Genentech Fully Supports Efforts to Increase Transparency
Genentech fully supports efforts to increase transparency around the partnership between the industry and healthcare professionals.
We believe the partnership between the medical community and companies like ours who discover and develop medicines is critically important to our shared goals of advancing scientific knowledge and delivering new medicines to patients in need.
Our ability to engage with doctors, researchers and opinion leaders in robust dialogue on approved and investigational medicines is vital to our research and development efforts. These external experts also lead the clinical trials evaluating the safety and efficacy of our medicines, and provide critical information and insight into patient needs.
Sunshine Act Compliance
The Sunshine Act, a.k.a. the National Physician Payment Transparency Program (Open Payments), is a section of the Patient Protection and Affordable Care Act of 2010. It requires pharmaceutical and medical device companies report certain payments to the Federal government.
Genentech is committed to ensuring that the Sunshine Act data we report is as accurate as possible, and we employed extensive processes to collect and review the data prior to submission.
We are also committed to providing healthcare professionals with the information they need to accurately track their Sunshine-reportable payments. To help in this effort, we have developed a secure online tool called Sunshine Track.
Want to see it in Action?Launch our user guide
Our Sunshine Track® Tool
Sunshine Track is a secure online portal that will allow you to review your Sunshine-reportable payments before they are reported to the government.
With a click or tap, Sunshine Track allows you to inquire about or dispute any Sunshine-reportable information that you think may be inaccurate.
Note: Sunshine Track is not supported by Internet Explorer 8 or earlier.
Welcome to Genentech’s Sunshine Track
This user guide describes the features and functionality in the Sunshine Track tool. To get started, choose a topic below.
Sunshine Track Features include
- Secure login
- Optional automated email notifications when new or updated Sunshine-reportable data is available for your review
- Filters that allow you to quickly zero in on the data you’re most interested in
- Optimized for use on multiple devices: mobile, laptop, tablet
Learn More About the Sunshine Act, a.k.a. Open Payments
Disclaimer: This document is not intended to provide legal advice. For legal advice concerning the Federal Physician Payment Sunshine Statute, please consult your institution or legal counsel.
Reportable period start date
CMS issued the Sunshine Act final rule on February 1, 2013, and established August 1, 2013 as the start date for data collection.
Report due to government
Genentech reports the data annually to CMS on March 31.
Government Publication Date
CMS will publish the data publicly by June 30.
Required Reporting Entities
APPLICABLE GROUP PURCHASING ORGANIZATION
The term 'applicable group purchasing organization' means a group purchasing organization (as defined by the Secretary) that purchases, arranges for, or negotiates the purchase of a covered drug, device, biological, or medical supply which is operating in the United States, or in a territory, possession, or commonwealth of the United States.
The term 'applicable manufacturer' means a manufacturer of a covered drug, device, biological, or medical supply which is operating in the United States, or in a territory, possession, or commonwealth of the United States.
Definition of Covered Products
The term 'covered device' means any device for which payment is available under title XVIII or a State plan under title XIX or XXI (or a waiver of such a plan).
COVERED DRUG, DEVICE, BIOLOGICAL, OR MEDICAL SUPPLY
The term 'covered drug, device, biological, or medical supply' means any drug, biological product, device, or medical supply for which payment is available under title XVIII or a State plan under title XIX or XXI (or a waiver of such a plan)
Information Requirements in the Disclosure
- Business address
- Physician specialty
- National provider identifier
- The value of the transfer or payment
- The Brand/scientific name of the associated drug or device
- Form of payment
- Cash or cash equivalent
- In-kind items or services
- Stock, a stock option, or any other ownership interest, dividend, profit or other return on investment
- Nature of Payment
- Entity or individual that received payment at the request of or designated on behalf of covered recipient
Specific Payment Types Which Must be Reported
- consulting fees
- compensation for services other than consulting
- Travel and lodging (including the specified destinations)
- food & beverage
- charitable contribution
- royalty or license
- current or prospective ownership or investment interest
- direct compensation for serving as faculty or as a speaker for a medical education program
- Space rental or facility fees (when paid to a teaching hospital)
Covered People and Entities
- Teaching hospitals
Excluded from Reporting
A transfer of anything of value which is less than $10, unless the aggregate amount transferred to, requested by, or designated on behalf of the covered recipient by the applicable manufacturer during the calendar year exceeds $100.
- Product samples that are not intended to be sold and are intended for patient use
- Educational materials that directly benefit patients or are intended for patient use
- The loan of a covered device for a short-term trial period, not to exceed 90 days, to permit evaluation of the covered device by the covered recipient
- Items or services provided under a contractual warranty
- A transfer of anything of value to a covered recipient when the covered recipient is a patient
- Discounts (including rebates)
- In-kind items used for the provision of charity care
- A dividend or other profit distribution from, or ownership or investment interest in, a publicly traded security and mutual fund
- In the case of an applicable manufacturer who offers a self-insured plan, payments for the provision of health care to employees under the plan
- If the transfer is payment solely for the non-medical professional services
- If the transfer is payment solely for the services of the covered recipient with respect to a civil or criminal action or an administrative proceeding
Clinical Development Investigations
Reportable, but not required to publicly disclose until either:
- FDA approval date or
- Four calendar years after payment date
Failure to report subject to a penalty of not less than $1,000, but not more than $10,000 for each payment or other transfer of value not reported.
The total civil penalty will not exceed $150,000 per calendar year.
Knowingly failing to submit payment data results in a penalty of not less than $10,000, but not more than $100,000, for each payment.
Penalty will not exceed $1,000,000 per calendar year.
State law preemption
All state laws that impose the same reporting requirements are pre-empted by this law.
State laws that impose different reporting or prohibition provisions shall continue to be effective.