This article examines the shifting timeline for Open Payments registration, the dispute resolution process, and as of August 15, the dates for the public database. As the many announcements from the Centers for Medicare and Medicaid Services (CMS) over the last year demonstrate, it has been difficult for both manufacturers and physicians to understand their responsibilities under the law. Manufacturers had their data submission deadline pushed back several times. Physicians received ambiguous instructions on when and how to register to review their payments. Most recently, CMS took their Open Payments system off-line for 11 days to resolve data integrity issues.
CMS has long stated that the Open Payments data submission deadline for manufacturers was March 31, 2014. However, for a long time CMS avoided any certainty regarding a date for companies to be able to register in Open Payments and actually submit that data. CMS’ website, emails, and presentations noted that manufacturers would be able to register and submit their transfers of value in “Early 2014” for many months.
Also, in August, 2013, CMS stated that physicians and teaching hospitals “may register with the Open Payments system at any time beginning in early 2014.”
AUGUST 2013
In the first week of August, 2013, CMS offered a presentation stating that physicians and manufacturers would be able to register in Open Payments in “early 2014. The Open Payments website also had this timeline for data submission:
On November 19, 2013, CMS hosted a webinar and set forth the following timeline, which adjusted the physician timeline:
For all of January 2014, manufacturers were still unsure what “early 2014” meant, despite data submission being due less than 2 months away. Weeks went by with CMS explicitly dodging the answer during conference calls.
Finally, on February 7, 2014, CMS announced a new approach to data submission. Their announcement stated:
On February 18, Open Payments registration and data submission for applicable manufacturers and applicable GPOs will open with a two-phased approach for this first reporting year of this new program:
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Phase 1 (February 18 through March 31) includes user registration in CMS’ Enterprise Portal and submission of corporate profile information and aggregate 2013 payment data.
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Phase 2 (begins in May and extends for no fewer than 30 days) includes industry registration in the Open Payments system, submission of detailed 2013 payment data, and legal attestation to the accuracy of the data.
Notably on February 18, Open Payments opened with no information about “aggregate” data submission.
March 17, 2014
“Later, in May 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.”
March 28, 2014
“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. For more information on the differences between Phase 1 and Phase 2 requirements, review the Phase 1/Phase 2 Comparison Document.”
March 31, 2014
“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. For more information on the differences between Phase 1 and Phase 2 requirements, review the Phase 1/Phase 2 Comparison Document.”
April 17, 2014
CMS hadn’t offered many hints as to when physicians and teaching hospitals would be able to access their information on Open Payments until April. CMS hosted a webinar aimed at covered recipients, and provided the following timeline:
May 1, 2014
CMS announced: “Physician and Teaching Hospital CMS Registration Begins June 1”
May 7, 2014
“As previously announced, CMS expects to begin Phase 2 of Open Payments registration and data submission for industry in late May/June 2014. Phase 2 will run for no fewer than 30 days.”
Industry heard no announcement from CMS until May 22, 2014, the Thursday evening before Memorial Day weekend. CMS announced that like Phase 1, Phase 2 was being broken up into two steps as well.
Step 1: June 1-June 30, 2014, authorized officials of applicable manufacturers and applicable GPOs will be required to:
- Complete Open Payments system registration for themselves and their reporting entity;
- Confirm the accuracy of the reporting entity profile data submitted for Phase 1; and
- Delegate roles and responsibilities by nominating system users to fill specific user roles.
Step 2: June 9-June 30, 2014, the Open Payments system will also allow:
- Submitters to perform final data submission (which includes a series of checks to match the reported data to the appropriate physicians and teaching hospitals); and
- Attesters to attest to the accuracy of their submitted detailed 2013 payment or other transfer of value data, or ownership/investment interest data.
June 6, 2014
CMS pushed back physician registration at least a month by splitting up registration
Phase 1 (available now): Includes user registration in CMS’ Enterprise Portal.
Phase 2 (begins in July): Includes physician and teaching hospital registration in the Open Payments system, and allows them to review and dispute data submitted by applicable manufacturers and applicable GPOs prior to public posting of the data. Note: Any data that is disputed, if not corrected by industry, will still be made public but will be marked as disputed.
June 12, 2014: Webinar Timeline
June 30, 2014
According to an official email companies from CMS, the agency will not enforce penalties for reporting non-compliance until after July 7th.
July 2, 2014
On July 2, CMS moved pushed physician registration to mid-July. This was now a trend” From “early 2014,” to mid-2014, to June 2014, to July 2014, to mid-July 2014.
“In mid-July, physicians and teaching hospitals can begin registration in the Open Payments system. Although registration is voluntary for these groups, it is required if the physician or teaching hospital wants to access the data so that they can review and dispute what has been reported about them by applicable manufacturers and applicable group purchasing organizations (GPOs).”
Phase 2 is when physicians and teaching hospitals are allowed to:
- Register in the Open Payments system,
- Delegate roles and responsibilities by nominating system users to fill specific user roles, and
- Review and dispute data submitted by applicable manufacturers and applicable GPOs prior to public posting of the data. Note: Any data that is disputed, if not corrected by industry, will still be made public but will be marked as disputed.
July 3, 2014:
CMS proposes changing Sunshine Act reporting requirements, potentially expanding CME reporting.
July 11, 2014: CMS released the official start date for physician registration, and also the review and dispute process (which started the same day).
“Physicians and Teaching Hospitals: Open Payments System Registration Begins on July 14. Although registering in the Open Payments system is voluntary, it becomes a mandatory process if physicians and teaching hospitals want the opportunity to review and dispute data submitted by applicable manufacturers and applicable group purchasing organizations (GPOs) prior to public posting on September 30, 2014.”
“The Open Payments review, dispute and correction process begins on July 14 and ends on August 27. This process spans a total of 60 days. The initial 45-day period (July 14 through August 27) is for physicians and teaching hospitals to review and initiate any disputes they may have regarding the data reported about them by applicable manufacturers and applicable GPOs. The remaining 15-day period (August 28 through September 11) is additional time that has been provided to industry to submit dispute corrections.”
10:00pm EDT Monday August 4, 2014:
System Failure
August 7, 2014; 3:58 PM: CMS makes a statement about the Open Payments system.
“The Open Payments system has been taken offline temporarily to investigate a reported issue,” says the Centers for Medicare and Medicaid Services (CMS). Thus, physicians, teaching hospitals and authorized representatives may not register and review data at this time.
CMS states that “[f]or each day the Open Payments system is offline for this incident, CMS will adjust the Open Payments review and dispute deadline and the following 15-day corrections period deadline accordingly.”
August 15, 2014
CMS announces new dispute resolution timeline in light of 11-day delay:
- Review and dispute (45 days): 7/14/2014-8/2/2014 (20 days), 8/15/2014-9/8/2014 (25 days)
- Correction period (15 days): 9/9/14 – 9/23/14
- Public website launch: 9/30/2014
ProPublica also reported that up to “one-third” of the physician payment data will not be published until June 2015. We are awaiting an official CMS comment on this.