understand the “humane and sympathetic” argument for offering healthcare to all Americans. I also understand that not all Americans are in the same position I am, of having a good job, which allows me to afford healthcare. However, healthcare is not going to help people if the government goes “bankrupt” due to complete financial insolvency. It is not going to help the working class individual who begins to lose large percentages of their earned wages. Why not work to fix Medicare and Medicaid? Why not work on initiatives to increase the number of doctors in this country, to help eliminate access issues?
More importantly, why does reform have to be a government run insurance plan? My main opposition for government-backed and sponsored healthcare is that it will not bring about the changes needed to provide access for those who need it. Any government plan will almost assuredly be mismanaged and full of waste, which will not successfully provide affordable access to healthcare for everyone who needs it. I believe that if the government wants reform, it should avoid offering healthcare plans, and should instead work with private insurers to ensure that affordable plans are offered. From my perspective, government oversight is a significantly better option, both short-term and long-term, than government ownership.
Sources:
[1] Massachusetts Health Care Reform Plan: An Update
http://www.kff.org/uninsured/upload/7494-02.pdf
[2] Massachusetts’ Plan: A Failed Model for Health Care Reform
http://pnhp.org/mass_report/mass_report_Final.pdf
[3] This Is Going to Hurt, August 12, 2009
http://pharmexec.findpharma.com/pharmexec/Web+Exclusives/This-Is-Going-to-Hurt/ArticleStandard/Article/detail/618558?contextCategoryId=47505
[4] Projected Deficits and Surpluses in CBO’s Baseline
http://www.cbo.gov/ftpdocs/105xx/doc10521/budgetprojections.pdf
scotthoffman@cis-partners.com
Disclaimer: This is Part Two of a two part article on Healthcare Reform. This article represents a position against healthcare reform, yesterday’s article presented a position for universal healthcare. We would love to hear your (constructive) feedback, so feel free to post a comment responding to either position, or both.
I would also like to start this article with a disclaimer for the readers. Healthcare reform is a very complex issue that impacts a wide spectrum of individuals, ranging from manufacturers to insurers to the general public. The information I am going to present in this article is only a high level summary of a few arguments opposing healthcare reform. The reasons I am opposed to government-backed healthcare reform are the failure of the Massachusetts reform, the shortcomings of Medicaid and Medicare and, lastly, the prospective cost to taxpayers.
The first issue I would like to highlight is the failure of the healthcare reform enacted in Massachusetts in 2006. To provide a brief background, on April 12, 2006, Massachusetts passed bipartisan legislature requiring all adults to purchase health insurance. If the individuals did not purchase a plan, fines of up to 50 percent of the cost of a health insurance plan would be levied [1]. Additionally, employers employing 11 or more individuals were required to provide health insurance coverage for their employees, or pay a contribution of up to $295 annually per employee [1]. The other key component of the plan was the provision of government-funded subsidies to low-income individuals to assist with the purchase of health insurance [1].
Three years after the passing of the plan, the healthcare situation in Massachusetts has not improved. First, universal healthcare is still not universal (although roughly half of those previously uninsured have subsequently become insured), and more importantly, surveys show that individuals have “substantial problems in access to care” in the state [2]. The state plan has failed to ensure the availability of comprehensive plans at affordable prices and has actually negatively impacted some individuals by requiring high co-pays that the low income individuals subscribing to the plan cannot afford. [2].
The second issue is that the legislation does nothing to control administrative costs and wasteful spending (it has actually increased healthcare costs), and does nothing to address the key drivers of high health care costs, the overuse of high-technology care and the underdevelopment of primary care [2]. In addition (and in support of my third argument), the plan has cost more than originally estimated, resulting in charges to taxpayers of $1.1 billion and $1.3 billion in 2008 and 2009 respectively, resulting in cuts to other state sponsored programs [2]. To summarize, healthcare costs continue to increase, co-payments are still high and Massachusetts’ budget is a mess, which, to me, represents a clear failure.
After reading the above argument some will say that the government now has a blueprint of what areas it should focus on to make healthcare reform successful; as well as a guide of what not to do. My next point is meant to illustrate that whenever the government gets involved, all you get is a very expensive, poorly forecasted, inefficient program full of “bureaucratic politics.” To illustrate, you only have to look at the government’s last foray into healthcare for the public; Medicare and Medicaid. Since most people reading this are familiar with these two programs, I am going to take a stance on why they are not effective. My main point in bringing up Medicare and Medicaid is not that the programs aren’t beneficial, because I believe they do help their intended targets. However, I feel that the government has not properly forecasted the cost and growth of the programs and, on top of that, they have mismanaged them, resulting in huge deficits.
To illustrate the above point, Medicaid currently represents 7% of the federal budget, and is projected to account for roughly 8.5% by 2013. Total Medicaid expenditures on benefits were $329.4 billion in 2007, and according to the Office of the Actuary, they are predicted to increase at an average of 8% to 9% per year for the next 10 years, reaching $735.2 billion by 2017 [3]. The effects of these cost increases on states already experiencing budget deficits could be significant. Plus, the federal government won’t be able to bail them out because according to the Congressional Budget Office (CBO), the government is currently projected to have a deficit of $7.1 trillion by 2019 [4]. Take a second to consider that amount of money, and then assess whether the government understands how to effectively manage and budget money. Personally, I think the answer is pretty clear.
I will keep my final argument brief because this is only a personal argument opposing government healthcare reform. The government has a deficit of approximately $7.1 trillion dollars and is planning on spending roughly $1 trillion on healthcare reform. Where is the money going to come from? The costs are almost assuredly going to be passed to you and I: the taxpayers. I know there was an agreement with the Pharma industry for $80 billion, but when was the last time any industry just gave away $80 billion (and sponsored a $150 million advertising campaign)? In my research and experience, this has never happened. That means Pharma is planning on not only recouping the $80 billion, but also turning some semblance of a profit (after all, profit is the fundamental principle of business), which means eventually the tax payer is going to be on the hook. I don’t know how you personally feel, but I would like to keep the money I work hard to make, and not give it away to the government.
In closing, I understand the “humane and sympathetic” argument for offering healthcare to all Americans. I also understand that not all Americans are in the same position I am, of having a good job, which allows me to afford healthcare. However, healthcare is not going to help people if the government goes “bankrupt” due to complete financial insolvency. It is not going to help the working class individual who begins to lose large percentages of their earned wages. Why not work to fix Medicare and Medicaid? Why not work on initiatives to increase the number of doctors in this country, to help eliminate access issues?
More importantly, why does reform have to be a government run insurance plan? My main opposition for government-backed and sponsored healthcare is that it will not bring about the changes needed to provide access for those who need it. Any government plan will almost assuredly be mismanaged and full of waste, which will not successfully provide affordable access to healthcare for everyone who needs it. I believe that if the government wants reform, it should avoid offering healthcare plans, and should instead work with private insurers to ensure that affordable plans are offered. From my perspective, government oversight is a significantly better option, both short-term and long-term, than government ownership.
Sources:
[1] Massachusetts Health Care Reform Plan: An Update
http://www.kff.org/uninsured/upload/7494-02.pdf
[2] Massachusetts’ Plan: A Failed Model for Health Care Reform
http://pnhp.org/mass_report/mass_report_Final.pdf
[3] This Is Going to Hurt, August 12, 2009
http://pharmexec.findpharma.com/pharmexec/Web+Exclusives/This-Is-Going-to-Hurt/ArticleStandard/Article/detail/618558?contextCategoryId=47505
[4] Projected Deficits and Surpluses in CBO’s Baseline
http://www.cbo.gov/ftpdocs/105xx/doc10521/budgetprojections.pdf
Wednesday, September 2, 2009
Healthcare for All Americans, Part One - Pro
By: Katie Lapins, CIS Director of Small and Mid-Market Pharma
katielapins@cis-partners.com
Disclaimer: This is Part One of a two part article on Healthcare Reform. This article represents a position for universal healthcare, tomorrow’s article presents a position against healthcare reform. We would love to hear your (constructive) feedback, so feel free to post a comment responding to either position, or both.
I would like to begin this article with my own disclaimer for the readers. There are many aspects of the current healthcare debate that I do not fully understand. I am the first to admit that I have not read the entire 1,000+ pages in the proposed bill. I also know that you can find at least one statistic to support your position on almost anything, so while I see merit in both sides of the argument, I cannot state unequivocally which is the most accurate, true or realistic.
However, to me, the debate of healthcare reform is about something entirely different. Healthcare should not be something that only working Americans enjoy. It should not be something that drives a family into bankruptcy or prevents someone from working because they will lose their Medicaid coverage. It should also not be something that bureaucrats or employees, in Washington, DC or in private insurance companies, make decisions about. It should be about having access to the best realistic treatment available for a reasonable fee.
Here are a few examples of what I’m talking about:
In the Denver Post recently, a physician in private practice was interviewed about healthcare reform (1). His daughter was diagnosed with brain cancer and when he and his wife realized they would quickly hit their maximum lifetime benefits, his wife quickly got a job with the City and County of Denver, which has an insurance benefit that does not have a lifetime maximum limit. He decided to close his practice and go to work for Kaiser Permanente, because he claimed that it offered a more sustainable model of healthcare.
An acquaintance of mine quit her job to stay home with a newly adopted child. Shortly thereafter, her husband experienced a significant mental illness which, for safety and legal reasons, meant she had to file for divorce. She was then diagnosed with a brain tumor and because of her financial situation, she qualified for Medicaid. Now that she is healthy, she would like to get a job. Unfortunately, she will not qualify for healthcare because of her pre-existing condition and lack of private insurance. She is therefore better off staying unemployed because she will then continue to qualify for Medicaid. She is willing to pay a premium to stay on Medicaid, and wants to work, but the system does not allow for this option.
An estimated 8,000 people were recently treated in Los Angeles by Regional Area Medical, a non-profit organization first designed to attend to the medical needs of developing countries. They now have waiting lines in the US wherever they go, and are often forced to turn people away (2).
At a similar event in Tennessee, an executive for Cigna realized that the care people were receiving was “in public in stalls intended for livestock.” (3) This executive, Wendell Potter, resigned from his position because he felt like he could no longer participate in a system with a goal of maximizing profits that was not benefitting its constituents.
The insurance industry is in business to maximize its return to shareholders. The more premiums an insurance company can take in and the less it has to pay out for services, the better its returns. This goal is opposite of the goal of the medical industry, which is to prevent, diagnose and treat medical problems. I understand and agree that there are perverse incentives within the medical field to run up huge bills to receive additional fees; therefore, part of any reform should be altering this system. However, I do not believe that outcomes related to these systemic issues negatively impact my treatment in the same way as would an insurance company denying treatment or approving procedures based on cost.
Many critics often claim that the US Government should not be in charge of health insurance. In case people had not noticed, it already is. The US Government administers Medicaid in conjunction with the States, and Medicare is a Federal program that, by all accounts, is extremely successful. The Public Health Service program and the healthcare provided through the Department of Veterans Affairs are also Federal programs that overall, are successful. Are they perfect? Heavens, no, but at least their goal is not the opposite of mine when it comes to my healthcare.
I would like to know what percentage of those who oppose healthcare reform do not have health insurance. How many of them turn down Medicare when they become eligible to participate? It is easy to oppose healthcare reform when you are not the one being denied access or treatment, and when you are not the one filing for bankruptcy because of the cost of treatment.
Basic healthcare is a human right. In the United States, we have the best healthcare in the world, but not the best access in the world. I have heard statistics and personal stories about people having to wait for life saving treatment in other countries that have a national healthcare plan. I do not doubt these stories, and they are just as heartbreaking as the stories I’ve shared above. However, in the US, access and delivery of healthcare is a problem for 45 – 50 million Americans, which, in my opinion, is a disgrace.
Sources:
(1)Karen Auge, “Why costs spiral up,” Denver Post, August 23, 2009, 16A
(2)http://video.msn.com/video.aspx?mkt=en-us&vid=43fef8f9-c591-495b-9669-3f70bc85e077&fg=rss&from=34
(3)http://www.nytimes.com/2009/08/27/opinion/27kristof.html?_r=1&emc=eta1
katielapins@cis-partners.com
Disclaimer: This is Part One of a two part article on Healthcare Reform. This article represents a position for universal healthcare, tomorrow’s article presents a position against healthcare reform. We would love to hear your (constructive) feedback, so feel free to post a comment responding to either position, or both.
I would like to begin this article with my own disclaimer for the readers. There are many aspects of the current healthcare debate that I do not fully understand. I am the first to admit that I have not read the entire 1,000+ pages in the proposed bill. I also know that you can find at least one statistic to support your position on almost anything, so while I see merit in both sides of the argument, I cannot state unequivocally which is the most accurate, true or realistic.
However, to me, the debate of healthcare reform is about something entirely different. Healthcare should not be something that only working Americans enjoy. It should not be something that drives a family into bankruptcy or prevents someone from working because they will lose their Medicaid coverage. It should also not be something that bureaucrats or employees, in Washington, DC or in private insurance companies, make decisions about. It should be about having access to the best realistic treatment available for a reasonable fee.
Here are a few examples of what I’m talking about:
In the Denver Post recently, a physician in private practice was interviewed about healthcare reform (1). His daughter was diagnosed with brain cancer and when he and his wife realized they would quickly hit their maximum lifetime benefits, his wife quickly got a job with the City and County of Denver, which has an insurance benefit that does not have a lifetime maximum limit. He decided to close his practice and go to work for Kaiser Permanente, because he claimed that it offered a more sustainable model of healthcare.
An acquaintance of mine quit her job to stay home with a newly adopted child. Shortly thereafter, her husband experienced a significant mental illness which, for safety and legal reasons, meant she had to file for divorce. She was then diagnosed with a brain tumor and because of her financial situation, she qualified for Medicaid. Now that she is healthy, she would like to get a job. Unfortunately, she will not qualify for healthcare because of her pre-existing condition and lack of private insurance. She is therefore better off staying unemployed because she will then continue to qualify for Medicaid. She is willing to pay a premium to stay on Medicaid, and wants to work, but the system does not allow for this option.
An estimated 8,000 people were recently treated in Los Angeles by Regional Area Medical, a non-profit organization first designed to attend to the medical needs of developing countries. They now have waiting lines in the US wherever they go, and are often forced to turn people away (2).
At a similar event in Tennessee, an executive for Cigna realized that the care people were receiving was “in public in stalls intended for livestock.” (3) This executive, Wendell Potter, resigned from his position because he felt like he could no longer participate in a system with a goal of maximizing profits that was not benefitting its constituents.
The insurance industry is in business to maximize its return to shareholders. The more premiums an insurance company can take in and the less it has to pay out for services, the better its returns. This goal is opposite of the goal of the medical industry, which is to prevent, diagnose and treat medical problems. I understand and agree that there are perverse incentives within the medical field to run up huge bills to receive additional fees; therefore, part of any reform should be altering this system. However, I do not believe that outcomes related to these systemic issues negatively impact my treatment in the same way as would an insurance company denying treatment or approving procedures based on cost.
Many critics often claim that the US Government should not be in charge of health insurance. In case people had not noticed, it already is. The US Government administers Medicaid in conjunction with the States, and Medicare is a Federal program that, by all accounts, is extremely successful. The Public Health Service program and the healthcare provided through the Department of Veterans Affairs are also Federal programs that overall, are successful. Are they perfect? Heavens, no, but at least their goal is not the opposite of mine when it comes to my healthcare.
I would like to know what percentage of those who oppose healthcare reform do not have health insurance. How many of them turn down Medicare when they become eligible to participate? It is easy to oppose healthcare reform when you are not the one being denied access or treatment, and when you are not the one filing for bankruptcy because of the cost of treatment.
Basic healthcare is a human right. In the United States, we have the best healthcare in the world, but not the best access in the world. I have heard statistics and personal stories about people having to wait for life saving treatment in other countries that have a national healthcare plan. I do not doubt these stories, and they are just as heartbreaking as the stories I’ve shared above. However, in the US, access and delivery of healthcare is a problem for 45 – 50 million Americans, which, in my opinion, is a disgrace.
Sources:
(1)Karen Auge, “Why costs spiral up,” Denver Post, August 23, 2009, 16A
(2)http://video.msn.com/video.aspx?mkt=en-us&vid=43fef8f9-c591-495b-9669-3f70bc85e077&fg=rss&from=34
(3)http://www.nytimes.com/2009/08/27/opinion/27kristof.html?_r=1&emc=eta1
Tuesday, September 1, 2009
Gardasil May Have Some Competition
By: Grete Dudek, CIS Compliance Associate
gretedudek@cis-partners.com
A little over one year after Dana Zelig’s article “CDC and FDA Stand by Merck’s Gardasil” (1) was published on the Pharma Compliance Blog, the FDA and CDC released a statement saying that they “continue to find that Gardasil is a safe and effective vaccine.” (2) The timing of this report is interesting, because Gardasil, a Human Pappillomavirus (HPV) vaccine manufactured by Merck, and Cervarix, an HPV vaccine manufactured GlaxoSmithKline, are both going before the FDA Vaccines and Related Biological Products Advisory Committee on September 9th. (3) The Committee will be debating whether or not to expand the use of Gardasil, which is currently only recommended for females ages 9-26, to also include males. The thought is that if men are vaccinated as well, not only will they be protected from genital warts and certain cancers, they will also prevent the spread of HPV to girls and women. The second topic to be addressed by the Advisory Committee meeting is the approval of Cervarix. If Cervarix is approved, Gardasil will face competition from another HPV vaccine for the first time in U.S. markets; the drugs are currently both approved in other countries around the world.
Although the vaccines were both developed to protect against HPV, there are some notable differences between them. Gardasil is a tetravalent vaccine, meaning it contains and protects against 4 strains of HPV- two that cause 70% of cervical cancer, and two that cause 90% of genital warts. Cervarix protects against two strains, the same two most common cancer causing strains as Gardasil, but is designed with an adjuvant to promote long term anti-body production. Cervarix has also been shown to protect against the five most cervical cancer-causing strains of HPV (4), and GSK released information at the International Human Papillomavirus conference in Sweden that Cervarix “generated a significantly higher immune response (neutralising antibodies and B cells) compared to Gardasil (5)”. Gardasil, too, has been shown to protect against strains of HPV other than the four contained in the vaccine.
A second HPV vaccine entering the U.S. market might refuel the debate on whether young girls should be vaccinated. The CDC has recommended that girls as young as 11 or 12 get vaccinated, but when the states tried to make the vaccine mandatory for school entry, parents refused, saying that the vaccine could promote promiscuity. Although the vaccines are safe, there is concern that “even a rare thing may be too much of a risk (6),” especially for healthy young girls, and women who have regular Pap tests. Cervical cancer “particularly affects girls who don’t have access to health care and Pap tests, (6)” and “since 80 percent of the 280,000 cervical cancer deaths a year occur in poor countries (7),” these vaccines could be particularly valuable in developing countries. With limited access to healthcare, Pap tests or other regular cervical cancer screenings, women in developing countries are at risk for late detection of cervical cancer. The World Health Organization (WHO) has approved Gardasil and Cervarix for use in developing countries, allowing the UN and non-profit organizations to purchase and distribute the vaccines to those who need them most.
Sources:
1. http://pharmacomplianceblog.blogspot.com/2008/08/cdc-and-fda-stand-by-mercks-gardasil.html
2. http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm179549.htm
3. http://www.fda.gov/AdvisoryCommittees/Calendar/ucm178920.htm
4. http://www.fiercepharma.com/story/glaxos-cervarix-wards-more-hpv-strains/2009-07-07
5. http://www.gsk.com/media/pressreleases/2009/2009_pressrelease_10051.htm
6. http://www.nytimes.com/2009/08/19/health/research/19vaccine.html?em
7. http://www.reuters.com/article/rbssHealthcareNews/idUSL948126520090709
gretedudek@cis-partners.com
A little over one year after Dana Zelig’s article “CDC and FDA Stand by Merck’s Gardasil” (1) was published on the Pharma Compliance Blog, the FDA and CDC released a statement saying that they “continue to find that Gardasil is a safe and effective vaccine.” (2) The timing of this report is interesting, because Gardasil, a Human Pappillomavirus (HPV) vaccine manufactured by Merck, and Cervarix, an HPV vaccine manufactured GlaxoSmithKline, are both going before the FDA Vaccines and Related Biological Products Advisory Committee on September 9th. (3) The Committee will be debating whether or not to expand the use of Gardasil, which is currently only recommended for females ages 9-26, to also include males. The thought is that if men are vaccinated as well, not only will they be protected from genital warts and certain cancers, they will also prevent the spread of HPV to girls and women. The second topic to be addressed by the Advisory Committee meeting is the approval of Cervarix. If Cervarix is approved, Gardasil will face competition from another HPV vaccine for the first time in U.S. markets; the drugs are currently both approved in other countries around the world.
Although the vaccines were both developed to protect against HPV, there are some notable differences between them. Gardasil is a tetravalent vaccine, meaning it contains and protects against 4 strains of HPV- two that cause 70% of cervical cancer, and two that cause 90% of genital warts. Cervarix protects against two strains, the same two most common cancer causing strains as Gardasil, but is designed with an adjuvant to promote long term anti-body production. Cervarix has also been shown to protect against the five most cervical cancer-causing strains of HPV (4), and GSK released information at the International Human Papillomavirus conference in Sweden that Cervarix “generated a significantly higher immune response (neutralising antibodies and B cells) compared to Gardasil (5)”. Gardasil, too, has been shown to protect against strains of HPV other than the four contained in the vaccine.
A second HPV vaccine entering the U.S. market might refuel the debate on whether young girls should be vaccinated. The CDC has recommended that girls as young as 11 or 12 get vaccinated, but when the states tried to make the vaccine mandatory for school entry, parents refused, saying that the vaccine could promote promiscuity. Although the vaccines are safe, there is concern that “even a rare thing may be too much of a risk (6),” especially for healthy young girls, and women who have regular Pap tests. Cervical cancer “particularly affects girls who don’t have access to health care and Pap tests, (6)” and “since 80 percent of the 280,000 cervical cancer deaths a year occur in poor countries (7),” these vaccines could be particularly valuable in developing countries. With limited access to healthcare, Pap tests or other regular cervical cancer screenings, women in developing countries are at risk for late detection of cervical cancer. The World Health Organization (WHO) has approved Gardasil and Cervarix for use in developing countries, allowing the UN and non-profit organizations to purchase and distribute the vaccines to those who need them most.
Sources:
1. http://pharmacomplianceblog.blogspot.com/2008/08/cdc-and-fda-stand-by-mercks-gardasil.html
2. http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm179549.htm
3. http://www.fda.gov/AdvisoryCommittees/Calendar/ucm178920.htm
4. http://www.fiercepharma.com/story/glaxos-cervarix-wards-more-hpv-strains/2009-07-07
5. http://www.gsk.com/media/pressreleases/2009/2009_pressrelease_10051.htm
6. http://www.nytimes.com/2009/08/19/health/research/19vaccine.html?em
7. http://www.reuters.com/article/rbssHealthcareNews/idUSL948126520090709
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