Category Archives: Update from D.C.

Congressional Research Service Reports on Medical Device User Fee

The Congressional Research Service (CRS) issued a report describing current medical device user fees law, the impact of Medical Device User Fees Act (MDUFA) on FDA review time of various medical device applications and the agency’s medical device program budget, the MDUFA III proposal (legislative language and performance goals agreement), and issues that Congress is likely to take up as it works on the reauthorization of the medical device user fee program.

The report can be found here.

05/01/12: FDA warns hi HealthInnovations of illegal online hearing test

In a March 28th letter, an FDA official informed the CEO of hi HealthInnovations that the Online Hearing Test was operating without marketing approval or clearance from the FDA and was therefore illegal.  He advised them to immediately remove the Online Hearing Test until a new 510(k) application has been submitted and approved by the FDA.

hi HealthInnovations removed the Online Hearing Test.

ENT Today reported on the story…More.

02/09/2012: The Architectural and Transportation Barriers Compliance Board (Access Board) released proposed rules for accessibility standards for medical diagnostic equipment

The Architectural and Transportation Barriers Compliance Board (Access Board) is proposing accessibility standards for medical diagnostic equipment. The proposed standards contain minimum technical criteria to ensure that medical diagnostic equipment, including examination tables, examination chairs, weight scales, mammography equipment, and other imaging equipment used by health care providers for diagnostic purposes are accessible to and usable by individuals with disabilities.

The standards will allow independent entry to, use of, and exit from the equipment by individuals with disabilities to the maximum extent possible. The standards do not impose any mandatory requirements on health care providers or medical device manufacturers. However, other agencies, referred to as an enforcing authority in the standards, may issue regulations or adopt policies that require health care providers subject to their jurisdiction to acquire accessible medical diagnostic equipment that conforms to the standards.

Full text is linked here:

02/07/2012: Senate HELP Committee holds hearing on challenges and opportunities for accessible technologies

On Tuesday, February 7, the Senate Health, Education, Labor and Pensions (HELP) committee held a hearing to discuss the impact of technology in education and its accessibility for people with disabilities. This was the latest in a series of hearings that explore issues that impact the employment prospects for Americans with disabilities. The HELP committee’s overall goal for these hearings is to boost labor force participation for people with disabilities. This hearing focused on education, accessible technology and universal design.

The executive director of the National Federation of the Blind, Mark Riccobono, testified before Senator Tom Harkin on the importance of accessible technology used in K-12 and postsecondary educational institutions to the blind and to other students with disabilities, and was supported by the presence of over 100 members of his organization. Testimonies were also hear from:

  • Eve Hill , Senior Counselor to the Assistant Attorney General, Civil Rights Division, Department of Justice, Washington,
  • Dr. John B. Quick , Superintendent, Bartholomew Consolidated School Corporation, Columbus, IN, and
  • Mark Turner, M.A , Director, Center for Accessible Media, Accessible Technology Initiative, California State University, Long Beach, CA

The main conclusion of the hearing were that technology is being created with accessibility in mind. Therefore, they suggest there be federal oversight on the manufacturing of accessible technologies to ensure the devices are being created accessible rather than “retro-fitted”. Additionally, curricula must be created to make the use of technology accessible to all, such as using a large array of ways to present the information to students. Finally, there should be improved protections against inaccessible technology in education.

Watch the full hearing and read the testimonies here.

02/06/2012: CMS delays the demonstration project for prior authorization of power mobility devices until June 1, 2012

CMS announced this month that the agency will implement the Prior Authorization of Power Mobility Devices (PMD) Demonstration on or after June 1, 2012. CMS first announced last November that it would implement the PMD demonstration starting January 1, 2012, but decided to delay implementation after numerous groups (including the ITEM Coalition) expressed concerns with the process.
In response to comments received from stakeholders, CMS has made a number of modifications to the Prior Authorization of PMD demonstrations:

•CMS has completed a separate Paperwork Reduction Act (PRA) notification for this demonstration and the Recovery Audit Prepayment Review demonstration.
•CMS has removed the 100% Pre-Payment review phase (formerly Phase 1), which was our most immediate concern. The ITEM Coalition believes this process could have caused unnecessary disruption in access to mobility devices for Medicare beneficiaries with disabilities and chronic conditions.
•CMS will allow suppliers to perform the administrative function of submitting the prior authorization request on behalf of the physician/ treating practitioner.
•This demonstration will begin only after an OMB PRA control number is obtained. CMS anticipates the start of this demonstration will be on or after June 1, 2012.

For more information about these modifications see the CMS demo site.

CMS intends to conduct extensive education and outreach before and during the demonstration to clarify all demonstration requirements to ordering physicians, practitioners, suppliers and beneficiaries. The ITEM Coalition will keep its members updated on the opportunities for stakeholder outreach.