Certain pharmaceutical manufacturers and distributors of an investigational drug under an investigational new drug (IND) application must make their policies for evaluating and responding to requests under an expanded access program “public and readily available” by the end of this week pursuant to section 3032 of the 21st Century Cures Act (Cures). Cures, which became effective on December 13, 2016, provided a deadline for making the policies available on the later of: (i) 60 days after the enactment of Cures, or (ii) the first initiation of a phase 2 or phase 3 study with respect to the investigational drug. Therefore, the 60-day deadline expires on Saturday, February 11, 2017, for those manufacturers and distributors who are already conducting a phase 2 or 3 study under an IND. Continue reading
Tag Archives: compliance
Deadline Looms for Pharmaceutical Manufacturers and Distributors to Comply with New Expanded Access Program Reporting Requirements
The Department of Health and Human Services (HHS) Office of Inspector General (OIG) released this week its FY2016 Work Plan (Work Plan). The OIG Work Plan summarizes new and ongoing OIG reviews of various HHS programs and activities, which are selected based on a number of factors such as mandatory OIG review requirements; requests from Congress, HHS management, or the Office of Management and Budget (OMB); and previously identified issues. Some key, new OIG reviews in the FY2016 Work Plan include the following:
The Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) issued two reports yesterday calling for the HHS Office of Civil Rights (OCR) to strengthen its Health Insurance Portability and Accountability Act (HIPAA) enforcement efforts. In response to these reports, HHS announced that it will launch HIPAA audits early next year in order to be more proactive in HIPAA enforcement. Continue reading
Earlier today, the U.S. Department of Health and Human Services Office of Inspector General (OIG), in conjunction with the American Health Lawyers Association (AHLA), the Association of Healthcare Internal Auditors (AHIA) and the Health Care Compliance Association (HCCA), announced the release of a guidance document titled, “Practical Guidance for Health Care Governing Boards on Compliance Oversight” (2015 Guidance). The 2015 Guidance supplements previous guidance documents issued by the OIG in 2003, 2004 and 2007 related to oversight by boards of directors (BOD) for health care companies.
In addition to discussing BOD oversight expectations, the 2015 Guidance defines and discusses the relationship between the compliance, legal, internal audit, human resources (HR) and quality functions of an organization. The 2015 Guidance also tackles tough topics related to reporting to the BOD, identifying and auditing potential risk areas, and compliance accountability.
The 2015 Guidance document should be carefully reviewed by directors of health care companies, as well as compliance, legal, audit, quality and HR professionals.
Cooley is excited to release a new resource for health care and life sciences companies: Key Considerations for Health Care Fraud Government Investigations/Inquiries. This quick reference documents provides a list of steps that companies should consider taking before a government investigation/inquiry occurs, and key steps to take if a becomes aware of a government investigation/inquiry.
Visit our website to learn more about Cooley’s Health Care & Life Sciences Regulatory practice.
Last week, the U.S. Department of Health and Human Services (“HHS”) released two reports to Congress, pursuant to its obligations under the Health Information Technology for Economic and Clinical Health Act (the “HITECH Act”): a report on Breaches of Unsecured Protected Health Information for 2011 – 2012 (the “Breach Report”) and a report on compliance with the HIPAA Privacy and Security Rules for 2009 – 2010 (the “Compliance Report”). Continue reading