Life Science Compliance Update

September 30, 2014

Physician Payments Sunshine Act: Open Payments Is….Live?


Today, CMS launched its Open Payments System. The website went live at 2pm. Open Payments gives users the option of (1) downloading gigantic excel files of data or (2) using CMS’s “data explorer tool.”

We took advantage of both options, hoping to analyze the raw data using Excel and also to get a feel for what patients would experience if they wanted to use Open Payments to find their doctor.

Big Picture

CMS announced that the Sunshine reports revealed $3.5 billion in payments for the last five months of 2013, there were approximately 4.4 million payments.  Payments were made to 546,000 physicians and 1,360 teaching hospitals.

CMS broke down their data in several ways, including general payments and research payments, as promised. However, they also separated the data into “identifiable” at the physician level or “de-identified.” This made it necessary to combine all of these data sources to get an idea of the total amount of payments. It also demonstrated that research payment totals far exceed general payments. Furthermore, a full 90 percent of research data is de-identified.  

CMS says such data will be identified in 2015 following the submission of corrected data and physician and teaching hospital opportunity to review/dispute. Further, “data that were disputed and not resolved by the end of the September 11 review period have not been published and will be updated at a later date.” CMS puts the current de-identified data figure at 40 percent which is lower than what the data shows. 

We found the following figures:

General Payments: $976,743,814

This figure includes all meals (a huge portion of the data, many of which hover at or below $10); speaker and consulting fees; travel and lodging; educational materials; entertainment; and gifts.  There were 4,283,132 total payments in the general database.

  • The identifiable general payment reports 2,720,099 payments  for a total of $669,561,563 in payments or transfers of value
  • The de-identified data reports 1,563,033 payments for a total of  $307,182,251 

Research Payments: $1,486,242,674

Pharmaceutical companies spent vastly more on their research endeavors than on general payments. Notably, only about 10 percent of the research payments are identifiable on the covered recipient level in the Open Payments.

  • The identifiable research payment spreadsheet has 23,226 lines of data equaling $155,815,828
  • The de-identified data has 199,887 lines equaling $1,330,426,846

The best analysis of the data thus far is available at ProPublica which includes a break out of nature of payment categories.  

In the ProPublica report they mention that companies reported by operating unit.   The way the final rule was written, companies are penalized for mistakes on an operating unit basis and interpreted the requirement to report that way.

We will provide a detailed analysis and breakdown of the research payments category tomorrow.


How Will the Average Patient Use This Data?

In its press release, CMS announced that they were releasing the Open Payments data "to help consumers understand the financial relationships between the health care industry, and physicians and teaching hospitals." While we suspect the majority of users today were from the press, we attempted to use the system as an average patient would.

Instead of downloading an immense Excel file, we expect patients will use a page enabling them to “Explore the Datain order to search for their doctor, if they pursue Open Payments in the first place. When the site went live, we were able to access this database after a process of trying to figure out which choice was the one you could find your doctor in.  It was a slow, rocky ride. A partner at a leading data firm called us and expressed that they personally found the process difficult to use, so we can only imagine how a patient would feel. 

I first went to the "General Payments" category with identifying recipient information. Not knowing my particular doctor's identification number, I searched by last name. The data eventually filtered down to hundreds of doctors and thousands of payment transactions. I located my doctor, wrote down her identification number, and then organized the data set by identification numbers. Each scroll was met with a processing signal, but eventually I found my doctor's 15-20 meal payments one after the other in the list. I calculated about $200 worth of value. 

A fundamental issue in the usability of the site right now is how many categories there are for each payment. This will require patients to wade through a fair amount of confusing information before landing on each particular transfer of value, which they will then have to calculate up on their own. CMS has included a number of filtering options that can provide fairly advanced analysis of the payment data. We think that the press and/or the government may be taking more advantage of those analytic tools than patients. 

Starting around 3pm, the website stopped working, despite numerous retries. As of this evening, the website is refreshing more quickly and seems to be in semi-working order. We will provide updates about the system as we continue to work through the databases. 

Open Payments Data Photo


Today we posted important contextual information that users of the database should consider. The AMA and PhRMA have also released a statement on the Open Payments database today.  

November 21, 2012

Bart Kamen Medical Oncologist, Innovator and Infusion Pump Inventor 1949 - 2012

Barton Kamen
Imaging growing up on Long Island, NY starting medical school and working with your brother on the weekends and evenings in your parent’s basement to develop a new and greatly improved infusion pump.  That is what Bart Kamen, MD and his brother Dean did in the early 70’s. Now Dean has gone onto fame with inventing the Segway and perhaps hundreds of other devices, and Bart went the way of treating patients and developing cures for cancer. 

In late September of this year, Dr. Barton Aron Kamen, distinguished pediatric oncologist, cancer pharmacologist and “devoted family man.”  He was 63 and died from synovial sarcoma in the pleura.   

Among the numerous contributions he made to the medical community and the leadership roles he undertook, Dr. Kamen was a founding member of the Association of Clinical Researchers and Educators (ACRE).  Below is his obituary published in the UnionLeader, and some additional messages from the community. 

Dr. Kamen was born in Brooklyn, the son of Evelyn and the late Jack Kamen and grew up in Rockville Centre, N.Y.  He received his M.D.,Ph.D. from Case Western Reserve University and served his internship/residency and fellowship in pediatrics and pediatric hematology-oncology and pharmacology at Yale University.  His formal academic career consisted of three years at the Medical College of Wisconsin; 15 years at the University of Texas Southwestern Medical Center as professor of pediatrics and pharmalcology and distinguished professor of pediatrics followed by eight years as director of pediatric hematology-oncology and associate director of The Cancer Institute of New Jersey/Robert Wood Johnson Medical School, New Brunswick, N.J.  

The Cancer Institute recognized Dr. Kamen as a “compassionate and dedicated Pediatric Oncologist and a valued friend to the cancer community.”  “He will be sorely missed for his visionary approaches and advocacy for cancer research and patient quality of life,” the organization said in a statement. 

From 2007 to 2009, Dr. Kamen served as chief medical officer of the Leukemia Lymphoma Society and was to the present time a consultant to bio-pharmaceutical/cancer therapeutic companies, including Morphotek and Metronomx Group and also to the National Institutes of Health (NIH) in Washington, D.C.  During his career, Dr. Kamen was the recipient of the Scholar Award from the Leukemia Lymphoma Society; The Damon Runyon Walter Winchell Fellowship and the Burroughs Wellcome Clinical Pharmacology Award and was one of the few pediatric oncologists to be named to an American Cancer Society clinical research professorship. In addition, he was elected into the American Society of Clinical Investigation (Young Turk).  

Dr. Kamen had authored over 300 manuscripts and was the editor-in-chief of the Journal of Pediatric Hematology Oncology.  He also served on numerous editorial and advisory boards of other cancer journals. Barton served on the research and medical affairs committee of the American Cancer Society, as a commissioner of the New Jersey Commission for Cancer Research, and was on the board and treasurer of the National Coalition for Cancer Research (NCCR).  He was also a medical adviser for the Hole In The Wall Gang Camp, a consulting medical officer for the physical sciences oncology centers program of the National Cancer Institute and medical adviser for the Angiogenesis Foundation.  

Dr. Kamen's clinical and research interests were driven by the overarching goal of “translational research”-- taking best science to bedside.  His major laboratory interests for more than three decades had centered around folate biochemistry and anti-folate pharmacology.  He was currently developing treatment to prevent both resistance and toxicity, especially neurotoxicity from therapy.  He was also in the forefront of developing metronomic therapy for cancer, working with a non-profit in Geneva developing this model.  

Dr. Kamen truly loved being a physician and in pediatrics.  He nobly balanced the art and science of patient care and had a very special relationship with his patients and their families.  Holding their hands, listening--always treating the patient, earning their trust with his magic tricks.  He always said a magician is someone who is able to produce startling and amazing effects.  “I like to think I give life to kids -- and that's no trick.”  Bart Kamen was known by his colleagues as a brilliant scholar, physician and mentor and gentle man whose unfettered enthusiasm of learning, teaching, talking science and challenging the mainstay with his out of the box thinking for betterment of care was matched only by his love of his family and a good round of golf.  

At home he was the loving, prideful and devoted husband of 36 years to Ruth and the light of his life, his daughter, Libby.  He was a man of integrity, passion and had his priorities straight.  Dr. Barton Aron Kamen is survived by his wife, Dr. Ruth Saletsky Kamen; his daugher, Libby; his mother, Evelyn Kamen of Boca Raton, Fla.; his brothers, Dean Kamen of Bedford, N.H., and Mitchell Kamen of Coram, N.Y., and his sister, Terri Kamen Schulner of Wellington, Fla.  The family respectfully requests memorial contributions be offered to the Damon Runyon Cancer Research Foundation, Embrace Kids Foundation or FIRST, which was deeply saddened by his loss.

The Oncology Times also ran a touching piece on Dr. Kamen.   

Kamen’s mentor, Joseph R. Bertino, MD, Chief Scientific Officer and University Professor of Medicine and Pharmacology at UMDNJ-Cancer Institute of New Jersey/Robert Wood Johnson Medical School, said that Kamen was his first pediatric post-doctoral fellow at Yale when Bertino headed the medical school’s medical oncology program in the 1970s.  “We published our first paper together in 1980 when he was still a fellow, and it was clear that there was something very special about Bart.” 

Bertino noted that the two bonded and became good friends early on and continued collaborating through the years.  He said that after Kamen graduated from Case Western Reserve University, where he received his medical degree and doctorate in developmental biology, he came to Yale because of his interest in folate biochemistry and anti-folate pharmacology, which was Bertino’s area of expertise. 

Bertino said that one of the reasons he had left Memorial Sloan-Kettering Cancer Center after 15 years in 2002 to join the faculty at the Cancer Institute of New Jersey was to work with Kamen, who was then CINJ’s Associate Director and Director of Pediatric Hematology-Oncology. 

“Bart had tremendous energy and was passionate about science.  We would have lunch every Monday and he was always full of new information.  He told bad jokes, but the kids [his patients] loved him and he would break the ice with them with magic tricks,” he said, adding that Kamen developed the pediatric-oncology program from three to nine faculty members and increased the number of patients and protocols during his eight-year tenure there. 

Although Kamen did not see new patients in recent years, he did follow his former patients and delighted in seeing them come back, do well, and marry, Bertino noted.  

Kamen was recruited by William N. Hait, MD, PhD, to CINJ from the University of Texas Southwestern Medical Center after 15 years as Professor of Pediatrics and Pharmacology and Distinguished Professor of Pediatrics.  Hait, who was formerly CINJ’s Director and is now Head of Global Research and Development at Janssen, the pharmaceutical companies of Johnson and Johnson, said he knew Kamen since their days at Yale with Joe Bertino. 

Both oncologist-pharmacologists shared the Burroughs Wellcome Clinical Pharmacology Award one year and golfed together frequently.  “I brought Bart [to New Jersey] to take over pediatric oncology and he also served as a member of our executive committee and had a passion for teaching.  He was very intense, very smart, very analytical, and totally consumed by research focused on taking better care of his kids, especially treatments that were more effective and safer for cognition and the nervous system, which related to his earlier work on anti-folates.” 

Hait said that there was something very energetic and boyish about Kamen, a sentiment shared by others I spoke with including Ruth Kamen, who said that a colleague’s reference to Bart as a “boyish anarchist” was “spot on.” 

Joseph V. Simone, MD, said that he and Kamen “were pretty tight over the years” as they traveled through various pediatric oncology circles.  “Bart was an interesting guy who was really smart and committed, but he approached chemotherapy in a way that sometimes didn’t sit well with the cooperative groups. He was a humane and good doctor who really cared about his patients, and he also told some bad jokes.” 

American Cancer Society Chief Medical and Scientific Officer Otis W. Brawley, MD, knew Kamen since the early 1990s when Brawley was at the National Cancer Institute: “Bart was always trying to help people with their careers and gave me advice when we first met. He was always trying to create opportunities for other people, trying to connect people because he could see synergies between them.” 

Brawley said that Kamen was fascinated by how science worked, and had a sense of amazement and enthusiasm. He added that beyond Kamen’s basic decency he believed in the orthodox application of the science and believed in developing the medical evidence.  The two became even closer when Kamen was serving as Brawley’s chief medical officer counterpart at the Leukemia & Lymphoma Society. 

Ruth Kamen said that her husband was very close with his family and that he and his entrepreneur/inventor brother Dean, best known for the Segway, teamed to develop an infusion pump for drug delivery, building the prototypes in the basement of their parents’ home.  Bart also supported Dean’s FIRST Robotics as a lead judge for the Chairman’s Award. 

From the time of his diagnosis in May 2011 until this Labor Day when he was admitted to the hospital, Kamen was determined to maintain his quality of life and conduct business as usual. 

He continued working as Editor-in-Chief of the Journal of Pediatric Hematology Oncology (published, like OT, by Wolters Kluwer, Lippincott Williams & Wilkins) to consult, lecture, and publish, as well as making time to ride his bicycle and play golf, and according to Ruth, “he made each day a Camelot!”  She said that he had been scheduled to present a talk at Princeton University in early September but since he was hospitalized at the time, several people who had planned to attend the lecture visited him in his nearby hospital, spending about two hours with him. 

He died Sept. 27, but kept his promise to be there for his and Ruth’s anniversary and the 21st birthday of their daughter Libby, both earlier that month.  In addition to Ruth and Libby, and his brother Dean, of Bedford, NH, he is survived by his mother, Evelyn Kamen, of Boca Raton, Fla., his brother, Mitchell Kamen, of Coram, NY, and his sister, Terri Kamen Schulner, of Wellington, Fla. 

I am thankful to have had the opportunity to work with Bart and seen his enthusiasm for life first hand.  This weekend as we celebrate thanksgiving, we should give thanks for people like Bart who was willing to take risks to develop products that save lives.


July 26, 2012

Gordon West CME Leader and Advocate 1951-2012

Gordon West
The continuing medical education (CME) community lost one of its leaders and advocates this past week.  Gordon West, PhD, President of the Society of Academic Continuing Medical Education (SACME) passed away, on July 17, 2012.  Dr. West was 61, according to his obituary.  

For the last 12 years, West served as the Director of Continuing Education at the Annenberg Center for Health Sciences at Eisenhower.  “We are one of the few CME educational providers catering to a multidisciplinary group of health care professionals from the medical, nursing, pharmacy, psychology, dental and social service fields,” West said.  At the Annenberg Center, Dr. West directed and designed continuing education programs while ensuring every activity meets essential guidelines for credit; he was also involved in the development of long-range evaluation tools to assess program effectiveness. 

Dr. West was also Chair of the Legislative Committee for the Southern California Medical Education Council; a surveyor for the Accreditation Council for Continuing Medical Education (ACCME); a certified continuing medical education professional (CCMEP); and a member of the Alliance for Continuing Medical Education in the Health Professions.  He was a Presbyterian minister for 35 years and a professor at College of the Desert in Palm Desert, California for 15 years.  

Dr. West began his term as SACME President in June 2012.  He aspired to enhance working relationships among CME professional peer groups and intensifying the organization's network with other national associations.  “I also want to position CME as more than just issuing certificates and credit.”  He added, “I want to elevate how we educate patient-care teams among our multidisciplinary groups . . . to foster an ‘extended care’ team concept.”  Reflecting on the challenges and the future of the CME industry, Dr. West believed his term would be intriguing mainly due to the considerable uncertainty facing the profession.  Due to the current physician shortage, Dr. West believed technology would be a significant factor in CME delivery. 

“Physicians are busy balancing patient loads and managing patient costs, therefore, continuing education requires more targeted and convenient delivery.” Dr. West added, “We may need to design CME activity into smaller learning segments.”  Whether applying his people skills, exploring, designing, or launching a new program, Dr. West is sure about one thing - continuing education and learning are an ever- evolving work in progress. 

Dr. West earned a Doctor of Ministry from Columbia Theological Seminary in 1977.  In 1992, he received his PhD in Curriculum and Instruction from the University of South Florida.  He joined Eisenhower Medical Center in 1995 as chaplain and employee assistance coordinator and transferred to the Annenberg Center for Health Sciences at Eisenhower and the CME profession in 2000.  An accomplished educator and speaker, he conducted multiple-subject medical grand rounds, and had several published articles. 

In his kind demeanor, Gordon affected many of us. 

Gordon was a quiet leader who truly was one of the really nice guys in this or any field.” Stated Todd Dorman, Associate Dean for Continuing Education at Johns Hopkins. 

Lois Colburn, Executive Director of University of Nebraska Center for Continuing Education expressed deep respect, “Gordon was a treasured colleague and friend who had the wonderful ability to bring people to consensus in a quiet, thoughtful manner that left everyone feeling like a winner.   The very skills a good leader needs.”

Melinda Steel, a former SACME president reminisced, “Gordon was one of those people who was easy to talk to about anything.  When I first met him, we talked more about family and faith than about professional issues.  I knew immediately that he was the kind of person I could be friends with regardless of our professional connection.  He was a strongly ethical person but also compassionate and caring in making sure that he listened and heard all sides before gently guiding a decision process.” 

Melinda was touched by his enthusiasm “Gordon’s passions in the CME world were much the same as mine.  He believed in strengthening the ties between professional groups and working together to reach a common goal.  He believed CME was more than just providing continuing education to physicians; it was about enhancing quality through interprofessional teams to improve patient care and outcomes.”

Todd Dorman sums up everyones feelings in his reflections “I will miss him more than I can find words to say.” 

The family requests donations be made to the American Heart Association .


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