 For those suffering from cancer or other life-threatening illnesses, there may come a time when conventional medicine is no longer an effective course of treatment. It then becomes important to understand what a clinical trial is and what your insurance company is required by law to cover. Massachusetts is one of 24 states and the District of Columbia that mandates coverage for certain clinical trials.
Lack of such health insurance is a major barrier to many patients who want to enroll in trials.
Phases
Clinical trials are the testing phases of a new drug or treatment option. For instance, when pharmaceutical companies want to introduce their drug to consumers, they must first test it to make sure the drug works. They accomplish this through clinical trials, which are conducted in phases.
For a new drug, Phase I consists of testing a small group of people to determine the safety of a drug, its proper dosage and to identify side effects. Phase II involves testing a larger group to further gauge the drug’s safety as well as its effectiveness. Phase III includes the largest testing group, and continues to test the aspects covered in the previous phases. Its main purpose, however, is to determine if the treatment under study is better than the standard treatment. If Phase III is successful, the drug may become available to the public. At times Phase IV — which occurs after the drug has been marketed — is conducted in order to gauge the effects of long-term use.
Insured health plans in Massachusetts
 In Massachusetts, health insurers — including commercial health insurers, Blue Cross and Blue Shield of Massachusetts Inc. and health maintenance organizations — are required by a 2002 law, Chapter 257 of the Acts of 2002 (Chapter 257), to cover “qualified clinical trials to the same extent as if the care was considered non-investigational.” There are two parts to this law.
First, a clinical trial must be “qualified” and meet certain conditions:
• The trial is for the treatment of cancer;
• It is approved by certain agencies or organizations, such as the National Institutes of Health;
• It is administered by qualified personnel at a qualified facility;
• Phase I clinical trials can be conducted only at academic medical centers or an affiliated facility;
• There is reasonable expectation that the trial will provide benefits commensurate with the risks;
• The patient meets the selection criteria and has provided informed consent.
The second part of the law concerns the care covered. When you undergo a clinical trial, the professional services — doctor visits, radiology services, inpatient care and other standard medical procedures — will be covered, just as they would be if you were being treated with a conventional method. An exception to this rule is payment for an experimental drug. In most cases, the sponsor of the trial provides and pays for the drug being tested. Your plan will not pay for drugs and services that the investigator typically provides.
Self-insured health plans
These mandates do not cover all people who have employer-sponsored health insurance in Massachusetts. While insured health plans are common for small companies and individuals, larger companies are sometimes self-insured or self-funded and governed by the Employee Retirement Income Security Act of 1974 — commonly referred to as ERISA. ERISA is a federal law that protects the rights of employees covered under self-funded health plans in private industry. ERISA does not mandate coverage for clinical trials, so it is very possible your company’s health plan does not provide for it. To know for sure, check with your department of human resources. If your company has a self-insured plan, there may be different coverage details.
It is important to note that the type of plan you have is dictated by your company. For instance, while you may have a Blue Cross Blue Shield of Massachusetts card, it is your company that decides whether it is an insured or self-insured plan. Check with your company to make sure.
Medicare
Chapter 257 applies only to Massachusetts insured plans. Medicare, on the other hand, is a federal health insurance plan for those 65 and older, people under the age of 65 with certain disabilities and those with end-stage renal disease (permanent kidney failure that requires transplantation or dialysis). In 2000, Medicare introduced guidelines for routine care for those volunteering for medical research.
If you have Medicare you will be covered for:
• Room and board for a hospital stay that Medicare would pay for even if you weren’t in a clinical trial;
• An operation to implant an item that is being tested;
• Treatment of side effects and complications of the new care;
• Any other routine costs of items and services.
Medicare does not cover all expenses, however. It will not pay for any items that the study provides for free, or items or services that are only used to collect data and are not relevant to your personal health. For instance, if multiple CT scans are taken only to collect data, the service will not be reimbursed. Medicare will also not pay for out-of-pocket expenses such as coinsurance and deductibles that are always the responsibility of the patient.
Medicaid
Right now, Massachusetts’ Medicaid program, or MassHealth, “does not pay for research or experimental treatment.”
You should talk with your doctor about the best clinical trials for you. He or she will be able to recommend the most appropriate treatment facility for your condition.
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