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  • Regulatory NewsRegulatory News

    FDA, CMS Teaming up to Co-Regulate Lab-Developed Tests

    • 20 April 2015
    The US Food and Drug Administration (FDA) is teaming up with the US Centers for Medicare and Medicaid Services (CMS) to better regulate lab-developed tests (LDTs), which are currently overseen—haphazardly—by both agencies. Background The move is related to FDA's efforts late last year to regulate LDTs more similarly to traditional medical devices, and in particular in vitro diagnostics (IVDS). FDA has long maintained its authority to regulate LDTs, which are tests devel...
  • Regulatory NewsRegulatory News

    FDA Announces First-Ever Approval Under CMS Parallel Review Program

    The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have jointly approved the first-ever product through a parallel review pilot program that seeks to accelerate the process by which device products obtain government reimbursement decisions. Background The pilot program, known as Parallel Review , was conceived in October 2011 as a way to allow companies to get their products from an investigational stage to reimbursement ...
  • FDA-CMS Parallel Review Program Gets Expected Extension to Cover Medtronic, Other Devices

    In an expected announcement, the US Food and Drug Administration (FDA) and US Centers of Medicare and Medicaid Services (CMS) have announced they plan to extend and continue a pilot program first launched in 2011 to investigate how devices could close the gap between regulatory approval and reimbursement by payors. Background The pilot program, known as Parallel Review , was conceived in October 2011 as a way to allow companies to get their products from an investigati...
  • Feature ArticlesFeature Articles

    Sunshine Act Reporting: Research Payments and Requests for Delayed Publication

    On 8 February 2013, the US Centers for Medicare and Medicaid Services (CMS) issued its final rule on the reporting requirements for certain payments and other transfers of value under the Patient Protection and Affordable Care Act ( PPACA ), commonly referred to as the Physician Payment Sunshine Act ( Sunshine Act ). 1 The types of payments, identifying information and classifications for such payments and transfers are outlined in the final rule and require manufac...
  • Medtronic Renal Denervation Device Accepted for Joint FDA-CMS Review

    Medical device manufacturer Medtronic has announced that its Symplicity Renal Denervation System has been accepted under a relatively new program that will see the device concurrently reviewed by both the US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS). Background The pilot program, known as Parallel Review, was conceived in October 2011 as a way to allow companies to get their products from an investigational stage to reim...
  • Long-Awaited Sunshine Act Regulation Released

    • 04 February 2013
    The US Centers for Medicare and Medicaid Services (CMS) have released a long-awaited rule that would require all pharmaceutical, medical device and biopharmaceutical companies to report transfers of value to the US government in the hopes of increasing transparency. Background The rules, the Physician Payment Sunshine Act- better known as the Sunshine Act -are a core part of the 2010 Patient Protection and Affordable Care Act . Championed by Sens. Charles Grass...
  • Senator Calls--Again--for White House to Release Sunshine Act Rules

    A prominent senator is once again calling upon federal officials to pass a long-delayed rule regarding the transparency of payments made by companies to healthcare providers, saying the delays are "unacceptable." Sen. Charles Grassley (R-IA), is the ranking Republican member of the Senate Committee on the Judiciary, and along with former Sen. Herb Kohl (D-WI) sponsored and wrote the Physician Payments Sunshine Act (Sunshine Act), which eventually became part of the 201...
  • Sunshine Act Clears CMS Review, But Final Promulgation Could be Months Off

    • 29 November 2012
    Signs are emerging that a long-awaited landmark regulation governing the transparency of gifts given to medical practitioners by industry has entered its last clearance stage before final promulgation. The rule, Transparency Reports and Reporting of Physician Ownership of Investment Interests , is the direct result of the Patient Protection and Affordable Care Act (PPACA) -colloquially known as Obamacare-the seventh title of which contains the "Physicians Payment Suns...
  • Trade Associations Want Time Before Sunshine Act Begins

    • 29 August 2012
    The Centers for Medicare and Medicaid Services (CMS) is prepared to publish a final rule for the Physicians Payments Sunshine Act , but some trade associations are asking for more time before implementation of that rule. According to CMIO , four life science trade associations sent a letter to CMS, insisting sufficient notice be given before collection of data begins. They are asking for 180-day grace period after the final rule is released before reporting is required...
  • CMS Announces Planned Data Collection Under Sunshine Act Delayed Until 2013

    • 08 May 2012
    The US Centers for Medicare and Medicaid Services (CMS) announced 3 May it would postpone a planned data collection mandated by the Physician Payments Sunshine Act (PPSA) , saying it would not collect any information until 1 January 2013. CMS's 19 December 2011 proposed rule on Section 6002 or PPSA stipulated the agency would begin collecting data from manufacturers this year covering their payments, gifts and other forms of compensation given to physicians. The age...
  • CMS Coverage Decision Based on FDA Parallel Review Program

    A decision by the US Centers for Medicare & Medicaid Services (CMS) to cover transcatheter aortic valve replacement (TAVR) procedures for patients enrolled in Medicare is among the first under an October 2011 memorandum of understanding with the US Food and Drug Administration (FDA). "This decision is particularly important as it highlights cooperative efforts among CMS, FDA, the Agency for Healthcare Research and Quality, medical specialty societies and the medica...
  • New US Bioeconomy Blueprint Addresses Regulatory Hurdles for Drugs, Medical Devices

    The White House Office of Science and Technology (OST) released its National Bioeconomy Blueprint , which charts the course for the future development of bioscience research in the US and addresses numerous regulatory issues. The blueprint is described as a priority of the administration because of the "tremendous potential for growth and job creation." While basic research is an important aspect of the bioeconomy, said OST, regulatory issues are key drivers of ...