Life Science Compliance Update

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June 08, 2017

AccessRx FAQs Posted on DC Department of Health Website

FAQ2

In April 2017, the Department of Health (DOH) in the District of Columbia (D.C.) quietly posted Frequently Asked Questions (FAQs) regarding AccessRx reporting requirements. AccessRx requires manufacturers and labelers of prescription drugs that are dispensed in D.C. who engage in marketing in D.C. to report to the Department of Health their costs for pharmaceutical drug marketing in D.C. Under the regulations, manufacturers and labelers are required to report their prescription drug marketing costs in an annual report filed with the DOH on or before July 1 of each year.

The FAQs range from simple questions, such as who is required to report and when the reporting deadline is (answers noted above) to more complex questions, such as how the “activity date” should be reported (answer below).

Submission Timeline

The FAQs also address the problem of late submissions – they are accepted, but must be approved by the Program. For permission, manufacturers and labelers can email dc.accessrx@dc.gov – and what file format AccessRx reports should be in (Microsoft Excel – the DOH specifically requests that reports are not submitted as PDFs and that the file not be password-encrypted).

Is Double Reporting Required?

One FAQ touches upon whether payments to physicians and teaching hospitals that are reported to Open Payments should also be reported to AccessRx. The DOH answers no, physician and teaching hospital payments should not be reported to both Open Payments and AccessRx. Manufacturers are not required to report payments through AccessRx if they have been reported to Open Payments and CMS. In fact, payments to physicians and teaching hospitals should only be reported to AccessRx in very special circumstances, when they have not been reported to Open Payments.

Reportable Gifts

According to the FAQs, gifts – including food and beverages – given to physician offices and/or medical practices should be attributed to named individuals or entities. Expenditures to physician offices or medical practices that cannot be reasonably allocated to individuals may be reported as a group or non-individual gift; however, expenditures on gifts to physicians must be excluded. Gifts given to an entire office or practice should not be reported as a gift to an individual but should be reported as a non-individual gift. However, gifts given to physicians should not be rolled into gifts to a group. Further, gifts to physicians reportable to Open Payments should not be reported to AccessRx.

Advertising Expenses

When it comes to reporting advertising expenses, the “Activity Date” can be reported in ranges. “Activity date” refers to when the advertising took place. For television or radio advertisements, the date reported should correspond to when the activity happened, and the payment amount should correspond to the cost of the activity. For mailings or email promotion, the date could be when the materials were mailed or sent out.

Conclusion

Even if a manufacturer did not make payments to healthcare providers in D.C., the manufacturer is not required to submit gift expenses to AccessRx. However, the manufacturer must still report aggregate and advertising expenditures to AccessRx if the manufacturer utilized detailers or employed/contracted with anyone who was engaged in marketing or advertising in D.C.

The annual report is to be submitted with a filing fee of $5,000.00, which is payable exclusively by check and checks are to be made payable to the D.C. Treasurer. Such a hefty filing fee (one that is required by any manufacturer/labeler who markets or advertises in D.C.) leads one to think that this isn’t about transparency or any other reason D.C. and others give for reporting requirements, but instead is as a cash cow to line the city’s financial coffers.

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