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MDMA and R-Squared Announce Partnership MDMA and R-Squared, an industry leader in compliance consulting and solutions, announced a new, multi-year partnership. R-Squared will serve as MDMA's preferred provider of Evidence-Based Compliance management systems, including programs that demonstrate best practices around financial relationships with, and tracking spending to, physicians and other referral sources. Press Release

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MDMA Chairman Joe Kiani, Chairman and CEO of Masimo Corporation, and MDMA Executive Director Mark B. Leahey are included in the “100 Notable People in the Medical Device Industry.” Read more

Congress Delays Medicare Competitive Bidding Program for DME
July 15, 2008 – With the override of the Presidential veto of the Medicare bill, Congress sustained legislation to prevent anticipated reductions in Medicare payments to physicians while delaying implementation of the controversial competitive bidding program. MDMA is pleased that Congress realized the problem structure of the competitive bidding program and the harm to patient access that was to likely occur as a result of implementation of the new reimbursement scheme.

MDMA Expresses Concern Over EU Recasting Initiative
July 2, 2008 - MDMA submitted comments to the European Commission expressing concerns with its medical device recasting initiative. MDMA’s comments reflect the consensus of leading European trade associations who share similar concerns about the detrimental impact of the proposal.
MDMA’s comment letter

MedPAC Agrees with MDMA to Implement Short-Term Fix for Charge Compression
June 19, 2008 - As part of MedPAC’s comment letter to CMS regarding the proposed inpatient prospective payment system (IPPS) rule, the advisory committee agreed with MDMA and other device stakeholders that CMS should implement a short-term fix to address the problems associated with charge compression. MedPAC specifically cited the use of a regression-based approach, as suggested in the 2007 RTI report commissioned by CMS, as the most appropriate approach to ensure adequate and timely payments for implantable devices.
MedPAC’s comment letter

MDMA Submits Comments on Proposed IPPS Rule
June 13, 2008 - MDMA submitted comments last week on the proposed Medicare Inpatient Prospective Payment System (IPPS) rule. In the rule, CMS addressed two key areas of concern for device manufacturers: charge compression and new technology add-on payments. MDMA commended CMS for addressing the issue of charge compression, whereby CMS proposes to create a separate cost center to dampen the price distortion caused by grouping higher cost devices with lower cost items. MDMA also urged CMS to take action to immediately address the problems associated with price distortion caused by charge compression. In addition, MDMA also commended CMS for taking positive steps in bringing greater clarity to the new technology add-on payment process.
MDMA’s comment letter

FDA Surveillance Will Not Burden Industry, According to Agency Official
May 30, 2008 - Thomas Gross, the Director of the FDA Centers for Device and Radiological Health, Division of Postmarket Surveillance announced that the new FDA postmarket surveillance system, the Sentinel Initiative will not place additional regulatory burdens upon the device industry. The Sentinel Initiative stems from the Food and Drug Administration Amendments Act of 2007 and would allow for greater collaboration between the FDA and CMS to monitor post-market adverse events. The initiative would focus on creating a database to track adverse events in real time by utilizing claims data from the Medicare prescription drug program for public health and safety research, quality initiatives, care coordination and other research and analysis. Gross cited that regulations for device approvals already in place will effectively monitor postmarket events.
More information

MDMA Testifies on FDA Globalization Act
May 14, 2008 - Kelvyn Cullimore, President & CEO of Dynatronics Corp. and MDMA Board Member, testified this week on the FDA Globalization Act. The hearing, held by the House Energy and Commerce, Subcommittee on Health, highlights the Committee’s efforts to move forward the legislation which would create additional user fees for manufactures and increase the number of pre-approval inspections in foreign and domestic facilities. Cullimore, on behalf of MDMA, expressed several concerns with the bill. Specifically, he cited that the legislation, as currently drafted, would compel manufacturers to pay additional and overly-burdensome user fees, despite the fact that the industry just recently agreed to double the amount of fees paid under the Food and Drug Administration Amendments Act of 2007. In addition, Cullimore argued that the legislation would also cause delays in access to innovative and life-saving medical technologies by requiring pre-approval inspections for products regardless of the level of risk posed.
MDMA's Complete Testimony

MDMA Submits Comments on FDA Reprint Guidance
April 21, 2008 -Today MDMA submitted comments to the FDA related to the distribution of medical or scientific journal articles and reference publications that involve off-label use of medical devices. Previously, Section 401 of the Food and Drug Administration Modernization Act set out guidelines that allowed the dissemination of information on unapproved uses of FDA-approved products. As long as the guidelines were met by the manufacturers, the dissemination of this type of information was not viewed by the FDA as evidence of an intent to promote the product for an unapproved or off-label use. However, Section 401 expired on Sept. 30, 2006.
MDMA's comments

CMS Releases Proposed Inpatient Rule
April 14, 2008 - The Centers for Medicare and Medicaid Services (CMS) released the proposed hospital Inpatient Prospective Payment System (“IPPS”) rule. As expected, CMS addressed several areas of concern to the medical device industry including, but not limited to, charge compression, new technology add-on payments, physician owned medical device companies and gainsharing.
More information on the rule

Proposed Patent Rules Exceed PTO’s Authority
April 7, 2008 - The US District Court for the Eastern District of Virginia granted GlaxoSmithKline a summary judgment in its challenge to the final rule on continuation applications issued by the PTO last August. In sum, the judge ruled that the proposed rules exceed PTO's statutory rule-making authority which does not extended to "substantive" rule-making. MDMA is pleased with the court's decision. It will ensure that innovators will be able to protect their IP in the medical technology field.
MDMA’s Comment Letter

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