TN 63 (03-11)

Citations:

Social Security Act, Social Security Act as amended in 2010, Section 1613(a) ;

Public Law 111-255,

Public Law 114-63

A. Introduction to payments for clinical trial participation

On October 5, 2010, the President signed into law the “Improving Access to Clinical Trials Act”. This Act provides for the income and resource exclusion of compensation received for participating in clinical trials researching treatment of rare diseases or conditions. The exclusions apply to the first $2,000 per calendar year received by an SSI beneficiary, spouse, or deemor in compensation for clinical trials that meet the criteria detailed in section SI 00830.735, Payments for Clinical Trial Participation.

B. Policy for resource exclusion of payments for clinical trial participation

Effective May 1, 2011, exclude from countable resources the first $2,000 of compensation received per calendar year by an SSI beneficiary, spouse, or deemor for participating in a clinical trial for a rare disease or condition that meets the income exclusion criteria listed in SI 00830.735, Payments for Clinical Trials Participation.

IMPORTANT: Excluded clinical trial compensation payments do not need to be separately identifiable. For more information on how to identify commingled funds (excluded with non-excluded funds), see SI 01130.700.

C. Procedure for developing resource exclusion for Clinical Trial Compensation

1. When to develop

Develop this exclusion only when an individual alleges the receipt of compensation excludable under this provision and the exclusion would permit eligibility for regular or conditional SSI benefits, in that order.

IMPORTANT: Apply the resource exclusion to excludable clinical trial compensation even if received prior to the SSI application date.

2. How to develop

Determine if the alleged or verified clinical trial compensation amount was excluded from income under SI 00830.735C.1.

• exclude as a resource the unspent portion of the compensation amount, if the income exclusion applied.

• do not exclude the unspent portion of the compensation amount, if the income exclusion did not apply; and

• do not exclude from resources any amounts excluded from income according to the rebates and refunds policies in SI 00815.250.

D. References

• SI 00830.735 Payments for Clinical Trial Participation