Life Science Update: December 2009

Medical Device Manufacturers Association

Senate Debates Health Care Reform, Conflict Delays Progress

The United States Senate began formal debate on H.R. 3590, the Patient Protection and Affordable Care Act (PPACA). Debate is expected to extend until before the Christmas holiday and remains uncertain whether the bill has enough momentum to pass. Democrats still face the challenge of obtaining the necessary 60 votes needed for passage. The PPACA contains several provisions of interest to device manufacturers including an annual $2 billion tax on the industry, physician sunshine, comparative effectiveness research, payment bundling and shared savings pilot programs, an extension of the gainsharing demonstration project, and the creation of a Medicare Commission.

MDMA is working closely with Senate staff to improve the device related provisions, including the device tax. While MDMA opposes the imposition of a new tax on the industry, it is becoming less likely that the tax will be excluded in its entirety. Therefore, we are also engaged in discussions to minimize the impact of the tax on our membership, if it is included in the final bill. Specifically, MDMA has been working with the National Venture Capital Association and other groups on an amendment that would exempt the first $100M in U.S. sales from any tax and U.S. sales from $100M-$150M would be taxed at half the rate. We are also seeking to delay the start date of the tax date until 2013 and make it deductible.


CMS Announces New-Technology Add-on Payment Town Hall Meeting

CMS announced that it will be holding a Town Hall Meeting on the Fiscal Year 2011 applications for new-technology add-on payments for the Inpatient Prospective Payment System. The new-technology add-on process is designed to ensure adequate payment for new medical services and technologies under the IPPS. In the past, MDMA has commented on the lack of clarity and guidance provided by CMS to companies who are applying for the add-on payments.

The meeting will be held on Wednesday, February 10, 2010 starting at 1:00 PM AM EST at CMS in Baltimore. In addition, CMS will hold an informational workshop on the new-tech add-on process beginning at 8:30 AM.

More information can be found here:
http://www.cms.hhs.gov/acuteinpatientpps/08_newtech.asp


GAO Looks at First Round of Competitive Bidding of Durable Medical Equipment

The Government Accountability Office released a report focusing on the first round of competitive bidding for durable medical equipment. The Centers for Medicare and Medicaid Systems is currently in the process of transitioning reimbursement for DME products to a competitive bidding model from a traditional fee schedule. However, the program and transition has been plagued with criticism. Among other things, the GAO report found that round 1 of the bidding process presented several problems to suppliers, including poor timing and lack of clarity in bid submission information, a failure to inform all suppliers that losing bids could be reviewed, and an inadequate electronic bid submission system.

Read the report:

http://www.gao.gov/new.items/d1027.pdf

Global Administrator | 12/16/2009 8:50:22 AM | 0 Comments