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BIO Magazine - CMSS Physician Payment “Sunshine” Act FAQs Δεκέμβριος 2015
Δεκέμβριος 2015 No38

BIO News

CMSS Physician Payment “Sunshine” Act FAQs
CMSS Physician Payment “Sunshine” Act FAQs

These FAQs are intended as a resource for CMSS member organizations to create their own guidance document. The answers are based on the guidance that is publicly available as of August 23, 2013. This is a new reporting program, and many of the questions are still being clarified. Societies may take different positions on some of these questions. Readers of this document are encouraged to consult their attorneys, funding organizations, and CMS for interpretations of the Physician Payment Sunshine Act (PPSA) and the regulations operationalizing it. The information in this document is not legal advice.

 

  1. I.                  manufacturers are required to collect data on payments or transfers of value they make.

     

    2)    Are any physicians excluded from being covered by the Physician Payment Sunshine Act?

     

    Fellows are not exempt from the reporting requirements

    What Must Be Reported?

 

1) Payments or Transfers of Value Exceeding $10

 

In general, payments or transfers of value exceeding $10 must be reported. If a PPSA exclusion3 applies, it can supersede the “$10 or greater” reporting rule and result in manufacturer reporting not being mandated.

 

 

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2 A GPO is defined as an entity that is created to leverage the purchasing power of a group of businesses to obtain discounts from vendors based on the collective buying power of the GPO members.

3 The following are excluded from being reported under the PPSA: certified and accredited CME, buffet meals or snacks at large-scale events, product samples not intended for sale but for patient use, in-kind items used for the provision of charity care, discounts, the loan of a medical device for the short-term, transfers of value and payments made to a physician in return for non-physician services from the physician (e.g., physician who is also a lawyer  providing legal services to an applicable manufacturer or GPO), items or services provided under a contractual warranty, a dividend or other profit distribution, or ownership or investment interest in a publicly traded security and mutual fund.

 

 

 

 

 

 

 

 

 

 

2) Non-Accredited/Non-Certified Continuing Medical Education (CME)-

 

The PPSA creates blanket reporting rules for transfers or payments of value arising from being the faculty speaker OR a physician attendee at a non-accredited/non-certified CME event. All tuition and educational fees arising from non-accredited/non-certified CME, as well as any lodging, meals, speaker fee, or travel funds the speaker physician receives must be reported

 

 

 

3) Educational Materials Given to the Physician Not Meant to be of Benefit to the Patient or Not Used With the Patient-

 

The PPSA requires reporting of medical textbooks (e.g., reference manuals, the DSM-5, casebooks, guidebooks and other similar materials) and journal reprints provided by an applicable pharmaceutical or medical device manufacturer or GPO to a physician.

 

4) Meals at Meetings When the Physician is Identifiable to the Manufacturer

 

In instances in which the value of a meal funded by an applicable manufacturer or GPO exceeds $10, and the persons partaking of the meal are “readily identifiable” at the time the meal is being provided to the applicable manufacturer or GPO, the meal is reportable. Only persons partaking of the meal are reportable. For example, a physician who bring his/her lunch to the meeting, while every other physician consumes the lunch provided by the manufacturer, will not be reported.

 

Note: There is a reporting exception for instances in which a buffet is served to physicians as part of a large-scale meeting.

 

 

 

 

 

5) Indirect Transfers Made to a Third Party When the Manufacturer “Requires, Instructs, or Directs” the Payment or Transfer of Value be Provided to A Physician

 

Indirect payments or transfers of value that an applicable manufacturer or GPO makes to a third party, such as a physician organization, are reportable when the manufacturer requires, instructs, or directs the payment or transfer of value be provided to a specific physician or intended generally for physicians. It does not necessarily matter that the manufacturer does not know in advance of the payment or transfer the name of the physician or physicians benefiting from the indirect transfer. If the manufacturer is requiring, instructing, or directing the transfer be made to a physician or group of physicians, and the manufacturer could become aware of the identity of physicians to whom a transfer has been made within the period of time specified by the rule operationalizing the PPSA (which is “during the reporting year or by the end of the second quarter of the following reporting year”), the manufacturer must report the names of the physicians benefiting from the payment or transfer of value to CMS.

 

Note: CMS establishes an independence test when assessing whether an indirect transfer must be reported. If the manufacturer retains the independence in determining whether a physician or group of physicians benefits from the payment, CMS mandates the indirect transfer be reported.

 

 

6)   Payments or Transfers of Value for Research

 

The physician serving as the principal investigator gets reported, as well as the institution performing the research. Research payments will be displayed by CMS in a separate section of the Open Payments public website.

 

 

 

 

  1. III.            What Is Excluded from PPSA Reporting?

 

 

1)   Payments or Transfers of Value Less than $10

 

CMS has said that a transfer of anything for which the value is less than $10 need not be reported. However, if over the course of a calendar year the aggregate amount transferred to, requested by, or designated on behalf of the physician or teaching hospital by the applicable manufacturer or GPO exceeds $100, the payment or transfer of value is reportable.

 

Note: Payments or transfers of value for less than $10 provided at large-scale conferences and similar events, as well as events open to the public, do not need to be reported nor included for the purposes of the aggregate threshold, even if the aggregate total for a covered recipient exceeds the aggregate threshold ($100 in CY 2013).

 

2)   Speaker Physician’s Fees, Travel, Meals, and Lodging Arising from an Accredited/Certified CME Event in instances in which all of the following criteria are met:

 

(1)                        the CME program meets the accreditation or certification requirements and standards of the Accreditation Council for Continuing Medical Education, the American Academy of Family Physicians, the American Dental Association’s Continuing Education Recognition Program, the American Medical Association, or the American Osteopathic Association,

 

(2)                        the applicable manufacturer does not select or suggest the covered recipient speaker nor does it provide the third party vendor with distinct, identifiable individuals to be considered as speakers for the accredited or certified continuing education programs; AND

 

 

(3)                        the applicable manufacturer does not directly pay the covered recipient speaker.

 

 

 

3)   Attendee Physician’s Educational and Tuition Fees Arising from an Accredited/Certified CME in instances in which all of the following criteria are met:

 

(1)            the CME program meets the accreditation or certification requirements and standards of the Accreditation Council for Continuing Medical Education, the American Academy of Family Physicians, the American Dental Association’s Continuing Education Recognition Program, the American Medical Association, or the American Osteopathic Association,

(2)            the applicable manufacturer does not select or suggest the covered recipient speaker nor does it provide the third party vendor with distinct, identifiable individuals to be considered as speakers for the accredited or certified continuing education programs; AND

(3)            the applicable manufacturer does not directly pay the covered recipient speaker.

 

Note: Only the Speaker Physician at an accredited CME event qualifies for not reporting the meal, lodging, and travel fees which arise from his/her serving as faculty at an accredited CME. The Attendee Physician only gets a reporting exclusion for his/her tuition and educational fees arising from attending an accredited CME event. So any lodging, meals, or travel fees provided by the applicable manufacturer or GPO to the accredited CME attendee physician must be reported.

 

 

 

 

4)   Educational Materials or Items Directly Benefiting Patients or Intended for Patient Use

 

To claim this reporting exclusion, the educational materials being used must directly benefit the patient and/or be of use to the patient while he/she is seeing the physician. A human skeletal set would be an example of an item that could qualify for this reporting exclusion.

 

 

 

 

5)   Buffet Meals, Snacks, Soft Drinks, or Coffee Generally Available to All Participants of Large-Scale Conferences and Similar Large-Scale Events

 

CMS excludes buffet meals, snacks, soft drinks, and coffee provided by manufacturers from being reported in instances in which these items are made generally available to all participants of a large-scale conference or similar large-scale event.

 

 

 

 

6)   Indirect Payments or Other Transfers of Value where the Applicable Manufacturer is Unaware of the Identity of the Covered Recipient

 

CMS defines an applicable manufacturer as being unaware of the identity of a covered recipient if the manufacturer does not “know” (i.e., actual knowledge, acts in deliberate ignorance of the truth, or acts in reckless disregard of the truth) the identity of the covered recipient during the reporting year or by the end of the second quarter of the following reporting year.

 

Note: With respect to indirect transfers made by a manufacturer to a physician society and earmarked “for the purpose of funding awards or grants for physicians,” CMS expressly states in the rules operationalizing PPSA that these awards or grants would constitute indirect payments to covered recipients and would be subject to reporting requirements. In this instance, CMS does not indicate there is a reporting exclusion where the manufacturer does not know the specific identity of the physician or physicians benefiting from the awards or grants it has funded. It simply concludes awards or grants provided generally to “physicians” constitute indirect payments that must be reported. We believe manufacturers are likely to be cautious and report all awards and/or grants they indirectly fund for physicians through physician societies.

 

 

Additional PPSA reporting exclusions include:

 

  • In-kind items used for the provision of charity care
  • Discounts or rebates
  • Loan of a medical device for the short-term
  • Transfers of value and payments made to a physician in return for non-physician services from the physician (e.g., physician who is also a lawyer providing legal services to an applicable manufacturer or GPO)
  • Items or services provided under a contractual warranty
  • A dividend or other profit distribution, or ownership or investment interest in a publicly traded security and mutual fund.

 

 

 

  1. V.                How does PPSA Affect Physician Societies?

 

1) Will the PPSA be more likely to impact individual members or physician societies?

 

PPSA will affect both physician members and their professional societies. It will affect physician members directly because they will be subject to being reported for covered payments from manufacturers. Societies will be indirectly affected because manufacturers that sponsor society functions will put pressure on the societies to provide  them with names of physician members who must be reported as a result of such sponsorships.

 

2) Can member physicians be unaware of having been reported as receiving a gift of value? How will members know if a commercial entity reports a gift of value to them, of which they do not have actual knowledge?

 

Yes, CMS will provide a general notice to physicians registered through its Open Payments website portal that the manufacturer data is available for review. However, if a physician does not sign up on the CMS website and/or regularly check the OPEN PAYMENTS website, then he or she will not receive such notification and may miss the opportunity to review and dispute manufacturer reports. Note that this only a general notification – it will not notify specific physicians when their names are reported by manufacturers.

 

 

3) Are there any actions a physician society can take on the collective behalf of its members to assist in compliance or education about their role and rights under the PPSA?

 

Physician societies should educate their members about internal tracking, signing up for CMS notifications, and raising general awareness of the Sunshine Act and its potential implications. Physician societies should also notify their members when they provide those members’ names to particular manufacturers in connection with a reportable transfer of value.

 

 

4) Is the federal “Sunshine” Act the only law under which physicians may be reported by pharmaceutical or medical device manufacturers and/or GPOs for receiving payments or transfers of value from them?

 

Some states enacted their own “Sunshine” reporting laws prior to the implementation of Section 6002 of the federal Affordable Care Act, known as the Physician Payment Sunshine Act.

 

The rule operationalizing the federal Physician Payment “Sunshine” Act clarifies that any provisions of existing state “Sunshine” reporting laws which directly conflict with manufacturers being able to fulfill the provisions of the federal “Sunshine” Act are preempted, thus superseded, by the applicable provision of the federal “Sunshine” Act.

 

To see whether your state has its own “Sunshine” physician payment law, go to the AMA’s chart of state “Sunshine” laws at https://www.ama-assn.org/resources/doc/washington/state-sunshine-laws-chart.pdf.

Additionally, states have consumer protection laws which may require physician disclosure to patients of certain relationships with manufacturers prior to rendering treatment.

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