A representative of the Open Payments Team at CMS, hosted a Webinar on Thursday, October 29, 2015 about Open Payments and the new submittal and data collection changes for CY2015 data and CY 2016 data, respectively. This webinar comes on the heels of a presentation by Mr. Brown, presented at the Sixteenth Annual Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum, in late October.
Both presentations shed light on the progress CMS has made on data submission and answered some open questions, a summary of which is laid out below.
Stakeholder Feedback Changes
The representative mentioned that they had received a lot of stakeholder feedback and were working on making some responsive changes, including the ability to exchange reporting entity and covered recipient contact information to help facilitate the review and dispute process. The system will now ask you what contact information you want shared with the individuals/organizations reviewing your records, and you can input the most convenient way to contact you.
CMS also received a lot of comments on the special character restrictions; most of the unnecessary special character restrictions have now been removed.
The ability to download reported records will also be enhanced in the update: the downloaded records will now be enhanced to include dispute information and be extended to covered recipient uses. Each download is limited to 400,000 records, which stands in contrast to the upload limit of 250MB. Therefore, CMS recommends that your uploaded data be less than 250MB and 400,000 records so the same files that are uploaded can be downloaded all at once.
One more change CMS has made from stakeholder feedback is that the covered recipient interface will allow users to distinguish whether a record identifies them as a covered recipient or a principal investigator.
Help Desk Feedback Changes
In addition to stakeholder feedback, CMS received feedback from their help desk. One of the new updates will be that reporting entities may delete records that have a status of “system processing.”
Additionally, recipient type and details on payment records and principal investigator information on research records cannot be changed after final submission. Changes require the original record to be deleted and a new record with updated information to be submitted. CMS wanted to draw attention to the fact, however, that while reporting entities can delete old records and replace them with new records, the Open Payments system will treat them as new submissions and it may appear as though the records were submitted late.
The final change being made in response to help desk feedback is the character limit for physician/principal investigator state license number has been increased. The character limit will now be twenty-five characters for manual submission and 28 characters for bulk file upload (25 license, 1 hyphen, 2 state code).
Validation Edits
In the 2015 program year, CMS will reject records that are submitted with an NDC (National Drug Code) but without a marketed name. NDCs will also be validated for proper format – dashes must be included in the appropriate positions. The drug name is required in addition to the NDC for several reasons, (1) it is a requirement in the Open Payments Final Rule, and (2) as a more technical point, Open Payments data is not connected to the drug data directly, so for consumers to understand the publicly available information, the marketed name is an important component.
Also, in the next year, research and general payment amounts may not contain a “$0” value amount. For ownership records, “$0” may only be entered in “Total Amount Invested” or “Value of Interest” field, but not both at the same time. If both the total amount invested and the value of interest are equal to zero, there is nothing to report.
For records that contain data in physician-specific fields and hospital-specific fields simultaneously, those records will now be rejected. CMS only wants either the hospital reported or the physician-covered recipient, not both.
Teaching Hospital Complications
Last year, there was some confusion as to which organization should be listed in the Open Payments database: the teaching hospital on the list is the organization that you make the research or general payment to directly. CMS provided this slide during the webinar in hopes that it would shed some light on the confusing hierarchy.
Also related to Teaching Hospitals, CMS provided the below flow chart to use in determining when and how to report payments to Teaching Hospitals.
Stock as a Form of Payment
CMS also touched upon how to handle stock as a form of payment. Essentially, if the stock is publicly traded, it should be reported as a General Payment, Form: Stock. If the stock is not publicly traded, it should be reported as a General Payment and as Ownership.
Stock Options as a Form of Payment
Stock Options as a form of payment is a little trickier. If the stock is publicly traded, payment of transfer of value in the form of stock options should be reported as a General Payment, Form: Stock Options. If the stock is not publicly traded, it should also be reported as a General Payment, Form: Stock Options, but if the options are exercised also need to be reported as Ownership or Investment Interest. If the options are not exercised, they are just reported as General Payment, Form: Stock Options.
Ownership and Investment: Stock
If you have an ownership interest in stock and it is publicly traded, there is nothing more to report. If you have an ownership interest in the form of stock, and it is not publicly traded, new holdings need to be reported in “Dollar Amount Invested” and total holdings should be reported as of the last feasible valuation date in “Value of Interest.”
GPOs and PODs
A manufacturer must report each payment to a physician owned distributor (POD) (e.g., LLC, etc.) as an indirect payment to a covered recipient physician. PODs, as a subset of GPOs, must report their physician ownership interests annually.
2015 Physician Fee Schedule Reminders
The 2015 Physician Fee Schedule, implemented November 13, 2014, made some regulation changes to allow for consistency in reporting. For data collected in CY2016, the device and medical supply names will be required and therapeutic area and product category will be optional. CMS wants to move to a more uniform way of reporting medical devices and drugs, making it easier on consumers and patients to read and understand their physicians’ reports.
CME Payments
Additionally, with regard to CME payments, compensation (either direct or indirect payments) for physician speakers at accredited or certified continuing education events must be reported if the payment was directed towards a specific physician. However, CMS did update their section on CME payments because they would like for patients to be able to understand their physicians’ reports. CMS states that if you are making a direct or an indirect payment to a covered recipient physician, within the context of providing the CME, then that is a reportable event. If by virtue of the relationship you have with the CME organization, it does not meet the definition of a direct or indirect payment, then it is not a reportable event.
Essentially, when determining whether to report a CME payment or not, always review whether it fits into the definition of a direct or indirect payment. If it does, it is reportable; if not, do not report. CMS has outlined in several FAQ’s the criteria for determining if the CME payment qualifies as a payment.
Compliance
Failure to timely, accurately, or completely report each payment or transfer of value, or ownership or investment interest is subject to a penalty of $1,000 – $10,000 per payment/interest, with a maximum annual penalty of $150,000.
Knowingly failing to timely, accurately, or completely report each payment or transfer of value, or ownership or investment interest is subject to a penalty of $10,000 to $100,000 per payment/interest, with a maximum penalty of $1,000,000.
Resources Available
CMS announces periodic webinars and Q&A sessions for industry professionals and offers a Help Desk email: openpayments@cms.hhs.gov.