Life Science Compliance Update

July 11, 2013

Senator Grassley Asks 50 States for Coordination Procedures with CMS for Sanctioned Physicians

Senator Charles Grassley (R-IA), the co-author of the Sunshine Act, recently sent letters to all 50 states this week asking how they sanction doctors in their state health programs and whether they alert the federal government when they do. The letters cited examples from ProPublica's reporting on its new Prescriber Checkup campaign, which identified doctors who had been kicked out of state Medicaid programs, but were still able to continue prescribing drugs to patients under Medicare.

Grassley expressed his concern that States were not communicating with Medicare or CMS about state or Medicaid related violations. As a result, patients may be exposed to unsafe medical treatment and millions of tax payer dollars may be wasted on fraudulent, abusive, and unreliable providers.

In his letter, Grassley explained that by statute (citing a recently enacted regulation implementing a new section of the Affordable Care Act), Medicare must terminate any individual physician or entity from its rolls if that provider was terminated under any State's Medicaid program. However, the requirement to terminate only applies if the provider, supplier, or individual was terminated or had their billing privileges revoked "for cause. Accordingly, any Medicaid provider terminated "without cause" will not be mandatorily removed from Medicare.

States have broad discretion in terminating providers and may do so both for and without cause. Unfortunately, this flexibility means that States may bar doctors from State Medicaid programs and state medical boards may even censure providers because of fraudulent activity without reporting that the action was taken "for cause." As a result, a "without cause" termination enables duplicitous and untrustworthy providers to continue to draw from Medicare, wasting tax dollars and putting patients at risk, Grassley wrote.

After citing the various incidents ProPublica found in its initial Prescriber Checkup reporting, Senator Grassley asked that the States submit answers to the following questions by July 15, 2013.

  1. Please provide your definition of both (i) for cause and (ii) without cause termination.
  2. Please provide any factors you consider when determining without cause provider termination over for cause, including how much notice you give the provider
  1. Is termination from Medicare a factor in your termination considerations?
  1. Please provide the ten (10) most recent physicians, including their Medicare provider numbers, who were terminated for cause, as well as the allegations against and detailed reasoning for their termination.
  1. Please provide the ten (10) most recent physicians, including their Medicare provider numbers, who were terminated without cause, as well as the allegations against and detailed reasoning for their termination. Please exclude those physicians who were terminated without cause due to inactivity within the program.
  1. Does the Medicaid program reimburse for prescriptions that are issued by a provider that has been terminated?
  1. Once you have terminated a provider from Medicaid, do you notify the Centers for Medicare and Medicaid Services ("CMS")? If yes:
  1. Please list the last five (5) providers, including Medicare provider numbers, you have transmitted to CMS.
  2. How many providers has CMS terminated from Medicare due to your notifications? Please list each of these providers, including their Medicare provider number.
  3. Please describe the manner in which you notify CMS.
  4. What information do you include in your notification?

If not, why not?

October 26, 2010

Letters from Grassley: Veteran Advisor Questioned For His Experience and Service

Stephen Ondra MD 
In the middle of a serious re-election campaign one would not expect Senator Grassley to be sending letters questioning the validity of a decorated veteran serving at the Veterans Administration.  But apparently, Senator Grassley has some free time on his hands and is questioning one of the most decorated veterans in government service because of his success in developing medical products. 

On May 10, 2009, President Obama appointed Stephen Ondra, M.D., as Senior Policy Advisor for Health Affairs in the Department of Veterans Affairs (VA). Prior to his appointment, Dr. Ondra served on the Veterans Affairs group in the Obama-Biden Presidential Transition Team, as well as on the Obama-Biden Campaign Health Policy and Veteran’s Policy committees.

Dr. Ondra’s experience within military health matters is significant. According to a short biography on the VA’s website, he first entered government service as a Cadet at the U.S. Military Academy. After completing pre-medical studies at Illinois Wesleyan University in 1984, he re-entered Army service while earning his doctorate at Rush Medical College in Chicago. He completed his residency training at Walter Reed Army Medical Center in Washington, D.C., where he received specialized instruction in spine surgery and reconstruction in both the neurosurgery and orthopedic specialties.

Dr. Ondra served in Saudi Arabia from 1990 to 1991 in support of Operations Desert Shield and Desert Storm. His service was recognized with a Bronze Star and Army Commendation Medal. Following his deployment, he was assigned to Walter Reed and became the Director of Spine and Skull-base Surgery. He left the military service in 1994 and joined the Clinical Faculty at the University of Michigan.

In 1996, he moved to Illinois’ Northwestern University, where he served as the Residency Program Director Vice Chair, Director of Spine Surgery, Director of the Spinal Deformity Fellowship, Director of Spine Research, and Medical Director of the Neuro-Spine Intensive Care Units. He also chaired the Medical Device and Technology Committee at Northwestern Memorial Hospital. In 2006, he was promoted to Professor of Neurological Surgery at Northwestern.

Dr. Ondra also has work significantly with government agencies. He chaired the Scientific Advisory Board for the Defense Spinal Cord and Column Injury Project for the Department of Defense, and served on the Medical Coverage Advisory Committee with the Centers for Medicare and Medicaid Services at the Department of Health and Human Services.

It would seem from his dedicated service to the military and his extensive experience and expertise in the area of spinal surgery, that Dr. Ondra’s record makes him perfect for the position he is currently in. However, Senator Charles Grassley (R-IA) believes one part of Dr. Ondra’s record makes his appointment questionable: his work with industry.

Last month, Grassley sent a letter to Erik Shinseki, Secretary of the VA, regarding Dr. Ondra’s financial relationship with medical device maker Medtronic. Specifically, Grassley acknowledged that his committee had found that for consulting services and speaking engagements, Dr. Ondra received almost $4 million from Medtronic while he was Director of Spine Surgery at Northwestern University. Grassley also pointed out that Dr. Ondra was also the principal investigator or active participant on six recent studies focusing on the spine, which were all funded by Medtronic.

Grassley based his concern on the fact that the Obama administration had stated that it would “Free the Executive Branch from Special Interest Influence.” Specifically, “No political appointees in the Obama-Biden administration will be permitted to work on regulations or contracts directly and substantially related to their prior employer for two years. It would seem like Obama made another exception to this policy for Dr. Ondra.

 His letter recognizes that Dr. Ondra was not an employee of Medtronic but Grassley asserts that he acted as an “agent of the company when promoting and speaking about medical devices on its behalf.” He uses these actions to suggest that his work with Medtronic helped Dr. Ondra get the position as Senior Policy Advisor for Health Affairs at the VA.

In particular, Grassley cites emails sent by the Chairman of the Board, President and Chief Executive Officer of Medtronic, William Hawkins, III to Medtronic Senior Vice President and head of the spinal and biologics unit, Steve La Neve, on January 16, 2009. The emails showed the high-level Medtronic officials discussing ways to nominate Dr. Ondra for the position.


As a result, Grassley asserted that the public had a right to know whether Dr. Ondra’s “policy advice and decisions at the VA are vulnerable to potential conflicts of financial interest.” To achieve the transparency and accountability Grassley asked Secretary Shinseki to provide documents or information regarding any financial disclosure or conflict of interest forms submitted prior to his appointment; emails between Medtronic regarding Dr. Ondra; any contact Dr. Ondra has had with Medtronic in his position; and the VA’s protocol for dealing with conflicts of interest.


Secretary Shinseki responded to Grassley’s letter by stating that Dr. Ondra has “executed and complied with the Administration’s ethics pledge, and that he correctly and fully disclosed his finances under the governing rules, and that he had no conflicts regarding Medtronic or any other firm when he assumed his VA duties, and has none since.”


Mr. Grassley however, not satisfied by this response, sent another letter to Shinseki last week, asking to clarify Dr. Ondra’s role, if any, in consulting with Medtronic, and also asked for additional information about Dr. Ondra’s emails and payments from Medtronic.


The Iowa Senator also sent a letter Medtronic CEO William A. Hawkins, III regarding this matter. He used this letter to ask the same questions he did of Shinseki: whether anyone from Medtronic had any contact with Dr. Ondra since his appointment; any emails between them; and what Medtronic’s policies are for interacting with senior government officials who were former contractors or consultants.


What this story demonstrates is another misguided attempt to discredit the legitimate, ethical, and legal experience and expertise of not only a highly qualified physician, but also one whose medical service is distinguished itself in the military. Additionally, the payments Dr. Ondra received from royalties were for work in product development that represented “fair market value and are completely appropriate compensation for the intellectual property he contributed.”


While there is no question that transparency for our veterans receiving medical care is an important task, discrediting the work of a highly trained and experience veteran doctor is problematic. Efforts within Congress should be to focus on ways to make veterans healthier given all of the problems with post-traumatic stress disorder and numerous other health issues associated with service and combat.


Having exposure and experience with industry has given Dr. Ondra the necessary experience to help guide the VA to provide better services to veterans. From the beginning, he was open and transparent about these relationships because he recognized the value they had provided him. He is proud, as are most physicians who work with industry, of the accomplishments and opportunities he achieved by collaborating with industry, and the positive impact this progress has had for patients and veterans.


Now it is time for Congress to work with Dr. Ondra and use his successful experience to find ways that industry can aid veterans and wounded soldiers, America’s most important patients.


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