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Medical Device Blog – QA & Regulatory Updates from Emergo Group
As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That\'s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you\'ll enjoy the content.
US Government to Require Device Manufacturers to Disclose Payments to Doctors
The Obama Administration has announced plans to require medical device and pharmaceutical companies to report payments they make to US doctor and other health care providers for research, consulting and travel.
According to a recent New York Times report (tiered subscription required), the new rules are designed to tackle influence these payments have on doctors’ treatment decisions; payment from a medical device manufacturer to a doctor has the potential to make it likelier that that doctor will prescribe that manufacturer’s device instead of cheaper alternatives, evidence suggests.
The new rules will require companies with at least one product covered by Medicare or Medicaid to disclose all payments to doctors who are not their own employees. Payment data they provide will be published online.
Types of payments falling under these requirements include compensation for development, assessment or promotion of new products as well as royalty payments to inventors, payments to teaching hospitals for research and even “$25 worth of bagels and coffee to a doctor’s office for a meeting.” Companies’ chief executives, chief financial officers and/or chief compliance officers must attest to each report’s accuracy.
Administration officials believe more than 1,100 firms will be impacted by the new rules; failure to comply will incur penalties of up to $10,000 for each payment a firm fails to disclose. Knowingly failing to report payments will incur penalties of up to $100,000 per violation, capped at $1 million per year.
The Centers for Medicare & Medicaid Services (CMS) is accepting public comment on the rules through February 17th, after which final rules will be implemented.
Markets: USATags: CMS, Medicaid, medical device, Medicare, new york times
Author: Stewart EisenhartDate: January 23, 2012
New US Reimbursement Policy Targets Some Medical Devices
A new Centers for Medicare & Medicaid Services (CMS) policy going into effect early next year will require prior authorization for some medical devices and equipment for Medicare patients in seven US states.
The new policy will also require pre-payment of reimbursement claims for some medical devices across 11 US states.
These reimbursement policy changes are intended to cut down on improper payments.
According to a Massdevice analysis of the new CMS policy, the new prior authorization requirements target 15 procedures, including pacemaker and defibrillator surgeries, spinal fusion procedures and joint replacements. These requirements will be implemented in two phases: During the first three to nine months of 2012, Medicare administrators will conduct prepayment reviews of certain medical equipment claims, followed by outright implementation of prior authorization requirements.
The prior authorization policy will affect Medicare recipients in California, Florida, Illinois, Michigan, New York, North Carolina and Texas. Claim pre-payment requirements will impact California, Florida, Illinois, Louisiana, Michigan, Missouri, New York, North Carolina, Ohio, Pennsylvania and Texas.
Markets: USATags: CMS, Medicaid, medical device, Medicare, reimbursement, US
Author: Stewart EisenhartDate: December 6, 2011
US Device Manufacturers Feeling Price Pressure from Hospitals
Medical device manufacturers in the US market are reporting mounting pressure to lower product prices as clients such as hospital groups seek to lower procurement costs and stem operating losses.
According to a survey by hospital group purchasing organization Premier Inc. (via Dow Jones Newswire), hospitals have lost more than $1 billion due to high-cost medical devices and have indicated interest in purchasing lower-cost alternative products in the future.
In another Premier survey of hospital executives cited by the Dow Jones article, a majority of respondents reported plans to seek less expensive alternatives to brand-name medical devices that could provide similar or better clinical outcomes, potentially squeezing profits for top-tier manufacturers like Medtronic and Boston Scientific.
Hospitals’ 2010 losses stemmed from Medicare reimbursement shortfalls for cardiac and orthopedic procedures involving implantable medical devices, Premier reports; highest losses involved heart valve replacement and spinal fusion procedures. Manufacturers have traditionally relied on physician practices as clients for sales of cardiac and orthopedic devices, but hospital groups have bought up much of that client base in recent years.
In the Dow Jones story, analysts at Goldman Sachs and Mizuho Securities expressed caution regarding medical device industry growth next year in part due to Premier’s findings on hospital groups’ purchasing plans. But while cardiac and orthopedic device manufacturers may feel the most pressure to reduce prices, makers of lower-cost and commoditized medical devices and supplies should be much less impacted by hospital groups’ buying decisions.
Markets: USATags: FDA, Goldman Sachs, hospital groups, medical device, Medicare, Medtronic, Mizuho, reimbursement
Author: Stewart EisenhartDate: October 24, 2011
Parallel Review Pilot for Innovative Devices Launched by FDA and CMS
A parallel review pilot program newly deployed by the US FDA and the Centers for Medicare & Medicaid Services (CMS) could expedite the review process for some cutting-edge devices and make Medicare reimbursement requirements more transparent.
The program allows concurrent review of devices by both FDA and CMS staff, minimizing the time between FDA 510(k) clearance or approval and Medicare coverage decisions. Although FDA and Medicare reviews of medical devices are not identical, both agencies use clinical data to inform their decisions.
Devices qualifying for parallel review include:
- New technologies that have been granted a pre-investigational device exemption (IDE) or approved IDE application designation
- New technologies that would require either a supplemental application for premarket approval or a de novo petition
- New technologies falling within Part A or Part B Medicare categories that are not subject to national coverage decisions
The program is slated to last for up to two years, but will accept only three to five submissions per year. Assuming the program’s pilot phase proves successful, the agencies should seriously consider expanding access to the program to a wider variety of medical devices.
