INDEPENDENT REGULATORY REVIEW COMMISSION Actions Taken by the Commission [30 Pa.B. 4981] The Independent Regulatory Review Commission met publicly at 10:30 a.m., Thursday, September 7, 2000, and took the following actions:
Regulations Approved:
Department of State #16-22: Campaign Finance Forms (amends 4 Pa. Code §§ 174.1, 176.2, 176.8, 177.1, 177.2 and 177.9).
Department of Health #10-143: Emergency Medical Services (amends 28 Pa. Code Chapters 1001--1015).
The Independent Regulatory Review Commission met publicly at 10:30 a.m., Thursday, July 13, 2000, and took the following action:
Regulation Disapproved:
State Board of Medicine and State Board of Nursing #16A-499: Certified Registered Nurse Practitioners Prescriptive Authority (adds 49 Pa. Code §§ 18.53--18.57 and 21.283--21.287).
Commissioners Voting: John R. McGinley, Jr., Chairperson, Alvin C. Bush, Vice Chairperson, by Phone, Arthur Coccodrilli, Robert J. Harbison, III, John F. Mizner
Public Meeting held
September 7, 2000Department of State--Campaign Finance Forms; Regulation No.16-22
On February 22, 2000, the Independent Regulatory Review Commission (Commission) received this proposed regulation from the Department of State (Department). This rulemaking amends 4 Pa. Code §§ 174.1, 176.2, 176.8, 177.1, 177.2 and 177.9. It was published in the March 4, 2000, Pennsylvania Bulletin, with a 30-day public comment period. The final-form regulation was submitted to the Commission on August 7, 2000.
The final regulation amends references to official campaign reporting forms and adds a new provision that allows filers to submit their reports on diskette, provided the filing meets the Department's technical specifications. It also deletes the reporting forms from the regulation.
We have determined this regulation is consistent with the statutory authority of the Department of State (25 P. S. § 2621(a)) and the intention of the General Assembly. Having considered all of the other criteria of the Regulatory Review Act, we find promulgation of this regulation is in the public interest.
By Order of the Commission:
This regulation is approved.
Commissioners Voting: John R. McGinley, Jr., Chairperson; Alvin C. Bush, Vice Chairperson, by Phone; Arthur Coccodrilli; Robert J. Harbison, III; John F. Mizner, by Proxy
Public Meeting held
September 7, 2000Department of Health--Emergency Medical Services; Regulation No. 10-143
On January 29, 1999, the Independent Regulatory Review Commission (Commission) received this proposed regulation from the Department of Health (Department). This rulemaking amends 28 Pa. Code Chapters 1001--1015. The proposed regulation was published in the February 13, 1999 Pennsylvania Bulletin with a 30-day public comment period. The final-form regulation was submitted to the Commission on August 7, 2000.
This rulemaking is a comprehensive revision of the procedures, rules and standards of the Emergency Medical Services system administered by the Department. The primary impetus for this rulemaking is Act 82 of 1994 which amended the Emergency Medical Services Act.
We have determined this regulation is consistent with the statutory authority of the Department (35 P. S. § 6937.1) and the intention of the General Assembly. Having considered all of the other criteria of the Regulatory Review Act, we find promulgation of this regulation is in the public interest.
By Order of the Commission:
This regulation is approved.
____Commissioners Voting: John R. McGinley, Jr., Chairperson; Alvin C. Bush, Vice Chairperson, by proxy; Arthur Coccodrilli, dissenting; Robert J. Harbison, III; John F. Mizner, dissenting
Public Meeting held
July 13, 2000Regulation No. 16A-499 State Board of Medicine and State Board of Nursing--Certified Registered Nurse Practitioners Prescriptive Authority
On September 17, 1999, the Independent Regulatory Review Commission (Commission) received this joint proposed regulation from the State Board of Medicine and the State Board of Nursing (Boards). This rulemaking adds 49 Pa. Code §§ 18.53--18.57 and 21.283--21.287. The proposed regulation was published in the October 2, 1999 Pennsylvania Bulletin with a 30-day public comment period. The final-form regulation was submitted to the Commission on June 6, 2000.
This rulemaking will authorize Certified Registered Nurse Practitioners (CRNP) to prescribe and dispense drugs. In order for a CRNP to prescribe and dispense drugs, the regulations establish education requirements, specify categories of drugs CRNPs may and may not prescribe, require collaborative agreements with physicians, specify CRNP identification requirements and specify physician supervision requirements.
The final regulation contains significant amendments to the proposed version of the regulation. There are three areas that do not meet our criteria as explained below.
First, the Boards added a 2:1 ratio of CRNPs to physicians in §§ 18.57 and 21.287 of the final regulation. This ratio raises questions concerning protection of the public health, need and reasonableness (71 P. S. § 745.5a(i)(2) and (3)). These provisions were not in the proposed regulation.
Commentators believe the 2:1 ratio will unnecessarily restrict the availability of healthcare, particularly in underserved rural and urban areas. They also observe that the regulation requires part-time CRNPs to meet the same ratio as full-time CRNPs.
The Preamble does not explain how the 2:1 ratio was determined. The Boards state that CRNPs prescribing drugs is the norm in 42 states. Commentators have stated that only two of those states use a ratio, and that the ratio is higher than the 2:1 ratio in this regulation. The Boards should amend or delete this requirement or explain why it is appropriate.
Second, the waiver process in §§ 18.57(a) and 21.287(a) lacks clarity (71 P. S. § 745.5a(i)(3)). The provision allows a physician to ''apply for a waiver . . . for good cause, as determined by the Boards.'' This is new language added to the final regulation.
Commentators believe the waiver process is not clearly defined in the regulation. The regulation should be amended to state how to apply to the Boards for a waiver, what information is required, and what criteria the Boards will use to evaluate a request for waiver.
Finally, the requirement in §§ 18.53(2) and 21.283(2) for ''a specific course in advanced pharmacology of not less than 45 hours'' does not reasonably allow existing CRNPs to comply, would impose unnecessary costs on them, and would impose adverse effects on competition (71 P. S. § 745.5a(i)(1) and (3)). Prior to 1992, pharmacology was integrated into other courses in the CRNP curricula. Approximately 40% of practicing CRNPs may not be able to document a ''specific'' course, even though they may have had equivalent education. A further concern is that the Boards will allow more favorable treatment for out-of-State equivalency for CRNP certification under existing §§ 18.42 and 21.272 (relating to Certification by endorsement; currently licensed), but would foreclose the opportunity for Pennsylvania's CRNPs to demonstrate an equivalency of the 45-hour advanced pharmacology course. The regulation should allow all CRNPs the opportunity to demonstrate an equivalency of the 45-hour advanced pharmacology course to the Boards.
We have determined this regulation is consistent with the statutory authority of the State Board of Medicine (63 P. S. § 422.15(b)) and the State Board of Nursing (63 P. S. § 212) and the intention of the General Assembly. However, after considering all of the other criteria of the Regulatory Review Act discussed above, we find promulgation of this regulation is not in the public interest.
By Order of the Commission:
This regulation is disapproved.
JOHN R. MCGINLEY, Jr.,
Chairperson[Pa.B. Doc. No. 00-1646. Filed for public inspection September 22, 2000, 9:00 a.m.]
