[Federal Register Volume 69, Number 104 (Friday, May 28, 2004)]
[Rules and Regulations]
[Pages 30580-30587]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-12096]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 440

[CMS-2132-F]
RIN 0938-AM26


Medicaid Program; Provider Qualifications for Audiologists

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Final rule.

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SUMMARY: This final rule will revise the requirements for audiologists 
furnishing services under the Medicaid program. As a result, the 
requirements will create consistency with the Medicare program's 
definition of a qualified audiologist by recognizing State licensure in 
determining provider qualifications. These revised standards will 
expand State flexibility in choosing qualified audiologists.

DATES: Effective Date:
    These regulations are effective on June 28, 2004.

FOR FURTHER INFORMATION CONTACT: Mary Clarkson, (410) 786-5918.

SUPPLEMENTARY INFORMATION: 

I. Background

A. Medicaid Requirements

    Medicaid is the Federally assisted State program authorized under 
title XIX of the Social Security Act (the Act) that provides funding 
for medical care provided to certain needy aged, blind, and disabled 
persons, families with dependent children, and low-income pregnant 
women and children. Each State determines the scope of its program, 
within limitations and guidelines established by the law and 
implementing regulations at 42 CFR chapter IV, subchapter C. Each State 
submits a State plan that, when approved by us, provides the basis for 
granting Federal funds to cover part of the expenditures incurred by 
the State for medical assistance and the administration of the program.
    Section 1902(a) of the Act specifies the eligibility requirements 
that individuals must meet in order to receive Medicaid. Other sections 
of the Act describe the eligibility groups in detail and specify 
limitations on what may be paid for as ``medical assistance.'' Under 
section 1905(a) of the Act, States must provide certain basic services. 
Section 1905(a) of the Act also identifies categories of services 
States may provide as medical assistance.
Audiology Services
    Under the Medicaid program, States have the option of providing 
services for individuals with speech, hearing, and language disorders. 
Services for individuals with speech, hearing, and language disorders 
historically have been permitted under the Secretary's discretionary 
authority under section 1905(a)(11) of the Act, which authorizes the 
Medicaid program to make Federal funding available for State 
expenditures under an approved State Medicaid plan for audiology 
services for eligible individuals provided by audiologists meeting the 
provider requirements stipulated in Federal regulations at 42 CFR 
440.110(c). States have discretion to further define audiology services 
by specifying the amount, duration, and scope of the service. 
Furthermore, while States can elect whether they plan to provide 
audiology services to their adult Medicaid population, they are 
mandated to provide all medically necessary services to Medicaid-
eligible persons under 21 years of age under the Federally mandated 
Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) 
program. Combined with requirements for providing services to children 
with disabilities under the Individuals with Disability Education Act 
(IDEA) (Pub. L. 105-17, enacted on June 4, 1997), Medicaid is 
responsible for payment of a substantial number of school-based speech, 
hearing, and language services provided by, or under the direction of, 
qualified providers defined at Sec.  440.110(c).
    Under Medicaid, States are permitted the flexibility to provide 
audiology services under a variety of benefits. The majority of States 
offering audiology services do so under their home health benefit 
defined at Sec.  440.70, or under optional benefits such as the 
therapies benefit defined at Sec.  440.110, the rehabilitation benefit 
defined at Sec.  440.130(d), or the clinic benefit defined at Sec.  
440.90. However, regardless of the benefit used to provide audiology 
services, the specific provider requirements at Sec.  440.110(c) must 
be adhered to. Current Medicaid rules governing audiology services also 
permit States the flexibility to provide audiology services by, or 
under the direction of, a qualified audiologist. This flexibility is 
recognized and widely used by States to provide audiology services to 
Medicaid-eligible children under IDEA in school-based settings.
    Existing regulations at Sec.  440.110(c)(2) require audiologists to 
hold a certificate of clinical competency from the American Speech-
Hearing-Language Association (ASHA), or its equivalent, to furnish 
audiology services. Individuals with speech, hearing, and language 
disorders must be referred by a physician or other licensed 
practitioner of the healing arts within the scope of his or her 
practice under State law.

B. Medicare Audiology Requirements

    Before the Social Security Amendments of 1994 (Pub. L. 103-432, 
enacted on October 31, 1994), statutory requirements governing the 
Medicare program required speech pathologists and audiologists to meet 
the academic and clinical experience requirements for a Certificate of 
Clinical Competence (CCC-A) granted by ASHA. In accordance with section 
146 of the Social Security Amendments of 1994, Medicare revised its 
statutory requirements for speech pathologists and audiologists, 
removing the requirement for ASHA certification and placing primary 
reliance for determining provider qualifications on State licensure.
    In summary, section 1861(ll)(3)(B) of the Act currently governing 
Medicare audiology services, defines an audiologist as an individual 
with a master's or doctoral degree who is licensed by the State or who 
meets specific academic and clinical requirements if providing services 
in a State that does not license audiologists.
    Unlike the Medicaid program, Medicare does not permit audiology 
services to be provided under the direction of a qualified audiologist.

C. Creating Consistency With the Medicare Program

    As noted in our April 2, 2003, proposed rule (68 FR 15974), the 
revision of the Medicare requirements in 1994 prompted letters from 
audiology professionals and interested congressional members urging us 
to create consistency in the Medicaid and Medicare programs' definition 
of a qualified audiologist by adopting the Medicare definition of 
qualified audiologist to recognize the role of State licensure in 
defining a Medicaid qualified audiologist. Proponents recommending the 
change stated that

[[Page 30581]]

the Medicaid definition had not changed in over 20 years and predated 
the national trend toward greater reliance on State determinations of 
professional qualifications through licensure. Our April 2, 2003, 
proposed rule noted that our initial responses to letters urging 
consistency expressed reluctance to change the Medicaid requirements 
due to the potential of adversely affecting quality and access to care 
as well as State flexibility. In addition, we noted our concern about 
adversely impacting services provided to children receiving school-
based audiology services under IDEA since school providers are often 
exempt from State licensure laws.
    As we discussed, continued requests to reconcile the differing 
definitions prompted us to consider options for changing the Medicaid 
regulations in a manner that would not compromise State flexibility and 
quality of care. As we stated in our April 2, 2003, proposed rule, the 
revised requirements are a result of meetings and interviews with 
parties most likely to be affected by such a change.
    As in the April 2, 2003, proposed rule, we again note that this 
rule addresses the qualifications of audiologists as defined under 
Sec.  440.110(c). The requirements under Sec.  440.110(c)(2) addressing 
qualified speech-language pathologists (SLPs) remain as defined in 
existing regulations.

II. Provisions of the Proposed Regulations

    On April 2, 2003, we published a proposed rule in the Federal 
Register that specified our intent to revise the existing Medicaid 
regulations governing audiologists to adopt the Medicare standards to 
recognize State licensure as a qualifying provider standard. Unlike 
Medicare's standards, however, we proposed to apply the ``default'' 
standards to States that license, as well as to those States that do 
not license audiologists or that have specific licensure exemptions. 
Thus, all audiologists are required to have met specific academic and 
clinical standards, regardless of whether they practice in a State that 
has a licensure program, no licensure program, or that exempts certain 
audiologists from licensure. As we indicated in the April 2, 2003, 
proposed rule, the revised requirements also serve to recognize the 
autonomy of the professions of audiology and speech-language pathology 
by adding a new paragraph (c)(3) Sec.  440.110 to separately define a 
qualified audiologist. We also stated that the revised audiology 
requirements increased State flexibility in determining who is 
qualified to provide Medicaid audiology services. We noted that our 
research of national audiology usage and review of currently approved 
Medicaid State Plans also led us to conclude that most, if not all, 
qualified audiologists currently enrolled in the Medicaid program will 
continue to be qualified as a result of the continued flexibility in 
this rule. We commented on our expectation that States will continue to 
provide audiology services using the flexibility already granted under 
the Medicaid program to provide audiology services using individuals 
meeting State provider qualifications and working within State practice 
acts ``under the direction of'' a qualified Medicaid audiologist.
    Additionally, we noted that conforming the Medicare and Medicaid 
provider requirements serve to eliminate the confusion providers may 
experience in complying with Federal rules and help to reduce or 
eliminate conflict where audiologists provide services to both the 
Medicaid and Medicare populations. We also pointed out that the revised 
standards eliminate inconsistencies in Medicaid provider standards and 
eliminate the need for equivalency rulings, which were administratively 
burdensome and time-consuming for States to obtain.
    Finally, because the authority to provide services under direction 
remains unchanged, the preamble of the April 2, 2003, proposed rule 
included our guidance on providing audiology services ``under the 
direction of.'' We included the guidance in response to requests for 
our interpretation of acceptable standards of practice when providing 
services under the direction of a qualified audiologist.

III. Analysis of and Responses to Public Comments

    We received 107 timely letters containing over 1,323 public 
comments in response to the April 2, 2003, proposed rule. The comments 
came from a variety of correspondents, including professional 
associations, physicians, health care workers, State Medicaid programs, 
and members of the Congress. We reviewed each commenter's letter and 
grouped like or related comments. After associating comments, we placed 
them in categories based on subject matter or based on the section(s) 
of the regulations affected and then reviewed the comments. All 
comments relating to general subjects, such as the format of the 
regulations, were similarly reviewed. This process identified areas of 
the proposed regulation that required review in terms of their effect 
on policy, consistency, or clarity. The following is a summary of the 
comments received and our response to those comments.

Reconciling Medicare and Medicaid Definitions

    Comment: Fifty-two commenters stated they thought it important for 
us to speak with one voice on who is a qualified audiologist to 
reconcile the Medicare and Medicaid rules.
    Response: As stated in the April 2, 2003, proposed rule, the 
primary purpose for revising the existing audiology provider 
requirements is to reconcile the Medicare and Medicaid definitions. We 
agree it is important for us to create consistency in the Medicare and 
Medicaid programs wherever possible. We believe our proposal 
incorporating State licensure as a standard defining a qualified 
Medicaid audiologist helps to bring the two definitions into closer 
conformity and creates increased flexibility for States and providers 
of audiology services.

State Licensure

    Comment: Sixty-three commenters stated that deferring to State 
licensure is the most appropriate course of action since many new 
audiology graduates are declining to purchase private certification and 
many who previously purchased their private certification are no longer 
doing so, choosing instead to rely on State licensure. Many also stated 
that State licensure, rather than private certification, is the most 
widespread system for determining the qualifications of health care 
professionals and best serves the goal of consumer protection. The 
majority of these commenters also said that recognition of State 
licensure serves to improve access to audiology services, particularly 
in rural States where ASHA-certified individuals are not always 
available.
    Response: As proposed, the revised Medicaid standards incorporate 
recognition of State licensure in defining a qualified Medicaid 
audiologist. As we stated in the proposed rule, we believe recognition 
of State licensure will afford States increased flexibility in 
determining who is qualified to provide Medicaid audiology services, 
thereby increasing the provider pool of ``qualified'' individuals.
    Comment: Two commenters expressed support of the proposal to 
recognize State licensure, but stated that if private certification is 
mentioned in our rules, the American Board of Audiology certification 
must be included.

[[Page 30582]]

    Response: While we appreciate the intention behind this suggestion, 
we do not plan to specifically cite the American Board of Audiology 
certification as a qualifying standard since the primary purpose in 
revising the Medicaid audiology standards is to recognize the role of 
State licensure. Continued reference and reliance on the ASHA CCC-A in 
the final rule serves to continue our recognition of individuals 
currently qualified and enrolled in the Medicaid program by virtue of 
their ASHA certification. In addition, retention of ASHA certification 
as a provider standard helps ensure that those individuals who are 
dually certified as speech-language pathologists and audiologists do 
not face additional compliance burdens by having to comply with two 
different standards within the Medicaid program itself.
    Comment: Twenty-seven respondents stated they supported the generic 
definition of an audiologist in instances where State licensure does 
not exist or where there are special provider exemptions. One commenter 
felt the proposed standardized definition would enhance access to 
services by virtue of removing any confusion regarding the 
qualifications of the individuals(s) providing the needed services. 
Others commented that the generic definition of an audiologist is very 
important for those States, and those circumstances, where licensure 
does not exist or apply, particularly since a State license should 
determine ability to practice--not membership in a political lobbying 
group. A few commenters who expressed support of the generic definition 
also stated that the generic definition helped resolve concerns around 
licensure exemptions of school-based audiology providers.
    Response: We agree that the generic definition of an audiologist is 
very important for those States, and in those circumstances, where 
licensure does not exist or apply. As we noted previously, the proposed 
``generic standards'' serve to provide additional consumer protections 
by ensuring that Medicaid audiology services continue to be provided 
by, or under the direction of, professionally recognized individuals 
who have completed academic and clinical training programs consisting 
of demonstrated high quality industry standards.
    Comment: Two respondents expressed overall support of the revised 
standards but strongly encouraged us to recognize State licensure as 
the sole national standard for defining qualified audiologists.
    Response: We do not believe recognition of State licensure as the 
sole national standard for defining qualified audiologists is in the 
best interests of the Medicaid population. As stated in the April 2, 
2003, proposed rule, because many States either choose not to license 
audiologists or exempt audiologists practicing in specific settings 
from licensure, we believe it imperative that we also incorporate 
quality standards defining qualified audiologists that guarantee 
Medicaid-eligible individuals receive services from recognized, 
qualified professionals in their field.
    Comment: One respondent supported the April 2, 2003, proposed rule 
but expressed concern that the requirement of 350 clock-hours of 
supervised clinical practicum creates a more restrictive environment 
than current State licensure requirements. The respondent stated that 
``this restriction would reduce the number of audiologists available to 
the Medicaid population and increase the provider registration burden 
to the local program to verify training hours rather than simply 
verifying licensure.''
    Response: As stated in the April 2, 2003, proposed rule, we believe 
the inclusion of minimum standards relating to the provision of 
Medicaid audiology services serves to address concerns about quality of 
care in instances where State licensing does not apply. In addition, 
the proposed Medicaid standards are consistent with the Medicare 
program standards, helping to further create consistency between the 
two programs.
    We note, however, that we are unclear as to this comment since 
States currently are required to meet the existing Medicaid 
requirements at Sec.  440.110(c), which require that an individual be 
ASHA-certified or working toward certification. Since ASHA 
certification requires a minimum of 375 clock-hours of clinical 
practicum, we do not believe the proposed requirement of 350 clinical 
clock-hours is more restrictive. In addition, we believe States 
continue to enjoy the additional flexibility afforded them under the 
Medicaid program since the proposed standards retain the provision 
permitting audiology services to be provided under the direction of a 
qualified audiologist.
    We also should point out that as a usual and customary business 
activity, the Medicaid program requires States to ensure that enrolled 
Medicaid providers meet all qualification requirements set forth in 
Federal and State law. Providers of Medicaid services must be in 
compliance with any relevant Federal provider requirements at the time 
services are furnished to appropriately claim and receive Medicaid 
reimbursement.

ASHA Certification

    Comment: Twenty-three respondents expressed support for the April 
2, 2003, proposed rule and retention of the CCC-A. The respondents 
stated they are pleased that we recognize the need to retain the CCC-A 
as the professional industry standard that ensures quality services 
continue to be provided to Medicaid beneficiaries. Many specifically 
stated concern that removal of the CCC-A would present a special 
problem for Medicaid services furnished in the school setting, 
especially where a teacher's certificate is used in lieu of State 
licensure. Four additional commenters felt that continued reliance on 
the ASHA CCC-A retains compliance for dually certified individuals and 
ensures reciprocity.
    Seventeen commenters supported retaining ASHA certification, 
specifically because they believe State licensure alone is not a 
sufficient tool to establish competency. They stated that because not 
all States license audiologists and because not all States have 
universal licensure, reliance on State licensure results in audiology 
services being provided by lesser or unqualified individuals.
    Two commenters stated that we should retain the current rule and 
reliance on ASHA. They believe that the CCC-A should continue to be the 
primary credentialing authority so as not to weaken the quality of the 
workforce and quality of care.
    Response: Our proposed definition of a qualified audiologist 
continues recognition of the CCC-A as a standard for determining 
qualifications to provide Medicaid audiology services. As we noted, the 
existing requirements at Sec.  440.110(c)(2), which rely on ASHA 
certification or its equivalent to define a Medicaid speech-language 
pathologist, remain unchanged. Therefore, retention of the CCC-A serves 
to maintain consistency in provider standards within the Medicaid 
program, as well as limit the administrative burden to States and to 
individuals who are dually certified. In addition, as we stated above, 
we believe the standards requiring specific academic achievements and 
clinical training proposed in this rule serve as added protection to 
ensure services are provided by professionally recognized and qualified 
audiologists.
    Comment: We received nine comments in support of the proposed rule 
but objecting to mandating

[[Page 30583]]

affiliation with ASHA or any credentialing bodies to receive 
reimbursement for Medicaid audiology services. Three additional 
respondents stated they do not support continued reliance on ASHA 
stating that it is a monopoly with no value to its membership.
    Response: While it is not our role to comment on the personal 
merits of membership in national organizations, it is our role to 
ensure that Medicaid beneficiaries receive services from professionally 
recognized, highly qualified individuals in the field of audiology. 
Federal and private deeming agencies have recognized the CCC-A as a 
quality credentialing program for over 30 years. Thus, Medicare and 
Medicaid regulations governing speech, language, and hearing services 
have historically placed reliance on the knowledge and skills inherent 
with ASHA certification. Our intent in revising the Medicaid standards 
is not to eliminate reliance on those quality standards but to conform 
the Medicare and Medicaid programs through recognition of State 
licensure to define a qualified audiologist. Our revised standards 
continue recognition of ASHA certification, not only because it is a 
recognized industry quality standard, but more importantly because it 
ensures continuity and reciprocity for those providers who are dually 
certified and/or currently enrolled in the Medicaid program by virtue 
of certification. Thus, ASHA certification is no longer mandated, but 
is retained as one method by which individuals qualify to provide, or 
continue to provide, Medicaid audiology services.

Support April 2, 2003, Proposed Rule

    Comment: We received a considerable number of comments in support 
of the April 2, 2003, proposed rule overall. In summary, seventy-three 
commenters wrote in strong support of the rule and urged us to 
finalize. Forty-five of these same commenters stated they believe the 
April 2, 2003, proposed rule would improve access to Medicaid audiology 
services. Sixty-three stated they supported recognition of State 
licensure, twenty-seven thought the generic definition of an 
audiologist very important in States and instances where licensure does 
not exist or apply, and fifty-two said they thought it important that 
we reconcile the Medicare and Medicaid rules defining a qualified 
audiologist.

Opposed to April 2, 2003, Proposed Rule

    Comment: We received a total of thirteen timely letters containing 
a variety of comments in opposition to the April 2, 2003, proposed 
rule. Eight commenters expressed opposition to the April 2, 2003, 
proposed rule ``urging CMS to make significant revisions to correct the 
severe flaws in this regulation'' and stating the rule 
``inappropriately and broadly expands the scope of practice of 
audiologists, presenting grave patient care concerns and devastating 
consequences on the quality of health care available to Medicaid 
patients with hearing disorders.''
    Several others also commented that the April 2, 2003, proposed rule 
subverts a physician's role as the first point of patient contact. 
Specifically, commenters stated that hearing and balance disorders are 
medical conditions that require a full history and physical examination 
by a physician and a medical diagnosis with medical management and 
treatment options presented and pursued by a physician. Other 
commenters stated that audiologists do not and should not engage in 
prescribing care for hearing and balance disorders. Several commenters 
stated, ``audiologists and speech-language pathologists, as non-
physician health professionals, simply do not possess the training 
necessary to carry out medical responsibilities that physicians do.'' 
Five commenters stated the rule should specifically include physicians 
as providers.
    Two commenters opposed the rule stating that we should retain the 
current rule and the ASHA CCC-A to avoid weakening the quality of 
workers and care.
    Response: The requirements finalized in this rule address our 
commitment to conform the Medicare and Medicaid programs through 
recognition of State licensure as a qualifying Medicaid standard. It 
does not change the scope of practice of professional audiology 
services. It also does not alter the current role of physicians in 
evaluating and determining an individual's need for audiology services. 
Existing regulations at Sec.  440.110(c) require that an individual be 
referred by a physician or other licensed practitioner of the healing 
arts within the scope of his or her practice under State law before the 
receipt of audiology services. Therefore, physicians and other licensed 
practitioners practicing within the scope of State law continue to play 
an important role in ensuring that individuals receive appropriate 
medical evaluations and assessments to diagnose the need for audiology 
services. We agree with the comment that audiologists do not possess 
the training necessary to carry out the medical responsibilities of 
physicians and therefore should provide only those audiology services 
within the scope of practice governing their profession.
    Also in response to the above comments, we again point out that the 
Medicaid program permits speech-language and hearing services to be 
provided by physicians or under the supervision of physicians, under 
Medicaid's physician services benefit in accordance with regulations at 
Sec.  440.50. Audiology services may be provided under this benefit as 
the qualifications of a physician can be construed as including those 
of providers of speech-language and hearing services as long as their 
services are provided ``within the scope of practice of medicine or 
osteopathy as defined by State law * * * or under the personal 
supervision of an individual licensed under State law to practice 
medicine or osteopathy.''
    Thus, in response to the comment to include physicians in our final 
rule, we do not plan to adopt this suggestion. As noted above, Medicaid 
regulations continue to require a physician referral before receipt of 
audiology services as defined under Sec.  440.110(c). In addition, 
Medicaid regulations at Sec.  440.50 permit physicians working within 
State practice acts to provide, or supervise the provision of, 
audiology services.
    In response to the comments opposing the April 2, 2003, proposed 
rule in favor of retaining the existing requirement for ASHA 
certification due to quality concerns, we believe our proposed 
standards, which include recognition of State licensure, combined with 
specific academic and clinical training standards and continued 
recognition of ASHA certification, continues our commitment to ensure a 
quality workforce and quality care.
    Comment: We received seven comments in opposition to the April 2, 
2003, proposed rule because ``it established a gatekeeper role and 
impedes access to hearing health care services by facilitating 
establishment of a gatekeeper system of care and inappropriately 
placing audiologists as gatekeepers to Medicaid hearing services.''
    Response: See our detailed response to comments on physician 
involvement above. We do not believe the April 2, 2003, proposed rule 
inappropriately places audiologists as gatekeepers to Medicaid hearing 
services since Sec.  440.110(c) continues to require a referral by a 
physician or other licensed practitioner of the healing arts before 
receipt of audiology services. Our proposed standards address 
reconciling the Medicare and Medicaid provider requirements through 
recognition of State licensure and do not authorize

[[Page 30584]]

broadening the scope of audiology services beyond the parameters of the 
profession.
    Regarding the above, we wish to note our concern that a number of 
the comments we received regarding the role of physicians in providing 
Medicaid audiology services are the result of the guidance included in 
the preamble of the April 2, 2003, proposed rule, which offered our 
interpretation for appropriately providing services under the direction 
of a qualified audiologist. We believe we may have inadvertently caused 
some confusion by using terminology typically associated with physician 
services, and not audiology services. Specifically, our use of phrases 
such as ``prescribe the type of care provided'' and ``to ensure 
beneficiaries are receiving services in a safe and efficient manner in 
accordance with accepted standards of medical practice,'' apparently 
gave some readers the impression that we intend to expand the scope of 
practice for participating audiologists. We did not intend to do so.
    Therefore, as noted below, the guidance regarding services provided 
``under the direction of'' in this final rule has been revised to 
include language more appropriately reflecting the nature and scope of 
professional practice for audiologists providing Medicaid services.

Miscellaneous Comments

    Comment: One commenter expressed concern that the April 2, 2003, 
proposed rule eliminates hearing aid specialists from Medicaid stating 
that ``hearing aid specialists are integral members of the hearing 
healthcare team as they assess hearing and select, fit, and dispense 
hearing aids and related devices while providing instruction, 
rehabilitation, and counseling in the use and care of hearing aids and 
related devices.''
    Response: We do not agree that this final rule eliminates hearing 
aid specialists from participation in the Medicaid program. Further, 
this final rule will not affect the ability of hearing aid specialists 
to provide Medicaid-funded services. Currently, under Medicaid, it is 
possible for a hearing aid specialist to provide and receive Medicaid 
payment for services if he or she meets the provider requirements at 
Sec.  440.110(c) and if the State offers those services under its 
Medicaid program. Individuals not meeting the specific requirements at 
Sec.  440.110(c) may still be eligible to provide services ``under the 
direction of'' if so permitted within their scope of practice under 
State law. In addition, hearing aid services may be reimbursed 
depending upon the method in which they are covered under a State's 
Medicaid plan. For example, if hearing services are being provided by 
individuals licensed in the State as physicians, or under the 
supervision of a physician as defined in the Medicaid's physician 
services benefit at Sec.  440.50, then providers must meet the provider 
qualifications applicable to those requirements. Providers must meet 
those qualifications because the qualifications of a physician can be 
construed as subsuming those of providers of speech-language and 
hearing services when they are provided as physician services.
    Comment: Two respondents expressed concern that their organizations 
were not included in discussions and meetings before publication of the 
April 2, 2003, proposed rule. One ``respectfully urges its inclusion 
whenever issues relating to hearing health are considered.'' The other 
``* * * would like to request a meeting to discuss these issues, and 
any other speech, language, and hearing health care issues of interest 
to CMS.''
    Response: It was not our intent to exclude any particular group or 
organization from participating in discussions and meetings before 
publication of the April 2, 2003, proposed rule. As we stated in the 
preamble, the intent of the contacts before publication was to gain an 
understanding of the implications change would have on Medicaid 
programs, providers, and beneficiaries. While we believe the 
information gained achieved that goal, we acknowledge and appreciate 
the commenters' interest in the Medicaid program and the formation of 
its rules and policies. As always, we wish to remain responsive to all 
concerns and welcome future opportunities to discuss issues of mutual 
interest.

Services Provided ``Under the Direction of''

    Comment: Fourteen respondents commented positively on the guidance 
for providing services under the direction of a qualified audiologist. 
All urged us to strengthen the guidance to better ensure that Medicaid 
beneficiaries receive audiology services provided, or appropriately 
supervised, by a qualified audiologist. Three of the respondents 
suggested we establish what constitutes an appropriate supervisory 
ratio of Medicaid qualified providers v. ancillary support staff 
consistent with State laws and practices. They also believe we should 
set appropriate ratios of direct contact/supervisory time with the 
Medicaid recipient for both assessment and intervention. One commenter 
suggested strengthening our policy to advise audiologists in 
supervisory roles what recourse options they have if asked to supervise 
more ancillary support staff than is ethically reasonable, and to 
require States and school systems to provide ancillary support staff 
with the ability to reach the qualified audiologist by means of 
personal contact, telephone, pager, or other immediate means.
    Response: We appreciate the commenters' concerns and suggestions on 
ways to strengthen the guidance for providing services under direction. 
In response to the suggestion that we establish staffing ratios, we are 
not establishing a ratio of providers to ancillary staff because we 
believe this is best done by States in a manner that addresses the 
unique circumstances within the State. In addition, we believe placing 
specific requirements on States may go beyond the authority of the 
guidance contained in this document and would require revisions to the 
regulatory requirements at Sec.  440.110(c). We have, however, 
incorporated more general language offering our guidance with respect 
to staffing ratios by stating that we expect contractual agreements 
between providers to include requirements such as appropriate 
supervisory ratios and information on reporting instances of abuse of 
ethical practices. In response to the suggestion to require States and 
school systems to provide contact information, we revised the guidance 
to indicate our expectation that individuals working under the 
direction of a qualified audiologist be given contact information to 
enable them to directly contact the supervising audiologist as needed 
during treatment.
    We also would like to say that our guidance in this area is 
evolving, particularly as it relates to speech-language and hearing 
services provided to Medicaid-eligible children in schools. We 
anticipate that we will continue to update and provide guidance as 
necessary to States and providers through various means such as State 
Medicaid Manual guidelines, letters to State Medicaid Directors, and 
educational documents, as well as direct technical assistance to State 
Medicaid agencies.

IV. Provisions of the Final Regulations

    This final rule incorporates the provisions of the proposed rule. 
Thus, we are adopting the provider standards in the proposed rule as 
final.
    Thus, this regulation creates a separate definition at Sec.  
440.110(c)(3) pertaining to qualified audiologists under the Medicaid 
program. We are making a minor technical revision to

[[Page 30585]]

Sec.  440.110(c)(2) to remove the reference to audiologists. Section 
440.110(c)(1) remains unchanged and continues to require ``a patient be 
referred by a physician or other licensed practitioner of the healing 
arts within the scope of his or her practice under State law'' to 
receive Medicaid audiology services.
    In addition, although not part of the standards affected by this 
final rule, we are reiterating the guidance for providing services 
``under the direction of.'' The guidance is intended as our 
interpretation of appropriate practice standards when providing 
audiology services under direction set forth Sec.  440.110(c)(1). In 
response to public comments, we have made some revisions to clarify and 
eliminate confusion regarding an audiologist's scope of practice and to 
strengthen the guidance to ensure quality services are being provided 
in an appropriate and professional manner (specific responses to 
respondents' comments are addressed in section III).

``Under the Direction of''

    Audiology services provided under Sec.  440.110(c)(1) require that 
the ``services be provided by or under the direction of an audiologist 
for which a patient is referred by a physician or other licensed 
practitioner of the healing arts within the scope of his or her 
practice under State law.''
    We interpret the authority to provide services ``under the 
direction of'' an audiologist to mean that a federally qualified 
audiologist who is directing audiology services must supervise each 
beneficiary's care. To meet this requirement, the qualified audiologist 
must see the beneficiary at the beginning of and periodically during 
treatment, be familiar with the treatment plan as recommended by the 
referring physician or other licensed practitioner of the healing arts 
practicing under State law, have continued involvement in the care 
provided, and review the need for continued services throughout 
treatment. The supervising audiologist must assume professional 
responsibility for the services provided under his or her direction and 
monitor the need for continued services. The concept of professional 
responsibility implicitly supports face-to-face contact by the 
qualified audiologist at least at the beginning of treatment and 
periodically thereafter. Thus, audiologists must spend as much time as 
necessary directly supervising services to ensure beneficiaries are 
receiving services in a safe and efficient manner in accordance with 
accepted standards of practice. To ensure the availability of adequate 
supervisory direction, supervising audiologists must ensure that 
individuals working under their direction have contact information to 
permit them direct contact with the supervising audiologist as 
necessary during the course of treatment.
    In many cases, qualified audiologists are employed by entities such 
as a Medicaid agency, clinic, or school. In such instances, the terms 
of the audiologist's employment must ensure that the audiologist is 
adequately supervising any individual providing audiology services. In 
addition to the supervisory requirements described above, employment 
terms should provide for supervisory ratios that are reasonable and 
ethical and in keeping with professional practice acts in order to 
permit the supervising audiologist to adequately fulfill his or her 
supervisory obligations and ensure quality care.
    In all cases, documentation must be kept supporting the qualified 
audiologist's supervision of services and ongoing involvement in the 
treatment services. Because Medicaid law requires that documentation be 
kept supporting the provision and proper claiming of services, 
appropriate documentation of services provided by supervising 
audiologists, as well as services performed by individuals working 
under the direction of a qualified audiologist, are necessary. Absent 
appropriate service documentation, Medicaid payment for services may be 
denied providers.
    Where appropriate, audiology services must adhere to all State 
requirements and State practice acts governing the provision of 
services under the direction of a qualified audiologist. As with all 
Medicaid benefits that permit services furnished under direction, both 
Federal and State requirements must be met at the time services are 
furnished for the Medicaid program to appropriately provide Federal 
financial participation for services furnished on behalf of Medicaid 
eligible individuals.

V. Collection of Information Requirements

    This document does not impose any information collection and 
recordkeeping requirements. Consequently, it need not be reviewed by 
the Office of Management and Budget under the authority of the 
Paperwork Reduction Act of 1995.

VI. Regulatory Impact Statement

A. Overall Impact

    We have examined the impacts of this rule as required by Executive 
Order 12866 (September 1993), Regulatory Planning and Review, the 
Regulatory Flexibility Act (RFA) (September 16, 1980, Pub. L. 96-354), 
section 1102(b) of the Social Security Act, the Unfunded Mandates 
Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
    Executive Order 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives, and if regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety 
effects, distributive impacts, and equity). A regulatory impact 
analysis (RIA) must be prepared for major rules with economically 
significant effects ($100 million or more in any 1 year).
    We are unable to provide a specific dollar estimate of the economic 
impact this final regulation will have on State and local governments 
and participating providers. Because the flexibility permitted under 
Medicaid allows States to provide audiology under various Medicaid 
benefits, it is not possible to capture accurate expenditure data.
    We have determined, however, that this rule is not a major rule 
under Executive Order 12866, and that this rule will not have a 
significant economic impact on a substantial number of small entities. 
We have made this determination because while we believe this rule will 
permit States to have more flexibility in determining who is qualified 
to provide audiology services, we do not anticipate any increase in 
States' use of audiology services due to this regulation. Section 
804(2) of title 5, United States Code (as added by section 251 of Pub. 
L. 104-121), specifies that a ``major rule'' is any rule that the 
Office of Management and Budget finds is likely to result in--
     An annual effect on the economy of $100 million or more;
     A major increase in costs or prices for consumers, 
individual industries, Federal, State, or local government agencies, or 
geographic regions; or
     Significant adverse effects on competition, employment, 
investment productivity, innovation, or on the ability of United 
States-based enterprises in domestic and export markets.
    In addition, consistent with the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 through 612), we prepare and publish an initial 
regulatory flexibility analysis for proposed regulations unless we have 
determined that the regulations would not have a significant impact on 
a substantial number of small entities. For purposes of the RFA, we do 
not consider States or individuals to be small entities.

[[Page 30586]]

    The RFA requires agencies to analyze options for regulatory relief 
of small businesses. For purposes of the RFA, small entities include 
small businesses, nonprofit organizations, and government agencies. 
Most hospitals and most other providers and suppliers are small 
entities, either by nonprofit status or by having revenues of $6 
million to $29 million in any 1 year. For purposes of the RFA, 
audiologists that generate total revenues of $6 million or less in any 
1 year are considered to be small entities. The Small Business 
Administration (SBA) categorizes small businesses for audiologists 
along with physical, occupational, and speech therapists. The total 
number of providers within this category that have total revenues of 
between $5 million and $7.5 million or less in any 1 year is 23,823 
that they consider small businesses. Those firms and establishments 
with total revenue above $7.5 million are not considered small 
businesses according to the SBA. Therefore, approximately 0.92 percent 
of audiologists are considered small businesses. (For further 
information on the SBA size standards, see 65 FR 69432.)
    In addition, section 1102(b) of the Act requires us to prepare a 
regulatory impact analysis if a rule may have a significant impact on 
the operations of a substantial number of small rural hospitals. Such 
an analysis must conform to the provisions of section 604 of the RFA. 
For purposes of section 1102(b) of the Act, we define a small rural 
hospital as a hospital that is located outside a Metropolitan 
Statistical Area and has fewer than 100 beds. This rule will not have a 
significant impact on small rural hospitals. The Medicaid program 
permits States the flexibility to provide audiology services under a 
variety of benefits. The majority of States do so under the home health 
benefit, the therapies benefit, and the rehabilitation benefit serving 
a variety of Medicaid beneficiaries. In addition, current Medicaid 
rules permit States the flexibility to provide audiology services by, 
or under the direction of, a qualified audiologist. This provider 
flexibility is recognized by States and is widely used to provide 
audiology services to children through school-based services programs. 
Because this rule retains the ability for audiology services to be 
provided ``under the direction of,'' the rule will not have an impact 
on how States currently provide services to their Medicaid populations. 
Therefore, small rural hospitals are not affected.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule that may result in expenditures in any 1 year by 
State, local, or tribal governments, in the aggregate, or by the 
private sector, of $110 million. We do not anticipate this rule will 
have an effect on the States, local, or tribal governments, or on 
private sector costs. As we stated earlier, this regulation gives 
States more flexibility in determining qualified audiologists thereby 
giving them the ability to choose from a larger provider pool of 
``qualified'' individuals. However, because we expect the primary users 
of Medicaid audiology services, such as children and seniors, to remain 
fairly constant, we do not anticipate any significant increase in the 
use of audiology services due to this rule. In addition, because 
Medicaid audiology services are optional for States to provide to their 
Medicaid populations, many States choosing to do so limit utilization 
in some manner. In addition, many States limit the use of optional 
services such as audiology in favor of mandatory Medicaid benefits. 
States providing audiology services to children under the EPSDT program 
primarily do so as part of their school based services program under 
IDEA. Since all 50 States currently have a school-based services 
program in operation, we do not anticipate this rule to have any 
significant effect on audiology services provided to Medicaid children.
    Additionally, recognizing that States currently use the flexibility 
permitted in the Medicaid law to provide audiology services ``under the 
direction of'' a qualified audiologist, we expect States will continue 
to do so by providing audiology services using individuals working 
under the supervision of qualified audiologists.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed rule (and subsequent 
final rule) that imposes substantial direct requirement costs on State 
and local governments, preempts a State law, or otherwise has 
Federalism implications. We do not believe this rule in any way will 
impose substantial direct compliance costs on State and local 
governments or preempts or supersedes State or local law. This rule 
permits States to use State-licensed audiologists to provide Medicaid 
audiology services, thereby giving them increased flexibility in 
providing Medicaid audiology services. In addition, after researching 
national audiology usage and reviewing States' currently approved 
Medicaid State Plans, we anticipate that most, if not all, qualified 
audiologists currently enrolled in the Medicaid program will continue 
to be qualified as a result of the continued flexibility established in 
this rule. For this reason, we do not believe that the change in 
requirements for audiologists included in this rule will result in 
reduced access to services, or otherwise result in fewer audiology 
services available through the Medicaid program. We also anticipate 
that States will continue to provide audiology services by using the 
additional flexibility already granted under the Medicaid program to 
provide audiology services using individuals meeting State provider 
qualifications and working within State practice acts ``under the 
direction of'' a qualified Medicaid audiologist. We believe the 
additional flexibility set forth in this rule to recognize State 
licensure will serve to enhance States' ability to provide services. We 
do not, however, anticipate this rule will have a significant effect on 
the actual provision of audiology services in State Medicaid programs, 
and, therefore, the rule does not have Federalism implications.

B. Anticipated Effects

    We anticipate this rule will give States increased flexibility in 
determining who is a Medicaid-qualified audiologist. We also anticipate 
that the quality care standards established in this rule will help 
ensure that Medicaid audiology services continue to be provided by, or 
under the direction of, highly qualified and trained individuals. 
Additionally, we believe conforming the Medicare and Medicaid provider 
requirements will help eliminate any confusion providers may experience 
in complying with Federal rules and help reduce or eliminate conflict 
where audiologists provide services to both the Medicaid and Medicare 
populations (such as in nursing facilities or through home health care 
agency providers). Additionally, this final rule also serves to 
eliminate inconsistencies in Medicaid provider standards by no longer 
recognizing equivalency rulings. Under the current Medicaid rules, 
States can seek equivalency rulings from their State Attorney General 
in instances where they believe State licensure is equivalent to ASHA 
certification. Since this rule recognizes State licensure that meets 
Medicare-equivalent standards, equivalency rulings are no longer 
necessary or required. We believe States will look favorably on the 
elimination of equivalency rulings since they proved administratively 
burdensome and time-consuming to obtain.

[[Page 30587]]

C. Alternatives Considered

    In developing the policies set forth in this rule, we met with 
professional organizations and interested parties to solicit their 
ideas and concerns. We also worked with our national regional office 
staffs to review currently approved Medicaid State Plans for 
information on the provision of audiology services in States' Medicaid 
programs. We considered the role of audiology services in the Medicaid 
program and the potential impact changes in the standards for audiology 
providers will have overall. We considered several options that 
suggested we-- (1) make no change to the current Medicaid audiology 
requirements; (2) retain current requirements but issue updated policy 
guidance on issues such as provider equivalency authority; (3) rewrite 
the current Medicaid regulations to adopt the current Medicare 
requirements; and (4) rewrite the current Medicaid regulations to adopt 
the Medicare standards, but with minimum standards that apply in States 
that license as well as those that do not license or that exempt some 
practitioners from State licensure requirements.
    After much research and consideration of the impact of each of the 
options, we concluded that option 4--the standards contained in this 
rule--best satisfies the Secretary's intention, and addresses the 
request raised by interested parties, to conform the definition of a 
qualified audiologist under the Medicare and Medicaid programs by 
recognizing the role of State licensure as a Medicaid provider 
requirement. We also concluded that the standards in this rule best 
continue to recognize the broad program discretion granted States under 
Medicaid by retaining program flexibility while at the same time also 
building in quality standards that continue to ensure Medicaid services 
are provided to all Medicaid-eligible individuals by recognized, highly 
trained professionals.

D. Conclusion

    For the reasons stated above, we are not preparing analyses for 
either the RFA or section 1102(b) of the Act because we have determined 
that this rule will not have a significant economic impact on a 
substantial number of small entities or a significant impact on the 
operations of a substantial number of small rural hospitals.
    In accordance with the provisions of Executive Order 12866, this 
regulation was reviewed by the Office of Management and Budget.

List of Subjects Affected in 42 CFR Part 440

    Grant programs--Health, Medicaid.

0
For the reasons set forth in the preamble, the Centers for Medicare & 
Medicaid Services amends 42 CFR chapter IV as set forth below:

PART 440--SERVICES: GENERAL PROVISIONS

Subpart A--Definitions

0
1. The authority citation for part 440 continues to read as follows:

    Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 
1302).

0
2. In Sec.  440.110, paragraph (c)(2) is revised, and a new paragraph 
(c)(3) is added to read as follows:


Sec.  440.110  Physical therapy, occupational therapy, and services for 
individuals with speech, hearing, and language disorders.

* * * * *
    (c) * * *
    (2) A ``speech pathologist'' is an individual who meets one of the 
following conditions:
    (i) Has a certificate of clinical competence from the American 
Speech and Hearing Association.
    (ii) Has completed the equivalent educational requirements and work 
experience necessary for the certificate.
    (iii) Has completed the academic program and is acquiring 
supervised work experience to qualify for the certificate.
    (3) A ``qualified audiologist'' means an individual with a master's 
or doctoral degree in audiology that maintains documentation to 
demonstrate that he or she meets one of the following conditions:
    (i) The State in which the individual furnishes audiology services 
meets or exceeds State licensure requirements in paragraph 
(c)(3)(ii)(A) or (c)(3)(ii)(B) of this section, and the individual is 
licensed by the State as an audiologist to furnish audiology services.
    (ii) In the case of an individual who furnishes audiology services 
in a State that does not license audiologists, or an individual 
exempted from State licensure based on practice in a specific 
institution or setting, the individual must meet one of the following 
conditions:
    (A) Have a Certificate of Clinical Competence in Audiology granted 
by the American Speech-Language-Hearing Association.
    (B) Have successfully completed a minimum of 350 clock-hours of 
supervised clinical practicum (or is in the process of accumulating 
that supervised clinical experience under the supervision of a 
qualified master or doctoral-level audiologist); performed at least 9 
months of full-time audiology services under the supervision of a 
qualified master or doctoral-level audiologist after obtaining a 
master's or doctoral degree in audiology, or a related field; and 
successfully completed a national examination in audiology approved by 
the Secretary.

(Catalog of Federal Domestic Assistance Program No. 93.778, Medical 
Assistance Program)

    Dated: January 23, 2004.
Dennis G. Smith,
Acting Administrator, Centers for Medicare & Medicaid Services.

    Approved: February 23, 2004.
Tommy G. Thompson,
Secretary.


    Editorial Note: This document was received at the Office of the 
Federal Register on May 25, 2004.


[FR Doc. 04-12096 Filed 5-27-04; 8:45 am]
BILLING CODE 4120-01-P