On Tuesday, CMS held a webinar to explain its two phases of Sunshine Act/Open Payments registration for applicable manufacturers and group purchasing organizations. A summary follows below:
Introduction
On February 25, 2014, the Centers for Medicare & Medicaid Services (“CMS”) hosted a webinar presentation to explain the requirements for Open Payments Phase 1 registration and data submission. The webinar started with an overview of the presentation’s objectives which were to discuss the Phase 1 timeline, the portal registration, and provide a list of resources available to assist applicable manufacturers and group purchasing organizations during the Phase 1 process. CMS stated that there would be a question and answer session after the presentation and that questions not addressed could be submitted to the CMS help desk and/or answered by the user manuals available on the Open Payments website. In addition, a copy of the webinar slides and the audio portion of the presentation will be made available online next week.
CMS stated that Open Payments was proceeding with a two phase process to Open Payments reporting. During Phase 1, CMS said Authorized Officials (AOs) would be required to register with the Enterprise Identity Management (EIDM) system to generate a user profile. The EIDM registration process would establish login credentials for Open Payments. Phase 1 registration began on February 18 and will continue through March 31, 2014. Phase 2 will require a complete entity registration as well as the establishment of additional users, e.g., data submitters. That process will begin in May and will have a 30 day window for registration. As Open Payments technically requires reporting to be submitted by March 31, 2014, CMS said it will use its enforcement discretion and not consider entities to be noncompliant with their reporting obligations until the close of the Phase 2 data submission period. CMS stated that participating in Phase 1 is mandatory for applicable manufacturers and group purchasing organizations with reportable payments.
Registering with EIDM
(Note entities that already have EIDM credentials can skip this step). EIDM credentials are required to access Open Payments. Users are instructed to visit CMS’s Enterprise portal at portal.cms.gov. Then users are to select “new user registration” and read and agree to the terms and conditions. Next, personal information will need to be entered to begin the identity proofing process. Once information has been entered, users can create a user id and password along with three challenge question and answers. When registration is complete, the user will receive an onscreen confirmation and email confirmation. The email will contain the user id and confirm that the EIDM credentials are active.
Registering with Open Payments
Users will need to request access to Open Payments. On CMS’s secure portal, users are to read and accept the terms of credentials. Enter the EIDM user name and password and select “log-in.” Next, users are to request application access by clicking “Request Access Now” tab. Under the application description select “Open Payments” and under role select “Open Payments User.” Users will then need to complete an identity verification process (separate from the EIDM process). There will be another terms and conditions page which user will need to read and accept. Users will then review and confirm the personal information on their account, if there are any errors they need to be corrected via the EIDM credential process. Users will then see an onscreen confirmation page and access to Open Payments will be immediate, however users will need to log out and then log back into the system. If there is any failure in the verification/registration process, users are advised to contact Experian support center. If Experian cannot resolve the issue, users are instructed to email CMS help desk with a subject line of “EIDM RIDP unsuccessful” and users will need to follow up with CMS via a paper submission on company letterhead so that an authorized official can be verified for Open Payments. CMS said the manual paper submission process could take up to two weeks and thus advised early registration.
Once registered, users can log into CMS’s secure portal and select a yellow “Open Payments” tab. Under the tab, there is an instruction document available to assist data submission.
Phase 1 Data Submission
CMS advised users to consult the instructions document on Open Payments. During Phase 1, aggregate data will be collected along with the entity information provided through the EIDM process. For the data submission, entities must report: (1) total amount of payments, (2) total number of payments, and (3) total number of covered recipients for the 2013 reporting year. CMS provide an example (paraphrased below):
8/10/2013 Dr. Jones $100
8/20/2013 Dr. Smith $239
9/20/2013 Dr. Jones $200.
Under this example the aggregate data would be reported as follows: (1) total payments - $539. (2) total number of payments – 3, (3) total number of covered recipients – 2.
Phase 1 data submission will be through email and NOT through Open Payments. The email address is contained in the instructions document and the email submission can only contain one attachment. AOs can designate individuals to send the email; however, the AO’s EIDM credentials will need to be used in the email.
Questions and Answers (Qs and As that have been addressed previously are not included)
*Note that CMS alerted the audience that there are new FAQs available on the Open Payments website*
Q. There appears to be a disconnect between the format of the email subject line in the instructions document and what is actually generated on EIDM as users can choose their own user id.
A. There is an error in the instructions document that is being corrected. Keep the format described in the instructions documents but use the id that is generated through the EIDM process.
Q. Foreign nationals are experiencing difficulties in the EIDM verification process.
A. CMS is aware of this issue. CMS advises these users to contact the help desk for support.
Q. Do type II applicable manufacturers (common ownership) need to register for Phase 1 even if they plan to be part of a consolidated report?
A. There are no consolidated reports as part of Phase 1. All entities must register even if they will be part of a consolidated report later in Phase 2.
Q. Can you use a company’s address (instead of a home address) for the EIDM registration process?
A. Using a company address will likely impede the verification process.
Q. Do entities need to report payments entitled to delayed publication in Phase 1?
A. Yes, and these payments need to be reported in Phase 2 as well.
Q. Can we submit/edit data after Phase 1 during the Phase 2 process?
A. Yes, you can edit and modify data submitted in Phase 1 during Phase 2.
Q. When can we submit the assumptions document?
A. During Phase 2.
Q. How does delegation of data submission occur during Phase 1?
A. This does not occur until Phase 2. Data submitters are part of the Phase 2 process.
Q. Are social security numbers required for Phase 1?
A. They are not required as part of the EIDM process; however, this information will be required to complete the Open Payments user process.
Q. What is the difference between the March 31 data submission (Phase 1) and the May 1 data submission (Phase 2)?
A. Phase 1 is only three points of aggregate data. Phase 2 will include the submission of more granular payment data.
Q. How can one retrieve a EIDM user identification?
A. This will be addressed in a future FAQ.
Q. Are you required to report payments to physicians who reside outside the United States?
A. If the physician meets the Open Payments definition of a physician, then the payments are reportable.
Q. Does an entity need an AO to complete the Phase 1 process?
A. An AO is needed to register with EIDM and Open Payments. The email data submission can be completed by a designee of the AO.
Q. Can a director fulfill the role of an AO?
A. CMS leaves interpretation of an appropriate AO to the discretion of the entity.
Q. Is the EIDM user id assigned or generated by the user?
A. It is generated by the user during the EIDM registration process.
Q. Do physicians need to register during Phase 1?
A. Covered recipients are not required to take any action during Phase 1. They have the option of registering after Phase 2 and reviewing reported payments (CMS expects this to occur on August 1).
Q. Will CMS have a hotline to assist reporting entities?
A. CMS does not currently have a hotline, but is in the process of creating one.
Q. Do DME providers need to enroll in Phase 1?
A. If the DME is an applicable manufacturer, then they must register during Phase 1.
Q. Is credit history information required to be submitted during the EIDM process?
A. No, however aspects of this information may asked during EIDM registration.
Q. The order of the reporting columns is different in the sample template and the instruction document.
A. Follow the sample template, CMS is in the process of updating the instruction document.
Q. Does CMS still intend to meet the September 30 date for public disclosure of reportable payments?
A. Yes.
Q. Are reporting entities required to inform physicians about Phase 1 reporting?
A. No, but CMS encourages notification to minimize subsequent disputes during the review process.
Q. Are you supposed to separate out payment categories (research, general, ownership) into three separate emails for Phase 1?
A. No, all payments are to be combined in one email. Payment categories should be inputted by the addition of columns, not rows.
Q. Will there be a test environment for Phase 2 data submission?
A. No, but there will be a functionality test to check the format of submitted information.
Q. What happens to the data submitted during Phase 1?
A. It will be inputted into Open Payments and populated in the system during Phase 2. Entities can review the data and edit as needed.
Q. When can entities edit submitted data?
A. Any time prior to the submission deadline.
Q. What is the email format for Phase 2 data submission?
A. There is no email format. Phase 2 data submission will be through Open Payments.
Q. Can CMS provide an example of what a covered recipient will see once reportable payments are uploaded?
A. Yes, CMS in the future will provide examples.
Q. Do delegates need their own EIDM credentials?
A. During Phase 2, delegates will need their own EIDM credentials.
Q. Can someone else submit the information required for EIDM verification on behalf of the AO?
A. Only the AO should be completing the EIDM process during Phase I. Delegates can send the data submission email on behalf of the AO.
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Please let me know if you have any questions.
Julie Tibbets is a partner in the Food, Drug & Device practice at Alston & Bird LLP where she focuses her practice advising manufacturers and marketers of drugs, biologics, and medical devices on marketing, medical affairs, and health care professional related interactions as well as Sunshine Act compliance. This posting is intended to be informational and does not constitute legal advice regarding any specific situation. This material may also be considered attorney advertising under court rules of certain jurisdictions. Julie can be reached at julie.tibbets@alston.com or at 202.239.3444.