By now, you’ve heard the Physician Payment Sunshine Act (PPSA) passed on February 1 of this year. The PPSA goes into effect August 1. As this date fast approaches, I have questions about what this will mean for us.
As physicians, we are duty bound to remain free from conflict of interest that may influence our patient care decisions. There is no question that a conflict of interest may serve to undermine the trust that is essential to the therapeutic doctor–patient relationship. The critical issue on which we should focus is that transparency should help to maintain this essential trust. While the PPSA is a well-intentioned attempt to enhance transparency in physician relationships with manufacturers of medications, devices, and medical supplies, it may require a “user’s manual” for interpretation. It is also true that relationships between physicians and manufacturers are often helpful in advancing the science of discovery and facilitating the lifesaving and quality of life–enhancing changes to our medical practices that we have seen in the past two decades.
Only time will tell if the data that manufacturers submit to the Centers for Medicare and Medicaid Services (CMS) as of August 1 will be meaningful to the general public and if the PPSA is beneficial to the doctor–patient relationship. In the meantime, this is what you should know about complying with the PPSA.
PPSA, Physicians, and Industry
According to CMS, the PPSA is designed to promote transparency in the financial relationships between physicians and industry. Pharmaceutical and device manufacturers must begin tracking payments of gifts of $10 or more to “covered recipients,” as well as reporting covered recipients’ ownership or investments in their companies.
Who Is a Covered Recipient?
The law states that covered recipients include all physicians and teaching hospitals. This includes physicians who do not treat patients, such as medical researchers and physician administrators. It does not include other healthcare professionals such as nurses, nurse practitioners, physician assistants, or pharmacists.
What Will Be Reported?
Any payments or transfers of value from an applicable manufacturer must be reported to CMS. Applicable manufacturers include pharmaceutical and medical device companies. Both direct and indirect payments or transfers of value must be reported.
Payments and transfer of value include items from the list below that exceed $10 in value.
- Consulting fees
- Compensation for services other than consulting
- Travel (including the specified destinations)
- Charitable contributions
- Royalties or licenses
- Current or prospective ownership or investment interests
There are some exceptions to this list that include, but are not limited to:
- Transfers of value of less than $10 unless the aggregate amount over a year exceeds $100, with an exception to the aggregation requirement for items provided at conferences and large scale events;
- Product samples for patients;
- Educational materials that directly benefit patients;
- Discounts or rebates; and
- In-kind items for charity care.
How Will Reporting Work?
Applicable manufactures must begin collecting data on August 1, 2013, and report it to CMS by March 31, 2014. The first set of data will be released on a public website by September 30, 2014. The report will include, but not be limited to:
- Physician’s name;
- National Provider Identifier (NPI) number;
- Amount and date of payment or transfer of value;
- Name of related covered drugs or biologics, if any; and
- Whether the payment or transfer of value was provided to a physician holding ownership or investment interests in the manufacturer.
What Does This Mean for Me?
As a physician, you should prepare yourself by retaining records on any transfers of value you have with applicable manufactures. This will be helpful when CMS releases your file for review. Physicians and teaching hospitals will be able to register with CMS to receive a notice of the review process. More information on the review process will be available closer to the review period. You will have 45 days to review the reports before they are published online, and there will be an additional 15 days allowed for dispute resolution following the review period.
Commonly Asked Questions
1. I had a cup of coffee in the exhibit hall at a pharmaceutical company’s booth. Will this be reported?
- No, under the final rule, applicable manufacturers are not required to report the names of people who access food in the exhibit hall during a conference, unless the applicable manufacturer can establish the identities of who partook in the food.
2. Why is the ACR asking for my NPI number on the annual meeting registration form?
- Many of the companies who exhibit are required to report transfers of value that take place in the exhibit hall during the meeting. An example of a transfer of value would include a textbook that a company is giving away. The inclusion of NPI numbers will help ensure accurate reporting. Providing your NPI number to the ACR is optional. If you provide your NPI number, the ACR will include your NPI number as part of the information encoded in your meeting badge. The data will only be transferred to an exhibiting company if you give the exhibitor permission to scan your badge.
3. I was asked to speak at an association conference that receives support from pharmaceutical companies. Will my compensation be reported?
- Your compensation will not be reported as long as the program meets the accreditation requirements of ACCME, AOA, AMA, AAFP, or ADA CERP; the applicable manufacturer does not directly pay the covered-recipient speaker; and the applicable manufacturer does not select the covered-recipient speaker.
- The ACR plans a majority of its educational activities in accordance to these guidelines. It is recommended you ask the organizer of the conference if your compensation will be reportable.
4. I am an investigator on a study. Will my payments be reported?
- Yes, payments or transfer of value that may be related to research funding is reportable. Only the study’s principal investigator (PI) is linked to a study and included in the reporting. The manufacturer will report the total payment, who they made it to (contract research organization or university, site), and the information on the PI.
5. I attended an industry-supported symposium at the ACR annual meeting. Will my meal be reported?
- Yes, your meal will be reported because manufacturers must report attendees of specific manufacturer-sponsored meals where participants are clearly identifiable.
6. A pharmaceutical representative brought a meal to the staff in my group practice. How will it be reported?
- For meals provided in a group practice, the manufacturer must divide the number of actual recipients (including physicians and support staff) by the total cost of the meal. If the amount exceeds $10 per person, the manufacturer must report on the individual physician recipient. Physicians in the practice that did not participate in the event are not reportable; however, physicians must be reported if they attend an event, even if they don’t partake in a meal.
As you can see, there is a wide range of information that will be reported—everything from ownership interests to meals at industry-sponsored meetings to clinical research that may be critical in the development of a novel therapeutic agent.
As physicians, it is important that we be proactive and ensure that payments and transfers of value are reported correctly. Information about the PPSA is available for review on the CMS website, www.cms.gov. In addition, the American Medical Association (www.ama-assn.org/ama/pub/advocacy/topics/sunshine-act-and-physician-financial-transparency-reports.page) is a great resource for up-to-date information about the PPSA.
The ACR is continually monitoring the PPSA as well as other external factors that affect physicians. As these rules go into effect and reporting begins, track your reportable payments and transfers of value to ensure your data on the CMS website accurately reflect your relationship with industry.
In addition to making sure that our own data are reported with accuracy, we will need to carefully follow society’s—and our patients’—interpretation of the data that will become publicly available. We may need to help shine some light on this new level of transparency associated with the PPSA.
Dr. Uknis is professor of medicine and senior associate dean for admissions and strategy at Temple University in Philadelphia. Contact her at [email protected].