On March 15, the Centers for Medicare and Medicaid Services (CMS) released guidance on the drug price negotiations provisions of the Inflation Reduction Act (IRA). The guidance contains CMS’s interpretations for a range of elements in the drug price negotiation process, including the manufacturer specific data elements that it will review in potential adjusting its view of the appropriate price.
While other data elements also deserve manufacturers’ attention, CMS’s approach to accounting for manufacturer costs associated with research, development and manufacturing will have profound implications for biopharmaceutical manufacturers. The agency’s proposed factors omit substantial investments while improperly treating others as sunk costs. As innovators prepare to comment on CMS’s guidance, they will want to convey the need for more fulsome consideration of these investments in the upcoming negotiations.
Tuesday’s decision by Judge Richard Leon of the U.S. District Court for the District of Columbia categorically approving the merger of AT&T and Time Warner, without imposing any conditions or limitations and rejecting granting a stay for appeal purposes, will, unless blocked if there is an appeal, open the way for a series of pending vertical merger deals.
A “vertical merger” is a merger of two companies that do not compete and that are at different levels of the product or service-provision process. Such mergers do not reduce the number of competitors in a given market and, by ...
Our colleagues Mark E. Lutes, Robert J. Hudock, and Patricia M. Wagner have issued an alert on modifications to the HIPAA privacy, security, and enforcement rules. Following is an excerpt:
On January 17, 2013, the Department of Health and Human Services released the highly anticipated, 563 page, Health Insurance Portability and Accountability Act (“HIPAA”) regulations (the “Final Rule”) that have been delayed for over 3 years. The Final Rule will be published in the Federal Register on January 25, 2013. The Final Rule addresses many of the compliance issues and ...
Please join Epstein Becker Green’s Health Care & Life Sciences and Labor & Employment practitioners as we continue to review the Affordable Care Act and its ongoing impact on employers and their group health plans.
In less than a year, employers employing at least 50 full-time employees will be subject to the Employer Shared Responsibility provisions. Under these provisions, if employers do not offer health coverage or do not offer affordable health coverage that provides a minimum level of value to their full-time employees, they may be subject to a tax penalty under the proposed ...
On Monday, July 2, 2012, Epstein Becker Green conducted a webinar titled "Decision 2012: What's In, What's Out, and What's Next?" examining the monumental decision (PDF) issued by the Supreme Court of the United States on the Patient Protection and Affordable Care Act.
This webinar analyzed the decision and its implications for the states, the health care and life sciences industry, and employers. It also addressed potential congressional activity and the decision's impact on the presidential election.
On Monday, July 2, 2012, Epstein Becker Green conducted a webinar titled "Decision 2012: What's In, What's Out, and What's Next?" examining the monumental decision (PDF) issued by the Supreme Court of the United States on the Patient Protection and Affordable Care Act.
This webinar analyzed the decision and its implications for the states, the health care and life sciences industry, and employers. It also addressed potential congressional activity and the decision's impact on the presidential election.
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