Open Payments dispute period begins April 1, now applies to advanced practice providers

We want to remind you of the “Open Payments” federal program which may affect you as a provider. Section 6002 of the Affordable Care Act required the Centers for Medicare and Medicaid Services (CMS) to establish a program, now known as the “Physician Sunshine Act” or “Open Payments.” The program’s goal is to increase public awareness of financial relationships between drug and device manufacturers and health care providers. As in previous years, data is publicly reported for all physicians and teaching hospitals in the health system, and as of this year, also for physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and anesthesiologist assistants, and certified nurse midwives.

Under this program, manufacturers of drugs, devices, biologicals, and medical supplies are required to report payments or other transfers of value they make to physicians and advanced practice providers, and ownership or investment interests of physicians and advanced practice providers, to CMS. CMS will then collect the data annually, aggregate it, and publish it on a public website to give the public and the press access to information about payments to individual physicians and advanced practice providers.

Since this program may affect you as an individual, the intent of this letter is to inform you of some of its possible effects and actions you may wish to take. In contrast to many other conflict of interest issues in which responsibility for management lies with Penn State or Penn State Health, the responsibility for Open Payments and decisions regarding how to respond to the program lies with you as an individual.

Physicians and advanced practice providers are not required to send any information to CMS. This will be done by drug and device manufacturers and by group purchasing organizations (GPOs). It is important, however, to make sure that CMS has received accurate information because incorrect information could potentially impact your professional reputation. CMS, the Penn State College of Medicine, and Penn State Health strongly encourage you to do the following:

• Become familiar with the information that will be reported about certain providers.
• Keep records of all payments and other transfers of value received from drug or device manufacturers.
• Registration is now open, but it is fairly complex. It requires two different registrations.
  • The first is for the overall CMS portal website (which requires two steps), and the second is specific to Open Payments. If you have not already completed the registration process, register with CMS and subscribe to the CMS listserve to receive updates regarding the program (especially information reported about you). The process for registration is now published on the web site https://www.cms.gov/OpenPayments/Program-Participants/Covered-Recipients/Registration . This is a two-step process that CMS estimates will take 30 minutes.
  • NOTE: If you have previously registered but have not logged in within 60 days, you will be prompted to answer challenge questions to unlock your account and create a new password. If you have previously registered in these systems but have not logged in within 180 days, the account will be inactivated and you should call the CMS Open Payments Help Desk to reinstate the account.
    • Here is the contact information for the CMS Open Payments Help Desk: 1-855-326-8366, Monday through Friday, from 8:30 a.m. to 7:30 p.m. (EST), excluding Federal holidays, or send an email to openpayments@cms.hhs.gov.
  • Closely review the information manufacturers and GPOs submitted on your behalf.
  • If the information submitted about you is incorrect, follow the procedures outlined by CMS to dispute it. You must note the dispute directly in the Open Payments system, which will alert the manufacturer of the dispute. CMS has revised the dispute display to show contact information for the person at the company who is responsible for resolving the disputed payment. When disputing a payment, or if you have questions about a reported payment, you should note this contact information. CMS strongly encourages individuals to include their own contact information in the comments with the disputes to facilitate rapid resolution of the dispute.
  • If you are a College of Medicine faculty member/researcher or a PSH provider involved in clinical trials: if the information from CMS is correct, make sure your COINS disclosure accurately matches this information.

Manufacturers must report all payments or other transfers of value they make to you, either directly or indirectly. These payments include the following categories, including some (in bold) that you would ordinarily consider an integral part of your role as a provider and/or faculty member and not as financial relationships with industry:

• Consulting fees
• Compensation for services other than consulting, including serving as faculty or as a speaker at an event other than a continuing education program
• Honoraria
• Gifts
• Entertainment
• Food and beverages
• Travel and lodging
• Education costs
• Research charitable contributions
• Royalty or license
• Current or prospective ownership or investment interest
• Compensation for serving as faculty or as a speaker for an unaccredited and non-certified continu­ing education program
• Compensation for serving as faculty or as a speaker for an accredited or certified continuing educa­tion program
• Grants

Payment data collection for calendar year 2021 was due to CMS on March 31, 2022. The 45-day review and dispute period began April 1, 2022. This is the period during which individual providers should examine reports related to payments made to them, if any, and enter disputes. We are presently in this 45-day period. Once the end of the review and dispute period ends (May 15, 2022), public reporting will occur in June, 2022. Disputes must be initiated in the Open Payments system by May 15, 2022 in order to be reflected in the June 2022 data publication.

The College of Medicine and Penn State Health Conflict of Interest Program offices are happy to provide more information or try to answer any of your questions about this program. For information or to contact our offices:

• College of Medicine, visit https://research.med.psu.edu/research-support/conflict-of-interest/ or contact either Marisa Klein at COIProgram@pennstatehealth.psu.edu or (717)531-0003 ext. 283526, or Dr. Neal Thomas at COIProgram@pennstatehealth.psu.edu or extension (717)531-5337.
• Penn State Health, contact Joseph Roberson at jroberson@pennstatehealth.psu.edu.

Please realize that we may not able to assist you with CMS website issues. This is a government website, and we have no other information on the navigation of the website outside of what is posted. The helpline to the CMS website is 1-855-326-8366, and the helpline has been very responsive to issues.

In light of increased media scrutiny of physician disclosures at other institutions, we urge you to visit the Open Payments website during the review and dispute period, check that the reported information is accurate, and, if applicable, also ensure that the information in your COINS disclosure is complete and accurate.

For information or to register, you may also access the Federal CMS Dedicated Open Payments website at https://www.cms.gov/OpenPayments or email CMS at openPayments@cms.hhs.gov.

If you're having trouble accessing this content, or would like it in another format, please email the Penn State College of Medicine web department.