How CMS is implementing the “Open Payments Program”: Applicable manufacturers and GPOs (industry), as well as physicians and teaching hospitals (covered recipients) must register (1) with CMS. Industry submits data and attests to their accuracy (2). Covered recipients who have registered will soon have the opportunity to review and dispute the data (3). CMS will notify industry of any disputes, but dispute resolution (4) is between the covered recipient and industry. Source: MLN Connects

AAOS Now

Published 7/1/2014
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Richard N. Peterson, JD

Foggy Forecast for Sunshine Act

CMS releasing procedure information slowly

During a National Provider Call sponsored by the Medicare Learning Network® in June, providers learned more about how the Centers for Medicare & Medicaid Services (CMS) plans to implement provisions of the Physician Payment Sunshine Act. But the presentations raised even more questions about how physicians can interact with what CMS is calling the “Open Payments Program” and what they will be required to do in the event of a dispute over the information.

According to CMS, the Open Payments program “is a national transparency program requiring certain manufacturers and group purchasing organizations (GPOs) to disclose their financial relationships with physicians and teaching hospitals.” CMS sees its role as a neutral facilitator, ensuring that reporting and disclosure are complete, accurate, and clear and presenting the data on a public website.

Following are some common questions and answers about the Act and its implications for physicians.

Sunshine Act questions
Which physicians are considered “covered recipients?”

Covered physicians include practicing doctors of medicine, osteopathy, dental medicine, dental surgery, podiatric medicine, and optometry. Chiropractors are also considered covered physicians. It should be noted that even if a physician does not participate in the Medicare program or have any relationship with CMS, data from industry on that physician will be part of the Open Payments program.

Which teaching hospitals are covered?
Affected teaching hospitals include those that CMS has recorded as receiving payment(s) under Medicare direct graduate medical education (GME), indirect medical education (IME), or psychiatric hospital IME programs. A link to the list of affected teaching hospitals can be found below.

2013 Open Payments Cycle: Teaching Hospital

Who are considered “immediate family members”?
The law requires applicable GPOs and manufacturers to report ownership or investment interest held by physician owners or investors and their immediate family members. Immediate family members include the physician’s spouse, natural or adoptive parent, child, sibling, stepparent, stepchild, stepbrother, stepsister, father-, mother-, daughter-, son-, brother-, or sister-in-law, grandparent or grandchild, and spouse of a grandparent or grandchild.

What type of data are collected?
This program captures ownership or investment interests, payments or other “transfers of value” made in connection with a research agreement, and other payments or transfers of value paid directly or indirectly to physicians or teaching hospitals.

What information on physicians will be reported by manufacturers?
Manufacturers will report the physician’s full legal name, area of medicine (primary and specialty), primary business address, national provider identification (NPI) number, state professional license number, and email address. Name and NPI will be shown as they appear in the National Plan and Provider Enumeration System (NPPES).

What information on payments will be reported by manufacturers?
The following information on payments will be reported:

  • The amount, date, form, and nature of payment or other transfer of value or ownership/investment interest
  • The number of payments/transfers of value
  • The reason for the payment (ie, consulting fee, honoraria, gift, entertainment, food/beverage, travel/lodging, education, research, charitable contribution, space rental or facility fee, royalty or license, current or prospective ownership or investment interest, grant, compensation for services other than consulting, direct compensation for serving as faculty or speaker for a medical education program, whether accredited or not)
  • The name of the related covered drug, device, biologic, or medical supply, if applicable
  • The name of the individual or entity the physician indicated to receive the payment, if the payment was designated to a third party.

When was this information collected?
The information that will be released to the public on September 30, 2014, was collected from August to December 2013.

Registration questions
Can physicians see the reports before the data become public?

Yes, provided physicians take the following steps:

  1. Register on the CMS Enterprise Portal website (https://portal.cms.gov) and request access to the Open Payments system. Registration opened on June 1, 2014.
  2. Register on the Open Payments system website (http://go.cms.gov/openpayments). Registration opened on July 1, 2014.

Registration is voluntary, but the physician must register on both sites to participate in the review and dispute process before the data become public.

Why do physicians have to register twice?
The first registration is part of the CMS Enterprise Identity Management (EIDM) system, which is how CMS verifies user identities. The EIDM system will match the information provided by the physician to information provided by Experian, the credit monitoring company, and make a “soft credit” inquiry about the individual. This is done strictly to verify the individual’s identity; the information provided will not be stored in EIDM or in the Open Payments system.

The second registration is into the Open Payments website itself. Once registered here, physicians will be able to view, verify, and dispute (if necessary) the data submitted by manufacturers and GPOs.

Can physicians authorize someone else to check the data provided by the manufacturers?
Yes. In this situation, both the physician and the other user would have to register in both the Enterprise Portal and the Open Payments systems. The physician can then delegate the other user as an authorized representative to review and dispute the data. The other user will need to accept that nomination as an authorized representative.

The physician can specify the limits of the authorized representative’s access to information. For example, the representative may have “view only” privileges, which permit access to view the data only. Or, the representative could be allowed to “review and dispute” the records relating to the physician. The most extensive authorization is “modify profile,” which enables the representative to update phone numbers and addresses. However, the representative will not be able to view all of the physician’s personal data, or to modify or reset a physician’s user ID or password.

Can an authorized representative for a physician in a group practice register other physicians in the practice?
No. Each physician must register separately and individually. However, once registered, all physicians in the practice may name the same individual as their authorized representative.

Can a physician name more than one authorized representative to review the data?
No; a physician may have only one authorized representative at a time. However, the physician can replace an authorized representative with another individual at any time.

Is there any penalty if a physician does not register with the system?
No. However, if a physician does not register, he or she will not be able to view and dispute the information in advance of its becoming public on September 30, 2014.

Dispute and resolution
What if a physician notices an error in his or her data?

Physicians and teaching hospitals will have 45 days to review and dispute the data supplied by manufacturers. Manufacturers and GPOs will have 15 days to correct or resolve issues around disputed information. Disputed information that is not resolved before the data is released will be published on the website, but will be marked as under dispute. CMS will not mediate any dispute.

Who decides how disputed information can be resolved?
CMS has stated that the responsibility belongs to the manufacturer that collected the data. If the manufacturer decides that the data are valid and the dispute is without cause, it can dismiss the dispute.

How would a physician know whether the data are correct?
Although manufacturers and GPOs are required to keep track of any payments or transfers of value, physicians have no obligation to do so. However, without records, physicians might find it difficult to dispute information posted about them. CMS has developed free mobile applications that physicians and teaching hospitals may use in tracking data under the Open Payments program. The applications are available for the iOS (Apple) and Android mobile platforms. The apps can be used for information collection and storage only.

CMS also recommends that physicians gather and organize records on any payments or transfers of value received from applicable manufacturers and GPOs between Aug. 1 and Dec. 31, 2013. It also suggests that physicians register on the CMS listserv to receive email updates on the program.

Will the same process be followed next year?
Data collected by manufacturers and GPOs in 2014 (Jan. 1–Dec. 31) and subsequent years must be submitted to CMS by March 31 of the following year. Beginning in 2015, the data will be published annually on June 30.

For more information on the Sunshine Act, visit www.aaos.org/sunshineact

For links to the CMS Enterprise EIDM registration and the Open Payments program registration websites, Enterprise EIDM registration site.

AAOS General Counsel Richard N. Peterson, JD, can be reached at peterson@aaos.org