Clinical Trials are Covered under Health Care Reform

Health Care Reform/ACA/Obamacare  requires health plans to pay the routine care costs of patients who participate in clinical trials for the prevention, detection and treatment of cancer and other life-threatening conditions.  Read the entire article ⇒ Kaiser Health News – Simple Explanation 8.24.2010 explanation of how clinical trials are an essential benefit under Health Care Reform

Specimen Platinum Policy – Clinical Studies Page 71

Experimental Exclusion Page 109   163

Independent Medical Review Page 153

Learn more About Clinical Studies including relevant History, Policies, and Laws.

United Health Care

CIGNA Fact Sheet

Clinical Trials.Gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.

The problem wasn’t the costs of the clinical trial itself:

The cancer center would pay to administer the drug and analyze the results. But if Crusoe participated in the trial, his health plan would stop covering all the other doctor visits, hospital stays, tests and treatment related to treating his cancer.  Routine patient care refers to the range of medical services people with a particular diagnosis might need. It includes treatment for side effects and other medical issues that might arise as a result of the trial.  Although Medicare and many private health plans already cover such costs, some plans decline to do so on the grounds that clinical trials are experimental, say experts. More than half of states require coverage of routine costs in a clinical trial, but state requirements vary. The new law sets a minimum standard. section 2709(a) * 

Life Threatening Conditions

‘life-threatening condition’ means any disease or condition from which the likelihood of death is  probable unless the course of the disease or condition is interrupted.  (of an illness, situation, etc) that makes it possible that the person affected will die  ‘‘§2709 (e)  *   Collins
Links & References 

Federal Register Ryan White Regulations Section 2695  42 USC 300ff-131

42 USC 300gg-8 Coverage for individuals participating in approved clinical trials

CA Insurance Codes for clinical studies related to cancer  Health & Safety Code 1370.6

Insurance Code 10145.4

(a) For an insured diagnosed with cancer and accepted into a phase I, phase II, phase III, or phase IV clinical trial for cancer, every policy of disability insurance that provides hospital, medical, or surgical coverage in this state shall provide coverage for all routine patient care costs related to the clinical trial if the insured’s treating physician, who is providing covered health care services to the insured under the insured’s health benefit plan contract, recommends participation in the clinical trial after determining that participation in the clinical trial has a meaningful potential to benefit the insured. For purposes of this section, a clinical trial’s endpoints shall not be defined exclusively to test toxicity, but shall have a therapeutic intent.

(b) (1) “Routine patient care costs” means the costs associated with the provision of health care services, including drugs, items, devices, and services that would otherwise be covered under the plan or contract if those drugs, items, devices, and services were not provided in connection with an approved clinical trial program, including the following:

(A) Health care services typically provided absent a clinical trial.   [Essential Benefits]

(B) Health care services required solely for the provision of the investigational drug, item, device, or service.

(C) Health care services required for the clinically appropriate monitoring of the investigational item or service.

(D) Health care services provided for the prevention of complications arising from the provision of the investigational drug, item, device, or service.

(E) Health care services needed for the reasonable and necessary care arising from the provision of the investigational drug, item, device, or service, including the diagnosis or treatment of the complications.

[Medical Necessity    *    Clinical Guidelines UM Utilization Management]

(2) For purposes of this section, “routine patient care costs” does not include the costs associated with the provision of any of the following:

(A) Drugs or devices that have not been approved by the federal Food and Drug Administration and that are associated with the clinical trial.

(B) Services other than health care services, such as travel, housing, companion expenses, and other nonclinical expenses, that an insured may require as a result of the treatment being provided for purposes of the clinical trial.

(C) Any item or service that is provided solely to satisfy data collection and analysis needs and that is not used in the clinical management of the patient.

(D) Health care services which, except for the fact that they are not being provided in a clinical trial, are otherwise specifically excluded from coverage under the insured’s health plan.

(E) Health care services customarily provided by the research sponsors free of charge for any enrollee in the trial.

(c) The treatment shall be provided in a clinical trial that either (1) involves a drug that is exempt under federal regulations from a new drug application or (2) that is approved by one of the following:

(A) One of the National Institutes of Health.

(B) The federal Food and Drug Administration, in the form of an investigational new drug application.

(C) The United States Department of Defense.

(D) The United States Veterans’ Administration.

(d) In the case of health care services provided by a contracting provider, the payment rate shall be at the agreed-upon rate. In the case of a noncontracting provider, the payment shall be at the negotiated rate the insurer would otherwise pay to a contracting provider for the same services, less applicable copayments and deductibles. Nothing in this section shall be construed to prohibit a disability insurer from restricting coverage for clinical trials to hospitals and physicians in California unless the protocol for the clinical trial is not provided for at a California hospital or by a California physician.

(e) The provision of services when required by this section shall not, in itself, give rise to liability on the part of the insurer.

(f) This section shall not apply to vision-only, dental-only, accident-only, specified disease, hospital indemnity, Medicare supplement, CHAMPUS supplement, long-term care, or disability income insurance, except that for specified disease and hospital indemnity insurance, coverage for benefits under this section shall apply, but only to the extent that the benefits are covered under the general terms and conditions that apply to all other benefits under the policy. Nothing in this section shall be construed as imposing a new benefit mandate on specified disease or hospital indemnity insurance.

(g) Nothing in this section shall be construed to prohibit, limit, or modify an insured’s rights to the independent review process available under Section 10145.3 or to the Independent Medical Review System available under Article 3.5 (commencing with Section 10169).

(h) Nothing in this section shall be construed to otherwise limit or modify any existing requirements under the provisions of this chapter or to prevent application of deductible or copayment provisions contained in the policy.

(i) Copayments and deductibles applied to services delivered in a clinical trial shall be the same as those applied to the same services if not delivered in a clinical trial.

(Amended by Stats. 2002, Ch. 664, Sec. 156. Effective January 1, 2003.)


Coverage for Individuals Participating in Approved Clinical Trials

In general, PHS Act section 2709(a),6 as added by the Affordable Care Act, states that if a group health plan or health insurance issuer in the group and individual health insurance market provides coverage to a qualified individual (as defined under PHS Act section 2709(b)), then such plan or issuer:

(1) may not deny the qualified individual participation in an approved clinical trial with respect to the treatment of cancer or another life-threatening disease or condition;

(2) may not deny (or limit or impose additional conditions on) the coverage of routine patient costs for items and services furnished in connection with participation in the trial; and

(3) may not discriminate against the individual on the basis of the individual’s participation in the trial.

A qualified individual under PHS Act section 2709(b) is generally a participant or beneficiary who is eligible to participate in an approved clinical trial according to the trial protocol with respect to the treatment of cancer or another life-threatening disease or condition; and either: (1) the referring health care professional is a participating provider and has concluded that the individual’s participation in such trial would be appropriate; or (2) the participant or beneficiary provides medical and scientific information establishing that the individual’s participation in such trial would be appropriate.

Q3:  Will the Departments be issuing regulations addressing PHS Act section 2709 prior to its effective date?

No.  The statutory language of PHS Act section 2709 is self-implementing and the Departments do not expect to issue regulations in the near future.  PHS Act section 2709 is applicable to non-grandfathered group health plans and health insurance issuers offering group or individual health insurance coverage for plan years (in the individual market, policy years) beginning on or after January 1, 2014.

Until any further guidance is issued, group health plans and health insurance issuers are expected to implement the requirements of PHS Act section 2709 using a good faith, reasonable interpretation of the law.  The Departments will work together with employers, plans, issuers, states, providers, and other stakeholders to help them come into compliance with the law and will work with families and individuals to help them understand the coverage for clinical trials provision and benefit from it as intended.

For questions about the coverage for clinical trials provision, including complaints regarding compliance with the statutory provision by health insurance issuers, contact your state department of insurance (contact information is available by visiting or the Centers for Medicare & Medicaid Services, Center for Consumer Information and Insurance Oversight at 1-888-393-2789.  For employment-based group health plan coverage, you also may contact the Department of Labor at or 1-866-444-3272.

PHS Act section 2709 also is incorporated into section 715(a)(1) of ERISA and section 9815(a)(1) of the Code.  Accordingly, the Departments have concurrent jurisdiction over the implementation of PHS Act section 2709.   Copied from


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