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  • Regulatory NewsRegulatory News

    New House E&C Chairman to Consider Value-Based Drug Price Negotiations

    The newly minted chairman of the influential House Energy & Commerce Committee is looking to tackle pharmaceutical price gouging with a new bill and comments on how there need to be more negotiations to bring down prices. In an interview with The Oregonian this week, Rep. Greg Walden (R-OR), who attended Tuesday’s meeting with President Donald Trump and pharmaceutical CEOs , said: “Right now they're prevented from having those negotiations by law. We would fix that...
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    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...
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    Senate Democrats to Trump: Work With us to Lower Drug Prices

    Sens. Sherrod Brown (D-OH), Al Franken (D-MN) and 17 of their Democratic and Independent colleagues on Tuesday sent a letter to President-elect Donald Trump, urging him to combat the pharmaceutical industry’s “abusive tactics” that “price lifesaving drugs out of reach for those in need.” The senators lay out five actions to address the rise in pharmaceutical prices, including: Allowing the secretary of the Department of Health and Human Services to negotiate drug pric...
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    CMS Drops Medicare Part B Drug Payment Pilot

    The Centers for Medicare and Medicaid Services (CMS) late Thursday decided to abandon a pilot plan that aimed to lower Medicare pharmaceutical spending. The Part B Drug Payment Model , first unveiled in March, would have tested whether alternative drug payment designs will lead to a reduction in Medicare expenditures. CMS said in a statement on Friday to Focus : "After considering comments, CMS will not finalize the Medicare Part B Drug Payment Model during this Adm...
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    HHS Inspector General to Examine Medicaid Drug Rebate Program in Wake of EpiPen Fiasco

    In light of concerns over the misclassification of Mylan’s EpiPen and subsequent overcharging of the federal government for the life-saving allergy drug, the Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) late last week said it will review the Medicaid Drug Rebate Program. OIG’s review will examine the accuracy of Medicaid drug rebate classification data, the US Food and Drug Administration’s (FDA) approval status for drugs paid for by t...
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    CMS Updates Drug Pricing Dashboard, Calls for Affordable and Accessible Pharmaceuticals

    As the rising prices of pharmaceuticals continue to hurt Americans' pockets, the US Centers for Medicare & Medicaid Services (CMS) are using transparency to highlight some of the steepest price spikes that are costing Medicare and Medicaid the most. In order to provide a better sense of “the frequency and pervasiveness of these increases,” CMS’ acting administrator Andy Slavitt, chief data officer Niall Brennan and deputy chief of staff Tim Gronniger on Monday announced...
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    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...
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    What Drugs Really Cost: GAO Wants CMS to Find Out

    In order to help ensure the accuracy of Medicare Part B drug payment rates, the US Government Accountability Office (GAO) on Monday urged Congress to require all manufacturers of Part B drugs paid at average sales price (ASP) to submit sales price data to the Centers for Medicare & Medicaid Services (CMS). What’s more, GAO is calling on Congress to ensure that CMS has the authority to request source documentation to periodically validate drug companies’ pricing data, wh...
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    Democrats Call on Theranos CEO to Testify About Regulatory Shortcomings, Inaccurate Test Results

    A group of high-ranking House Democrats have launched an inquiry into blood testing startup Theranos over its adherence to clinical laboratory testing standards. Following inspections last year, the US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) each cited Theranos for a number of compliance issues. In a letter dated 30 June 2016, Reps. Frank Pallone (D-NJ), Gene Green (D-TX) and Diana DeGette (D-CO) call on Theranos CEO ...
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    FDA Draft Guidance to Assist CMS With IDE Coverage Decisions

    The US Food and Drug Administration (FDA) on Tuesday released new draft guidance to clarify difficulties in categorizing investigational medical devices for Medicare coverage, just two days before a memorandum of understanding is set to take effect between FDA and the Centers for Medicare and Medicaid Services (CMS). While an agreement has been in place between the two agencies for more than two decades, FDA says it has run into issues with some devices not easily fittin...
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    Pew: Insurance Claims Must Include UDIs to Track Device Safety

    The Pew Charitable Trusts says that adding unique device identifiers (UDIs) to insurance claims forms is critical to the success of several federal initiatives to improve medical device safety and patient care. Dr. Josh Rising, director of healthcare programs at Pew, told Focus on Wednesday about his organization's efforts to improve device surveillance and how incorporating UDIs into claims forms can aid those efforts. "The goal of Pew's medical device project is to ...
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    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 ...