By: Steven Moore, CIS Director of Business Development
stevenmoore@cis-partners.com
The Pharma Compliance Blog was launched in April of 2007, and two years later we at the PCB have hit a great milestone: 50,000 visitors! To put it in perspective, that is about the capacity of the new Yankee Stadium, the greatest franchise on the planet (that one’s for Chris Cobourn, our esteemed Practice Lead). It’s about the number of students in Penn State’s student body. It’s also about the amount of dollars that Alex Rodriguez makes in one at bat. Wait --- that makes it sound small…
During the past two years we’ve learned, we’ve laughed, we’ve cried (like when I had Lyme Disease --- sorry CIS, had to get that one in there for a snicker at me), and we’ve even embraced the term “GP Geek”. Collectively, I’m proud to be a “Compliance Geek” with all of our fellow readers!
The Blog was always intended to be a gathering place where members of the Pharmaceutical industry, and anyone else who is interested, can gain access to insightful analysis on pressing compliance issues - outside of the conference world. We aimed to create a space where Pharmaceutical professionals could gather, without fear of pop ups or advertisements about CIS (or about anything else, for that matter). Basically, the intent of the Blog was to make it a knowledge repository, almost like a ‘virtual conference,’ and I’m proud to say that two years later, we have stuck to this plan (and have even had a little bit of fun along the way).
As we move forward, I encourage you to send me (stevenmoore@cis-partners.com) and Dana Zelig (who has taken over managing the blog on a day-to-day basis --- and done quite a fantastic job; danazelig@cis-partners.com) any suggestions that you may have to help make the Blog more informative and/or useful to you and your respective teams. I lost my pride a long time ago, so we’re always open to suggestions. We do, however, prefer good ones. (I would make a smiley face here, but I hate that --- so just assume I’m smiling.)
Back when I obviously had time on my hands, I would try to ‘Google’ “Pharma Compliance” (of course in quotes because it helps narrow the search down) and spend about 4 hours trying to find a hit for the Blog. Now, when I do the very same thing, it’s the 3rd hit on Google, thanks to all of you visiting and helping to improve the content of our site. We take note of what you’re reading and try and tailor our approach to what seemingly makes you tick, and we promise to apply that same mentality moving forward.
I thank all of you who have been following the Pharma Compliance Blog during the past two years for reading, and for your comments on our content. CIS looks forward to continued work with you and your respective teams. Once again, please never hesitate to contact us with questions or comments.
Finally, know that the Pharma Compliance Blog is, and will remain: Your Space. For Your Space.
Next up: 75,000.
:)
(so I lied...)
Steven.
*
Wednesday, April 29, 2009
Tuesday, April 28, 2009
Protection of FDA Whistleblowers
By: John Jordan, CIS Senior Compliance Associate
johnjordan@cis-partners.com
A whistleblower is someone who reports the misconduct of a certain entity. The misconduct could be a violation of a law, rule, regulation, and/or a direct threat to public interest, such as fraud, health/safety violations, and corruption. Senator Chuck Grassley, Republican of Iowa, has been a vocal advocate in the protection of FDA Whistleblowers. Grassley is a longtime advocate of whistleblower protections for federal employees. He co-authored the Whistleblower Protection Act of 1989, and has since co-sponsored legislation to update the law. Grassley also conducts extensive congressional oversight. He has sought administrative and legislative reforms to address problems he has revealed at the Food and Drug Administration (FDA) during the last five years.
Last month, Senator Grassley protested a signing statement President Obama attached to the American Recovery and Reinvestment Act, the $410 billion spending bill that was issued as a stimulus to our nation's economy, for the way it contradicts the protection of whistleblowers. President Obama’s signing statement says,
The senator thinks the signing statement sends a message from the President that will prevent whistleblowers from coming out to report misconduct. Senator Grassley also stated last month that employees of the FDA deserve clarification from their Acting Commissioner about their ability to communicate with Congress and the Inspector General, following a memo issued last week, warning employees about releasing information.
Grassley further goes on about the protection of whistleblowers by stating,
In a letter to Dr. Frank Torti, Acting Commissioner of the FDA, Grassley states his feelings towards the protection of whistleblowers by saying, “The right of employees, individually or collectively, to petition Congress or a Member of Congress, or to furnish information to either House of Congress, or to a committee or Member thereof, may not be interfered with or denied.”(2) He asks for additional clarification of protection for whistleblowers, and outlines successful changes that whistleblowers have brought about.
Whistleblowers provide a check and balance that our organizations need. Without them companies could, knowingly or unknowingly, get away with violations that could have been prevented. Whistleblowers cause more organizations to be proactive in making sure they are compliant with the laws, rules, and regulations set in place for them. They also help the government in finding the organizations that cross the line of misconduct and must be punished for their actions. As Senator Grassely states, "FDA employees...have the right to be free from fear of retaliation or reprisal."(2)
Sources:
1. Obama Undercuts Whistle-Blowers, Senator Says:
http://www.nytimes.com/2009/03/17/us/politics/17signing.html?_r=1
2. Grassley Works to Protect FDA Whistleblowers: http://www.pharmaceuticalonline.com/article.mvc/Grassley-Works-To-Protect-FDA-Whistleblowers-0001
johnjordan@cis-partners.com
A whistleblower is someone who reports the misconduct of a certain entity. The misconduct could be a violation of a law, rule, regulation, and/or a direct threat to public interest, such as fraud, health/safety violations, and corruption. Senator Chuck Grassley, Republican of Iowa, has been a vocal advocate in the protection of FDA Whistleblowers. Grassley is a longtime advocate of whistleblower protections for federal employees. He co-authored the Whistleblower Protection Act of 1989, and has since co-sponsored legislation to update the law. Grassley also conducts extensive congressional oversight. He has sought administrative and legislative reforms to address problems he has revealed at the Food and Drug Administration (FDA) during the last five years.
Last month, Senator Grassley protested a signing statement President Obama attached to the American Recovery and Reinvestment Act, the $410 billion spending bill that was issued as a stimulus to our nation's economy, for the way it contradicts the protection of whistleblowers. President Obama’s signing statement says,
“I do not interpret this provision to detract from my authority to direct the
heads of executive departments to supervise, control and correct employees’
communications with the Congress in cases where such communications would be
unlawful or would reveal information that is properly privileged or otherwise
confidential.”(1)
The senator thinks the signing statement sends a message from the President that will prevent whistleblowers from coming out to report misconduct. Senator Grassley also stated last month that employees of the FDA deserve clarification from their Acting Commissioner about their ability to communicate with Congress and the Inspector General, following a memo issued last week, warning employees about releasing information.
Grassley further goes on about the protection of whistleblowers by stating,
"Federal laws protect whistleblowers and allow people who work in the federal
bureaucracy to discuss what's happening inside an agency with other officials.
Attempts to silence whistleblowers are illegal. If the memo sent last week
was intended to have a chilling effect on FDA employees who want to speak up
about problems, then that memo is contrary to the President's call for open and
transparent government, and the Acting Commissioner needs to set the record
straight."(2)
In a letter to Dr. Frank Torti, Acting Commissioner of the FDA, Grassley states his feelings towards the protection of whistleblowers by saying, “The right of employees, individually or collectively, to petition Congress or a Member of Congress, or to furnish information to either House of Congress, or to a committee or Member thereof, may not be interfered with or denied.”(2) He asks for additional clarification of protection for whistleblowers, and outlines successful changes that whistleblowers have brought about.
Whistleblowers provide a check and balance that our organizations need. Without them companies could, knowingly or unknowingly, get away with violations that could have been prevented. Whistleblowers cause more organizations to be proactive in making sure they are compliant with the laws, rules, and regulations set in place for them. They also help the government in finding the organizations that cross the line of misconduct and must be punished for their actions. As Senator Grassely states, "FDA employees...have the right to be free from fear of retaliation or reprisal."(2)
Sources:
1. Obama Undercuts Whistle-Blowers, Senator Says:
http://www.nytimes.com/2009/03/17/us/politics/17signing.html?_r=1
2. Grassley Works to Protect FDA Whistleblowers: http://www.pharmaceuticalonline.com/article.mvc/Grassley-Works-To-Protect-FDA-Whistleblowers-0001
Monday, April 27, 2009
Nurse-midwives in PA Have Won the Right to Write
By: Judy Fox, CIS Senior Compliance Manager
judyfox@cis-partners.com
Nurse-midwives across the state of Pennsylvania have been waiting for an important, and much anticipated arrival. For years, Pennsylvania has been the only state that prohibited Nurse-midwives from prescribing drugs, but that is one distinction Pennsylvania no longer carries. In 2007, PA Governor Ed Rendell signed House Bill 1255, granting prescriptive authority to Nurse-midwives. The Board of Medicine had 12 months to construct regulations to implement the law. In early April of this year the law went into effect, but the Board of Medicine still has to construct the application for mid-wives who want to apply for the authority, so it may be some time yet before the law is fully realized.
Why was Pennsylvania one of the last states to allow Nurse-midwives the practice of writing prescriptions? Previous attempts to grant the rights were met with resistance from physicians who often cited potential abuse as one of their concerns. Don McCoy, a Pennsylvania Medical Society Vice President and one of the authors of the regulations implementing the law, said that the abuse concern was addressed by requiring that a written agreement between the Nurse-midwife and a collaborating physician be on file with the Board of Medicine.
There are over 300 Nurse-midwives in the state of PA, but according to Vivian Lowenstein, President of the Pennsylvania Association of Licensed Midwives (PALM), only about 250 are practicing. In order to be licensed by the state Board of Medicine, applicants must be Registered Nurses; complete a midwife program; and must have and adhere to a collaborative agreement with a supervising physician.
In order to prescribe medications, Nurse-midwives must:
1) Have a Masters degree or its substantial equivalent (Certified Nurse-midwives (CNM’s) are not required to have a Master’s degree to practice);
2) Complete at least 45 hours of coursework specific to advanced pharmacology;
3) Have at least 16 hours of the 30 CEU’s required to renew the RN license every 2 years to be in pharmacology in order to continue prescribing;
4) Have a collaborative agreement with a physician that, at a minimum, identifies the categories of drugs the CNM may prescribe or dispense and the drugs which require referral, consultation or co-management;
5) Ensure that the collaborative agreement is with a physician with hospital clinical privileges in the specialty area of the care in which the physician is providing collaborative services;
6) Limit prescriptions for Schedule II drugs to 72 hours and not extend the prescription without the approval of the collaborating physician;
7) Prescribe Schedule III-IV drugs only up to 30 days and with any refill approval by the collaborating physician;
8) Consult with the collaborating physician before prescribing Psychotropic drugs.
The requirements certainly seem to provide controls around Nurse-midwives prescribing drugs, and to address the concerns about potential abuse, but PALM is justified in its position that there is a difference between an unlicensed midwife and a Nurse-midwife. Those differences support the feeling that the concerns for potential abuse are unwarranted and the requirement for collaborative agreements is nothing more than needless red tape.
In the meantime, there continues to be a gap in women’s healthcare access. Over the past several years, the rising cost of medical malpractice insurance has diverting many obstetricians and gynecologists from Pennsylvania. Nurse-midwives certainly help to fill the gap for pregnant women, if - and when – the Commonwealth of PA and the Board of Medicine empowers them to do so.
Sources:
www.pamidwives.com
www.ap.org
http://readingeagle.com
House Bill 1255: http://www.legis.state.pa.us
judyfox@cis-partners.com
Nurse-midwives across the state of Pennsylvania have been waiting for an important, and much anticipated arrival. For years, Pennsylvania has been the only state that prohibited Nurse-midwives from prescribing drugs, but that is one distinction Pennsylvania no longer carries. In 2007, PA Governor Ed Rendell signed House Bill 1255, granting prescriptive authority to Nurse-midwives. The Board of Medicine had 12 months to construct regulations to implement the law. In early April of this year the law went into effect, but the Board of Medicine still has to construct the application for mid-wives who want to apply for the authority, so it may be some time yet before the law is fully realized.
Why was Pennsylvania one of the last states to allow Nurse-midwives the practice of writing prescriptions? Previous attempts to grant the rights were met with resistance from physicians who often cited potential abuse as one of their concerns. Don McCoy, a Pennsylvania Medical Society Vice President and one of the authors of the regulations implementing the law, said that the abuse concern was addressed by requiring that a written agreement between the Nurse-midwife and a collaborating physician be on file with the Board of Medicine.
There are over 300 Nurse-midwives in the state of PA, but according to Vivian Lowenstein, President of the Pennsylvania Association of Licensed Midwives (PALM), only about 250 are practicing. In order to be licensed by the state Board of Medicine, applicants must be Registered Nurses; complete a midwife program; and must have and adhere to a collaborative agreement with a supervising physician.
In order to prescribe medications, Nurse-midwives must:
1) Have a Masters degree or its substantial equivalent (Certified Nurse-midwives (CNM’s) are not required to have a Master’s degree to practice);
2) Complete at least 45 hours of coursework specific to advanced pharmacology;
3) Have at least 16 hours of the 30 CEU’s required to renew the RN license every 2 years to be in pharmacology in order to continue prescribing;
4) Have a collaborative agreement with a physician that, at a minimum, identifies the categories of drugs the CNM may prescribe or dispense and the drugs which require referral, consultation or co-management;
5) Ensure that the collaborative agreement is with a physician with hospital clinical privileges in the specialty area of the care in which the physician is providing collaborative services;
6) Limit prescriptions for Schedule II drugs to 72 hours and not extend the prescription without the approval of the collaborating physician;
7) Prescribe Schedule III-IV drugs only up to 30 days and with any refill approval by the collaborating physician;
8) Consult with the collaborating physician before prescribing Psychotropic drugs.
The requirements certainly seem to provide controls around Nurse-midwives prescribing drugs, and to address the concerns about potential abuse, but PALM is justified in its position that there is a difference between an unlicensed midwife and a Nurse-midwife. Those differences support the feeling that the concerns for potential abuse are unwarranted and the requirement for collaborative agreements is nothing more than needless red tape.
In the meantime, there continues to be a gap in women’s healthcare access. Over the past several years, the rising cost of medical malpractice insurance has diverting many obstetricians and gynecologists from Pennsylvania. Nurse-midwives certainly help to fill the gap for pregnant women, if - and when – the Commonwealth of PA and the Board of Medicine empowers them to do so.
Sources:
www.pamidwives.com
www.ap.org
http://readingeagle.com
House Bill 1255: http://www.legis.state.pa.us
Thursday, April 23, 2009
Corporate Compliance and the Foreign Corrupt Practices Act
By: Alaina Anderson, CIS Compliance Manager
alainaanderson@cis-partners.com
It seems with every corner we turn, there are more reasons to have a comprehensive corporate compliance program. Here in the pharmaceutical arena, we often discuss the Office of Inspector General (OIG) Compliance Program Guidance for Pharmaceutical Manufacturers, the False Claims Act, the Anti-Kickback Statute, the PhRMA Guidelines and various state laws on the related topics.
However, it appears that the Foreign Corrupt Practices Act (FCPA) should be held in the same light as the above mentioned laws and guidelines. This is essentially an anti-kickback law regarding conduct with foreign officials. In my eight years in the industry, I have not worked with a pharmaceutical company that did not conduct business across international borders, which means this law likely applies to a great number of pharmaceutical companies.
The FCPA specifically applies to:
A few accounts from the 2009 Global Ethics Summit cite the Deputy Chief of the Criminal Fraud Section of the Department of Justice (DOJ), Mark Mendelsohn, and his predictions for 2009. He anticipates an increase in activity through additional enforcement resources and increasing multi-jurisdictional investigations. Additionally, he specifically called out the enforcement efforts involving pharmaceutical and medical device industries, domestically with the Anti-Kickback Act and internationally with the FCPA.
Most of the concerns heard earlier this year at CBI’s Pharmaceutical Compliance Congress in relevance to FCPA adherence are regarding interactions with third party vendors. The discussions at the Compliance Congress emphasized the following: If experiencing cultural or regional resistance to a written agreement or the terms of a written agreement, it is recommended that your legal department/firm handles the negotiations. But the fact remains that here in the US, a written agreement is expected and audit rights must be followed; simply naming your audit rights in the agreement is not nearly enough.
In order to adhere to the FCPA and avoid related allegations, a comprehensive compliance program is recommended. Such a program includes:
It is vital that reported allegations whether involving internal or third party personnel is taken seriously. Allegations should be investigated in a timely fashion and documentation should be maintained that describes the investigation and remediation, if applicable. And last, but far from least, remember to include FCPA as a regular part of your corporate compliance auditing and monitoring program. If you do discover inappropriate activities related to the FCPA, it is vital that you disclose them to the DOJ.
Sources:
[i] Pilchen, S. M. et al. FCPA and False Claims Act Enforcement: Corruption Crackdown in the US and Abroad presented March 12, 2009.
Gerlach, P.V. et al. (2007). US and PRC anti-bribery laws: regulation: risk and prevention in the life sciences industry. Retrieved from www.practicallaw.com/7-378-8724
Myers, C. (2009) FCPA Enforcement Under the Obama Administration: Siemens Case Sets New Precedent. Retrieved from www.hklaw.com/id24660/PublicationId2578/ReturnId31/contentid53964/
alainaanderson@cis-partners.com
It seems with every corner we turn, there are more reasons to have a comprehensive corporate compliance program. Here in the pharmaceutical arena, we often discuss the Office of Inspector General (OIG) Compliance Program Guidance for Pharmaceutical Manufacturers, the False Claims Act, the Anti-Kickback Statute, the PhRMA Guidelines and various state laws on the related topics.
However, it appears that the Foreign Corrupt Practices Act (FCPA) should be held in the same light as the above mentioned laws and guidelines. This is essentially an anti-kickback law regarding conduct with foreign officials. In my eight years in the industry, I have not worked with a pharmaceutical company that did not conduct business across international borders, which means this law likely applies to a great number of pharmaceutical companies.
The FCPA specifically applies to:
- US persons, or agents thereof
- US companies, or agents thereof
- Entities subject to US securities laws, or agents thereof
- Any person committing a prohibited act of corrupt payments while in the territory of the US
A few accounts from the 2009 Global Ethics Summit cite the Deputy Chief of the Criminal Fraud Section of the Department of Justice (DOJ), Mark Mendelsohn, and his predictions for 2009. He anticipates an increase in activity through additional enforcement resources and increasing multi-jurisdictional investigations. Additionally, he specifically called out the enforcement efforts involving pharmaceutical and medical device industries, domestically with the Anti-Kickback Act and internationally with the FCPA.
Most of the concerns heard earlier this year at CBI’s Pharmaceutical Compliance Congress in relevance to FCPA adherence are regarding interactions with third party vendors. The discussions at the Compliance Congress emphasized the following: If experiencing cultural or regional resistance to a written agreement or the terms of a written agreement, it is recommended that your legal department/firm handles the negotiations. But the fact remains that here in the US, a written agreement is expected and audit rights must be followed; simply naming your audit rights in the agreement is not nearly enough.
In order to adhere to the FCPA and avoid related allegations, a comprehensive compliance program is recommended. Such a program includes:
- Written policies and procedures
- Training on applicable laws, regulations, policies and procedures
- A hotline for reporting compliance issues
- Auditing and monitoring activities
It is vital that reported allegations whether involving internal or third party personnel is taken seriously. Allegations should be investigated in a timely fashion and documentation should be maintained that describes the investigation and remediation, if applicable. And last, but far from least, remember to include FCPA as a regular part of your corporate compliance auditing and monitoring program. If you do discover inappropriate activities related to the FCPA, it is vital that you disclose them to the DOJ.
Sources:
[i] Pilchen, S. M. et al. FCPA and False Claims Act Enforcement: Corruption Crackdown in the US and Abroad presented March 12, 2009.
Gerlach, P.V. et al. (2007). US and PRC anti-bribery laws: regulation: risk and prevention in the life sciences industry. Retrieved from www.practicallaw.com/7-378-8724
Myers, C. (2009) FCPA Enforcement Under the Obama Administration: Siemens Case Sets New Precedent. Retrieved from www.hklaw.com/id24660/PublicationId2578/ReturnId31/contentid53964/
Tuesday, April 21, 2009
Measuring Drug Risks and Benefits, with One Simple Box
By: Amanda Zanetti, CIS Compliance Associate
amandazanetti@cis-partners.com
Changes may be coming for Pharma companies if all goes well for researchers at Dartmouth University, and these changes would come in the form of new direct-to-consumer advertisements. Researchers Dr. Steven Woloshin and Dr. Lisa Schwartz just released the results of two randomized trials for drug facts boxes, that would accompany direct-to-consumer print ads. These boxes are similar in structure to the nutrition facts you would see on a food or beverage. However, they would be informing the potential consumer of the risks and benefits associated with the drug. Consumers would be able to see how well the drug worked compared to a placebo, and learn the type and frequency of side effects. In addition, the box offers the drug’s indications, guidance as to who should and should not take the drug, and things to consider while on the drug. According to the results of the trial, consumers who viewed an advertisement with a drug facts box were more knowledgeable about the drug than consumers who viewed only the print advertisement.
If federal regulators adopt these drug facts boxes, one result will be a more educated consumer. The drug fact boxes give the consumer an easy way to see some of the information they would probably ignore in the fine print. They allow for consumers to make a decision based on facts rather than what an ad says. With a drug facts box, consumers can decide for themselves if the perceived value is greater than the perceived risk.
However, not everyone is in agreement that the drug facts boxes are beneficial. Some argue that one can already find all the information contained in the drug facts box in the fine print, and that adopting these boxes may be a bit excessive. In addition, some feel that these boxes could pose a threat to manufacturers and consumers alike; while the boxes do inform consumers, the risks may scare them away from a potentially beneficial drug. This could be bad news for pharmaceutical companies, but also for consumers who would really benefit from the drug treatment.
Sources:
http://www.annals.org/cgi/content/full/0000605-200904210-00106v1
http://www.nytimes.com/2009/02/26/business/media/26adco.html?scp=1&sq=a%20push%20to%20spell%20out%20a%20drug's%20risks&st=cse
amandazanetti@cis-partners.com
Changes may be coming for Pharma companies if all goes well for researchers at Dartmouth University, and these changes would come in the form of new direct-to-consumer advertisements. Researchers Dr. Steven Woloshin and Dr. Lisa Schwartz just released the results of two randomized trials for drug facts boxes, that would accompany direct-to-consumer print ads. These boxes are similar in structure to the nutrition facts you would see on a food or beverage. However, they would be informing the potential consumer of the risks and benefits associated with the drug. Consumers would be able to see how well the drug worked compared to a placebo, and learn the type and frequency of side effects. In addition, the box offers the drug’s indications, guidance as to who should and should not take the drug, and things to consider while on the drug. According to the results of the trial, consumers who viewed an advertisement with a drug facts box were more knowledgeable about the drug than consumers who viewed only the print advertisement.
If federal regulators adopt these drug facts boxes, one result will be a more educated consumer. The drug fact boxes give the consumer an easy way to see some of the information they would probably ignore in the fine print. They allow for consumers to make a decision based on facts rather than what an ad says. With a drug facts box, consumers can decide for themselves if the perceived value is greater than the perceived risk.
However, not everyone is in agreement that the drug facts boxes are beneficial. Some argue that one can already find all the information contained in the drug facts box in the fine print, and that adopting these boxes may be a bit excessive. In addition, some feel that these boxes could pose a threat to manufacturers and consumers alike; while the boxes do inform consumers, the risks may scare them away from a potentially beneficial drug. This could be bad news for pharmaceutical companies, but also for consumers who would really benefit from the drug treatment.
Sources:
http://www.annals.org/cgi/content/full/0000605-200904210-00106v1
http://www.nytimes.com/2009/02/26/business/media/26adco.html?scp=1&sq=a%20push%20to%20spell%20out%20a%20drug's%20risks&st=cse
Monday, April 20, 2009
The Device and Drug Double Standard is Coming to an End
By: Justin Will, Esq. CIS Compliance Manager
justinwill@cis-partners.com
As the push toward transparency in the healthcare industry is making the world of devices and drugs more and more similar, there still remains a glaring difference that was created by the U.S. Supreme Court several months ago. The discrepancy was put in motion in February of 2008 in Riegel v. Medtronic[1] when the Supreme Court ruled in favor of Medtronic that federal law prohibits suits in state courts for product liability against makers of heart stents, artificial joints and other critical medical devices. Then, in March 2009, in a product liability suit (Wyeth v. Levine[2]) involving a drug maker the court ruled that this type of case is not prohibited. In other words – an injured consumer can sue a drug maker but not a device manufacturer.
On March 5, 2009 - a day after the Wyeth ruling, U.S. Reps. Frank Pallone, Jr. (D-NJ), Chairman of the Energy and Commerce Subcommittee on Health, and Henry A. Waxman (D-CA), Chairman of the Energy and Commerce Committee, introduced legislation in the House that will reverse the U.S. Supreme Court decision in Medtronic that denies injured patients the ability to seek compensation for their injuries and gives medical device makers blanket immunity.[3]
Representative Waxman’s press release states, “The Medical Device Safety Act of 2009 is designed to protect patients from dangerous and defective devices by correcting the Court's flawed interpretation of the MDA. The legislation explicitly clarifies that state product liability lawsuits are preserved.”
Sources:
[1] Riegel v. Medtronic, Inc. 128 S.Ct. 999 (2008)
[2] Wyeth v. Levine 129 S.Ct. 1187 (2009)
[3] Press Release, Rep. Henry Waxman, “Health Leaders Introduce Legislation Reversing Supreme Court’s Medical Device Decision” (March 5, 2009).
*
justinwill@cis-partners.com
As the push toward transparency in the healthcare industry is making the world of devices and drugs more and more similar, there still remains a glaring difference that was created by the U.S. Supreme Court several months ago. The discrepancy was put in motion in February of 2008 in Riegel v. Medtronic[1] when the Supreme Court ruled in favor of Medtronic that federal law prohibits suits in state courts for product liability against makers of heart stents, artificial joints and other critical medical devices. Then, in March 2009, in a product liability suit (Wyeth v. Levine[2]) involving a drug maker the court ruled that this type of case is not prohibited. In other words – an injured consumer can sue a drug maker but not a device manufacturer.
On March 5, 2009 - a day after the Wyeth ruling, U.S. Reps. Frank Pallone, Jr. (D-NJ), Chairman of the Energy and Commerce Subcommittee on Health, and Henry A. Waxman (D-CA), Chairman of the Energy and Commerce Committee, introduced legislation in the House that will reverse the U.S. Supreme Court decision in Medtronic that denies injured patients the ability to seek compensation for their injuries and gives medical device makers blanket immunity.[3]
Representative Waxman’s press release states, “The Medical Device Safety Act of 2009 is designed to protect patients from dangerous and defective devices by correcting the Court's flawed interpretation of the MDA. The legislation explicitly clarifies that state product liability lawsuits are preserved.”
Sources:
[1] Riegel v. Medtronic, Inc. 128 S.Ct. 999 (2008)
[2] Wyeth v. Levine 129 S.Ct. 1187 (2009)
[3] Press Release, Rep. Henry Waxman, “Health Leaders Introduce Legislation Reversing Supreme Court’s Medical Device Decision” (March 5, 2009).
*
Thursday, April 16, 2009
CIS Updates!
Dear Readers,
Just wanted to take a minute to point your attention to the CIS Upcoming Events bar on the left side of the blog. CIS is proud to be participating in the following upcoming conferences and events:
CBI’s 11th Annual Medicaid Rebates Conference
Tuesday, May 19th – Thursday, May 21st
Walt Disney World Swan Hotel
Orlando, FloridaCIS is an event sponsor!
CIS will also be presenting on the following topics:
Managing Customer Data for Your Government Calculations
Chris Cobourn
Recent Events and Trends in Auditing and Monitoring
Clarissa Crain
CIS Cocktail Reception on Wednesday, May 20th!
Click here for conference info!
Mastering the Government Programs Systems Environment -Assessing Your Current Toolset and Evaluating Your Options
Hosted by CIS and ExL Pharma
Wednesday, June 3, 3009
1PM – 3PM, EDT
To register online click here! (Sign up before May 8th for Early Bird Pricing!)
DIA – 45th Annual Meeting
Sunday, June 21st – Wednesday, June 24th
San Diego Convention CenterSan Diego, CA
CIS is an event sponsor!!
Click here for conference info!
To get more information about these events, please contact CIS Marketing Associate Jackie O'Connor at jacquelineoconnor@cis-partners.com. As always, we look forward to seeing you!
*
Just wanted to take a minute to point your attention to the CIS Upcoming Events bar on the left side of the blog. CIS is proud to be participating in the following upcoming conferences and events:
CBI’s 11th Annual Medicaid Rebates Conference
Tuesday, May 19th – Thursday, May 21st
Walt Disney World Swan Hotel
Orlando, FloridaCIS is an event sponsor!
CIS will also be presenting on the following topics:
Managing Customer Data for Your Government Calculations
Chris Cobourn
Recent Events and Trends in Auditing and Monitoring
Clarissa Crain
CIS Cocktail Reception on Wednesday, May 20th!
Click here for conference info!
Mastering the Government Programs Systems Environment -Assessing Your Current Toolset and Evaluating Your Options
Hosted by CIS and ExL Pharma
Wednesday, June 3, 3009
1PM – 3PM, EDT
To register online click here! (Sign up before May 8th for Early Bird Pricing!)
DIA – 45th Annual Meeting
Sunday, June 21st – Wednesday, June 24th
San Diego Convention CenterSan Diego, CA
CIS is an event sponsor!!
Click here for conference info!
To get more information about these events, please contact CIS Marketing Associate Jackie O'Connor at jacquelineoconnor@cis-partners.com. As always, we look forward to seeing you!
*
Tuesday, April 14, 2009
CIS Gets Published!
"Organizing Your Commercial Compliance Programs"
(as published in Pharmaceutical Commerce on March 28, 2009)
By: Christopher Cobourn, CIS VP of Regulatory Compliance and Clarissa Crain, CIS Compliance Director
chriscobourn@cis-partners.com and clarissacrain@cis-partners.com
Two of CIS' finest were published in Pharmaceutical Commerce last month, and we are extremely proud! Their article "Organizing Your Commercial Compliance Programs" was published on March 28, 2009.
We are providing the article's intro on the PCB; for the entire article please see the following link: http://www.pharmaceuticalcommerce.com/frontEnd/1122-compliance_OIG_off_label_PhRMA_Coburn_Crain.html
Congratulations Chris and Clarissa, keep up the good work!
(as published in Pharmaceutical Commerce on March 28, 2009)
By: Christopher Cobourn, CIS VP of Regulatory Compliance and Clarissa Crain, CIS Compliance Director
chriscobourn@cis-partners.com and clarissacrain@cis-partners.com
Two of CIS' finest were published in Pharmaceutical Commerce last month, and we are extremely proud! Their article "Organizing Your Commercial Compliance Programs" was published on March 28, 2009.
We are providing the article's intro on the PCB; for the entire article please see the following link: http://www.pharmaceuticalcommerce.com/frontEnd/1122-compliance_OIG_off_label_PhRMA_Coburn_Crain.html
Regulatory attention has intensified over commercial activities.
Here’s what to do to minimize risks and raise compliance levels:
The concept of Commercial Compliance in U.S. manufacturing has evolved
very quickly over the past 5 or 6 years, resulting in increased regulatory
requirements and investigation activity. While the security of the supply chain
and the ethical promotion of drugs has been a significant focus, recent
investigative trends show a shift in the government’s focus. Now, the federal
government and states are becoming increasingly interested in sales, marketing,
and distribution activities that ultimately affect the sales or prices witnessed
by the government. This has led to an increase in Federal False Claims Act
investigations and Off-Label Promotion investigations...
Congratulations Chris and Clarissa, keep up the good work!
Monday, April 13, 2009
Understanding the Changing GP Calculation Environment and Evaluating your System Options
By: Chris Cobourn, VP of Regulatory Compliance
chriscobourn@cis-partners.com
There are 3 key things to consider when evaluating the evolving "GP Pricing Environment."
1. Guidance is continually evolving, sometimes dramatically as in the case of the Final Rule. We in the pharma industry must continue to keep our methodology current, and to update our systems and tools.
2. The "Audit-ability Factor" has grown. With certification requirements, the CMS 10-Year Rule, and the OIG Work-plan creating the need for a proactive audit environment, we must have the capability to view complete and accurate detailed transactional data in order to demonstrate that our calculations are accurate.
3. Your company’s choice of systems and tools can affect your audit-ability. There are low cost, resource intensive tools such as Microsoft Excel (lower audit-ability), large Commercial GP systems (higher audit-ability), and third parties who use automated tools to perform your calculations and provide GP expertise (high audit-ability).
Regardless of the size or type of your company, we all face similar challenges, and some of these considerations may be keeping you up at night. Can you rely on your current systems and toolset? Can you feel comfortable with your certification? What are the real risks to the business? What are my options?
We work with companies at various stages across the GP spectrum: those who have a system in place but want to audit or assess their system, those who are implementing a system and want to make sure that GP requirements are being met, and those who are struggling with spreadsheets but are not sure what other options they have, or what is right for their business.
Wherever you are on the spectrum, I think it is important to be informed and to focus on "audit-readiness." I would also encourage you to reach out to others in the industry - you will soon realize that you are facing similar challenges. Feel free to give me a call or send an email as well, I can provide a fresh perspective and answer the questions you might have when evaluating different systems.
Those who work in the GP space understand the complexities and challenges of an always-evolving GP compliance environment. Often, your key struggle is articulating your needs within your own organization, especially in this very budget-conscious environment. Managers on the business side of your organization want to be able to evaluate the true risk to the organization, and to conduct practical value and cost-benefit analyses for your business.
Thanks, and again, feel free to reach out to me at any time with questions and comments!
Chris
chriscobourn@cis-partners.com
There are 3 key things to consider when evaluating the evolving "GP Pricing Environment."
1. Guidance is continually evolving, sometimes dramatically as in the case of the Final Rule. We in the pharma industry must continue to keep our methodology current, and to update our systems and tools.
2. The "Audit-ability Factor" has grown. With certification requirements, the CMS 10-Year Rule, and the OIG Work-plan creating the need for a proactive audit environment, we must have the capability to view complete and accurate detailed transactional data in order to demonstrate that our calculations are accurate.
3. Your company’s choice of systems and tools can affect your audit-ability. There are low cost, resource intensive tools such as Microsoft Excel (lower audit-ability), large Commercial GP systems (higher audit-ability), and third parties who use automated tools to perform your calculations and provide GP expertise (high audit-ability).
Regardless of the size or type of your company, we all face similar challenges, and some of these considerations may be keeping you up at night. Can you rely on your current systems and toolset? Can you feel comfortable with your certification? What are the real risks to the business? What are my options?
We work with companies at various stages across the GP spectrum: those who have a system in place but want to audit or assess their system, those who are implementing a system and want to make sure that GP requirements are being met, and those who are struggling with spreadsheets but are not sure what other options they have, or what is right for their business.
Wherever you are on the spectrum, I think it is important to be informed and to focus on "audit-readiness." I would also encourage you to reach out to others in the industry - you will soon realize that you are facing similar challenges. Feel free to give me a call or send an email as well, I can provide a fresh perspective and answer the questions you might have when evaluating different systems.
Those who work in the GP space understand the complexities and challenges of an always-evolving GP compliance environment. Often, your key struggle is articulating your needs within your own organization, especially in this very budget-conscious environment. Managers on the business side of your organization want to be able to evaluate the true risk to the organization, and to conduct practical value and cost-benefit analyses for your business.
Thanks, and again, feel free to reach out to me at any time with questions and comments!
Chris
Thursday, April 9, 2009
Observations of a Traveling Salesman: A Few of My Favorite Things
By: Steven Moore, CIS Director of Business Development
stevenmoore@cis-partners.com
I love Business Development. I love getting out there and meeting new people on a weekly basis. I love presenting, and interacting with both clients and potential clients alike. I love providing compliance solutions that help clients protect their growth for years and years to come. But being on the road does have its humorous and, quite honestly, annoying side. Hey, you can’t have it all! So, in the spirit of The Sound of Music, here are a few of my favorite things:
Conference calls on the road. Besides the constant annoyance for those on the call with the ‘whirring’ of cars and other noises from the road, it’s IMPOSSIBLE to get a word in and, when you do, it’s as if you’ve channeled Darth Vader. Blue Tooth devices have been a savior for this part of being on the road, but it’s another toy to play with while you’re trying to drive. I had to laugh to myself the other day when I realized that I had operating --- at the same time --- the following: Garmin Navigation System, iPod, Cell Phone, Blue Tooth, Phone charger, and Automobile. I’m thinking final component in this series should get a bit more attention. Anyone else? So I can type in navigation directions, email, text, surf the internet, pick a playlist from my iPod, charge my phone, make a call, operate my blue tooth and, oh yeah, DRIVE A CAR! I drive a red HHR folks. Stay away. You can usually spot me at a Rest Stop.
Eating on the road. Not a great recipe for health. I recently went to client lunch at Red Robin with these brilliant aspirations that I was going to find something healthy and stick with my new OLC (“Operation Lifestyle Change” for those of you playing along at home --- this is an article for another day). So I scanned the menu and realized that Red Robin could be the last remaining establishment on the face of the Earth without a single healthy thing (salads don’t count because, well, I would only order a Chicken Caesar and a Chicken Caesar is like a safe cigarette. You think you’re being healthy but you’re clearly not.) I also just recently ate a lunch from 7-11. I then stopped at a Rest Stop again.
Rest stops. Remarkable places, really. I mean, who doesn’t love ‘people watching’ . Every time I stop along some road, I marvel at the diversity of the people at EVERY rest stop. Chinese, Indian, Black, White, Brown, Purple… It’s America in a nutshell! I’ve also seen some of the most fascinating individuals at rest stops…but we won’t go there. I have to ask: Where do they all come from? And, perhaps most importantly, where are these people going?
Peeing on the road. Well, not on the road... most times. When you’re trying to make it to a meeting and are amped (GP pun intended) up on 6 cups of coffee, your bladder begins to yell at you to pull over at every available rest stop. I was recently on a two hour trip to North Jersey (which is the best for rest stops because the NJ Turnpike has about 4,000) and stopped 3 times to pee. I highly recommend the Joyce Kilmer Rest Stop as it usually has lighter traffic and shorter lines than the Walt Whitman --- of course, that is if you can hold it on your way North. Three stops for a two hour trip is a lot of stops for anyone --- let alone a 29 year old. All I can say is that Boehringer Ingelheim could make some good money marketing FloMax to future prospects like this guy.
The Airport Security Line. I’m a big believer in getting places early but, inevitably, I get to the airport too early. I hate the thought having to run through the airport and potentially miss a flight for an important meeting. That being said, the whole Airport Security thing is quite a hassle. I remember the days of throwing some stuff into a tray and walking through the scanner relatively simply. Now, don’t get me wrong, I’m ALL about security, especially in the wake of some of the awful events of recent past and the current global situation, but I never thought I’d have to get naked to get on a plane. First it was the belt, then my sport jacket, then the shoes (thanks shoe-bomber guy). The ladies, of course, like it when I go through security but, as you all know, I’m a shy guy. Then there’s this whole liquid thing. It has to be less than 3oz and has to be in clear zip lock bag --- but not just any kind --- it has to be the smaller kind. I recently forgot that I had put a full Vitamin Water in my bag and got through security and they asked if they should throw it away or if I wanted it. I had time, so I took the Vitamin Water back --- chugged it --- and got naked again to go through security. Take that, The Man. Of course I then had to pee 4 times on the plane ride…
There you have it --- a few things that make road trips that much more enjoyable. So when I show up at your place next time, know that I’m well fed, fully clothed, and that I avoided any accidents in the entertainment center that is my car. I may, however, ask to use your restroom.
For Your Space,
Steven.
*
stevenmoore@cis-partners.com
I love Business Development. I love getting out there and meeting new people on a weekly basis. I love presenting, and interacting with both clients and potential clients alike. I love providing compliance solutions that help clients protect their growth for years and years to come. But being on the road does have its humorous and, quite honestly, annoying side. Hey, you can’t have it all! So, in the spirit of The Sound of Music, here are a few of my favorite things:
Conference calls on the road. Besides the constant annoyance for those on the call with the ‘whirring’ of cars and other noises from the road, it’s IMPOSSIBLE to get a word in and, when you do, it’s as if you’ve channeled Darth Vader. Blue Tooth devices have been a savior for this part of being on the road, but it’s another toy to play with while you’re trying to drive. I had to laugh to myself the other day when I realized that I had operating --- at the same time --- the following: Garmin Navigation System, iPod, Cell Phone, Blue Tooth, Phone charger, and Automobile. I’m thinking final component in this series should get a bit more attention. Anyone else? So I can type in navigation directions, email, text, surf the internet, pick a playlist from my iPod, charge my phone, make a call, operate my blue tooth and, oh yeah, DRIVE A CAR! I drive a red HHR folks. Stay away. You can usually spot me at a Rest Stop.
Eating on the road. Not a great recipe for health. I recently went to client lunch at Red Robin with these brilliant aspirations that I was going to find something healthy and stick with my new OLC (“Operation Lifestyle Change” for those of you playing along at home --- this is an article for another day). So I scanned the menu and realized that Red Robin could be the last remaining establishment on the face of the Earth without a single healthy thing (salads don’t count because, well, I would only order a Chicken Caesar and a Chicken Caesar is like a safe cigarette. You think you’re being healthy but you’re clearly not.) I also just recently ate a lunch from 7-11. I then stopped at a Rest Stop again.
Rest stops. Remarkable places, really. I mean, who doesn’t love ‘people watching’ . Every time I stop along some road, I marvel at the diversity of the people at EVERY rest stop. Chinese, Indian, Black, White, Brown, Purple… It’s America in a nutshell! I’ve also seen some of the most fascinating individuals at rest stops…but we won’t go there. I have to ask: Where do they all come from? And, perhaps most importantly, where are these people going?
Peeing on the road. Well, not on the road... most times. When you’re trying to make it to a meeting and are amped (GP pun intended) up on 6 cups of coffee, your bladder begins to yell at you to pull over at every available rest stop. I was recently on a two hour trip to North Jersey (which is the best for rest stops because the NJ Turnpike has about 4,000) and stopped 3 times to pee. I highly recommend the Joyce Kilmer Rest Stop as it usually has lighter traffic and shorter lines than the Walt Whitman --- of course, that is if you can hold it on your way North. Three stops for a two hour trip is a lot of stops for anyone --- let alone a 29 year old. All I can say is that Boehringer Ingelheim could make some good money marketing FloMax to future prospects like this guy.
The Airport Security Line. I’m a big believer in getting places early but, inevitably, I get to the airport too early. I hate the thought having to run through the airport and potentially miss a flight for an important meeting. That being said, the whole Airport Security thing is quite a hassle. I remember the days of throwing some stuff into a tray and walking through the scanner relatively simply. Now, don’t get me wrong, I’m ALL about security, especially in the wake of some of the awful events of recent past and the current global situation, but I never thought I’d have to get naked to get on a plane. First it was the belt, then my sport jacket, then the shoes (thanks shoe-bomber guy). The ladies, of course, like it when I go through security but, as you all know, I’m a shy guy. Then there’s this whole liquid thing. It has to be less than 3oz and has to be in clear zip lock bag --- but not just any kind --- it has to be the smaller kind. I recently forgot that I had put a full Vitamin Water in my bag and got through security and they asked if they should throw it away or if I wanted it. I had time, so I took the Vitamin Water back --- chugged it --- and got naked again to go through security. Take that, The Man. Of course I then had to pee 4 times on the plane ride…
There you have it --- a few things that make road trips that much more enjoyable. So when I show up at your place next time, know that I’m well fed, fully clothed, and that I avoided any accidents in the entertainment center that is my car. I may, however, ask to use your restroom.
For Your Space,
Steven.
*
Wednesday, April 8, 2009
A Possible End to Deal-Making Between Pharma Companies and Generic Drug Makers
By: Suma Kallurkar, CIS Senior Compliance Manager
sumakallurkar@cis-partners.com
Patent protection is one of the most critical factors in a pharmaceutical company's financial success. Expiration of a patent for a key drug product, and the ensuing competition from generic products launched in the market, presents a tremendous challenge that pharma companies spend years preparing to overcome. Many pharma companies over the years have utilized the tactic of paying generic drug manufacturers to delay the launch of their generic products, in essence buying more time in which they retain exclusivity and allowing them to realize billions of dollars more in sales.
However, if the current Democratic administration gets its way, pharma companies may no longer be able to make such deals with generic drug makers to ward off the entry of competing generic products. The administration has been focusing on evaluating ways to reduce health care costs. It believes that bringing an end to such deals between pharma companies and generic drug makers would help save billions of dollars in costs, as generic drugs are often available for as little as a quarter of the cost of brand-name counterparts. Such savings would undoubtedly benefit consumers directly.
The Federal Trade Commission (FTC) has sought to fight such payments for the last several years by filing lawsuits against them, but these attempts have not fared well. In addition, similar legislation has been unsuccessful when raised in the recent past. The house has re-introduced a bill (originally introduced in the last Congress) to ban the above-described payments in patent litigation settlements between pharma companies manufacturing branded products and generic drug makers. A subcommittee hearing on the bill was held Tuesday, March 31. Proponents of the legislation hope to enact it into law this year with the support of President Obama, although it is not completely clear at this time whether or not Obama will indeed support it.
Currently, approximately 10 brand-name prescription drugs are protected by such agreements made with generic manufacturers. From the pharma perspective, eliminating the option to make deals with generic drug companies to delay the marketing of generic products will undoubtedly increase the challenges already faced from generic competition. A major concern is that reduced revenue based on entry of generics could hurt the ability to re-invest in research and innovation. However, from the health care and consumer perspective, the benefits of the significant cost savings cannot be understated, and could contribute greatly to a reduction in health care costs, thereby also benefitting economic growth. It remains to be seen whether this administration will be successful in eliminating such deals between pharma companies and generic drug makers.
Sources:
House of Representatives Committee on Energy and Commerce:
http://energycommerce.house.gov/Press_111/20090331/rush_open.pdf
Wall Street Journal:
http://online.wsj.com/article/SB123843757514670479.html
sumakallurkar@cis-partners.com
Patent protection is one of the most critical factors in a pharmaceutical company's financial success. Expiration of a patent for a key drug product, and the ensuing competition from generic products launched in the market, presents a tremendous challenge that pharma companies spend years preparing to overcome. Many pharma companies over the years have utilized the tactic of paying generic drug manufacturers to delay the launch of their generic products, in essence buying more time in which they retain exclusivity and allowing them to realize billions of dollars more in sales.
However, if the current Democratic administration gets its way, pharma companies may no longer be able to make such deals with generic drug makers to ward off the entry of competing generic products. The administration has been focusing on evaluating ways to reduce health care costs. It believes that bringing an end to such deals between pharma companies and generic drug makers would help save billions of dollars in costs, as generic drugs are often available for as little as a quarter of the cost of brand-name counterparts. Such savings would undoubtedly benefit consumers directly.
The Federal Trade Commission (FTC) has sought to fight such payments for the last several years by filing lawsuits against them, but these attempts have not fared well. In addition, similar legislation has been unsuccessful when raised in the recent past. The house has re-introduced a bill (originally introduced in the last Congress) to ban the above-described payments in patent litigation settlements between pharma companies manufacturing branded products and generic drug makers. A subcommittee hearing on the bill was held Tuesday, March 31. Proponents of the legislation hope to enact it into law this year with the support of President Obama, although it is not completely clear at this time whether or not Obama will indeed support it.
Currently, approximately 10 brand-name prescription drugs are protected by such agreements made with generic manufacturers. From the pharma perspective, eliminating the option to make deals with generic drug companies to delay the marketing of generic products will undoubtedly increase the challenges already faced from generic competition. A major concern is that reduced revenue based on entry of generics could hurt the ability to re-invest in research and innovation. However, from the health care and consumer perspective, the benefits of the significant cost savings cannot be understated, and could contribute greatly to a reduction in health care costs, thereby also benefitting economic growth. It remains to be seen whether this administration will be successful in eliminating such deals between pharma companies and generic drug makers.
Sources:
House of Representatives Committee on Energy and Commerce:
http://energycommerce.house.gov/Press_111/20090331/rush_open.pdf
Wall Street Journal:
http://online.wsj.com/article/SB123843757514670479.html
Tuesday, April 7, 2009
It’s That Time Again – Revisit Your GP Documentation!
By: Katie Lapins, Director Small and Mid-Market Pharma, and Chris Cobourn, VP of Regulatory Compliance
katielapins@cis-partners.com and chriscobourn@cis-partners.com
The recent Tricare legislation and the introduction of additional state reporting requirements for Medicaid related data may mean it’s time to update your GP documentation to account for these changes. While investigating new programs and their impact on your operations, it is also a great time to review all of your documents, including those affected by the changes made by the Final Rule. Key components that changed and should receive special attention include smoothing of assumptions, and evaluation of discounts and bona fide fees for services.
A core component of an effective documentation program is to define and implement a reasonable and consistent review cycle that ensures documents are compliant with current regulations. Here are a few areas where dramatic changes may have occurred in your company’s operations and are not yet captured in your documentation:
The key takeaway is this: Don’t let that GP Documentation just sit on your shelf! You have to see the documents as living and breathing, and they must be kept current in terms of your operations and the regulations.
As a final note, be sure to develop and implement a document naming convention that indicates the version of the document used at any given time and that you are using the current version. Remember, with the 10-Year Rule, you want to be able to show which policy and procedure documentation was valid at the time of the calculation, so document change control is a key component of audit-ability!
*
katielapins@cis-partners.com and chriscobourn@cis-partners.com
The recent Tricare legislation and the introduction of additional state reporting requirements for Medicaid related data may mean it’s time to update your GP documentation to account for these changes. While investigating new programs and their impact on your operations, it is also a great time to review all of your documents, including those affected by the changes made by the Final Rule. Key components that changed and should receive special attention include smoothing of assumptions, and evaluation of discounts and bona fide fees for services.
A core component of an effective documentation program is to define and implement a reasonable and consistent review cycle that ensures documents are compliant with current regulations. Here are a few areas where dramatic changes may have occurred in your company’s operations and are not yet captured in your documentation:
- The new Tricare rule, which may require separate policies and procedures, and its impact on your existing documents (i.e. clarifying the treatment of Tricare sales and rebates in your other GP calculations
- SPAP and Supplemental Programs (your company’s participation may have evolved over time)
- State Medicaid reporting requirements, such as those required by Maine and New Mexico
- Updates based on findings from an internal assessment or audit
- Updates based on a change in the company’s products and/or contracting strategies
The key takeaway is this: Don’t let that GP Documentation just sit on your shelf! You have to see the documents as living and breathing, and they must be kept current in terms of your operations and the regulations.
As a final note, be sure to develop and implement a document naming convention that indicates the version of the document used at any given time and that you are using the current version. Remember, with the 10-Year Rule, you want to be able to show which policy and procedure documentation was valid at the time of the calculation, so document change control is a key component of audit-ability!
*
Monday, April 6, 2009
Is Health Care Weighing Down the U.S. Economy?
By: Barb Lutz, CIS Senior Compliance Manager
Barbaralutz@cis-partners.com
President Barack Obama has only been in office for a little over two months and has already started his push for Congress to overhaul the U.S. Health Care system in 2009. He was quoted as saying, “The cost of our health care has weighed down our economy and the conscience of our nation long enough.”1 In fact, he even places part of the increasing budget deficit on expanding medical expenses. One of the biggest health care issues the nation is facing is that as the U.S. population ages, the costs of Social Security, Medicare and Medicaid will increase. CMS (The Centers for Medicare and Medicaid Services) recently reported that government spending on Medicare and Medicaid will reach $721 billion in 2009. These programs cover around 100 million people. Another major issue is that there are approximately 46 million people without health coverage because it is unaffordable.
I found these statistics to be pretty disturbing and was anxious to see what steps President Obama would be taking to correct surging health care costs. So far, he has not given exact specifics on what steps he will take to correct this issue, but has made some recommendations to Congress for a plan to slow down the increasing costs of Social Security, Medicare and Medicaid by identifying fraud in the program. He even expects Congress to reduce funding for underperforming programs that are not yielding the desired responses. President Obama wants to put into place changes that will help Americans afford coverage, and even expand government health programs to cover more uninsured Americans. This may even include the possibility of expanding Medicare coverage to Americans as young as 55. Obama also wants to modernize and create efficiencies in the health care system by moving health records into a single digital format.
I also read that President Obama is holding five Regional White House Forums on Health Care Reform. The first was held on March 12th in Dearborn, Michigan. Although President Obama did not attend, 400 people did attend the two-hour forum, including CEOs of health care systems and insurance companies; representatives of labor unions, workers, retirees, nursing professors, as well as other stakeholders in the health care overhaul debate. The overriding message from the forum was that “widespread agreement on the need for health care reform was made clear by comment after comment.”2 Other discussions included the need to accentuate preventive, wellness and primary care and to find a way to better utilize health information technology. This forum was one of five scheduled throughout the country.
It will be very interesting to see how President Obama’s recommendations on overhauling U.S. health care and the future forums play out in the next few months. Expect to see upcoming blogs on this subject as I continue to follow the upcoming Health Care Forums, and President Obama’s progress on this tough issue facing our nation.
Sources:
1. http://www.bloomberg.com/apps/news?pid=20601202&sid=aKlHsp88FGh0&refer=healthcare
2. http://kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=57470
Barbaralutz@cis-partners.com
President Barack Obama has only been in office for a little over two months and has already started his push for Congress to overhaul the U.S. Health Care system in 2009. He was quoted as saying, “The cost of our health care has weighed down our economy and the conscience of our nation long enough.”1 In fact, he even places part of the increasing budget deficit on expanding medical expenses. One of the biggest health care issues the nation is facing is that as the U.S. population ages, the costs of Social Security, Medicare and Medicaid will increase. CMS (The Centers for Medicare and Medicaid Services) recently reported that government spending on Medicare and Medicaid will reach $721 billion in 2009. These programs cover around 100 million people. Another major issue is that there are approximately 46 million people without health coverage because it is unaffordable.
I found these statistics to be pretty disturbing and was anxious to see what steps President Obama would be taking to correct surging health care costs. So far, he has not given exact specifics on what steps he will take to correct this issue, but has made some recommendations to Congress for a plan to slow down the increasing costs of Social Security, Medicare and Medicaid by identifying fraud in the program. He even expects Congress to reduce funding for underperforming programs that are not yielding the desired responses. President Obama wants to put into place changes that will help Americans afford coverage, and even expand government health programs to cover more uninsured Americans. This may even include the possibility of expanding Medicare coverage to Americans as young as 55. Obama also wants to modernize and create efficiencies in the health care system by moving health records into a single digital format.
I also read that President Obama is holding five Regional White House Forums on Health Care Reform. The first was held on March 12th in Dearborn, Michigan. Although President Obama did not attend, 400 people did attend the two-hour forum, including CEOs of health care systems and insurance companies; representatives of labor unions, workers, retirees, nursing professors, as well as other stakeholders in the health care overhaul debate. The overriding message from the forum was that “widespread agreement on the need for health care reform was made clear by comment after comment.”2 Other discussions included the need to accentuate preventive, wellness and primary care and to find a way to better utilize health information technology. This forum was one of five scheduled throughout the country.
It will be very interesting to see how President Obama’s recommendations on overhauling U.S. health care and the future forums play out in the next few months. Expect to see upcoming blogs on this subject as I continue to follow the upcoming Health Care Forums, and President Obama’s progress on this tough issue facing our nation.
Sources:
1. http://www.bloomberg.com/apps/news?pid=20601202&sid=aKlHsp88FGh0&refer=healthcare
2. http://kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=57470
Friday, April 3, 2009
Overseeing the Overseers
By: Gary Miller, CIS Compliance Associate
garymiller@cis-partners.com
What happens when the individuals or groups, put in place to be the formal oversight of a process, have insufficient oversight themselves? Eric G. Campbell, PhD, of the MGH Institute for Health Policy, says in situations such as these, they cannot accomplish their fundamental mission of ensuring appropriate conduct.1 In this case he speaks of the IRBs (Institutional Review Boards) , “committees charged with ensuring that clinical studies uphold patient rights and follow ethical guidelines.”1
In a study done by the Massachusetts General Hospital Institute for Health Policy, it was discovered that many IRBs do not require members to disclose industrial relationships, and that procedures for defining , reporting, and handling conflicts vary widely among institutions.1 Research Hospitals, and subsequently the millions of patients impacted by the decisions these IRBs are making, rely on these committees to have safe, ethical, and successful trials as their main goal, with total disregard for any personal or business benefit. Without a proper, consistent policy on relationship disclosure and conflict of interest measures, who is to know the agenda of the members of these committees?
The FDA, under the Bioresearch Monitoring (BIMO) Program, “conducts inspections to determine if IRBs are operating in compliance with current FDA regulations and statutory requirements and if the IRBs are following their own written procedures.”2 In reviewing the Information Sheet Guidance For IRBs, Clinical Investigator and Sponsors: FDA Institutional Review Board Inspections, published by the FDA, it is unclear who, if anyone, reviews the actual policies under which the IRBs are operating. As shown in this study, however, it is clear the policies that some IRBs have in place are lacking vital regulations necessary for them to fulfill their main purpose of ethical guidance.
The FDA, along with the Department of Health and Human Services (HHS), has recently released a Final Rule on IRB registration requirements, stating the need for IRBs to register with the federal government through a system maintained by the HHS. The rule states that the IRB registration requirements will make it easier for FDA to inspect IRBs and to convey information to them.3 However, the final rule seems to omit addressing the issue of conflict of interest disclosure. The final rule does not mandate the need to disclose conflicts of interest that may exist within an IRB, continuing this gap between protocol and proper agenda.
As CIS continues to grow its breadth of expertise, and with the publication of this study, research hospitals may be looking for resources to review the policies and protocols they have in place for their IRBs. This will ensure they are prepared for any inspections conducted by the FDA, and will ultimately allow the IRBs to properly perform their job on a consistent and honest basis.
1. Boards Overseeing Clinical Studies Don't Always Require Members To Disclose Potential Conflicts, Article Date: 27 Mar 2009 - 2:00 PDT, Sue McGreevey, Massachusetts General Hospital, http://www.medicalnewstoday.com/articles/143853.php
2. Information Sheet Guidance For IRBs, Clinical Investigator and Sponsors s: FDA Institutional Review Board Inspections, http://www.fda.gov/oc/ohrt/irbs/reviewboard.pdf
garymiller@cis-partners.com
What happens when the individuals or groups, put in place to be the formal oversight of a process, have insufficient oversight themselves? Eric G. Campbell, PhD, of the MGH Institute for Health Policy, says in situations such as these, they cannot accomplish their fundamental mission of ensuring appropriate conduct.1 In this case he speaks of the IRBs (Institutional Review Boards) , “committees charged with ensuring that clinical studies uphold patient rights and follow ethical guidelines.”1
In a study done by the Massachusetts General Hospital Institute for Health Policy, it was discovered that many IRBs do not require members to disclose industrial relationships, and that procedures for defining , reporting, and handling conflicts vary widely among institutions.1 Research Hospitals, and subsequently the millions of patients impacted by the decisions these IRBs are making, rely on these committees to have safe, ethical, and successful trials as their main goal, with total disregard for any personal or business benefit. Without a proper, consistent policy on relationship disclosure and conflict of interest measures, who is to know the agenda of the members of these committees?
The FDA, under the Bioresearch Monitoring (BIMO) Program, “conducts inspections to determine if IRBs are operating in compliance with current FDA regulations and statutory requirements and if the IRBs are following their own written procedures.”2 In reviewing the Information Sheet Guidance For IRBs, Clinical Investigator and Sponsors: FDA Institutional Review Board Inspections, published by the FDA, it is unclear who, if anyone, reviews the actual policies under which the IRBs are operating. As shown in this study, however, it is clear the policies that some IRBs have in place are lacking vital regulations necessary for them to fulfill their main purpose of ethical guidance.
The FDA, along with the Department of Health and Human Services (HHS), has recently released a Final Rule on IRB registration requirements, stating the need for IRBs to register with the federal government through a system maintained by the HHS. The rule states that the IRB registration requirements will make it easier for FDA to inspect IRBs and to convey information to them.3 However, the final rule seems to omit addressing the issue of conflict of interest disclosure. The final rule does not mandate the need to disclose conflicts of interest that may exist within an IRB, continuing this gap between protocol and proper agenda.
As CIS continues to grow its breadth of expertise, and with the publication of this study, research hospitals may be looking for resources to review the policies and protocols they have in place for their IRBs. This will ensure they are prepared for any inspections conducted by the FDA, and will ultimately allow the IRBs to properly perform their job on a consistent and honest basis.
1. Boards Overseeing Clinical Studies Don't Always Require Members To Disclose Potential Conflicts, Article Date: 27 Mar 2009 - 2:00 PDT, Sue McGreevey, Massachusetts General Hospital, http://www.medicalnewstoday.com/articles/143853.php
2. Information Sheet Guidance For IRBs, Clinical Investigator and Sponsors s: FDA Institutional Review Board Inspections, http://www.fda.gov/oc/ohrt/irbs/reviewboard.pdf
Wednesday, April 1, 2009
Are You Tiptoeing Through Mid-level Sampling, or Plowing Through It?
By Judy Fox, CIS Senior Compliance Manager
judyfox@cis-partners.com
Note: For the purpose of this article, the term “mid-level practitioner” means an individual practitioner other than a physician, such as a nurse practitioner, who is licensed, registered, or otherwise permitted to prescribe and/or dispense prescription drug products.
While the title of this article is a nod to the tulips and daffodils that have started to bloom here in PA, ”tiptoeing” also serves as an accurate description of the delicate maneuvering required to achieve compliance in mid-level sampling.
Navigating numerous state laws isn’t easy, and sampling training is never the most popular subject at sales meetings. But both must be done, and both must be based on state laws. The guidance is specific, so training and procedures should be equally specific. The guidance states:
At CIS, we conduct our fair share of Sample Accountability Audits and Assessments, and we review sampling training and documentation. Often, the transactions reviewed during these audits aren’t pretty when it comes to compliance for sampling mid-level practitioners.
CIS has reviewed corporate programs that contain all sorts of caveats to mid-level sampling: training slides that specifically prohibit it, procedures that require signed collaborative agreements, or training and compliance manuals that don’t address the issue at all. During interviews with members of sales forces, we have found, time and time again, that many sales representatives and managers have little, if any knowledge of the existence of state sampling laws. Nevertheless, mid-levels are sampled frequently, creating a potential compliance risk for the manufacturers.
Some procedures and training programs outline a one-time sampling rule, in which a sales representative could sample a new target, and would be notified if he or she had sampled an invalid practitioner. This notification would include instructions to cease any additional sampling to the practitioner in question. The sales force had been trained that “no news was good news” when it came to the practitioner in question, but compliance with the verification and notification procedures were never fully monitored or tested. As a result, no news was not, in fact, good news. No news was just what it sounded like: no news.
Corrective actions in such a situation would require the sales representatives to cease sampling certain targets, making for an uncomfortable conversation for some who had worked hard to build a relationship with the mid-level practitioner.
Sampling is no more secure when it is tracked electronically through a Sales Force Automation (SFA) tool. While most SFA systems can be programmed to “lock-out” a practitioner and prohibit sampling someone without a valid state license, not all systems will lock out a mid-level practitioner based on the corresponding state laws. During the interview process, we at CIS have come to find out that not only are sales forces largely unaware of state laws governing mid-level sampling, but manufacturer and SFA vendors rarely discuss the SFA user requirements for sampling mid-level practitioners.
Where does that leave an already resource-strapped sample compliance department? The issue has been identified, but finding the right solution to the problem and finding the resources to implement it can be difficult. The DEA offers a chart entitled, “Mid-Level Practitioners Authorization by State;”2 however, this chart is limited to the restrictions regarding the sampling of controlled substances. The FDA does not provide such assistance. The compliance risk presented by mid-level practitioner sampling can only be mitigated through research. A company looking to engage in mid-level sampling should conduct a state-by-state search of applicable regulations, in order to develop the appropriate procedures for compliant sampling.
Sources:
1 www.fda.gov
2 http://www.deadiversion.usdoj.gov
3 http://kcsun3.tripod.com/id110.htm
judyfox@cis-partners.com
Note: For the purpose of this article, the term “mid-level practitioner” means an individual practitioner other than a physician, such as a nurse practitioner, who is licensed, registered, or otherwise permitted to prescribe and/or dispense prescription drug products.
While the title of this article is a nod to the tulips and daffodils that have started to bloom here in PA, ”tiptoeing” also serves as an accurate description of the delicate maneuvering required to achieve compliance in mid-level sampling.
Navigating numerous state laws isn’t easy, and sampling training is never the most popular subject at sales meetings. But both must be done, and both must be based on state laws. The guidance is specific, so training and procedures should be equally specific. The guidance states:
“One comment stated that, in some States, advanced practical nurses are licensed
to prescribe certain drugs, but are prohibited from obtaining samples of the
same drugs. The comment asserted that, under the proposed definition of
“licensed practitioner,” such non-physician practitioners would be permitted to
obtain samples. In developing the proposed definition of licensed
practitioner, the agency was not aware that some States may permit practitioners
to prescribe certain drugs, but prohibit them from obtaining samples of those
drugs. Because the agency does not wish to interfere with States’
authority to determine who may request and receive drug samples, the agency
clarifies that a practitioner who is prohibited by State law from receiving
samples of certain types of drugs is not permitted to do so under PDMA even
though he or she is licensed or authorized to prescribe those drug.”1
At CIS, we conduct our fair share of Sample Accountability Audits and Assessments, and we review sampling training and documentation. Often, the transactions reviewed during these audits aren’t pretty when it comes to compliance for sampling mid-level practitioners.
CIS has reviewed corporate programs that contain all sorts of caveats to mid-level sampling: training slides that specifically prohibit it, procedures that require signed collaborative agreements, or training and compliance manuals that don’t address the issue at all. During interviews with members of sales forces, we have found, time and time again, that many sales representatives and managers have little, if any knowledge of the existence of state sampling laws. Nevertheless, mid-levels are sampled frequently, creating a potential compliance risk for the manufacturers.
Some procedures and training programs outline a one-time sampling rule, in which a sales representative could sample a new target, and would be notified if he or she had sampled an invalid practitioner. This notification would include instructions to cease any additional sampling to the practitioner in question. The sales force had been trained that “no news was good news” when it came to the practitioner in question, but compliance with the verification and notification procedures were never fully monitored or tested. As a result, no news was not, in fact, good news. No news was just what it sounded like: no news.
Corrective actions in such a situation would require the sales representatives to cease sampling certain targets, making for an uncomfortable conversation for some who had worked hard to build a relationship with the mid-level practitioner.
Sampling is no more secure when it is tracked electronically through a Sales Force Automation (SFA) tool. While most SFA systems can be programmed to “lock-out” a practitioner and prohibit sampling someone without a valid state license, not all systems will lock out a mid-level practitioner based on the corresponding state laws. During the interview process, we at CIS have come to find out that not only are sales forces largely unaware of state laws governing mid-level sampling, but manufacturer and SFA vendors rarely discuss the SFA user requirements for sampling mid-level practitioners.
Where does that leave an already resource-strapped sample compliance department? The issue has been identified, but finding the right solution to the problem and finding the resources to implement it can be difficult. The DEA offers a chart entitled, “Mid-Level Practitioners Authorization by State;”2 however, this chart is limited to the restrictions regarding the sampling of controlled substances. The FDA does not provide such assistance. The compliance risk presented by mid-level practitioner sampling can only be mitigated through research. A company looking to engage in mid-level sampling should conduct a state-by-state search of applicable regulations, in order to develop the appropriate procedures for compliant sampling.
Sources:
1 www.fda.gov
2 http://www.deadiversion.usdoj.gov
3 http://kcsun3.tripod.com/id110.htm
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