The Office of Inspector General (OIG) of the Department of Health Human Services (HHS) is seeking input on Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP. The OIG describes this request for information (RFI) as part of HHS’s endeavor “to transform the health … Continue Reading
As covered in “Court Overturns $350 Million Judgment in FCA Case: Materiality, Scienter, and Causation Standards Preclude Liability by “’Zaps, Traps, and Zingers’”, Andy Bernasconi discusses a recent case, in which the Middle District of Florida issued a blistering opinion vacating a $350 million judgment in a False Claims Act (FCA) case and granting the … Continue Reading
Last month, Lindsey provided readers of the Drug and Device Law blog with an overview of United Health Services, Inc. v. U.S. ex rel. Escobar, a False Claims Act (FCA) case that was bringing the implied certification theory of FCA liability before the U.S. Supreme Court for review. The FCA imposes liability on anyone who knowingly … Continue Reading
We’ve covered the French Sunshine Act, which requires French pharmaceutical companies to disclose their links to healthcare providers, extensively over the past few years and most recently here. France on the whole, however, has been lagging behind many other countries when it comes to anti-corruption laws. It looks like that’s about to change in ways … Continue Reading
The HITECH Act—including the HITECH Final Rule’s provisions about HIPAA, data privacy, security, and breach notification—is an issue we have covered in detail previously. According to a June 17, 2015 press release, the former CFO of the Shelby Regional Medical Center in Texas has pleaded guilty to making a false statement in “representing that the … Continue Reading
Reed Smith’s Global Regulatory Enforcement Law Blog features a post on a recent decision by the French Supreme Administrative Court (Conseil d’Etat) that expands the scope of the French Sunshine Act. “French Supreme Administrative Court Decision Significantly Broadens the Scope of the French Sunshine Act,” written by Reed Smith attorneys Daniel Kadar and Caroline Gouraud, … Continue Reading
The number of qui tam actions brought under the False Claims Act (FCA) has increased over the past several years. There are now more opportunities for potential allegations of FCA violations on the part of health care providers, and more eligible whistleblowers to bring those alleged violations to the government's attention. Given these circumstances, providers should take time to assess their current insurance coverage for defending and resolving FCA claims.… Continue Reading
The Office of Inspector General (OIG) of the Department of Health and Human Services published a major proposed rule on October 3, 2014 amending the Anti-Kickback Statute (AKS) safe harbors and the Civil Monetary Penalty (CMP) rules to protect a number of payment practices not previously allowed under those regulations. The proposed rule and the … Continue Reading
The Office of Inspector General (OIG) of the Department of Health & Human Services issued a Special Advisory Bulletin (SAB) on September 19, 2014 discussing the coupon programs employed by many pharmaceutical manufacturers to reduce or entirely eliminate patient copayments to obtain brand-name drugs. As mentioned on our Health Industry Washington Watch blog, the SAB … Continue Reading
In “From Sea to Shining Sea: French and US Sunshine Laws,” (Law360 subscription required), Reed Smith attorneys Elizabeth Carder-Thompson and Daniel Kadar discuss recent legislation from both sides of the Atlantic designed to increase the transparency of relationships between drug and medical device manufacturers on one hand and physicians and teaching hospitals on the other. … Continue Reading
Patient Assistance Programs (PAPs) provide important help to patients of limited means who do not have insurance coverage for drugs and need assistance covering drug costs, often for chronic illnesses. The Office of the Inspector General (OIG) of the Department of Health and Human Services has now issued an advisory bulletin, dated May 21, 2014, … Continue Reading
The Office of Inspector General (OIG) of the Department of Health and Human Services has issued a proposed rule that would institute several changes to the health care program civil monetary penalty (CMP) regulations. Under the proposed rule, the OIG would have the expanded authority to enforce significant CMPs on providers and suppliers in a variety of scenarios.
Reed Smith has prepared a Client Alert summarizing and analyzing the Proposed Rule, including the various scenarios under which CMPs could be issued under the proposed regulations as well as the changes in technical language proposed by OIG to more clearly define the scope of CMP regulations.… Continue Reading
The Office of Inspector General (OIG) of the Department of Health and Human Services identifies the underlying purpose of its exclusion authority as to protect federal health care programs and their beneficiaries from "untrustworthy health care providers, i.e., individuals and entities who pose a risk to program beneficiaries or the integrity of these programs." The OIG now has published a new proposed rule that would greatly expand the bases upon which it could affirmatively exclude an individual or entity from participation in federal health care programs.
Reed Smith has prepared a Client Alert that provides an overview of the Proposed Rule, including: proposed revisions to definitions; new grounds for exclusion; clarifications to existing regulations to add mitigating and aggravating factors; early reinstatement procedures; and proposed procedural changes in the OIG's exclusion authorities.… Continue Reading
This past year both the U.S. and France enacted substantial new reporting and disclosure requirements under their respective Sunshine Acts, which were designed to increase the transparency of the financial relationships between manufacturers and health care professionals and to allow patients to make more informed decisions regarding their health treatments. The U.S. and French Sunshine … Continue Reading
We have been reporting for some time on issues involving the Office of the Inspector General (OIG) scrutiny of physician-owned distributors (PODs). In March 2013, we analyzed an OIG Special Fraud Alert on PODs and in October we reported on an interesting challenge to the Fraud Alert filed by a medical device manufacturer in the U.S. District Court for the Central District of California. That suit argued that the Fraud Alert unfairly and unconstitutionally burdened the plaintiff's First Amendment rights of free speech and due process. In this post, we report on the disposition of that case, and several other related POD developments.… Continue Reading
The regulatory enforcement environment in China remains tense, as both the Chinese government and media bring new actions and allegations against life sciences manufacturers in both the pharmaceutical and device sectors. We are seeing: Increased attention to medical device sector Enforcement actions spreading to smaller cities Continued pressure on pharmaceutical sector Reports of misconduct by … Continue Reading
Reed Smith’s Global Regulatory Enforcement Law blog features a post on the recent publication of the application decree to the “French Sunshine Act” by the French Ministry of Health. “A Brave New World? The ‘French Sunshine Act’ imposes online disclosure of contracts with HCPs, as well as of payments of ‘advantages’ to HCPs, dating back … Continue Reading
In preparation for data collection to begin under the Physician Payment Sunshine Act Final Rule on August 1, 2013, the Centers for Medicare & Medicaid Services (CMS) released yesterday the list of teaching hospital covered recipients to which payments and other transfers of value must be reported by applicable drug and device manufacturers. The list, … Continue Reading
This post was also written by Scot T. Hasselman and Andrew C. Bernasconi. Yesterday the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would dramatically increase the potential reward to an individual who provides a tip leading to the recovery of Medicare funds from a current maximum of $1,000 to a … Continue Reading
On February 1, 2013, the Centers for Medicare & Medicaid Services released the long-awaited final rule implementing the physician payment transparency provisions, commonly referred to as the Physician Payment Sunshine Act, in the Obama administration’s 2010 health care reform legislation. The Sunshine Act joins the list of significant federal laws addressing potential conflicts of interest … Continue Reading
On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) of the Department of Health and Human Services (HHS) released the long-awaited Final Rule to implement the “Sunshine” provisions of the Affordable Care Act of 2010 (ACA). The Sunshine provisions – intended to provide increased transparency on the scope and nature of financial … Continue Reading
This post was written by Mark S. Hersh and Paul E. Breene. Government investigations can be both time-consuming and hugely expensive. Earlier this year, the U.S. Department of Justice and the U.S. Department of Health and Human Services announced that its 2011 health care fraud prevention and enforcement efforts resulted in record-breaking recoveries totaling more … Continue Reading
This post was also written by Thomas W. Greeson. Providers and suppliers have until April 16, 2012 to comment on the proposed rule to implement provisions of Section 6402(a) of the Affordable Care Act that require “persons” receiving Medicare and Medicaid funds to report and return overpayments no later than 60 days after the date … Continue Reading
In yet another reminder about the importance of maintaining evidence on company-issued laptops, blackberries, or other electronic devices; the United States District Court for the Northern District of California recently sanctioned a qui tam relator for destroying more than 10,000 documents on his company-issued laptop. Moore v. Gilead Sciences, Inc., No. C 07-03850 SI, 2012 WL 669531 (N.D. Cal. Feb. 29, 2012).… Continue Reading
