Genentech Fully Supports Efforts to Increase Transparency

CMS issued the Sunshine Act final rule on February 1, 2013, and established August 1, 2013 as the start date for data collection.

Genentech reports the data annually to CMS on March 31.

CMS will publish the data publicly by June 30.

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.

APPLICABLE MANUFACTURER

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.

COVERED DEVICE

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)

• Name
• 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

• consulting fees
• compensation for services other than consulting
• honoraria
• gift
• entertainment
• Travel and lodging (including the specified destinations)
• food & beverage
• education
• research
• 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
• grant
• Space rental or facility fees (when paid to a teaching hospital)

• Physicians
• Teaching hospitals

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

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.

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.