[Federal Register: May 28, 2004 (Volume 69, Number 104)]
[Rules and Regulations]
[Page 30580-30587]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28my04-10]
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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