Patient Protection and Affordable Care Act
CASRO provided the following comments to the Centers for Medicare and Medicaid Services (CMS) concerning the implementation of the transparency provisions of the Patient Protection and Affordable Care Act of 2010. These comments not only reaffirm and reinforce the Sunshine Act's reporting exclusion for payments to physicians for participation in pharma market research, but also seek specific notice of this exemption for pharma market research in the rule-making.
"Understandably, many pharmaceutical manufacturers are extremely cautious in their efforts to ensure compliance with all statutorily imposed rules. It is CASRO's wish that the final regulations provide increased clarity that payments made to physicians for participation in pharmaceutical market research are exempt from the Act's reporting requirements, where the pharmaceutical manufacturer is unaware of the physician respondents' identity, so that manufacturers will better understand Congress's intent to except such payments."If this statutory exclusion is reiterated in the rulemaking, we have stronger evidence to take to the legal counsel at pharmaceutical manufacturers.