The Final Rule to implement the Physician Payment Sunshine Act—Section 6002 of the Patient Protection and Affordable Care Act (released on February 1) —will make information publicly available about payments or transfers of value to physicians and teaching hospitals (“covered recipients”) from applicable manufacturers and group purchasing organizations (GPOs). The Centers for Medicare & Medicaid Services (CMS) will publish the information on a public website.
The following questions and answers provide additional details about the Final Rule and the ways in which ASCO members may come into contact with its provisions while participating in ASCO events or activities.
Q: When does the Physician Payment Sunshine Rule take effect?
A: Applicable manufacturers and GPOs must begin data collection on August 1, 2013. Data will be reported to CMS starting March 31, 2014. CMS will publish the data in a public database on September 30, 2014.
Q: Who is a covered recipient?
A: A “covered recipient” is a teaching hospital or any physician who is currently licensed and legally authorized to practice, except for a physician who is an employee of the applicable manufacturer that is reporting the payment. Medical residents are not covered recipients.
Q: What information will be reported?
A: The applicable manufacturer or GPO must include its name as well as the name of the covered recipient, specialty, business address, NPI number if available, and State professional license number. The data collected will also include the amount and date of the payment (or transfer of value); form and nature of the payment; name of the related drug, device, or biological; and whether the payment is eligible for delayed publication (some research payments related to new products may be eligible for delayed reporting).
Q: What is meant by “form of payment”?
A: Forms of payment include cash or cash equivalent; in-kind items or services; stock, stock options, or any other ownership interest; and dividend, profit or other return on investment.
Q: What is meant by “nature of payment”?
A: The final rule applies to the following “nature of payment” categories: consulting fee, compensation for services other than consulting, including serving as faculty or as a speaker at an event other than a continuing education program; honoraria; gift; entertainment; food and beverage; travel and lodging; education; 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 education program; grant; space rental or facility fees.
Q: Will all payments for Continuing Medical Education (CME) be reported under this rule?
A: Any payment made to a speaker at a continuing education program does not need to be reported when all of the following conditions are met: (1) The program meets the accreditation or certification requirements and standards of the ACCME, AOA, AMA, AAFP or ADA CERP; (2) the applicable manufacturer does not select the covered recipient speaker nor does it provide the third party vendor with a distinct, identifiable set of individuals to be considered as speakers for the accredited or certified continuing education program; and (3) the applicable manufacturer does not directly pay the covered recipient speaker.
Q: Will indirect payments, such as those made through a third party, be reported?
A: The rule excludes some types of indirect payments where the applicable manufacturer is unaware of the identity of the covered recipient. Indirect payments that must be reported include payments or other transfers of value to a covered recipient through a third party, where the applicable manufacturer (or GPO) requires, instructs, directs, or otherwise causes the third party to provide the payment or transfer of value, in whole or in part, to a covered recipient(s) (or a physician owner or investor)—regardless of whether the applicable manufacturer specifies the specific covered recipient.
Q: Will food and beverage provided at conferences or in a clinical setting be reported?
A: For buffet meals provided at conferences to all attendees or other similar large-scale settings where it would be difficult to establish the identities of the physicians who partook in the meal or snack, reporting will not be required. For other group meals (including those provided in a clinical setting), applicable manufacturers must report the per person cost (not the per covered recipient cost) of the food or beverage for each covered recipient who actually partakes in the meals (that is, actually ate or drank a portion of the offerings), unless the cost is lower than $10 per participant. Physicians who do not wish to participate in a meal may refuse to participate and will not be included in reporting on that meal.
Q: What is excluded from reporting?
A: Small payments or other transfers of value, defined as those less than $10 are excluded, except when the total annual value of payments or other transfers of value provided to a covered recipient exceeds $100. CMS made an additional exception for the aggregation requirement for conferences and large events where tracking who receives small items would be difficult. Certain educational materials, if they are intended for use by or with a patient, are excluded. In addition, applicable manufacturers are not required to report or track buffet meals, snacks, soft drinks, or coffee made generally available to all participants of a conference or similar events where it is difficult to identify the identity of those who partook in the offering.
Physicians should check with their own practices and institutions about other ways the Final Rule may impact them. For more information,visit https://www.federalregister.gov/articles/2013/02/08/2013-02572/medicare-....