CMS Webinar Summary: Open Payments Registration
- Today’s Centers for Medicare & Medicaid Services (CMS) webinar on registration was targeted to applicable manufacturers/GPOs and individuals responsible for Open Payments compliance at those entities (CEO, CCO, etc.)
- CMS started with a high-level program overview. Industry drug and device manufacturers and GPOs providing payments or transfers of value (TOVs) to doctors or teaching hospitals will collect that information and report it to CMS.
- CMS explained that the Open Payments program adds transparency to the nature and extent of those relationships and helps consumers make informed decisions.
- The program has four key time points:
o Data Collection: Aug 31-Dec 31, 2013
o Registration & Submission: Early 2014
o Review and Correction: Mid 2014 (doctors and teaching hospitals will register and review the data and manufacturers and GPOs will update data, as needed)
o Publication: Late 2014
- CMS explained that registration is a two-step process: (1) complete CMS registration on Enterprise Identity Management (EIDM), if not already done for another CMS business application, which ensures secure access to CMS and allows registration, authentication, authorization, and identity lifecycle management (create login credentials at https://portal.cms.gov – CMS will notify users of EIDM when registration is available); (2) complete Open Payments registration to obtain secure and open access (create entity and self/authorized representative profile; CMS will vet each registration and then confirm registration).
- CMS explained that vetting is verifying manufacturer/GPO is an entity, that authorized official is linked to the vetted entity and that authorized official is significantly positioned to act on entity’s behalf. CMS said to register early to allow time for vetting.
- Creating the entity and/or Self Profile: CMS said that a “C” level representative of company should be the authorized representative, but he/she may delegate functions to another officer.
o Authorized official profile: includes name, suffix, job title, business address and phone, and email address.
o Entity profile: includes legal name, doing business as name, address and telephone number, tax ID number, D&B DUNS number, FDA establishment identifier, URL of parent company, and indication as to whether a consolidated report will be provided.
- CMS explained that other individuals also may be nominated to obtain a user accounts should the authorized official choose to nominate individuals to delegate roles under Open Payments (there are three roles: officer, submitter, and attester); CMS will email that individual and let them know if they have been nominated and will provide instructions on how to obtain a user account. These individuals will have to accept the nominations to obtain user accounts.
- What can you be doing now: CMS said to determine or discuss user roles now. Determine who will register and who will submit and/or attest to data on behalf of the entity.
- A forthcoming webinar on December 3, 2013 1:00PM EST will include an in-depth Q&A on data submission and registration. CMS said questions must be submitted by November 30. Questions can be submitted to OpenPayments@cms.hhs.gov.
- CMS then answered some questions from the audience:
o CMS said an entity can have up to 10 users registered in Open Payments but later said they can have up to 10 of those users as attesters, up to 10 of those registered users as submitters, and up to 5 acting in the officer role. However, a minimum of 2 registered users are required per the final rule.
o When will companies be able to register? CMS said in early 2014. Entities should sign up for Open Payments updates on cms.gov to ensure they receive timely updates when registration goes live next year.
o Can a company’s lawyer be an authorized official? CMS said it needs to be a C-level official or higher. The authorized official will then be vetted. Then, the authorized official can nominate an officer. CMS did state that a Chief Compliance Officer will be considered a C-level employee.
o Does the authorized official have to be the same person as the officer? No, the authorized official can nominate individuals to serve various roles – companies can have up to 10 users and have multiple user roles to assist the needs of the company.
o How much time will the vetting process take? CMS expects that it may take up to a week or 2 weeks so CMS encourages companies to register early.
o Can the officer and attester role be the same person? Yes.
o What if you don’t have a D&B DUNS number? CMS encourages entities to obtain such a number because it will be used for vetting. Without this number, vetting may take longer.
o Can the FAQs be supplied as an attachment on the Open Payments website so manufacturers can download them? CMS said they are working on adding dates for version control to the information provided on the website. CMS is working on this for future updates to the website.
o Is there a registration fee? No. Registration is free and mandatory for applicable entities.
o Provide a list of people who can serve as authorized official? CMS said there is no such list and organizations will need to determine this internally. It must be a C-level executive or the equivalent, CMS said.
o For a company that makes no TOVs or payments to report but which is physician owned, do they need to register? CMS said entities do not need to register if they do not have any payments or TOVs to report.
o When will EIDM be available for registration? Registration on EIDM (step one) is available now based on CMS’s statements. EIDM users will then later be alerted to the availability of Open Payments registration in early 2014.
o Do submitter and attester roles have to be employees of the company? The attester does but the submitter does not need to be. The authorized official can perform all three roles though – officer, submitter, and attester, but he/she has the option to delegate those roles as well. With that being said, each entity is required to have a minimum of 2 users registered even if the authorized official is taking on all 3 roles.
o Will the health insurance marketplace roll-out issues impact the roll-out of the Open Payments website and program? No, CMS does not expect those issues to have any impact here.
o If I’m a third party, can I submit information on the main entity’s behalf? Yes, but the entity needs to register first and the authorized official can then nominate the third-party to submit data.
o Will third-party companies be able to register if they are providing data submission services for a company? Yes, but the company will need to nominate them first.
o Will a contact name be listed in case of dispute resolution? CMS said they are still working on that question and more information will be released in the future.
o Vetting processes explained: CMS said it will take the following steps to vet authorized officials: (1) an automated process will mine industry databases based on information provided at registration and verify the user; or(2) a manual vetting process will take place where the Open Payments vetting team will contact the organization and perform a manual vetting process if the automated process fails.
o Test submissions: CMS said test submissions are optional and are meant to test the format of the submission.
o How extensive will testing be to ensure functionality of the website to manage the volume of data? CMS said it is doing extensive testing on submission of files. File sizes and limits will be discussed at the next webinar.
o What is the process for consolidated registration? Does each company have to register individually? Yes, they must first register individually before they can be included in a consolidated report.
o Is there any update on whether journal reprints will be part of the educational exemption? CMS said it does not have that information available and will provide an update at a later time.
o We are a cardiac monitoring company supplying cardiac monitors to physicians. I don’t believe we have a D&B number, what should we do? CMS strongly encourages companies without D&B numbers to apply for one. CMS also said to check with D&B in case you have a number already and do not realize that you do.
o Will there be a separate process for registering non-US companies? CMS does not believe so.
o If you have multiple FDA registered establishments, how do you list all of the establishment numbers/locations in Open Payments? CMS said there will be capability for doing so in the registration system.
o If submitting a consolidated report, each entity will still need to register individually, however once listed in a consolidate report an entity cannot submit its own report individually.
o If the vetting process is unable to proceed automatically through checking business databases then an entity must contact CMS to initiate manual vetting.
o What about physician registration? CMS said information about physician registration will be provided at a later webinar (likely next year).
o Who must serve as the data submitter? CMS said it is up to each entity to determine who will serve in that role.
o Explain distributor registration where the distributor takes title to the product? CMS said to submit this question to the help desk for further clarification.
o Will the slides from today’s webinar be available online? CMS said the December 3 webinar will be a follow-up to this webinar and will provide further clarification and they will try to make these slides available online.
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 matters and 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.