Abbott Laboratories (Abbott), an Illinois company, will pay over $1.6 billion in penalties to the federal government and several states related to its alleged illegal promotion of the prescription drug Depakote for off-label uses, as announced by the settling parties on May 7, 2012. Specifically, the government has alleged that the Company: marketed Depakote, in nursing… Continue Reading
Category Archives: Pharma & Medical Devices
Subscribe to Pharma & Medical Devices RSS FeedSunshine Act Implementation Delayed Until 2013
Posted in Health Care Reform, Pharma & Medical DevicesWith little fanfare, the Centers for Medicare & Medicaid Services (CMS) announced today on the CMS Blog that it is delaying data collection under the Sunshine Act until 2013. Pharmaceutical and medical device manufacturers and group purchasing organizations covered by the Sunshine Act thus will not have to begin collecting data before January 1, 2013. … Continue Reading
Massachusetts House Votes to Repeal Gift Ban Law
Posted in Pharma & Medical Devices, PhysiciansEarlier this week the Massachusetts House of Representatives voted 128-22 to repeal the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct (often called the “gift ban” law). The gift ban law prohibits pharmaceutical and medical device manufacturers from giving gifts and certain other items of value to health care providers, and requires disclosure of permitted… Continue Reading
ML Strategies Posts Weekly Health Care Reform Update on April 2, 2012
Posted in Health Care Reform, Pharma & Medical Devices, UncategorizedML Strategies has posted its weekly Health Care Reform Update. This publication provides timely and concise information on implementation of the Affordable Care Act, and other state and federal administrative and legislative activities related to health care reform. This week’s Update discusses last week’s oral arguments before the U.S. Supreme Court in the multi-state challenge to the Affordable Care Act,… Continue Reading
DOJ’s Strategies – FCPA and Health Care Fraud
Posted in Pharma & Medical Devices, State & Federal Audits, Investigations & LitigationFor insights into how Foreign Corrupt Practices Act (FCPA) enforcement is creeping into the pharmaceutical and medical device manufacturer arena, see this article, which I co-authored with Paul Pelletier, former principal deputy chief of the Criminal Division’s Fraud Section at the Department of Justice (DOJ). It discusses how DOJ is now using “letters of inquiry” and other informal practices to… Continue Reading
ML Strategies Posts Weekly Health Care Reform Update on March 12, 2012
Posted in Accountable Care Organizations, Health Care Reform, Pharma & Medical Devices, UncategorizedML Strategies has posted its weekly Health Care Reform Update. This publication provides timely and concise information on implementation of the Affordable Care Act, and other state and federal administrative and legislative activities related to health care reform.
New FDA Research Consent Form Requirements – Effective Today
Posted in Clinical Trials & Research/FDA, Pharma & Medical DevicesWritten by Dianne J. Bourque Starting today, March 7, 2012, clinical research consent forms for certain FDA-regulated clinical trials must contain a specific statement advising participants that clinical trial information will be entered into the ClinicalTrials.gov database. ClinicalTrials.gov is a clinical trial registry maintained by the National Institutes of Health/National Library of Medicine (NIH/NLM). It… Continue Reading
Government Health Care Enforcement: How 2011 Actions Are Impacting 2012 Priorities
Posted in Fraud & Abuse, Pharma & Medical Devices, State & Federal Audits, Investigations & LitigationHealth care providers and pharmaceutical and medical device manufacturers are operating in an environment of intense scrutiny. As discussed in a Mintz Levin client advisory, in 2011, the federal government directed extraordinary resources and attention to detecting and prosecuting health care fraud and abuse. Numerous law enforcement agencies are casting a wide net and are… Continue Reading
CMS Proposed Rules for Reporting AMP and Best Price May Have Impact Beyond Medicaid Drug Rebates
Posted in Health Care Reform, Payors & PBMs, Pharma & Medical DevicesWritten by Theresa Carnegie, Ellyn Sternfield and Nili Yolin On February 2, 2012, CMS issued proposed regulations that further refine and define how pharmaceutical manufacturers must calculate Medicaid drug rebates in the wake of health care reform (the Proposed Rule). Specifically, the Proposed Rule changes the definition of “bona fide services fee,” which is a key… Continue Reading
ML Strategies Posts Weekly Health Care Reform Update on February 6, 2012
Posted in Health Care Reform, Pharma & Medical Devices, UncategorizedML Strategies has posted its weekly Health Care Reform Update. This publication provides timely and concise information on implementation of the Affordable Care Act and other state and federal administrative and legislative activities related to health care reform.
Proposed Physician Payment Sunshine Act Regulations Leave Many in the Dark
Posted in Health Care Reform, Pharma & Medical DevicesThe Centers for Medicare & Medicaid Services (CMS) recently issued a proposed rule giving pharmaceutical and medical device manufacturers as well as group purchasing organizations some insight into how CMS intends to implement the Physician Payment Sunshine Act, which was enacted as part of health care reform. In an article published in BNA’s Health Care… Continue Reading
Massachusetts DPH Issues Guidance On the Sunshine Act’s Preemption of “Gift Ban” Law
Posted in Health Care Reform, Pharma & Medical DevicesAs discussed in a previous post, CMS recently issued a proposed rule implementing the Sunshine Act, but many pharmaceutical and medical device manufacturers are still trying to determine the scope of their continuing obligations under related state laws, such as the Massachusetts “gift ban” law. The proposed rule addressed preemption of state laws but merely stated that the state law preemption clause… Continue Reading
Sunshine Act: Proposed Regulations Shed Some Light on Implementation
Posted in Fraud & Abuse, Health Care Reform, Pharma & Medical Devices, PhysiciansWritten by Brian Dunphy and Karen Lovitch Pharmaceutical and medical device manufacturers, along with physicians and teaching hospitals, who have been grappling with how to implement the requirements of the federal Physician Payment Sunshine Act have finally received long-awaited guidance. Yesterday CMS published an overdue proposed rule required by the Sunshine Act that fills in some key details. … Continue Reading
Delay in Publication of Sunshine Act Regulations Persists Despite Bipartisan Pressure
Posted in Health Care Reform, Pharma & Medical DevicesWritten by Kevin Kappel and Karen Lovitch CMS has yet to issue regulations required under the federal Physician Payment Sunshine Act even though they were due on October 1, 2011. As discussed in an earlier post on this blog, this lack of guidance is problematic for pharmaceutical and medical device manufacturers covered by the Sunshine… Continue Reading
Guidance for Biotech/Life Sciences Companies on Avoiding Litigation with Contract Partners
Posted in Pharma & Medical Devices, State & Federal Audits, Investigations & LitigationBioWorld Perspectives recently published an article by Mintz Levin attorneys Sam Davenport and Matt Hurley entitled “Avoiding Litigation While Protecting Your Interests,” which discusses the essential steps for companies to take after entering into a collaboration, license, or supply agreement to avoid ending up in litigation down the road. The article is particularly relevant for biotechnology… Continue Reading
President Obama Signs Executive Order to Reduce Prescription Drug Shortages
Posted in Clinical Trials & Research/FDA, Health Care Reform, Pharma & Medical Devices, UncategorizedWritten by Brian Platton On October 31, 2011, President Obama signed and released an Executive Order directing the FDA and the Department of Justice to take actions designed to reduce prescription drug shortages, protect consumers, and prevent price gouging regarding certain prescription drugs. http://www.c-span.org/uploadedfiles/Content/Documents/wh103111_prescription-drug-order.pdf This Executive Order directs the FDA to expand and help expedite… Continue Reading
Will the Supreme Court Weigh In? Implied Certification Theory Under the False Claims Act
Posted in Fraud & Abuse, Pharma & Medical Devices, State & Federal Audits, Investigations & LitigationCan a factually accurate claim submitted to the government for payment be “false or fraudulent” under the False Claims Act (FCA)? For many years, federal courts have grappled with the issue, as discussed in a Mintz Levin client advisory that I recently co-authored with Tom Crane. Under a legal fiction called implied certification theory, a claim can be… Continue Reading
OIG Advisory Opinion 11-15 Nixes Laboratory Management Services Joint Venture
Posted in Clinical Laboratories, Fraud & Abuse, Pharma & Medical DevicesIn an Advisory Opinion long awaited by many in laboratory industry, the OIG concluded that a proposed arrangement that would have allowed physicians to profit from their own referrals for anatomic pathology services would “pose more than a minimal risk of fraud and abuse.” The American Clinical Laboratory Association and other industry organizations have been… Continue Reading
Manufacturers Still in the Dark About the Sunshine Act
Posted in Health Care Reform, Pharma & Medical DevicesManufacturers of pharmaceuticals, devices, and biological or medical supplies are well aware of an impending January 1, 2012 deadline to start collecting information for reports mandated by the federal “Physician Payments Sunshine Act,” which was part of health care reform legislation. But the Centers for Medicare & Medicaid Services (“CMS“) recently missed its October 1st deadline… Continue Reading
Will Congress Unite on PDUFA Reform Legislation?
Posted in Pharma & Medical DevicesWritten by Kevin Kappel The Prescription Drug User Fee Act (PDUFA), which provides the framework for the regulation of pharmaceuticals and raises fees to help ensure timely and safe oversight of pharmaceuticals, is due for reauthorization, and Committees in both Chambers of Congress have already held hearings. In addition, the FDA is actively engaging stakeholders on a draft framework for the… Continue Reading
