Robert J. Dickson600 Georgetowne Court

Wexford, PA 15090724-272-1527

June 11, 2015

The Honorable Keith RothfusUnited States House of Representatives1205 Longworth BuildingWashington, DC 20515

RE: The Physician Payments Sunshine Act

Dear Congressman Rothfus:

The Affordable Care Act (ACA) has been controversial. One seemingly small part of ACA constitutes regulatory overkill and takes productive resources away from more important aspects of providing high quality healthcare to patients. This section of the ACA, The Physician Payments Sunshine Act (“Sunshine”), is reporting of payments and financial relationships between physicians and teaching hospitals and manufacturers of medical products. This section of ACA is administered by the Centers for Medicare and Medicaid (“CMS”)

The Objective of the Regulations Cannot Be Met The intent of the law is to identify which financial relationships are beneficial or which may cause conflicts of interest. However, CMS does not take a position on which are beneficial and which may result in conflicts of interest but rather believes that transparency will discourage the the development of inappropriate relationships. Once disclosed, how is the public or patient to make a decision on which relationships are beneficial and which may cause a conflicts of interest if CMS does not? Even if the public/patient would quiz a doctor or a hospital administrator about a financial relationship it is doubtful that a conclusion about a conflict of interest could be reached. Accordingly, the objective of Sunshine cannot be met.

Amounts to Be Reported Are Too SmallThe regulations require that all individual transactions in excess of $10 or more than $100 a year in the aggregate be reported. This results in a large number of transactions individually in excess of $10 being reported that do not exceed $100 per year in the aggregate. The reporting of large number of small payments wastes the time of manufacturers, hospitals, doctors and CMS. So consideration should be given to not requiring individual payments of small amounts to be reported unless they exceed a reasonable dollar threshold. This will enable everybody to focus on the larger amounts that would be more likely to result in a conflict of interest. Does anyone really believe that a conflict of interest could exist for an amount, say for the allocation of the costs of a group purchase of a dinner, say for $11?

CMS Overreach on Transfers of ValueThe concept of transfers of value is nebulous and results in items being identified as transfers of value that are an overreach by CMS. For example, manufacturers attempt to support valid independent medical education. Now CMS has proposed that companies that distribute peer-reviewed literature to physicians report those distributions as payments to physicians. H.R. 293, introduced by Congressman Michael Burgess, MD, R-Texas, would halt CMS's planned expansion, if passed. Along with most medical associations we support H>R> 293, but it does not go far enough.

Reporting Results is a Duplication of Effort Hospitals generally have codes of conduct that doctors need to comply with and these codes of conduct frequently require reporting of conflicts of interest. Accordingly, the Open Payment regulations are frequently duplicating the efforts of hospitals to avoid physicians’ conflicts of interest. The reporting and the evaluation of conflicts of interests should be left up to the govern bodies within a hospital since they are closer to and can investigate the issues.

In addition, doctors and manufacturers are already required to comply with other conflict of interest laws such as the Stark Act. The Open Payment regulations duplicate the intent of other laws dealing with conflicts of interest. Layers of additional regulatory requirements that CMS do not form an opinion will not reduce potential conflicts of interest.

Physician Specialties Unrelated to Business. A business might have products that are marketed to only one or a few physician specialties. For example an orthopedic products company may only market to orthopedic surgeons. However, an officer of a company might be related to a physician in another specialty or a physician that is a member of the board might have another specialty. The regulations require that all transfers of value to physicians even if they have specialties unrelated to the business be reported. So, for example, if the company markets a product only sold to orthopedic physicians, but a company officers wife is a cardiovascular pediatrician, the company must report report any Christmas presents in excess of $10 that he purchased for his wife. This seems a little unreasonable.

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Based upon the above observations, Congress should eliminate the Physician Payments Sunshine Act that is part of ACA. There is little sense in attempting to change a regulation that will not meet its objectives.

Sincerely yours,

Robert J. Dickson

Robert Dickson is chief financial officer of CardiacAssist, Inc., a medical device company headquartered in Pittsburgh, PA. The opinions in letter are those of Robert Dickson and not those of CardiacAssist, Inc.