NOTICES
Notice of Comments Issued
[33 Pa.B. 5792] 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 Committee 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final-form regulation must be submitted within 2 years of the close of the public comment period or it will be deemed withdrawn.
Close of the Public IRRC Comments Reg. No. Agency/Title Comment Period Issued 16A-5116 State Board of Nursing
CRNP Prescriptive Authority Fees
(33 Pa.B. 4462 (September 6, 2003))10/6/03 11/5/03 10-174 Department of Health
Out-of-Hospital Do-Not-Resuscitate Orders
(33 Pa.B. 4450 (September 6, 2003))10/6/03 11/5/03 16A-5211 State Board of Optometry
Continuing Education, Fees, Certification to Treat Glaucoma
(33 Pa.B. 4464 (September 6, 2003))10/6/03 11/5/03
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State Board of Nursing Regulation No. 16A-5116
CRNP Prescriptive Authority Fees
November 5, 2003 We submit for consideration the following comments that include references to the criteria in the Regulatory Review Act (71 P. S. § 745.5b) which have not been met. The State Board of Nursing (Board) must respond to these comments when it submits the final-form regulation. The public comment period for this regulation closed on October 6, 2003. If the final-form regulation is not delivered within 2 years of the close of the public comment period, the regulation will be deemed withdrawn.
1. General.--Statutory authority, reasonableness, clarity.
Board counsel indicated that the fees in this regulation will be applied retroactively to November 18, 2000. In addition, the Board-generated application form for Certified Registered Nurse Practitioner (CRNP) prescriptive authority also states this intent. We have two concerns.
First, there is no mention of the intended retroactive application of these proposed fees in the proposed regulation or its preamble. The Board must clearly explain its intent to the regulated community and establish a justifiable rationale for retroactive collection of fees.
Second, if the Board intends to retroactively apply these fees upon the regulated community, it must justify its statutory authority to do so.
2. Section 21.253. Fees.--Fiscal impact, reasonableness, clarity.
There have been numerous comments that the proposed fees are quite costly and unreasonable. We have four related concerns.
First, the Board pointed out that many of the applications received from CRNPs for collaborative agreements for prescriptive authority are voluminous and contain unnecessary information. As a result, Board staff must undergo a more time-consuming review of the application to ensure that the required information is present and accurate.
The Board indicates that it has developed a simplified form for collaborative agreements for prescriptive authority, but this form is only used by a small percentage of applicants. To avoid the review of unnecessary information and to lower the corresponding costs on the regulated community, the Board should consider adding a provision that all applicants must use the Board-generated collaborative agreement form. This would allow the Board to lower the proposed fee.
Second, the proposed regulation is unclear on what circumstances will require the filing of additional collaborative agreements for prescriptive authority. The vagueness of this provision may cause applicants to submit additional collaborative agreements to the Board when they are not necessary, thus causing the CRNP to pay unnecessary extra fees to the Board.
The Board has indicated that an additional collaborative agreement must be filed only when the primary supervising physician changes or another primary supervising physician becomes necessary. The Board should add or amend language in § 21.285 to clearly indicate when an additional collaborative agreement for prescriptive authority must be filed.
Third, the Board stated that a collaborative agreement may have an unlimited number of substitute physicians and these can be easily added or deleted at any time without cost to the CRNP. Section 21.285(b)(1) should be amended to clearly reflect the Board's procedures for making amendments to collaborative agreements regarding substitute physicians.
Finally, the Board has indicated that it is necessary to review and approve the collaborative agreements to ensure that all of the necessary requirements are met. In cases where the CRNP is only changing the primary supervising physician, the Board should consider reasonable filing alternatives to reduce the financial burden on the regulated community. The fee could be eliminated or a more reasonable, lesser fee could be charged because less information will need to be reviewed on the new submission.
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Department of Health Regulation No. 10-174
Out-of-Hospital Do-Not-Resuscitate Orders
November 5, 2003 We submit for consideration the following comments that include references to the criteria in the Regulatory Review Act (71 P. S. § 745.5b) which have not been met. The Department of Health (Department) must respond to these comments when it submits the final-form regulation. The public comment period for this regulation closed on October 6, 2003. If the final-form regulation is not delivered within 2 years of the close of the public comment period, the regulation will be deemed withdrawn.
1. Section 1005.3. Right to enter, inspect and obtain records.--Clarity.
The preamble states the Department's intention to use a reference to Subpart A. However, this reference is not shown in § 1005.3. Was it the Department's intention to publish the subsections under § 1005.3?
2. Section 1051.13. Person who loses authority to function as a surrogate.--Reasonableness.
There are three questions related to the change of surrogates. First, does an out-of-hospital do-not-resuscitate (DNR) order remain valid if it was established by a surrogate who is subsequently replaced? If so, how could the new surrogate become aware of an existing out-of-hospital DNR order?
Second, this section places responsibilities on former surrogates. However, there is no parallel provision that places responsibilities on the current surrogate. Should similar responsibilities, such as contacting the attending physician, be placed on the current surrogate?
Finally, subsections (b) and (c) require a former surrogate to help the physician locate ''the patient or the patient's current surrogate.'' (Emphasis added.) If the patient is unable to communicate, it may be difficult for the physician to locate the current surrogate. Should the word ''or'' be replaced by ''and''?
3. Section 1051.23. Disclosures to patient requesting out-of-hospital DNR order. Section 1051.24. Disclosures to surrogate requesting out-of-hospital DNR order.--Protection of the public health, safety and welfare.
We have three questions. First, why don't §§ 1051.23(9) and 1051.24(5) mandate a physician to contact the patient or surrogate to rescind the out-of-hospital DNR order if the physician discovers the diagnosis of the terminal condition was in error? If the premise for the out-of-hospital DNR order is in error, an ''attempt'' to notify the patient or surrogate may not sufficiently protect the patient.
Second, why don't §§ 1051.23(6) and 1051.24(4) require notice to the physician if the patient or surrogate revokes the out-of-hospital DNR order without the physician's approval or knowledge? Subsequent notice to the physician should be required, particularly if a surrogate revoked the order.
Finally, to what other procedures is the Department referring in § 1051.23(5)? The Department should specify what these procedures are by cross-referencing them or delete the phrase ''in accordance with other procedures'' from this paragraph.
4. Section 1051.26. Physician refusal to issue an out-of-hospital DNR order.--Reasonableness; Clarity.
We have two questions on paragraph (2). First, a physician who is not willing to issue an out-of-hospital DNR order is required to ''offer to assist the patient or surrogate to secure the services of another physician who is willing to issue an out-of-hospital DNR order.'' As written, this requirement presumes that the attending physician knows what diagnosis and conclusion another physician will make. Why is the phrase ''who is willing to issue an out-of-hospital DNR order'' appropriate?
Second, to what degree is a physician required to assist a patient in obtaining an out-of-hospital DNR order from another physician? Will a referral be sufficient?
5. Section 1051.29. Duty to contact patient or surrogate.--Protection of the public health, safety and welfare.
This section requires a physician to ''make a good faith effort'' to contact the patient to rescind the out-of-hospital DNR order if the physician discovers the diagnosis of the terminal condition or permanent unconsciousness was in error. If the premise for the out-of-hospital DNR order is in error, shouldn't notification of the patient or surrogate be mandatory?
6. Section 1051.30. Physician destruction of out-of-hospital DNR order, bracelet or necklace.
The preamble states that a physician must have confirmation of the destruction of the out-of-hospital DNR order from a ''reliable person'' if they do not destroy the order themselves. Subsection (b) does not include this language. The phrase ''reliable person'' should be added to subsection (b) and defined in § 1051.2.
7. Section 1051.51. Implementation of out-of-hospital DNR order.--Reasonableness; Clarity.
Subsection (a) of this section states ''. . . the EMS provider shall implement the out-of-hospital DNR order only if it contains original signatures.'' We have two concerns.
First, why are ''original signatures'' required? Also, how can the emergency medical services provider readily determine if the out-of-hospital DNR order contains original signatures?
Second, commentators have suggested that prehospital practitioners should be able to accept an unaltered copy of the original out-of-hospital DNR order. Is there any reason an unaltered copy wouldn't be acceptable?
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State Board of Optometry Regulation No. 16A-5211
Continuing Education, Fees,
Certification to Treat Glaucoma
November 5, 2003 We submit for consideration the following comments that include references to the criteria in the Regulatory Review Act (71 P. S. § 745.5b) which have not been met. The State Board of Optometry (Board) must respond to these comments when it submits the final-form regulation. The public comment period for this regulation closed on October 6, 2003. If the final-form regulation is not delivered within 2 years of the close of the public comment period, the regulation will be deemed withdrawn.
Section 23.205. Application procedure.--Consistency with the enabling statute.
Section 3(a)(2.5)(I) of the Optometric Practice and Licensure Act (act) (63 P. S. § 244.3(a)(2.5)(i)) requires optometrists to maintain professional liability insurance in the amounts of $200,000 per occurrence and $600,000 per annual aggregate. However, therapeutically certified optometrists are required to have professional liability insurance in the amounts of $1 million per occurrence and $3 million per annual aggregate. See section 4b(b) of the act (63 P. S. § 244.4b(b)).
It is our understanding that when an applicant applies for a license as a therapeutically certified optometrist, the applicant must verify, by signature under a statement, that the optometrist has the greater amount of insurance coverage. However, this requirement is not in the proposed regulation. To provide sufficient notice to prospective applicants, the final-form regulation should include the greater insurance requirements established by the act.
JOHN R. MCGINLEY, Jr.,
Chairperson
[Pa.B. Doc. No. 03-2247. Filed for public inspection November 21, 2003, 9:00 a.m.]
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