Life Science Compliance Update

February 06, 2018

Tomorrow: CMS To Host Open Payments Webinar/Q&A

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Tomorrow, February 7, 2018, the Centers for Medicare and Medicaid Services (CMS) will be hosting a Webinar and Question and Answer session with CMS Open Payments program experts from 2:00 pm to 3:00 pm EST. CMS has been hosting these every few months for stakeholders to get some of their important questions answered.

During this webinar/Q&A session, the Open Payments team will present an overview of system enhancements and data submission activities and will then be able to respond to your questions about the 2017 Open Payments program year.

If you have a question, you must go online and register at least fifteen minutes prior to the webinar here. Once you are registered, you will receive an email with instructions on how to join the call and ask a question.

If you do not have a question, but want to listen to the call to gain insightful information, you can dial in to (844) 396-8222 and enter meeting number 900 984 780 when prompted.

August 04, 2016

CMS Hosts Special Open Door Forum

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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.

 

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