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29 posts from March 2014

March 31, 2014

Physician Payments Sunshine Act: Phase I Aggregate Report Due Today, Instructions for filing

Today March 31, 2014, is the final day that applicable manufacturers and group purchasing organizations must submit their Phase I aggregate physician payment sunshine data to CMS Open Payments. We are republishing the guide to filing Phase 1 for those applicable manufacturers who are scrambling to figure out the rule and get it in today. Good luck!!!

Companies must register with Open Payments and submit their aggregate Sunshine data by March 31. As we've reported, CMS split data submission into two phases.

Phase 1: (February 18 through March 31) includes user registration in CMS' Enterprise Portal, submission of corporate profile information and aggregate 2013 payment data.

Phase 2: includes industry registration in the Open Payments system, submission of detailed 2013 payment data, and legal attestation to the accuracy of the data. JUST UPDATED BY CMS: "Later, in May/June of this year, applicable manufacturers and GPOs will participate in Phase 2 by completing registration in the Open Payments system, submitting detailed 2013 payment data, and legally attesting to the accuracy and completeness of the data. More information about Phase 2 will be forthcoming in the coming weeks.

Phase 1 Instructions:

Step 1: New User Registration with CMS Enterprise Portal (EIDM Registration)

The first step of Phase 1 requires the company's "authorized official," the executive-level officer who can legally represent the organization, to register with the Enterprise Identity Management (EIDM) system in order to generate a user profile. The EIDM registration process establishes login credentials for Open Payments. Users select "New User Registration," and complete the process, explained in detailed screenshots here.  Entities that already have EIDM credentials can skip this step.



CMS notes that the authorized official can delegate data submission duties to others (referred to as authorized representatives) after the official completes EIDM registration. This manual delegation is done through the sharing of the authorized official's CMS user ID directly with another person in their entity, who can then use that information to complete data submission on the authorized official's behalf. This exchange is performed outside of CMS systems.

 

Step 2: Registering with Open Payments

On CMS's secure portal, users must to read and accept the terms of credentials and enter their EIDM user name and password. Users will then need to complete an identity verification process (separate from the EIDM) in order to register with Open Payments. The registration is very similar to the EIDM registration. View the step by step slides which go through a fairly self-explanatory process here, beginning on page 10. 

If users run into any failures in the registration process, CMS advises them 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 stated that the manual paper submission process could take up to two weeks, so at this point, we hope that registration works!

 

Step 3: Phase 1 Data Submission

After registration, the authorized official can download the data submission instruction document and the sample template. The instruction document is not available on the Open Payments website, and is only accessible after CMS registration is completed. During Phase 1, companies are responsible for three categories of information for the aggregate data submission.

In the sample template, you'll see the below data elements for aggregate information regarding the applicable manufacturer's or applicable GPO's 2013 payment report. The bullets below the data field provide further explanation of the amounts that should be filled-in for each data element:

Category 1: General payments aggregate data:

  1. Total aggregate amount (in dollars and cents) of general payments or other transfers of value the applicable manufacturer or applicable GPO has provided to covered recipients or physician owners/investors during the reporting period (August 1, 2013—December 31, 2013).
  2. Total number of payments or other transfers of value made.
  3. Total number of covered recipients (unique/non-duplicate) or physician owners/investors that were recipients of the payments or other transfers of value during the reporting period.

Category 2: Research payments aggregate data:

  1. Total aggregate amount (in dollars and cents) of research payments or other transfers of value the applicable manufacturer or applicable GPO has provided to covered recipients or physician owners/investors during the reporting period.
  2. Total number of payments or other transfers of value made.
  3. Total number of covered recipients (unique/non-duplicate) or physician owners/investors that were recipients of the payments or other transfers of value during the reporting period.

Category 3: Ownership or investment interests aggregate data:

  1. Total number of physician owners or investors, or their immediate family members, who held ownership or investment interest in the entity during the reporting period.

 

After registration has been completed, the authorized official or authorized representatives must submit the corporate profile information and aggregate 2013 payment data to CMS as instructed on the webpage and in the data submission instruction document. As explained in the instruction document, the CMS user ID must be noted in the subject line of the email sent to CMS containing the aggregate data. 

When Phase 1 data has been submitted as instructed, the Open Payments Help Desk will reply directly to the submitter, confirming if the submitted data meets all requirements. If information is missing or improperly formatted, CMS will provide additional instructions on how to correct the data submission.

How does Phase 1 Differ from Phase 2?

 

Phase 2, which CMS states will begin in May and extend for at least 30 days, requires much more information than Phase 1. Applicable manufacturers and applicable group purchasing organizations must:

  • Complete corporate (entity) registration
  • Complete "authorized official" registration
  • Register additional users (beyond the authorized official)
  • Submit detailed 2013 payment data via the Open Payments system
  • Attest to the timeliness, accuracy and completeness of the detailed 2013 payment data submission

CMS notes that they will not exercise enforcement prior to the close of Phase 2 data submission. Phase 1 acts like the trial run, with companies submitting only the entire sum of payments, while Phase 2 will provide the data that will populate CMS' searchable list of specific transactions.

CMS offered a side by side comparison of Phase 1 and 2, broken down into categories: EIDM Registration, Open Payments Registration, Data Submission, and General Differences. View our article, including this comparison here.

Question and Answer Session from CMS Webinar

CMS hosted a webinar on the registration process and Phase 1, which included the outline of information provided above. They also had a question and answer session. RAPS transcribed a number of the notable questions, which we have added below.

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 1. Delegates can send the data submission email on behalf of the AO.

   

 

March 28, 2014

CBI’s Medical Education & Research Grants Breakthrough Summit

The Center for Business Intelligence (CBI) will be holding its Medical Education & Research Grants Breakthrough Summit in San Francisco, CA, April 29–30, 2014. CBI's Summit will cover the value of quality improvement initiatives and patient education and engagement in a post-Sunshine and ever-changing regulatory environment. The meeting is designed to give attendees the latest updates on evolving medical education approaches.

CBI notes: "The shift to evidence-based healthcare requires the integration of the latest research evidence with clinical expertise, as well as consideration for the individualized circumstances of patients. The Medical Education industry is primed to examine how evidence in practice can equip educational leaders and healthcare experts to connect and translate the highest quality education into the highest quality healthcare. As such, the West Coast Medical Education & Research Grants Breakthrough Summit is designed to help attendees achieve similar objectives."

CBI announced the following learning objectives for this Summit:

  1. HEALTHCARE SYSTEMS: Discuss how the shifting healthcare environment impacts individual employers, collective healthcare systems and the personalized care of patients

  2. INNOVATIVE DESIGN: Cultivate innovation in educational design through initiatives that focus on improving quality of care

  3. PATIENT ENGAGEMENT: Establish ideas that better engage patients as active participants of the Medical Education process.

The full two-day schedule is available here, and the speakers, here. During the conference, experts will provide insight on a number of important topics, including:

  • Patient-centric educational approaches
  • The intersection of emerging technology and educational design
  • The impact of CME on clinical integration and physician behavior
  • Metrics of funded activities
  • Best practices for grant writing and review
  • Sunshine interpretations and assumption documents
  • The impact of healthcare reform, including ACOs and PCMHs, on CME

Thomas Sullivan, President of Rockpointe and Editor of Policy and Medicine will be moderating a panel titled:

Spotlight on Sunshine — Discussion around Sunshine Interpretations and Reconciliation

Moderator:
Thomas Sullivan
President
Rockpointe

Panelists:
Pamela Mason, BS, CCMEP, FACME
Director, Medical Education Grants Office
AstraZeneca

Anouk Lindley
Manager, Independent Educational and Research Grants
Shire Pharmaceuticals

Kari K. Loeser
Senior Director and Senior Compliance Counsel
Jazz Pharmaceuticals

Chrissy Bradshaw
Director, Regulatory and Compliance Services
Porzio Life Sciences LLC

For information about registration, click here.

Sign4Compliance Eases the Sunshine Act’s Requirements

The Physician Payments Sunshine Act requires companies to track almost every transfer of value made to physicians. Sign4Compliance is an app that collects all this necessary information to comply with the Sunshine Act and stores it in one place. 

Sign4Compliance allows companies to create events, add or import registrants from existing meeting management software, use an iPad to sign in attendees at events, and compile reports. The program consists of easy-to-use and well organized applications to help companies from starting an event to submitting a report to the Centers for Medicare and Medicaid Services (CMS). 

Sign4Compliance provides one instrument to comply with the Sunshine Act's myriad requirements. The app can be used alone or with preexisting meeting and event software, which is good news for companies that wish to simplify their current data collection practices. 

Furthermore, Sign4Compliance isn't simply a data storage device. It includes on-site NPI lookup capabilities where the NPI tool automatically fills in registrant information and detects duplicates in the system. 

The app allows event attendees to sign an acknowledgement electronically on the iPad app. Signatures are then recorded in the database and can be reviewed as images in the iPad app or downloaded as PDFs from the online dashboard. 

 Once a companies capture attendee information, Sign4Compliance allows the users to create and export reports in a variety of formats, which then can be submitted to the companies' aggregate spend system.

Right now, Sign4Compliance is offering a free account to allow users to get started with the service. We signed up in less than five minutes, including time for the iPad app to download. The free account allows users to use the app for one event at a time with up to 15 registrants. For higher volume users, Sign4Compliance offers additional services, including the ability to track unlimited attendees and archive all events.

If you have any questions or if you'd like to upgrade to a low or high volume account, call 610-292-8088 or email sales@sign4compliance.com.  

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