Tag Archives: Conflicts of Interest

OIG Calls for Stronger Conflict-of-Interest Oversight for Medicare Part D P&T Committees

A recent OIG report, “Gaps in Oversight of Conflicts of Interest in Medicare Prescription Drug Decisions,” examines how Medicare Part D drug plan pharmacy and therapeutics (P&T) committees ensure that formulary decisions are not biased by conflicts of interest. Based on a survey of P&T committees and a review of their written policies, along with … Continue Reading

OIG Highlights Potential ZPIC Conflicts of Interest

The OIG recently examined potential conflicts of interest that could affect the impartiality of Zone Program Integrity Contractors (ZPIC) — Medicare contractors that perform program integrity activities designed to fight Medicare fraud, waste, and abuse. The OIG found that most companies that submitted proposals for ZPIC contracts (offerors) and/or their subcontractors had business and contractual … Continue Reading

HHS Issues Final Financial Conflict-of-Interest Rules for Researchers

On August 25, 2011, HHS published a final rule on the Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service (PHS) Funding is Sought and Responsible Prospective Contractors. The final rule revises 1995 standards on this subject in order to “update enhance the objectivity and integrity of the research process” and … Continue Reading

FDA Publishes Draft Guidance on Financial Disclosures by Clinical Investigators

FDA has released for public comment a draft guidance document entitled “Financial Disclosures by Clinical Investigators.”   The guidance, which will supersede March 2001 guidance on this issue, seeks to respond to a January 2009 HHS Office of the Inspector General (OIG) report that concluded that clinical investigators may not be disclosing all financial interests (). … Continue Reading

OIG Reports on Institutional Conflicts of Interest at NIH Grantees

The OIG has issued a report entitled "Institutional Conflicts of Interest at NIH Grantees." While noting that some National Institutes of Health (NIH) grantee institutions have voluntarily adopted institutional conflicts of interest policies, the OIG recommends that NIH promulgate rules to mandate that grantee institutions to identify, report, and address institutional financial conflicts in a consistent … Continue Reading

HHS Proposes Regulations on Financial Conflicts of Interest in Research

On May 20, 2010, HHS published a proposed rule to amend the Department’s regulations regarding the responsibility of applicants to promote objectivity in research for which Public Health Service (PHS) funding is sought. The proposed revisions are intended to expand and add transparency to investigator disclosure of significant financial interests and enhance regulatory compliance and … Continue Reading

Unimplemented OIG Recommendations

On March 11, 2010, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) published its “2010 Compendium of Unimplemented Office of Inspector General Recommendations,” which outlines previous OIG recommendations designed to achieve savings and increase the effectiveness of HHS programs. The OIG highlights priority recommendations in a number of … Continue Reading

CMS Manual Transmittal on Authorized Compendia for Off-Label Uses of Cancer Drugs

On January 30, CMS issued a Medicare Benefit Policy Manual transmittal entitled "Revision of Definition of Compendia as Authoritative Source for Use in the Determination of a Medically-Accepted Indication of Drugs/Biologicals Used Off-label in Anti-Cancer Chemotherapeutic Regimens." The transmittal makes changes to conform to the MIPPA compendia requirement that provides that effective January 1, 2010, no … Continue Reading

NIH Grantees’ Financial Conflicts of Interest Policies

The OIG has issued a report entitled “How Grantees Manage Financial Conflicts of Interest in Research Funded by the National Institutes of Health.” The OIG identified a number of vulnerabilities in National Institutes of Health (NIH) grantee institutions’ identification, management, and oversight of financial conflicts of interest. For example, 90% of grantee institutions rely solely on researchers’ … Continue Reading

Compendia Conflicts of Interest

CMS has posted a white paper on "Potential Conflict of Interest in the Production of Drug Compendia" produced by the Duke Evidence-based Practice Center under contract to the Agency for Healthcare Research and Quality (AHRQ). The report addresses, among other things: where in the compendia processes conflict of interest may arise; an "ethical framework" for … Continue Reading

Objectivity in Research PHS-Funded Research

On May 8, 2009, HHS published an advance notice of proposed rulemaking seeking comments on whether the HHS should amend its regulations on the responsibility of applicants for promoting objectivity in research for which Public Health Service (PHS) funding is sought. Specifically, HHS is considering whether to revise current regulations to provide a more rigorous approach … Continue Reading

IOM Report on Conflicts of Interest in Medicine

On April 28, 2009, the Institute of Medicine (IOM) issued a report endorsing new voluntary and regulatory measures to strengthen protections against financial conflicts of interest in medicine. The report addresses conflicts of interest in a number of settings, including biomedical research, clinical care, physician training, and continuing medical education. Among other things, the IOM recommends improving … Continue Reading

MedPAC Report to Congress — Medicare Payment/Transparency Provisions

On February 27, 2009, MedPAC released its March 2009 Report to the Congress: Medicare Payment Policy. The report includes a series of recommendations for Medicare payments designed to assure beneficiaries’ access to care and preserve Medicare’s long-term sustainability, particularly through reductions in payment updates for 2010. The report also includes recommendations to increase transparency of physician financial … Continue Reading

Clinical Investigator Financial Disclosure

The HHS Office of Inspector General (OIG) has issued a report on “The Food and Drug Administration’s Oversight of Clinical Investigators’ Financial Information,” which concludes that clinical investigators may not be disclosing all financial interests. The OIG found that only 1% of clinical investigators disclosed a financial interest, and the FDA cannot determine whether sponsors have … Continue Reading

GAO Report on FDA Advisory Committees

The Government Accountability Office (GAO) has issued a report examining the FDA’s advisory committee processes. Specifically, the GAO examined: (1) how FDA recruited individuals for membership and evaluated candidates for potential conflicts of interest, (2) barriers that were reported to recruiting qualified individuals to serve on committees, and (3) the proportion of standing and temporary members, … Continue Reading

FDA Advisory Committee Guidance

On August 4, 2008, the Food and Drug Administration (FDA) released a series of final guidance documents designed strengthen its management of FDA advisory committees. Among other things, the new policies include stricter limits on financial conflicts of interest for committee members (including a $50,000 cap on the personal financial interest an advisor may have in … Continue Reading

FDA Draft Guidance on Distributing Off-label Use Journal Articles

On February 20, the Food & Drug Administration (FDA) proposed guidelines for manufacturers of drugs and devices who would like to distribute scientific and medical articles that discuss off-label uses of approved products. The draft guidance is entitled “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved … Continue Reading