As hospitals and physicians continue the trend toward alignment, integration and the creation of accountable care organizations, there are a number of considerations hospital executives should include in their discussions with regards to the running of clinical trials. Some institutions in which the medical staff is independent, rather than employed, have a hands-off approach to overseeing clinical trials. Whether your institution will continue to have an independent medical staff, or if you plan to align more closely with physicians, there are issues and liabilities that must be at the center of your decision.
The majority of sponsored clinical trials — that is, clinical trials funded by pharmaceutical or medical device companies — are conducted in community hospitals and independent community physician practices.[1] This type of research, and the relationships it creates, are the subject of significant federal regulatory attention with regards to financial conflicts of interest.
The risk of a conflict of interest can create a headache for a hospital's compliance officer when the physician is not an employee. Even if the clinical trial is run from the physician's independent practice, if that patient is referred to the hospital for services such as labs and radiology that may be used to gather data for the trial, the institution should be aware of it.
A study by the Tufts Center for the Study of Drug Development showed that patients in clinical trials are undergoing more and more procedures, including X-rays, blood draws and biopsies. Some of those procedures could be happening at your institution.
Another vulnerable area for hospitals is in the surgical suite where surgeons may undertake medical device trials or where anesthesiologists may be investigators for drug companies. A physician-investigator may negotiate a clinical trial agreement with a research sponsor but not include the hospital in the agreement. This means the hospital might not be indemnified if part of the trial takes place in its facilities.
Hospital executives should understand their liability and compliance responsibilities. The National Institutes of Health requires institutions to have conflict of interest policies that include the documentation, management and reporting of significant financial interests. Last year, HHS issued final rules that strengthen the accountability provisions. Starting next year, the federal government, through the Physician Payment Sunshine Act, requires any drug, device or medical supply manufacturer to report any compensation or benefit given to a physician.
The top priority in any clinical trial is, of course, patient safety and protection. Ensuring that an investigator's consent form for research is in compliance with the hospital's informed consent rules requires diligence. The hospital's medical staff office may want to consider including a requirement that all clinical trials be reviewed by the hospital's IRB as a part of the granting of hospital privileges. Alternatively, the hospital may require that the physician provide a copy of the current IRB approval along with the clinical trial agreement. The hospital may also require that it be added as a party to all clinical trial agreements.
Another area of concern for hospital executives is in billing. Medicare pays the routine costs of "qualified" clinical trials. But they don't look too kindly on double billing, which they consider fraud. Conducting a detailed Medicare coverage analysis, which includes a review of what trials are qualified as well as what items and services are included, is essential for hospitals that may be treating clinical trial participants. This helps ensure complete compensation for the care, and helps prevent billing errors for non-reimbursable items or items for which the sponsor is responsible.
In some cases, the hospital enters an agreement with the sponsoring company to conduct a clinical trial and names a non-employee physician as the principal investigator. If the hospital and the physician are to share the compensation for conducting the trial, both parties are getting into dangerous Stark Law territory and should consider legal counsel.
Hospital executives, compliance officers and physicians must navigate a minefield of conflict of interest provisions, anti-kickback laws and false claims acts. Having clearly defined compliance policies and enforcement strategies regarding the conduct of clinical trials at your facility is the first step in protecting the institution from government scrutiny.
Kimberly Irvine is executive vice president, operation at The Biomedical Research Alliance of New York. BRANY is a national organization providing support services to sponsors, research sites and investigators involved in clinical research in a wide variety of therapeutic areas, medical devices, biologic and diagnostic trials. BRANY is the largest alliance of clinical trial research sites in the United States including over 200 affiliates. Services include expedited study start-up, central IRB, monitoring and auditing, compliance consulting and continuing education for research professionals.
Footnotes:
[1] Steinbrook R. Gag clauses in clinical trial agreements. New England Journal of Medicine. 2005 May 26;352(21):2160-2
The majority of sponsored clinical trials — that is, clinical trials funded by pharmaceutical or medical device companies — are conducted in community hospitals and independent community physician practices.[1] This type of research, and the relationships it creates, are the subject of significant federal regulatory attention with regards to financial conflicts of interest.
The risk of a conflict of interest can create a headache for a hospital's compliance officer when the physician is not an employee. Even if the clinical trial is run from the physician's independent practice, if that patient is referred to the hospital for services such as labs and radiology that may be used to gather data for the trial, the institution should be aware of it.
A study by the Tufts Center for the Study of Drug Development showed that patients in clinical trials are undergoing more and more procedures, including X-rays, blood draws and biopsies. Some of those procedures could be happening at your institution.
Another vulnerable area for hospitals is in the surgical suite where surgeons may undertake medical device trials or where anesthesiologists may be investigators for drug companies. A physician-investigator may negotiate a clinical trial agreement with a research sponsor but not include the hospital in the agreement. This means the hospital might not be indemnified if part of the trial takes place in its facilities.
Hospital executives should understand their liability and compliance responsibilities. The National Institutes of Health requires institutions to have conflict of interest policies that include the documentation, management and reporting of significant financial interests. Last year, HHS issued final rules that strengthen the accountability provisions. Starting next year, the federal government, through the Physician Payment Sunshine Act, requires any drug, device or medical supply manufacturer to report any compensation or benefit given to a physician.
The top priority in any clinical trial is, of course, patient safety and protection. Ensuring that an investigator's consent form for research is in compliance with the hospital's informed consent rules requires diligence. The hospital's medical staff office may want to consider including a requirement that all clinical trials be reviewed by the hospital's IRB as a part of the granting of hospital privileges. Alternatively, the hospital may require that the physician provide a copy of the current IRB approval along with the clinical trial agreement. The hospital may also require that it be added as a party to all clinical trial agreements.
Another area of concern for hospital executives is in billing. Medicare pays the routine costs of "qualified" clinical trials. But they don't look too kindly on double billing, which they consider fraud. Conducting a detailed Medicare coverage analysis, which includes a review of what trials are qualified as well as what items and services are included, is essential for hospitals that may be treating clinical trial participants. This helps ensure complete compensation for the care, and helps prevent billing errors for non-reimbursable items or items for which the sponsor is responsible.
In some cases, the hospital enters an agreement with the sponsoring company to conduct a clinical trial and names a non-employee physician as the principal investigator. If the hospital and the physician are to share the compensation for conducting the trial, both parties are getting into dangerous Stark Law territory and should consider legal counsel.
Hospital executives, compliance officers and physicians must navigate a minefield of conflict of interest provisions, anti-kickback laws and false claims acts. Having clearly defined compliance policies and enforcement strategies regarding the conduct of clinical trials at your facility is the first step in protecting the institution from government scrutiny.
Kimberly Irvine is executive vice president, operation at The Biomedical Research Alliance of New York. BRANY is a national organization providing support services to sponsors, research sites and investigators involved in clinical research in a wide variety of therapeutic areas, medical devices, biologic and diagnostic trials. BRANY is the largest alliance of clinical trial research sites in the United States including over 200 affiliates. Services include expedited study start-up, central IRB, monitoring and auditing, compliance consulting and continuing education for research professionals.
Footnotes:
[1] Steinbrook R. Gag clauses in clinical trial agreements. New England Journal of Medicine. 2005 May 26;352(21):2160-2
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