Volume 2, Issue 4, October 2006



In this issue of the MDMA Quarterly Review:

-  CMS Issues Revised CED Guidance and IPPS Final Rule

– Hospital Group Purchasing Organization (GPO) Scrutiny Continues in NY Times

– Gainsharing Demonstrations Announced by CMS

– Small Business Innovation Research (SBIR) Grants

– Leadership in Washington

– MDMA Holds Two Successful Workshops in California

– MDMA’s 9th Annual Coverage and Reimbursement Conference



On July 12th, the Centers for Medicare and Medicaid Services (CMS) released the long-awaited revised guidance document on Coverage with Evidence Development (CED). The guidance clarifies particular applications of CED as well as the legal bases for incorporating CED into the larger National Coverage Determination (NCD) process. In particular, the revision identifies two sub-types of CED, including (1) coverage conditioned on specific data collection to ensure patients are receiving care consistent with the parameters of the NCD (referred to as Coverage with Appropriateness Determination (CAD)), and (2) coverage conditioned on patient participation in a clinical study (referred to as Coverage with Study Participation (CSP)). MDMA remains concerned that additional data collection requirements may be an impediment to the diffusion of new medical technology and we submitted comments strongly emphasizing that CMS must collect, aggregate and disclose research data collected through CED in a manner that minimizes the burden on patients, providers and manufacturers.


To read MDMA’s comment letter, please click here.

On August 1st, CMS released the hospital inpatient final rule and industry was pleased that the final rule scaled back some of the changes that CMS had put forward in the proposed rule.  The final rule seeks to phase in the revised methodology tempering the short- and long-term impact of the changes, and specifically acknowledges MDMA’s concern that procedure complexity as well as patient severity must each be represented in the eventual revised DRG system.  MDMA looks forward to collaborating with CMS as the agency works toward an enhanced DRG system.

Click here to read the IPPS Final Rule and click here to read CMS’s press release.



The New York Times ran a front-page story in July about hospital executives who received tens of thousands of dollars for advising companies on how to sell their products to hospitals. These hospital executives belong to the Healthcare Research and Development Institute (HRDI), a for-profit company owned by three dozen hospital executives, but underwritten by forty or so of its handpicked corporate members, all suppliers to hospitals. The story included mention of MDMA’s efforts to reform the GPO industry. The NY Times also noted Connecticut Attorney General Richard Blumenthal’s ongoing investigation into whether HRDI allows certain vendors to buy access to hospital leaders who are in a position to influence what supplies or services their institutions purchase. To read the entire article, please click here.



In September, CMS published solicitations for two gainsharing demonstration projects:
The Physician-Hospital Collaboration Demonstration, September 8th.

The Medicare Hospital Gainsharing Demonstration, September 14th.

While MDMA is pleased that CMS is taking a broader approach to gainsharing that focuses on quality and process improvements, we remain concerned that if not properly structured, the demonstrations will adversely impact patient care and innovation. MDMA continues work with CMS to ensure that these programs focus on quality and do not provide perverse incentives to physicians to use a particular brand of product or to limit appropriate care.



In July, the Senate Small Business and Entrepreneurship Committee approved the Small Business Administration reauthorization bill including the Bond amendment which will allow majority ventured back companies to participate in up to 25 percent of the total SBIR Program. Although the bill is stalled in the Senate, MDMA hopes that the Congress will address this issue in the lame duck session when it reconvenes in mid-November. MDMA has been working in collaboration with other associations to restore eligibility of small business concerns that are owned in majority part by venture capital companies and we were pleased with this compromise language.


                

The Medical Device Manufacturers  

Association (MDMA) is a national trade association based in Washington, D.C. that represents independent manufacturers of medical devices, diagnostic products and health care information systems.

MDMA seeks to improve the quality of patient care by encouraging the development of new medical technology and fostering the availability of beneficial innovative products.

We invite you to learn more about the many challenging issues facing the entrepreneurial sector of the medical technology industry, and the value of MDMA membership.

                   Email Erin Jones,

           MDMA's membership director:
            ejones at medicaldevices.org

       

 

In September, Dr. Mark B. McClellan announced his resignation as CMS Administrator. Dr. McClellan began serving as CMS Administrator in 2004 and prior to that served as FDA Commissioner. Leslie Norwalk, previously deputy administrator, has been named acting Administrator.

Click here to read more about the resignation.

Dr. Andrew von Eschenbach’s nomination to become the next Commissioner of the Food and Drug Administration (FDA) stalled in September. While the Senate Health Education Labor and Pensions Committee approved Dr. von Eschenbach’s nomination, two Republican Senators have placed a hold on a full Senate confirmation vote. Until this issue is resolved, Dr. von Eschenbach will continue to serve as acting Commissioner.

MDMA in cooperation with MDMA, in cooperation with CHI, BIOCOM, and Latham & Watkins LLP, held a Premarket Approval (PMA) and 510(k) Premarket Notification Workshop in San Diego, California, on September 28, 2006. Attendees learned the regulations governing 510(k) and PMA premarket submissions from leading FDA attorneys, industry representatives, and FDA officials. This workshop was designed to help companies understand the technical requirements of submissions, provide practical advice on how to prepare them, and help manage and maximize communications with FDA.

Also in September, MDMA, in cooperation with Vector Resources, LC and the Southern California Biomedical Council (SCBC), held a product commercialization workshop in Los Angeles on September 14, 2006. Participants interacted with leading healthcare executives who shared their real-world experience in successfully executing a wide range of product commercialization approaches. Attendees learned more than six proven strategies for the commercialization of medical devices, as well as discussed the ones best suited for various types of products and companies. Click here to read more.



This Fall, MDMA will host its 9th Annual Coverage, Reimbursement and Health Policy Conference in Washington, DC. This conference offers an opportunity to hear from leaders in Medicare policy, including senior CMS officials, Congressional staffers, and reimbursement consultants. Through presentations and interactive sessions, attendees will learn about evolving challenges in evidence requirements, how new legislation is affecting reimbursement, and strategies for obtaining speedy, adequate reimbursement for new technologies.
Click here to register online.