As we discussed in an earlier post, the data collection obligations under the Physician Payment Sunshine Act commenced on August 1, 2013, and all affected “applicable manufacturers” and group purchasing organizations should at this point have some form of compliance process in place for this purpose. However, as many companies are still fine-tuning their data collection processes, we thought it would be helpful to compile the following checklist that summarizes the information that needs to be considered in preparing for the first report that must be submitted to the Centers for Medicare & Medicaid Services (CMS) by March 31, 2014.

CMS Report Contents

1. Form of Payment. The following transfers of value to covered recipients must be reported:

• Cash or cash equivalent
• In-kind items or services
• Stock, stock option, or any other ownership interest
• Dividend, profit, or other return on investment

2. Nature of Payment. The finalized nature of payment categories that must be reported are:

• 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 (including the specified destinations)
• Education
• Research
• Charitable contribution
• 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
• Grant
• Space rental or facility fees (teaching hospitals only)

If a payment or other transfer of value is associated with multiple categories, such as traveling to a meeting under a consulting contract, the travel expenses should remain distinct from the consulting fee expenses; for each payment or transfer of value reported, applicable manufacturers may report only a single nature of payment and single form of payment.

For lump sum payments or other transfers of value, an applicable manufacturer must break out the distinct parts of the payment that fall into multiple categories for both form of payment and nature of payment.

CMS provided some additional explanation of and context for the nature of payment categories, including, but not limited to, the following:

Compensation for Services Other Than Consulting. This category is intended to capture compensation for activities or services that traditionally are not considered consulting services (e.g., speaking engagements unrelated to continuing education, or promotional or marketing activities).

Honoraria. Honoraria are distinguishable from the above category in that they generally are provided for services for which custom prohibits a price from being set.

Research. Research is included in the list of nature of payment options, and the rule also includes special rules for how to report payments or other transfers of value for research purposes, in recognition of the unique nature of research payments among the enumerated categories.

(i) Scope of Research. The research category applies to “a systematic investigation designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social sciences research. This term encompasses basic and applied research and product development.” For purposes of this rule, a payment or other transfer of value that is categorized as having been made for “research” purposes must be subject to a written agreement or subject to a research protocol or both. Material transfers (such as provision of a protein) to a researcher for discovery collaboration does not need to be reported when not part of a commercial or marketing plan and when it precedes the development of a new product because, in that context, the transferred material does not have independent economic value.

(ii) Reporting Research Payments. Applicable manufacturers must report research payments separately in a different template from other payments and transfers of value, since it will require reporting of slightly different information. Applicable manufacturers will not be responsible for reporting whether a payment was direct or indirect. Instead, a single research payment will be reported once and include the entity paid as well as the name of the principal investigator(s). When reporting the entity or individual that received the payment, CMS intends for an applicable manufacturer to report the entity or individual that received the payment, either directly from the applicable manufacturer or indirectly through a Contract Research Organization (CRO) or a Site Management Organization (SMO).

For each research-related payment, an applicable manufacturer will be required to report each of the following:

• Name of the research institution/other entity or individual receiving payment (regardless of whether a covered recipient)
• Total amount of research payment
• Name of study
• Name of related covered drug, device, biological, or medical supply and NDC (if any)
• Principal investigator(s), including name, NPI state professional license number(s) and associated states for at least one state where the physician maintains a professional license, specialty and primary business address, context of research (optional), and ClinicalTrials.gov identifier (optional)

For pre-clinical research, applicable manufacturers have to report only the name of the research institution, principal investigator(s), and the total amount of the payment; they do not have to report an associated product or study name.

(iii) Total Research Payment Amount. The amount should include the aggregated amount of any payments for services included in the written agreement or research protocol. The payment amount should not include any payments for activities that are separate or segregable from the written agreement or research protocol or are paid through a method different from that of the research. For example, meals and travel should be reported separately unless included in a written agreement or research protocol and paid for through the larger research contract. CMS will not require reporting of payments to non-covered recipients that are not passed through to covered recipients.

3. Specific Categories of Information for Each Payment or Other Transfer of Value to a Covered Recipient

Name. An applicable manufacturer must report a physician covered recipient’s full name as reported in NPPES, including the middle initial (which may be left blank if no middle initial appears in NPPES).

Business Address. The full street address of a physician’s primary practice location must be reported as the business address.

Specialty and NPI. An applicable manufacturer must report the physician’s individual NPI, rather than any group NPI, and a single provider taxonomy code as reported in NPPES should be used for the specialty.

Date of Payment. An applicable manufacturer may use its discretion as to whether to report the total payment on the date of the first payment as a single line item or to report each individual payment as a separate line item. The agency expects that the methodology employed should be consistent within a single “nature of payment” category (e.g., all hotel stays should be reported using the first date that the physician stayed in the hotel).

Context. Applicable manufacturers are allowed to provide brief contextual information for each payment or other transfer of value, but it will not require them to do so.

Related Covered Drug, Device, Biological or Medical Supply. Applicable manufacturers must report a related product name for all payments or transfers of value unless there is no related product. If a payment or other transfer of value is not related to at least one covered product, then applicable manufacturers should report “none” or “non-covered product.” If a payment or other transfer of value is related to at least one covered product as well as to a non-covered product, the applicable manufacturer must report the name of the covered product and may report the name of the non-covered product.

When a payment or transfer of value is associated with multiple covered products, an applicable manufacturer may report up to five covered products for each interaction, but the manufacturer should not report a percentage of the interaction dedicated to each product. As for the product name, an applicable manufacturer must report the market name of the product and include the National Drug Code (NDC), if any. If a market name is not yet available, the manufacturer should use the name registered on ClinicalTrials.gov. For devices and medical supplies, § 403.904(c)(8)(ii) allows reporting of either the name under which the device or supply is marketed or the therapeutic area or product category.