Life Science Compliance Update

105 posts categorized "CMS"

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.

 

April 09, 2015

Open Payments Issues For Physicians To Watch For In The Dispute Resolution Period

Review Period

To comply with the Physician Payments Sunshine Act, drug and medical device manufacturers submitted their 2014 Open Payments reports to the Centers for Medicare and Medicaid Services (CMS) on Friday, April 3. On Monday, April 6, the dispute resolution process kicked off—physicians and teaching hospitals have a 45-day window until midnight May 21, 2015 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. This data will be published in a public database on June 30, 2015. Physicians and teaching hospitals aren’t required to review their information, but given the potential for reputational harm or even conflict-of-interest related disciplinary actions resulting from being paired with incorrect payments, physicians should take the time to look into the database.

Steven 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. We recently spoke with Ladd about this year’s process. He highlighted several issues with the process that may make it very time consuming and difficult for physicians to check their records.

Registration Issues

Ladd stated that currently the system has some serious issues regarding log-in for physicians who already registered last year. The CMS Enterprise Portal 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. Considering most physicians registered last year to view their payments and had no real reason to check back in, the majority of physicians (specifically those without an Open Payments agent) will at least have to unlock their accounts. CMS recommends that “to unlock an account, go to the CMS Enterprise Portal, enter your user ID, and correctly answer all challenge questions; you’ll then be prompted to enter a new password.” Ladd notes, however, that answering the three challenge questions often does not actually unlock the account. In Ladd’s experience, he has answered the security questions (which he has verified to be correct), saved his work, and then been redirected to the start of the registration process. This happens “over and over again,” he states.

The result is that a majority of physicians will have to call the Help Desk just to change their password to initially log on to Open Payments. For future reference, physicians can submit questions to the Help Desk via email at openpayments@cms.hhs.gov or by calling 1-855-326-8366.

Ladd estimates that if registration goes smoothly (and not counting unplanned website outages), physicians should be able to get into the system to view their payments within 30 minutes to an hour. However, Ladd has already encountered and documented a number of outages this year, including one “for regularly scheduled maintenance” during the normal business hours (see more images at https://twitter.com/Primacea).

Steve Ladd Twitter

Dispute Difficulties

Once physicians get into the system and examine their reports, they may or may not find inaccuracies. Ladd notes that most companies are very responsive to requests for changes, and work to get the correct information for their physician consultants. However, the internal processes of certain manufacturers do not allow them to simply go into Open Payments and fix errors in their submitted reports—these companies must instead wait for a dispute to be formally filed with CMS. Because of the split in how companies will respond to physician requests and disputes, Ladd states that Primacea now immediately files disputes with CMS to avoid going back-and-forth with companies that may have varying policies.

In addition to the problems with initiating and resolving disputes, the underlying cause of many incorrect payments has to do with the inherent conflict between manufacturers and physicians under the Sunshine Act. Indeed, companies don’t want to risk potentially being hit with steep fines for underreporting. They face no consequences for over-reporting. Ladd states that reporting by different business silos may result in double or even triple reporting of physician payments. These could be large dollar figures, notes Ladd, and the implications of erroneous reports could be significant.

More Records, More Interested Physicians

In Primacea’s experience, many more physicians are interested in their Open Payments reports this year than last. This isn’t very surprising considering that many doctors likely saw the implications of faulty payment data last year, as local and in some cases national media outlets honed in on doctors with the most money next to their names. Ladd notes that the doctors who had a bad experience with the data in Year 1 have in many cases alerted their colleagues and friends to look into the system to avoid a similar situation. Ladd notes that, on a number of occasions, he has been contacted by hospital administration staff to ask for help in going through the payment records to safeguard the hospital’s reputation, which may be called into question if many of their doctors end up with vast amounts of money next to their name. 

Another point worth noting is the sheer number of payment records in this year’s database. The first year of Open Payments reporting covered five months of data—from August 2013-December 2013. As many as half of those payments were actually de-identified or dropped off completely from the database in the first year due to matching issues in the system. This year, however, manufacturers submitted 12 months’ worth of payment data, and the previously unpublished payments will also be in the system. “This could result in 4-5 times as much data,” notes Ladd.

Last week we covered the issues on the data submission side. CMS continues to experience some matching issues where, for example, two physicians have the same name. While the matching has greatly approved from last year, the vast amount of data in the system this year foreshadows at least some mismatched names and payments.

Adding to the confusion, the vast majority of physicians were incorrectly notified that they failed a “vetting process” for Open Payments. Primacea has been working with CMS to help a number physicians complete the registration process. Ladd reports that, despite physician registration data perfectly matching the NPPES database (the “gold standard” for the vetting process), CMS informed the physicians that they cannot complete their registration until a new version of CMS software is released.

Bad Publicity from Bad Data

“Most doctors don’t want to have long conversations about whether they lied on their conflicts of interest forms,” Ladd adds. Erroneous data, including double reporting from companies, or payments that have no bearing on what the physician has done, are both embarrassing and, worse, could diminish the physician’s desire to do work with industry going forward. The risk to reputation may suppress innovation, as physicians deliver essential services by undertaking research and providing education.  

“It looks like it’s going to be an uphill slog,” stated Ladd, who notes that the review and dispute process may drive some physicians to “cross their fingers and hope there are no mistakes next to their name.” Given the obstacles to getting into the Open Payments database, physicians may need help along the way.

 

Steven Ladd is the president of Primacea, the first organization dedicated to serving the best interests of physicians and hospitals who advance medicine in collaboration with industry.

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