Q Review Volume 4, Issue 3 - July 2008

Top News


Congress Delays Medicare Competitive Bidding Program for DME
Congress sustained legislation this July to prevent anticipated reductions in Medicare payments to physicians while delaying implementation of the controversial competitive bidding program. Congress eventually secured votes to ensure passage of the bill as well as enough votes to overturn a veto. As speculated, the President vetoed the measure because of his opposition to cuts to the Medicare Advantage program.

The measure includes several provisions of interest to device manufacturers. First, the bill includes a delay in implementation of the competitive bidding program for durable medical equipment (DME). MDMA, and many other stakeholders, have voiced concerned that the program has been wrought with significant administrative problems which have caused many small medical suppliers to be unfairly excluded from the bidding process. The provision in H.R. 6331 would delay the first round of bidding for a period of 18 to 24 months. The second round would be delayed until 2011. Bids for the first round will need to be resubmitted. The legislation also creates an ombudsman of the competitive bidding process to allow bidders to communicate problems or unfair practices. The delay in the program would be offset by a 9.5 percent reduction nationally to the 10 categories of DME included in the first round of the bidding process.

An additional important provision in the legislation includes new accreditation requirements for providers of diagnostic imaging. The related provisions in H.R. 6331 would specifically mandate providers to be accredited by January 1, 2012 in order to be eligible for the technical component of Medicare payments specifically designated for imaging services.

The bill prevents cuts for Medicare payments for a period of 18 months.



MDMA Testifies Before Congress Expressing Concerns with FDA Globalization Act
Kelvyn Cullimore, President and CEO of Dynatronics, Inc. and MDMA Executive Board Member, testified in May 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 continues working to education Members of Congress and Committee staff about the potentially harmful consequences that the legislation will have on patient access to innovative, medical technologies.
Read MDMA’s complete testimony


 

Other News

CMS Releases Inpatient Payment System Proposal; MDMA Comments
MDMA submitted comments 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 is currently drafting comment letters to CMS on proposed rules for the Outpatient Prospective Payment System and the Medicare Physician Fee Schedule.
MDMA’s IPPS Comment Letter


MDMA Holds Successful Annual Meeting
In June, MDMA held its Annual Meeting in Washington, DC. Attendees heard from a broad range of policymakers and key opinion leaders in the medical device arena, including Former HHS Secretary Tommy Thompson, CDRH Director of Device Evaluation Donna Bea Tillman, and CMS Director of Coverage and Analysis, Steve Phurrough. In addition to numerous panels, attendees also participated in a Congressional Fly-In, meeting with their Congressional Representatives and Senators to inform them about the policy issues facing medical technology companies.
Read Annual Meeting highlights and view photos

 


CMS Announces Demonstration Plan to Bundle Hospital Payments
The Centers for Medicare and Medicaid Services (CMS) announced that it will begin a demonstration project to test the use of bundled payments for both physician and hospital services. The demonstration will apply to select episodes of care in the inpatient setting. Currently, during a hospital stay, services are paid under both a set amount under the Inpatient Prospective Payment System for hospital services and under the Physician Fee Schedule for physician services. The select sets of procedures included in the bundled payment demonstration are 28 cardiac and 9 orthopedic inpatient surgical services. The demonstration project will take place in Texas, Oklahoma, New Mexico, and Colorado.

MDMA will monitor the implementation of the demonstration project to ensure that innovative medical technologies are appropriately reimbursed under any potential modification to the existing payment systems.
More information




Congress Provides FDA with an Additional $150M in Appropriations
In June, Congress approved a supplemental appropriations bill which includes additional funds for the Food and Drug Administration. Specifically, the Agency received $150 million in additional funding for Fiscal Year 2008. The Centers for Devices and Radiological Health received slightly more than $20 million in additional funding for the remainder of the fiscal year.

 


Waxman, Pallone Introduce Preemption Legislation
Congressman Henry Waxman (D-CA) and Frank Pallone (D-NJ) introduced legislation to overturn the federal preemption decision by the Supreme Court in Riegel v. Medtronic. In that case, the Court ruled that the federal PMA approval process preempted state statues in determining the safety and effectiveness of medical technologies.

MDMA filed an amicus curiae brief with the Court in support of preemption. MDMA continues to believe that FDA approval process, as intended by Congress, should determine the safety and effectiveness of medical devices. The Waxman-Pallone legislation would open up the regulatory process to multiple state entities, leading to inconsistent product indications and labeling. The legislation would also prohibit patient access to innovative and life-saving medical technologies.
The Medical Device Safety Act of 2008
 



New CMS-FDA Initiatives Hopes to Provide Post-Market Information in Real Time
A new joint initiative between the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA) would allow for greater collaboration between the two agencies 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. The database stems from recommendations from a 2006 Institute of Medicine report in addition to requirements in the 2007 Food and Drug Administration Amendments Act.
More Information