ADA’s Submission to CMS

September 11, 2023

The Honorable Chiquita Brooks-LaSure
Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1784-P
Mail Stop C4-26-05
7500 Security Boulevard
Baltimore, MD 21244-1850

Re: CMS-1784-P; Medicare Program; CY 2024 Payment Policies under the Physician Payment Schedule and Other Changes to Part B Payment and Coverage Policies

The Academy of Doctors of Audiology (ADA) appreciates the opportunity to comment on the CY2024 Medicare Physician Fee Schedule (MPFS) Proposed Rule (2024 MPFS Proposed Rule) put forward by the Centers for Medicare and Medicaid Services (CMS).

The Continued Annual Decrease in Reimbursement for Audiology Services is Unsustainable

The 2023 Medicare Physician Fee Schedule (MPFS) Proposed Rule includes yet another decrease in the conversion factor (from $33.89 in 2023 to a proposed $32.75 in 2024). This reduction in the conversion factor would translate to an estimated 3.36% reduction in reimbursement for audiology and vestibular services. This continued, yearly assault on Medicare reimbursement is unsustainable and devastating to practices as they grapple with inflation and increasing labor costs.¹ We respectfully request that CMS re-evaluate this reduction and begin to explore alternative means of retaining budget neutrality other than solely through reductions in healthcare provider reimbursement.

ADA Supports the Creation and Implementation of New Auditory Osseointegrated Device Codes, and Opposes their Valuation

ADA supports the creation and implementation of 926X1 (Diagnostic analysis, programming, and verification of an auditory osseointegrated sound processor, any type; first 60 minutes) and 926X2 (Diagnostic analysis, programming, and verification of an auditory osseointegrated sound processor, any type; each additional 15 minutes [list separately in addition to code for primary procedure]) for CY 2024.

However, ADA strongly disagrees with the valuation of 926X1 and 926X2. The RVU work value of 1.25 for 926X1 is lower than other, less technical timed audiology codes (for example, 92620 has a work value of 1.50 and 92626 has a work value of 1.40) and inconsistently valued to other similar durable medical equipment programming codes (92601 has a work RVU of 2.30 and 92603 has a work RVU of 2.25).

The paltry reimbursement of these new codes, will make it financially challenging for audiologists to continue to provide these procedures given the time and equipment required. Access to care will most certainly suffer as a result. ADA, therefore, respectfully requests that CMS reconsider their valuation of these new codes and ensure that it is commensurate with other similarly timed or programming codes.

ADA Commends CMS for Identifying Statutory Challenges Impacting the Provision of Audiology Services Under Medicare in the CY2023 MPFS Final Rule and Recommends Expansion of Beneficiary Direct Access to Include all Audiology Services in 2024

The CY2023 MPFS Final Rule contained provisions to allow audiologists to furnish certain diagnostic audiology services without a physician order, through use of an AB modifier. ADA applauds CMS for confirming its administrative authority to remove the physician order requirement as a condition of coverage for audiology services via notice and rulemaking, for attempting to align Medicare reimbursement policies with best practices in the delivery of hearing and balance services, and for taking ADA recommendations to create and implement the AB modifier, instead of the originally proposed GAUDX code.

ADA recommends that CMS take further steps to streamline access to audiology services for Medicare Part B beneficiaries by eliminating the physician order requirement for coverage in its entirety.

ADA agrees with CMS’ assessment that the classification of audiologists within the Medicare statute is incongruent with statutory classifications for similarly trained non-physician providers (NPP), who are categorized as practitioners under section 1842(b)(18)(C) of the Act. ADA also concurs with CMS’ assessment that the statutory classification of audiology services as “other diagnostic tests” under section 1861(s)(3) of the Act prohibits coverage of audiology treatment services when delivered by audiologists. CMS documented the misalignment between CMS policies and audiology’s scope of practice, in the Medicare Benefit Policy Manual Chapter 15 – Covered Medical and Other Health Services, as follows:

“F. Audiological Treatment. There is no provision in the law for Medicare to pay audiologists for therapeutic services. For example, vestibular treatment, auditory rehabilitation treatment, auditory processing treatment, and canalith repositioning, while they are generally within the scope of practice of audiologists, are not those hearing and balance assessment services that are defined as audiology services in 1861(ll)(3) of the Social Security Act and, therefore, shall not be billed by audiologists to Medicare.”²

Members of Congress, with support from ADA and a broad coalition of audiologists, physicians, consumers, and industry representatives are seeking a legislative remedy to address Medicare’s statutory deficiencies in the classification of audiologists and audiology services. This legislation, the Medicare Audiology Access Improvement Act (S.2377), seeks to amend the definition of audiology services to include Medicare-covered treatment services that audiologists are licensed to provide under their state scope of practice, to reclassify audiologists as practitioners under 1842(b)(18)(C) of the Act, and to remove the physician order requirement as a condition of coverage for all Medicare-covered audiology services.

Despite existing statutory deficiencies that must be addressed to optimize delivery of audiology treatment services, CMS should use its administrative authority to completely eliminate the physician order requirement for coverage for Medicare Part B beneficiaries to obtain medically necessary diagnostic services from an audiologist. Doing so will markedly improve service delivery and decrease time to obtain treatment for older adults experiencing hearing and balance problems.

• CMS Should Remove the Physician Order Requirement as a Condition of Coverage for All Medicare-Covered Audiology Services

Despite the implementation of the AB modifier, ADA continues to request the complete removal of the physician order requirement for services performed by qualified licensed audiologists. Medicare beneficiaries, taxpayers, and providers will be best served by the complete removal of the physician order requirement for medically necessary audiologic and vestibular services (listed on the CMS Audiology Code list at https://www.cms.gov/audiology-services) when provided by a licensed audiologist.

Audiologists should be authorized to provide these medically necessary, audiologic and vestibular services, as they do to every other payer, including Medicaid, Tricare, and commercial health plans, without a physician order or modifier. If over utilization is concern, CMS could create a National Coverage Determination (NCD) consistent with the current Novitas Local Coverage Determination (less the physician order requirement) at https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=35007.

• CMS has a longstanding history of deferring to state scope of practice as a means of qualifying providers to deliver services for coverage

CMS manuals and Medicare benefit policy transmittals align eligibility for reimbursement with state scope of practice.^3,4,5 Audiologists’ scopes of practice are far more consistent across the United States than are many other providers for whom Medicare defers to state scope of practice in coverage determinations.

Licensed audiologists are legally authorized in every U.S. state and territory to provide Medicare covered audiologic and vestibular services without physician oversight or supervision. Audiologists are licensed in every state to provide comprehensive, diagnostic audiologic assessments, tinnitus evaluations, auditory processing evaluations, auditory prosthetic device evaluations, activation, and programming, evoked potential testing, and vestibular evaluations, without documented incident. Because of the availability of remote assessment tools, resources, and portable equipment, these services can be provided in most places of services, including, but not limited to, the patient’s home, via telehealth, an office, in- or outpatient hospital, assisted living or nursing facilities, and/or specialty clinics/centers. The complete removal of the Medicare physician order requirement would greatly improve beneficiary access to audiologic and balance care, especially in assisted living and nursing facilities and in rural areas.

• Audiologists are already responsible for determining medical necessity regardless of whether a physician order is obtained

As CMS noted in its comments, audiologists have been allowed to enroll in the Medicare program and bill independently for their audiology services since 2008. A 2020 study demonstrated that primary care physicians billed far more rotary chair vestibular tests than either audiologists or otolaryngologists, so much so, that the authors recommended a need for training to stem over utilization.⁶ Maintaining a physician order requirement for any of the Medicare-covered services that audiologists provide forces beneficiaries to spend time and money for an unnecessary office visit that has not been shown to have any meaningful clinical impact on outcomes.

• Other Programs and Payers Allow and Encourage Uncompromised Direct Access for Beneficiaries

CMS stated the following in the 2023 MPFS Proposed Rule:
“In addition, we have heard from interested parties that an order is not required for audiology services by certain other public or private health insurers including Medicare Advantage plans, Medicaid, plans under the Federal Health Benefit Program, and the Veterans Administration. We do not know the scope of services that are covered by these plans or insurers when furnished by audiologists, including whether these health insurers cover only hearing and balance assessment services (as the Medicare program does in accordance with the statute) or also hearing aid examinations for the prescription, fitting, and programming of hearing aids or other services excluded from payment under Medicare Part B and/or whether only some or all of the plans allow payment directly to audiologists for some or all of the covered services without a physician/NPP order. Additionally, we note that some of these health insurance programs involve closed systems with greater levels of inter-professional communication and control (for example, within certain accountable care organizations (ACOs), managed care plan networks, or through various Veterans Affairs medical centers). In contrast, the physicians and practitioners furnishing care under the fee-for-service Medicare Part B program often practice independently from each other, which can pose barriers to communication and coordination of care between health care professionals such as audiologists and the treating physicians or other practitioners.”

ADA is pleased to provide supporting documentation as evidence that a physician order is not mandated for coverage for beneficiaries seeking audiology services under Medicare Part C (Advantage), Medicaid, the Veteran’s Health Administration, Tricare, Federal Employee Health Benefit Plans, and commercial health plans⁷. None of these non-HMO health plans require a physician order for coverage of medically necessary, comprehensive, audiologic or vestibular items or services, irrespective of the relationship between the audiologist and the beneficiary’s treating/attending physician or non-physician practitioner.

• No Physician Order Required for Medicare Part C Beneficiaries
  Publicly available Medicare Advantage plan data for plan benefit packages (PBP) related to hearing benefits denotes information about diagnostic hearing evaluations (typically covered under medical portion of the plan and not the supplemental portion). With the exception of HMO plans, the vast majority do not have a referral/order requirement. CMS, having oversight of the Medicare Advantage program should be able to provide documentation if such a requirement exists. If such a requirement does exist, commercial insurers participating in Medicare Advantage are not complying with it.
• No Physician Order Required for Medicaid Beneficiaries
  While Medicaid provisions for audiology services vary greatly state by state, ADA has found no evidence of a statutory or regulatory requirement for a physician order for patients seeking audiology services. CMS, having oversight of the Medicaid program should be able to provide documentation if such a requirement exists. If such a requirement exists, the vast majority of Medicaid plans are not complying with it.
• No Physician Order Required for The U.S. Veteran’s Health Administration (VHA) Beneficiaries
  As reported in her 2019 commentary⁸, Carolyn Clancy, M.D., the Assistant Under Secretary for Health for Discovery, Education and Affiliate Networks at the VHA, the practice of direct scheduling for audiology and optometry services, which is allowed throughout the VA system, reduced patient wait times and resulted in more productive use of primary care clinician time. Further, patients have praised the program.
• No Order Required for Tricare Beneficiaries
  Tricare, the uniformed services health care program for active duty service members (ADSMs), active duty family members (ADFMs), National Guard and Reserve members and their family members, retirees and retiree family members, does not mandate a physician order for audiology services.
• No Order Required for Federal Employee Health Benefit Plan Beneficiaries
  In 1998 Congress amended Title 5, Chapter 89 Section 8902 (k)(1) of the U.S. Code, clarifying that the U.S. Office of Personnel Management (OPM) and Federal Employee Health Benefits Plans were authorized to allow direct access to any licensed or certified provider (by Federal or State law), as follows:
  
  “(2) Nothing in this subsection shall be considered to preclude a health benefits plan from providing direct access or direct payment or reimbursement to a provider in a health care practice or profession other than a practice or profession listed in paragraph (1), if such provider is licensed or certified as such under Federal or State law.”⁹
  
  Federal Blue Cross and Blue Shield began allowing beneficiaries to have coverage for audiology services without a physician order on January 1, 2001.

• Direct Access is Safe and Effective

There is no evidence to support deficiencies in care coordination or communication from audiologists to treating/attending physicians or non-physician practitioners in these direct access care delivery models.

Audiology malpractice insurance rates at $500 a year on average, are among the lowest of any clinical doctoring profession in the nation. Data obtained from the National Provider Data Bank (NPDB) indicates that audiologists are among the providers with the fewest malpractice claims.¹⁰ According to CMS’ own fee schedule, the majority of Malpractice Relative Value Units (RVU) for audiology and vestibular services range from 0.01 to 0.05. By comparison, physician and nonphysician practitioners have malpractice RVUs that range from 0.01 to .32 for Evaluation and Management (E/M) codes 99202 through 99215.

There is also no significant evidence of cases or complaints filed with state licensure boards or state attorneys general against audiologists. ADA could find no documented evidence of mismanagement, misdiagnosis, and/or malpractice associated with audiologists evaluating audiologic and/or vestibular conditions, nor any evidence illustrating that an audiologist does not refer to medical personnel, specifically otolaryngologists/otologists, dermatologists, neurologists, when medically necessary and warranted.

A 2008 study demonstrated the effectiveness of audiologists triaging vestibular disorders, when compared to other providers¹¹, and a 2010 study conducted at the Mayo Clinic Jacksonville demonstrated the safety of Medicare beneficiary direct access to audiologists.¹² On the contrary, there is significant evidence of mismanagement and misdiagnosis of auditory and vestibular conditions by physicians and other medical personnel.^13,14,15

As reported previously in this comment, Medicare Part B is the only payer that requires a physician order for coverage of audiologic and vestibular evaluation and treatment services. A 2017 AAO-HNS guideline on BPPV (https://journals.sagepub.com/doi/full/10.1177/0194599816689667) acknowledges audiologists among the providers that diagnose and treat, acknowledges the prevalence among older adults, and acknowledges significant burdens associated with delayed care. Please find enclosed correspondence from Senator Elizabeth Warren and Senator Rand Paul requesting removal of the physician order requirement for audiology services.

There is no data to support that direct access to audiologists for evaluation of audiologic and vestibular disorders poses more risks than the same patients being first evaluated by a physician or non-physician practitioner, who have documented evidence of misdiagnosis of these conditions. CMS must use the data available to improve beneficiary access to care.

Audiologic and vestibular evaluation and treatment occurs safely and effectively every day in audiology practices across the United States. The only time that ADA has been able to document “patient safety” concerns related to Medicare direct access to audiology services, they have been raised by very providers who stand to lose the office visit fee for services to write the order.

Medicare beneficiaries should not require a physician order prior to the provision of any medically necessary, Medicare covered audiologic and/or vestibular service. As we have previously reiterated, the physician order requirement does not exist in state licensure, nor in any other corner or facet of healthcare delivery or health plan coverage and no legitimate safety issues have been documented.

Other ADA Recommendations for Improvements to the CMS Regulations for Providing Medicare Beneficiary Direct Access to Audiology Services

• Implementation of the AB Modifier

While ADA recommends the complete removal of the physician order requirement as a condition for coverage for Medicare Part B beneficiaries seeking care from an audiologist, ADA provides additional recommendations to address the significant challenges and limitations experienced by providers and beneficiaries related to implementation of the CY2023 regulations, authorizing limited audiologic services to be provided once per 12 months without a physician order.

First, there are still Medicare Administrative Contractors (MAC) that are denying accurately submitted claims where the physician order was not required, and the AB modifier was appropriately utilized. We respectfully request that CMS immediately engage with contractors to remedy this situation.

Secondly, limited guidance has been made available at https://www.cms.gov/audiology-services to guide stakeholders in the operationalization of these changes. Some of the most prominent challenges are:

• Lack of beneficiary education and understanding of the policy change, especially as to whether or not they have received additional audiologic testing, without a physician order, in the past 12-months.
• Lack of provider access to information as to whether or not the beneficiary has received additional audiologic testing, without a physician order, in the past 12- months.
• Lack of ordering physician/provider education and understanding of the policy change, especially as to whether or not they have received additional audiologic testing, without a physician order, in the past 12-months. As a result, there are physicians and ordering providers who are refusing to provide orders, when required (i.e. acute, vestibular, and additional medically necessary testing beyond one visit per 12 months).
• Lack of definition as to what constitutes “non-acute” versus “acute” hearing problems. ADA’s expectation was that CMS would develop a national coverage policy better defining these terms and what diagnoses constitute an “acute” condition or illness.

If CMS decides to retain the AB modifier and the limited direct access, we respectfully request that CMS work with stakeholders to create additional guidance and coverage policies to reflect their intended operationalization and implementation of the AB modifier and limited direct access to audiologic evaluation.

ADA reiterates that the most effective approach for improving access to audiology services via removal of the physician order requirement for coverage is to make the policy universal for all the audiology services that are currently covered when delivered by audiologists and to use the mechanisms and protocols that CMS has already implemented to track outcomes.

• ADA strongly recommends removal of the term “non-acute” as the term does not exist in the International Classification of Diseases, 10th Revision (ICD-10) diagnoses that correspond to the vast majority of audiologic or vestibular conditions experienced commonly by Medicare beneficiaries. The physician order requirement should be driven by the procedures being performed and not predicated on factors that are not commonly used to represent audiologic disorders and conditions.
• ADA strongly recommends allowing the following procedures to have no limitations on the number of visits per 12 months without a physician order. These procedures are indicated in Table A.

These procedures, by their very nature, 1) require physician involvement during candidacy and as the implanting surgeon, 2) require an on-going, collegial relationship between the audiologist and implanting surgeon throughout the process, 3) require limited physician involvement post-activation, and 3) require a re-evaluation time frame that typically exceeds once per 12 months. The required physician order has always been an administrative nuisance and barrier to care for the beneficiary. Also, given the numbers of auditory prosthetic device recipients, over-utilization should not be a concern as data can be tracked via the surgical procedure codes. In an effort to contain misuse and over-utilization, this AB modifier use could also be tied to specific ICD-10 diagnosis codes, such as H90 (conductive and sensorineural hearing loss), Z44 (encounter for fitting and adjustment of external prosthetic device), Z45 (encounter for adjustment and management of implanted device) and Z96.2 (presence of otological and audiological implants). These codes accompanying this modifier and, possibly, the associated ICD-10 codes, would be paid individually at their calendar year (CY) allowable rates and would not be subject to the one visit per 12 months limitations.

Table A: Audiologic Services Furnished Personally by an Audiologist Without a Physician/NPP Order for Evaluation to Determine Candidacy for a Surgically Implanted Hearing Device (for Example, a Cochlear Implant or an Osseointegrated Implant), for Post-Surgical Evaluation of Performance or for the Diagnostic Analysis and Subsequent Reprogramming of a Cochlear Implant Or Auditory Brainstem Implant

CPT Code	Short Descriptor
92601	Cochlear implt f/up exam <7.
92602	Reprogram cochlear implt <7.
92603	Cochlear implt f/up exam 7/>.
92604	Reprogram cochlear implt 7/>.
92626	Eval aud funct 1st hour.
92627	Eval aud funct ea addl 15.
92640	Aud brainstem implt program.
926X1	Diagnostic analysis, programming, and verification of an auditory osseointegrated sound processor, any type; first 60 minutes.
926X2	Diagnostic analysis, programming, and verification of an auditory osseointegrated sound processor, any type; each addnl 15 minutes.

ADA Recommendations for Code Additions to Telehealth Category 3

ADA wholeheartedly supports transitioning all of the currently assigned Category 2 Telehealth procedures to Category 3 procedures through CY2024 and beyond.

ADA recommends, for consideration, the following codes be added to the Telehealth Category 3 list:

Table B: Audiology Telehealth Codes

CPT Code	Descriptor
92620	Evaluation of central auditory function, with report; initial 60 minutes.
92621	Evaluation of central auditory function, with report; each additional 15 minutes.
92540	Basic vestibular evaluation, includes spontaneous nystagmus test with eccentric gaze fixation nystagmus, with recording, positional nystagmus test, minimum of 4 positions, with recording, optokinetic nystagmus test, bidirectional foveal or peripheral stimulation, with recording, and oscillating tracking test, with recording.
92541	Spontaneous nystagmus test, including gaze and fixation nystagmus, with recording.
92542	Positional nystagmus test, minimum of 4 positions, with recording.
92544	Optokinetic nystagmus test, bidirectional, foveal, or peripheral stimulation, with recording.
92545	Oscillating tracking test, with recording.
92546	Sinusodial vertical axis rotational testing.
92547	Use of vertical electrodes.
92537	Caloric vestibular test with recording, bilateral; bithermal (i.e. one warm and one cool irrigation for each ear for a total of four irrigations).
92538	Caloric vestibular test with recording, bilateral; monothermal (i.e. one irrigation in each ear for a total of two irrigations).
92548	Computerized dynamic posturography sensory organization test (CDP-SOT), 6 conditions (ie, eyes open, eyes closed, visual sway, platform sway, eyes closed platform sway, platform, and visual sway), including interpretation and report.
92549	Computerized dynamic posturography sensory organization test (CDP-SOT), 6 conditions (ie, eyes open, eyes closed, visual sway, platform sway, eyes closed platform sway, platform, and visual sway), including interpretation and report; with motor control test (MCT) and adaptation test (ADT). All of these services can be provided with technical support and allow for technical/professional component split in CPT coding.
92517	Vestibular evoked myogenic potential (VEMP) testing, with interpretation and report, cervical (cVEMP).
92518	Vestibular evoked myogenic potential (VEMP) testing, with interpretation and report, ocular (oVEMP).
92519	Vestibular evoked myogenic potential (VEMP) testing, with interpretation and report, cervical (cVEMP) and ocular (oVEMP).
92650	Auditory evoked potentials; screening of auditory potential with broadband stimuli, automated analysis.
92651	Auditory evoked potentials; for hearing status determination, broadband stimuli, with interpretation and report.
92652	Auditory evoked potentials; for threshold determination at multiple frequencies, with interpretation and report.
92653	Auditory evoked potentials; neurodiagnostic, with interpretation and report.
926X1	Diagnostic analysis, programming, and verification of an auditory osseointegrated sound processor, any type; first 60 minutes.
926X2	Diagnostic analysis, programming, and verification of an auditory osseointegrated sound processor, any type; each additional 15 minutes.

As it pertains to patient safety, the Veteran’s Administration has shown, for many years, that audiology services can be safely provided, via telehealth, without sacrificing patient outcomes or quality of care.16 The technology required to perform these procedures via telehealth, in many cases with the assistance of an audiology assistant or technician at a remote location, is readily available. Audiologists outside the VHA system may be reluctant to invest in these technologies, personnel, and necessary infrastructure if Medicare coverage is not permanently established.

ADA Recommendations for Proposed MIPS Provisions

As it pertains to the Merit Based Incentive Payment System (MIPS) and as outlined in the Proposed Rule, ADA is supportive of the addition of Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented and Connection to Community Service Provider.

ADA thanks CMS for their continued support of the inclusion and expansion of audiology within the MIPS system.

ADA also respectfully requests that the following measures be added to the Audiology Specialty Set. These include:

• Closing the Referral Loop: (Quality ID#374)
• Assigned to procedures: 69200, 69209, 69210, 92517, 92518, 92519, 92537, 92538, 92540, 92541, 92542, 92544, 92545, 92546, 92547, 92548, 92549, 92550, 92552, 92553, 92555, 92556, 92557, 92550, 92567, 92570, 92584, 92650, 92651, 92652, 92653, 92620, 92621,92625, 92626, 92627, and 95992.

Conclusion

ADA appreciates the opportunity to provide CMS with its detailed analysis of the 2024 MPFS Proposed Rule and constructive recommendations for improvement. ADA is grateful for CMS’ interest in expanding access for Medicare beneficiaries to audiology services by taking steps to remove the physician order requirement for coverage of certain audiology services.

The physician order mandate, which is unique to the Medicare Part B program, creates barriers, however implemented, to access to audiology services for Medicare beneficiaries that other Americans do not face. Evidence supports the universal removal of the physician order requirements and the use of current mechanisms and protocols for tracking beneficiary access and service utilization. Even with the statutory challenges related to the classification of audiologists and audiology services, astutely described by CMS in its proposal, implementation of universal direct access will be the most effective, least burdensome approach that will allow CMS to achieve state goals.

ADA believes that Medicare policies should be constructed to align with evidence-based practices and modernizing policies related to the provision of audiology services is long overdue. Streamlining access to safe, effective audiologic care can help save the system and the beneficiary resources, which can be used to stabilize reimbursement and ensure continued patient access to the care that they need when they need it.

ADA will be pleased to offer further information or expertise in policy design or implementation in the provision of audiology services and we look forward to working with CMS on developing educational resources that will be most useful for beneficiaries and audiologists in the coming months.

Please contact This email address is being protected from spambots. You need JavaScript enabled to view it. if we can assist you in any way.

Respectfully,

Enclosure: October 12, 2022 Letter from Senator Elizabeth Warren and Senator Rand Paul to Administrator Chiquita Brooks LaSure regarding removal of the physician order requirement for audiology services.

References

1. https://www.pwc.com/us/en/industries/health-industries/library/behind-the-numbers.html
2. Medicare Benefit Policy Manual Chapter 15 – Covered Medical and Other Health Services (Rev. 11426, 05-20-22) https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf
3. https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/bp102c07.pdf
4. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_a_hospitals.pdf
5. https://www.cms.gov/files/document/r10639bp.pdf
6. Adams ME, Yueh B, Marmor S. Clinician Use and Payments by Medical Specialty for Audiometric and Vestibular Testing Among US Medicare Beneficiaries. JAMA Otolaryngol Head Neck Surg. 2020;146(2):143–149. doi:10.1001/jamaoto.2019.3924
7. https://www.amplifonusa.com/content/dam/ahhc/documents/downloadable-files/provider/2022%20Provider%20Resource%20Manual.pdf
8. Clancy, Carolyn, MD, Creating World-class Care and Service for Our Nation’s Finest: How Veterans Health Administration Diffusion of Excellence Initiative is Innovating and Transforming Veterans Affairs Health Care. The Permanente Journal, Volume 23, No. 4. December 1, 2019. https://doi.org/10.7812/TPP/18.301
9. Title 5, Section 8902 (k)(1) of the U.S. Code, amended in 1998, https://www.congress.gov/105/plaws/publ266/PLAW-105publ266.pdf
10. https://www.npdb.hrsa.gov/resources/publicData.jsp
11. Polensek SH, Sterk CE, Tusa RJ. Screening for vestibular disorders: a study of clinicians' compliance with recommended practices. Med Sci Monit. 2008 May;14(5):CR238-242. PMID: 18443546.
12. Safety of Audiology Direct Access for Medicare Patients complaining of Impaired Hearing, Journal of the American Academy of Audiology, Volume 21, Number 6, 2010, David Zapala et al.
13. Kerber KA, Newman-Toker DE. Misdiagnosing Dizzy Patients: Common Pitfalls in Clinical Practice. Neurol Clin. 2015 Aug;33(3):565-75, viii. doi:10.1016/j.ncl.2015.04.009. PMID: 26231272; PMCID: PMC9023124.
14. Mirly, Alan & Brockett, Jeff. (2018). Sudden Sensorineural Loss in Primary Care : An Often-Missed Diagnosis. Physician Assistant Clinics. 3.10.1016/j.cpha.2017.12.001.
15. Royl, Georg & Ploner, Christoph & Leithner, Christoph. (2011). Dizziness in the Emergency Room: Diagnoses and Misdiagnoses. European neurology. 66. 256-63. 10.1159/000331046.
16. (Chad Gladden, AuD presentation), NASEM: https://www.nationalacademies.org/documents/embed/link/LF2255DA3DD1C41C0A42D3BEF0989ACAECE3053A6A9B/file/DC856F457C400E2D48316693C42F75CEABA3F3EBCBB0?noSaveAs=1

 

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October 12, 2022

Chiquita Brooks-LaSure
Administrator
Centers for Medicare & Medicaid Services
U.S. Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244–8016

Dear Administrator Brooks-LaSure:

We write regarding the Calendar Year 2023 Medicare Physician Fee Schedule proposed rule that would use the Centers for Medicare & Medicaid Services’ (CMS) existing administrative authority to allow patients limited access to audiology services without a physician order. We support removal of the physician order requirement and appreciate CMS’s recognition of its authority to make that change without further statutory authority. However, the remaining conditions of the proposal still pose burdens on patients seeking audiology services. We urge CMS to streamline access to audiology services by removing the physician order requirement entirely for Medicare Part B beneficiaries, as reflected in the bipartisan Medicare Audiologist Access and Services Act (MAASA).

Access to hearing health services is a critical part of overall health care. While hearing loss is common, access to hearing health services is not. Nearly 38 million Americans experience some degree of hearing loss.1 Older Americans are particularly affected, with nearly one in three people between the ages of 65 and 752 and around half of adults 75 or older reporting difficulty hearing.3 Americans with hearing loss are at a greater risk of developing Alzheimer’s disease and Alzheimer’s disease related dementias,4 and they are also more likely to experience feelings of loneliness and isolation, which the COVID-19 pandemic has only exacerbated.5 Although Medicare covers a range of hearing health services, outdated regulations prevent many beneficiaries from actually accessing these services. Medicare is an= outlier among most federal and private insurance providers in requiring a physician order for coverage of audiology services. The Department of Defense, the Veterans Health Administration, and a majority of plans offered through the Federal Employees Health Benefit system allow direct access to covered audiology services without a physician referral.6 Many private insurance plans and Medicare Advantage plans similarly allow direct access.

We were glad to see CMS recognize and use existing authority to expand access to audiology services by removing the burdensome requirement for a physician order. The requirement for a physician order for a diagnostic test was only put in place with the 1996 regulations and only refers to the statutory prohibition in the Social Security Act against Medicare paying for items or services that “are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.”7 Therefore, this language in no way requires a physician referral for audiology services, but rather prohibits paying for unnecessary services.8

While we support your acknowledgement that there is no statutory language to prohibit Medicare from allowing direct access to audiologists, the current proposal is complex and limited. The proposed rule creates an unnecessary barrier for patients by allowing direct access to an audiologist without a physician referral only for certain “non-acute” hearing assessments and only once every 12 months.9 Allowing beneficiaries direct access to audiologists in all cases could reduce the number of appointments and referrals needed before a patient receives care, increase provider choice, and lower program costs and out-of-pocket expenses for patients.

Streamlining beneficiary access to services provided by audiologists – both through improved access to the full range of Medicare covered services audiologists are expertly qualified to provide, and through enactment of MAASA – will support the Food and Drug Administration’s recent actions to make hearing aids available over-the-counter (OTC) for approximately 30 million Americans with mild to moderate hearing loss.10 Now, providing more robust direct access to audiology services could make it even easier for older Americans considering OTC or prescription hearing aids to obtain expert audiological assessments to determine the best product for their specific type of hearing loss.

This proposal is a welcome first step. However, CMS has the authority to allow Medicare beneficiaries streamlined access to audiology services by removing the physician order requirements. Therefore, we urge CMS to use existing authority to fully eliminate the physician order requirement to help improve access to critical hearing health care services.

Sincerely,

References

1. The New York Times, “Hearing Aids for the Masses,” Shira Ovide, April 12, 2021, https://www.nytimes.com/2021/04/12/technology/hearing-aids.html.
2. National Institute on Aging, “Hearing Loss: A Common Problem for Older Adults,” November 20, 2018, https://www.nia.nih.gov/health/hearing-loss-common-problem-older-adults.
3. Id.
4. U.S. Department of Health and Human Services, “National Plan to Address Alzheimer’s Disease: 2021 Update,” December 27, 2021, https://aspe.hhs.gov/reports/national-plan-2021-update.
5. NPR, “Untreated Hearing Loss Linked To Loneliness And Isolation For Seniors,” Rochelle Sharpe, September 12, 2019, https://www.npr. org/sections/health-shots/2019/09/12/760231279/untreated-hearing-loss-linked-toloneliness-and-isolation-for-seniors; The Seattle Times, “For older adults, isolation can lead to overwhelming loneliness,” Paige Cornwell, September 19, 2021, https://www.seattletimes.com/seattlenews/mental-health/forolder-adults-isolation-can-lead-to-overwhelming-loneliness/#:~:text=The%20Mental%20Health%20Project%20is,mobility%20for%20children%20and%20families.
6. National Academies of Sciences, Engineering, and Medicine, “Hearing Health Care for Adults: Priorities for Improving Access and Affordability,” 2016, p.128, http://www.nationalacademies.org/hmd/Reports/2016/Hearing-Health-Care-for-Adults.aspx.
7. 42 USC 1395y.
8. Memorandum from Sheree Kanner, Hogan Lovells, to Academy of Doctors of Audiology, “Medicare Coverage of Diagnostic Audiology Services,” October 14, 2016, https://www.audiologist.org/_resources/documents/news/Scope-of-Practice-Patients-Over-Paperwork.pdf.
9. Center for Medicare and Medicaid Services, Calendar Year (CY) 2023 Medicare Physician Fee Schedule Proposed Rule, July 7, 2022, https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2023-medicarephysician-fee-schedule-proposed-rule.
10. Tweet by the White House, September 26, 2022, https://twitter.com/WhiteHouse/status/1574530518233894912?s=20&t=XtMeiUN_KUikmgbm94A7Gg.