Volume #34 - October/November 2021

Cheers!

Kim

Monthly Coding and Reimbursement Tips

State and Federal Surprise Medical Billing

Surprise medical billing is when individuals unknowingly receive bills for out of network or non-covered care.

Most managed care agreements require that an individual be notified, in writing, and acknowledge their financial responsibilities as it relates to out of network or non-covered care. This type of written acknowledge must be in place before the service is rendered. Use of a form like this can offer protections for the individual and the provider surrounding managed care and surprise medical billing requirements. Transparency is invaluable.

Most audiologists in most clinical setting may have limited exposure to the Federal Surprise Medical Billing Proposed Regulations.

Many states though have comprehensive surprise medical billing regulations that may impact audiologists.

The impact of these regulations varies greatly by state, practice setting and managed care status. As a result, there is no "one size fits all" answer. It is important for audiologists to discuss their situation with their legal counsel and/or practice administration.

Book Spotlight

Every audiologist who works in any facet of audiologic evaluation or treatment MUST read Of Sound Mind by Nina Kraus, PhD.

This amazing book clearly explores the Hearing Brain and the importance of sound in our daily lives and communications. You can view a video where she discusses Music and the Mind at the Lincoln Center of Performing Arts.

So, the OTC Proposed Rules are FINALLY been released and we can now see how close my predictions were to the actual outcomes. Let's do a compare my expectations versus the realities within the Rule.



To review, here is what I anticipated might be addressed, versus the language of the proposed bill (in red and bold):

• Creation of a separate class of hearing aid specific to over the counter and direct to consumer hearing aids. This occurred as expected.
• Define what constitutes an “over the counter hearing aid”. This also occurred.
• Include output and gain limits. Part of this occurred. Output limits of 115dBSPL are being proposed but no gain limit. I actually support this aspect of the Proposed Rule. Gain limits "limit" access and competition. It is disingenuous to care about gain and output NOW that the product looks like a hearing aid (when we did not care when it looked like a headphone).
• Restrict purchase to those 18 years of age and older. Done
• Require an open access software platform (can be programmed or adjusted by anyone). Done
• Require return for credit capacity, regulated by the Federal Trade Commission (FTC). Sadly, this is lacking. This is something I hope many address in their Proposed Rule comments.
• Removal of the current medical clearance and medical waiver requirement for all adult hearing aid purchases, irrespective of the class of the hearing aid. Done
• Require a printed user brochure be supplied with every hearing aid purchase, irrespective of the class of the hearing aid. Actually, the Proposed Rule takes this a bit farther and allows for electronic or phone access to additional information about the product. I like this.
• Reconfiguration of the entire classification system for hearing aids, including the current Class I and Class II devices, over the counter devices, and personal sound amplification products. Done. The proposed hearing aid classifications are OTC, Prescription, Bone Conduction and Air Conduction, with draft guidance on personal sound amplification products.
• Requirement for audiometric prescription from an audiologist or physician (consistent with the Eyeglass Rule in optometry) prior to the purchase of a non-OTC hearing aid. This would include otoscopy and pure-tone audiometry. This too would be regulated by the FTC. This kind of, sort of happened but the "prescription", in my opinion, is still a bit ill-defined in the proposal. There is also, sadly, zero FTC engagement. I hope this is remedied in the Final Rule.
• Eliminate all manufacturers limitations on the sale of hearing aids as long as the FDA and/or FTC regulations are met. This could allow for the remote, direct to consumer delivery of every class of device, using telehealth. This too is consistent with the Eyeglass and Contact Lens Rules. This is also, sadly, not clear as of yet. The answer revolves around the "prescription" itself.
• Require an open access software platform (can be programmed or adjusted by anyone). Ugh! Still not addressed for the prescription and air conduction classes. This should be a priority because this issue was mentioned in both the PCAST and NASEM reports.
• Require return for credit capacity, regulated by the Federal Trade Commission (FTC), which does not currently exist in FDA regulations or in every state hearing aid dispensing law. Another aspect that has not been fully addressed.
• Require greater pre-market approval for new and emerging technologies. Done.

So, it looks as though I made some pretty solid predictions! My years of engagement have finally born fruit. Heck, a paper I co-authored was even cited. Who knew people were even listening! I will be anxious to see what the Final Rule and resulting regulatory guidance ultimately look like.

I encourage ALL stakeholders to make their own comment (please be careful of stock comment opportunities being put forth; most of these can be tied directly to industry and clinic ownership groups who SAY they support audiology but really only support their own bottom lines). You can comment here. You have until January 16, 2022 to submit your comment and, to quote the Hunger Games (which I LOVE and sometimes I think this industry resembles), "Remember who the real enemy is".

In the meantime, evolve your evaluation, treatment, and care delivery models. Practice to the top of your license and skill set. Become everything that disruptive entrants can never be. Put the patient and their outcomes first. And, finally, support your profession, with time and treasure, at the state and national levels. State audiology associations, especially, will need all of us and our membership and advocacy dollars as this fight heads to the State level.