The Centers for Medicare & Medicaid Services (CMS) issued today another round of FAQs related to the implementation of the Sunshine Act. Pharmaceutical, biotechnology and medical device manufacturers and group purchasing organizations (GPOs) started tracking data on August 1, 2013. Below is a list of the new 25 CMS FAQs organized by category with a link to the answer from CMS for each:
FAQ8984: Is a physician located outside of the United States considered a physician covered recipient for purposes of Open Payments?
FAQ8994: Should applicable manufacturers and applicable group purchasing organizations use the information found in NPPES if they ascertain that their information regarding physicians’ unique identifiers is more accurate that what is listed in NPPES [National Plan and Provider Enumeration System]?
FAQ9002: Are dental schools that are affiliated with universities and health care institutions, but do not match the name or address information provided on CMS’ teaching hospital list, still considered teaching hospitals for the purposes of reporting?
FAQ8968: Is a distributor considered an applicable manufacturer if it holds title to devices and drugs and distributes and sells medical devices and drugs from a manufacturer to hospitals and ambulatory surgery centers or covered recipients for use in surgical procedures, and payment for all products is limited to commercial insurance and private payer only?
FAQ8972: Will CMS issue opinions exempting applicable manufacturers or applicable group purchasing organizations from Open Payments reporting requirements?
FAQ8974: Are distributions to physician owners of LLC units in a physician owned distributor (POD) considered reportable payments or other transfers of value or are they incidents of ownership and not considered reportable?
FAQ8978: Is a manufacturer of dental alloys considered an applicable manufacturer for purposes of Open Payments? Are payments or other transfers of value provided to dental labs reportable or only payments or other transfers of value provided to dentists?
FAQ8982: Is a distributor for an applicable manufacturer responsible for reporting to CMS payments or other transfers of value to health care professionals?
FAQ8990: Is leasing included in the actions that constitute “assistance or support” to determine if an entity is considered an applicable manufacturer under prong 2 of the definition for an applicable manufacturer at 42 C.F.R § 403.902?
REPORTABLE PAYMENTS / TRANSFERS OF VALUE AND EXCLUSIONS
FAQ8960: Are free repairs or services, and/or additional training offered by applicable manufacturers included in the contractual warranty exclusion in 42 C.F.R. § 403.904(i)(6)?
FAQ8962: Are applicable manufacturers required to report uncollected payments for a covered device owed by a covered recipient to an applicable manufacturer as a payment or other transfer of value?
FAQ8970: How should applicable manufacturers and applicable group purchasing organizations report transfer royalties, which are financial interests in a company provided in conjunction with an intellectual property assignment?
FAQ8986: Is a textbook donation to a medical center library for the general use of all employees reportable?
INDIRECT PAYMENTS / TRANSFERS OF VALUE
FAQ8976: Is a payment or other transfer of value provided by an applicable manufacturer’s distributor to a covered recipient considered a reportable indirect payment if the payment or other transfer of value is from the distributor’s own resources and the distributor does not hold title to any of the applicable manufacturer’s products?
FAQ8992: Is a payment or other transfer of value considered indirect if an applicable manufacturer utilizes a market research company’s services to conduct double-blinded market research with primary care physicians, which includes paying physicians for participating?
FAQ9004: Are awards from specialty societies provided to physician covered recipients considered indirect payments if the awards are funded by grants from applicable manufacturers?
NATURE OF PAYMENT / TRANSFER OF VALUE
FAQ8966: Is a newsletter created by an ad agency on behalf of a pharmaceutical client that is an applicable manufacturer, consisting of a few journal abstracts on the disease state and information on patient adherence, a reportable payment or other transfer of value? If so, what “nature of payment” category should the newsletter be reported in? Additionally, can the ad agency as a third party collect and maintain the physician information that is required for reporting?
CALCULATING PAYMENT / TRANSFER OF VALUE
FAQ8964: Are tax and payments for shipping and handling including in calculating value for a payment or other transfer of value?
FAQ8980: What should distributors, which offer a multitude of covered and non-covered products, report in the Product Indicator data element regarding related covered drug, device, biological or medical supply?
FAQ8988: Is a contract research organization (CRO) that performs clinical trials according to protocols for pharmaceutical companies required to report a budgeted amount contracted for medical safety, which is performed by the CRO’s employed physician?
FAQ8996: Are applicable manufacturers that receive research grants from National Institute of Health (NIH) required to report a sub-award from the NIH grant as a research payment, where the applicable manufacturer contracts with medical centers or universities to conduct research?
FAQ8998: Are research payments provided to a Military Medical Center that is not a teaching hospital covered recipient required to be reported for Open Payments?
FAQ9000: Is information regarding a physician principal investigator required for reporting if he/she is a military physician?
MEDICAL DEVICE LOANS
FAQ8956: For purposes of the 90-day exclusion for a loan of a covered device, does the loan begin when an applicable manufacturer provides the covered device to a covered recipient or when the covered device is first used by a covered recipient?
FAQ8958: If the same medical device is loaned to three different teaching hospitals for a period of 30 days each is that considered one loan subject to the short term loan exclusion? If three identical devices are loaned to three different teaching hospitals is that considered three separate loans subject to the short term exclusion?