Medicaid Guidance for Speech-Language Pathology Services: Addressing the "Under the Direction of" Rule

Background

Medicaid guidance for reimbursement of speech-language services provided in school settings is specific regarding the qualifications of the speech-language pathologist providing those services, but offers no specific direction regarding reimbursement for services provided by clinicians not meeting those standards. According to the Centers for Medicare and Medicaid (CMS), the federal agency that administers Medicaid, professionals who do not meet the qualification standards may, according to state requirements, provide services “under the direction of” a qualified speech-language pathologist. CMS has enabled individual states to establish standards for those persons who do not hold the speech-language pathology qualification standards specified by CMS and guidance for what entails “under the direction of.” As a result, there are great differences nationwide in the qualifications of personnel who are providing services for Medicaid billing in the schools and in the expectations of the supervising speech-language pathologists.

This situation raises the potential for several untenable legal, ethical, and workload situations for speech-language pathologists. Information gathered from the Department of Health and Human Services Office of Inspector General (OIG) audits of 18 states' Medicaid school-based programs (2003) revealed a variety of procedural errors in the areas of provider qualifications and appropriate documentation, including insufficient documentation to show that a lesser or unqualified provider was under the direction of a qualified provider. Furthermore, as Medicaid billing for school-based special education services has increased, ASHA members have voiced more frequent concerns regarding supervision of, directing, and “signing off” for Medicaid reimbursement for other speech-language clinicians in their school districts. Respondents to the ASHA 2003 Omnibus survey and to questionnaires distributed to Special Interest Division 16 members and to ASHA 2003 Schools Conference participants expressed a need for ASHA guidance on this issue.

In order to minimize any adverse effect on students receiving services in the school and any legal, ethical, and workload impact on the supervising speech-language pathologist, this document specifies the recommended minimum qualification and supervisory requirements for both the supervising and the supervised speech-language clinicians.

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History of Medicaid Billing for School-Based Speech-Language Pathology Services

Medicaid is a federal program, with certain requirements that apply nationwide. However, it is also a federal-state partnership. Each state prepares a plan outlining its program, including provider qualifications and services. Before implementation, each state plan must be approved by CMS. CMS is organized by region, with approval occurring at the regional office. As a result, despite CMS's oversight authority, the policies and procedures regarding Medicaid implementation vary from state to state. In some cases, a policy approved in one state would not be approved in another.

In 1988, the Medicare Catastrophic Coverage Act prohibited restriction of Medicaid funds to reimbursement of services outlined in the Individualized Education Plan (IEP) of a child with a disability. The Conference Committee Report specified that, while the state education agencies are financially responsible for educational services, in the case of a Medicaid-eligible child with handicaps, state Medicaid agencies remain responsible for the “related services” identified in the child's IEP if those services are covered under the state's Medicaid plan (see ASHA, 1991).

The 1997 Reauthorization of the Individuals with Disabilities Education Act ( IDEA, 1997) recognized the ability of school districts to bill Medicaid for certain special education services and included parental protections regarding access to special education services. IDEA assures that evaluations and IEP-specified services will be provided to the child by qualified special education providers, as defined by that state's education agency. IDEA does not address specific qualification standards nor does it require state education agencies to establish the same standard as the state's Medicaid agency.

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Provider Qualifications

The state-to-state variability in Medicaid programs is evident in the definition of personnel who are qualified to provide speech-language pathology services and services that are to be provided by personnel who don't meet the qualification standards. Each state establishes its own requirements for personnel qualifications, using the federal standard as the basis for state laws and regulations. States may also define the provision of services by lesser or unqualified personnel when they are “under the direction of” qualified personnel. Further, states are authorized to establish the qualification standards of persons who determine the medical necessity of the service.

Professional Standards. Medicaid guidance establishes the federal standard for qualified speech-language pathologists as “… an individual who—

1. Has a certificate of clinical competence from the American Speech [Language] Hearing Association;

2. Has completed the equivalent educational requirement and work experience necessary for the certificate; or

3. Has completed the academic program and is acquiring supervised work experience to qualify for the certificate.” (U.S. Department of Health & Human Services [DHHS], 2004; 42 CFR 440.110 (c) (i))

As states establish their own standards for “equivalent,” they generally use criteria developed by the state Board of Audiology and Speech-Language Pathology for licensure or by the state Board of Education for teacher certification or licensure. CMS must approve any determination of equivalency. CMS requires that each state justify the equivalency determination and submit the opinion of the state's attorney general regarding equivalency.

“Under the Direction of” Rule. Federal Medicaid guidance addresses provisions of services by lesser or unqualified speech-language pathologists (or audiologists):

“Services for individuals with speech, hearing, and language disorders means diagnostic, screening, preventive, or corrective services provided by or under the direction of a speech[-language] pathologist or 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.” (U.S. DHHS, 2004; 42 CFR 440.110 (c) (i))

CMS has offered minimal guidance to states regarding implementation of the “under the direction of” provision. On May 28, 2004, CMS published the Final Rule on Medicaid Audiology Qualifications ( U.S. DHHS, 2004). This rule offers language to clarify when services are furnished by or “under the direction of” a federally qualified audiologist (see Appendix A for the complete language). It also defines “qualified audiologist” as follows:

“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:

1. 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.

2. 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:

   1. Have a Certificate of Clinical Competence in Audiology granted by the American Speech-Language-Hearing Association.

   2. 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.”

The detailed requirements in section (ii)(B) above are essentially ASHA's 1993 requirements for the Certificate of Clinical Competence.

CMS has not offered comparable guidance for services provided “under the direction of” a qualified speech-language pathologist. The Health Care Financing Administration or HCFA (the former name of CMS) periodically surveyed coverage policies implemented by its regional offices and offered policy clarification. In 2001, a regional notice was issued to the states in HCFA Region IV (Alabama, Georgia, Kentucky, Mississippi, South Carolina and Tennessee) regarding “under the direction of” for speechlanguage pathology and audiology services. See Appendix B for the complete language in this notice.

Without clear and complete guidance from CMS, states and localities outside of Region IV can establish their own standards for “…under the direction of …,” resulting in the lack of any supervision requirements or vague, nonspecific requirements. The result is a high degree of variability in the standards.

Medical Necessity. Medicaid guidance indicates that services provided to children must be medically necessary. This standard is verified “by a physician or other licensed practitioner of the healing arts within the scope of his or her practice under state law” (U.S. DHHS, 2004; 44 CFR Section 440.120 (c ) (i)). Through the Medicaid state plan process, each state establishes whether this referral must be made by physicians or whether it may be made by speech-language pathologists licensed under state law.

Medical and Educational Requirements in Personnel Qualifications. One of the challenges of applying the Medicaid qualification and supervision requirements to the public education environment is the difference between qualifications and standards for medical providers versus educational providers. Medicaid sets provider qualification standards at the federal level that apply to all states. In contrast, provider qualification standards in education are the purview of each state. These standards vary from state to state and historically have not been based on ASHA certification. In the past, when the bachelor's level was the highest degree in the field, that degree was the educational standard. Gradually, master's degrees became more prevalent and served as the standard for ASHA certification and state licensure, but educational standards did not keep pace. States began to change their requirements following reauthorization of IDEA in 1986, when that Act required states to assure that personnel providing special education services meet the highest qualification standards set in the state. Since many states had the masters' degree (with or without ASHA certification) as the highest standard in the profession, the IDEA requirements moved state education agencies to amend their teacher credentialing standards to be comparable.

Currently, in 38 states, individuals entering a public school system must have at least a master's degree to work as a speech-language pathologist. However, even in those states, there are individuals who were “grandfathered,” continuing to be employed as a result of entering the school system when only a bachelor's degree was required. Further, there are states that provide emergency credentials for persons to provide services to students with speech-language impairments. The emergency credentials generally include requirements for meeting the qualification standards. However, depending upon the state's requirements, persons without background in the field may receive emergency credentials.

As states' Medicaid agencies worked to establish state equivalency standards to meet the federal speech-language pathology qualification standards, they had to address the varying standards between state licensure and state education credentials. As a result, there are vast differences nationwide in the credentials of persons recognized as qualified to provide reimbursable services and those who can provide services only “under the direction of” qualified personnel.

Table 1 reflects the variations in qualifications for supervisor and supervisee that may be recognized by various state Medicaid policies. As state terminology for speech-language clinicians and paraprofessionals will vary greatly, it is important to look at specific states' qualification standards, rather than the position title, to determine the qualifications of the specific person.

Challenges. The varying qualification requirements for supervisor and supervisee can create challenges in the relationships among staff and in the system. Although the relationship between the supervisor and the supervisee will vary by situation, ASHA members have reported the following challenging scenarios:

• A recent graduate with master's degree is asked to supervise a 25-year veteran with a bachelor's degree who holds state education credentials.

• Colleagues with different credentials have worked as equals for 5 years. When the school district decides to claim Medicaid reimbursement, the relationship changes as one staff member is now required to supervise a colleague or peer.

• A speech-language pathologist is required to review and sign paperwork of a less credentialed colleague without observing the actual delivery of service.

• A speech-language pathologist supervises several persons who are not qualified under Medicaid, in addition to carrying a full-time assignment and caseload.

• The supervising speech-language pathologist sees issues of concern. Yet with no evaluation authority (the principal conducts the personnel evaluation), he or she has limited ability to elicit a change in the supervisee's behavior.

Recommended Personnel Qualification Standards. In order to assure quality services to students with speech-language impairments, ASHA recommends that certain minimum qualification standards be met for both the supervisor and the supervisee. The recommended minimum qualifications for supervisors are an ASHA CCC and a contract with the employer of the supervised speech-language pathologist(s). In addition, the following standards are preferred for the supervisor:

• active interest in supervision

• training in supervision

• two or more years of experience after receiving a CCC

• willingness to serve in this role.

ASHA recommends that, at a minimum, supervisees (1) hold a standard state education license or certificate in speech-language disorders, (2) be a graduate student intern participating in an ASHA accredited program and receiving supervision in accordance with the supervision requirements of the CAA ( ASHA, 2000), (3) be an undergraduate intern participating in an undergraduate program in communication disorders and receiving supervision equivalent to the supervision requirements of the CAA, or (4) be a speech-language pathology assistant supervised according to ASHA guidelines ( ASHA, 2004). This standard excludes persons with emergency credentials from a state department of education (regardless of whether they have a degree in speech-language pathology) and paraprofessionals other than speech-language pathology assistants.

These standards are reflected in Table 2. The sections of the table that are shaded reflect those persons with qualifications who are recommended as either the supervisor or supervisee.

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Supervision

The speech-language pathologist who supervises^[2] personnel providing services to Medicaid eligible students is ethically and legally bound to assure that these students receive appropriate and high-quality speech-language services. This standard of care can be assured only when the supervisor directly observes the services provided, regularly reviews relevant paperwork, and confers with the supervisee. Supervisors must have explicit knowledge of the nature of services provided, should be able to suggest needed program modifications to the IEP team, and should facilitate development of supervisee clinical skills when needed.

The following supervision recommendations apply only to speech-language services received by Medicaid-eligible students “under the direction of” the qualified provider. Supervision guidelines for clinical fellows, student interns, and speech-language pathology assistants have been clearly defined in other documents (see Appendix C for Summary Table of Minimum Supervision Requirements) and may be above and beyond the guidelines described in this document. For those supervisees, those guidelines must also be followed, although a supervisor may meet components of those requirements while observing services for Medicaid-eligible students.

Supervisor Definition. As described previously, qualified providers supervising speech-language services to Medicaid-eligible students—

• should be speech-language pathologists holding a Certificate of Clinical Competence in Speech-Language Pathology from ASHA

• should have at least 2 years of experience following ASHA certification

• should have an active interest in supervision

• should have training in the supervisory process

• must be willing to serve in this role.

Supervision is a complex and multilayered task requiring knowledge and/or skills in clinical work, interpersonal relationships, regulatory issues, clinical writing and documentation, and clinical teaching. For supervising Medicaid-eligible students in the schools, knowledge of educational curriculum, district or state student assessment procedures, and classroom management also are needed. The above recommendations for supervisors were developed to assure that supervising clinicians possess the needed experience, information, motivation, and interest to assume this role. In addition, these tasks require considerable expenditure of time, effort, and skill on the part of the supervisor. As a result, supervision responsibilities should be factored into workload formulas to support the supervisor adequately to meet these demands.

Supervision Tasks. The multifaceted roles of supervisors are discussed in Clinical Supervision in Speech-Language Pathology and Audiology ( ASHA, 1985), which identifies 13 tasks integral to the supervisory process. These tasks are restated in this document to ensure that supervisors, supervisees, and administrators recognize the breadth of responsibilities assumed when serving in this role:

1. establishing and maintaining an effective working relationship with the supervisee;

2. assisting the supervisee in developing clinical goals and objectives;

3. assisting the supervisee in developing and refining assessment skills;

4. assisting the supervisee in developing and refining management skills;

5. demonstrating for and participating with the supervisee in the clinical process;

6. assisting the supervisee in observing and analyzing assessment and treatment sessions;

7. assisting the supervisee in development and maintenance of clinical and supervisory records;

8. interacting with the supervisee in planning, executing, and analyzing supervisory conferences;

9. assisting the supervisee in evaluation of clinical performance;

10. assisting the supervisee in developing skills of verbal reporting, writing, and editing;

11. sharing information regarding ethical, legal, regulatory, and reimbursement aspects of the profession;

12. modeling and facilitating professional conduct;

13. demonstrating research skills in the clinical or supervisory process.

These tasks clearly identify that supervision includes clinical teaching. The skills of the clinician providing speech-language service will affect the quality of that service. Supervisee development is often discussed using a continuum model ( Anderson, 1988; McCrea & Brasseur, 2003). Beginning supervisees need explicit evaluation/feedback. As supervisees become more independent, supervisors provide less direct instruction. Supervisory interactions must be adjusted to meet the needs of each individual supervisee. Supervisors may facilitate growth of a supervisee's skills by demonstrating and modeling, questioning, providing feedback, joint problem solving, or acting more as a consultant with skilled supervisees. Quality services for students will be assured only when supervisees are competent clinicians and paraprofessionals. Potential supervisors, supervisees, and their administrators must accept that the skills of the supervisee will be analyzed and that goals for improvement will be established when needed. Supervisors should involve supervisees in setting goals and assure that the established goals are specific and appropriate ( Dowling, 2001).

Supervisory Relationship. As identified in this document, the range of professionals who fall under the “lesser or unqualified provider” determination is broad and will vary from state-to-state (see Table 1). This presents a special challenge to the supervisor, who potentially is charged with supervising more experienced paraprofessionals, graduate student interns, or long-time colleagues. While the supervisor does assume ultimate responsibility for the services provided, both supervisor and supervisee should collaborate to provide quality speech-language services to students in the schools.

Supervision Recommendations. The nature, frequency, and length of supervision must be adequate to ensure that quality speech-language services are provided. The following recommendations are considered to be appropriate levels of observation, contact, and review needed to accomplish this goal, with the understanding that the time allocation will vary based on the individual circumstances and the needs of the student and supervisee. These recommendations build upon the language from the CMS Final Rule of Medicaid Audiology Qualification. The levels of direct and indirect supervision should be increased when client complexity, supervisee preparation, experience, and/or performance indicate the need for more guidance. Supervisory interactions should be maintained at an adequate level to allow the supervisor to determine whether the quality of services offered is appropriate. Graduate student supervisees or speech-language pathology assistants may require more demonstration or specific direction from the supervisor, while more experienced clinicians may benefit from a mentorship model.

Direct Supervision. At least twice per quarter, the ASHA-certified speech-language pathologist will directly observe each Medicaid-eligible student receiving speech-language services. The observation may be on-site or through real-time distance video technology. The length of the observation is not prescribed but should be adequate to ensure that the students are “receiving services in a safe and efficient manner in accordance with accepted standards of medical practice ( U.S. DHHS, 2004).

Indirect Supervision. At the beginning of each school year, the supervisor will review the IEP for each Medicaid-eligible student and determine that the speech-language service plan is appropriate.

At least twice per quarter, the supervisor will confer with the supervisee about each Medicaid-eligible student. The conference may be live, by phone, or by e-mail, and should include—

• discussion of direct observations

• review of records

• review of goals and progress made.

At least twice per quarter, the supervisor will review relevant paperwork for each Medicaid-eligible student to determine that the services provided are consistent with those prescribed in the IEP. Paperwork review should include—

• session notes

• attendance records

• progress reports (when applicable)

• updated assessment results (when applicable)

• relevant data.

Documentation. Records of supervisory contacts should be maintained and include—

• date of supervisor's review and approval of speech-language component of the IEP

• date of observation for each Medicaid-eligible student

• log of indirect supervision contacts (e.g., paperwork reviewed)

• date, agenda, and action plan for conference with supervisee.

Supervisors should be sure that they comply with their state's Medicaid requirements regarding documentation and signoff.

Time Allocation for Supervision. Appropriate time needs to be allocated within both the supervisor's and the supervisee's workloads to address the requirements for both direct and indirect supervision. The time allocation will vary based on the individual circumstances. The number of individuals one supervisor can supervise will also vary, depending on individual needs. The supervisee's and supervisor's credentials, skills, experience, workload, and travel distance should be considered when allocating time.

The time necessary for direct supervision can be calculated based on the number of Medicaid-eligible students and how they are individually scheduled. It is important to determine if the state Medicaid agency has a time frame and, if so, to adhere to it. In addition, it is wise to observe supervisees in each environment or service delivery model (e.g., individual versus group intervention, pull-out versus classroom intervention). In order to provide appropriate direct supervision, the supervisor must have flexibility within his or her schedule to vary the time for the observations to occur on a monthly basis.

In addition to time for direct supervision, time must also be allocated for indirect supervisory tasks. The supervisor's review of record documentation will not require time from the supervisee. However, time should be allocated in both schedules for conferences and demonstrations or modeling.

In summary, the function of supervision should be considered part of the workload for both the supervisor and the supervisee. Supervision of persons for Medicaid billing cannot be added to an existing workload without some adjustment of duties or case-load. The amount of supervision necessary should be individually assessed, allocated, and reviewed periodically, with adjustments made as needed.

30580 Federal Register / Vol. 69, No. 104 / Friday, May 28, 2004 / Rules and Regulations

authorized representative of the claimant when, and only when, such claim is filed electronically.

Dated: May 24, 2004.

Marybeth Peters,

Register of Copyrights.

[FR Doc. 04-12142 Filed 5-27-04; 8:45 am]

BILLING CODE 1410-33-P

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.

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:

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30581 Federal Register / Vol. 69, No. 104 / Friday, May 28, 2004/Rules and Regulations

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 § 440.110(c). The requirements under § 440.110(c)(2) addressing qualified speech-language pathologists (SLPs) remain as defined in existing regulations.

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30582 Federal Register / Vol. 69, No. 104 / Friday, May 28, 2004/Rules and Regulations

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 § 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.

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30583 Federal Register / Vol. 69, No. 104 / Friday, May 28, 2004/Rules and Regulations

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.

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30584 Federal Register / Vol. 69, No. 104 / Friday, May 28, 2004/Rules and Regulations

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.

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30585 Federal Register / Vol. 69, No. 104 / Friday, May 28, 2004/Rules and Regulations

§ 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 § 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 § 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.

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30586 Federal Register / Vol. 69, No. 104 / Friday, May 28, 2004/Rules and Regulations

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.

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30587 Federal Register / Vol. 69, No. 104 / Friday, May 28, 2004/Rules and Regulations

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FEDERAL COMMUNICATIONS COMMISSION

47 CFR Part 1

[WT Docket No. 99-217; FCC 04-41]

Promotion of Competitive Networks in Local Telecommunications Markets

AGENCY: Federal Communications Commission.

ACTION: Final rule, petition for reconsideration.

SUMMARY: In this document the Commission addresses four petitions seeking Reconsideration and/or Clarification of the Commission's determination to extend to users of fixed-wireless telecommunications antennas the same OTARD (Over-the-Air-Reception Devices) protections previously available to customers of multi-channel video service.

DATES: Effective July 27, 2004.

FOR FURTHER INFORMATION CONTACT: Cara

Voth, Broadband Division, Wireless Telecommunications Bureau, at (202) 418-0025.

SUPPLEMENTARY INFORMATION: This is a summary of the Commission's Order on Reconsideration, (Order) released on March 24, 2004 (FCC 04-41). The full text of the Order is available for inspection and copying during normal business hours in the FCC Reference Center, Room CY-A257, 445 12th Street, SW., Washington, DC 20554. The complete text may also be purchased