The Centers for Medicare and Medicaid Services (CMS) recently published the 2014 payment data detailing in a searchable database the transfers of value drug and device manufacturers make to physicians and teaching hospitals. While manufacturers alone are responsible for collecting and reporting this data—and face penalties for non-compliance with the Open Payments requirements—physicians bear a large share of media scrutiny and professional liability for inflated or otherwise inaccurate reports. Thus, CMS allows for a 45-day window after manufacturers submit data and before the data is released to the public for physicians to log-in to Open Payments, review any payments attributed to them, and potentially alert the manufacturers of any misreporting or other issues they find.
Earlier this year, CMS re-iterated their position that they will not be involved in mediating disputes. However, “CMS will monitor disputes and resolutions to inform the program auditing process,” they stated. “How many disputes are initiated as well as the volume of unresolved disputes,” will be of particular interest to the government.
Physicians, teaching hospitals, principal investigators, or their agents may review records, affirm records, initiate disputes, or withdraw disputes on the Open Payments website. But even if covered recipients do not check on their data and affirm their records, the payment data will still be published regardless of whether recipients ever log in to the Open Payments system. Once the dispute is reviewed, it can be resolved in one of three ways:
- Resolved – manufacturers update and resubmit the disputed data.
- “Resolve No Change” – indicates that the applicable manufacturer or applicable GPO and the physician or teaching hospital have resolved the dispute in accordance with the guidance in the Final Rule. This action should only be taken when dispute resolution does not require a change to the data by the reporting entity.
- Withdrawn – a physician or teaching hospital can withdraw a dispute initiated against a record.
If a dispute cannot be resolved, however, then the latest, attested-to data manufacturers submitted to CMS will be published and marked under dispute. While manufacturers have the final say regarding disputes, they are kept in check by the fact that physicians can continually dispute payments after manufacturers remove the disputes.
How many physicians are reviewing and/or disputing their data?
Since the Sunshine Act was first on manufacturers’ radars, the “review and dispute” process has been an uncertainty. Companies had no idea how many physicians would be logging into the Open Payments system, reviewing the transactions, and entering disputes. Would one hotline for disputes suffice, for example, or would a dedicated team need to be on call ready to handle countless phone calls over a slice of pizza? View our article from last year on stakeholder comments to the review and dispute process.
CMS announced that for the 2014 reporting year “[r]egistered physicians and teaching hospitals reviewed nearly 30% of the total value of the reported data.” The agency reported that of the 11.41 million records, totaling $6.49 billion in 2014, 2,569 records totaling $18.22 million were left disputed when the data was published on June 30. This represents 0.02% of the records and 0.28% of the total value reported.
With the help of Open Payments Analytics, we were able to capture which Nature of Payments categories had the most lingering disputes.
Centers for Medicare and Medicaid Services, Open Payments Data
—
Manufacturers have an incentive to resolve disputes before publication, both to maintain collaborative relationships with doctors and also avoid added scrutiny into their Open Payments data. Thus it is not surprising that there are relatively few payments left disputed in the grand scheme of the reported data. It will be interesting to see the disputing trends as more doctors learn about Open Payments and become familiar with the system.
In the coming issue of Life Science Compliance Update, we are featuring an article entitled “I Never Ate That Bagel! Navigating Compliance Risks Associated with Disputes Under the Physician Payments Sunshine Act,” by Abraham Gitterman, JD, FDA/Healthcare Associate at Arnold and Porter. In it, Gitterman offers some recommendations for manufacturers to consider when addressing disputes, not only to resolve inaccuracies to ensure compliance with the Sunshine Act, but also to identify and potentially mitigate additional compliance risks that may arise from or be attributed to disputes.