TN 110 (03-11)

Citations:

Social Security Act as amended in 2010, Section 1612(b) ;

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 and testing treatment of rare diseases or conditions as defined in Section 5(b)(2) of the “Orphan Drug Act”. The income exclusion applies to the first $2,000 per calendar year received by an SSI beneficiary, spouse, or deemor as compensation for participation in clinical trials that meet the criteria detailed in this section.

B. Glossary of terms

1. Clinical trial

A clinical trial is a research study designed to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials (also called medical research or research studies) serve to determine whether new drugs or treatments are both safe and effective.

2. Informed consent form

An informed consent form is a document that describes the rights of the clinical trial participants and includes key information about the study, including but not limited to: purpose, duration, required procedures, reasonably foreseeable risks, reasonably expected benefits, contacts, and any compensation or reimbursement information. Department of Health and Human Services (HHS) regulations at 45 C.F.R. 46.116 generally requires the administrators of clinical trials involving human subjects to obtain the participants’ signed informed consent. 

3. Institutional review board (IRB)

An IRB is a committee of physicians, statisticians, researchers, community advocates, and others responsible for ensuring that a clinical trial is ethical and protects the participants. In the United States, an IRB must approve the clinical trial before the trial begins.

4. Orphan Drug Act

The “Orphan Drug Act”, Public Law 97-414, promotes the development of drugs for rare diseases and conditions.

5. Rare disease or condition

A rare disease, also known as an “orphan” disease, is generally any disease or condition that affects less than 200,000 people in the United States. Certain conditions that affect more than 200,000 people may be considered orphan diseases if they meet other criteria in the “Orphan Drug Act”.

6. Types of clinical trials

There are five types of clinical trials:

1. Diagnostic trials look for better tests or procedures for diagnosing a particular disease or condition;

2. Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness;

3. Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes;

4. Screening trials test the best way to detect certain diseases or health conditions; and

5. Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.

C. Policy for income exclusion of payments for clinical trial participation

1. Payments as compensation for clinical trial participation

Effective April 3, 2011, exclude from income the first $2,000 paid during a calendar year to an SSI beneficiary, spouse, or deemor as compensation for participation in a clinical trial, but only if the clinical trial meets the following requirements:

• must be reviewed and approved by an IRB;

• must involve research and testing of medical treatments; and

• must target a rare disease or condition.

Do not exclude from income any compensation received prior to April 3, 2011, for participation in clinical trials that meet the criteria in SI 00830.735C.1. (in this section). Apply regular SSI income counting rules to those payments.

For instructions on developing unearned income, see General Rules for Developing Unearned Income in SI 00830.005.

2. Payments as reimbursement for expenses incurred while participating in a clinical trial

The income exclusion for clinical trial compensation does not apply to payments received as reimbursement for expenses incurred while participating in a clinical trial. Exclude reimbursement payments following the instructions in SI 00815.250, Rebates and Refunds. Some examples of reimbursable expenses are travel to and from research location, meals, etc.

Payments to reimburse clinical trial participants for expenses incurred while participating in the trial do not reduce the $2,000 calendar year maximum.

D. Procedure for developing income exclusion for clinical trial compensation

Request the “informed consent form” from the clinical trial participant. The informed consent form provides most of the information needed to determine whether the income exclusion applies.

NOTE: The informed consent form is primary evidence. If the participant is currently involved in the clinical trial, he or she must submit the informed consent form as evidence. If the participant does not have the informed consent form, instruct him or her to obtain a copy from the clinical trial administrator.

Some clinical trial participants may submit an official letter from the administrator of the clinical trial, which provides all the relevant information of the informed consent in a summarized format. You can use this letter in lieu of the informed consent form.

1. Informed consent form is available

HHS regulations dictate that IRBs must approve all informed consents; therefore, we can accept an informed consent form as proof that an IRB reviewed and approved the clinical trial.

To determine if the clinical trial meets the other exclusion requirements, review the informed consent form and follow the instructions in this table:

2. Informed consent form is unavailable

If the “informed consent form” is unavailable as evidence, request any of the following information from the clinical trial participant:

• name and location of the clinical trial,

• name of disease or condition, or

• name, phone, and address of the clinical trial administrator.

Clinical Trials.gov provides key information about clinical trials in the United States, such as purpose and contact information. Use the information provided to locate the clinical trial in the Clinical Trials.gov website.

If the clinical trial appears in the Clinical Trials.gov website, assume an IRB approved the clinical trial. All clinical trials in the United States involving human subjects must meet federal regulations by having an IRB review and approve the research.

To determine if the clinical trial meets the other two exclusion requirements, look for the following details in the clinical trial information:

• type of clinical trial, which is usually listed under the primary purpose, the title, or stated in the purpose summary; and

• name of the condition.

Follow the instructions in this table:

3. Document the clinical trial information

Request verification of date, frequency, and amount of payments (e.g. check stubs, payment receipts, informed consent form, etc). If payment documentation is unavailable, accept the individual’s allegation and exclude the clinical trial compensation without further development. Follow the next steps using MSSICS:

1. document the payment information as “Other Income Or Support Not Previously Mentioned”;

2. select “Other”, number 34, in the “IOTH” screen;

3. enter the following explanation under “If Type Is Other Explain”: clinical trials act; and

   • IMPORTANT: Enter the explanation phrase exactly as it appears. The exact phrase is necessary to gather critical management information pertaining to these provisions.

4. annotate the MSSICS Report of Contact (DROC) screen with the procedure and evidence used to apply the income exclusion and lock it. For example, document the DROC with all the pertinent information gathered from the informed consent form, such as disease type, amount paid, and time of participation. For more information on electronic evidence documentation and retention, see GN 00301.286.

   For non-MSSICS use the EVID screen under the Shared Processes Menu to document this exclusion.

NOTE: Fax a copy of the informed consent form, or form from the administrator of the clinical trial, into the Certified Electronic Folder (CEF). For more information on faxing documents into the CEF, see DI 81010.090.

E. References

• SI 00810.410 - Infrequent or Irregular Income Exclusion

• SI 00815.250 - Rebates and Refunds

• SI 00830.005 - General Rules for developing Unearned Income

• SI 00830.100 - Expenses of Obtaining Income

• SI 01130.735 - Payments for Clinical Trials Participation