Notice of Comments Issued [29 Pa.B. 6385] Section 5(g) of the Regulatory Review Act (act) (71 P. S. § 745.5(g)) provides that the designated standing committees may issue comments within 20 days of the close of the public comment period, and the Independent Regulatory Review Commission (Commission) may issue comments within 10 days of the close of the committee comment period. The Commission comments are based upon the criteria contained in section 5a(h) and (i) of the act (75 P. S. § 745.5a(h) and (i)).
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 regulations must be submitted by the dates indicated.
Final-Form Submission Reg. No. Agency Issued Deadline 16A-499 State Board of Nursing
& State Board of
Medicine Joint
Regulation12/2/99 11/01/01 Certified Registered
Nurse Practitioners
Prescriptive
Authority
(29 Pa.B. 5101 (October 2, 1999)) 16A-600 State Board of Vehicle
Manufacturers12/2/99 11/01/01 Dealers &
Salespersons
Application Fees(29 Pa.B. 5105 (October 2, 1999)) 57-207 Pennsylvania Public
Utility Commission12/2/99 11/01/01 Natural Gas Choice
and Competition
(29 Pa.B. 5098 (October 2, 1999)) State Board of Nursing & State Board of Medicine
Joint Regulation No. 16A-499Certified Registered Nurse Practitioners Prescriptive Authority December 2, 1999 We have reviewed this joint proposed regulation from the State Board of Nursing and the State Board of Medicine (Boards) and submit for consideration the following objections and recommendations. Subsection 5.1(h) and (i) of the Regulatory Review Act (71 P. S. § 745.5a(h) and (i)) specify the criteria the Commission must employ to determine whether a regulation is in the public interest. In applying these criteria, our Comments address issues that relate to protection of the public health, safety and welfare, reasonableness, implementation procedures and clarity. We recommend that these Comments be carefully considered as you prepare the final-form regulation.
1. Sections 18.53 and 21.283 Prescribing and dispensing drugs.--Protection of the Public Health, Safety and Welfare, Implementation Procedures and Clarity.
Collaborative Agreements
Under existing regulations, a certified registered nurse practitioner (CRNP) works in collaboration with and under the direction of a physician. Collaborative agreements establish the conditions of the working relationship.
We have three concerns. First, the term ''collaborative agreement'' as used in this regulation should be defined. Second, §§ 18.53 and 21.283 should specifically require a collaborative agreement to be established and signed by the physician and CRNP before the CRNP can prescribe and dispense drugs. Finally, the regulations should also specify the required content of a collaborative agreement.
Subsection (1)
Subsection (1) allows a CRNP to prescribe and dispense drugs if the CRNP has completed an equivalent CRNP program in another state. However, how equivalency will be determined is not clear. The regulation should provide the criteria or standards the Board will use to establish reciprocal equivalency.
Subsection (2)
Subsection (2) requires a CRNP to complete an advanced pharmacology course. We have two concerns with this requirement.
First, some CRNP programs have specific advanced pharmacology courses while others integrate the course material into the overall curriculum. It is unclear what qualifies as an advanced pharmacology course.
Second, how will practicing CRNPs meet this requirement if their formal education did not specifically include an advanced pharmacology course? The Boards should specify the training required before a CRNP can prescribe and dispense drugs.
2. Sections 18.54 and 21.284 Prescribing and dispensing parameters.--Protection of the Public Health, Safety and Welfare, Reasonableness, Consistency with Existing Regulations and Clarity.
General
Physicians, hospitals and CRNPs have expressed concerns with the inclusion and exclusion of certain types of drugs. The Preamble does not provide background information concerning how the Boards developed the lists of drugs to be permitted, restricted or excluded. The enabling statutes do not specify the types of drugs that CRNPs can prescribe. Instead, the statutes direct the Boards to jointly promulgate regulations authorizing CRNPs to perform medical diagnosis and prescription. For this reason, the Boards should explain the basis for restrictions and prohibitions of certain drugs in this proposed regulation.
Subsection (a)
This subsection states that the American Hospital Formulary Service Pharmacologic-Therapeutic Classification will be used to identify drugs that the CRNP may prescribe and dispense. The statement seems to contradict the subsections that follow.
Subsection (a) seems to incorporate by reference a document listing the drugs that a CRNP is allowed to prescribe and dispense. Yet, the following subsections specifically list those drugs. It is our understanding that the purpose of this subsection is to provide a reference document for the types of drugs discussed in this section. If this is the case, the words ''which the CRNP may prescribe and dispense subject to the parameters identified'' should be deleted.
Subsection (b)
This subsection states that a CRNP may prescribe and dispense a drug from the following categories ''without limitation.'' What is the purpose of the phrase ''without limitation''? What impact will it have on collaborative agreements?
In existing regulations at 49 Pa. Code §§ 18.21 and 21.251, the Boards state that a CRNP:
. . . performs acts of medical diagnosis or prescription of medical therapeutic or corrective measures in collaboration with and under the direction of a physician licensed to practice medicine in this Commonwealth.
Depending on how it is implemented, the phrase ''without limitation'' could be seen as inconsistent with existing regulations. The Boards should clarify their intent.
Subsection (c)
This subsection states that a CRNP may prescribe and dispense a drug from the following lists or categories if that authorization is documented in the collaborative agreement. What documentation will be required to meet this requirement?
Subsection (e)
This subsection sets forth the procedures to follow when a collaborating physician discovers that a CRNP is prescribing or dispensing a drug inappropriately. There are two concerns with this subsection.
First, why does the regulation use the word ''learn'' to describe a physician's method of determining that a CRNP is prescribing or dispensing a drug inappropriately? What is required of a physician under a collaborative agreement?
Second, when a collaborating physician finds that a CRNP has inappropriately prescribed a drug, this subsection directs the CRNP to stop prescribing the drug and immediately advise the patient to stop taking the drug. This is the only course of action available under the regulation. Is it appropriate in all instances for a patient to immediately stop taking a drug? For example, some drug prescriptions come with warnings that abruptly stopping the therapy is dangerous and should only be done in consultation with a physician. Shouldn't the regulation require corrective action on behalf of the patient rather than simply requiring the CRNP to end the therapy?
Subsection (f)
The second sentence of paragraph (1) is confusing. When a CRNP writes a prescription for a Schedule II controlled substance, the CRNP must notify the collaborating physician ''immediately (within 24 hours).'' The subsection is unclear on whether the notice must be immediate or within 24 hours.
Subsection (g)
Subsection (g)(2) states that a CRNP may not prescribe a drug for a use not ''permitted'' by the United States Food and Drug Administration (FDA). The FDA does not prohibit or regulate the use of drugs once they are approved and released for general clinical practice. Therefore, the Boards intent in using the word ''permitted'' is unclear. The Boards should explain the purpose of this paragraph.
Subsection (h)
This subsection requires that the prescription blank bear the name and certification number of the CRNP and also identify the collaborating physician. The House Professional Licensure Committee expressed the concern that a CRNP who prescribes medications should also provide a clear and conspicuous notice to patients that he or she is a CRNP. The Boards should review what additional CRNP identification requirements are needed in the regulation.
State Board of Vehicle Manufacturers,
Dealers and Salespersons
Regulation No. 16A-600Application Fees December 2, 1999 We have reviewed this proposed regulation from the State Board of Vehicle Manufacturers, Dealers and Salespersons (Board) and submit for consideration the following objections and recommendations. Subsections 5.1(h) and (i) of the Regulatory Review Act (71 P. S. § 745.5a(h) and (i)) specify the criteria the Commission must employ to determine whether a regulation is in the public interest. In applying these criteria, our Comments address issues that relate to fiscal impact and clarity. We recommend that these Comments be carefully considered as you prepare the final-form regulation.
1. General.--Clarity.
The Regulatory Analysis Form (RAF) doesn't contain the past 3-year expenditure history for programs affected by the regulation. This information is required in item # 20b. The Board should include this information in the RAF accompanying the final-form regulation.
2. Section 19.4. Fees.--Fiscal Impact and Clarity
Administrative overhead costs
In the proposed regulation's fee report forms, there are significant differences in the costs covered by different fees except for ''Administrative Overhead'' costs. According to staff at the Department of State and its Bureau of Professional and Occupational Affairs (BPOA), the allocated share of overhead cost for each fee category is calculated by dividing total overhead costs by the number of active licensees. This methodology for overhead cost allocation is not unreasonable and has been consistently applied. On the other hand, the staff cost allocations are based on estimates of the actual time BPOA staff spends performing the tasks related to each fee.
For overhead cost allocations, there appears to be no relationship to the services covered by the fees or frequency of fee payments. Therefore, there is no indication that the fees will recover actual or projected overhead costs. In addition, the allocated costs are based on past expenditures rather than estimates or projections of future expenditures. Hence, there is no certainty that the fees' ''projected revenues will meet or exceed projected expenditures'' under section 30(b) of the Board of Vehicles Act (63 P. S. § 818.30(b)).
We question the use of a constant overhead cost allocation that appears to be unrelated to the actual costs of activities covered by different fees. Even though this process was used to determine other fees, why should BPOA maintain this approach? The Board and BPOA should specifically identify the overhead costs, or portion of the total overhead, to be recouped by these fees, and review their methodology for allocating these overhead costs. Is it the Board's goal to allocate all overhead costs by category to each fee? If so, we do not believe the current allocation formula gives the desired result.
Differing overhead costs
The administrative overhead costs for all fees are $11.53, except for the certification of license history and verification of license fees, which are $9.76. The Board should explain why these administrative costs are different.
''Business name or post office address change'' and ''Business physical location change'' fees
We have two concerns about these fees. One, the Board increased the ''Business name or post office address change'' fee by 100%, and the ''Business physical location change'' fee by 200%. We understand that these fees haven't changed since 1989, and that the Board utilized a recent performance audit when computing the new fees. However, the Board should provide a more detailed explanation of the fee increases for these services.
Two, the fee report form for the ''Business name or post office address change'' fee includes the phrase ''No Inspection Required.'' The fee report form for ''Business physical location change'' includes the phrase ''Inspection Required.'' The regulation doesn't make it clear that one application requires an inspection, while the other does not. For increased clarity, the Board should consider adding these two phrases to their respective fee titles.
Pennsylvania Public Utility Commission
Regulation No. 57-207
Natural Gas Choice and Competition December 2, 1999 We have reviewed this proposed regulation from the Pennsylvania Public Utility Commission (PUC) and submit for your consideration the following objections and recommendations. Subsections 5.1(h) and (i) of the Regulatory Review Act (71 P. S. § 745.5a(h) and (i)) specify the criteria the Commission must employ to determine whether a regulation is in the public interest. In applying these criteria, our Comments address issues that relate to statutory authority, legislative intent, fiscal impact and clarity. We recommend that these Comments be carefully considered as you prepare the final-form regulation.
1. Section 53.69. Fixed rate option--Clarity.
Applicable Revenue Threshold
This proposed regulation is based on Section 1307(f) of the Natural Gas Choice Competition Act (Act). Section 1307(f) of the Act applies to distribution companies with annual operating revenues over $40 million. However, the Regulatory Analysis Form indicates that distribution companies with revenues in excess of $6 million must comply with this regulation. The PUC should explain this discrepancy and clarify the applicability of § 53.69 in the final regulation.
2. Section 53.69 (a), (b) and (e)--Statutory Authority, Legislative Intent, Fiscal Impact, Clarity.
Subsection (a)
This subsection allows a natural gas distribution company to offer the fixed rate option for either the heating season or another time period, as long as the time period does not exceed 12 months. It appears to be in direct conflict with the act. The following statutory provisions illustrate that the Legislature did not contemplate allowing a distribution company to offer the fixed rate option for a time period shorter than 12 months.
Section 1307(f)(1)(ii) of the act establishes ''a fixed rate option which recovers natural gas costs over a 12-month period.'' Additionally, Section 1307(f)(3) provides that ''at the end of such 12-month period,'' the distribution company shall file a statement with the PUC, indicating the difference between rates charged and the cost of natural gas. Finally, Section 1307(f)(5) provides that the PUC shall determine the amount of refund to the consumer by the distribution company by evaluating actual natural gas costs ''in the previous 12-month period.'' (Emphasis added.)
Therefore, we question the PUC's statutory authority to offer the fixed rate option for less than 12 months.
If the PUC can demonstrate its statutory authority for a time period less than 12 months, it must clarify what it means by ''another time period.'' The regulation should include minimum and maximum time frames.
Subsection (b)
This subsection requires a separate reconciliation of the fixed rate option sales. We understand that separate reconciliation of these sales refers to a distinct calculation within a single 1307(f) proceeding. The PUC should clarify this point in the final regulation.
Subsection (c)
How is the date determined for the time period that ''ends on the 1st day of the 12-month fixed rate option contract period?'' Additionally, letter (E) of the Preamble states: ''The process of when and how customers may elect to sign up for participation in a fixed rate offering needs to be established.'' These two statements are confusing.
Does the time period, as well as the sign up period, begin on the first day of the 1307(f) filing period? If so, nothing in the regulation supports that statement. For clarity, the PUC should specify this time frame in the final regulation.
In addition, letter (E) of the Preamble lists particular items that would be included on a customer's application form for the fixed rate option. These requirements should be included in a new proposed regulation with an opportunity for public comment.
3. Response to the PUC's Request for Comments--Statutory Authority.
Fixed rate option with no reconciliation
Section 1307(f)(1)(ii) of the Act requires the fixed rate option be ''subject to annual reconciliation'' if the natural gas distribution company adjusts its rates more often than quarterly. However, the PUC has requested comments on allowing the fixed rate option with no reconciliation. Since the Act requires annual reconciliation of the fixed rate option, the PUC does not have the statutory authority to allow the fixed rate option without reconciliation.
Fixed rate option for companies with annual operating revenues less than $40 million and greater than $6 million
The PUC requested comments on the appropriate reconciliation period for the fixed rate option for natural gas distribution companies with annual operating revenues less than $40 million and greater than $6 million. The PUC specifically asked if these companies could apply their current gas cost rate reconciliation period to the fixed rate option.
Can the PUC allow companies with revenues less than $40 million to offer a fixed rate option? As noted above, Section 1307(f)(1)(ii) of the Act only applies to companies with annual operating revenues greater than $40 million.
JOHN R. MCGINLEY, Jr.,
Chairperson[Pa.B. Doc. No. 99-2147. Filed for public inspection December 17, 1999, 9:00 a.m.]
