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Massachusetts Finalizes Regulations on Physician-Industry Relationships March 13, 2009 - Officials in Massachusetts gave final approval to a law which creates a new code of conduct governing interactions between healthcare practitioners and drug and device manufacturers.

The law places new regulations on the physician-manufacturer relationship by requiring disclosure on financial arrangements and limiting most forms of gifts. The regulations take effect July 1 of this year and the first company disclosure reports will be due on July 1, 2010. Read More

MDMA will hold a members only webinar on March 24th to discuss the impact of the new Massachusetts law. Register here

Patent Reform Legislation Introduced
March 4, 2009 - New legislation aimed at reforming the patent system was introduced in both chambers of Congress this week. The bills introduced in each house are comparatively similar, with several minor differences. The bill includes provisions that would dramatically alter the manner in which damages are awarded in infringement cases; a position MDMA and many other innovative industries do not support. More information

President Releases Budget Details February 27, 2009 - The President this week highlighted the need to reform the health care system in his first address to a joint session of Congress. In addition, the President also released his 2010 budget this week, which includes substantial increases in health care spending. Citing the need to provide health care coverage to every American, the President outlined a plan to reduce spending and increase tax revenues. Areas the President seeks to address related to health care include implementing a competitive bidding model for Medicare Advantage plans, continuing efforts towards comparative effectiveness, and increasing hospital payment bundles. Read more

CMS Panel Agrees with MDMA Recommendation February 20, 2009 - MDMA presented at the February 2009 Ambulatory Payment Classification (APC) Panel to provide recommendations on how to improve the outpatient payment system in Medicare and ensure that beneficiaries. The purpose of the APC Panel is to make recommendations to CMS on how to improve the overall payment system in the outpatient setting.

After reviewing MDMA’s presentation, the Panel voted to recommend a critical MDMA recommendation aimed at ensuring that CMS carefully review severe payment variations resulting in a 10 percent change or greater. CMS will now have to address this recommendation in its proposed rule making process.
To view MDMA’s comment letter, click here

Economic Stimulus Nears Completion February 13, 2009 - The economic stimulus package has passed both the House of Representatives and the U.S. Senate. Conferees from the two bodies have come to an agreement on a final legislation and the legislation appears to be heading towards final passage. The legislation includes $1.1 billion in appropriations to fund comparative effectiveness research through the Agency for Health Care Research and Quality and the National Institutes of Health. Early drafts of the legislation included references to cost consideration. However, MDMA and others were successful towards advocating that the comparative effectiveness language for on clinical comparisons. Read more


Daschle Withdraws from HHS Secretary Consideration February 6, 2009 - Former Senator Tom Daschle withdrew his nomination to be Secretary of Health and Human Services this week. The move comes in light of growing criticism regarding the Senator’s failure to pay back-taxes as well as other potential improprieties. The move leaves several unanswered questions including what the Senator’s departure means for healthcare reform, who will the President nominate next, and what implications the departure has for the selection a FDA Commissioner and CMS Administrator.

Other Recent Headlines

Lawmakers Propose FDA Inspections Bill

MDMA Holds Membership Webinar on 2009 Agenda

GAO Releases Report Validating Current 510(k) Review Process

Massachusetts Device Marketing Proposed Regulations Released

 

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