​​50 N.J.R. 1338(a)

VOLUME 50, ISSUE 11, JUNE 4, 2018
RULE PROPOSALS

Reporter
50 N.J.R. 1338(a)
NJ - New Jersey Register  >  2018  >  JUNE  >  JUNE 4, 2018  >  RULE PROPOSALS  >  LAW AND PUBLIC SAFETY -- DIVISION OF CONSUMER AFFAIRS

Interested Persons Statement

INTERESTED PERSONS
Interested persons may submit comments, information or arguments concerning any of the rule proposals in this issue until the date indicated in the proposal. Submissions and any inquiries about submissions should be addressed to the agency officer specified for a particular proposal.
The required minimum period for comment concerning a proposal is 30 days. A proposing agency may extend the 30-day comment period to accommodate public hearings or to elicit greater public response to a proposed new rule or amendment. Most notices of proposal include a 60-day comment period, in order to qualify the notice for an exception to the rulemaking calendar requirements of    N.J.S.A. 52:14B-3. An extended comment deadline will be noted in the heading of a proposal or appear in a subsequent notice in the Register.
At the close of the period for comments, the proposing agency may thereafter adopt a proposal, without change, or with changes not in violation of the rulemaking procedures at    N.J.A.C. 1:30-6.3. The adoption becomes effective upon publication in the Register of a notice of adoption, unless otherwise indicated in the adoption notice. Promulgation in the New Jersey Register establishes a new or amended rule as an official part of the New Jersey Administrative Code.
Agency


LAW AND PUBLIC SAFETY > DIVISION OF CONSUMER AFFAIRS > STATE BOARD OF MEDICAL EXAMINERS

Administrative Code Citation

Proposed Amendments: N.J.A.C. 13:35-2A.2, 2A.4, 2A.5, 2A.6, 2A.7, 2A.9, 2A.10, 2A.11, 2A.14, and 2A.16
Text

Limited Licenses: Midwifery
Authorized By: State Board of Medical Examiners, William Roeder, Executive Director.
Authority: N.J.S.A. 45:9-2.
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
Proposal Number: PRN 2018-050.
Submit written comments by August 3, 2018, to:
   William Roeder, Executive Director
   State Board of Medical Examiners
   PO Box 183
   Trenton, NJ 08625-0183
   or electronically at: http://www.njconsumeraffairs.gov/Proposals/Pages/default.aspx.
The agency proposal follows:
Summary
The Board of Medical Examiners (Board) has reviewed the rules governing the practice of licensed midwives and proposes amendments to these rules to reflect current practice standards for midwifery. The Board proposes to amend N.J.A.C. 13:35-2A.2 to delete the term "affiliated physician" and replace it with "consulting physician." The Board believes that the term "consulting physician" more accurately describes the relationship between a licensed midwife and the physician with whom he or she has clinical guidelines. The Board proposes to replace "affiliated physician" with "consulting physician" throughout Subchapter 2A. The Board also proposes to amend the definitions of "certified midwife (CM)" and "certified nurse midwife (CNM)" in N.J.A.C. 13:35-2A.2. The proposed amendments delete a phrase that stated that a certified midwife is not a registered nurse. The proposed amendments require a certified midwife to currently hold, or have held in the past, certification by the American Midwifery Certification Board (AMCB), which is the successor to the American College of Nurse Midwives Certification Council (ACC). The proposed amendments require a certified nurse midwife to currently hold, or have held in the past, certification from the American College of Nurse Midwives (ACNM) or the AMCB. The Board proposes to amend N.J.A.C. 13:35-2A.4 to delete reference to the ACC and replace it with reference to the AMCB.
The Board proposes to amend N.J.A.C. 13:35-2A.5 to replace the Midwifery Model of Care with the Midwives Alliance of America Core Competencies (2014) as the standard for certified professional midwife practice. The proposed amendments also provide an address for the Midwives Alliance of North America.
N.J.A.C. 13:35-2A.7 establishes license renewal requirements for licensed midwives. The Board proposes to amend this rule to require licensed midwives to submit proof that they are currently certified by the ACNM, AMCB, or North American Registry of Midwives (NARM) when renewing licensure. A licensee renewing as inactive will not be required to submit proof that he or she is currently certified, but will need to submit such proof if he or she elects to reactivate his or her license.
N.J.A.C. 13:35-2A.9 and 2A.11 set forth procedures that a licensed midwife must follow when a patient is at increased risk during [page=1339] pregnancy. The rules set forth the risk factors that trigger these procedures. The Board has reviewed these risk factors and proposes to amend these rules, so that the list of increased risk factors reflect current practice standards for midwifery.
N.J.A.C. 13:35-2A.9(b)1vii lists chronic anemia and/or hemoglobinopathy as a risk factor. The Board proposes to amend this to remove anemia and to require that chronic hemoglobinopathy have a history of transfusion.  N.J.A.C. 13:35-2A.9(b)1ix lists drug addiction as a risk, proposed amendments to this subparagraph include any psychoactive substance addiction as a risk.  N.J.A.C. 13:35-2A.9(b)1xi lists the taking of daily oral medication for asthma as a risk factor. The proposed amendments would list severe asthma defined by the European Respiratory Society/American Thoracic Society as a risk factor. This subparagraph incorporates the December 12, 2013 International ERS/ATS Guidelines on Definition, Evaluation and Treatment of Severe Asthma, as amended and supplemented. Proposed new subparagraphs (b)1xvi and xvii also list hepatitis with abnormal liver function and/or detectable viral loads and a Body Mass Index of over 40 as additional risk factors.
N.J.A.C. 13:35-2A.9(b)2iii lists a history of preterm labor and/or delivery as a risk factor. The Board proposes to amend this subparagraph, so that only preterm delivery would be a risk factor.  N.J.A.C. 13:35-2A.9(b)2iv lists parity of six or more as a risk factor. The proposed amendments would rephrase this, so that grand multiparity would be a risk factor.  N.J.A.C. 13:35-2A.9(b)2vii lists previous placental abruption as a risk factor; the proposed amendments would add accreta as a risk factor.  N.J.A.C. 13:35-2A.9(b)2ix lists previous cervical surgeries as a risk factor; proposed amendments to this subparagraph would establish that such surgeries are not a risk factor, if a patient has had a subsequent pregnancy that went to term.  N.J.A.C. 13:35-2A.9(b)2x establishes that intra-uterine growth restriction and/or delivery of an infant weighing less than 2,500 grams at 36 weeks as a risk factor. The Board proposes to amend this subparagraph to remove reference to an infant weighing less than 2,500 grams at 36 weeks or more.
N.J.A.C. 13:35-2A.9(b)3ix lists PAP smear indicating dysplasia as a risk factor. The Board proposes to amend this subparagraph, so that it will address cervical dysplasia requiring colposcopy.  N.J.A.C. 13:35-2A.9(b)3x lists placenta previa as a risk factor. The proposed amendments would revise this subparagraph, so that it would include only placenta previa lasting past 28 weeks of gestation. The Board proposes to include a new risk factor of evidence of placenta accrete abruption. Recodified N.J.A.C. 13:35-2A.9(b)3xii lists medicated pre-term labor as a risk factor. Proposed amendments to this subparagraph would revise this requirement, so that it will only apply to pre-term labor with cervical changes.
Proposed amendments to N.J.A.C. 13:35-2A.11(a)1 clarify that the references to 37 weeks and 34 weeks are to weeks of gestation.  N.J.A.C. 13:35-2A.11(a)2 lists a premature rupture of membranes more than 24 hours before the onset of contractions as a risk factor. The Board proposes to increase the number of hours to 48. The Board proposes to amend N.J.A.C. 13:35-2A.11(a)6, so that it does not refer to "completed" gestation.  N.J.A.C. 13:35-2A.11(a)8 lists malpresentation as a risk factor. The Board proposes to amend this subsection, so that it lists non-vertex presentation as a risk factor. The Board also proposes to add a new risk factor of hypertensive disorder and/or Hemolysis, Elevated Liver Enzymes, and Low Platelet (HELLP) syndrome as proposed new N.J.A.C. 13:35-2A.11(a)10.  N.J.A.C. 13:35-2A.11(b)1 lists the development of hypertension or preeclampsia as a risk factor. The Board proposes to amend this paragraph, so that severe preeclampsia and/or HELLP syndrome would be a risk factor.  N.J.A.C. 13:35-2A.11(b)6 lists malpresentation as a risk factor. The Board proposes to amend this paragraph, so that it lists non-vertex presentation as a risk factor.
P.L. 2017, c. 28 requires health care practitioners with prescriptive authority to complete education in programs or topics on issues concerning prescription opioid drugs, including responsible prescribing practices, alternatives to opioids for managing and treating pain, and the risks and signs of opioid abuse, addition, and diversion. The Board proposes to amend N.J.A.C. 13:35-2A.14 to implement the education requirements of P.L. 2017, c. 28. The proposed amendments reorganize the rule and require CNMs seeking prescriptive authority to complete the education in prescription opioid drugs. The Board proposes to amend N.J.A.C. 13:35-2A.16 to provide the correct name for the National Association of Nurses Practitioners in Women's Health.
As the Board has provided a 60-day comment period on this notice of proposal, this notice is excepted from the rulemaking calendar requirement pursuant to N.J.A.C. 1:30-3.3(a)5.
Social Impact
The proposed amendments will benefit licensed midwives and the patients who receive services from licensed midwives as they will clarify the risk factors that necessitate special procedures.
Economic Impact
Proposed amendments to N.J.A.C. 13:35-2A.7 may impose costs on licensed midwives who are not currently certified by the ACNM, AMCB, or NARM. Such midwives will need to pay for such certification in order to renew licensure. The Board does not believe that the rulemaking will have any other economic impact.
Federal Standards Statement
A Federal standards analysis is not required because there are no Federal laws or standards applicable to the proposed amendments.
Jobs Impact
The Board does not believe that the proposed amendments will increase or decrease the number of jobs in New Jersey.
Agriculture Industry Impact
The Board believes the proposed amendments will have no impact upon the agriculture industry in New Jersey.
Regulatory Flexibility Analysis
Since licensed midwives are individually licensed by the Board, they may be considered "small businesses" under the Regulatory Flexibility Act (Act), N.J.S.A. 52:14B-16 et seq.
The costs imposed on small businesses by the proposed amendments are the same as the costs imposed on all licensed midwives as discussed in the Economic Impact statement above. The Board does not believe that licensed midwives will need to employ any professional services to comply with the requirements of the proposed amendments. The proposed amendments do not impose any recordkeeping or reporting requirements, but do impose compliance requirements as discussed in the Summary above.
As the proposed amendments will protect the health, safety, and welfare of patients who receive services from licensed midwives, the Board believes that the proposed amendments should be applied uniformly to all licensed midwives.
Housing Affordability Impact Analysis
The proposed amendments will have an insignificant impact on the affordability of housing in New Jersey and there is an extreme unlikelihood that the proposed amendments would evoke a change in the average costs associated with housing because the proposed amendments concern the provision of services by licensed midwives.
Smart Growth Development Impact Analysis
The proposed amendments will have an insignificant impact on smart growth and there is an extreme unlikelihood that the proposed amendments would evoke a change in housing production in Planning Areas 1 or 2, or within designated centers, under the State Development and Redevelopment Plan in New Jersey because the proposed amendments concern the provision of services by licensed midwives.
Regulations

Full text of the proposal follows (additions indicated in boldface thus; deletions indicated in brackets [thus]):
SUBCHAPTER 2A.  LIMITED LICENSES: MIDWIFERY
13:35-2A.2   Definitions
The following words and terms, when used in this subchapter, shall have the following meaning, unless the context clearly indicates otherwise:
[page=1340] ["Affiliated physician" means a person who holds a plenary license to practice medicine and surgery in New Jersey, issued by the Board, who adheres to clinical guidelines with a licensed midwife.]
…
"Certified midwife (CM)" means a person [who is not a registered nurse and] who [holds certification from] is or ever was certified by the American [College of Nurse Midwives Certification Council (ACC)] Midwifery Certification Board (AMCB) or its successors as a certified midwife.
"Certified nurse midwife (CNM)" means a person who is a registered nurse and who [holds certification from] is or ever was certified by the American College of Nurse Midwives (ACNM) or the [ACC] AMCB or their successors as a certified nurse midwife.
…
"Consulting physician" means a person who holds a plenary license to practice medicine and surgery in New Jersey, issued by the Board, who adheres to clinical guidelines with a licensed midwife.
…
13:35-2A.4   Application for licensure
(a) An applicant for licensure as a midwife shall submit to the Committee:
1.-3. (No change.)
4. A notarized copy of Certification from either ACNM, [ACC] AMCB, NARM, or their predecessors or successors;
5.-7. (No change.)
(b) (No change.)
13:35-2A.5   Independent practice
(a)-(c) (No change.)
(d) Certified professional midwives shall conduct their practice pursuant to standards set forth [by the NARM in the Midwifery Model of Care (2000)] in the Midwives Alliance of North America Core Competencies (2014), [as amended and supplemented,] available from [North American Registry of Mid-wives, 5257 Rosestone Drive, Lilburn, GA 30047] the Midwives Alliance of North America, PO Box 373, Montvale, NJ 07645, which is incorporated herein by reference, as amended and supplemented, as part of this rule.
13:35-2A.6   [Affiliated] Consulting physicians; clinical guidelines
(a) Prior to beginning practice as a midwife, a licensee shall enter into [an affiliation] a consulting agreement with a physician who is licensed in New Jersey and who:
1.-3. (No change.)
(b) The licensee shall establish written clinical guidelines with the [affiliated] consulting physician [which] that outlines the licensee's scope of practice.
(c) The clinical guidelines shall set forth:
1.-3. (No change.)
4. The circumstances under which consultation, collaborative management, referral, and transfer of care of women between the licensee and the [affiliated] consulting physician are to take place, and the manner by which each is to occur;
5. (No change.)
6. If the licensee does not hold prescriptive authority pursuant to N.J.A.C. 13:35-2A.14, a list of all medications the licensee may dispense or administer pursuant to the directions of the [affiliated] consulting physician;
7. A mechanism for determining the availability of the [affiliated] consulting physician, or a substitute physician, for consultation and emergency assistance or medical management when needed; and
8. (No change.)
(d) A licensee shall provide clinical guidelines and the identity of his or her [affiliated] consulting physician(s) to the Board upon request.
(e) The clinical guidelines shall include provisions for periodic conferences with the [affiliated] consulting physician for review of patient records and for quality improvements.
(f) A licensee who practices without establishing clinical guidelines with [an affiliated] aconsulting physician commits professional misconduct as proscribed by N.J.S.A. 45:1-[21(e)]21.e.
13:35-2A.7   Licensure; biennial license renewal; license suspension; reinstatement of suspended license; inactive status; return from inactive status
(a) All licenses issued by the Board shall be issued for a two-year biennial licensure period. A licensee who seeks renewal of the license shall submit a completed renewal application, proof that he or she is currently certified by the ACNM, AMCB, or NARM, and the renewal fee as set forth in N.J.A.C. 13:35-6.13 prior to the expiration date of the license.
(b)-(f) (No change.)
(g) Renewal applications shall provide the licensee with the option of either active or inactive status. A licensee electing inactive status shall pay the inactive license fee set forth in N.J.A.C. 13:35-6.13 and shall not engage in practice. A licensee electing inactive status shall not be required to submit proof that he or she is currently certified by the ACNM, AMCB, or NARM.
(h) A licensee who elected inactive status and has been on inactive status for five years or less may be reinstated by the Board upon completion of the following:
1. Payment of the reinstatement fee; [and]
2. Submission of an affidavit of employment listing each job held during the period the licensee was on inactive status, which includes the name, address, and telephone number of each employer[.]; and
3. Submission of proof that he or she is currently certified by the ACNM, AMCB, or NARM.
(i) (No change.)
13:35-2A.9   Management of antepartum women at increased risk
(a) A licensee may participate in the management of antepartum patients at increased risk under the following conditions:
1. The [affiliated] consulting physician and licensee shall have agreed to include the woman at increased risk in the caseload;
2. The [affiliated] consulting physician and licensee shall have established and documented a management plan for all women identified as at increased risk, which shall delineate the role of both the [affiliated] consulting physician and the licensee in the care of the woman. The management plan shall set forth the following:
i.-iv. (No change.)
3. The management plan shall be reviewed periodically by the licensee and the [affiliated] consulting physician and revised when necessary.
(b) The following are risk factors that require management as outlined in (a) above:
1. Maternal health status:
i.-vi. (No change.)
vii. Chronic [anemia and/or] hemoglobinopathy with a history of transfusion;
viii. (No change.)
ix. [Drug] Any psychoactive substance addiction;
x. (No change.)
[xi. Asthmatic on daily oral medication;]
xi.Severe asthma as defined in the December 12, 2013 International ERS/ATS Guidelines on Definition, Evaluation and Treatment of Severe Asthma, published by the European Respiratory Society/American Thoracic Society, 25 Broadway, New York, NY 10004, incorporated herein by reference, as amended and supplemented;
xii.-xiii. (No change.)
xiv. History of cerebrovascular accident; [or]
xv. History of cancer[.];
xvi. Hepatitis with abnormal liver function and/or detectable viral loads; or
xvii. Body Mass Index (BMI) over 40.
2. Maternal reproductive health history:
i.-ii. (No change.)
iii. Preterm [labor and/or] delivery;
[iv. Parity of six or more;]
iv.Grand multiparity;
v.-vi. (No change.)
vii. Previous placental abruption or accreta;
[page=1341] viii. (No change.)
ix. Previous cervical surgeries including Loop Electrosurgical Excision Procedures (LEEP), cone biopsies, or three or more surgical cervical dilitations, unless the patient has had a subsequent term pregnancy; or
x. Intra-uterine growth restriction [and/or delivery of an infant weighing less than 2,500 grams at 36 weeks or more].
3. Current maternal obstetrical status:
i.-viii. (No change.)
ix. [PAP smear indicating] Cervical dysplasia requiring colposcopy;
x. Placenta previa persisting past 28 weeks gestation;
xi.Evidence of placenta accreta and/or abruption;
[xi.] xii. [Medicated pre-term] Pre-term labor with cervical change; or
[xii.] xiii. (No change in text.)
13:35-2A.10    Intrapartum management
(a)-(b) (No change.)
(c) In addition to the tasks outlined in (a) above, a Certified Nurse Midwife (CNM) or Certified Midwife (CM) may:
1. Repair third degree lacerations upon the direction of the [affiliated] consulting physician;
2.-3. (No change.)
13:35-2A.11    Management of intrapartum women at increased risk
(a) If a woman receiving care from a licensee evidences any of the following conditions, the licensee shall only participate in the birth if it takes place in a licensed hospital:
1. Pre-term labor less than 37 weeks gestation. If pre-term labor is less than 34 weeks gestation, [an affiliated] a consulting physician shall be present at the birth;
2. Premature rupture of membranes more than [24] 48 hours before onset of regular contractions;
3.-5. (No change.)
6. Post-datism (greater than 42 weeks [completed] gestation);
7. (No change.)
[8. Malpresentation; or]
8.Non-vertex presentation;
9. Evidence of chorioamnionitis[.]; or
10. Hypertensive disorder of pregnancy and/or Hemolysis, Elevated Liver Enzymes, and Low Platelet (HELLP) syndrome.
(b) If a woman receiving care from a licensee evidences the following during the intrapartum phase the licensee shall arrange for the presence of [an affiliated] a consulting physician at the hospital; or, if the woman is not in a hospital, arrange for the immediate transfer of the woman to a hospital obstetric unit:
1. [Development of hypertension or] Severe preeclampsia and/or Hemolysis, Elevated Liver Enzymes, and Low Platelet (HELLP) syndrome;
2.-5. (No change.)
6. [Malpresentation] Non-vertex presentation; or
7. (No change.)
13:35-2A.14    Prescriptive authorization
(a) A CNM who is licensed with the Board of Medical Examiners may apply for authorization to prescribe drugs (as used within this section, the term "drugs" shall include drugs, medicine, and devices). The CNM shall make application on forms prescribed by the Board and shall demonstrate:
1.-2. (No change.)
3. Evidence of satisfactory completion of a minimum of 30 contact hours in pharmacology, [which included instruction in fundamentals of pharmacology and therapeutics, including principles and terminology of pharmacodynamics and pharmaco-kinetics,] which was either[:] part of the midwifery program the CNM completed pursuant to N.J.A.C. 13:35-2A.4(a)3 or a pharmacology course offered by, or affiliated with, a college or university accredited by an accrediting association recognized by the U.S. Department of Education. The 30 contact hours shall include:
[i. Part of the midwifery program the CNM completed pursuant to N.J.A.C. 13:35-2A.4(a)3; or
ii. A pharmacology course offered by, or affiliated with, a college or university accredited by an accrediting association recognized by the U.S. Department of Education.]
i.Instruction in fundamentals of pharmacology and therapeutics, including principles and terminology of pharmacodynamics and pharmaco-kinetics; and
ii. One contact hour on issues concerning prescription opioid drugs, including responsible prescribing practices, alternatives to opioids for managing and treating pain, and the risks and signs of opioid abuse, addiction, and diversion.
(b)-(i) (No change.)
13:35-2A.16    Colposcopies
(a) (No change.)
(b) A CNM or CM who wishes to perform colposcopies shall complete a 20-hour colposcopy course, given by a college or university accredited by an accrediting association recognized by the U.S. Department of Education or given by an organization recognized by either the American Society of Colposcopy and Cervical Pathology, the American College of Obstetrics and Gynecology, the American College of Nurse Midwives, or the National Association of Nurse Practitioners in [Reproductive] Women's Health.
(c)-(e) (No change.)