09.11.14
The Centers for Medicare & Medicaid Services (CMS) recently proposed four changes to the Physician Payment Sunshine Act’s transparency rules that could result in additional costs for medical device manufacturers.
The proposals would take effect Jan. 1 and impact current data collection for the 2014 calendar year, the law firm King and Spalding said. The firm says the agency’s proposed changes include:
CMS said the changes are being implemented to correct some of the unintended consequences in the current text and to make the reporting requirements consistent across the board for drug-, biologic-, and device-makers.
King and Spalding believes reporting the names of all products associated with a particular payment will be most burdensome for device-makers, as the pharmaceutical and biologics industries already are required to do so.
Industry should be cautious of falling out of line with the law. In addition to its auditing powers, CMS can severely penalize non-compliant device-makers.
“A failure to report data in an accurate and timely fashion can lead to CMPs [civil monetary penalties] ranging from $1,000 to $10,000 per transaction, while a knowing failure to report data in an accurate and timely fashion can lead to CMPs ranging from $10,000 to $100,000 per transaction,” according to Bloomberg.
The CMS in May released its second phase of reporting requirements that took effect in July, requiring device-makers to register, report, and attest to the accuracy of information regarding payment to physicians and teaching hospitals during the last five months of 2013.
The proposals would take effect Jan. 1 and impact current data collection for the 2014 calendar year, the law firm King and Spalding said. The firm says the agency’s proposed changes include:
- Removing the exclusion for payments to physicians for speaking at certain accredited continuing education programs;
- Requiring manufacturers to report the marketed name of all product associated with reported payments or transfers of value (if any);
- Separating existing form descriptors used in reporting ownership interests into three distinct form descriptors, including “stock,” “stock options,” and “other ownership interest”; and
- Removing the definition of “covered device.”
CMS said the changes are being implemented to correct some of the unintended consequences in the current text and to make the reporting requirements consistent across the board for drug-, biologic-, and device-makers.
King and Spalding believes reporting the names of all products associated with a particular payment will be most burdensome for device-makers, as the pharmaceutical and biologics industries already are required to do so.
Industry should be cautious of falling out of line with the law. In addition to its auditing powers, CMS can severely penalize non-compliant device-makers.
“A failure to report data in an accurate and timely fashion can lead to CMPs [civil monetary penalties] ranging from $1,000 to $10,000 per transaction, while a knowing failure to report data in an accurate and timely fashion can lead to CMPs ranging from $10,000 to $100,000 per transaction,” according to Bloomberg.
The CMS in May released its second phase of reporting requirements that took effect in July, requiring device-makers to register, report, and attest to the accuracy of information regarding payment to physicians and teaching hospitals during the last five months of 2013.