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

  • Regulatory NewsRegulatory News

    Device Industry Backs Proposed Changes to Anti-Kickback Statute, Stark Law

    Device industry group AdvaMed on Wednesday pledged its support for proposed the Department of Health and Human Services (HHS) changes to modernize and clarify the regulations that interpret the physician self-referral law, known as the “Stark Law,” and the federal anti-kickback statute. In addition to addressing concerns that these laws unnecessarily limit the ways in which health care providers can coordinate care for patients, the proposed rule from HHS’ Office of th...
  • Regulatory NewsRegulatory News

    HHS OIG to CMS: Avoid Paying Twice for the Same Drugs

    The US Department of Health and Human Services (HHS) Office of Inspector General (OIG) on Tuesday issued a report calling on the Centers for Medicare & Medicaid Services (CMS) to “do more to avoid paying twice for the same drugs.” The OIG found that Medicare Part D paid for drugs during 2016 that hospices should have paid for under the Medicare Part A hospice benefit. “On the basis of our sample results, we estimated that the Part D total cost was $160.8 million for dru...
  • Regulatory NewsRegulatory News

    CMS Plots to Increase Breakthrough Device Payments

    The Centers for Medicare and Medicaid Services (CMS) late Tuesday proposed a new rule that would increase payments for medical devices designated by the US Food and Drug Administration (FDA) as breakthrough devices. CMS explains how at the time of approval for these devices with a breakthrough designation, real-world data on outcomes in different patient populations is often limited. So, it can be challenging for device firms to meet the requirement for demonstrating a ...
  • Regulatory NewsRegulatory News

    FDA, CMS, CDC Launch Task Force for Emergency Diagnostics

    Three US Department of Health and Human Services agencies announced Tuesday the launch of the Tri-Agency Task Force for Emergency Diagnostics (TTFED) to better respond to public health emergencies. With the distinct roles set for each of the agencies, TTFED is intended to leverage the expertise of the US Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) around the development...
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance to Help CMS With Coverage Decisions on Devices

    The US Food and Drug Administration (FDA) on Monday finalized guidance meant to assist the Centers for Medicare and Medicaid Services (CMS) in determining whether or not an investigational device should be reimbursed by CMS. The guidance, first drafted in June 2016, describes the process and information FDA uses to determine the appropriate classification for a device to be studied. "Importantly, the categorization paradigm has shifted from a more rigid approach ...
  • Regulatory NewsRegulatory News

    FDA, CMS: Second Parallel Review Decision Ever for NGS Test

    The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) on Thursday announced joint approval and coverage decisions for Foundation Medicine's FoundationOne CDx next generation sequencing (NGS) based test. The test was reviewed under FDA and CMS' parallel review program, and is only the second test to be approved and cleared under the program since its inception in 2011, the first being Exact Sciences' Cologuard colorectal cance...
  • Regulatory NewsRegulatory News

    CMS Shifts Coding and Payment Policy for Biosimilars Under Medicare Part B

    The Centers for Medicare and Medicaid Services (CMS) late Thursday announced that it would finalize a policy to separately code and pay for biosimilar products under Medicare Part B, signaling a win for industry. CMS said it is making the change as it was "persuaded that that there is a program need for assigning Part B biosimilar biological products into separate HCPCS [Healthcare Common Procedure Coding System] codes, specifically that this policy change will addr...
  • Regulatory NewsRegulatory News

    Abbvie, Amgen Deal on Humira Biosimilars Likely to Cost CMS More Than $1B

    Late last week, Amgen and AbbVie settled litigation over when competition for the world’s best-selling biologic Humira (adalimumab) will hit the market, and for the US, the settlement decided on 31 January 2023, while the EU will see competition 16 October 2018. The deal between the two companies means that AbbVie’s Humira, which was first approved by FDA in 2002 and accumulated sales of more than $130 billion in its first 15 years on the market, will be on the U...
  • 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

    2016 CMS Data on Industry Payments to US Physicians, Hospitals: Company Breakdowns

    The US Centers for Medicare and Medicaid Services (CMS) on Friday released 2016 data on more than $8 billion in payments (which is on par with 2015 data) made by 1,481 pharmaceutical, biotech and medical device companies to more than 600,000 physicians and 1,146 hospitals. In total, CMS calculated that $2.8 billion was spent on general payments and $4.36 billion on research payments.  In its breakdown of the numbers, CMS says that more than $1 billion in 2016 was s...
  • Regulatory NewsRegulatory News

    Congress Calls on HHS to Reverse Biosimilar Reimbursement Policy

    Sen. Pat Roberts (R-KS), and Reps. Joe Barton (R-TX) and Anna Eshoo (D-CA) as well as 52 other representatives and nine senators sent letters to Tom Price, Health & Human Services secretary, and Seema Verma, administrator for the Centers for Medicare & Medicaid Services (CMS) with concerns about the biosimilar reimbursement policy from a recently issued final rule. The final rule, issued by CMS on 30 October 2015, stipulates that each biosimilar of the same refere...
  • Regulatory NewsRegulatory News

    Theranos Agrees to Two Year Ban, Refunds Every Arizonan Who Purchased a Blood Test

    As part of an agreement reached with Arizona attorney general Mark Brnovich, the medical device startup Theranos on Tuesday agreed to pay $4.65 million for about 1.5 million blood tests sold to more than 175,000 Arizonans. The deal was forged after Theranos said it ultimately had to void or correct over 830,000 test results, which was about 11% of all results. A day earlier, Theranos announced it would settle with the federal Centers for Medicare & Medicaid Se...