Medical Devices Today

Republicans Renew Push To Repeal Device Tax; Broad Support Questionable

Article preview from "The Gray Sheet" - January 31, 2011

Republicans in Congress introduced bills last week that would repeal the medical device excise tax before it takes effect in 2013, but few Democrats have jumped on board publicly so far.

Medtech Intellectual Property Highlights of 2009

Medtech Intellectual Property Highlights of 2009: Federal Circuit, USTPO and Beyond
By Jason R. Kraus and Brian W. Oberst Faegre & Benson

The past year heralded a number of events that could directly affect the way medtech companies do business. Among these are the Federal Circuit decision in Prometheus—which may shape the future of medical method claims—as well as possible policy shifts within the U.S. Patent and Trademark Office. The following is an overview of some significant legal, legislative and regulatory developments medtech companies will want to monitor in 2010. Read more...

Firms Budget For Device Tax In 2011, But Push For Further Delay

Full article reprinted from "The Gray Sheet" - January 18, 2010

Device makers are beginning to budget for a 2011 start date for a new tax on medical device sales, but that does not mean they have given up hope for a further delay of the tax. Read more...

Senate Approves Device Tax; Details Now Up To House-Senate Conferees

Breaking news story reprinted from "The Gray Sheet" - December 24, 2009

With the Senate passage of landmark health care reform legislation, it is all but inevitable that device companies will be facing a new government fee for the long term.

With Device Tax Seeming Inevitable, Groups Align On Small-Firm Protections

Full article reprinted from "The Gray Sheet" - December 14, 2009

Groups representing the device industry have aligned to push an amendment to the Senate health care reform bill to exempt more pre- and low-profit companies from the proposed $20 billion device tax. Read more...

House Bill Lowers Device Tax, But Offers No Break For Start-Ups

Article preview  reprinted from "The Gray Sheet" - November 2, 2009

The updated House health care reform bill includes a substantially reduced device industry excise tax compared to a Senate bill, but includes no exceptions for small businesses. Read more...

Combination Product Rules Clear OMB, To Be Released In Weeks

Article preview from "The Gray Sheet" - September 21, 2009

Two key proposed rules from FDA's Office of Combination Products have finally received Office of Management and Budget approval and should be out for comment in the coming weeks, according to OCP Director Thinh Nguyen. Read more...

Device Firms Dig In Against Baucus Fee, Despite Class I, Revenue Exceptions

Article preview reprinted from "The Gray Sheet" - September 21, 2009 The device industry lobbying machine has accelerated in opposition to Sen. Max Baucus' plan for a $40 billion fee on manufacturers in the lead up to Finance Committee health reform mark-up sessions this week. Read more...

Medicare Gainsharing Demos Still Have A Pulse, CMS Release Confirms

Article perview reprinted from "The Gray Sheet" - August 24, 2009

Two Medicare demonstration projects targeting the practice of hospital-physician gainsharing resurfaced in a CMS press release last week after a period of obscurity. Read more...

Labs, Test Makers To Finance Committee: Say "No" To Medicare Co-Pay

Full article reprinted from "The Gray Sheet" - August 10, 2009

Clinical laboratory stakeholders are trying to prevent a 20% Medicare lab co-payment provision from making it into the Senate Finance Committee's highly anticipated health care reform package. Read more...