The Adventures of Steven Moore, Scooter Boy, Part Tres: A Trilogy Comes to a Close

It is with great regret that as I write this article I am making plans to return my Scooter to the local Home Health Care Center. I’ve laughed. I’ve cried. I’ve hurled. It’s been a whirlwind 8 weeks and I thought I’d share with all of my friends the top 10 things I’ve learned as Scooter Boy.

10. Chicks dig Scooters: I had to beat them off with a stick --- or was it a cane…? Granted, most of them were collecting Social Security, but I try and aim for quantity, not quality. In years, that is.

9. Old people are not only older than us and have whiter hair --- they’re actually a lot smarter than me: Older folks go to the doctor when something hurts. They use devices that help them cope with the issues they have. They’ve learned that listening to your body requires getting up and going to the doctor as soon as possible. Me? Nope. I demolished my Achilles Tendon on December 15th and then waited 3 days and a CIS holiday party to get to the doctor. However, this is where things changed. I saw someone at the doc’s riding on a Scooter and it hit me, “I’m a Mooreon.” Perhaps it’s time to grow up and stop acting like a tough guy and do what’s best for my body. So I researched and picked up my Scooter a few days later. It was a savior and I’m going to miss it, but I have honest, newfound respect for my elders who don’t let perception get in the way of allowing themselves to cope with their issues. This section is way too serious for this article so, to sum it up, old people kick ass. Can I say ass on the Pharma Compliance Blog? I just did. Twice. Sh*t.

8. Stevocol and Alcohol can help you deal with Protocol: Stevocol is listening to my own body. Alcohol is a substance that relaxes, depresses, angers and puts you to sleep all in the same night. Protocol is what you’re supposed to do per the doctor. By listening to myself and drinking a beer or four at aptly timed moments, I was effectively able to put myself to sleep so I listened to what the doctor said. Therefore, for the math majors and all of the compliance folks reading: Steveocol + Alcohol = Protocol or, what I like to call, Scootpliance.

7. Drinking and driving also pertains to Scooters: I had one slip during my time as Scoots the Wonder Boy. The idiot that I am decides to try and race back and forth from room to room on my Scooter while timing myself from run to run. I’m no Apolo Ohno or Lindsey Vonn, but I felt I could take anyone on a Scooter --- even the most experienced Scooter-wielding folks from the aforementioned #9. However, on this particular night, I decided to turn into Mario Scootereti and slipped off my Scooter and used my bad foot to break the fall. Mistake. Bigger mistake was consuming a couple (or a couple, couple) cold ones prior to embarking on this clearly, misguided mission. So a warning to all of you out there: Scoots don’t let Scoots drink and drive.

6. The best time to get hurt is when you get 51.5” of snow in 5 days: Granted, it would have been great if my Scooter had snow tires, but being cooped up for 8 weeks can only be tolerable during this winter in the Northeast. Quietly, without telling me, my wife called the TV show ”Haulin’ House” and moved us to Buffalo. I can’t tell you how hard it was to watch my wife do all that shoveling while sipping a warm cup of coffee inside our toasty home. Hey, don’t think of me that way! I shouted out plenty of directions and orders from time to time!

5. Birdwatching from a Scooter makes you the biggest dork on the planet: Do I really have to expand on this one?

4. The best medicine is laughter --- at yourself: I have to admit, calling yourself Scooter Boy and publishing it to the world is not something everyone would do, but I’ve learned that laughing at yourself can sometimes change your perspective on things. A lot of people have it a lot worse than me in this life and I thought that embracing my sudden transformation from 30 to 86 would be fun. I can’t believe the feedback I’ve gotten and how many clients are now emailing me starting with “Dear Scoots” or “Hey Scooter Boy”. I laugh every time, and I thank you all for the support. Not to be melodramatic, but it was a tough time for me, especially considering how active I like to be, but you indulging my want to deride myself and playing along has seriously helped contribute to my spirits and healing. Thank you. Now that I’ve gotten that out of the way, can I sell you some Compliance services?

3. I’m more thankful than ever for healthcare: My surgeon, Dr. Steven Cohen of the Rothman Institute, was astoundingly responsive and performed a flawless surgery. If you’re in the Philly area and need a great Orthopedic Surgeon, look no further. I’m walking under my own power 6 weeks after surgery and, from what I’ve read, that’s REALLY fast. Dr. Cohen was one of many impressive, kind folks I met during my ‘ride’ and tenure as Scooter Boy. If you have healthcare, be thankful for it…

2. Showering in a chair rocks: Yup, that’s right. I had to buy a chair with handle bars to shower for the first few weeks while I was unable to walk or stand. We are now at 8 weeks and it’s still in the shower despite my ability to easily get in and get out. What? Imagine you always stood up to watch TV and then someone introduced you to a recliner. Would you ever return the recliner?

1. My wife, Noreen, is the most amazing human being on Earth: Any woman that can put up with me for 8 weeks to date, and basically do everything for me for the first 4, has got to be one incredible person. I publicly thank my soul mate for keeping me grounded, sane and for making me laugh when all I really wanted to do was cry.

For Your Space,
Steven.

For those of you who missed the first installment and Part Deux, please check out these links:
http://pharmacomplianceblog.blogspot.com/2010/01/adventures-of-steven-moore-scooter-boy.html
http://pharmacomplianceblog.blogspot.com/2010/01/adventures-of-steven-moore-scooter-boy_12.html

Sebelius Requests Explanation from WellPoint on Premium Increases

By: Scott Hoffman, CIS Senior Compliance Associate
scotthoffman@cis-partners.com

Healthcare reform hasn’t been in the press much in the last few weeks after the results of the Massachusetts Senate elections; however, that is most likely going to change. WellPoint, which operates Blue Cross and Blue Shield plans in 14 states [2], recently announced premium rate hikes of up to 39% and that has drawn the ire of those insured as well as the government, specifically Kathleen Sebelius, Secretary of Health and Human Services (HHS). WellPoint raised the premiums 39% for residents of California, while residents of Maine are going to see a 23% increase, Oregon 15% and Kansas up to 20% [1]. Kathleen Sebelius stated that she has some degree of skepticism about a company with profits of $2.7 billion in the fourth quarter alone needing to impose rate hikes on 800,000 customers so they can keep their profit margins going [2]. In light of the increases, she has requested an explanation as to why WellPoint needs to increase their rates to that extent.

In response WellPoint sent a letter to HHS outlining the following points in order to justify the hikes:

1. Healthy customers are dropping coverage to save money while sicker ones retain it and run up medical bills
2. Healthy customers are switching to cheaper insurance options, further reducing revenue
3. Some customers are moving into a higher age category that carries higher premiums
4. Deductibles and co-payments haven't gone up with inflation
5. Prices for medical care are rising
6. People are using more healthcare, and again, age is a factor [3]

In addition to the points made above, Brian Sassi, President of the Consumer Business Unit, stated, “We need to make sure that our premiums cover the cost of claims.” WellPoint made approximately $2.75 billion in profit during the fourth quarter of last year, (as well as an additional $2 billion from the sale of one of its businesses, but that doesn’t really count in the context of this topic), which seems to me like the cost of their premiums is more than adequately covering the cost of the claims [4]. I have to admit, a company generating $2.75 billion in one quarter from core operations, in this economy, seems to be a pretty healthy business. Granted I have only a broad understanding of the insurance business, but a quick look at Yahoo! Finance (ticker symbol WLP for those wanting to check) shows me the last three years resulted in profits of $2.5 billion in 2008, $3.3 billion in 2007 and $3.1 billion in 2006. This just further goes to show the costs of premiums are definitely covering the cost of claims year in and year out.

When Scott Brown was elected to fill the Massachusetts Senate seat, Healthcare Reform lost a lot of momentum. Now that this WellPoint rate hike is in the news and gaining attention, you can be sure Healthcare Reform will begin to be debated again. You can also be sure that both Democrats and Republicans will not be seeing eye to eye on how to combat increases like this in the future as both sides still can’t agree on how this should be addressed [5]. Should be an interesting couple of months….

Sources:
[1] http://news.yahoo.com/s/ap/20100213/ap_on_he_me/us_insurance_rates_states
[2] http://tpmdc.talkingpointsmemo.com/2010/02/california-insurers-rate-hike-becomes-rallying-point-for-health-care-reform.php
[3] http://news.yahoo.com/s/ap/20100211/ap_on_he_me/us_insurance_rates_wellpoint_glance
[4] http://www.usatoday.com/money/industries/insurance/2010-02-11-wellpoint-explains-hike_N.htm
[5] http://online.wsj.com/article/SB10001424052748704337004575059913178282490.html

Articles of the Week!

Courtesy of: Scott Hoffman, Senior Compliance Associate
scotthoffman@cis-partners.com

1) No Reform? Look For More Consolidation
http://www.fiercepharma.com/story/no-reform-look-more-consolidation/2010-02-08

2) Leverage Sought In Health Summit
http://online.wsj.com/article/SB10001424052748703615904575053770388352204.html

3) WellPoint Blames Big Premium Hike On Dempgraphics
http://www.usatoday.com/money/industries/insurance/2010-02-11-wellpoint-explains-hike_N.htm

4) Medicines Not Working? There’s An App For That
http://www.reuters.com/article/idUSTRE61A0Q320100211

5) Scientists Find First Genes Linked To Stuttering
http://news.yahoo.com/s/ap/20100211/ap_on_sc/us_med_stuttering_genes

2011 White House Budget

By John Jordan, Compliance Associate
johnjordan@cis-partners.com

February 1, 2010, President Obama released his proposed budget for the fiscal year of 2011. The fiscal year starts in October, 2010. The total for the 2011 budget is $3.8 trillion. With this said, the current year’s deficit will be a record breaking $1.6 trillion, and 2011 projected deficit would be $1.3 trillion. As many of us are wondering, how does this affect the Pharmaceutical area? The Department of Health and Human Services received $81.3 billion in support from the President’s budget . This is slightly down from the approximately $82 billion estimated for 2010. According to the Budget documentation some of the key highlights include:

• Supports health insurance reform by expanding patient-centered health research to give patients and physicians the best available information on what treatments will work the best for them. Also in supporting investments in health information technology, expanding prevention and wellness activities, and launching payment reform demonstration programs in Medicare.
• Adds $290 million for healthcare centers to expand health care access to the medically underserved.
• Expands support for biomedical research, by providing an increase of $1 billion for the National Institutes of Health.
• Invests approximately $1.4 billion to strengthen food safety efforts.
• Supports over 8,500 healthcare professionals in medically underserved areas through the National Health Service Corps.
• Continues a commitment to invest in the Indian Health Systems.
• Invests more than $3 billion for HIV/AIDS prevention and treatment activities to expand access to affordable healthcare and prevention services.
• Includes $25.5 billion for a 6-month extension of the American Recovery and Reinvestment Act (ARRA) temporary increase in Federal Medicaid match.
• Increases funding towards bio-defense medical countermeasure development.
• Places renewed emphasis on preventing, detecting, and recouping fraudulent, wasteful, and abusive payments in Medicare, Medicaid, and Children’s Health Insurance Program (CHIP).
• Increase of $1.6 billion for child care to serve 235,000 more children than could be served without additional funds in 2011 for the programs Head Start and Early Head Start.
• Increases help for families caring for aging relatives at home.

The $25.5 billion allocated for the 6-month extension of the ARRA is to help States maintain their Medicaid programs during a period of high enrollment and not enough funding within the State revenue systems. This provides the States with fiscal relief for an extended 6-month period. President Obama’s budget also has an increase of $250 million aimed toward the prevention of fraud. This is supposed to ensure that the government, including the Department of Justice, the Office of Inspector’s General, etc., will strongly enforce the penalties to a manufacturer if there is a case of fraud towards the Medicaid, Medicare, and CHIP programs.

In addition to those accounts within the Department of Health and Human Services, there were a few changes that took place between the 2010 budget and 2011 budget proposal. The Administration decided to terminate the funding for the projects in the Health Care Facilities and Construction, the Denali Commission, which supports the construction of health facilities in Alaska, and the Delta Health Initiative, which consists of training healthcare professionals, and the purchase of equipment in Mississippi. These programs were designated as being private health care facilities and should not be included in Federal spending.

The Administration feels that it will be saving money in the long run by investing in certain sectors of the Department of Health and Human Services. For example, it feels that for every dollar spent to prevent and fight healthcare fraud and improper payments, approximately $1.55 will be saved. Another view is that by putting forth legislation to provide additional program integrity authority to the Centers for Medicare and Medicaid Services (CMS), CMS can take specific actions against providers that do not follow appropriate Medicare payment requirements. Another method of fraud prevention is to require States to track and monitor providers’ drug billing, tracking, and utilization patterns that could help deduce whether or not payments are being paid inappropriately.

With this budget in place, the President’s advisors are predicting that the deficit will decrease in the future and that investing now will pay off in the long. According to an article in the New York Times,

“Over 10 years, according to the administration, the budget would save an
estimated $1.2 trillion, mainly by ending the Bush tax cuts for the richest
Americans and freezing some domestic spending for three years. But that total is
roughly one-fifth of the size of the debt that will pile up from now to 2020,
the budget shows.”

Peter Orszag, President Obama’s budget director, also states that Obama will keep his promise towards reducing the deficit in half by the end of his term.

There is also another side of the argument in regards to the deficit. According to some research, it is shown that the national deficit would reach $18.6 trillion in the year 2020, if everything is accepted in President Obama’s proposal. This statement was made by James Capretta, who served as an associate director at the White House Office of Management from 2001-2004. A deficit that large would likely start an economic crisis. “At some point, the flood of Treasury debt instruments worldwide would lead lenders to demand higher rates of return for their loans, or perhaps to runaway inflation — or more probably both. The result could be quite devastating to private-sector business investment, productivity and job growth, making it all the more difficult to get out from under the debt spiral that would ensue,” states Capretta.

Sources:
1. http://www.whitehouse.gov/omb/budget/Overview/
2. http://www.nytimes.com/2010/02/02/us/politics/02budget.html
3. http://www.foxnews.com/politics/2010/01/31/obama-offers-budget-deficits-far-number-crunchers/http://www.kaiserhealthnews.org/Columns/2010/February/020410Capretta.aspx

The MMR Vaccine and Autism – A Broken Link?

By Suma Kallurkar, CIS Senior Manager
sumakallurkar@cis-partners.com

In 1998 a landmark study was published in the British medical journal, The Lancet, which first suggested a link between autism and the vaccine for measles, mumps and rubella (MMR). The consequences of the study were highly significant, as it spurred concerns among British parents that the MMR vaccine could cause autism. These concerns spread to the U.S. as well, and over the last decade, many parents have chosen not to have their children receive the MMR vaccine. Although there has been subsequent scientific evidence that shows no causal link between the MMR vaccine and autism, anti-vaccine sentiment has remained strong, much to the dismay of the medical community.

Now, 12 years later, The Lancet has fully retracted the study after the General Medical Council, an independent regulatory panel in the UK, investigated and found the lead author of the study, Andrew Wakefield, to have acted unethically in the conduct of the study. Of particular concern to the journal was that the children were not treated ethically and had been picked for the study rather than being referred by physicians. The unethical conduct includes:

• Lack of ethics approval for certain actions conducted by some of the researchers (including Wakefield)
• Certain claims in the study were false
• Wakefield received payment from solicitors representing parents who believed their children had been harmed by the MMR vaccine
• Blood was drawn at a child’s birthday party where the children were paid

Many argue that this retraction has come too late, and that the damage done by the study may be difficult to un-do. The study has been credited with causing a decline in MMR vaccination rates and a subsequent rise in measles. It will be difficult to allay the fear that many parents have developed with regard to vaccines, despite the strong evidence that there is no link between vaccines and autism. Fears have been exacerbated by the stark rise in diagnosis of autism over the years. The medical community will have to continue to work at convincing many of these parents of the benefits of vaccines to their children.

Sources:

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2810%2960175-7/fulltext

http://online.wsj.com/article/SB10001424052748704022804575041212437364420.html?mod=WSJ_hpp_MIDDLENexttoWhatsNewsSecond

http://news.bbc.co.uk/2/hi/health/8493753.stm

http://blogs.wsj.com/health/2010/02/02/the-end-of-a-paper-that-linked-autism-to-a-vaccine/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+wsj%2Fhealth%2Ffeed+%28WSJ.com%3A+Health+Blog%29&mod=smallbusiness

Finally - An Uplifting Story About Prescription Drugs

By: Jon Dellaquila, Compliance Manager
jondellaquila@cis-partners.com

We have all heard various arguments around healthcare reform and its impact on the pharmaceutical industry, and deservedly so; healthcare is vitally important to all of our wellbeing. The rising cost of prescription drugs has become a concern to many over the years, and suffering through the worst recession in decades certainly does not help. In a 2009 survey conducted by the Consumer Reports National Research Center, 70 percent of the 2,004 participants had to modify their lifestyle in order to afford their prescription drugs. A more stunning conclusion from this study revealed that 28 percent of the people polled actually stopped filling their prescriptions because they were unable to afford them.[1] These facts are very concerning. People with potentially life-threatening conditions are putting their own health at risk in order to survive financially. Scary, very scary. Many people reading this may be affected, or may know someone who has faced a similar situation. I unfortunately, can relate to the latter. However, the situation involving this person close to me actually worked out for the best.

Growing up, I always wanted to be a Pharmaceutical Sales rep and decided to head towards a financial degree in college. However, the day before I was to leave for my sophomore year, I had to have knee surgery to repair a torn medial meniscus. Being the naturally inquisitive person I am, I asked if I could watch it. So I did, even after the nurse told me that no one actually makes it through; they typically pass out. I made it though, and after that, I switched my entire class schedule for the fall semester because I had decided I wanted to be a doctor. I never made it to med school, but did find myself working in the pharmaceutical industry and eventually working in the field of Oncology clinical research.

A relative of mine was diagnosed with Stage IV lung cancer, and her doctors indicated that chemotherapy would probably not be effective in her particular case; instead they suggested simply monitoring her progress. For a year, everything was great and nothing had changed. Recently however, her physician suggested that it may be worthwhile for her to try a relatively new cancer treatment, which targets a specific receptor that is significantly expressed in several types of cancer. This drug is currently approved as a second line therapy; however, not as a first line therapy for her particular cancer. Since she did not receive chemotherapy and she would be using it as a first line therapy, it would not be covered by insurance. She was to take it every day for a year... at a cost of $5,000 a month. Do the math; it is a significant amount of money for one year that very few could possibly afford. What would you do?

I put on my Oncology hat and started doing some research about the drug, the company that makes it and if there were any programs she would be eligible for that provided assistance. Turns out, the company itself offered a patient assistance program; however, she was denied based on her income level. Well, a friend of hers got involved and wrote a letter to the company. A week or so later, an individual from the company called my relative and informed her that they were going to help her out. They would provide the drug to her - free of charge. It was a story that was hard to believe; one you hope for, one you pray for. One I just had to share.

As the great Jimmy Valvano said in his 1993 ESPY acceptance speech, “Don’t give up, don’t ever give up.”[2] If you or someone you know is in a similar position where a prescription drug becomes too expensive to afford or is simply unaffordable from the start, utilize the internet. Explore the drug and how it works, research the company that makes it. Do not be afraid to reach out to a friend in the industry or ask your doctor. You never know what programs may be out there that could provide assistance. Times may get tough and money can get tight, but you can never put a price tag on your life.

For assistance on programs that are available, please visit ‘Rx Assist, the Patient Assistance Program Center at http://www.rxassist.org/.[3]

Sources:
[1] http://www.consumerreports.org/health/prescription-drugs/sticker-shock-at-the-pharmacy-counter/overview/sticker-shock-at-the-pharmacy-counter.htm - Accessed on February 5, 2010.

[2] http://www.jimmyv.org/remembering-jim/espy-awards-speech.html - Accessed on February 5, 2010.

[3] http://www.rxassist.org/ - Accessed on February 5, 2010.

My 2010 Super Bowl Glog

By Steven P. Moore, Director, Business Development
stevenmoore@cis-partners.com

8:20AM: As an amateur meteorologist and admitted snowstorm aficionado, I was happy and proud to proclaim 2’ of snow in Philly last Tuesday. Now my excitement has turned to concern as another potentially significant storm could drop 12” or more snow on Tuesday and Wednesday. I’m no math major, but with 28.5” on the ground in Philly, that’s like 80”. Crazy.

6:20PM: Hearing the ‘Walter Payton Award’ reminds me that I’m old enough to remember the original Super Bowl Shuffle in 1985. Man, I’m old. And I just ticked off a lot of people.

6:21PM: The National Anthem. B. Michael Jackson’s, uh, Carrie Underwood’s outfit. D-.

6:25PM: Dwight Howard and LeBron James renew the Michael Jordan and Larry Bird McDonald’s “nothing but net” commercials and say “Who’s that?” when Larry Bird shows up. That’s like a rookie golfer seeing Jack Nicklaus and asking the same question. Or, for those who are not golf fans, it’s like a new member of the Jersey Shore seeing “The Situation” and asking the same questions. C+ because the dunks were amazing --- with the potential for higher grades if the commercial ‘evolves’ throughout the game.

6:27PM: Heads. Sweet.

6:28PM: Calling Colts 31-28. Ask my wife if this actually happens.

6:34PM: Doritos. Dog takes off his collar --- puts it on his owner, then barks in order to shock his owner. I wasn’t a huge fan but my sister Allyson (shout out Ally!) texted me and said that everyone laughed where she was… so I’ll give it a B+!

6:35PM: The Saints punt. Is that the first time their punter had to kick it away this year?

6:42PM: Bud Light house commercial. C+. Were it Guinness or Dirty Martinis. A.

6:43PM: Betty White commercial from Snickers. B+ because that guy drilled her and then, when back in the huddle, the guy says, “C’mon, you’re playing like Betty White!!!”

6:45PM: Super Bowl Shuffle commercial from Boost. I absolutely have to give it an A because Jim McMahon came out on, wait for it, A SCOOTER!!!!! The Pharma Compliance Blog has apparently gone viral…

6:52PM: Russell Crowe in Robin Hood. I’m in. Of course when it comes out On Demand. What? Going to the movies is expensive!

6:53PM: Doritos kid slaps his Mom’s date and says, “Keep your hands off my Doritos and keep your hands off my momma.” C. Predictable. If he kicked him in the groin I may have given it a C+.

7:02: Colts 10-0. Dang Peyton looks good. What a throw to Garcon!

7:03PM : Coke and The Simpsons. Year after year Coke just gets it. Amazing. They have few comparators. A.

7:04PM: GoDaddy.com. They should try and use sex a bit more in their ads. I heard it sells. C-.

7:05PM: Doritos ‘playing dead’ commercial. Their 3rd commercial that has not been very good in my opinion… C. How much time does creative have to spend millions?

7:07PM: Monster.com. Groundhogs can’t play the violin. They can only predict whether there will be 6 more weeks of winter. At our pace in the Northeast, there will be 18 more weeks of winter… Did I mention there’s another foot or more coming to Baltimore and Philly. What the heck would 50” of snow look like???

7:12PM: Jabari Greer is hurt and my wife and I realize that we’ve lost yet another name choice for our first born son. First it was Plaxico, then it was Anquan. Now Jabari. The curse continues.

7:18PM: Budweiser Human Bridge Commercial. B because there was ANOTHER shot of a guy on a SCOOTER!!! Were it a Guiness or Dirty Martini truck. A.

7:20PM: “Hi. I’m Mark Sanchez and this message is to all the women out there. Peyton Manning owned us.”

7:21PM: CareerBuilder.com Casual Fridays commercial with everyone in their underwear followed by a group of grown men singing ‘I Wear No Pants’ while marching in their underwear. A combined C- for way too many unattractive people in their skivvies.

7:21PM and 6 seconds: My wife and I turn to each other and immediately break out in song: “Pants on the ground, pants on the ground, lookin’ like a fool with your pants on the ground. With the gold in yo mouth, hat turned sideways pants at the ground. Call yourself a cool cat lookin’ like a fool, walkin’ downtown with your pants on the ground. Get up, hey, get your pants off the ground, lookin’ like a fool, walkin’ talkin’ with your pants on the ground. Get up, hey, get your pants off the ground, lookin’ like a fool with your pants on the ground.”

7:23PM: Brett Favre at 50 years old and the 2020 MVP by Hyundai. 2010: I’m retiring. I’m not retiring. 2011: I’m retiring. I’m not retiring. 2012: I’m retiring. I’m not retiring. 2013: I’m retiring. I’m not retiring. 2014: I’m retiring. I’m not retiring. 2015: I’m retiring. I’m not retiring. 2016: I’m retiring. I’m not retiring. 2017: I’m retiring. I’m not retiring. 2018: I’m retiring. I’m not retiring. 2019: I’m retiring. I’m not retiring. I just wanted you to feel what it would be like if we actually had to live through that. I just threw up.

7:25PM: Dove for Men, eh Really? This is much like Old Spice for women or after shave for your legs. Good luck with that Dove.

7:36AM: Dodge Charger: Man’s Last Stand. And here I thought my Scooter was getting the ladies all excited! By the way, I’m looking into snow tires for my Scooter…

7:41PM: Alice in Wonderland. Does Johnny Depp ever play a normal human. Edward Scissorhands, Willy Wonka, Jack Sparrow and now this… He won Sexiest Man Alive and no one even knows what he really looks like. That’s impressive…

7:42PM: Punxutawney Polamalu sees his shadow. Man, missing the playoffs makes you desperate during the offseason. (My boss is a big Steelers fan and I can email you my resume if you’d like…)

7:43PM: The Saints go for it on 4th down and do not get it. Calling Bill Bellichik…

7:52PM: 10-6 Colts at the half. Nice first half but not nearly as high scoring as I predicted. Look forward to a high scoring and high flying 2nd half --- or course after I get to hear The Who. I wonder if they will they come out on Scooters? How about the NFL books something current like Green Day, John Mayer or General Larry Platt?

8:07PM: The Who is rockin’. Seriously. I take back my comment from 7:52 but still would have liked to see The General perform Pants on the Ground live! “It’s only Teenage Wasteland!” I’m singing aloud and my wife is not appreciative… Wait a second…are they lip synching?????

8:21PM: Sean Peyton. Go for it on 4th down at the 1 yard line. Fail. Onside kick to start the 2nd half. Pass. The man is fearless. Or crazy. I’m still not sure. 13-10 Saints!

8:29PM: Punch Buggy commercial --- I like it but I HATE Volkswagen. C.

8:31PM: CBS: Call Barney Stinson. Legend --- wait for it --- ary.

8:38PM: Peyton Manning goes right back down the field dissecting the Saints defense. A shot of the Manning family up in their private booth. Giants fans throw objects…

8:43PM: New E*Trade baby. I was skeptical because I loved the old baby --- and his buddy Benny with the golden pipes, “Take, these broken wings…”. However, that was hilarious. “Was that Milkaholic Lindsey over?” “Milkawhat.” A+. I laughed my arse off…

8:52PM: Oh my God. Google doesn’t even need to advertise --- have they ever? That commercial was absolutely incredible. I’m giving it the very first A++ in my Super Bowl Glog history. No damn wonder they’ve been able to do what they’ve done. That was beyond smart. Wow. Remember that KGB Sumo Wrestling commercial anymore? I didn’t think so…

8:59: Budweiser 55. At what number of calories does a beer cease to be a beer and become a flavored water? That’s become a contest between beer companies these days. It’s like someone coming out with “7 Minute Abs.”

9:25PM: Saints grab the lead!!! What a game!!! 2 point conversion fails. 22-17. Wait --- overturned! 24-17!

9:34PM: Budweiser Clydesdale and the baby steer Forrest Gump take off… Nice! B+.

9:48PM: Congrats to the New Orleans Saints! 31-17 victors. All kidding aside, it’s a great story for a city with some seriously tough circumstances the past few years!

For Your Space,
Steven.

Articles of the Week!

Courtesy of: Jackie O'Connor, CIS Marketing Associate
jacquelineoconnor@cis-partners.com

1) 'Vegetative state' man responds to questions
http://www.cnn.com/2010/HEALTH/02/04/vegetative.state/index.html

2) Study fails to link saturated fat, heart disease
http://www.reuters.com/article/idUSTRE61341020100204

3) Doctors Stunned When 3-Year-Old Girl's Brain Tumor 'Disappears'
http://www.foxnews.com/story/0,2933,584921,00.html

4) FDA Concerned Dissolvable Tobacco Appeals to Kids
http://www.washingtonpost.com/wp-dyn/content/article/2010/02/04/AR2010020403627.html

5) Artificial Pancreas Helps Type 1 Diabetics During Sleep
http://news.yahoo.com/s/hsn/20100205/hl_hsn/artificialpancreashelpstype1diabeticsduringsleep

Government Programs and Pricing Compliance Summit Next Week!

GP Summit Update:
MDRP 101/201 Workshops Cancelled Monday Due to Weather, Tuesday Program to Proceed for those in Attendance.

With the near record snowfall in Baltimore on Saturday and another storm approaching on Wednesday, IIR has cancelled MDRP 101 and 201 workshops at the GP Summit on Monday, February 8th and is offering a consolidated full day session on Tuesday, February 9th.

For more information, please click here.


CIS is a participating speaker and exhibitor!

Government Programs and Pricing Compliance Summit
When: February 8-10th
Where: Baltimore, MD
http://www.iirusa.com/gp/welcome.xml
Hyatt Regency Baltimore

Monday, February 8th
B2 GP Town Hall Forum
8:45AM – 5PM

GP 201 is an advanced full-day GP Town Hall Forum. It is your unique opportunity for access to top agency officials to discuss topical issues. Now in its third year, this forum has become the “talk of the town” as the place to have a working dialog between your peers in the GP environment, including the agencies, law firms and industry. The unique venue is designed for experienced GP professionals, fostering discussion on operational issues and challenges across the programs.

The GP Town Hall forum begins with a discussion on the current status of health care legislation, including the policy and operational impacts on Government Programs. Each subsequent session throughout the day focuses on general topics across programs as well as specific programs. There are no formal slides or presentations. Each program session covers topical issues and challenges and will have various perspectives, including those from agencies, legal, industry and consultants. Attendees are invited to participate in the discussion and to ask questions to the panel members.

The full day GP 201 Forum includes:

• New Challenges in Managing the Government Business – What does healthcare reform mean to the government and commercial businesses? What is the timing of any reform and what are the key considerations for manufacturers when making projections?
• Restatements and Recalculations – What are the rules and guidelines for recalculations and restatements across the programs? How do the requirements of the programs differ? What are the operational challenges associated with a recalculation and restatement?
• Mergers, Acquisitions and Divestitures – How do companies manage their reporting responsibilities in the complex environment of the acquisition of companies and/or products, as well as sales and divestiture of products? What level of due diligence in GP should companies do when they are contemplating M&A activity?
• Topical Policy and Operational Issues – What are the “hot topics” in policy and operational issues across Medicaid, Medicare Part B, OPA/PHS and the VA?
• Overview of the OIG – Review of each branch and mission of the OIG

Moderators:
Christopher Cobourn, CIS VP, Regulatory Compliance
William Baxter, CIS Strategic Advisor, Government Affairs

Track B:
Tuesday, February 9th
1:45PM-2:30PM
Developing an Effective Risk Management Strategy Across Government Programs: Proactive Testing, Monitoring and Audit practices
Proactive audits are now built into the budgets of regulators and an audit could happen at any time. Are you ready? It is vital to develop a strategic Risk Management plan to manage risks across Government Programs. Effective Risk Management means a proactive Testing, Monitoring and Audit plan which uses "audit readiness" as a key benchmark of your program compliance. Topics in this session include:

• Defining Risk Management
• The importance of "OIG Audit Readiness"
• Defining Testing, Monitoring, and Audit
• Developing and Implementing a meaningful program
• Developing and Implementing effective corrective actions
• Working through and with infrastructure limitations

Clarissa Crain, CIS Director, Commercial Consulting Services

Track B:
Tuesday, February 9th
2:30PM-3:15PM
Panel:
Risk Management Strategies Government Program Compliance

• What constitutes sufficient documentation?
• How do the SOX 404 requirements affect manufacturers in terms of resource commitments, time, systems, vs. perceived, or real, value?
• Determine the anticipated areas of compliance that are expected to see the greatest level of activity in the foreseeable future?
• Hear new exposures areas for consideration.

Panelist: Clarissa Crain, CIS Director, Commercial Consulting Services

Track B:
Tuesday, February 9th
3:45PM-4:15PM
Panel:
Covered Products and the Product Master
Pharmaceutical Manufacturers should ensure that they have a correct understanding of “Covered Products” in the Medicaid Program, as well as the VA and PHS programs, and are in compliance with their reporting requirements under the programs. Manufacturers should be “in-synch” between their GP Reporting function and their Regulatory function to ensure that they are aligned with their product definitions and that what is entered in CMS’ DDR system is accurate. This will become increasingly important as the OIG, DOJ and states put increased scrutiny on Medicaid Reimbursement and identify where the government may be reimbursing for non-covered products. In this panel we discuss topics that include the definition of a covered product, as well as recommended best practices for manufacturers to develop and maintain an accurate and auditable product master.
Moderator: Amy VanDeCar, CIS Director, Commercial Consulting Services

Wednesday, February 10th
11:30AM-12:15PM
Roundtable (B): Current Hot Topics Government Reimbursement Programs
Moderator: Christopher Cobourn, CIS VP, Regulatory Compliance

Social Networking Sites and Pharma

By Craig Kubicek, CIS Compliance Associate
craigkubicek@cis-partners.com

Social networking sites have become a hit around the world. Facebook, Myspace, and Twitter, to name a few, have revolutionized our ability to communicate with one another. Social networking has allowed us to keep in contact with friends, family, celebrities, athletes, and businesses. However, pharmaceutical companies are not as willing as most individuals to create profiles for themselves on social networking sites. There are few regulations designed primarily to govern the behavior of pharmaceutical companies in social networking contexts, but many pharmaceutical companies have made cautious and limited entries into the social networking realm.

Pharmaceutical companies understand that many guidelines and regulations designed for other communications media apply to behavior in the social networking realm, but the lack of regulations and guidelines specifically addressing conduct in the social networking sphere makes many pharmaceutical companies reluctant to make a splash in social networking.

Some pharmaceutical companies have already made it into the social networking space and have taken advantage of its unique ability to stay in constant contact with people. However, in November 2010, the U.S. Food and Drug Administration may create some rules and regulations between pharmaceutical companies and social networking. A public hearing is scheduled for November addressing, “ how pharmaceutical companies use the web and social-media tools to market their products, the first step in a long overdue process that will finally establish guidelines for how drug makers proceed in a Web 2.0 world.” [1]

Obviously, not every pharmaceutical company is using social networking sites. Without guidance on how the sites can be utilized, pharmaceutical companies are understandably cautious about entering this world. Guidelines for existing media are often not robust enough to apply to social networking, while guidelines addressing the unique issues related to social networking have yet to be written. Still, pharmaceutical companies don’t want to be left behind while the internet moves towards a Web 2.0 interface, becoming more interactive and user-oriented.

When trying to determine the appropriateness of a promotional activity, pharmaceutical companies can turn to the Division of Drug Marketing, Advertising, and Communications (DDMAC), a division of the FDA that is responsible for reviewing pharmaceutical advertisements. The DDMAC keeps an eye out for false or misleading information in drug ads, but they perform a wide variety of other tasks, as well, including:

“providing written comments to pharmaceutical sponsors on proposed promotional
materials to ensure clear and unambiguous communication of the laws and
regulations relating to prescription drug promotion; reviewing complaints about
alleged promotional violations; initiating enforcement actions on promotional
materials that are false or misleading; comparing the product labeling and
promotional materials of various closely related products to ensure that the
regulatory requirements are consistently and equitably applied; traveling to
major medical meetings and pharmaceutical conventions to monitor promotional
exhibits and activities; and acting as a liaison between DDMAC and other
divisions within the FDA on promotional issues.” [2]

While some existing guidelines and regulations governing TV, radio, print, and internet promotions undoubtedly apply to the social networking sphere, it’s not clear how these guidelines should or will be applied. Some aspects of social networking, especially those allowing for user feedback, create potential problems which simply are not possible in other, more traditional forms of media.

Joe Natale, the Vice President of Childrenwithdiabetes.com (a Johnson and Johnson subsidiary) has this to say about the role of a drug company and social networking: “There’s a tremendous responsibility that a company has to shoulder when they get into this space, where there are going to say good things about you, bad things about you, there will be adverse events that take place, there’s going to be off-label advocacy. These are things that make healthcare regulatory people extremely nervous.” [3]

When given the opportunity to provide feedback, internet users are more than happy to voice their opinions. Pharmaceutical companies have correctly identified this as a possible problem for many reasons. User feedback could be a source of negative publicity because “user-generated content will include complaints about injuries caused by their drugs' side effects. The law requires these ‘adverse events’ to be reported to the FDA. The FDA's adverse-event databases are regularly combed by lawyers looking for potential class-action suits.” [4] Users could also advocate off-label uses for drugs in a forum created by a pharmaceutical company – would this be a case of a pharmaceutical company advocating off-label drug use in violation of regulations, or would it be considered the opinion of a third party with no relation to the drug or its manufacturer? Nobody knows for sure – guidelines addressing scenarios like this have not yet been issued.

For now, it looks like most pharmaceutical companies are keeping their hands out of social networking to avoid the many regulatory grey areas that surround it. Until the industry figures out effective ways of utilizing social networking sites and is given guidelines on how social networking tools can and cannot be used, you won’t be seeing any posts on your Facebook wall from drug manufacturers.

[1] http://adage.com/digital/article?article_id=139228
[2] http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm
[3] http://industry.bnet.com/pharma/1000309/a-qa-with-jjs-joe-natale-on-why-pharma-stays-stuck-in-the-webs-past/
[4] http://www.brandweek.com/bw/content_display/current-issue/e3ie08aadb553c2ade9caea50c91352c7aa

Common Field Sales Complaint #1 – “It always feels like somebody’s watching me”

By Judy Fox, CIS Compliance Director
judyfox@cis-partners.com

No doubt everyone is familiar with the annoyance of having a song stuck in your head all day long, regardless of whether you like the song or not. By now everyone has seen and heard the commercials with a stack of money with eyes that feature a remix of Rockwell’s song, “Somebody’s Watching Me” playing in the background. If the commercial hits just right, that song stays with you all day long. Welcome to my world. I hear that song playing in my head constantly, but not because of the commercial.

As an auditor, I am often called upon by a Compliance Officer to interact with Field Sales Representatives for various projects such as audits, investigative interviews, and ride-along assessments. More times than not, throughout the course of my interactions, I hear the same complaint from both representatives and their direct managers, “Why can’t I just be left alone to do my job?” This is the point when the song starts playing in my head.

In my role as a Compliance Consultant, I can usually tie that type of statement into a disconnect between the Compliance Office and the Field Sales Force when it comes to communicating and understanding the importance of the compliance program. To some extent, if you are a member of a Field Sales Force, it should feel like somebody is watching you. After all, activities in the field often end up being some of the riskiest areas of compliance. So how can the Compliance Office monitor a Field Sales Force, and make sure that they understand and respect the consequences of non-compliance?

It starts at the top. Executive management has to make it clear that compliance is taken seriously and that the Compliance Office has a responsibility to monitor activities. The various departments responsible for monitoring compliance, such as Sample Accountability, also have to be empowered to discipline and enforce the consequences of non-compliant activities. Discipline for repeat non-compliant behaviors by an individual or within a district should include reprimands for individuals and their managers. In my experience, knowing that there is shared accountability has always shaken Field Sales Managers out of a “look the other way” mentality.

It seems rather simple, doesn’t it? So why is there such a problem out there? Again, I can only speak from experience, but the problem usually starts with the involvement of the Sales Department in compliance decisions. For example, Sales doesn’t want Compliance to put a damper on a national sales meeting, so they may allow only a fraction of the agenda for compliance training, or they just ignore it during a meeting all together and the training takes place over a web based session. Not that web based training isn’t effective, it just doesn’t always send a strong enough message when it is the only place compliance is mentioned. Sometimes, Sales Managers don’t want to burden a top-producing representative with the stress of an audit, so they push for a postponement. The managers can’t be blamed – it is their job to get their team selling, but they are only players in the promotional game and, as with any game, there are rules. Just like a professional athlete, breaking the rules of a game can be costly. You can’t send a team out onto the field without them knowing the rules and the consequences for breaking the rules. While I am not what one would consider an avid sports fan, I have seen my share of pee-wee, high school, college and professional games and I have never seen a coach ignore a player who made a costly mistake caused by forgetting, ignoring or flaunting the rules.

A compliance program should work in the same way. Using Sample Accountability as an example again, the most compliant and successful programs track and trend non-compliant behaviors and, most importantly, hold representatives and their managers accountable for non-compliance by imposing significant disciplinary and, ultimately, financial consequences. When someone knows that they may not qualify for their bonus because of their actions or when a manager may not qualify for a bonus because of the behavior of a direct report, they tend to all remember the rules of the game.

In addition to empowering those responsible for various compliance-based roles, Executive Management has to have clearly defined roles and authority of both Sales Management and Compliance. Sales cannot be allowed to interfere with the work done by Compliance in any way. Sales has a job to do and everyone in the company can be affected if they don’t do it well, but the role of Compliance is to determine the rules regarding how the Field Sales Force can and cannot do its job. Everyone needs to understand that the rules are based on federal and state regulations, and Executive Management needs to emphatically endorse the fact that the rules are not negotiable. Ignoring the rules should never be an option.

One of the best ways that Compliance can make sure no one is breaking the rules is by watching everyone and making it clear that, “Somebody’s Watching You.”

Ha! See if you can get that song out of your head now!

Children's Hospitals May Request "Retroactive Rebates" Under the 340B Program

By: Chris Cobourn, VP of Regulatory Compliance
chriscobourn@cis-partners.com

Manufacturers have recently begun receiving letters from Children’s Hospitals seeking “retroactive rebates” dating back to February, 2006 under the new 340B program extension to Children’s Hospitals. Here are my thoughts on the matter.

Manufacturers should be mindful of the requirements that are outlined for Children’s Hospitals in the Federal Register Notice: 340B Drug Pricing Program- Children’s Hospitals from the HHS. The Notice was published in the Federal Register / Vol 74, No 168 / Tuesday, September 1, 2009 as documentation of final guidance regarding the extension of the 340B Outpatient Drug Program to Children’s Hospitals that meet requirements of the 340B Program. Children’s hospitals meeting these requirements may be eligible for retroactive rebates because, according to the rule:

“…children’s hospitals, as covered entities for purposes of the PPA,
besteffectuates the statutory scheme and therefore children’s hospitals are
coveredentities for purpose of the PPA…”

Retroactive rebates could have a substantial financial impact, with the rebates being the difference between the commercial price paid and the price the entity would have paid under the 340B program; however, it may be unlikely that many Children’s Hospitals will be able to meet the burden of proof necessary to be eligible for such rebates.

There are a few key requirements that have to be met (see section F on the notice, page 45211). Requirements include:

1. Hospitals have one year from the final rule (September 1, 2009) to request the rebate
2. Hospitals have 30 days from when they become eligible for the program to request the rebate (in writing to the manufacturer)
3. Hospitals must provide a listing of products, prices paid, and the retrospective rebate sought as evidence to manufacturers
4. In order to be eligible for a retroactive rebate, the entity would have to show that it has “satisfied all requirements for participation in the 340B program back to the date discounts are requested” (see the important note below)
5. The covered outpatient drugs must be evidenced to not to create issues of duplicate discounts through Medicaid

Note: Item #4 above may be the most difficult criteria for entities to demonstrate, as it includes the prohibition of entities purchasing any drug through a GPO. It should also be noted that HRSA has specifically stated that this prohibition is blanket to all drugs. In other words, just because a given product was not purchased under a GPO agreement does not mean it is eligible. If the Hospital purchased any drugs from a GPO during the period of time in question, then they are precluded from this opportunity.

It is the responsibility and obligation of the Children’s Hospital to provide manufacturers of evidence of all the requirements outlined in the Federal Register. The entity has to have auditable records supporting claims for retroactive rebates.

In the end, the fiscal impact of the allowance of rebates should be minimal to manufacturers, as most entities will not meet requirements. However, this will not mean that letters will not continue to come in to manufacturers. It seems there is a great deal of confusion in the Children’s Hospital channel as to how this opportunity is being extended, and what the requirements are. Therefore, some Children’s Hospitals are extending letters to manufacturers within the timeframe outlined in the Federal Register simply to reserve the right to pursue retro rebates should they find that they are eligible.

The bottom line for manufacturers is that they should seek for the Hospitals to meet the burden of proof outlined by the Register prior to extending rebates. It is not only the obligation of the entity to provide sufficient evidence of compliance with the requirements; it is further their obligation to work with manufacturers to resolve disputes.