Increased FDA/CMS Coordination: What it Means for Industry

is being presented by Dr. Edward E. Berger, Principal and Founder, with Larchmont Strategic Advisors and airs on Tuesday, April 12th, 2011. For more details, or to register please visit our site at www.fxconferences.com

Efforts to improve communications and coordination between FDA and CMS, including an initiative to implement a formal program for parallel review of new products by the two agencies, have sparked industry concern over the potential blurring of the heretofore bright line between the FDA’s market clearance function and CMS’ responsibility for Medicare coverage and payment determinations. This concern is compounded by the absence of established mechanisms at CMS for the safeguarding of company confidential information contained in regulatory submissions.

This audio conference presentation looks at the present status and likely outcomes of FDA/CMS interagency coordination efforts, and evaluates the opportunities as well as the threats posed by those efforts to developers of new therapeutics, devices and diagnostics.

Comparative Effectiveness Research: Threat or Opportunity?

is being presented by Dr. Edward E. Berger, Principal and Founder, of Larchmont Strategic Advisors and airs on Wednesday, September 22nd, 2010. For more details or to register, please visit our site at www.fxconferences.com

Comparative effectiveness research (CER), a prominent component of legislative and regulatory efforts to rationalize the use of health care resources, improve outcomes and constrain the explosive growth of health care spending, is widely perceived as a financial threat by medical technology and pharmaceutical companies. During the current healthcare reform debate, industry has supported stringent limits on payers’ use of CER results in an effort to minimize its impact. But CER also has the potential to define new market opportunities for existing technologies and to open new pathways for the introduction of innovative diagnostics and therapeutics. Opposition to CER initiatives may foreclose significant growth potential for industry.

This presentation explores how CER is likely to be implemented, analyzes the nature of the threat posed by CER to the commercial status quo, and evaluates the opportunities that a robust implementation of a CER program would create.

Medicare Coverage of Clinical Trials: Opportunities & Obstacles

is being presented by Dr. Edward Berger, Larchmont Strategic Advisors and airs on Wednesday, April 14, 2010. For more details or to register, please visit our site at www.fxconferences.com

Medicare can help companies defray the cost of drug and device clinical trials by paying for some services delivered to program beneficiaries enrolled in “qualified” trials. In considering whether to seek Medicare coverage, trial sponsors and clinical sites need to be aware of the administrative obstacles introduced by the need to comply with fraud and abuse regulations and the Secondary Payer Statute.

This conference provides a detailed review of Medicare’s clinical trial coverage policies, the different rules that apply to device (IDE) and pharmaceutical (IND) trials, and the compliance issues that complicate the decision to seek Medicare funding.

Comparative Effectiveness Research: Threat or Opportunity?

Comparative effectiveness research (CER), a prominent component of legislative and regulatory efforts to rationalize the use of health care resources, improve outcomes and constrain the explosive growth of health care spending, is widely perceived as a financial threat by medical technology and pharmaceutical companies. During the current healthcare reform debate, industry has supported stringent limits on payers’ use of CER results in an effort to minimize its impact. But CER also has the potential to define new market opportunities for existing technologies and to open new pathways for the introduction of innovative diagnostics and therapeutics. Opposition to CER initiatives may foreclose significant growth potential for industry.

This presentation explores how CER is likely to be implemented, analyzes the nature of the threat posed by CER to the commercial status quo, and evaluates the opportunities that a robust implementation of a CER program would create.

Comparative Effectiveness Research: Threat or Opportunity? is being presented by Dr. Edward E. Berger, Principal and Founder, Larchmont Strategic Advisors and airs on Thursday, December 3, 2009. For more details or to register, please visit our site at www.fxconferences.com

Medicare Coverage of Clinical Trials: Opportunities & Obstacles

Medicare can help companies defray the cost of drug and device clinical trials by paying for some services delivered to program beneficiaries enrolled in “qualified” trials. In considering whether to seek Medicare coverage, trial sponsors and clinical sites need to be aware of the administrative obstacles introduced by the need to comply with fraud and abuse regulations and the Secondary Payer Statute.

This conference provides a detailed review of Medicare’s clinical trial coverage policies, the different rules that apply to device (IDE) and pharmaceutical (IND) trials, and the compliance issues that complicate the decision to seek Medicare funding.

Medicare Coverage of Clinical Trials: Opportunities & Obstacles is being presented by Dr. Edward Berger, Principal, with Larchmont Strategic Advisors and airs on Tuesday, July 21, 2009. For more details or to register for this audio conference, please visit our site at www.fxconferences.com