NOTICES
INDEPENDENT REGULATORY REVIEW COMMISSION
Notice of Comments Issued
[38 Pa.B. 1111]
[Saturday, March 1, 2008]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final-form regulation must be submitted within 2 years of the close of the public comment period or it will be deemed withdrawn.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 Period IRRC
Comments Issued10-186 Department of Health
Confidentiality of Patient Records and Information
37 Pa.B. 6529
(December 15, 2007)1/14/08 2/13/08 14-510 Department of Public Welfare
Payment for Burial and Cremation
37 Pa.B. 6534
(December 15, 2007)1/14/08 2/13/08 16A-4926 State Board of Medicine
Nurse Midwife Prescriptive Authority
37 Pa.B. 6539
(December 15, 2007)1/14/08 2/13/08 57-258 Pennsylvania Public Utility Commission
Electronic Filing
37 Pa.B. 6112
(November 17, 2007)1/16/08 2/15/08
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Department of Health
Regulation #10-186 (IRRC #2654)
Confidentiality of Patient Records and Information
February 13, 2008 We submit for your consideration the following comments on the proposed rulemaking published in the December 15, 2007 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 Department of Health (Department) to respond to all comments received from us or any other source.
1. Statutory authority; Consistency with the intent of the General Assembly.
The Department has cited the Pennsylvania Drug and Alcohol Abuse Control Act (act) (71 P. S. § 1690.101--1609.115) as one of the statutes that provides it the authority to promulgate this regulation. We agree that section 104(j) of the act (71 P. S. § 1690.104) provides the Department broad authority to promulgate regulations necessary to carry out provisions of the act. We note that the act also establishes the Pennsylvania Advisory Council on Drug and Alcohol Abuse (Council) as the recognized advisory council to the Department for drug and alcohol programs. Section 103(e)(2) of the act (71 P. S. § 1690.103(e)(2)) imposes an obligation on the Department to ''seek the written advice and consultation'' of the Council when promulgating regulations ''necessary to carry out the purposes of this act.''
Commentators, including the Council, have expressed concern that the Council was not consulted as required by section 103(e)(2). In addition, Representative George Kenney, Republican Chairman of the Health and Human Services Committee, and Senator Michael Stack, have submitted comments expressing a similar concern. Based on our review of the minutes of the Council's recent meetings and input from the Council, we concur that the Department did not seek the written advice and consultation of the Council on this version of the proposed rulemaking in a meaningful way. What is the Department's statutory authority for proceeding with the rulemaking without first seeking the written advice and consultation of the Council?
We recommend that the Department consider withdrawing this proposed regulation to provide the Council to an opportunity to review it as required by section 103(e)(2). In the alternative, we recommend that the Department issue an advanced notice of final rulemaking. This would allow the regulated community, including the Council, an opportunity to resolve as many remaining concerns as possible prior to the submittal of the final-form regulation.
2. Possible conflict with statutes.
Commentators have stated that the proposed regulation conflicts with Act 106 of 1989 (40 P. S. §§ 908-1--908-8) (Act 106) and a related Commonwealth Court case, The Insurance Federation of PA v. Commonwealth, 929 A.2d 1243 (2007) (Insurance Federation of PA). As noted by the Court in that case, ''Act 106 plainly provides for mandatory benefits and . . . nothing solely on its face, apart from certification and referral [from a licensed physician or psychologist], limits the availability of mandatory benefits by any extraneous procedures.''
We believe that certain sections of this proposed regulation conflict with Act 106 because they appear to allow third-party payers to deny addiction treatment benefits to insureds who have been certified and referred by a licensed physician or psychologist. The specific provisions that conflict with Act 106 are addressed in more detail below. However, as a general comment, we recommend that the final-form regulation include provisions that clearly state that third-party payers may not deny treatment to insureds covered by Act 106 who have the necessary certification and referral from a licensed physician or psychologist, regardless of what patient information is obtained via consensual or nonconsensual release of the patient record.
3. Need for the regulation.
According to the Regulatory Analysis Form, the compelling public interest that justifies this rulemaking is twofold. First, it will correct a conflict with federal confidentiality regulations ''thereby reducing any perceived complexities in the regulations that drug and alcohol treatment facilities must comply with.'' Second, the Department states that some of the provisions of the existing regulation that are being replaced by this proposal are ''outdated and impede service delivery and the coordination of care for individuals with substance abuse problems.''
We have two concerns. First, the Department has failed to identify the specific sections of the Federal regulations that conflict with the existing regulations. We request the specific sections that are in conflict be identified.
Second, the Department has failed to explain why the regulations are outdated and how they impede service delivery and coordination of care. The final-form regulation should provide a more detailed explanation on why this regulation is needed. In addition, the Department should quantify how many people a year do not receive treatment because the existing regulation is inadequate.
4. Protection of the public health, safety and welfare.
The Department has stated that the risks associated with not making the proposed amendments are ''increased regulatory obstacles to drug and alcohol treatment facilities in the delivery of treatment services to the individuals they serve.'' Representative Frank Oliver, Chairman of the Health and Human Services Committee, Representatives George Kenney and Gene DiGirolamo and Senators Michael Stack, Roger Madigan and Mike Folmer, along with a large segment of the regulated community, disagree with this statement. They believe the proposed regulation will increase obstacles in the delivery of treatment services because the client and counselor relationship, which relies on trust and the expectation of confidentiality, will be undermined. They note addiction is a unique form of illness because of cultural attitudes and stigmas associated with it. In order for individuals suffering from addiction to seek treatment and communicate freely with counselors, ensuring confidentiality is paramount.
We agree with the commentators that an unintended consequence of the proposal could be fewer people seeking and receiving treatment for their drug and alcohol addiction problems for fear that personal and potentially embarrassing information could be released to others. In the Preamble to the final-form regulation, the Department should explain why this proposal will not discourage people who need help with their drug or alcohol problems from seeking the necessary treatment, and how it adequately protects the public health, safety and welfare of the citizens of this Commonwealth.
5. Economic or fiscal impact of the regulation.
The Department has indicated that the proposal will not impose any costs on the regulated community. Commentators, including Representative Oliver, disagree with that statement. They note the proposal will increase the administrative burden of treatment service providers, including extensive training that will be needed to implement the regulations. How did the Department determine that the regulated community will not experience a negative fiscal impact when the proposal is implemented?
6. Implementation procedures and timetables for compliance by the public and the regulated community.
As noted above, the regulated community believes extensive training will be needed to implement this regulation. Accordingly, we recommend that the effective date of the regulation be 6 to 12 months after it is published as a final rule in the Pennsylvania Bulletin. This would provide the Department and the regulated community time to develop the necessary procedures for administering the rule and train those that will be implementing it.
Section 255.5. Confidentiality of patient records and information. 7. Section 255.5(a) Definitions.--Need; Clarity and lack of ambiguity.
Government officials
This definition reads as follows:
Officials or employees of Federal, State or local government agencies responsible for assisting a patient to obtain benefits or services due to the patient as a result of the patient's drug or alcohol abuse or dependence.We have four concerns. First, § 1.7(e) of the Pennsylvania Code and Bulletin Style Manual states that a term being defined may not be included as part of the definition. Accordingly, this definition needs to be amended. Second, what is meant by the following terms or phrases: ''assisting a patient,'' ''benefits'' and ''services?'' We recommend that these terms or phrases be defined so that it is clear which individuals will have access to patient information. Third, is there a difference between ''abuse'' and ''dependence?'' This should be explained in the final-form regulation. Finally, would the defined term include probation and parole officers?
Medical authorities and medical personnel
Physicians, nurses, emergency medical technicians and other persons employed, licensed, certified or otherwise authorized by law to provide medical, mental health or addiction treatment to a patient fall under this definition. We have four concerns. First, the definition does not specify what licensing or certifying authorities would be acceptable. Would a physician or nurse licensed or certified by another state or country fall under this definition? Second, the phrase ''otherwise authorized by law'' is vague. What laws would apply? Third, the inclusion of the word ''employed'' in this definition would open the scope of this definition to any employee of an entity that provides medical, mental health or addiction treatment services. We suggest that only people licensed or certified in a particular medical field directly related to addiction treatment be included in this definition. Finally, we recommend that the terms ''mental health'' and ''addiction treatment'' be defined.
Patient record
This definition may include information such as ''medical, psychological, social, occupational, financial and other data prepared or obtained as part of the diagnosis, classification and treatment of a patients.'' We raise three issues. First, Representative Dennis O'Brien, Speaker of the House, wrote to express his concern with ''provisions that provide for the dissemination of drug and alcohol addiction treatment records and other personal information to third party payers.'' (Emphasis added.) We are also concerned about the release of personal information to third-party payers and others that would have access to it under this proposal, and the potential for misuse or abuse of that information, either intentional or unintentional. What is the need for including the ''social, occupation, financial and other data'' of the patient in this definition?
Second, what is meant by the phrase ''patient's treatment?'' This should be defined in the final-form regulation.
Finally, the term ''other data'' is vague and should be deleted.
Program
Similar to our concerns with the definition of ''medical authorities and medical personnel,'' we believe this definition is vague. In particular, the terms ''institution,'' ''practitioner,'' ''project'' and ''other entity'' should be defined. Also, the inclusion of the phrase ''or holding itself out to provide treatment for drug or alcohol abuse or dependence'' is problematic because it could apply to entities not properly licensed or certified. We recommend that the definition be narrowed to treatment facilities licensed by the Department.
8. Section 255.5(b) Scope and policy.--Need; Reasonableness; Clarity and lack of ambiguity.
Paragraph (1)
This paragraph states that this section of the regulation applies to the record of a patient ''seeking, receiving or having received'' treatment. Why are records of patients that have received treatment included? How long will the records be available for consensual and nonconsensual release?
Paragraph (2)
Under this paragraph, patients are to expect that their information will be treated with respect and confidentiality by those providing services. Does the phrase ''those providing services'' mean the same thing as the defined term ''program?'' If so, we recommend that the defined term be used. In addition, we recommend that the expectation of privacy be extended to any entity that may have access to patient information or a patient's record. What are the consequences for a program or other entity that violates the confidentiality of patient information or a patient's record? How will the Department determine if programs are in compliance with the regulation? We have similar concerns with Paragraph (4).
Paragraph (3)
This paragraph states the record of a patient receiving addiction treatment services is the property of the program providing services. Who owns the record of a patient that has already received addiction treatment services and how can that record be released? This should be explained in the final-form regulation.
Paragraph (5)
Redisclosure of patient information is prohibited under Paragraph (5), unless otherwise noted. We have two concerns. First, we agree with Speaker O'Brien's concern that ''the proposed regulations do not provide sufficient safeguards against subsequent intentional and unintentional dissemination by third party payers.'' What protects the confidentiality of the patient record after it leaves the program? We recommend that the final-form regulation list the specific Federal and State laws and regulations that prohibit any entity or individual from redisclosing any information contained in the patient record and the penalties associated with violating the regulations and statutes. If no laws or regulations exist that protect the patient record once it is released by the program, how can the Department ensure the confidentiality of these records?
Second, what does the phrase ''unless otherwise noted'' refer to? If redisclosure is permitted under this regulation, the sections that address redisclosure should be cross-referenced.
Paragraph (6)
Under this paragraph, disclosure of patient information from a patient record may not be used to initiate or substantiate criminal charges ''against the patient.'' We have two questions. First, can information obtained from a patient's record be used to initiate or substantiate criminal charges against other people?
Second, if a patient is on probation or parole, can information obtained from that patient's record be used to revoke the probation or parole?
9. Section 255.5(c) Consensual release of patient records and information.--Statutory authority; Need; Reasonableness; Implementation procedures; Clarity and lack of ambiguity.
Paragraph (2)
This paragraph states that a program can release information to government officials and third-party payers ''to obtain benefits due the patient as a result of his drug or alcohol abuse or dependence.'' The Department should clarify whether ''benefits due the patient as a result of his or her drug or alcohol abuse or dependence'' means addiction treatment or treatment for other conditions (for instance, cirrhosis of the liver) that may develop as a result of drug or alcohol dependence. We note that defining the terms ''benefits'' and ''services'' as recommended above would aid in the clarification of this paragraph.
In addition, to be consistent with the definition of ''government officials,'' we recommend that the phrase ''or services'' be added after the word ''benefits.''
Paragraph (2)(i)
This paragraph reads as follows: ''A program shall limit the patient information released to government officials and third-party payers to the information necessary to accomplish the specific purpose for the disclosure.'' We have two concerns. First, who determines what information is necessary? Is the program responsible for this decision or do government officials and third-party payers make the determination? If a dispute arises between the program and government officials or third-party payers as to what information is necessary, how will it be resolved? Will a patient be able to receive treatment while the dispute is being resolved? We recommend that the final-form regulation specify which party is responsible for making this determination and how disputes will be resolved.
Second, the phrase ''to the information necessary to accomplish the specific purpose for the disclosure'' is vague. It is our understanding that the specific purpose of the disclosure can only be to obtain benefits that are due the patient. If that is the case, Paragraph (2)(i) should be amended to explicitly state that fact.
Paragraph (2)(ii)
This paragraph limits information that can be released to a government official or a third-party payer. We have three concerns. First, the following terms are used in this paragraph, but are not defined: ''medical necessity,'' ''concurrent review,'' ''coordination of care'' and ''entitled service benefits.'' We recommend that these terms be defined.
Second, the Department should clarify whether third-party payers accessing patient records under this provision may use them to determine ''medical necessity'' and to deny addiction treatment benefits to a patient who is covered by Act 106 and has been certified and referred by a licensed physician or psychologist. Pursuant to Insurance Federation of PA, a third-party payer covered by Act 106 is obligated to pay for specified addiction treatment services whenever an insured is certified and referred by a licensed physician or psychologist. If a determination of medical necessity could result in such a denial, the Department should explain its statutory authority for promulgating this provision, in light of Act 106 and Commonwealth Court's ruling in Insurance Federation of PA.
Third, the Department should explain the need for third-party payers to access patient records under this provision. Since third-party payers covered by Act 106 must provide addiction treatment benefits to certified and referred patients, what need might they have for this information?
Paragraph (4)
Under Paragraph (4), a program may disclose patient information to a patient's probation or parole officer. Unlike paragraph (2), which limits the information from a patient's record that can be released to government official and third-party payers, this paragraph appears to allow the officer to review the entire patient record. What is the need for allowing a probation or parole officer access to the entire patient record? How often do probation or parole officers request to see patient records?
Paragraph (4)(ii)
Similar to our concern on Paragraph (2)(i) on who determines what information is necessary, who will determine if a probation or parole officer has a need for the patient record? Is the program responsible for this decision or do the officers make the determination? If a dispute arises between the program and the officers as to actual need, how will it be resolved? We recommend that the final-form regulation specify which party is responsible for making this determination and how disputes will be resolved.
10. Section 255.5(d) Nonconsensual release of patient records and information.--Statutory authority; Need; Reasonableness; Implementation procedures; Clarity and lack of ambiguity.
This subsection pertains to the nonconsensual release of patient records and information. If patient records and information are released under this subsection, we recommend that the patient be informed of the release, what information was released, who the information was released to and why the information was released. We also recommend that any information released without the consent of the patient be released at the same time to the patient.
Paragraph (3)
Paragraph (3) and Subparagraphs (3)(i) and (ii) use the undefined term ''communications.'' We recommend that it be defined in the final-form regulation.
Paragraph (5)
Under this paragraph, nonconsensual release of a patient record is permitted for the purpose of conducting scientific research if there is written agreement that patient names and identifying information will not be disclosed. The final-form regulation should specify who must be parties to the written agreement.
Paragraph (6)
This paragraph reads as follows: A program may disclose information from patient records to persons reviewing records on program premises in the course of performing audits or evaluations on behalf of any Federal, State or local agency which provides financial assistance to the program or is authorized by law to regulate its activities, or on behalf of any third-party payer providing financial assistance or reimbursement to the program or performing utilization or quality control reviews of the program.We have four concerns. First, the phrase ''to regulate its activities'' is vague. Many government agencies regulate the activities of programs, for example, taxing authorities and building inspectors. The scope of Federal, State or local agencies that could have access to a patient's record should be amended to mirror the definition of ''government officials'' found in Subsection (a).
Second, the Department should define the following terms: ''audit,'' ''evaluation,'' ''utilization review'' and ''quality control review.'' The final-form regulation should also explain what is being audited, evaluated or reviewed and what standards are being used to quantify the results of the audits, evaluations or reviews.
Third, the Department should explain whether disclosure of information under this provision could result in denial of addiction treatment benefits to insureds who are covered by Act 106 and have been certified and referred by a licensed physician or psychologist. If so, the Department should explain its statutory authority for promulgating this provision, in light of Act 106 and Insurance Federation of PA.
Fourth, the Department should provide further information as to the intended use by third-party payers of information released under this subsection. Since third-party payers covered by Act 106 must provide addiction treatment benefits to certified and referred patients, what need might they have for this information?
Paragraph (7)
This paragraph states the following: ''Patient information made available under this section shall be limited to that information relevant and necessary to the purpose for which the information is sought.'' We have two concerns. First, the phrase ''relevant and necessary'' is subjective and open to interpretation. It does not establish a binding norm that is clear to the regulated community. What a program believes is ''relevant and necessary'' can be different than what law enforcement personnel, those conducting scientific research, federal, state or local agencies and third-party payers believe is ''relevant and necessary.'' Similar to our concern on Paragraph (c)(2)(i), who determines what information is necessary? Is the program responsible for this decision or do others make the determination? If a dispute arises between the program and those requesting the information as to what information is necessary, how will it be resolved? Will a patient be able to receive treatment while the dispute is being resolved? We recommend that the final-form regulation specify which party is responsible for making this determination and how disputes will be resolved.
Second, this provision applies to ''this section,'' which is all of § 255.5. We suggest that the paragraph be amended to state ''this subsection,'' which could be § 255.5(d).
11. Section 255.5(e) Patient's access to records.--Implementation procedures; Clarity and lack of ambiguity.
Under this subsection, patients have a right to inspect their own records. If a program removes portions of a patient's records before the inspection occurs, that program must document the reasons for it and keep them on file. Patients also have a right to appeal a decision limiting access to their records. We have two recommendations. First, the final-form regulation should specify how long a program must keep the reason for denying access on file.
Second, the details of how a patient can appeal a decision of a program to limit access to their records should also be included in the final-form regulation.
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Department of Public Welfare
Regulation #14-510 (IRRC #2655)
Payment for Burial and Cremation
February 13, 2008 We submit for your consideration the following comments on the proposed rulemaking published in the December 15, 2007 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 Department of Public Welfare (Department) to respond to all comments received from us or any other source.
1. Section 283.6. Submission of form for payment.--Reasonableness; Implementation procedure; Clarity.
This section and section 283.7 refer to ''a form approved by the Department'' which an individual must complete and submit to the Department in order to request the payment for burial or cremation. There is no information on the content of this form or how individuals can obtain the form or a copy. For example, is this form available through the Department web site? A description of the form's content indicating the basic information required by the Department for a payment request and directions on how to obtain the form should be included in the final-form regulation.
2. Section 283.21. Department payment.--Fiscal impact; Protection of public health, safety and welfare; Reasonableness.
This section begins with this sentence: ''The Department's total payment for burial or cremation, or both, is $750 for goods and services and interment charges.'' This maximum payment rate was increased from $350 to the current amount by a Notice of Rule Change (NORC) that was published in the Pennsylvania Bulletin by the Department on June 10, 2000. In its comments on this proposed regulation, Community Legal Services of Philadelphia (CLS) raised a concern that the payment rate was too low. Citing two sources indicating that the average cost of a funeral was close to $6,000, CLS urged the Department to increase the payment rate.
Neither the NORC in 2000 nor the documentation with this proposed regulation explained the basis for the payment rate of $750. The Department should review its payment rate and provide an explanation with its submittal of the final-form regulation. As a part of its review and explanation, the Department should include specific information on the payment rates used by state agencies for cremation or burial in neighboring states.
3. Section 283.22. Resources that do not reduce Department payment.--Fiscal impact; Reasonableness; Clarity.
Concerning the term ''small contributions'' in section 283.22(1), is there any maximum monetary amount (dollar limit) that the Department will use in determining what constitutes ''small contributions'' or will this be a ''case-by-case'' decision? If there is a maximum dollar amount, it should be listed in the final-form regulation.
There are two concerns regarding section 283.22(2). First, it is unclear whether the phrase ''up to a total of $750'' applies to sections 283.24(b) and (c)(2)--(14). Should section 283.22(2) include a reference to section 283.24?
Second, what is the impact of the phrase ''up to a total of $750''? Does this mean that a combined total of $1,500 could be generated using the Department payment and other sources, and for each dollar over that combined total, the Department payment will be reduced by an equal amount? This formula should be described in the final-form regulation.
4. Section 283.24. Resources reducing Department payment.--Fiscal impact; Reasonableness; Clarity.
In Subsection (b), how will these ''resources'' be calculated in reducing the Department's payment? As noted, it is unclear whether section 283.22(2) applies. Will the Department payment be reduced dollar-for-dollar or will contributions from other sources be allowed to total $750 before the Department payment is reduced? What is the difference between Subsection (b) and Subsection (c)(3)? These questions need to be clarified in the final-form regulation.
In Subsection (c), the phrase ''except as specified in § 283.22 (relating to resources that do not reduce Department payment)'' is unclear. Specifically, is this a reference to section 283.22(2)? Is the intent of this phrase that contributions from the sources listed in section 283.24(c) will not reduce the Department payment except when they exceed $750, and therefore, the combined total (Department payment and other sources) could reach $1,500 before the Department's payment will be reduced? The process that will be used to reduce the Department's payment needs to be described in detail in the final-form regulation.
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State Board of Medicine
Regulation #16A-4926 (IRRC #2656)
Nurse Midwife Prescriptive Authority
February 13, 2008 We submit for your consideration the following comments on the proposed rulemaking published in the December 15, 2007 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. General--Statutory authority; Legislative intent; Economic impact; Protection of the public health, safety and welfare; Need; Reasonableness; Clarity.
Collaborating physician
Many comments were submitted asking for clarification regarding whether doctors of osteopathy can be collaborating physicians. The Board operates under the authority of the Medical Practice Act, which contains the following definitions:
''Medical doctor'' an individual who has acquired one of the following licenses to practice medicine and surgery issued by the board: . . .''Midwife or nurse-midwife'' an individual who is licensed as a midwife by the board. ''Physician'' a medical doctor or doctor of osteopathy.(63 P. S. § 422.2. Emphasis added.)The Board's existing regulation (49 Pa. Code § 18.1) defines ''collaborating physician'' as ''a medical or osteopathic medical doctor who has hospital privileges in obstetrics, gynecology or pediatrics and who has entered into a collaborative agreement with a midwife.'' (Emphasis added.)
Act 50 of 2007 (Act 50) expanded the scope of practice for nurse midwives by adding prescriptive authority. Act 50 consistently and exclusively uses the term physician eight times in describing the collaboration required. Hence, the Medical Practice Act, as amended, continues to include both medical doctors and doctors of osteopathy. For example, Section 2 of Act 50 (adding 63 P. S. § 422.35(c)) states:
(c) Authorization.--(1) A nurse-midwife is authorized to practice midwifery under a collaborative agreement with a physician and regulations promulgated by the board. (Emphasis added.)Section 2 of Act 50 also adds Subsection (d) which states:
(d) Collaborative agreements.--The physician with whom a nurse-midwife has a collaborative agreement shall have hospital clinical privileges in the specialty area of the care for which the physician is providing collaborative services. (Emphasis added.)Contrary to the statutory definition of ''midwife,'' the expansive intent of Act 50 and its existing regulation, the Board proposes to limit the scope of practice of midwives by amending the definition of ''midwife'' in its regulation at section 18.1. The proposed amendment to the regulation's definition would limit collaboration to a physician ''licensed by the Board to practice medicine.'' Since the Board only licenses medical doctors, this definition could subject nurse midwives who collaborate with doctors of osteopathy to disciplinary action by the Board.
This amendment inappropriately attempts to amend the Medical Practice Act's definition of midwife quoted above. The amendment also erroneously reflects the statutory term ''medical doctor,'' rather than the term ''physician'' the General Assembly chose to use throughout Act 50. As a result, the amendment imposes a limitation not found in the Medical Practice Act, Act 50 or the Board's existing regulation.
A joint comment was submitted on February 6, 2008, by Majority Chairman P. Michael Sturla and Minority Chairman William F. Adolph, Jr. of the House Professional Licensure Committee (House Committee) suggesting that the definition of ''midwife'' be altered to include physicians licensed by the State Board of Osteopathic Medicine along with a similar amendment to section 18.5. Collaborative agreements.
Public comment was submitted by a broad spectrum of professionals asking the Board to include collaboration with doctors of osteopathy. The American College of Nurse-Midwives and the Pennsylvania Association of Licensed Midwives believe the proposed regulation inappropriately redefines midwife because Act 50 addresses the practice of midwifery, not the definition of midwifery. The Pennsylvania Medical Society asks the Board to ''recognize that osteopathic physicians could also be collaborating physicians.'' The Pennsylvania Academy of Family Physicians also asks for alternative language to ''permit a midwife to practice in collaboration with allopathic and osteopathic physicians.'' The Hospital and Healthsystem Association of Pennsylvania asks the Board to retain the existing definition. The University of Pennsylvania Health System states ''These regulations appear to eliminate the opportunity to share the responsibility for midwifery collaboration with these qualified physicians. This change is another obstacle to midwifery practice that was not intended by the legislation.'' The Birth Center commented that ''This would eliminate a whole group of collaborating physicians and would restrict access to care.'' Many other similar comments were submitted.
Additionally, public comment noted that midwives perform functions that do not require collaboration. They believe the proposed amendment to the definition of ''midwife'' would require a collaborative agreement for the entire practice of midwifery, which was not required prior to this proposed regulation.
As stated previously, the proposed amendment to the definition of ''midwife'' is inappropriate because it attempts to amend the statutory definition. Further, the Medical Practice Act defines the term ''physician'' as both a medical doctor and a doctor of osteopathy, and Act 50 uses that term. The Preamble is devoid of explanation of why the Board proposes to restrict collaboration to medical doctors and why this action by the Board is in the public interest. Clearly, Act 50 sought to expand the practice of nurse midwives, and the Board needs to explain why it is imposing a restriction. We are particularly concerned that the regulation will restrict or limit access to the type of care envisioned in Act 50. We recommend that the Board maintain the existing definition of midwife and delete the proposed amendment. If the Board believes it must exclude doctors of osteopathy from collaborating with nurse midwives, the Board needs to explain why this exclusion is in the public interest, including in relation to this comment and our criteria:
* The authority the Board believes it has to amend the statutory definition of ''midwife.'' In addition, the Board's authority to limit collaboration to only medical doctors and to exclude doctors of osteopathy.
* How the limitation on collaboration is consistent with the legislative intent of Act 50, which the Board states it is implementing through this regulation. Also, what inquiry the Board made regarding legislative intent prior to proposing the amendment and whether any legislative remedy was sought.
* The economic impact of the limitation, particularly as it limits availability of nurse midwife care to collaboration with medical doctors.
* Any circumstances the Board is aware of that justifies the limitation in regard to protection of the public health, safety and welfare.
* Why the limitation is needed and reasonable.
Clarity of physician requirements
Amendments to sections 18.5(h), 18.6a(c) and 18.9(b) specify actions to be taken by collaborating physicians rather than nurse midwives. The regulation under Chapter 18, Subchapter A, Licensure and regulation of midwife activities should only address midwife activities. While these provisions and actions are needed, they should be deleted from Subchapter A in as far as they address collaborating physician actions and placed in the appropriate regulation that addresses actions required by physicians.
Appropriate Certification Body
The regulation deletes the definition of ''ACNM--The American College of Nurse-Midwives'' and adds the definition ''AMCB--The American Midwifery Certification Board.'' The acronym ACNM is then replaced throughout the regulation with AMCB.
Many public commentators believe this designation is either incorrect or incomplete. Some say the American Commission on Midwifery Education is the proper accrediting body. Another commentator believes the regulation needs to recognize the evolution of accreditation from prior to 1991 through the present so that currently practicing midwives will not be excluded. We recommend that the Board review the comments and licenses of practicing midwives so that the final-form regulation recognizes existing licensees and uses the appropriate accrediting entities.
2. Section 16.13. Licensure, certification, examination and registration fees.--Economic impact; Clarity.
Application of fees
The House Committee requests clarification of the fee for verification of licensure. Commentators also outlined concerns about the application of the fees. The concerns essentially were whether fees apply to each nurse midwife in a group practice or whether they apply to a group practice as a whole. Commentators demonstrated a significant impact depending on how the fees are applied. We could not determine from the rate schedule in this section or the information accompanying the regulation how these fees would be applied. The final-form regulation should clarify how the fees are applied and the Board should explain why the resulting revenue is reasonable and necessary. In addition, the Board should explain how the fees will not restrict the availability of midwives.
3. Section 18.1. Definitions.--Need; Clarity.
Collaboration
Several commentators requested the addition of a definition of ''collaboration.'' The Board should consider adding this definition.
Midwife Colleague
The House Committee questioned the reason for adding this definition, stating no other medical practitioner has a definition for a colleague. We also question why this definition is needed. The defined term is only used in section 18.6a(c) Inappropriate practice. The term ''midwife colleague'' is always used in conjunction with the term ''midwife'' and therefore the actions required are identical. If a distinction is intended, it is not clear what that distinction is within this regulation. Therefore, we recommend deleting the definition of ''midwife colleague'' and also deleting the term from section 18.6a(c).
4. Section 18.5. Collaborative agreements.--Need; Reasonableness; Economic impact; Clarity.
Existing provisions for collaborative agreements
Provisions for collaborative agreements already exist in the Board's regulations for Certified Registered Nurse Practitioners (CRNPs) in section 18.55 and there are similar provisions for written agreements for Physician Assistants (PAs) in section 18.142. However, there are differences in the requirements proposed for nurse midwives collaborative agreements as compared to CRNPs and PAs. For example, a CRNP collaborative agreement must be signed by both the physician and the CRNP (49 Pa. Code § 18.55(a)) and there are similar signature requirements for a PA's written agreement (49 Pa. Code § 18.142(a)(1)). However, there is no signature requirement in either the existing provisions of section 18.5 or its amendments. We recommend that the Board review and compare the collaborative agreement provisions for nurse midwives with the requirements for CRNPs and PAs, and either align the requirements for nurse midwives with them or explain the need to vary from them.
Minimum requirements
While this section addresses collaborative agreements, section 18.6(6)(ii) specifies minimum requirements for a collaborative agreement. We recommend moving the minimum requirements in section 18.6(6)(ii) to this section to improve clarity.
''. . . submitted to the Board for review.''
Subsection (g) requires the collaborative agreement to be submitted to the Board ''for review.'' We note that the parallel provision for CRNPs in section 18.55(b)(7) does not require review and only states that their collaborative agreements must ''Be kept at the primary practice location of the CRNP and a copy filed with the Bureau of Professional and Occupational Affairs.'' Commentators said the collaborative agreements can involve as many as 15 physicians and would require filing amendments several times every year. Commentators also questioned how long a review will take and whether they can practice while the collaborative agreement is being reviewed. The Board should explain why review is needed for nurse midwife agreements, but not for CRNPs. If this review is needed, the regulation needs to specify the review procedure and criteria, the status of an agreement while it is being reviewed, how long these reviews will take and how the nurse midwife will be notified of the result of the review.
5. Section 18.6. Practice of midwifery.--Protection of the public health, safety and welfare.
45 hours of course work specific to advanced pharmacology
Subparagraph (6)(i) requires ''45 hours of course-work specific to advanced pharmacology at a level above that required by a professional nursing education program.'' Several commentators point out that pharmacology is a rapidly evolving field and believe this provision should require current knowledge in advanced pharmacology. The Board should add a provision to make sure that the nurse midwife has current knowledge of pharmacology.
6. Section 18.6a. Prescribing, dispensing and administering drugs.--Reasonableness; Clarity; Protection of the public health, safety and welfare.
Schedule III or IV controlled substances
The House Committee requests that the Board add a language to address the requirement in 63 P. S. § 35(c)(2)(iv)(A). This provision states, in part:
In the case of a Schedule III or IV controlled substance, the prescription shall be limited to 30 days and shall only be refilled with the approval of the collaborating physician.We agree and recommend adding this provision to the regulation.
Delegation
Under 49 Pa. Code § 18.54(f)(3), CRNPs are prohibited from delegating their prescriptive authority assigned by the collaborating physician. We recommend adding a similar prohibition to this section.
Prescription blanks.
There are three concerns with Subsection (b). First, the Board should explain why the collaborating physician(s) are not required to be identified on the prescription blank.
Second, supervising physicians are prohibited from presigning prescription blanks for PAs under 49 Pa. Code § 18.158(b)(3). A similar provision should be added to the appropriate portion of the Board's regulations relating to supervising physicians for nurse midwives.
Finally, Paragraph (b)(2) states ''the signature of the midwife must be followed by the initials 'C.N.M.' or similar designation to identify the signer as a midwife.'' Would it be sufficient for the prescription blank to bear this designation, as well as the United States Drug Enforcement Administration registration number, in a printed format on the blank as described in Paragraph (b)(1)?
Inappropriate prescribing.
Subsection (c) requires the collaborating physician to immediately advise the patient of an inappropriate prescription. As stated previously in these comments, this provision should be directed to the actions required of the nurse midwife, particularly if the nurse midwife is the first to recognize an inappropriate prescription.
Recordkeeping requirements.
The House Committee requests an explanation of why the Board did not require physician signatures on the records of nurse midwives. We agree that under the recordkeeping requirements for PAs in 49 Pa. Code § 18.158(d)(4), a physician must countersign the patient record within 10 days. Why didn't the Board require physician signatures here?
Paragraph (d)(1) states:
When prescribing a drug, the midwife shall do one of the following:(i) Keep a copy of the prescription, including the number of refills, in a ready reference file.(ii) Record the name, amount, directions for use and doses of the drug prescribed, the number of refills, the date of the prescription and the midwife's name in the patient's medical records.The House Committee questions the use of the word ''ready'' in Subparagraph (i). The House Committee also believes that all drugs should be recorded in the patient's chart, regardless of whether they are also kept in a file. We agree.
Also, Subparagraph (i) requires the nurse midwife to keep a copy of the prescription. Would an electronic file of the prescription be sufficient rather than a physical copy? If so, the regulation should allow electronic recordkeeping.
7. Section 18.9. Notification of changes in collaboration.--Need; Feasibility; Clarity.
Need and feasibility
Several commentators believe this provision is not needed and will require several filings a year. We agree that multiple changes are bound to occur in practices with multiple physicians and nurse midwives. The Board should explain why it needs notification of changes in collaboration, what it will do with them and how the Board can feasibly review these changes.
Subsection (d)
The House Committee states the procedure in this section is unclear. We agree. The Board should rewrite this provision to improve clarity.
____
Pennsylvania Public Utility Commission
Regulation #57-258 (IRRC #2649)
Electronic Filing
February 15, 2008 We submit for your consideration the following comments on the proposed rulemaking published in the November 17, 2007 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 Pennsylvania Public Utility Commission (Commission) to respond to all comments received from us or any other source.
1. General.--Reasonableness; Clarity.
There are several places in this regulation that direct users to the Commission's web site for electronic filing registration information or instructions relating to this registration. However, the Commission staff has indicated that this information is not yet uploaded onto the web site. When will it be added? In order to adequately guide the regulated community, we recommend that this information be uploaded onto the Commission's web site prior to the effective date of the final-form version of this regulation.
2. Section 1.8. Definitions.--Reasonableness; Clarity.
Substantive Language in Definitions
The last sentence in the definitions of ''Confirmation of receipt,'' ''Filing user'' and ''Qualified user'' contain substantive language. Also, the entire definition of ''PDF-Portable Document Format'' is substantive. In order to assist the regulated community with compliance and to improve clarity, this language should be moved to the body of the final-form regulation.
Filing user
Commentators have stated that it is unclear how many people may use the same filing user code with permission of the registered filing user. This should be clearly stated in the final-form regulation. Also, will there be a limit on the number of users that an entity may register?
3. Section 1.16. Issuance of decisions by presiding officers.--Reasonableness.
Under Subsection (b), the Commission will mail a decision to parties that are not filing users. Commentators have suggested that the decision should also be placed on the Commission's web site in order to allow non-filing users to have access to these decisions on the same day as the parties that are served electronically. We agree. The Commission should consider posting decisions on its web site.
4. Section 1.32. Filing specifications.--Reasonableness; Clarity.
The term ''notice of revocation'' is used throughout Subsection (b)(5). What information should be included in this ''notice''? This information should be contained in the final-form regulation.
5. Section 1.36. Verification.--Clarity.
Subsection (c) requires an affidavit to be submitted ''in paper form no later than 3 business days . . . .'' The Commission staff indicates that more details on this submission are located in existing § 1.11(a)(1)--(3). For clarity, the Commission should add a cross-reference to these Subsections. A similar concern also applies to §§ 1.37(b)(2) and 5.502(b)(2)(ii).
6. Section 1.51. Instructions for service, notice and protest.--Clarity.
To be consistent with the language in the rest of the section, the word ''Indicates'' in Subsection (b)(2) should be ''Indication.'' Also, the word ''Provides'' in Subsection (b)(3) is not needed.
7. Section 1.53. Service by the Commission.--Reasonableness; Clarity.
The Office of Consumer Advocate asserted that Subsection (b)(3) should be amended to include the timeframe within which the Commission will send a notice of the posting and the link. It further stated that this should be clarified to say that the notice should occur simultaneously with the posting of the document. We agree.
ARTHUR COCCODRILLI,
Chairperson
[Pa.B. Doc. No. 08-370. Filed for public inspection February 29, 2008, 9:00 a.m.]
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