Have You Heard? (Sept 2018)

Hearing Associations Release Consensus Recommendations for New Over-the-Counter Hearing Aid Classification
Recommendations Outline Five Evidence-Based Safety and Effectiveness Priorities for FDA Consideration

On August 14th, ADA and other major U.S. hearing healthcare professional associations (Associations) announced the release of a consensus paper, “Regulatory Recommendations for OTC Hearing Aids: Safety and Effectiveness.” The consensus paper was developed by a working group representing all associations to provide guidance to the U.S. Food and Drug Administration (FDA) as it develops an over-the-counter (OTC) hearing device classification as mandated by the FDA Reauthorization Act of 2017 (FDARA). The consensus paper, which outlines five evidence-based recommendations related to the safety and effectiveness of this new class of devices, was jointly developed and endorsed by the Academy of Doctors of Audiology (ADA), American Academy of Audiology (AAA), American Speech-Language-Hearing Association (ASHA), and International Hearing Society (IHS).

The associations appreciate FDA’s recent statement that Section 709 (of FDARA) reflects a careful balance between consumer affordability and access to new technologies, while providing consumer protections to assure safety and effectiveness of OTC hearing aids. The consensus paper introduction, in part, states, “[The Working Group] strongly advocates that any solutions presented to the consumer rely on safe and effective medical devices and include safeguards that optimize consumers’ awareness and use of appropriate hearing care treatment.”

The consensus recommendations address: 1) the product requirements appropriate for OTC hearing devices targeting mild-to-moderate hearing impairment; 2) outside-of-the-box labeling appropriate for medical devices sold over-the-counter; 3) comprehensive inside-the-box labeling; 4) naming the products Self-Fit Over-the-Counter Hearing Devices, adopting risk classifications consistent with air conduction hearing aids, and limiting 510(k) exemptions; and 5) establishing strong consumer protection laws.

The Associations are committed to engaging with the FDA and other stakeholders in the coming months and years, during the continued development of the new OTC hearing device classification.

Visit www.audiologist.org for more information and to download the consensus paper.    
Student Business Plan Contestants Advance to Finals at AuDacity 2018
The Academy of Doctors of Audiology (ADA) Student Business Plan Competition at AuDacity, is designed to showcase the next generation of audiology leaders. The winners of the competition will receive a $5,000 grant to help pursue their dreams of a starting an audiology practice. For our 2018 competition, ADA partnered with Audigy, a preeminent, data-driven practice development company, representing 275 practices with 750 locations across North America.

This year’s competition included a unique scenario-based prompt that required entrants to consider how they would transition into ownership of, and help to grow, an existing practice. ADA had a fantastic group of students enter our competition and after several rounds of review and feedback from volunteer judges the following teams will advance to the finals:
  • Hearing For Life: Chelsea Montgomery, Rachael Pennock, Scheyere Ann Moir, University of South Florida
  • Low Vibrations Audiologic Services: Holly Botzum, University of Memphis
  • Sincear Hearing: Madison Graham, Ashley Malley, University of Colorado Boulder
“There has been tremendous interest in the ADA Student Business Plan competition this year,” said ADA Executive Director, Stephanie Czuhajewski. “We are especially grateful for the generous commitment of Audigy to support the next generation of autonomous audiologists through sponsorship of the business plan competition.”

The final round of the business plan competition will take place on Wednesday, October 24, during the Business Plan Luncheon at AuDacity 2018 in Orlando, Florida. In the meantime, contestants will have the opportunity to work with volunteer judges to further refine their plans and prepare presentations. During the luncheon, AuDacity attendees will have the opportunity to ask questions and provide feedback to the teams.    
CMS Proposed Physician Fee Schedule Excludes Audiology from QPP
The Centers for Medicare and Medicaid Services (CMS) released their proposed rule for the 2019 Payment Year Quality Payment Program (QPP) and Medicare Physician Fee Schedule (MPFS) July 12, 2018. Unfortunately, under the draft rule, audiologists are not eligible clinicians in the 2019 QPP program. As a result, we are not eligible to participate in the QPP program in 2019. The goal is that audiologists will be eligible by 2021, when full participation by all Medicare providers is required. The only Medicare eligible professions not included in the QPP in 2019 are qualified speech-language pathologists, qualified audiologists, certified nurse-midwives, and registered dietitians or nutrition professionals. Audiologists are now the only doctoring profession not to be included in the QPP program, as occupational therapists, physical therapists, clinical social workers and clinical psychologists are poised to join the program in 2019.

The only significant proposal to affect audiologists in the MPFS is the 0.25% payment increase. The proposed Medicare conversion factor for 2019 is $36.05, which is a very small increase over the 2018 conversion factor of $35.99. Also, as the Physician Quality Reporting System (PQRS) was retired on December 31, 2016 and, as a result, there was no reporting requirements for 2017, there will be no payment deductions applied to audiologists in 2019.

Many changes were proposed to both the QPP and MPFS. Unfortunately, again given audiology’s current status within the Medicare system, none of these changes apply to audiology or audiologists. These include:
  • Expansion of the low volume threshold for Merit Based Incentive Payment System (MIPS) and an opt-in provision for those providers who want to participate but do not meet the requirements due to low volume thresholds.
  • Allowing eligible providers to use time and medical decision making as a governing factor in selection of an Evaluation and Management code.
  • Addition of a communication technology based service code. This would provide coverage when the provider checks in with the patient via telephone or telepractice to determine if an office visit or other service is needed.
ADA submitted formal comments to CMS requesting that CMS consider including audiologists as eligible MIPS providers in the final Medicare Physician Fee Schedule. We will keep members informed as more information becomes available. Please visit www.audiologist.org to read ADA’s comments to CMS.