Sunshine Act Compliance

The Sunshine Act, or National Physician Payment Transparency Program (Open Payments), is a section of the Patient Protection and Affordable Care Act of 2010. This program requires manufacturers of pharmaceuticals, medical devices and biologics that participate in U.S. federal health care programs to report certain payments and items of value given to physicians and teaching hospitals to the Centers for Medicare and Medicaid Services (CMS).

Data is submitted on an annual basis. Once submitted, physicians will have 45 days to review and dispute errors before public release. This information can be accessed on the Open Payments Portal and disputes can be submitted directly to CMS.

At Chiesi USA, we greatly value our relationships with healthcare practitioners and are committed to collecting and reporting this data as accurately as possible.

Have further questions on the process? Please feel free to review the FAQs below or contact us at sunshine@chiesi.com.

FREQUENTLY ASKED QUESTIONS

Definitions

Applicable Manufacturer: A Manufacturer of at least one covered drug, device, biological or medical supply product is required to report payments or other transfers of value they make to physicians and teaching hospitals to CMS annually.

Covered Recipient: Any physician who is licensed in the U.S. or a teaching hospital that is on a list provided by Centers for Medicare and Medicaid Services (CMS).

Open Payments: Promulgated by the Patient Protection and Affordable Care Act of 2010, the federal program that collects and makes information public about financial relationships between the health care industry and Covered Recipients.

Payment or Transfer of Value (TOV): A direct or indirect monetary or non-monetary reimbursement, compensation, charitable contribution, benefit or gift. Manufacturers are required to report all TOVs under one of 14 categories. These categories include: consulting fees, grants, research, honoraria, meals, travel, amongst others.

Sunshine Act: The Physician Payment Sunshine Act, more commonly known as the Sunshine Act, is a section of the Patient Protection and Affordable Care Act of 2010 that requires pharmaceutical and medical device companies that participate in U.S. federal health care programs to report certain payments and items of value given to Covered Recipients.

FAQs

1. Can a Covered Recipient opt out of the reporting requirement?

Any TOV on a Covered Recipient that has an NPI or a teaching hospital that is on the annual CMS list must be reported.

2. Can a Covered Recipient opt out of receiving TOVs from Chiesi USA?

A Covered Recipient may choose not to partake in a meal provided by Chiesi at any educational program. In order to opt-out at a Chiesi speaker or dinner program, a Covered Recipient can either pay for the meal out of pocket or simply choose not to consume anything at the program. If a Covered Recipient chooses to opt-out of a meal at an in-service or office interaction, Chiesi USA will not be required to report that interaction to CMS.

3. Is there a minimum value that a Payment can be to be exempt from Open Payments Reporting?

Chiesi USA tracks all payments made to Covered Recipients no matter what the value is. CMS does have a De Minimis threshold for Applicable Manufacturers that are adjusted annually based on the consumer price index. This means that TOVs under a certain amount are not required to be reported unless in total the aggregate to more than that year’s specified amount. For more information please visit https://www.cms.gov/OpenPayments/Program-Participants/Applicable-Manufacturers-and-GPOs/Data-Collection.html

Are residents and fellows classified as Covered Recipients?

The Open Payments Act defines physicians as doctors of medicine (MD) and osteopathy (DO), dentists, podiatrists, optometrists and chiropractors who possess an active license to legally practice in the U.S. Fellows are reportable under this definition. Residents are not.

How will reprints be reported?

When a Covered Recipient receives a reprint, the amount that Chiesi spent on the reprint will be reported to Open Payments under the Covered Recipient’s name (De Minimis threshold taken into account). All other educational items will be reported by their associated value.

Can a Covered Recipient see the information Chiesi USA will be disclosing before it is published?

At this time, there is not an opportunity for a Covered Recipient to see data prior to submission. The Covered Recipient will be given the opportunity during the regulated review process on the Open Payments portal to look over the TOVs on the CMS Open Payments Portal prior to publication.

What can a Covered Recipient do if they want to dispute a TOV reported by Chiesi?

The Covered Recipient will need to create an account through the CMS Open Payments portal and follow the provided guidelines for initiating a dispute found here: https://www.cms.gov/OpenPayments/Program-Participants/Physicians-and-Teaching-Hospitals/Review-and-Dispute.html.

Can Chiesi not participate in Open Payments?

Under the qualifications provided by the CMS Open Payments Program below, Chiesi USA currently is required to report under Open Payments.

	Type 1 Manufacturer	Type 2 Manufacturer
Operate in US?	Your physical location is within the United States and/or your activities are within the United States. This includes any territory, possession, or commonwealth of the United States.
Activities	Engages in the production, preparation, propagation, compounding, or conversion of a covered drug, device, biological, or medical supply. This includes distributors or wholesalers that hold title to a covered drug, device, biological, or medical supply	Exists under common ownership with a Type 1 Applicable Manufacturer AND Provides assistance or support to such an entity with respect to the production, preparation, propagation, compounding, sale or distribution of a covered drug, device, biological or medical supply.
	Produces at least one product reimbursed by Medicare, Medicaid or Children’s Health Insurance Program AND If the product is a drug or biological, and it requires a prescription (or physician’s authorization) to administer OR If the product is a device or medical supply, and it requires premarket approval or premarket notification by the FDA.EXEMPTIONS Applicable Manufacturers and GPOs with less than 10 percent of revenues from covered products do not need to report all payments or other transfers of value as proposed, but rather are only required to report payments or other transfer of value that are related to one or more covered drugs, devices, biologicals or medical supplies. Foreign entities that may contribute to the manufacturing process of a covered product but have no business presence in the United States. Entities that only manufacture raw materials or components, which are not themselves covered products, will not be required to report unless they are under common ownership with an Applicable Manufacturer and assist such manufacturer with the production, preparation, propagation, compounding, conversion, marketing, promotion, sale or distribution of a covered drug, device, biological or medical supply. Entities such as hospitals, hospital-based pharmacies and laboratories that manufacture a covered product solely for use by or within the entity itself or by an entity’s own patients.Wholesalers or distributors that do not hold the title of a covered product will not be subject to the reporting requirements, unless they are under common ownership with an Applicable Manufacturer and provide assistance or support with respect to a covered drug, device, biological or medical supply.If an Applicable Manufacturer does not manufacture a covered drug, device, biological or medical supply except pursuant to a written agreement to manufacture the covered product for another entity, does not hold the FDA approval, licensure or clearance for the product, and is not involved in the sale, marketing or distribution of the product, then the manufacturer is only required to report payments or other transfers of value related to the covered product. This is described in the regulatory text at § 403.904(b)(4).

Where will the TOV information be reported?

The TOV information will be reported to CMS though a bulk file upload on the CMS Open Payments Portal.

When will the TOV information be published?

All TOV data reported by Chiesi USA will be published to the CMS website annually on June 30.

Will TOVs received for international engagements be reported under Open Payments?

Any TOV made to a US Covered Recipient will be reported under Open Payments no matter where the engagement took place.

If a Covered Recipient attends a CME event activity that Chiesi supports, will this be reported?

Starting in 2016, if Chiesi provides an indirect payment or other TOV to a continuing education organization for a continuing education event to physicians, and knows or finds out the identity of the physician attendees/speakers within the reporting year or by the end of the second quarter of the following reporting year, that payment will be reported to CMS, unless the CME event is accredited by the ACCME, AMA or similar organization that has like criteria.

If a Covered Recipient performs work as a contractor for Chiesi, will this be reported?

If a TOV to a Covered Recipient working as a contractor for Chiesi falls under any of the required reportable natures of payment on the CMS Open Payments template, it will be reported.

If a Covered Recipient donates their honorarium, will this be reported?

A Covered Recipient may choose to donate their honorarium. If the Covered Recipient chooses where to donate the honorarium, the TOV will still be reported under that Covered Recipient with a notation that the sum was donated. The Covered Recipient can also choose to waive their honorarium and have Chiesi USA donate it. In this case, it is not reported.

How do I learn more about the Sunshine Act?

Information about the Open Payments Sunshine Act can be found at www.cms.gov/openPayments

If you have further questions, please contact us at sunshine@chiesi.com.