Tag: research
CMS’s Final “Sunshine” Rule: Implications for Research
On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) released its long-awaited final rule (Final Rule) implementing Section 6002 of the Patient Protection and Affordable Care Act (ACA), commonly known as the “Physician Payment Sunshine Act” (Sunshine Act or Act).[1] The Sunshine Act was included in ACA to enhance disclosure and transparency of financial arrangements among physicians, teaching hospitals, and manufacturers of certain products (federally reimbursable drugs and biologicals as well as covered medical devices and medical supplies), and thereby reduce the risk of inappropriate financial incentives interfering with medical judgment and patient care. The Final Rule details requirements for processing and reporting payments by pharmaceutical, device, biological, and medical supply “applicable manufacturers”[2] to physicians and teaching hospitals that are “covered recipients.”[3] The Final Rule also sets forth requirements for reports of ownership and investment interests held … Read More »
HIPAA/HITECH Omnibus Final Rule: Implications for Research
The Department of Health and Human Services’ HIPAA/HITECH Omnibus Final Rule (Final Rule) includes a number of provisions that will alleviate certain restrictions and administrative burdens in human subjects research and help streamline the documentation associated with research. Here are the significant changes:
Compound Authorizations
The current HIPAA Privacy Rule generally prohibits “compound authorizations,” which are authorizations for use and disclosure of protected health information (PHI) that are combined with any other legal permission. An exception to this general prohibition permits combining an authorization for use and disclosure of protected health information in a research study with any other written permission for the same study, including an informed consent to participate in the research. However, until March 26, 2013, the effective date of the Final Rule, even the same study exception is unavailable if one of the authorizations or permissions conditions treatment, … Read More »
Still Waiting for Guidance on Informed Consent of Decisionally-Impaired Subjects
A July 11, 2012 article by Gina Kolata in the New York Times describes a recent discovery of a rare gene mutation that protects people from Alzheimer’s disease by slowing the production of beta amyloid. Excessive amounts of beta amyloid in the brain are believed to cause Alzheimer’s. The discovery bolsters hope that drugs, currently in development, that reduce levels of brain amyloid will prove effective in slowing the progression of Alzheimer’s.
The lack of clear guidelines for enrolling in clinical research decisionally-impaired subjects, or those who may become impaired over the course of a study may hinder efforts to conduct trials of Alzheimer’s drugs. In 2010, an Institute of Medicine summary of a workshop on the state of clinical trials in the United States noted that 27% of investigators in the U.S. failed to enroll any subjects in trials in … Read More »
Drug and Device Development Outsourcing
As companies outsource drug and device development overseas, reducing development time and research and development costs, additional legal concerns are raised. Last month a Shanghai court sentenced a researcher, employed by a leading Chinese pharmaceutical research firm, with 18 months’ probation, and ordered the employee to pay restitution for stealing and selling two patented compounds, owned by Merck.
The compounds were developed at the research firm, on behalf of Merck. Apparently the employee gained access to the compounds and sold them illegally. This case raises two important issues for manufacturers who outsource. First, can the outsourcing agreements with research firms adequately protect intellectual property rights and data from this type of misappropriation? Secondly, do patent portfolio strategies need to take into consideration these types of risks? To learn more about the case see the article attached….
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U.S. clinical trial website pairing — a need for privacy safeguards
Fox Trial Finder is a welcomed initiative in ongoing efforts to facilitate clinical trial participation. In a recent interview with ABC’s Diane Sawyer, Michael J. Fox, who suffers from Parkinson’s disease, said that in addition to his support for stem cell research addressing Parkinson’s, he also supports research looking for a cure on other fronts, including drug therapies and diagnostic tests. (Article Link) Toward that end, Fox’s Foundation for Parkinson’s Research recently launched an online initiative called Fox Trial Finder. This website promotes research across the country by pairing patients with clinical trials in their areas, based on the individual’s symptom profile. The foundation’s webpage notes that 30% of all clinical trials fail to recruit even one subject, and that 85% of clinical trials are delayed because of insufficient subject enrollment – so Fox’s initiative (and others like it that … Read More »
CMS’s Proposed “Sunshine” Regulations: Implications for Research
On Dec. 19, 2011, the Centers for Medicare & Medicaid Services (CMS) released a Proposed Rule to implement § 6002 of the Patient Protection and Affordable Care Act (PPACA), commonly referred to as the Physician Payment Sunshine Act (Sunshine Act). The Sunshine Act was included in PPACA to enhance disclosure and transparency of financial arrangements among physicians, teaching hospitals, and manufacturers of federally reimbursable drugs and biologicals and covered medical devices and medical supplies, and thereby reduce the risk of inappropriate financial incentives interfering with medical judgment and patient care. The Proposed Rule details requirements for processing and reporting payments by pharmaceutical, device, biological and medical supply “applicable manufacturers”1 to physicians and teaching hospitals that are “covered recipients.”2 The Proposed Rule also sets forth requirements for reporting ownership and investment interests held by physicians and their immediate family members in applicable … Read More »