Physician Payment Sunshine Provisions: Patient Protection Affordable Care Act Passed the House

Provision

Patient Protection Affordable Care Act – Passed House and Senate

Start Date for Recording

January 1, 2012

Start Date for Reporting

March 31, 2013

Publication of Reports

September 30, 2013 and June 30^th in future years

Definition of Entity (Who Reports)

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.

The term ‘manufacturer of a covered drug, device, biological, or medical supply’ means any entity which is engaged in the production, preparation, propagation, compounding, or conversion of a covered drug, device, biological, or medical supply (or any entity under common ownership with such entity which provides assistance or support to such entity with respect to the production, preparation, propagation, compounding, conversion, marketing, promotion, sale, or distribution of a covered drug, device, biological, or medical supply).

Report on self-referral

a requirement that the referring physician inform the individual in writing at the time of the referral that the individual may obtain the services for which the individual is being referred from a person other than a person described in subparagraph (A)(i) and provide such individual with a written list of suppliers (as defined in section 1861(d)) who furnish such services in the area in which such individual resides.’’.

Form of Reporting

• Electronic
• Searchable
• Easily Downloaded

Included in Disclosure

• Name;
• Business address;
• Physician specialty; 
• National provider identifier;
• The value of the payment or transfer of value;
• The name of the related drug, device, or supply, if available; to the level of specificity available;
• A description of the form of payment;  
  • Cash or cash equivalent
  • In-kind items of services
• Drug samples, the name, number, date, and dosage units of the sample.

Definition of Payment

• Gift;
• Food;
• Entertainment;
• Travel or trip;
• Honoraria;
• Research funding or grant;
• Education;
• Research;
• Charitable Contribution;
• Direct Compensation for Serving as Faculty or Speaker for Medical Education Program;
• Consulting fees;
• Ownership or investment interest;
• Royalties;  
• license fee;
• speaking fees;
• dividends;
• profit distribution;
• stock or stock option grant;
• Any categories of information the secretary determines appropriate;

Covered Recipient

• Physician; 
• Teaching hospital;

Excluded from Reporting

A transfer of anything the value of 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 (separate provision)
• Educational Materials
• Loan of a device for short term trial period (90 Days)
• Warranties
• Received as a Patient
• Discounts
• In-Kind used for provisions of charity care
• Dividends from stock ownership in publically traded companies
• Self Insurance Payments from Manufacturer for Employees
• Non Medical Professional Services
• Legal Services

Product Development

Payments under a product development agreement must be reported for services furnished in connection with the development of a new drug, device, biological, or medical supply, and must also be reported with the following information:  

The date of the approval or clearance of the covered drug, device, biological, or medical supply by the Food and Drug Administration; and

Payments made four calendar years after this date

Clinical Investigations

Confidential until either:

• Date of FDA approval or clearance;
• Payments made four calendar years after this date;

Penalties

A civil money penalty of not less than $1,000, but not more than $10,000, for each payment or other transfer of value or ownership or investment interest not reported.

The total amount of civil money penalties will not exceed $150,000.

Knowingly failing to submit payment information will result in a civil money penalty of not less than $10,000, but not more than $100,000, for each payment.

The penalty will not exceed $1,000,000.

Third Party Payments

Reported if they are requested by or designated on behalf of a physician

Reports

• Annual Reports to Congress
• Annual Reports to States

Pre-emption

Pre-Empts State Laws that are similar or weaker than this provision

Does not pre-empt more restrictive laws (lower limits of payments, gift bans….)