Manufacturers must submit their Open Payments reports to the Centers for Medicare and Medicaid Services (CMS) today, March 31. These records cover payments or other transfers of value from pharmaceutical and medical device companies to healthcare professionals given in 2014. This second year submission process is unique in that it covers an entire year of payments, rather than only five months’ worth, as was the case in the first round of Open Payments reporting.
Yesterday evening, CMS sent out an email confirming the deadline:
Tomorrow, Tuesday, March 31, 2015, is the final day for applicable manufacturers and group purchasing organizations (GPOs) to submit and attest to 2014 program year data and update 2013 program year data for publication by June 30, 2015. Complete your reporting entity’s data submission and attestation activities by logging into the Open Payments system through the EIDM Portal.
If you submitted data for the 2013 program year but have not yet begun the process for the 2014 program year, you will need to recertify in the Open Payments system before you can begin any 2014 submission activities. Use the Applicable Manufacturer and GPO Registration and Re-Certification – Quick Reference Guide [PDF] to help you complete this necessary step.
Lessons Learned, But Issues Remain
The initial Open Payments roll-out last year was problematic for manufacturers and physicians/teaching hospitals alike, and ultimately resulted in thousands of payment records being "de-identified" or outright removed from the database. CMS has attempted to fine tune the submission process by improving upon the matching formula used to verify a physician’s or teaching hospital’s identity as manufacturers attempt to enter their information into the system.
In addition to modifying the data matching algorithm for covered recipients, CMS also developed a Validated Physician List--a master list of their data. “To proactively assist with data matching, and in an effort to be fully transparent about the method and data sources used to validate submitted data, CMS is publishing a downloadable list of physician data in CSV format, which contains variations of physician first/last name, NPI and state license number, for physicians who were reported in the Open Payments system," CMS states. “This Validated Physician List is accessible in the Open Payments system via the CMS Enterprise Portal. CMS encourages applicable manufacturers and GPOs to utilize the provided physician list to avoid further inconsistencies in data reporting.”
While CMS’s efforts to improve the data submission process are appreciated, various consultants in the Open Payments space have indicated that CMS continues to use outdated physician and teaching hospital information for matching purposes and that the Validated Physician List has some gaps in the data. Several users have raised the issue that CMS has physicians still listed as a “student,” despite the fact that the physician is actively licensed by a state, for example. The result is that many HCPs are not being validated even by CMS’s updated matching logic, forcing at least one large aggregate spend firm to remove anywhere from 5-15 percent of the physicians, depending on the manufacturer.
Other issues include the fact that CMS has taken Open Payments offline on a number of occasions, including as recently as March 27. Companies have also reported challenges with submitting their corrections from last year, or continuing to delay publication of research payments. Manufacturers may request delayed disclosures related to research payments for investigational products in order to maintain confidentiality. These payments must be reported once the product receives FDA approval or four years have passed since the payments were made, whichever comes first.
Updated 3/31, 9:20 am: In addition to especially slow system performance in the last day of reporting, we have heard reports of zip codes being erroneously cleared out of covered recipient addresses in the submission stage. Another issue concerns how to report research spend to a teaching hospital with a physician principal investigator when the physician was (incorrectly) not included on CMS's master list. CMS has addressed this fact pattern for general payments, through the separate deleted file process described in the next section, but has not given guidance on whether it is better to report the research spend to the teaching hospital on-time with no principal investigator or to load the files separately and remove them, as CMS instructed for general payments.
During a call with manufacturers a few weeks ago, Doug Brown, Director of the Data Sharing and Partnership Group at CMS, stated that even given Open Payments’ revamped matching process, a situation may still arise where (1) a physician is not on CMS’s validated physician list, and (2) when companies submit the seemingly correct information, it is still being rejected by the system. “If we have a record that has an NPI, state license, and first and last name, and CMS cannot validate it using NPPES and PECOS,” than the system will not accept the record, Brown stated. ”So, there will be records attributable to covered recipients that the system will not be able to accept.”
Brown notes that he “does not want this to be something that "comes up down the road in an audit.” To avoid problems during an audit and resulting Civil Monetary Penalties, Brown advised companies to separate out the physician records that are problematic and that have been rejected. He stated that companies should separately submit all of the physician records that the system accepts, and attest to these. For the rejected pile of records, companies should nonetheless upload these records, which will be rejected, and then delete the entire file. Brown stated that Open Payments has a traceability capability that saves a lasting record that the company has submitted this file. Thus CMS will know that the company submitted transfers of value about individuals, even if there were problems with the ultimate submission process.
“Even when you delete the entire file, we do retain a record of this transaction actually occurring. And we can then look back later on, before contemplating any audit or any CMP action to make sure we have a firm understanding of those records that you attempted to report about," Brown states.
Vermont Reports Due April 1
Open Payments is just one aspect of reporting that manufacturers must juggle this spring. Vermont reports are due April 1 as well.
Unlike the Federal Sunshine Act, which requires disclosure of certain payments, Vermont law bans most gifts from manufacturers to healthcare professionals. This means manufacturers must be weary of payments made to any prescriber practicing in Vermont to make sure such transfers of value due not break the state law.
View Vermont's guide to its law here.
For any "allowable expenditures and permitted gifts," manufacturers must disclose these amounts to the state's Attorney General. Importantly, Vermont's list of reportable "covered recipients" is more expansive than the Federal law, so as not to be pre-empted. Indeed, the “Prescribed Products Gift Ban and Disclosure Law” applies to a broad list of “health care providers” (HCP), that includes a “health care professional, a hospital, nursing home, pharmacist, health benefit plan administrator, or any other person authorized to dispense or purchase for distribution prescribed products in Vermont.” Vermont law also requires manufacturers to disclose the distribution of samples of prescribed products to Vermont HCPs.
Vermont has been very active on enforcement of its gift ban and disclosure law this year, and does not seem to be letting up even after the Federal Sunshine Act has come into effect. View Vermont's list of enforcement actions.
Next Up For Open Payments: Physician Review and Dispute
CMS is hosting a webinar on April 15, entitled “Prepare to Review Reported Data” targeted at physicians, teaching hospitals, and physician office staff heading into the review and dispute phase of the Open Payments cycle.
During the call, CMS will provide a brief overview of the Open Payments program and highlight the parts of the program timeline when it is most critical for physicians and teaching hospitals to be aware and get involved. The call aligns with the beginning of the program phase when physicians and teaching hospitals are able to enter the Open Payments system and review the accuracy of data submitted about them, prior to the publication of this data on the CMS website.
Provide your insight into the Open Payments submission process, or offer any issues in a comment below.