OIG Releases Joint Compliance Guidance for Hospital – In a first-of-its-kind collaboration, the HHS Office of Inspector General (OIG) has released a new guidance document, “Practical Guidance for Health Care Governing Boards on Compliance Oversight,” which it developed in conjunction with the American Health Lawyers Association (AHLA), the Association of Healthcare Internal Auditors (AHIA), and the Health Care Compliance Association (HCCA). The OIG describes this document as a “joint educational resource to assist governing boards of health care organizations carry out their compliance plan oversight obligations.” The OIG’s news release is available here. The new guidance document is available by clicking here.
CMS Announces Hospital Compare Star Ratings – CMS announced on April 16, 2015, that it is adding star ratings to Hospital Compare, the agency’s public information website intended to assist consumers in choosing a hospital and understanding the quality of care they deliver. The Hospital Compare star ratings relate to patients’ experience of care at Medicare-certified acute care hospitals and are based on the data from the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (HCAHPS) measures that are included in Hospital Compare. Ratings will be updated each quarter. For more information, please click here.
Pricing Power in Health Care Markets – The National Academy of Social Insurance (NASI) released a report on April 17, titled Addressing Pricing Power in Health Care Markets: Principles and Policy Options to Strengthen and Shape Markets. The report addresses, among other things, insurer and provider market power, reasons for provider market power, key emerging trends, and offers guiding policy principles and policy options for addressing pricing power issues in health care markets.
Cancer in the Crosshairs: The Unique Regulatory and Transactional Challenges of Combination-Therapy Clinical Trials for Immuno-Oncology – On Thursday, April 30, 2015, King & Spalding will present an interactive web seminar discussing the unique and challenging aspects of conducting clinical trials of combination Immuno-Oncology therapies—i.e., two drugs from two companies administered in conjunction to test whether the combination is superior to a single-agent treatment regimen. A panel of experienced Life Sciences transactional and FDA/Regulatory attorneys will explore some of these challenges, including best practices for negotiating the clinical trial collaboration; design and control of the combination trial; supply of the drug products; control of the resulting clinical data; interactions with the FDA and other regulatory agencies; how to protect the added regulatory value created by combination clinical trials; and key topics that each company’s business, legal, commercial and clinical teams should consider. For more information and to register, please click here.
