45-day review period for Open Payments program begins in April

45-day review period for Open Payments program begins in April

Doctors of optometry will soon get their chance to review—and dispute, if need be—soon-to-be-released data on payments made to them in 2015 by drug and medical device manufacturers. Under the Centers for Medicare & Medicaid Services' (CMS') Open Payments transparency program, the 45-day review period for the data will begin in April.

Participate in a conference call on the Open Payments program on April 12.

After the review period, CMS will make the 2015 data available to the public on June 30 on its website. Therefore, it is important that doctors check their information to ensure its accuracy during the review period, says Douglas Totten, O.D., chair of AOA's Ethics and Values Committee.

Relationships between doctors and drug and device manufacturers have come under increasing scrutiny.

"During the Open Payments data process, errors and incorrect reporting may occur," Dr. Totten says. "It is prudent that each physician take advantage of the opportunity to review any reported data and possibly contest any incorrect information before it is posted for public viewing."

Part of the Affordable Care Act (ACA), the Open Payments system (also known as the "Sunshine Act") requires drug and device makers and group purchasing organizations to disclose payments or gifts to optometrists and other doctors on an annual basis. Publicly reported payments received by doctors include:

  • Cash or cash equivalent
  • In-kind items or services
  • Stocks, or stock options, or any other ownership interest, dividend, profit, or other return on investment
  • Any other form of payment or other transfer of value

Gifts might include travel and lodging, grants, consulting fees, honorarium, education, and food and beverages. The system is meant "to increases public awareness of financial relationships between drug and device manufacturers and certain health care providers."

What doctors of optometry need to know about Open Payments
To review their data, doctors must be registered in CMS' Enterprise Identity Management and Open Payments systems. Once registered, they will be sent a notification when their data is ready for review. CMS also will be posting a notice on its Open Payments webpage and sending notifications via its listserv.

To learn more about the Open Payments process, doctors can:

  1. Visit the CMS' review and dispute process Web page.
  2. Participate in a CMS conference call on the Open Payments program, its timeline and deadlines. The call is set for 2:30 p.m. to 3:30 p.m. (Eastern time) on April 12. Registration will close when available spaces for the call are filled or at noon on the day of the call.

If an AOA member wants to dispute his or her information, he or she must contact the manufacturer—CMS will not be arbitrating disputes—through the Open Payments system to dispute and resolve concerns about data. Once a dispute is received, the manufacturer can correct the data or leave it as posted, but marked as "disputed." If doctors have problems with disputed data, they may contact the AOA's Washington office by emailing Kara Webb, AOA associate director for coding and regulatory policy.

Transparency: A hot topic
Transparency—or the patient's right to know the financial relationships between his or her physicians and drug and medical device manufacturers—was behind Section 6002 of the ACA. The section does not prohibit these financial relationships. In fact, it calls them mutually beneficial.

"Collaborations among the medical product industry, physicians, and teaching hospitals contribute to the design and delivery of life-saving drugs, devices, biologicals, and medical supplies," the January 2016 CMS Open Payments user guide states.

Still, the CMS resource guide raises the issue for potential conflicts of interest and whether these relationships unduly influence "research, education and clinical decision-making in ways that compromise clinical integrity and patient care and may potentially lead to increased health care costs."

The link between payments to doctors and the manufacturers who give them gifts was scrutinized in a March 17 report by the ProPublica website. ProPublica analyzed the prescription patterns of doctors who wrote at least 1,000 prescriptions in 2014 under Medicare's drug program (Part D). The report focused on five specialties: psychiatry, cardiovascular disease, family medicine, internal medicine and ophthalmology.

AOA's Standards of Professional Conduct address issues of potential conflicts of interest, says Dr. Totten, who called patients the most important stakeholders for doctors of optometry. That's why doctors should make sure their Open Payments information is accurate and be prepared to explain those relationships. "Damage to a physician's reputation is a possible outcome if the reader does not interpret the information correctly," he says.

"It's important that optometrists never be influenced by an outside source or incentive to compromise what care is in the best interest of a patient," he says. "Doctors also should be aware to try to avoid situations that might even have the potential to appear as a conflict with the best interests of the patient, even if the situation or arrangement is entirely appropriate."

Click here to find more ethics and values resources from the AOA.

March 31, 2016

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