Life Science Compliance Update

April 20, 2016

CMS Update Call on Open Payments

Recently, the Centers for Medicare & Medicaid Services (CMS) held a National Provider Call on Open Payments: Program Overview and Prepare to Review Reported Data. Robin Usi and Erin Skinner took turns educating participants how to identify the parts of the review, dispute, and correction process and how to take appropriate actions in the Open Payments system.

What is Reported?

As a reminder, any direct or indirect payments, or other transfers of value, that are made to covered recipients (i.e., physicians, teaching hospitals, physician owners, investors). Certain ownership or investment interests that are held by physician owners or investors, or their immediate family members are also reported.

Who is Responsible for Reporting?

Applicable manufacturers of covered products and entities under common ownership with applicable manufacturers who also provide assistance and support, as well as applicable Group Purchasing Organizations (GPOs), are required to annually report to CMS.

Who is Reported On?

There are three categories of individuals and entities that are reported on – covered recipient physicians, covered recipient teaching hospitals, and physician owners or investors. Covered recipient physicians cover individuals, such as: doctors of medicine or osteopathy legally authorized to practice medicine or surgery by the state; doctors of dental medicine or dental surgery legally authorized to practice dentistry in the state; doctors of podiatric medicine legally authorized to perform by the state; doctors of optometry legally authorized to perform as a doctor of optometry by the state; and chiropractors licensed by the state and legally authorized to perform by the state. Covered recipient teaching hospitals can change from year to year and each year, Open Payments publishes a list of these teaching hospitals on their website.

Program Year Timelines

For the 2015 program year, data collection ran from January 1, 2015 through December 31, 2015. Payment data was submitted by applicable manufacturers and GPOs from February 1, 2016 through March 31, 2016. Therefore, the review and dispute period for physicians and teaching hospitals is April 1 through May 15, 2016, and the period for applicable manufacturers and GPOs to review and correct the data runs fifteen days after that close, to June 1, 2016. The data is scheduled to be displayed on the website on June 30, 2016.

Registration Process

In order to be able to review and dispute any data reported in the Open Payments system prior to its publication, users must register for the Open Payments system using the two-step registration process. Physicians and teaching hospitals who registered during 2013 or 2014 do not need to register again. Additionally, a physician may nominate one authorized representative to perform system functions on their behalf and teaching hospitals can designate up to ten authorized representatives and authorized officials to act on its behalf in the Open Payments system.

Review, Dispute, and Correction Record Statuses

There are several different status' that can show for each record. A status of "initiated" means the dispute has been initiated by a physician, teaching hospital, or principal investigator. Once the reporting entity acknowledges the dispute, the status will change to "acknowledged." If the reporting entity and physician, teaching hospital, or principal investigator have resolved the dispute in accordance with the Final Rule and no changes were made to the disputed record, the status will change to "Resolved No Change." If the dispute was resolved by the reporting entity with updates made to the record, the status will change to "Resolved." If the physician, teaching hospital, or principal investigator has withdrawn the dispute, the status will reflect that.

Question and Answer Session

At the end of the call, the presenters allotted time for questioners who had previously submitted questions and for those who were on the call and had specific questions.

The first question was whether or not every physician in a particular practice need to register for the Open Payments system. The answer was yes, each physician needs to register since all payments are reported to physicians individually. Once a physician has registered, they can appoint an authorized representative, but each physician needs their own account.

It is also important to note that CMS does not send an email of alleged payments to physicians, making it important for physicians to register for Open Payments so they can see what payments are being assigned to them.

Another question was asked about whether there are any plans for an institutional reviewer role in the future to allow compliance officers to review data for teaching hospital faculty process review and dispute. While CMS cannot speak to any current plans, they took comments under advisement for future improvements to the program.

For any other help or issues, CMS recommends that you contact the CMS Open Payments Help Desk.

April 18, 2016

District of Columbia Makes Changes Transparency Law to Align with Open Payments

Late last week with only a photo attachment, the District of Columbia Department of Health announced to the pharmaceutical industry that the District is changing its gift reporting requirements to meet the requirements with the new Open Payments reporting.

Chapter Eighteen of the District of Columbia Municipal Regulations requires manufacturers and labelers of prescription drugs dispensed in the District who engage in marketing in D.C. to report to the Department of Health their costs for pharmaceutical drug marketing in the District. Each manufacturer or labeler is required to report their annual prescription drug marketing costs in a report filed with the Department of Health on or before July 1 of each year.

This year, the aforementioned changes will be reflected in the Nature of Payment, Form of Payment, and Primary Purpose sections. The categories will have to align with Open Payments categories. Some responses will now be limited to the updated set of values.

While payments made to physicians or teaching hospitals must be reported to the United States Department of Health and Human Services (HHS), companies are not required to report this information to the District of Columbia. However, payments made to recipients other than physicians and teaching hospitals must be reported to the District of Columbia. Reporting requirements for aggregate and advertising expenses remain unchanged.

The D.C. Department of Health recommends that companies who have filed reports in previous years use the Microsoft Excel file published online, as it will reflect changes and updates in the law. Complete instructions for filling out the forms are found in the PDF document, as well as on the fifth tab of worksheet of the Excel document.

The Company Information, Gift Expenses, Advertising Expenses, and Aggregate Cost worksheets should be filled out electronically according to the instructions, and submitted in Excel format to dc.accessrx@dc.gov. The Company Information worksheet should also be printed and sent to the D.C. Department of Health, along with a $5,000 filing fee check made payable to "D.C. Treasurer."

This change was supposed to take place in 2013 when the Physician Payment Sunshine Act preempted state reporting. The District of Columbia is a little late to this change.

 

March 13, 2016

CMS Opens Physician and Teaching Hospital Registration for Open Payments 2015 Data

CMS has announced that the Open Payments system is now open for physician and teaching hospital registration. While registering in the Open Payments system is not required for physicians or teaching hospitals, it is required in order to be able to review and dispute records attributed to them. The review and dispute period will begin in April 2016 and last for 45 days.

When data submission ends, physicians and teaching hospitals who have registered can review and dispute any records attributed to them. The initial registration is a two-step process and takes approximately thirty minutes. First, register in the CMS Enterprise Identity Management System (EIDM), and then register in the Open Payments System, which is accessible via the EIDM.

If you registered last year, you are not required to register again this year. However, if it has been over 180 days since you logged onto the EIDM, your account has been deactivated and you will need to contact the Help Desk to reactivate it.

If you are a physician or teaching hospital interested in registering, you should have your National Provider Identifier (NPI) number, Drug Enforcement Agency (DEA) number, and state license number (SLN) available.

CMS plans to publish the 2015 payment data, along with updates to the 2013 and 2014 data sets, on June 30, 2016.

If you have any questions, you can contact the Help Desk at openpayments@cms.hhs.gov or (855) 326-8366, Monday through Friday from 8:30 am to 7:30 pm EST.

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