INDEPENDENT REGULATORY REVIEW COMMISSION Notice of Comments Issued [36 Pa.B. 7514]
[Saturday, December 9, 2006]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final-form regulation must be submitted within 2 years of the close of the public comment period or it will be deemed withdrawn.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/Title Close of
the Public
Comment PeriodIRRC
Comments
Issued47-12 Milk Marketing Board
Refrigeration Equipment; Records and Reports10/23/06 11/22/06 36 Pa.B. 5875 (September 23, 2006) 16A-5719 State Board of Veterinary Medicine
Recordkeeping10/30/06 11/29/06 36 Pa.B. 5984 (September 30, 2006) 16A-4313 State Board of Chiropractic
Patient Records10/30/06 11/29/06 36 Pa.B. 5979 (September 30, 2006)
____ Milk Marketing Board
Regulation #47-12
(IRRC #2564)Refrigeration Equipment; Records and Reports November 22, 2006 We submit for your consideration the following comments on the proposed rulemaking published in the September 23, 2006 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 Milk Marketing Board (Board) to respond to all comments received from us or any other source.
Section 146.4. Sale of equipment.--Clarity.
We have two concerns with this section.
First, Subsection (a)(2) contains the phrase ''or value of the equipment to the dealer at the time it was placed at the customer's location . . . .'' Is this phrase referring to the value equated using the depreciation formula in Subsection (c)? If so, a cross-reference should be added. If not, then the method of how the value under Subsection (a)(2) is determined should be set forth or cross-referenced in the final-form regulation.
Second, under Subsection (d), the dealer or subdealer should maintain certain items ''for review by the Board.'' Board staff indicated that these items must be maintained by the dealer for two years, based on Section 701(b) of the Milk Marketing Law (31 P. S. § 700j-701(b)). This subsection should be amended in the final-form regulation to clarify how long records must be maintained by inserting a cross-reference to the appropriate section of the Milk Marketing Law.
____ State Board of Veterinary Medicine
Regulation #16A-5719
(IRRC #2565)Recordkeeping November 29, 2006 We submit for your consideration the following comments on the proposed rulemaking published in the September 30, 2006 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 Veterinary Medicine (Board) to respond to all comments received from us or any other source.
Section 31.22. Recordkeeping.--Clarity.
We have three concerns with this section.
First, we agree with the House Professional Licensure Committee (HPLC) that the terms ''animal'' and ''patient'' are used interchangeably throughout the regulation, and recommend that one term be used consistently.
Second, the Board should clearly indicate which recordkeeping methods would meet the required standards. This section contains the phrase ''problem-oriented or similar format.'' The preamble states that a ''problem oriented medical record'' (POMR) is a ''recognized standard form of all medical recordkeeping.'' Board staff indicated that POMR is a general recordkeeping method and there are several more specific methods that fall under it. Which of these methods are acceptable to the Board?
Finally, Paragraph (4) requires the veterinary record of an animal, ''except a production animal,'' to include documentation of communication with a client. The Board excluded production animals because existing Federal regulations address communication between veterinarians and owners of production animals. The HPLC questioned whether a citation to the Federal regulations should be included in this regulation. We agree and recommend that the final-form regulation include a cross-reference to the appropriate Federal regulations.
____ State Board of Chiropractic Regulation
#16A-4313
(IRRC #2568)Patient Records November 29, 2006 We submit for your consideration the following comments on the proposed rulemaking published in the September 30, 2006 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 Chiropractic (Board) to respond to all comments received from us or any other source.
1. Need, Reasonableness and Economic impact of the regulation.
Standards for medical records
In response to question #16 of the Regulatory Analysis Form, the Board states the following:
On December 6, 2001, the Board received a petition under 1 Pa. Code § 35.18 to promulgate a regulation that would establish medical necessity definitional parameters in order to assist licensees to discharge their regulatory documentation obligation and establish guidelines for peer review and utilization review concerning chiropractic care. The Board held a work session on March 7, 2002. After extensive discussion at public meetings over the ensuing months, the Board concluded that its rulemaking should be directed toward setting forth standards for medical records, not attempting to define what is medically necessary.
The House Professional Licensure Committee (House Committee) asked the Board to further explain the rationale for this regulation. We agree that the Board has not explained the basis for its apparent disagreement with portions of the December 6, 2001 petition. The Board also needs to explain its conclusion that the rulemaking should only be directed toward standards for medical records rather than attempt to define what is medically necessary. It is not clear how this conclusion is consistent with this rulemaking that requires documentation of ''diagnosis and clinical necessity,'' defines separate levels of care and specifies how that care must be documented. The Board should respond to these concerns, provide support for the need for this rulemaking and explain its objectives.
Purposes of patient records
The House Committee also questioned whether the Board is taking a unique approach regarding the content of patient records. In its extensive comments on this regulation, Practice Masters, Incorporated (PM) believes its suggestions will make the regulation consistent with documentation standards in the industry.
The Board should explain what factors it considered in developing this regulation. Specifically, the Board should explain how the regulation is consistent with documentation standards of other health care licensing boards and how it supports processes such as peer review, documentation for compensation and utilization review.
2. Section 5.1. Definitions--Clarity.
Distinction between levels of care
While the regulation defines four levels of care (elective, maintenance, palliative and supportive) along with preventive service, the distinction between them is not sufficiently clear. The House Committee expressed concern with the lack of distinction between maintenance care and palliative care and asked for examples of each type of care. The House Committee asks the Board to carefully review the comments submitted by PM regarding the definitions. We agree. The Board should review all of the definitions and provide a clear delineation between all of the levels of care and service specified in the regulation.
Clarity affected by use of the negative
Several definitions include a description of what the term does not mean, rather than what the term does mean. This affects the clarity of the definitions. The Board should consider revising the following definitions for clarity: elective care, maintenance care, palliative care and preventive service.
3. Section 5.51. Patient records.--Clarity.
Human performance and sense of well-being
Subparagraph (c)(4)(i) requires the patient record to demonstrate ''how human performance and the sense of well-being was enhanced.'' These requirements are vague. What criteria must the licensee use in the documentation of these findings?
ALVIN C. BUSH,
Chairperson[Pa.B. Doc. No. 06-2429. Filed for public inspection December 8, 2006, 9:00 a.m.]
