The Centers for Medicare & Medicaid Services (CMS) released this week 28 new frequently asked questions (FAQs) related to reporting payments and transfers of value provided by applicable manufacturers and group purchasing organizations (GPOs) to physicians and teaching hospitals in connection with the federal Sunshine law.  The FAQs generally relate to reporting procedures, technical process questions for the CMS Open Payments system, fixing report errors, and the attestation process.  The new FAQs are posted below.  Cooley also maintains a CMS Open Payments FAQ tracker that can be accessed under the “Trackers and Presentations” section on the right side of the blog or under the “Resources” section at the top of the blog.

10054 If an applicable manufacturer or applicable GPO later determines an error across all payments or other transfers of value for meals provided to a specific physician, could an applicable manufacturer or applicable GPO submit a negative value record to offset the error for all payment records regarding meals for the specific physician?
10074 Are attesters for applicable manufacturers and applicable GPOs submitting a consolidated report required to be a Chief Executive Office, Chief Financial Officer, Chief Compliance Officer, or other Officer for all the entities included in the consolidated report?
10076 Is an applicable manufacturer company that dissolves or is purchased by another company responsible for reporting in Open Payments?
10078 Is data element 43 in the research payment template asking if a Principal Investigator covered recipient received a payment that was reportable in the general payment template?
10080 How can an applicable manufacturer request a delay in publication for a research-related payment, and how will CMS notify the applicable manufacturer if the delay is approved?
10082 Do applicable manufacturers need to report NPIs for teaching hospitals?
10084 Can a physician reimburse an applicable manufacturer for payments so that no information is reported about them in Open Payments?
10086 Can all payments made to a covered recipient during a reporting period for the same Nature of Payment category be combined into one payment?
10088 If two or more entities plan to submit a consolidated report, do all entities need to register in Open Payments?
10090 Is there a minimum value threshold that needs to be met in order for applicable manufacturers and applicable group purchasing organizations to be required to report?
10092 If an entity registered for Phase 1 in Open Payments but later determined that it is not an applicable manufacturer or applicable group purchasing organization (GPO), what action should be taken, if any?
10094 Since NPPES data may be updated by physicians on an ongoing basis, at what point in time may applicable manufacturers rely on the data?
10100 Including data lines and rows per file submission, what is the total allowable size for the data files to be submitted in Phase 2?
10102 How will data submissions be transferred to and received by CMS?
10104 Can a data file submission be broken down and submitted in multiple files based on the number of line items?
10106 Can one attestation cover multiple individually submitted data files, with all of the files as part of the same submission?
10108 Including zip codes, how will data validation be performed on data elements to be validated? And, what checks will be performed on each?
10110 What is the expected length of time for CMS to complete data validation on submitted data files?
10112 How will an applicable manufacturer or applicable GPO be notified if any portion of their submitted data file has failed data validation or contains any data errors?
10114 In the event of any data errors, will the applicable manufacturer or applicable GPO be returned their whole data file submission, or only the data lines failing validation?
10116 Will every data error in each line item be identified to eliminate resubmissions regarding the same line items?
10118 What is the resubmission process for an applicable manufacturer or applicable GPO to resubmit their corrected data files?
10120 Are large amounts of corrected data files capable of being resubmitted?
10122 If multiple records in a submitted data file have been rejected, can an applicable manufacturer or applicable GPO replace and submit an entirely new data file?
10124 Are attestations required as part of corrected record resubmissions?
10126 What is considered a timely re-submission of data? And can corrected data file resubmissions extend past the deadline?
10128 Can an applicable manufacturer or applicable GPO submit a dummy test data file submission to verify if their data is formatted correctly?
10130 How does CMS plan to handle the dispute process from an IT perspective?

Posted by Cooley

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