q review Issue 4, Volume 1 - January 2008

Top Stories


GPO’s Under Fire in the New York Times
In November, the New York Times documented the case of Cynthia Fitzgerald, the former Novation employee who filed a qui tam claim against the GPO. The article focused on Ms. Fitzgerald’s current litigation and explored, in depth, her allegations against Novation, one of the largest GPOs. Specifically, Ms. Fitzgerald outlines how her former employee established a system where suppliers would pay excessive incentives in order to gain access to Novation’s network of hospitals. In addition, she described how these incentives and non-reported rebates were not accurately reflected in Novation hospital cost reports to Medicare.
Click here to read the complete article


Congress Passed Scaled-down Medicare Package
Congress passed a last minute Medicare package at the end of 2007 that was substantially scaled-down from what was initially speculated and proposed. Having to contend with a scheduled 10.1 percent reduction in Medicare payments to physicians, Congress enacted a temporary 6 month patch to ensure that the reductions would not go into effect. At the same time, the new law also increased payments by .5 percent. The Physician Sunshine Act and The Transparency in Medical Device Pricing Act were not included in the final package. It is widely speculated, however, that the bill’s supporters will likely reexamine the issues of pricing and transparency throughout 2008.

The package also provided for a temporary reauthorization of the SCHIP program until March, 2009. No major policy changes were made to this program.



Patent Reform Highlighted in NY Times
The patent debate received greater visibility in early 2008 with a prominent article in the New York Times. The author was careful to characterize the current debate as large high-tech companies versus a mix of industries including venture capital, high-tech entrepreneurs and other industries including pharmaceuticals. This is a significant departure in media exposure that in the past has characterized the debate as exclusively high-tech companies against the pharmaceutical industry exclusively
The patent reform debate is likely to move forward early in February, 2008 as the Senate is poised to take up the measure. MDMA continues to advocate for reasonable patent reform where innovative and entrepreneurism is not stifled in the medical device industry.
Click here to read the complete article.

To learn more about MDMA's position on patent reform, click here.



FDA Begins Interactive Review
As set forth by the Food and Drug Administration Amendments Act of 2007 (FDAAA), FDA published its interactive review guidance document for both industry and FDA Staff. The interactive review process is aims at enhancing the review of 510(k), PMA and BLA submissions to establish a framework for a more aggressive set of performance goals by enhancing and facilitating communication between FDA staff and industry during the review of submissions.
To read the FDA guidelines, click here.



MDMA Hosts 10th Annual Coverage, Reimbursement and Health Policy Conference
On November 12th and 13th, the Medical Device Manufacturers Association (MDMA) held its 10th annual Reimbursement and Health Care Policy Conference in Washington, DC. The Conference presented a unique opportunity for MDMA members and non-members to interact with some of the leading stakeholders and decision makers within the reimbursement arena. Participants were treated to several in-depth presentations on basic Medicare reimbursement concepts, the international reimbursement landscape, the role of private investment and venture capital in developing reimbursement strategies, and the role of private payers for medical devices. Presentations were presented by several notable figures in health care, including Dr. Barry Straube of CMS and Dr. Scott Gottlieb of the American Enterprise Institute.
Click here to read more.

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Other News


New Certification to Accompany Device Applications/Submissions
As a result of the FDAAA of 2007, a new certification is now required to be submitted to the clinical trials data bank (ClinicalTrials.gov), including expanded information on clinical trials and information on the results of clinical trials. Applicants must certify, at the time of an application or premarket notification submissions that they have complied with this new requirement.

The application process is ongoing and applications can be found on the FDA website.
Application


CMS Moves Forward with Expansion of Competitive Bidding Program
CMS announced an expansion of the competitive bidding program for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). The competitive bidding program is intended to reduce Medicare costs of high-volume products under DMEPOS. The program, already in place in 10 metropolitan statistical areas (MSA), is expanding to 70 nationwide. In addition, CMS announced an expansion of product categories open to the bidding process including, among others, oxygen equipment, power wheelchairs and hospitals.

MDMA continues to be concerned about the unintended consequences of the program that can limit beneficiary access to life-saving medical technology. MDMA will also encourage the implementation of safeguards to ensure that competitive
bidding does not harm small, innovative manufacturers.
Click here to read CMS's press release.


HHS Offers Suggestions for Value-Based Purchasing
The Department of Health and Human Services (HHS) delivered to Congress a Report on the Medicare Hospital Value-Based Purchasing Program (VBP). The report, mandated by Congress, provides suggestions on how Medicare can be a more prudent purchaser of higher quality health care for Medicare beneficiaries. Included in the report is a plan for all facets of the proposed Medicare Hospital VBP program. Under the VBP, a percentage of a hospital’s base operating payment for each discharge would be contingent on the hospital’s actual performance on a specific set of measures.
The complete report can be found here.

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Upcoming Events


MDMA Compliance Seminar:
Key Fraud & Abuse Issues Facing Medical Technology Companies
March 14, 2008
Washington, DC

The MDMA Compliance Seminar provides attendees with an overview of key fraud and abuse issues facing medical technology companies. Government, industry and legal experts discuss recent trends in sales and marketing enforcement activities in the US and abroad. Speakers also address implementing the MDMA Guidelines, the impact of ongoing state and federal litigation, and future trends in compliance activities.
View agenda