In an advisory opinion posted on August 25, 2017, the Office of the Inspector General of the Department of Health and Human Services (“OIG”) determined that enforcement action would not be taken against a drug manufacturer’s proposal to replace products that require specialized handling that …
On August 21, 2017, the Health Resources and Services Administration (“HRSA”), the federal agency responsible for overseeing the 340B Drug Discount Program, published in the Federal Register a Notice of Proposed Rulemaking (“NPRM”) that would delay until July 1, 2018 the implementation of the Final …
Today the Health Resources and Services Administration (“HRSA”), the federal agency responsible for overseeing the 340B Drug Discount Program, published in the Federal Register a rule delaying until October 1, 2017 the implementation of a final regulation establishing the methodology for calculating the 340B ceiling …
A final regulation implementing the 340B Drug Discount Program has been caught in the regulatory freeze. In the waning days of the Obama Administration, the Health Resources and Services Administration (“HRSA”) of HHS issued a final regulation describing the methodology for calculating the 340B ceiling …
To complete our initial summaries (see here, here, and here) of the 21st Century Cures Act (Act), we want to highlight the three health care provisions included in Title IV – Delivery and Title V – Savings that we think are of most relevance to …
On December 7, 2016, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) published a Final Rule amending the safe harbor regulations under the Federal health care program antikickback statute (“AKS”) (42 U.S.C. § 1320a-7b(b)) and established exceptions to the Civil Monetary …
By Serra J. Schlanger – The Department of Health & Human Services Office of Inspector General (“HHS OIG”) recently released its work plan for fiscal year 2017. The annual work plan summarizes what HHS OIG plans to review during the upcoming year as part of its …
By Alan M. Kirschenbaum & David C. Gibbons – In separate actions implementing the Medicaid Drug Rebate Program (“MDRP”), CMS has delayed for three years the expansion of the MDRP to U.S. Territories, and issued a draft revised National Drug Rebate Agreement. Delay in Expansion to U.S. …
Technology continues to change the landscape of healthcare and companies are seeking new and innovative ways to leverage advances in other fields to improve quality of care and the diagnosis and treatment of disease. In doing so, they are required to navigate an increasingly complex …
By Serra J. Schlanger & Alan M. Kirschenbaum – We previously reported (here and here) on two opinions handed down by Judge Rya Zobel of the Federal District Court for the District of Massachusetts construing the discount safe harbor under the Federal health care program antikickback …
By Serra J. Schlanger & Alan M. Kirschenbaum – Judge Rya Zobel of the Federal District Court for the District of Massachusetts has dealt another blow to the Federal health care program antikickback statute (“AKS”) discount safe harbor, which drug and device manufacturers and their customers …
By Serra J. Schlanger & Alan M. Kirschenbaum – For 25 years, drug and device manufacturers and their customers have relied on the discount safe harbor under the Federal health care program antikickback statute (“AKS”) to protect procompetitive discount arrangements that save money for purchasers, patients, …
By Alan M. Kirschenbaum – Last October we reported on a proposed regulation published by the Texas Health and Human Services Commission (HHSC) to repeal a burdensome price reporting requirement for drug manufacturers under Texas Medicaid. HHSC has now finalized the proposed rule without change. See Texas …
By Anne K. Walsh – A drug or device company (or its officers, management, or employees) who are the target of a False Claims Act lawsuit or investigation face the potential threat of being excluded from Medicare, Medicaid, and other Federal health care programs. For a …
By Michelle L. Butler & and Alan M. Kirschenbaum – The Department of Veterans Affairs (VA) recently issued an Important Notice on its website regarding a change in policy with regard to covered drugs (drugs approved via new drug applications, including authorized generics, and biologics license …
