Rule Proposal

VOLUME 49, ISSUE 12
ISSUE DATE: JUNE 19, 2017
RULE PROPOSALS

LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
NEW JERSEY STATE BOARD OF RESPIRATORY CARE

Proposed Changes: N.J.A.C. 13:44F-3.3

Notice of Proposed Substantial Changes Upon Adoption to Proposed Amendments
 
Delegation to Unlicensed Persons
 
VOLUME 49, ISSUE 12
ISSUE DATE: JUNE 19, 2017
RULE PROPOSALS

LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
NEW JERSEY STATE BOARD OF RESPIRATORY CARE


Proposed Changes: N.J.A.C. 13:44F-3.3


Notice of Proposed Substantial Changes Upon Adoption to Proposed Amendments
 
Delegation to Unlicensed Persons
 
Proposed: July 5, 2016, at 48 N.J.R. 1354(a).
 
Authorized By: The State Board of Respiratory Care, Kenneth Capek, Chairman.
 
Authority: N.J.S.A. 45:1-15 and 45:14E-4.
 
Submit written comments by August 18, 2017, to:
 
   Dorcas O'Neal Executive Director
   New Jersey State Board of Respiratory Care
   124 Halsey Street
   PO Box 45031
   Newark, New Jersey 07101
   or electronically at: www.njconsumeraffairs.gov/Proposals/Pages/default.aspx.
 
   Take notice that the Board of Respiratory Care (Board) proposed amendments to N.J.A.C. 13:44F-3.3 on July 5, 2016, at 48 N.J.R. 1354(a), to remove the requirement for a follow-up visit by a respiratory care practitioner within 24 hours of delivery of nebulizer compressors, concentrators, and medical gas cylinders. The public comment period closed on September 3, 2016.
 
   The Board is proposing substantial changes to the amendments in response to comments received. A summary of the comments which prompted changes, and the agency response to those comments is provided below. This notice of proposed substantial changes is published pursuant to N.J.S.A. 52:14B-4.10.
 
   Comments were received from:
 
   1. Robert Glass, R.R.T., Clinical Manager, Respiratory Care Department;
 
   2. William H. Oliver, Jr., BS, RRT-NPS, CPFT, Director, Respiratory Care and Sleep, Virtua-Voorhees, and Interim Director, Respiratory Care, Virtua-Marlton;
 
   3. Ed Peters, BA, RRT;
 
   4. Daryl Rogers, MAS, RRT; and
 
   5. Lori-Ann Ligon, President, New Jersey Society for Respiratory Care.
 
   1. COMMENT: Five commenters objected to the proposed amendment to N.J.A.C. 13:44F-3.3(f) to specify that a follow-up visit is not required for the delivery of nebulizer compressors, concentrators, and medical gas cylinders because of the impact on patient care. One of these commenters believes that professional instruction in patients' homes is necessary to care for elderly and ill patients, keep their hospital visits to a minimum, and to ensure they are able to breathe properly. The commenter believes that many of the people at home using respirator devices are elderly, ill, and confused, and that they will not use these critical devices properly, which will lead to more hospital visits, illnesses, and deaths. Another commenter stated that to eliminate overview, care, and instruction by a licensed therapist borders on malfeasance. The commenter noted that, in the current healthcare atmosphere of hospital stay reductions, coupled with increasing monetary penalties for readmissions forcing greater reliance on home care interventions to maintain the health and safety of patients, the respiratory care practitioner plays an ever-increasingly important role in healthcare. One commenter stated that recent changes in the Centers for Medicare and Medicaid Services (CMS) reimbursement as it relates to patient readmission within the first 30 days of discharge would only decrease costs for the durable medical equipment provider and increase costs for the acute care facilities. The commenter further states that elimination of a visit by a respiratory care practitioner is counterproductive and would only increase the risk to the most vulnerable portion of the population. One of the commenters noted that the absence of a respiratory therapist visit would put the patient at risk for a potential unnecessary readmission. The commenter stated that when respiratory therapists visit the patient, they observe, document, reinstruct, and relay that information to the physician when necessary. The commenter further stated that, specifically, respiratory therapists: document and assure that the patient is receiving the prescribed therapy ordered by the physician and that the liter flow is clinically beneficial based on pulse oximetry testing; evaluate the patient for a conserving device, allowing the patient to become increasingly ambulatory and promoting an active lifestyle; and review medicine reconciliation to make sure that the patient is taking the accurate medication and self-administering the proper way. The commenter also noted that the respiratory therapist makes sure that the patient is wearing the cannula correctly, checks that the concentrator and tubing are being used appropriately, and that the patient and caregiver understand the clinical importance of its usage. The commenter believes that, with a tremendous focus on transitions of care in the post-acute setting, the removal of the respiratory therapist visit would put the patient's health at risk and there would be a greater economic impact to the healthcare spectrum long-term, specifically CMS penalties for readmissions.
 
   2. COMMENT: Two of the commenters suggested that the Board retain the follow-up visit by a respiratory therapist and amend N.J.A.C. 13:44F-3.3(f) to change the time period for the visit by a respiratory therapist from 24 hours to 72 hours. One of these commenters noted that this period of time assures that the physician's orders are being properly carried out, that the therapy is providing the desired outcome, and provides the physician with a firsthand assessment of the patient's tolerance and effectiveness of therapy. Another commenter believes that extending the period of time for the follow-up visit would allow for the durable medical equipment company to potentially merge two visits into [page=1667] one as typically the second visit is to evaluate patients for a conserving-device. The commenter also believes that there would be less of a fiscal impact on durable medical equipment companies as they would necessarily need to staff weekend therapists, thereby reducing labor costs.
 
   RESPONSE TO COMMENTS 2 AND 3: The Board agrees that a respiratory care therapist's follow-up visit ensures that the physician's orders are being properly carried out, and that the therapy is providing the desired outcome and provides the physician with a firsthand assessment of the patient's tolerance and effectiveness of therapy, which positively impacts patient health. The Board further agrees with the commenters that this follow-up visit is important after the delivery of nebulizer compressors, concentrators, and medical gas cylinders. In consideration of the comments received, the Board is amending proposed N.J.A.C. 13:44F-3.3(f) to retain the follow-up visit and extend to 72 hours the period of time for the follow-up visit to occur after delivery of nebulizer compressors, concentrators, and medical gas cylinders. The Board is further amending proposed N.J.A.C. 13:44F-3.3(f) to provide that if the nebulizer compressor, concentrator, or medical gas cylinder is used in conjunction with an artificial airway, including transtracheal oxygen catheters, the follow-up visit will continue to be within 24 hours of delivery.
 
   3. COMMENT: One commenter believes that the Economic Impact statements in the notice of proposal are flawed. The commenter stated that the elimination of the follow-up visit would negatively impact respiratory therapists' employment. The commenter stated that in an era of cost containment, durable medical equipment companies could utilize delivery drivers to provide the patient assessment and education, or increase the use of parcel post for equipment delivery. The commenter also stated that the Board receives letters from durable medical equipment providers inquiring about the need for respiratory therapists in delivering equipment and that it is likely that the proposed amendment to N.J.A.C. 13:44F-3.3(f) would encourage durable equipment providers to reduce the number of employed therapists. In addition, the commenter stated that patients will not see a cost savings because respiratory therapists cannot bill for follow-up visits.
 
   RESPONSE: As discussed in the Response to Comments 2 and 3, the Board is amending proposed N.J.A.C. 13:44F-3.3(f) to retain the existing follow-up visit by a respiratory care practitioner, and extend to 72 hours the period of time for the follow-up visit to occur after the delivery of nebulizer compressors, concentrators, and medical gas cylinders. The Board further proposes to amend N.J.A.C. 13:44F-3.3(f) to provide that if the nebulizer compressor, concentrator, or medical gas cylinder is used in conjunction with an artificial airway, including transtracheal oxygen catheters, the required follow-up visit will continue to be within 24 hours of delivery.
 
   Effect of Proposed Changes on Impact Statements Included in Original Proposal
 
   The proposed substantial changes on adoption will have an insignificant impact on the Economic Impact to the extent that retaining the existing requirement for a follow-up visit but extending the period of time for the visit to within 72 hours of delivery may allow respiratory care practitioners to see a greater number of patients. To the extent patients are currently billed for these follow-up visits, they will continue to incur such costs. The Board believes that any such costs are necessary and outweighed by the interest to ensure patient health. The proposed substantial changes on adoption will not affect the Social, Jobs, or Agriculture Industry Impacts; the Federal Standards Statement; the Regulatory Flexibility Statement; or the Housing Affordability or Smart Growth Development Impact Analyses as published in the original notice of proposal.
 
Full text of the proposed substantial changes to the proposed amendments follows (additions to proposal indicated in italicized boldface thus; deletions from proposal indicated in italicized cursive brackets [thus]):
 
SUBCHAPTER 3.    AUTHORIZED PRACTICE
 
13:44F-3.3 Delegation by a respiratory care practitioner to unlicensed persons
 
(a)-(e) (No change.)
 
(f) The licensed respiratory care practitioner who delegates tasks set forth in (d) above in an outpatient setting shall ensure that a follow-up visit from a licensee or a person exempt from respiratory care licensure pursuant to N.J.S.A. 45:14E-[9(c)]9.c takes place [within 24 hours of the delivery of the equipment to the patient for the purpose of conducting an in-person assessment of the equipment. The follow-up visit shall be documented in writing.
 
1. For purposes of this subsection, "equipment" shall exclude nebulizer compressors, concentrators, and medical gas cylinders.]
 
consistent with the following:
 
1. Except as provided in (f)2 below, within 24 hours of the delivery of the equipment, including compressors, concentrators, and cylinders that could be used in conjunction with an artificial airway, including transtracheal oxygen catheters, to the patient for the purpose of conducting an in-person assessment of the equipment.
 
2. Within 72 hours of the delivery of nebulizer compressors, concentrators, and medical gas cylinders, except for those that could be used in conjunction with an artificial airway, including transtracheal oxygen catheters.
 
3. The follow-up visit shall be documented in writing.
 
Recodify existing 1. and 2. as [2. and 3.] i. and ii.(No change to text.)