NOTICES
Notice of Comments Issued
[41 Pa.B. 6472]
[Saturday, December 3, 2011]Section 5(g) of the Regulatory Review Act (71 P. S. § 745.5(g)) provides that the Independent Regulatory Review Commission (Commission) may issue comments within 30 days of the close of the public comment period. The Commission comments are based upon the criteria contained in section 5.2 of the Regulatory Review Act (71 P. S. § 745.5b).
The Commission has issued comments on the following proposed regulations. The agencies must consider these comments in preparing the final-form regulation. The final-form regulation must be submitted within 2 years of the close of the public comment period or it will be deemed withdrawn.
IRRC Close of the Public Comments Reg. No. Agency/Title Comment Period Issued 16A-4320 State Board of Chiropractic 10/17/11 11/16/11 Licensure by Reciprocity
41 Pa.B. 4958 (September 17, 2011) 16A-4624 State Board of Dentistry 10/17/11 11/16/11 Expanded Function Dental Assistant
Scope of Practice and Continuing
Education41 Pa.B. 4960 (September 17, 2011) 16A-6514 State Board of Physical Therapy 10/17/11 11/16/11 Act 38 of 2008 Amendments 41 Pa.B. 4962 (September 17, 2011)
State Board of Chiropractic
Regulation #16A-4320 (IRRC #2907)
Licensure by Reciprocity
November 16, 2011 We submit for your consideration the following comments on the proposed rulemaking published in the September 17, 2011 Pennsylvania Bulletin. Our comments are based on criteria in Section 5.2 of the Regulatory Review Act (RRA) (71 P. S. § 745.5b). Section 5.1(a) of the RRA (71 P. S. § 745.5a(a)) directs the State Board of Chiropractic (Board) to respond to all comments received from us or any other source.
1. Whether the regulation is consistent with the intent of the General Assembly.
Section 504 of the Chiropractic Practice Act (Act) (63 P. S. § 625.504) allows the Board to grant licenses without further examination to individuals from other states and provinces of Canada if all of the following conditions are met:
• The standards for licensing in such states or provinces are substantially the same as those provided in the Act.
• Similar privileges are accorded persons licensed in this Commonwealth.
• The applicants hold valid licenses.
• The applicable rules and regulations prescribed by the Board are complied with.
According to the Preamble of this proposal, the purpose of this rulemaking is to amend the Board's existing regulations concerning licensure by reciprocity to base the determination upon standards for licensure at the time of graduation from chiropractic school and first licensure, rather than the current standards.
We are concerned that basing reciprocity determinations on anything other than current standards is inconsistent with Section 504 of the Act and the intent of the General Assembly. As noted above, one of the conditions that must be met in order for a reciprocal license to be granted is, ''The standards for licensing in such state or provinces are substantially the same as those provided in this act.'' 63 P. S. § 625.504(1). (Emphasis added.) In the Preamble to the final-form regulation, we ask the Board to explain how this proposal is consistent with the intent of the General Assembly and the requirement that the standards for licensing in other states or provinces is the same as standards currently found in the Act.
2. Need for the regulation.
According to the Regulatory Analysis Form submitted with the rulemaking, on average, a ''few dozen'' chiropractors apply for licensure by reciprocity each year. How many of these applicants are denied licensure because of the Board's existing regulations? We believe further explanation of the need for the regulation is required.
3. Determining whether the regulation is in the public interest.
Section 5.2 of the RRA directs this Commission to determine whether a regulation is in the public interest. 71 P. S. § 745.5b. When making this determination, the Commission considers criteria such as economic or fiscal impact and reasonableness. The Commission also considers the information a promulgating agency is required to provide under § 745.5(a) in the regulatory analysis form (RAF).
The information provided in Question #25 of the RAF submitted with this rulemaking is not sufficient to allow this Commission to determine if the regulation is in the public interest. Of particular interest is how this regulation compares to other states. When this rulemaking is returned in final-form, we ask the Board to provide an analysis of how other states address licensure by reciprocity. Without this information, we cannot determine if this proposed regulation is in the public interest.
4. Section 5.13. Licensure by reciprocity.—Implementation procedures; Clarity.
Subsection (a)(3)
This subsection requires applicants for licensure by reciprocity to have passing scores on certain parts of the National Board Examination (NBE). Subparagraph (a)(3)(i) requires applicants that graduated from chiropractic college after January 1, 1968 to pass Parts I and II of the NBE. Subparagraph (a)(3)(ii) requires applicants that graduated from chiropractic college after December 27, 1991, or first practiced after that date to pass Part III of the NBE. Subparagraph (a)(3)(iii) requires applicants that graduated from chiropractic college after May 23, 1997, or were first licensed to practice after that date to pass Part IV of the NBE. Would applicants that apply under Subparagraph (a)(3)(ii) have to pass Parts I and II of the NBE? Similarly, would applicants that apply under Subparagraph (a)(3)(iii) have to pass Parts I, II and III of the NBE? This should be clarified in the final-form regulation.
Subsection (a)(5)
This subsection requires applicants to present evidence that they have engaged in ''active clinical practice.'' The House Professional Licensure Committee submitted comments seeking clarification on what is meant by this phrase and whether it includes part-time practice. We agree that the phrase lacks clarity and suggest that it be defined in the final-form regulation.
Subsection (a)(6)
Under this subsection, applicants must present evidence of a passing score on the Pennsylvania Chiropractic Law Examination. We note that the Board's website includes a notice that the Pennsylvania Chiropractic Law Examination is no longer required. Applicants for licensure must instead complete an application that includes a page entitled ''Pennsylvania Chiropractic Legal Review'' to demonstrate to the Board that they are aware of the Board's rules and regulations and the Act. If this exam is no longer required, we suggest that this subsection be amended accordingly. We also suggest that other sections of the Board's regulations that reference the Pennsylvania Chiropractic Law Examination be amended.
Subsection (c)
This subsection states that an ''applicant's verification'' will satisfy the requirement that the applicant present evidence of experience required by Subsection (a)(5). How can an applicant satisfy this requirement? Is there a form that must be completed? This should be clarified in the final-form regulation.
State Board of Dentistry
Regulation #16A-4624 (IRRC #2908)
Expanded Function Dental Assistant Scope of Practice and Continuing Education
November 16, 2011 We submit for your consideration the following comments on the proposed rulemaking published in the September 17, 2011 Pennsylvania Bulletin. Our comments are based on criteria in Section 5.2 of the Regulatory Review Act (71 P. S. § 745.5b). Section 5.1(a) of the Regulatory Review Act (71 P. S. § 745.5a(a)) directs the State Board of Dentistry (Board) to respond to all comments received from us or any other source.
1. Section 33.205a. Practice as an expanded function dental assistant.—Clarity; Implementation procedures.
The regulation amends this section to include additional dental procedures that expanded function dental assistants (EFDAs) are permitted to and restricted from performing, in accordance with changes made to the Dental Law through Act 19 of 2010 (Act).
Subsection (a)
Subsection (a)(1)(viii) permits EFDAs to perform ''coronal polishing.'' A commentator questions whether this type of polishing would also include air polishing. To improve clarity, we recommend that the final-form regulation define ''coronal polishing.''
Subsection (b)
Subsection (b) provides a list of restricted EFDA practices. Two commentators recommend that this subsection also include language to prohibit EFDA performance of additional dental procedures, including periodontal instrumentation and ''prophylaxis, scaling (supragingival and subgingival), as it pertains to the practice of dental hygiene, root planning or periodontal probing.'' The Pennsylvania Association of Dental Hygienists points out that these latter functions fall under the scope of practice of dental hygienists.
We recognize that the Act explicitly states the procedures EFDAs cannot practice. Are the additional restrictions proposed by commentators consistent with those contained in the Act? If so, has the Board considered including them in the regulation?
2. Section 33.402. Continuing education subject areas.—Fiscal impact; Reasonableness; Need; Implementation procedures.
Subsection (g) adds a new continuing education requirement for EFDAs. Specifically, Subsection (g) requires EFDAs to complete three of 10 continuing education hours in coronal polishing. We raise six issues.
First, some commentators object to the imposition of this requirement, and suggest that given the level of training and education EFDAs already receive, this requirement is unnecessary. The Board should explain not only the need for EFDAs to complete continuing education in this subject matter, but also how the Board determined that 3 hours was an appropriate amount of training.
Second, Subsection (g)(1) states that EFDAs certified by March 31, 2011 must complete this new requirement during the biennial renewal period of April 1, 2011 to March 31, 2013. Several commentators assert that many EFDAs certified by this date already received coronal polishing training once the Act became effective. The House Professional Licensure Committee (HPLC) questions whether the Board would accept training hours in coronal polishing completed prior to April 1, 2011. We agree with the HPLC and commentators, and ask the Board to clarify whether coronal polishing training received by certified EFDAs prior to this period would satisfy this requirement.
Third, are there existing certified EFDAs who would not have completed coronal polishing training? If so, in order to accommodate these EFDAs, we recommend that instead of applying the current biennial renewal period, that the final-form regulation allow EFDAs certified by March 31, 2011 to complete their coronal polishing continuing education hours prior to March 31, 2013.
Fourth, two individual commentators question whether there are enough existing coronal polishing training providers to allow existing EFDAs to meet the March 31, 2013 deadline. The Board should clarify this issue.
Fifth, Subsection (g)(2) establishes that EFDAs certified after March 31, 2011 may complete their coronal polishing continuing education during the first complete biennial renewal period after their certification is granted. However, many EFDAs certified after this date will already have received this training as part of their formal education. As a result, the Pennsylvania Dental Association (PDA) indicates this subsection is unnecessary and should be removed. In the alternative, PDA recommends imposing this requirement only on those EFDAs who graduate from accredited EFDA programs during this current biennial renewal period. Has the Board considered this option?
Finally, the Board indicates that implementation of this regulation will not impose costs on the regulated community. (Regulatory Analysis Form #17). However, Subsection (g)(3) states that EFDAs may not complete their coronal polishing continuing education hours online or through distance education. Do accredited schools and providers offer this training at no cost to certified EFDAs? The Board should provide further explanation of the potential fiscal impact that may result from this new continuing education requirement.
State Board of Physical Therapy
Regulation #16A-6514 (IRRC #2910)
Act 38 of 2008 Amendments
November 16, 2011 We submit for your consideration the following comments on the proposed rulemaking published in the September 17, 2011 Pennsylvania Bulletin. Our comments are based on criteria in Section 5.2 of the Regulatory Review Act (71 P. S. § 745.5b). Section 5.1(a) of the Regulatory Review Act (71 P. S. § 745.5a(a)) directs the State Board of Physical Therapy (Board) to respond to all comments received from us or any other source.
1. House Professional Licensure Committee Comments.
The House Professional Licensure Committee (HPLC), in a letter dated October 26, 2011, submitted the following comments:
• The HPLC brings to the Board's attention that proposed Regulation 16A-6514 was published in the Pennsylvania Bulletin on September 17, 2011, approximately 2 years and 11 months past the 90 days from the effective date of the Act of July 4, 2008, (P. L. 293, No. 38).
• The HPLC questions the Board's statutory authority to include physical therapy assistant students in § 40.171(c) which relates to supervision ratio, since Act 38 of 2008 specifically limits the ratio to one physical therapist supervising no more than three physical therapist assistants.
We will review the Board's responses to these HPLC comments as part of our determination of whether the final-form regulation is in the public interest.
2. Economic Impact of the regulation.
In response to Regulatory Analysis Form (RAF) Question 17, the Board acknowledges that the regulated community will experience an increase in costs in relation to the requirements for continuing education and professional liability insurance. The Board also expects an increase in costs in approving additional continuing education programs and auditing in the response to RAF Question 19. We agree there will be costs associated with compliance.
However, the Board did not include any cost estimates associated with implementation and compliance in the response to RAF Questions 17, 19, 20 or 21. We recommend that the Board amend these responses to provide dollar estimates so that we can fully evaluate whether the final-form regulation is in the public interest.
3. Continuing education as a condition of renewal.—Consistency with statute.
The statute states that ''For each license renewal, a licensee shall complete within the immediately preceding two-year period at least 30 hours of continuing physical therapy education as approved by the board.'' 63 P. S. § 1307.2. Similar requirements are found in 63 P. S. §§ 1309(c)(1) and 1309.1(j) relating to certificates of authorization and physical therapist assistants, respectively. We also note that 63 P. S. § 1303(a), in part, states that the Board may adopt rules and regulations ''not inconsistent with law.''
Renewal is addressed in Sections 40.19. Renewal of physical therapist license; 40.63. Continuing education for direct access certificate holder; and 40.191. Renewal of certification. Subsection 40.63(b), relating to a direct access certificate holder, states that completion of continuing education is a condition of certificate renewal. We agree.
Our concern is that Sections 40.19 or 40.191 do not provide direct notice that if the continuing education requirement is not met, a license or certificate cannot be renewed. Direct and clear notice in the wording of the regulation will benefit both the Board and licensees in obtaining compliance. Clear notice can also avoid the expense of the Board taking actions against the licensee and the potential loss of income for the licensee. Therefore, while the intent and actions of the Board may be to not renew, we recommend that clear notice be provided in the regulation that the Board cannot renew a license or certificate if the licensee or certificate holder fails to complete the continuing education required by the statute.
4. Continuing competence.—Consistency with statute; Protection of the public health, safety and welfare; Fiscal impact; Need; Clarity.
The Board proposes to introduce ''continuing competence'' in Sections 40.68 and 40.193 which ''may satisfy in part'' continuing education requirements. In the Preamble, the Board explains:
Because sitting in lecture courses and other traditional methods to obtain information are not the only viable methods of assuring that licensees remain competent to practice, the Board is proposing to include what is often referred to as continuing competence in the array of methods for licensees to satisfy the continuing education requirement. This model is based upon the model currently being pursued by the FSBPT [Federation of State Boards of Physical Therapy].Consistency with statute
Under 63 P. S. § 1307.2, ''30 hours of continuing physical therapy education as approved by the board'' is required for each license renewal. Similar continuing education requirements are found in 63 P. S. §§ 1309(c) (1), 1309.1(j) relating to certificates of authorization and physical therapist assistants, respectively. These statutory provisions use the specific terms ''continuing education'' and impose a specific number of hours required.
The Board is empowered by statute to approve continuing education. Act 38 of 2008 did not include continuing competence. Therefore, it is not clear why the Board is including in regulation a separate category of continuing competence that the Board may approve to satisfy continuing education requirements. The Board should explain how the continuing competence provisions are consistent with the statute.
Alternatively, the Board should delete continuing competence from the regulation and consider adopting these activities as continuing education, provided the activity is valid as continuing education. We question, for example, whether activities such as submitting grant requests or holding a position in an organization would qualify as the equivalent of continuing education.
Need and protection of the public health, safety and welfare
In the Preamble, the Board states that lecture courses and other traditional methods to obtain information are not the only viable methods of assuring that licensees remain competent to practice. Recognizing that continuing education helps licensees remain competent to practice, in regard to continuing competence, the Board needs to demonstrate:
• Why continuing competence activities are needed in addition to traditional continuing education courses;
• Continuing competence activities in the regulation are a viable method of assuring licensees remain competent in practice; and
• How each continuing competence activity listed in the regulation will adequately protect the public health, safety and welfare if substituted for continuing education hours.
Clarity
A regulation establishes a binding norm between the agency and the regulated community. Sections 40.68 and 40.193 are extremely vague and present broad, idealistic concepts. For example, the opening subsections state that the ''Board will be guided by the following principles,'' however the guiding principles include statements such as ''there is no single right way to demonstrate competence.'' An approval process provision states ''the design of the activity must support the achievement of the objectives.'' We do not believe Sections 40.68 and 40.193 as presented in the proposed regulation establish binding norms. The Board should explain why it believes the continuing competence provisions rise to the level of regulation, how they would be enforced consistently and why they are in the public interest.
Fiscal impact
Sections 40.68 and 40.193 also state the Board will approve these activities. Given the broad context of the descriptions in Sections 40.68 and 40.193, the Board could conceivably receive many requests for approval of continuing competence activities. How much does the Board anticipate it will cost to review and approve continuing competence activities and how is the cost justifiable?
5. Section 40.11. Educational requirements for licensure by examination.—Clarity.
Subsection (a) requires an applicant to have graduated from a program ''accredited by CAPTE or by another National organization recognized by the Board that accredits physical therapy programs.'' It is not clear what other organizations an applicant could use to qualify. How can an applicant find the list of other National organizations recognized by the Board? The Board should consider maintaining a list on its website and referencing the website in the regulation.
6. Section 40.12. Application for licensure.—Clarity.
Subsection (b) requires the applicant to use forms supplied by the Board. Are these forms available online? If so, the regulation should include the web address where these forms can be found.
7. Section 40.17. Foreign-educated physical therapists applying to take the licensure examination and pursue clinical experience.—Consistency with statute; Clarity.
Documentation of authorization to practice
Under 63 P. S. § 1306(i)(2), an applicant for licensure who has been educated outside the United States is required to ''provide proof of holding an unrestricted license in the country where the applicant was educated.'' The Board is deleting Paragraph (3) which appears to reflect 63 P. S. § 1306(i)(2). Without Paragraph (3), how will the regulation adequately reflect the statutory requirement of 63 P. S. § 1306(i)(2)?
Substantial equivalency
Under 63 P. S. § 1306(i)(3), an applicant can provide satisfactory evidence in two ways. First, the applicant graduated outside the United States from a ''program accredited by the same accrediting agency that the board approves for programs within the United States. . . .'' Second, in all other instances, the graduate meets the requirements in 63 P. S. §§ 1306(i)(3)(i) to (iv). The Board should review Section 40.17 for consistency with 63 P. S. § 1306(i)(3) and explain how the regulation adequately reflects the statute.
8. Section 40.20. Inactive status of physical therapist license.—Reasonableness; Clarity.
Subsection 40.191(j) specifies the disciplinary provisions in the statute that may be invoked for practicing on an expired certificate. We recommend adding a similar provision to Section 40.20.
9. Section 40.67. Continuing education for licensed physical therapist.—Feasibility; Clarity.
Written request for waiver
The second sentence of Paragraph (a)(4) is not clear. It states, in part, ''A waiver or extension of time will not be granted unless a written request is submitted by the licensee; or . . . a physician . . ., or both.'' (Emphasis added.) The regulation is not clear because it does not state what circumstances would require a written request by both a licensee and a physician. As a practical matter, it would appear that all requests for a waiver would require an application by the licensee, except in the unique circumstance where the licensee is rendered incompetent by a disability or illness. It would also appear that a claim of disability or illness would require supporting documentation by a physician. We recommend that the Board clarify this provision. The same concern applies to Paragraph 40.192(a)(4).
Certificate of completion
Paragraph (b)(1) requires ''a certificate of completion issued by the course or program provider.'' A commentator states that not all continuing education providers give the participants certificates. In the commentator's experience, an APTA conference did not issue certificates. The Board should review Paragraph (b)(1) and explain how this provision is feasible for all of the continuing education courses approved by the Board. Alternatively, the Board should consider amending the regulation to allow other methods of proving the person attended the course or program.
60 days
Paragraph (d)(2) requires the provider to apply for approval of a continuing education course or program at least 60 days prior to the date of the course or program. The provider may also request a waiver of the 60 days. While this may provide the Board with enough time to review the application, we question the practical effect of these provisions. Can a provider advertise the program pending Board approval? How will those signing up for the course be treated fairly if the approval of the program is pending with the Board? The same concerns apply to Section 40.192(d)(2).
10. Sections 40.68. Continuing competence for licensed physical therapist and 40.193. Continuing competence for certified physical therapist assistant.—Reasonableness.
In addition to general questions on continuing competence, we have three specific concerns.
First, Paragraphs 40.68(c)(4) and 40.193(c)(2) provide an extra five contact hours for passing a review tool exercise from FSBPT. A commentator suggests deleting this credit since the testing has not been subjected to validity testing. The Board should review these provisions and consider either deleting the five credit hours for passing the review tool or explaining why the five contact hours are appropriate.
Second, several commentators have suggested adding credit for clinical instruction. Why didn't the Board include credit for clinical instruction in these sections?
Finally, the Board should review and explain each of the credits it will allow for the activities listed in the regulation and how these credits will specifically count toward continuing education hours.
11. Section 40.162. Application for certification.—Consistency with statute; Reasonableness; Clarity.
The statute states that to be eligible for certification a physical therapist assistant, ''applicant must be at least 18 years of age unless otherwise determined by the board.'' 63 P. S. § 1309.1(a). Paragraph (a)(1), as amended,states an applicant must be either ''at least 20 years of age'' or ''at least 18 years of age and the Board has determined that the candidate has proved the capability to accept and handle the responsibilities appurtenant to certification.'' We have three concerns.
First, why does the Board need to make a distinction in regulation between candidates that are 18 years old and 20 years old? Why don't other provisions in training or requirements for certification adequately establish the qualifications of an 18 year old candidate?
Second, why did the Board maintain the 20 years of age provision in Subparagraph (i) and how is it consistent with the statute?
Finally, in regard to the 18 years of age provision in Subparagraph (ii), the regulation needs to specify what standard an applicant must meet to satisfy Subparagraph (ii).
12. Sections 40.165. Authorization to provide services as physical therapist assistant under indirect supervision and 40.166. Temporary certificate to provide services as physical therapist assistant.—Clarity.
Both of these sections include a list of requirements needed in order to be granted a certificate in Subsections (b). However, Paragraphs 40.165(b)(3) and 40.166(b)(5) state the vague requirement that a certificate will be granted to an applicant who ''otherwise complies with this subchapter.'' Under what circumstances would the other requirements in Subsections (b) be waived for an applicant who ''otherwise complies with this subchapter''? We recommend deleting Paragraphs 40.165(b)(3) and 40.166(b)(5).
13. Section 40.191. Renewal of certification.—Reasonableness; Clarity.
Renewal application
Subsection 40.19(b) includes the caveat that ''failure of the Board to send or of the licensee to receive a biennial renewal application does not relieve the licensee of the biennial renewal responsibility.'' We recommend adding the same caveat to Subsection 40.191(b).
License, registration or certificate
Given what may be a broad range of titles, should Paragraph (c)(2) require disclosure of registrations and certificates in addition to licenses?
14. Miscellaneous clarity.
• Section 40.63(b) uses the date of January 1, 2011, which had already passed as of the date of publication of the proposed regulation in the Pennsylvania Bulletin. Should this date be changed or deleted?
• For consistency in Section 40.171, Subsection (c) should use the term ''licensed'' physical therapist.
• Subsection 40.191(c) refers to license renewal. Should this refer to certificate renewal?
SILVAN B. LUTKEWITTE, III,
Chairperson
[Pa.B. Doc. No. 11-2076. Filed for public inspection December 2, 2011, 9:00 a.m.]
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