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PA Bulletin, Doc. No. 24-283

NOTICES

INDEPENDENT REGULATORY REVIEW COMMISSION

Notice of Comments Issued

[54 Pa.B. 1164]
[Saturday, March 2, 2024]

 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 agency 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final-form regulation must be submitted within 2 years of the close of the public comment period or it will be deemed withdrawn.

Reg. No.Agency/TitleClose of the Public  
Comment Period
IRRC
Comments
Issued
16A-4955  State Board of Medicine
Physician Assistants
53 Pa.B. 7896 (December 16, 2023)
01/16/2402/15/24
16A-4518State Board of Cosmetology
Practice of Massage Therapy in Cosmetology or Esthetician Salons  
53 Pa.B. 7894 (December 16, 2023)
01/16/2402/15/24
16A-726State Board of Massage Therapy
Practice of Massage Therapy in Cosmetology or Esthetician Salons
53 Pa.B. 7908 (December 16, 2023)
01/16/2402/15/24

State Board of Medicine Regulation # 16A-4955 (IRRC # 3390)

Physician Assistants

February 15, 2024

 We submit for your consideration the following comments on the proposed rulemaking published in the December 16, 2023 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 Medicine (Board) to respond to all comments received from us or any other source.

1. Section 18.142. Written agreements.—Implementation procedures; Reasonableness.

Subsection (b)

 Section 18.142(b) proposes to delete the requirement that written agreements be approved by the Board. It is replaced with language that specifies that written agreements must be ''filed'' with the Board. Additional language is proposed to be added to clarify that the written agreements become effective upon submission to the Board. These amendments make the Board's regulations consistent with the requirements of Act 79 of 2021 (Act 79).

 Act 79 requires the Board to conduct a full review of 10% of all written agreements submitted. In addition to providing a framework for written agreements subject to review, the legislation required the Board to publish notice of the review process. This notice was published in the February 12, 2022, edition of the Pennsylvania Bulletin. Along with other administrative responsibilities and procedures related to Act 79, the notice details the review process for those written agreements, subject to the 10 percent review, and provides for discrepancy notices. It reads:

''The written agreement is prepared and submitted by the primary supervising physician, physician assistant or a delegate of the supervising physician and physician assistant. If the written agreement does not meet the requirements outlined in 4(a)—(d), Board staff sends a discrepancy notice to the supervising physician and physician assistant indicating that the written agreement application is subject to the 10% review. Within that discrepancy notice, Board staff provides the list of items that need to be remedied within the written agreement and a notification that the parties have 2 weeks to respond to the discrepancy notice. If the parties do not respond to the discrepancy notice within 2 weeks, the written agreement is void and the application status will be changed to expired. The physician assistant and supervising physician must submit an entirely new written agreement. The new written agreement is effective upon submission and is subject to 10% review. If a response to the discrepancy is received by the Board outside of the 2-week period, a second discrepancy notice will be sent to the parties indicating that the response is outside of the 2-week period and informing the parties that a new written agreement application must be submitted.'' (Emphasis added).

 Since inaction or delayed response to a discrepancy notice can trigger a change of status and require the submittal of a new written agreement by the physician, physician assistant, or their designee, we ask the Board to consider including these key provisions in the final-form regulation or explain why it is unnecessary to do so.

2. Section 18.151. Role of physician assistant.—Clarity.

Subsection (c)

 This subsection proposes to delete the prohibition that a physician assistant may not determine the cause of death. The Preamble to the proposed regulation explains that the amendment is intended to update the language to comply with the act of July 7, 2017 (P.L. 296, No. 17) (Act 17). Act 17 amended the Vital Statistics Law of 1953 to authorize physician assistants to medically certify a report of a death or fetal death to the Pennsylvania Department of Health's Bureau of Health Statistics and Registry.

 In 2012, similar legislation granting the same authority to certified registered nurse practitioners was implemented with the act of June 22, 2012 (P.L. 644, No. 68) (Act 68). In addition to updating Sections 502 (relating to Death and Fetal Death Registration: Information for Certificates) and 503 (relating to Death and Fetal Death Registration: Coroner Referrals) of the Vital Statistics Law, which identifies the list of medical professionals that can supply medical certification of death and make referrals to a coroner, Act 68 also revised Section 507 (relating to Death and Fetal Death Registration: Pronouncement of Death by a Professional Nurse). Specifically, Subsection (d) of Section 507 reads:

''. . .(d) Except as provided for under sections 502 and 503, this section provides for the pronouncement of death by professional nurses in accordance with the ''Uniform Determination of Death Act,'' but in no way authorizes a nurse to determine the cause of death. The responsibility for determining the cause of death remains with the physician, certified registered nurse practitioner or the coroner as provided under this act.'' (Emphasis added).

 Based on this language in Section 507(d), we are unable to discern if ''determine the cause of death'' is the same as to medically certify a report of death. On one hand, this section seems to affirm that determining the cause of death is meant to be synonymous with certifying a death. While on the other hand, we cannot ignore whether there is any relevance in the exclusion of physician assistants from the list of medical professionals under Section 507(d). We do not question the statutory authority of physician assistants to medically certify death and sign death certificates, but we take caution not to assume that ''determining the cause of death'' is the same as certifying a report of death. We ask the Board to clarify whether ''determine'' and ''certify'' are the same or different under the Vital Statistics Law and to modify, if necessary, this section in the final-form regulation.

 We also ask the Board to review this subsection to determine whether there is a role for the substitute supervising physician. Specifically, should the substitute supervising physician, if the attending physician or primary supervising physician is not available, be notified before contacting the coroner? Lastly, the Board should review and revise, if necessary, this section to ensure the consistent use of terms. Namely, we question whether ''attending physician'' and ''not available'' should be replaced by the proposed defined terms ''primary supervising physician'' and ''unable to supervise,'' respectively.

State Board of Cosmetology Regulation # 16A-4518 (IRRC # 3391)

Practice of Massage Therapy in Cosmetology or Esthetician Salons

February 15, 2024

 We submit for your consideration the following comments on the proposed rulemaking published in the December 16, 2023 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 Cosmetology (Board) to respond to all comments received from us or any other source.

Section 7.150. Practice of massage therapy in cosmetology or esthetician salons.—Fiscal impacts; Clarity; Reasonableness of requirements, implementation procedures, and timetables for compliance.

Clarity.

 Paragraph (a)(2) states that a massage therapist licensed under the act is permitted to practice massage therapy within the approved premises of a licensed cosmetology salon or a licensed esthetician salon if the massage therapist practices in accordance with ''this section, Chapter 20 (relating to State Board of Massage Therapy), the act and the Massage Therapy Law.'' Similarly, Subsection (b) states that a massage therapist providing massage therapy services within the approved premises of a salon shall practice in accordance with ''the act, this chapter and the Massage Therapy Law.'' Since these provisions are nearly duplicative, we ask the Board to combine and clarify the requirements for the regulated community.

Fiscal impacts: Reasonableness of requirements, implementation procedures, and timetables for compliance.

 Clause (a)(3)(ii)(A) states that the size of the separate massage therapy room must be a minimum of 120 square feet. A commenter asserts that this requirement is onerous and not a true requirement for the safe and effective application of massage therapy. The commenter also raises concerns related to salons who have already incorporated massage therapy using rooms that are less than 120 square feet in size. We agree that salons needing to expand rooms to meet this requirement would likely face significant fiscal impacts. We also recognize the potentially negative impact on massage therapists currently employed by salons that choose not to expand to meet the requirement.

 In the Regulatory Analysis Form provided with the regulatory package, the Board notes that the minimum requirement of 120 square feet was a concern raised by commenters as the Board was drafting the proposed regulation. The Board acknowledges that some salons may incur costs if renovations are necessary to meet the square foot requirements for massage therapy rooms, but asserts that most, if not all, massage therapy rooms currently in use should already be a minimum of 120 square feet in size because that is a generally accepted industry standard. Did the Board consider providing salons with an opportunity to obtain an exemption on a case-by-case basis?

 We note that the Board intends for the proposed regulation to be effective upon publication in the Pennsylvania Bulletin. Has the Board considered including a delayed implementation in order to provide a timeframe for salons that require renovations to comply?

 Finally, we note that this proposed regulation is being promulgated in conjunction with the State Board of Massage Therapy proposed regulation # 16A-726 (IRRC # 3392, ''Practice of Massage Therapy in Cosmetology or Esthetician Salons'') to ensure consistency between the standards of both boards. Therefore, we ask the Board to reevaluate with the Massage Therapy Board the reasonableness of the appropriate minimum square-footage requirement in the final regulation, as well as ways to minimize fiscal impacts from implementation of the final regulation.

State Board of Massage Therapy Regulation
# 16A-726 (IRRC # 3392)

Practice of Massage Therapy in Cosmetology or Esthetician Salons

February 15, 2024

 We submit for your consideration the following comments on the proposed rulemaking published in the December 16, 2023 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 Massage Therapy (Board) to respond to all comments received from us or any other source.

Section 20.62. Practice of massage therapy in cosmetology or esthetician salons.—Fiscal impacts; Reasonableness of requirements.

 Act 136 authorizes massage therapists to practice massage therapy within the approved premises of licensed cosmetology and esthetician salons under specified conditions. One condition is provided for in clause (a)(2)(ii)(A), which requires that massage therapy rooms be a minimum of 120 square feet in size. The Board states in the preamble that this is a generally accepted industry standard based on the size of a standard massage table and allowing room for a massage therapist to safely maneuver around it. However, a commenter is concerned that the requirement is overly restrictive without providing an opportunity for salons to request an exemption on a case-by-case basis. We agree that massage therapists currently employed by salons with rooms that do not meet the standard and that choose not to expand to meet the requirement may be negatively impacted.

 We note that this proposed regulation is being promulgated in conjunction with the State Board of Cosmetology (Cosmetology Board) proposed regulation # 16A-4518 (IRRC # 3391, ''Practice of Massage Therapy in Cosmetology or Esthetician Salons'') to ensure consistency between the standards of both boards. Therefore, we ask the Board to reevaluate with the Cosmetology Board the reasonableness of the appropriate minimum square-footage requirement in the final regulation, as well as ways to minimize fiscal impacts from implementation of the final regulation.

GEORGE D. BEDWICK, 
Chairperson

[Pa.B. Doc. No. 24-283. Filed for public inspection March 1, 2024, 9:00 a.m.]



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