Search Results for Coverage

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FDA Finalizes Guidance to Help CMS With Coverage Decisions on Devices By Zachary Brennan - Published 04 December 2017

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.

Categories: News, US, FDA, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: CMS coverage of medical devices, FDA guidance

Drug Reimbursement in Canada By George Wyatt, MBA - Published 01 September 2017

This article provides a high-level overview of the elements of prescription drug reimbursement in Canada and discusses the costs, processes and reimbursement plans associated with a number of federal health agencies and payers and describes some of the variety of drug plans in place.

Categories: Features, Canada, Health Canada, Biologics and biotechnology, Drugs, Reimbursement

Tags: Reimbursement, Coverage, Health Technology Assessment, HTA, Common Drug Review

Medical Technology: Connecting Reimbursement and Regulatory for US Medical Devices By Mark Domyahn - Published 21 August 2017

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.

Categories: Features, US, FDA, Medical Devices, Reimbursement

Tags: Reimbursement, Centers for Medicaid & Medicare Services, CMS, Payers, Coverage

NICE Joins FDA Program to Shorten Time Between Device Approval and Insurer Coverage By Zachary Brennan - Published 15 December 2016

The UK’s National Institute for Health and Care Excellence (NICE) on Wednesday announced that it would participate in the US Food and Drug Administration’s (FDA) Payer Communication Task Force (PCTF) to help speed patients’ access to new medical devices, diagnostics and other health-related technologies.

Categories: News, Europe, US, CDRH, NICE, Due Diligence, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy, Reimbursement

Tags: NICE, medical device insurer coverage, medical devices and approval

FDA and CMS Parallel Reviews of Devices to Continue By Michael Mezher - Published 21 October 2016

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.

Categories: News, US, FDA, Clinical, Medical Devices, Reimbursement, Submission and registration

Tags: Parallel review, National coverage determination, Centers for Medicare & Medicaid Services, CMS

FDA Looks to Bring Payers to the Table at Device Pre-submission Meetings By Michael Mezher - Published 23 February 2016

The US Food and Drug Administration (FDA) is calling on private health insurers and other payer groups that use clinical data to inform coverage decisions to participate in medical device pre-submission meetings to facilitate timelier access to new devices.

Categories: News, US, CDRH, Clinical, Communication, Medical Devices, Reimbursement, Submission and registration

Tags: Parallel Review Pilot Program, National Coverage Decision, NCD, Reimbursement

RAPS Switzerland Chapter to Host 2015 EU Medtech Reimbursement Roundtable By Zachary Brousseau - Published 04 June 2015

The elements of market access in Europe will be examined in depth at the 2015 EU Medtech Reimbursement Roundtable, taking place 25 June in Zurich, and hosted by the RAPS Switzerland Chapter.

Categories: HTML, Articles, Under RAPS, RAPS Events, Europe, Switzerland Chapter, RAPS, Medical Devices, Reimbursement

Tags: MedTech Roundtable, medtech, medical device, device, market access, reimbursement, pricing, coverage policy, Europe, EU

FDA Announces First-Ever Approval Under CMS Parallel Review Program By Alexander Gaffney, RAC - Published 12 August 2014

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.

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices, Reimbursement, Submission and registration

Tags: CMS, FDA CMS Pilot, Parallel Review, National Coverage Determination, NCD,

Germany: IQWiG Recommends Combination Rilpivirine for HIV By Louise Zornoza, RegLink - Published 06 July 2012

Categories: Regulatory Update

Tags: Coverage Decision, Reverse, IQWiG, Germany, HIV, HTA, CER

CMS Coverage Decision Based on FDA Parallel Review Program By Alexander Gaffney - Published 02 May 2012

Categories: FDA, Reimbursement

Tags: National Coverage Analysis, NCA, Edwards, Tavenner, TAVR, Medicare, Latest News, CMS, medical device

DHHS Releases New Regulations on Medicaid Covered Outpatient Drugs By Alexander Gaffney - Published 30 January 2012

Categories: Drugs, Reimbursement

Tags: Provider, Outpatient, Medicaid, Pharmaceuticals, Coverage, Latest News, DHHS, CMS

US Consumers Press For Experimental Drug Coverage By Alexander Gaffney - Published 24 January 2012

Categories: FDA

Tags: Harvard, Consumers, Experimental, Insurers, Coverage, Latest News, study

Canada’s Provincial Drug Formulary System By Thomas Wong and Gordon Jepson - Published 01 November 2011

Contrary to popular belief, the Canadian public healthcare system does not provide every resident with free prescription drug coverage and healthcare services. The truth is, Canada has a fairly comprehensive public healthcare system that covers some but not all drugs and services. In fact, prescription drug coverage is not available to the majority of Canadians under the public system and these individuals must either pay full price out of pocket or obtain private insurance.

Categories: Features, Canada

Tags: Coverage, Formulary, Provincial, drug