Life Science Compliance Update

August 04, 2016

CMS Hosts Special Open Door Forum

CMS-thumb

On Tuesday, August 2, 2016, The Centers for Medicare & Medicaid Services (CMS) hosted a Special Open Door Forum. The Special Open Door Forum was hosted for the CMS to obtain input from Open Payments stakeholders to inform future rulemaking and other enhancements to the program.

CMS is not currently under any statutory deadline or implementation schedule that is forcing the agency to make any changes to the current rule. However, stakeholder feedback is valued as CMS continues to move forward in enhancing the Open Payments system and refining the reporting requirements. According to CMS, the “focus is on increasing efficiency and minimizing burden while maintaining the goal of transparency in the healthcare industry.”

Comments from Stakeholders

Comments from stakeholders varied, as some comments came from healthcare providers (even physicians themselves) and some comments came from industry. Providers and industry sometimes agreed on a better way to do things, while other times the groups disagreed.

Teaching Hospitals

Much of the call discussed teaching hospitals and difficulties with reporting. For example, one caller worked within a hospital system with five teaching hospitals. The way Open Payments reporting is currently set up, it is hard to determine which teaching hospital is the one receiving each individual payment, since they all fall under the same corporate umbrella and tax ID number. The caller suggested that perhaps Open Payments can add a non-Public data element for providers to see to differentiate between hospitals, such as adding the Medicare provider number.

CMS once again reiterated the call for comments and suggestions from industry as to how teaching hospitals can be better defined and proper reporting better facilitated, so that payments are reported more accurately.

CMS/Open Payments Account

One caller noted that there is no way to opt out of the year long Open Payments process and that the current CMS accounts close after six months of inactivity; this caller in particular was wondering if there is a way for physicians to get notifications if they have been identified as having taken payments from industry, so they are reminded to log in more frequently to check, or if there is a way to change the CMS account system so that they are active for thirteen months instead of the current six. CMS’ comment was that there is no way to opt out, except decline to take payments, and that the six month window is a security system for the protection of users, but they will take the feedback under advisement.

Payment Categories

There was a bit of discussion surrounding current payment categories and whether additional payment categories should be added. One suggestion was to broaden the ownership category to include ongoing investment in firm or acquisition by a third party in which a physician has had ownership interest in the past.

Another comment was that as currently understood by that particular organization, the gift category is more or less a “de facto catch all” category for payments not easily put into any other payment category. They suggested that there be an payment category as an actual catch all.

Some members of the industry spoke out about how much additional work it would take on their end if there were additional categories, noting that oftentimes, current categories are both broad and specific enough to capture most of the payments made.

One physician spoke out and suggested that training and procedural workshops should be excluded from Open Payments reporting. They understood that, yes, there is a transfer of value there, but it is one that is not necessarily a conflict of interest; instead, it is one that actually betters patient care.

NPI Numbers

A caller from the medical industry requested that there be a way for physicians to be able to certify that payments are being linked to the right person. For example, right now, if Mary Jones, cardiologist, goes in to check her payments, there may be payments attributed to another Mary Jones, cardiologist in her list, but without NPI or some other identifying information, there is no way to confirm that those payments were linked to the correct Mary Jones. CMS noted that the statutes prohibit NPI numbers from being published in public data, but offered advice to go in and verify that the data is attributed properly through the registration process and review and dispute any incorrect payments. 

Dispute Process

There wasn’t much discussion about the review and dispute process, but one comment received was a suggestion that when disputes are initiated, the disputer should be required to input their telephone number and email address so they can easily be contacted.

Comments Requested

The Open Payments Solicitation can also be found in the proposed 2017 Physician Fee Schedule. If you have any questions about the Open Payments data, the website, or how to report, please contact openpayments@cms.hhs.gov. Any feedback and questions about the solicitation in the Physician Fee Schedule or the Open Door Forum can also be submitted to openpaymentscomments@cms.hhs.gov.

July 20, 2015

Open Payments: CMS Clarifies Continuing Medical Education FAQs, Confirms CME Funding Must Meet the Definition of "Indirect Payment" To Be Reportable

  CMS

On Friday, the Centers for Medicare and Medicaid Services (CMS) announced they had updated the Law and Policy page on the Open Payments website with information about the revised reporting requirements for continuing medical education. CMS also announced three FAQs for CME reporting. This information isn't necessarily "new" as CMS revised this page several months ago to correct what many felt was a misinterpretation of the Sunshine Act Final Rule regarding CME payments. This was, however, the agency's first announcement about the revision.

Under the Physician Payments Sunshine Act, pharmaceutical and device manufacturers must report to CMS direct or indirect transfers of value made to physicians and teaching hospitals. "Indirect payments" are situations where a manufacturer "requires, instructs, directs, or otherwise causes" a third party to provide payment or transfer of value, in whole or in part, to a covered recipient. 

Consistent with the regulations, in October 2014 CMS explained in the preamble to its final amended regulations to Open Payments that if a pharmaceutical or device manufacturer “provides funding to support a continuing education event but does not require, instruct, direct, or otherwise cause the continuing education event provider to provide the payment or other transfer of value in whole or in part to a covered recipient,” manufacturers are not responsible for reporting that transfer of value. ACCME-accredited CME, for instance, requires a complete firewall between commercial support and an education program. Manufacturers who provide CME funding must have absolutely no control over: (a) Identification of CME needs; (b) Determination of educational objectives; (c) Selection and presentation of content; (d) Selection of all persons and organizations that will be in a position to control the content of the CME; (e) Selection of educational methods; (f) Evaluation of the activity. (See ACCME Standards for Commercial Support 1.1)

CMS also states: “[n]ot all indirect payments are required to be reported, regardless if it is a payment to a continuing education organization.” For instance, if a manufacturer does “require, instruct, direct, or otherwise cause” the CME provider to provide the payment to a covered recipient, but does not know the identity of the covered recipient during the reporting year or by the end of the quarter of the following reporting year, such payment would not be reportable. CMS’s latest FAQs, outlined below, correctly re-iterate these points. 

In summary, starting in 2016 (with reporting due by March 31, 2017), CME related payments are only reportable if a manufacturer determines that the payment or transfer of value meets the definition of an “indirect payment” and the manufacturer is aware of the covered recipient’s identity within the reporting year or second quarter of the following year.

View screenshots from CMS's previous language here (zoom as necessary with the PDF). 

Frequently Asked Questions

If an applicable manufacturer gave a contribution to support a medical conference, but did not have any say in the content, speakers, or attendees, would this be considered an unrestricted donation? Or, is the fact that the money was specifically for an educational conference mean that it is, by definition, restricted?

Unrestricted donations to a medical conference as described in this FAQ would not be subject to reporting under Open Payments. Although there is no formal definition of an unrestricted donation, in this case we can take that term to mean a grant given by a reporting entity to a professional association for use without any restrictions, preconditions, or post-conditions in order to assist the professional or educational association with its administrative or educational needs. In accordance with the definition of an indirect payment at 42 C.F.R. §403.902, an applicable manufacturer that contributes funding to a medical/educational conference would be required to report the payment if the reporting entity determines that it meets the definition of an indirect payment at 42 C.F.R. §403.902. An indirect payment is defined at 42 C.F.R. §403.902 as a payment or other transfer of value made by an applicable manufacturer to a covered recipient through a third party, where the applicable manufacturer requires, instructs, directs, or otherwise causes the third party to provide the payment or transfer of value, in whole or in part, to a covered recipient.

Starting with 2016 Open Payments data collection and reporting to CMS in 2017, are payments provided by an applicable manufacturer to a continuing education organization for continuing education events reportable?

Yes, the payment is reportable if the applicable manufacturer determines that the payment meets the definition of an indirect payment, and the applicable manufacturer knows or can determine the identity of the covered recipient by the end of the second quarter of the following reporting year. An indirect payment is defined at 42 C.F.R. §403.902 as a payment or other transfer of value made by an applicable manufacturer to a covered recipient through a third party, where the applicable manufacturer requires, instructs, directs, or otherwise causes the third party to provide the payment or transfer of value, in whole or in part, to a covered recipient. In accordance with 42 C.F.R. §403.904(i)(1), indirect payments or other transfers of value do not have to be reported if the applicable manufacturer is unaware of the identity of the covered recipient during the reporting year or by the end of the second quarter of the following reporting year.

If several applicable manufacturers contribute funding to a continuing medical education (CME) program and there are several speakers, how is this reported?

In accordance with the definition of an indirect payment at 42 C.F.R. §403.902, applicable manufacturers that contribute funding to a CME program with several speakers are required to report the payments provided to physician speakers if they determine that the payments meet the definition of an indirect payment. An indirect payment is defined at 42 C.F.R. §403.902 as a payment or other transfer of value made by an applicable manufacturer to a covered recipient through a third party, where the applicable manufacturer requires, instructs, directs, or otherwise causes the third party to provide the payment or transfer of value, in whole or in part, to a covered recipient.

Consistent with the CMS Final Rule (CMS-5060-F), there are instances where indirect payments provided by an applicable manufacturer to a CME program are not reportable. In accordance with 42 C.F.R. §403.904(i)(1), indirect payments or other transfers of value are excluded from reporting where the applicable manufacturer is unaware of the identity of the covered recipient during the reporting year or by the end of the second quarter of the following reporting year.

If the payment is a reportable payment, then the amount should be equally divided among the known covered recipient speakers.

 

July 17, 2015

New Open Payments FAQs Shed Some Light on Year 2 Data

FAQ

The Centers for Medicare and Medicaid Services (CMS) recently added several new entries to its Frequently Asked Questions (FAQs). Most of the questions relate to the new round of data that the agency published on June 30. CMS addresses the payment records and the status of disputed records among other topics, and promises “in the coming month…to present another new, very detailed search interface that will translate the large datasets into more detailed visualizations."

"NEW" How is “de-identified” 2013 data being treated?

2013 data published last year included a set of “de-identified” records which removed payment recipients’ identifying information. This was done because CMS could not verify with full confidence that recipient identifiers were attributable to specific physicians or teaching hospitals and may also have included identifying information for multiple individuals.

Open Payments has since returned invalid records to the reporting entities for correction and has also enhanced the reporting system’s intake process to prevent invalid records from being ingested by the system. As a result, 2013 data records published as “de-identified” in 2014 will be published in 2015 with the recipients’ individual information included.

Key words: Open Payments, Sunshine Act  (FAQ12372)

"NEW" In what formats is the data presented?

CMS delivers Open Payments data in a number of ways to accommodate different users and their interests:

  • Search Tool: Site visitors can get immediate results using this standard search interface to find detailed information on individual physicians, teaching hospitals, or companies making payments.
  • Data Explorer: Users can select a dataset then customize the view using filters, sorts, and other actions to create their own, targeted views of the data and visualizations such as charts and graphs.
  • Data downloads: Users can download the data in comma-separated values (.csv) format, which allows users to open and explore the data using their own software on their own computer. With this option, the user must have robust data viewing software that allows for downloading and viewing data in large datasets.

Key words: Open Payments, Sunshine Act  (FAQ12362)

"NEW" What if a physician or teaching hospital registered (or tried to register) prior to May 20, 2015, but was unable to dispute records until after May 20?

Review and dispute officially ended on May 20, 2015 for the 2014 reporting cycle. Any disputes initiated after this date will not be reflected in the June 30, 2015 data publication. These disputes and any subsequent correction to those data will be reflected in the next data refresh.

Key words: Open Payments, Sunshine Act 
(FAQ12378)

 

"NEW" Did doctors and teaching hospitals have a chance to review the financial data reported about them?

Yes. During a 45-day physician and teaching hospital review and dispute period that ended on May 20, 2015, the dollar values and information about each transaction listed were available for review by doctors and teaching hospitals registered in the Open Payments system. They could confirm the information as correct or pursue corrections, via the dispute option, to remove, clarify, or adjust the information that had been attributed to them. This required 45-day review and dispute process affords the opportunity for physicians and teaching hospitals to review and dispute any data they feel is inaccurate or incomplete.

Key words: Open Payments, Sunshine Act (FAQ12376)

"NEW" Is any “de-identified” 2014 data being published?

No, no de-identified 2014 data is being published. Since last year, Open Payments has enhanced the reporting system’s matching logic (described above) and is now able to match most submitted records to valid physicians and teaching hospitals. In cases where a valid match is not found, the system returns the record to the submitter for correction.

Key words: Open Payments, Sunshine Act  (FAQ12370)

"NEW" Are there any records that you are not publishing?

Yes. The Open Payments final rule provides that some research payments related to new product development, or new uses of an existing product, may be granted a delay in publication for up to four years, or until Food and Drug Administration (FDA) approval is received.

Key words: Open Payments, Sunshine Act  (FAQ12374)

"NEW" Can a physician or teaching hospital still register in the Open Payments system and initiate a dispute after the May 20, 2015 deadline?

Physicians and teaching hospitals can register in CMS’ Enterprise Portal and the Open Payments system, and initiate disputes in the Open Payments system, at any point in the year. Please note, though, that the review and dispute period officially ended on May 20, 2015, for the 2014 reporting cycle, so any disputes initiated after this date will not be reflected in the June 30, 2015 data publication. These disputes will be reflected in the next data refresh reporting cycle. See the Open Payments System Quick Reference Guide – Review and Dispute Timing and Data Publication for detailed information on how disputes are shown in published records.

Key words: Open Payments, Sunshine Act (FAQ12392)

"NEW" Is there a methodology guide available providing technical details about the published data?

Yes, the Methodology Overview & Data Dictionary explains all of the technical specifications of the published data.

Key words: Open Payments, Sunshine Act  (FAQ12386)

"NEW" When calculating number of payments a doctor received, should users count entries (rows) or tally the number of payment fields within each payment?

Each row indicates one payment, transfer of value, or ownership amount per doctor; counting rows should provide the total number of payments.

Key words: Open Payments, Sunshine Act  (FAQ12368)

"NEW" How can disputes initiated by physicians and teaching hospitals be resolved?

Once the dispute is initiated, it can be resolved in one of three ways:

  1. Resolved - Disputed data is updated and then resubmitted and re-attested to by the applicable manufacturer or GPO.
  2. Resolved, no change - Indicates that both the applicable manufacturer or GPO discussed the dispute with the physician or teaching hospital, and both parties determined that no change in the data was necessary. Physicians and teaching hospitals can initiate a new dispute if they disagree with the “resolved, no change” status.
  3. Withdrawn – A physician or teaching hospital can remove a dispute opened on a record.

Key words: Open Payments, Sunshine Act (FAQ12388)

"NEW" What happens if physicians or teaching hospitals initiated disputes with the reported data before/after the review and dispute period ended on May 20, 2015?

The status of a dispute on a record has several effects on what data is published. Details of how disputes are shown in published records are explained in the Open Payments System Quick Reference Guide – Review and Dispute Timing and Data Publication.

Key words: Open Payments, Sunshine Act  (FAQ12390)

"NEW" My organization already downloaded the 2013 data last year; should we download just the new 2014 data this year?

CMS recommends that you re-download the 2013 data this year, in addition to downloading the new 2014 data. The 2013 data that’s being published on June 30 includes a number of additional records that were not included in the previous publication or were included only in de-identified form. Additionally, enhancements made since last data publication changed the previous system-assigned unique identifiers like Physician_Profile_ID, Record_ID, and Teaching_Hospital_ID. That means that identifiers in this year’s publication will not match identifiers in last year’s publication. For example, profile ID 123 used for Dr. John Smith in the last data publication is no longer associated with Dr. John Smith. Re-downloading the 2013 data will ensure that the profile ID your system has for 2013 matches the profile ID for 2014 data. CMS does not anticipate changing the system-assigned unique identifiers again.

Key words: Open Payments, Sunshine Act  (FAQ12382)

"NEW" What is CMS doing to make sure this information is friendly for consumers?

Since first publishing Open Payments data in September 2013, CMS has made many enhancements to the tools available to search and manipulate the data. Shortly after the initial data publication, CMS launched a data search tool to allow for consumer-friendly data searches that allows users to search for their personal physician, or search on criteria such as specialty, location, or types of payments received.

Continuing on that path, CMS is providing summary graphics of key data points on https://openpaymentsdata.cms.gov/. This new data dashboard will also be available in printable format. Additionally, in the coming month, CMS will present another new, very detailed search interface that will translate the large datasets into more detailed visualizations.

The program does not make assumptions or draw conclusions about the information reported, and CMS is directing consumers who may have questions about the information on the website to use it as one of the many discussion points in their doctor-patient relationship.

Key words: Open Payments, Sunshine Act  (FAQ12394)

"NEW" How often is Open Payments data refreshed or updated?

CMS will collect and publish this data every year. September 30, 2014, was the first publication of this data; it was then refreshed for the first time on December 19, 2014. This year, and for all years after, data publication is on June 30. CMS will also refresh the data once annually, after the initial publication.

Key words: Open Payments, Sunshine Act  (FAQ12380)

"NEW" Is CMS planning to provide any type of data summary sheets?

CMS is providing summary graphics of key data points on https://openpaymentsdata.cms.gov/. This new data dashboard will also be available in printable format. Besides that, CMS is not providing any other summary presentations of the data. The data is publically accessible and available for consumers and researchers to extract as they see fit.

Key words: Open Payments, Sunshine Act  (FAQ12364)

"NEW" How many records did CMS release on June 30, 2015? What is the value of those records?

For 2014, the data contains 11.4 million records, totaling $6.49 billion. That means that over the program’s entire lifespan, 15.7 million records of payments, other transfers of value, and ownership or investment interests are reported on the Open Payments website, totaling $9.9 billion. These records are attributable to over 600,000 physicians and more than 1,100 teaching hospitals.

Key words: Open Payments, Sunshine Act  (FAQ12358)

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