Urging Swift Action, MITA Outlines 2021 Policy Priorities in Letter to President Biden and His Administration

Feb 1, 2021, 09:06 AM

Washington, D.C. The Medical Imaging & Technology Alliance (MITA), the leading organization and collective voice of medical imaging equipment, radiopharmaceutical, contrast media, and focused ultrasound device manufacturers, sent a letter to President Biden and his Administration outlining key MITA policies priorities for 2021. The letter also underscored the indispensable role of medical imaging technologies in supporting improved public health outcomes and delivering care to the vulnerable and other patient populations. 

 “By supporting care pathways for screening, staging, evaluating, managing, and effectively treating patients with numerous medical conditions, including COVID-19, our technologies are an essential component of the nation’s healthcare infrastructure,” said Patrick Hope, Executive Director of MITA. “As this letter makes clear, we are eager to partner with President Biden and his Administration to leverage these technologies to ensure patients have ongoing access to safe and effective innovative medical imaging solutions.” 

 MITA outlined seven policy priorities for the new Administration to consider, including:  

  • Enabling patients to return to care quickly and safely by ensuring healthcare providers are adequately reimbursed for their services
  • Protecting patient safety by requiring third-party medical device servicing businesses to adhere to appropriate regulations, including registration with the Food and Drug Administration (FDA), filing Medical Device Reports (MDRs), and implementing quality management systems
  • Promoting patient access to innovative imaging technologies through improved transparency, accountability, and predictability of the Medicare national coverage determination process, as well as adequate reimbursement to support healthcare provider adoption of these technologies
  • Recognizing the value of imaging drugs, including positron emission tomography (PET) and single-photon emission computerized tomography (SPECT) radiotracers, by removing barriers to appropriate Medicare coverage of these products and ensuring appropriate payment for their use
  • Supporting efficient, consistent, and transparent FDA premarket review of medical imaging technologies via the Medical Device User Fee Agreement (MDUFA) V that maintains current performance levels and maintains appropriations as the majority share of FDA device program funding
  • Facilitating efficient, transparent, and adequately staffed Veterans Affairs (VA) and Department of Defense (DoD) procurement of medical imaging technologies, ensuring veterans and service members have access to medically necessary imaging exams
  • Supporting the ongoing stability and resilience of the thoughtfully developed international medical device supply chain

Along with the letter, MITA also included several issue briefs and background materials on key policy areas, including medical device servicing; radiopharmaceutical and PET reimbursement; and policies that promote medical innovation, among other topics.

“The historic health and economic disruptions of the last year demand immediate, decisive action on a multitude of fronts, not only from our leaders in Washington but from the entire medical technology sector,” added Hope. “In this unpredictable environment, public and private collaboration will be crucial. We look forward to engaging with President Biden and his team to support innovators, providers, and American patients.”