RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    Not Just Mylan: Misclassifications May Have Cost Medicaid More Than $1B

    The US Department of Health and Human Services' (HHS) Office of Inspector General (OIG) released a report this week finding that drugmakers may have caused the Medicaid program to lose out on $1.3 billion for 10 potentially misclassified drugs from 2012 to 2016. The release of the report follows a settlement between Mylan and the Department of Justice from August in which the drugmaker agreed to pay $465 million to settle claims relating to the misclassification ...
  • Feature ArticlesFeature Articles

    Medical Technology: Connecting Reimbursement and Regulatory for US Medical Devices

    This article discusses some basic US reimbursement concepts in the context of the regulatory function and the interplay of the two within the broader business strategy. Introduction Bringing new and innovative medical technologies to the US market has numerous challenges, including market identification, product development, regulatory and quality requirements, and demonstrating both clinical and economic effectiveness. In recent years, adequate reimbursement has beco...
  • Regulatory NewsRegulatory News

    Mylan Settles With DOJ for $465M Over EpiPen Medicaid Rebates

    Drugmaker Mylan announced on Thursday that it will pay $465 million to settle claims relating to the classification of EpiPen auto-injectors and EpiPen Jr. auto-injectors because of allegations of a misclassification of the product in the Medicaid Drug Rebate Program.  The government contended that Mylan improperly avoided paying Medicaid programs higher rebates for branded drugs by misclassifying EpiPen as a generic drug, even though EpiPen had no FDA-approved the...
  • Regulatory NewsRegulatory News

    Despite Industry Opposition, HHS to Fine Drug Companies for Overcharging Hospitals

    The US Department of Health and Human Services (HHS) on Thursday finalized a rule that would fine pharmaceutical companies for overcharging hospitals and clinics for drugs purchased under the 340B drug pricing program. The finalization of the rule, first proposed in 2010, follows fierce criticism of the plan from industry groups PhRMA, BIO and companies including Bayer and Teva. The final rule calls on drug companies to: calculate the 340B ceiling price on a quarterly...
  • Regulatory NewsRegulatory News

    Vermont Drug Price Transparency: New Law Calls Out Egregious Price Spikes

    Last June, Vermont Governor Peter Shumlin (D) signed into law a new pharmaceutical price transparency bill that sought to expose the companies and products seeing the largest price hikes. This month, Vermont released the first of the reports required under the law , calling into question price hikes from large brand name companies, including Amgen, Mylan, Abbott and Takeda, and generic drugmakers including Perrigo and a private company called Mutual Pharmaceutical Comp...
  • Regulatory NewsRegulatory News

    FDA and CMS Parallel Reviews of Devices to Continue

    A pilot program intended to reduce the time between clearance and Medicare coverage for innovative medical devices will continue on indefinitely, the US Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) announced on Friday. The program, known as parallel review, allows device makers to request a simultaneous, overlapping review by the two agencies with the goal of reducing the time between receiving a pre-market approval (PMA) or t...
  • Regulatory NewsRegulatory News

    Senators Grill CMS on Incorporating UDIs Into Insurance Claims Forms

    Senators Elizabeth Warren (D-MA) and Charles Grassley (R-IA) questioned the Centers for Medicare and Medicaid Services' (CMS) opposition to incorporating the unique device identifier (UDI) for medical devices into insurance claims forms. By not adding UDIs to insurance claims forms, Warren and Grassley warn that Medicare is making it more difficult to monitor device safety, which has resulted in millions of claims that could have been avoided with better monitoring. In ...
  • Regulatory NewsRegulatory News

    HHS Inspector General to Look Into Six FDA Programs in FY2016

    Over the next year, HHS’ Office of the Inspector General (OIG) plans to investigate the US Food and Drug Administration’s (FDA) requirements for post-marketing studies for new drugs, the exchange of information between drug supply chain partners and FDA’s oversight of networked medical devices in hospitals, as well as three other programs linked to the regulation of food and tobacco. Although the majority of OIG’s work is tied to the oversight of Medicare and Medicaid fu...
  • US Looking to Alternate Methods to Punish Drug Companies For Regulatory Non-Compliance

    US government officials are looking to clamp down on regulatory violations by the pharmaceutical industry-which has already paid $8 billion in fines over the last decade-by going after individuals within the companies more aggressively, reports USA Today. The US Department of Justice, in particular, is ramping up its use of the Park Doctrine-a legal doctrine that holds individuals within a company responsible for the actions of a company. Senator Chuck Grassley (R-IA) ...
  • Administration Budget Forcefully Against 'Pay-For-Delay,' Industry

    The Fiscal 2013 federal budget released on 13 February by the Obama administration laid out more than just the proposed spending levels for dozens of federal agencies, including the US Food and Drug Administration (FDA). Buried in the several-hundred page budget document are indications that the Obama administration intends to forcefully move against 'pay-for-delay' settlements that the Federal Trade Commission (FTC) considers to be "anticompetitive," biologic exclusivity...
  • DHHS Releases New Regulations on Medicaid Covered Outpatient Drugs

    The US Department of Health and Human Services (DHHS) released new draft regulations on Friday, 27 January that would implement portions of the Patient Protection and Affordable Care Act (PPACA) by revising reimbursement methodologies for outpatient drugs covered by Medicaid. Medicaid currently allows states to provide coverage of outpatient drugs to patients. Under the PPACA , DHHS is required to adjust the requirements for rebate agreements, drug pricing submission ...