The second year of Centers for Medicare and Medicaid Services’ (CMS) Open Payment program included in the Sunshine Act just completed its reporting deadline for device manufacturers to disclose how much money they paid physicians and teaching hospitals in 2014.
CMS will publish the new payment reports on June 30, 2015.
Do you know what information has been filed under your name?
Inherent Conflict Between Industry and Physicians
Companies submitted their unpublished payment reports on Friday, April 3, 2015. Hospitals and physicians now have until midnight May 21, 2015 to dispute information reported by the device companies.
Tom Sullivan of Policy and Medicine says there is an inherent conflict between industry and physicians in this process. Industry is rewarded for erring on the side of over-reporting and has final say over any disputed payments. Physicians have to engage a cumbersome process to double check industry’s reports and bear the burden of disputing any mistakes.
But the risks of bad publicity, or worse, false reports alerting regulators is too high to hope for the best.
CMS Tips for Successful Vetting
On April 15, 2015, CMS held a teleconference for physicians to help them through this process.
A troublesome point for physicians and teaching hospitals that consistently came up during the call, said Sullivan, is the lack of context or consistent reporting of the “Nature of Payments” categories by manufacturers.
For example, Sullivan said one caller talked about 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. “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, ” wrote Sullivan.
The agency provided a PowerPoint presentation that lists 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 [National Provider Identifier], 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 is the advice given by CMS.
View the PowerPoint for 2015 review and disputes here.
Unwelcome Publicity and DOJ Scrutiny
Once the data is published, the media feeding frenzy will start.
But there is something more important than unwelcomed publicity for physicians. Combined with CMS’ release of Medicare payments to physicians, the information tells the U.S. Department of Justice (DOJ) a lot. DOJ has publicly stated that the massive data upload now makes it easier for them to “find the needle in the haystack” when searching for physicians who they think might be crossing the Stark Law line.
Lew Morris, the Office of the Inspector General’s (OIG) former chief counsel said last year that manufacturers and healthcare providers could face multiple sources of scrutiny. The published data will likely be of interest to “whistleblowers and investigative reporters and law enforcement, ” among other groups, he said.
This attention could be unjustified for those “outliers that really aren’t outliers and are just a matter of information being put into the wrong category, ” added Morris, now an attorney at Adelman, Sheff & Smith.
Morris also said there is broad understanding that Sunshine implementation will involve some complications. Based on his conversations with his former colleagues at DOJ and OIG, he said it is unlikely that enforcers “are going to be handing out traffic tickets the first day that the rule goes into effect.”
Take Time to Look
Physicians are not required by law to double check industry payment reports, but Sullivan says that “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.”
According to a Modern Healthcare report, Toula Bellios, a director of CMS’ Center for Program Integrity, said, “Most doctors don’t even think it’s really relevant to their practices.”
Logging On
Physicians will find looking up their information “very time consuming and difficult, ” said Steven Ladd, president of Primacea, Inc., a consultant who has monitored Open Payments data for a large number of physicians over the past year.
There are some “serious issues” regarding log-in for physicians who already registered last year. If you have not accessed your Open Payment account within the last 60 days, you will be locked out. If it’s been six months, you’re deactivated.
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.”
Good luck with that, says Ladd.
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.
If all goes well, Ladd says physicians should be able to get into the system in about 30 to 60 minutes.
Double Check and Dispute
Once you get in and find inaccuracies, most companies are very responsive to requests for change and fix any inaccuracies, said Ladd.
But some companies won’t allow physicians to simply make the change without a dispute to be formally filed with CMS. Ladd says his firm now files disputes with CMS immediately to avoid going back and forth with companies.
Confusing Reporting
Sometimes 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.
This past January, ProPublica reported on flaws in the reporting process.
Drug and device makers misspell the names of their own products. For example Forest Laboratories misspelled Fetzime as Fetziima 953 times. Amedica Corp. sometimes called its Preference screw system “Preferance.”
Companies, for instance, routinely recorded payments associated with a single drug or device under multiple names. About 8.5% of the 4.3 million general payments companies reported to the government were not connected to specific products. More than 140 companies did not list products at all in their payment records so you don’t know which products relate to those payments.
ProPublica learned that some companies listed products in the wrong category, or listed them as both drugs and devices in the same payment records. For instance, Luitpold Pharmaceuticals Inc., a drug maker, did this in more than 8, 000 payment records. Uroplasty Inc., a medical device company, did it in about 2, 100 records. Other companies, including Exactech Inc., OsteoReady LLC, NeuWave Medical Inc. and Orthopediatrics Corp., reported payments this way hundreds of times apiece.
CMS doesn’t double-check what companies submit.
“We are very committed to not altering data, ” said Shantanu Agrawal, director of the agency’s Center for Program Integrity. “Our role is not to spell-check for the industry. The act of transparency also will improve the data itself.”
Bigger Data Set
An additional challenge this year is that a lot more data is being reported.
Last year only five months of data were reported (August to December 2013). Almost half of those payments were de-identified or dropped off completely due to matching issues in the system.
This year, manufacturers have submitted 12 months of payments data. Also, the previously unpublished data will be included. This could result in 4-5 time more data, said Ladd.
Sullivan says CMS continues to experience some matching issues such as two physicians having 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. 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.
2014: 4.5 Million Payments – $3.5 Billion
The last, limited, bunch of data was released in September 2014. It showed that manufacturers made 4.4 million payments to physicians and teaching hospitals during the five month time frame, valued at $3.5 billion.
In December 2014, CMS updated the website to include about 68, 000 new payments. The database now includes payment information for about 500, 000 physicians and 1, 360 teaching hospitals, totaling $3.7 billion.
Dispute Resolution
If you dispute a reported payment, the parties must resolve the problem within 15 days following the 45-day period.
If it’s not resolved by June 30, the payment will be published and noted as being disputed. You can still challenge information after the review period, but that won’t be noted until after the reporting cycle.
Reportable Items
The Sunshine Act covers meals, honoraria, travel expenses, and grants. It also requires disclosure of physician ownership in companies and investment interests in group purchasing organizations (GPOs).
Payments or transfers of value worth at least $10, and transactions of less than $10 if they total $100 or more in a given calendar year, must be reported. The range of items that must be reported includes cash or a cash equivalent, in-kind items or services, stock, consulting fees, compensation for services other than consulting, honoraria, gifts, entertainment, food, travel (including the destination), education, research, charitable contributions, royalties or licenses, current or prospective ownership or investment interest, speaker compensation for CME events, and grants.
To assure that payments are being reported accurately by companies, Sullivan says physicians should:
- Track their own payments from industry
- Clarify with industry representatives what will be reported
- Provide companies with identifying information such as their National Provider Identifier (NPI), state licensure information, business address, and specialty
- Inquire about the source of payments they receive, since transfers of value can occur indirectly—through specialty societies, for example—when funding originates with manufacturers
- Participate in the prepublication review-and-dispute period to validate reported data and identify potential inaccuracies.
- Updating NPI information or obtaining an NPI through the National Plan and Provider Enumeration System (https://npiregistry.cms.hhs.gov) is critical.
As stated above, physicians aren’t required to check on the data. But know whistleblowers, prosecutors and the media will check for you.
