Life Science Compliance Update

April 29, 2015

Open Payments Review & Dispute Resolution Ends May 20 for Physicians and Teaching Hospitals; No Extensions for Lost Disputed Records, Web Downtime

On April 6, the Centers for Medicare and Medicaid Services (CMS) opened the review and dispute period, during which healthcare providers can log-in to Open Payments and review the payments attributed to them. Originally, CMS announced on April 6, 2015 that physicians and teaching hospitals have 45 days from April 6, 2015 to voluntarily review data reported by drug and medical device makers about them, and, if necessary, dispute payments.  

April 6 2015

This week they clarified that the 45 day period ends on May 20, 2015.  Payments that are disputed but not resolved within 15 days after the review period (June 3) will be made public on June 30th. Providers can continue to register disputes until the end of the year, but resolutions will not be publicly displayed until the next reporting cycle.

May 20 2015

As we recently reported, the dispute resolution period got off to a rocky start for physicians looking to check on their data. Doctors reported that registration issues and website outages cost them a fair amount of time. The Open Payments system locks accounts if there is no activity for 60 days or more and deactivates accounts if there is no activity for 180 days or more, which also added to the challenge.

Lost Disputes

Most troubling, though, applicable manufacturers and covered recipients were notified by CMS that during an approximately 3 day window, records that had been disputed by physicians were lost in the system. This same email went to both manufacturers and covered recipients (physicians and teaching hospitals) the email is written in code for which the translation is "Our computer system lost the record of your disputes please enter again":

CMS Email

It is now up to the physicians to figure out whether their disputes are still there, then re-enter the disputes, before manufacturers can do anything about it. At CBI's aggregate spend conference in San Diego last week, Doug Brown of CMS spoke to the issue of lost disputes. He stated that CMS doesn't want manufacturers to correct the lost disputes, but instead to wait until covered recipients re-enter the dispute before they can correct them. CMS also noted that they are unsure how many disputes were lost in their system.

Polaris Management stated:

If you received notifications for disputes initiated by HCPs within the first few days of the 45-day dispute window, you may have a hard time locating them in the Open Payments system. This is due to a data refresh that occurred on April 8th, resulting in all disputed initiated between April 6th – 8th being lost. CMS has since reached out to HCPs letting them know if they initiated a dispute during this timeframe, they will have to do it all over again because it’s not longer in the system. However, this issue has not been proactively communicated to the Applicable Manufacturers that initially received the dispute notifications by email. So pay attention to the disputes that you’ve gathered and are researching, they may no longer be valid.

Despite the issues with the dispute resolution process (and the confusion surrounding the dispute date as evidenced by news reports running varying dispute deadlines - See bellow), CMS is holding to May 20th as the deadline for disputes. 

June30

This is the second reporting cycle for Open Payments, and it covers payments made in 2014. Last year, CMS published information about 4.45 million payments valued at $3.7 billion for the last five months of 2013. During the first year's review and dispute period, 26,000 physicians registered in the Open Payments system to review payments attributed to them. This is out of 366,000 physicians in the system--so only around 7 percent. It will be interesting to see whether the second year of the review phase attracts more interest from physicians, and if the final stretch of the process is hassle-free. 

For an interesting inside look at some of the problems affecting physicians engaged in the dispute process, see Steven Ladd's Twitter account, which he updates regularly. Ladd, the President of Primacea, is an expert at the review and dispute process, his company having monitored Open Payments data for a substantial number of physicians as their “Open Payments agent” over the past year. 

For example:

Ladd email

 

 

April 17, 2015

Open Payments Dispute Resolution Call Reveals Tension Between Manufacturers and Covered Recipients

CMS

On Wednesday afternoon, the Centers for Medicare and Medicaid Services (CMS) held a teleconference for physicians and teaching hospitals to help them through the process of reviewing their Open Payments data and potentially disputing their information. Notably, CMS has streamlined their teaching tools for physicians to a manageable 38-page PowerPoint (from over a hundred pages before, see p. 200). 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. Thus, manufacturers have the final say regarding disputes, but are kept in check by the fact that physicians can continually dispute payments after manufacturers remove the disputes. This seems to encourage an open dialogue between the two parties to collaborate and work through this process.

A troublesome point for physicians and teaching hospitals that consistently came up during the call is the lack of context or consistent reporting of the “Nature of Payments” categories by manufacturers. For example, one caller articulated the process of reviewing payments for physicians who received a device or instrument loan. “One manufacturer reported it as a gift, some as space rental, and some as consulting payments,” the caller noted. Indeed, it is up to the manufacturer to determine the nature of payment of certain transfers of value. For compliance personnel working in hospitals attempting to verify whether or not these payments are correct, it can be very difficult to determine the accuracy of such varying payment titles. This is especially true when manufacturers report payments to physicians as aggregate totals throughout a given year.

CMS agreed that the nature of payment categories may be expanded or clarified in the future, but noted that a public forum—with input from all parties—would be necessary to change the system.

Another important point is that the deadline for recipient disputes is until the end of the reporting year for the particular payment. “Physicians, teaching hospitals, and principal investigators have until the end of the 2015 calendar year to initiate disputes of data submitted in 2015,” states CMS. While disputes made outside of the initial 45-day window will not immediately show up, they will be on the database by CMS’s next data refresh, which comes at least once a year, according to the agency.  Disputes about 2013 payment, however, are past the due date.

Some other important notes brought up during the call included the fact that there is currently no download functionality on the Open Payments review and dispute program. For hospitals that employ a large number of physicians with many pages of payments, this becomes a major inconvenience for those that simply want to download and print out their list of reported transfers of value. Also, hospitals will continue to be listed exactly as they appear in CMS’s teaching hospital list. Many had requested that manufacturers list the department of a given teaching hospital where payments were made, given the size of many institutions. CMS confirmed that the master hospital list is the guiding document.  

The PowerPoint has a good deal of important information for covered recipients, so it is worth looking at. CMS listed a number of tips for successful physician vetting (where CMS vets doctor profiles against “CMS-approved sources to confirm the registrant is a covered recipient”) that are important to point out:

  • Make sure the name used for registration matches exactly with the name in the National Plan and Provider Enumeration System (NPPES). CMS notes: “If you changed your name in NPPES after Dec. 31, 2014, use the earlier version of your name that was in NPPES.”
  • Enter NPI, if available. “Enter exactly as listed in NPPES for the current calendar year,” CMS states. “Do not enter NPI if it was obtained after Jan. 1, 2015.”
  • Enter all active state license(s)
  • “Provide as much information as possible – more information can speed vetting and ensure all records associated with the physician will be accurately matched to them,” CMS states.

View the PowerPoint for 2015 review and disputes here.

 

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