The Latest on What's Happening in Trenton
Governor Murphy Proposes Fiscal Year 2018-2019 Budget
Governor Phil Murphy today presented his budget for fiscal year 2019 – a plan to promote his administration’s priorities including education, mass transit, and tax fairness to make New Jersey stronger and fairer. The budget includes appropriations totaling $37.4 billion and a projected surplus of $743 million.
In his speech, the Governor also made reference to supporting the Out of Network Legislation sponsored by Senator Vitale and Assemblyman Coughlin.
Legislative Leaders have promised a full and deliberative review of the Governor’s Budget. More details will be provided in future updates. Click here to read the full text of speech.
Last Minute Regulatory Adoption on Prescriber Acceptance of Compensation from Pharmaceutical Companies Extremely Burdensome
“Governor Murphy Publicly Committed to Improvements”
On January 16, the Attorney General enacted a restrictive new regulation which imposes limitations on the amounts of compensation, items of value, and meals provided to prescribers from pharmaceutical companies.
This was adopted in response to the opioid crisis because the Christie Administration and the Attorney General believed that physicians caused the crisis by indiscriminately prescribing opioids after being detailed by the pharmaceutical companies.
Especially in light of the legal troubles plaguing the Insys Therapeutics Corporation, the Attorney General saw fit to impose a $15 limit per prescriber on modest meals including food and refreshments provided at educational or promotional events, and a $10,000 cap on the amount prescribers can earn from pharmaceutical manufacturers for bona fide services (educational lectures and research excluded).
I have participated in meetings over the past month geared towards clarification of the current regulation and future regulatory changes. We are looking forward to an FAQ from the Office of the Attorney General within the next several weeks, and a new regulatory proposal over the next five months or so.
New Session Off to a Vigorous Start for Physician Issues
OON, Scope of Practice Top the List
Out of Network Legislation Will be Voted On in Assembly Financial Institutions and Insurance Committee and Senate Commerce Committee on March 5
The new legislative session began on January 9 and Governor Murphy was sworn in on January 16. I am pleased to report that there was no final action on the OON bill in the previous session which ended on January 8 but the issue is off to a brisk start this session.
The new Chair of the Assembly Financial Institutions and Insurance Committee – Assemblyman John McKeon has scheduled a vote on the legislation, A-2039 sponsored by Speaker Craig Coughlin for March 5. In addition, the Senate Commerce Committee came out with an agenda late last night which also has S-485 sponsored by Senator Vitale up for a committee vote. We remain steadfastly opposed to both bills. Grassroots memo will be distributed shortly.
PHYSICAL THERAPISTS SEEK “DRY NEEDLING”
In the first intense “scope battle” of the new legislative session, the physical therapy lobby aggressively mounted a challenge to physicians’ scope of practice, seeking the inclusion of “dry needling” within their lawful scope of practice. Despite vigorous objections from the physician groups, Senate Bill No. 431 sponsored by Senator Pou was released from the Senate Commerce Committee on February 15 along party lines with Senator Kean and Senator Cardinale voting “no”. However, immediately upon the bill’s release, it was referred to yet another committee, the Senate Budget and Appropriations Committee. We will continue to vigorously oppose this bill. Grassroots action will be required. We will keep you informed.
A summary of the bill is as follows:
This bill permits a physical therapist to perform dry needling if the physical therapist has successfully completed a dry needling continuing education and competency program approved by the New Jersey State Board of Physical Therapy Examiners, has two or more years of clinical experience treating patients as a licensed physical therapist in this State, holds a current and unrestricted license to practice physical therapy in this State, and has a current CPR certification issued by the American Red Cross, American Heart Association, National Safety Council, or any other agency or organization approved by the board.
The bill defines “dry needling” as a physical intervention that uses a dry, filiform needle, without medication or other deliverable, to penetrate the skin and stimulate underlying muscular tissue, connective tissues, or myofascial trigger points for the management of neuromusculoskeletal pain and movement impairments. The bill provides that “dry needling” does not mean the stimulation of auricular or distal points or the practice of acupuncture.
The bill establishes requirements for board-approved dry needling continuing education and competency programs, which must include at least 54 hours of instruction, attendance in person by a physical therapist, and the ability to complete the program in no more than two years. The required dry needling instruction must be taught by a licensed physical therapist who has a minimum of five years of clinical experience in the performance of dry needling or by a physician licensed to practice medicine and surgery in this State.
The bill provides that dry needling will only be performed by a physical therapist who meets the requirements of the bill, and the performance of dry needling may not be delegated to a physical therapist assistant or student physical therapist. A physical therapist who meets the requirements to perform dry needling may only utilize the specific dry needling techniques for which the physical therapist has completed instruction and demonstrated competency.
The bill also requires a physical therapist to obtain written informed consent from each patient prior to the provision of dry needling. The patient must receive a copy of the written informed consent and the physical therapist must retain a copy of the informed consent in the patient’s record. The informed consent must include, at a minimum, the following:
(1) the patient’s signature;
(2) the risks, benefits, and possible complications of dry needling;
(3) the treatment alternatives to dry needling;
(4) the physical therapist’s level of education regarding supervised hours of training in dry needling;
(5) the importance of consulting with the patient’s physician regarding the patient’s condition; and
(6) a clearly and conspicuously written statement that the patient is not receiving acupuncture.
The bill provides that a physical therapist may only use filiform needles labeled in accordance with the United States Food and Drug Administration guidelines when performing dry needling and must perform dry needling in a manner that is consistent with generally accepted standards of practice, including clean needle techniques, safe disposal of sharp objects, and the Occupational Safety and Health Administration’s bloodborne pathogens standard.
Under the bill, a physical therapist must maintain documentation in the patient record of each dry needling session. The documentation must include the treatment performed, the patient’s response to the treatment, and any adverse reactions or complications to the treatment.
Finally, the bill provides that, upon request of the board or a member of the general public, a physical therapist practicing dry needling must provide documentation of the education and training completed by the physical therapist as required by the provisions of the bill. The failure to provide documentation in response to a request by the board or a member of the general public will be deemed prima facie evidence that the physical therapist has not received the required training and will not be permitted to perform dry needling.
RE CAP of KEY LAWS FROM PREVIOUS SESSION
New Law Affecting “One Room” Surgery Centers Effective Immediately
Governor Christie signed (A-4995/S-287) into law also on January 15. Under the provisions of the new statute, registered surgical practices are now required to become licensed by the New Jersey Department of Health. Some of the benefits of becoming licensed include: exemption from licensing fees and the ambulatory facility gross receipts assessment, and the ability of any physician in addition to owners to use the center. There is also an expansion option. A One Room can now be combined with others or a larger ASC.
More information will be provided as the regulatory framework is announced by the Department of Health.
Statutory Changes to Current Opioid Law Effective Immediately
Benzodiazepines Added to PMP Requirements
S3604/A5242 sponsored by Senator Vitale and Assemblyman Coughlin make various revisions to the previous law enacted in May of 2017 to address the opioid crisis. The bills were signed by the Governor on January 15.
First, the new law revises P.L.2017, c.28 to provide that a practitioner must enter into a pain management agreement with a patient prior to the commencement of an ongoing course of treatment for chronic pain with a Schedule II controlled dangerous substance or any opioid, instead of upon issuing the third prescription. The bill also adds a definition of “chronic pain,” which means pain that persists for three or more consecutive months and after reasonable medical efforts have been made to relieve the pain or its causes, it continues, either continuously or episodically. The bill also clarifies, for the purposes of that law, that when determining whether a patient was previously issued a prescription for opioids that determination is to also include whether the patient also used or was administered a drug or its pharmaceutical equivalent.
This law also revises various statutory provisions related to the Prescription Monitoring Program (PMP), which was established in the Division of Consumer Affairs in the Department of Law and Public Safety pursuant to P.L.2007, c.244 (C.45:1-45 et seq.). The PMP is an electronic system for monitoring controlled dangerous substances dispensed in or into the State in outpatient settings. For the purposes of the PMP, the bill revises the definition of a "certified medical assistant,” and changes the required minimum clock hours of instruction required for certified medical assistants from 600 hours to 330 hours. The bill also adds two new definitions of “licensed athletic trainer” and “medical scribe,” and it authorizes such actors to access prescription monitoring information under the authorization and responsibility of a medical practitioner.
In addition, the new law provides that the Division of Consumer Affairs may make prescription monitoring information available on electronic systems that collect and display health information, such as an electronic system that connects hospital emergency departments for the purpose of transmitting and obtaining patient health data from multiple sources, or an electronic system that notifies practitioners of information pertaining to the treatment of overdoses, provided that the division determines the system has appropriate security protections in place. An electronic system that is approved by the division to integrate prescription monitoring information may be used by prescribers in hospital emergency departments who are required to access prescription monitoring information under the bill, as well as by other practitioners who are required to check prescription monitoring information when issuing certain prescriptions. The system may further be used to provide certifications that prescription monitoring information is being accessed for an authorized purpose.
The law also adds to the circumstances under which a practitioner or other authorized person is required to access prescription monitoring information. In addition to the first time the practitioner or other person prescribes a Schedule II controlled dangerous substance to a new patient for acute or chronic pain, it would be required to check prescription monitoring information:
(1) the first time a practitioner or other person prescribes a benzodiazepine drug that is a Schedule III or Schedule IV controlled dangerous substance;
(2) the first time the practitioner or other person prescribes a non-opioid drug other than a benzodiazepine drug that is a Schedule III or IV controlled dangerous substance, but only if the practitioner or other person has a reasonable belief that the person may be seeking a controlled dangerous substance, in whole or in part, for any purpose other than the treatment of an existing medical condition, such as for purposes of misuse, abuse, or diversion; and
(3) on or after the date that the division first makes prescription monitoring information available on an electronic system that collects and displays health information, any time a practitioner or other person prescribes a Schedule II controlled dangerous substance to a patient receiving care or treatment in the emergency department of a general hospital.
Current law provides certain exemptions from PMP monitoring requirements. The bill adds an exemption for a practitioner who is prescribing a controlled dangerous substance to a patient immediately after the patient has undergone an operation in a general hospital or a licensed ambulatory care facility or treatment for acute trauma in a general hospital or a licensed ambulatory care facility, so long as that operation or treatment was not part of care or treatment in the emergency department of a general hospital, and no more than a five-day supply is prescribed.
Finally, the law permits a physician assistant or an advanced practice nurse to, under certain circumstances; dispense narcotic drugs for maintenance treatment or detoxification treatment. The bill also provides that a physician assistant or advanced practice nurse, under certain circumstances, may make the determination as to the medical necessity for services for the treatment of substance use disorder, as provided in P.L.2017, c.28 (C.17:48-6nn et al.), and may prescribe such services.
Assembly Oversight, Reform and Federal Relations Committee Hearing On the Impact of Prospective Marijuana Legislation
The Committee Chairman, Assemblyman Joseph Danielsen (D 17) held a “by invitation only” hearing on March 5th that focused on the potential impact such a law would have on the public health, criminal justice system, and economy.
At that time, the Chairman announced that a series of hearings to gain the input of all would be held across the state. All the hearings will be on Saturday – starting with April 21 at Rowan University and then May 12 at Bergen County Community College. A third location in central New Jersey will be determined. Monday’s hearing did not address the various legislative proposals pending but instead focused on general information. This will continue to be a hot topic in the months ahead.
Bill To Mandate Warning Sticker On Opioid Prescription Vials Released From Committee
Legislation Assemblymen John Armato, and Vince Mazzeo (D-2) sponsored to require that all prescription opioid medications include a warning sticker advising patients of the risk of addiction and overdose was released on Monday by the Assembly Health and Human Services Committee. According to the bill’s sponsors, if this bill is enacted, New Jersey would become the first state in the nation to require this type of a warning label.
This bill, A-3292, would require the Director of the Consumer Affairs, in consultation with the Department of Health, to promulgate language for the sticker, which at a minimum, is to indicate the medication is an opioid, and that opioid medications carry a risk of addiction and overdose. Furthermore, it directions the sticker to be red in color with text printed in a white font to be easily and clearly readable. If signed into law, the bill would become effective four months after the date of enactment.
“Aid In Dying for the Terminally Ill Act” Released from Committee
A-1504 Sponsored by Assemblyman Burzichelli was released by the Assembly Judiciary Committee on Monday, March 12.
This bill establishes the “Aid in Dying for the Terminally Ill Act,” which will allow an adult New Jersey resident, who has the capacity to make health care decisions and who has been determined by that individual’s attending and consulting physicians to be terminally ill, to obtain medication that the patient may self-administer to terminate the patient’s life. Under the bill, “terminally ill” is defined to mean the patient is in the terminal stage of an irreversibly fatal illness, disease, or condition with a prognosis, based upon reasonable medical certainty, of a life expectancy of six months or less.
In order for a terminally ill patient to receive a prescription for medication under the bill, the patient is required to make two oral requests and one written request to the patient’s attending physician for the medication. The bill requires at least 15 days to elapse between the initial oral request and the second oral request, and between the patient’s initial oral request and the writing of a prescription for the medication. The patient may submit the written request for medication either when the patient makes the initial oral request, or at any time thereafter, but a minimum of 48 hours are to elapse between the attending physician’s receipt of the written request and the writing of a prescription for medication.
When a patient makes an initial oral request for medication under the bill’s provisions, the attending physician is required to provide the patient with information about the risks, probable results, and alternatives to taking the medication; recommend that the patient participate in a consultation concerning additional treatment opportunities, palliative care, comfort care, hospice care, and pain control options; and refer the patient to a health care professional who is qualified to discuss those alternative care and treatment options. The patient may choose, but is not required, to participate in such consultation. The attending physician is also required to recommend that the patient notify the patient’s next of kin of the request, but medication may not be denied if a patient declines, or is unable to, provide this notification.
The attending physician is required to refer the patient to a consulting physician for the purpose of obtaining confirmation of the attending physician’s diagnosis. Both the attending physician and the consulting physician are required to verify that the patient has made an informed decision when requesting medication under the bill. When the patient makes the second oral request, the attending physician is to offer the patient an opportunity to rescind the request. In addition, the attending physician is required to notify the patient that a request may be rescinded at any time and in any manner, regardless of the patient’s mental state.
A patient may make a written request for medication, in accordance with the bill’s provisions, so long as the patient: is an adult resident of New Jersey, as demonstrated through documentation submitted to the attending physician; is capable; is terminally ill, as determined by the attending physician and confirmed by the consulting physician; and has voluntarily expressed a wish to receive a prescription for the medication.
The bill requires a valid written request for medication to be in a form that is substantially similar to the form set forth in the bill. The bill requires the written request to be signed and dated by the patient and witnessed by at least two individuals who attest, in the patient’s presence, that, to the best of their knowledge and belief, the patient is capable and is acting voluntarily.
The bill requires at least one of the witnesses to be a person who is not:
(1) a relative of the qualified patient by blood, marriage, or adoption;
(2) at the time the request is signed, entitled to any portion of the patient’s estate upon the patient’s death; or
(3) an owner, operator, or employee of a health care facility where the patient is receiving medical treatment or is a resident.
The bill additionally requires that, if the patient is a resident of a long-term care facility, one of the witnesses is to be an individual designated by the facility. The patient's attending physician may not serve as a witness.
A written request form will be required to include an indication as to whether the patient has informed the patient’s next-of-kin about the request for medication and an indication as to whether additional treatment consultations have been recommended by the attending physician or undertaken by the patient.
If the patient complies with the bill’s oral and written request requirements, establishes State residency, and is found by both the attending physician and a consulting physician to be capable, to have a terminal illness, and to be acting voluntarily, the patient will be considered to be a “qualified terminally ill patient” who is eligible to receive a prescription for medication. The bill expressly provides that a person is not be considered to be a “qualified terminally ill patient” solely on the basis of the person’s age or disability or the diagnosis of a specific illness, disease, or condition.
If either the attending physician or the consulting physician believes that the patient may have a psychiatric or psychological disorder or depression, which causes impaired judgment, and which makes the patient incapable of making a request for medication, the physician will be required to refer the patient to a licensed psychiatrist or psychologist for counseling to determine whether the patient is capable. If such a referral is made, the attending physician is prohibited from issuing a prescription to the patient for medication under the bill unless the attending physician has received written notice, from the licensed psychiatrist or psychologist, affirming that the patient is capable.
Prior to issuing a prescription for requested medication, the attending physician is required to ensure that all appropriate steps have been carried out, and requisite documentation submitted, in accordance with the bill’s provisions. The patient's medical record is to include documentation of: the patient’s oral and written requests and the attending physician’s offer to rescind the request; the attending physician’s recommendation for alternative care and treatment consultations, and whether the patient participated in a consultation; the attending physician’s and consulting physician’s medical diagnosis and prognosis, and their determinations that the patient is terminally ill, is capable of making the request, is acting voluntarily, and is making an informed decision; the results of any counseling sessions ordered for the patient; and a statement that all the requirements under the bill have been satisfied.
A patient's request for, or the provision of, medication in compliance with the bill may not be used as the sole basis for the appointment of a guardian or conservator. The bill specifies that a patient’s guardian, conservator, or representative is not authorized to take any action on behalf of the patient in association with the making or rescinding of requests for medication under the bill’s provisions, except to communicate the patient’s own health care decisions to a health care provider upon the patient’s request. The bill prohibits any contract, will, insurance policy, annuity, or other agreement from including a provision that conditions or restricts a person’s ability to make or rescind a request for medication pursuant to the bill, and further specifies that the procurement or issuance of, or premiums or rates charged for, life, health, or accident insurance policies or annuities may not be conditioned upon the making or rescinding of a request for medication under the bill’s provisions. An obligation owing under a contract, will, insurance policy, annuity, or other agreement executed before the bill’s effective date will not be affected by a patient’s request, or rescission of a request, for medication under the bill.
Any person who, without the patient’s authorization, willfully alters or forges a request for medication pursuant to the bill, or conceals or destroys a rescission of that request, with the intent or effect of causing the patient's death, will be guilty of a crime of the second degree, which is punishable by imprisonment for a term of five to 10 years, a fine of up to $150,000, or both. A person who coerces or exerts undue influence on a patient to request medication under the bill, or to destroy a rescission of a request, will be guilty of a crime of the third degree, which is punishable by imprisonment for a term of three to five years, a fine of up to $15,000, or both. The bill does not impose any limit on liability for civil damages in association with the negligence or intentional misconduct of any person.
The bill provides immunity from civil and criminal liability, and from professional disciplinary action, for any action that is undertaken in compliance with the bill, including the act of being present when a qualified terminally ill patient takes the medication prescribed to the patient under the bill’s provisions. Any action undertaken in accordance with the bill will not be deemed to constitute patient abuse or neglect, suicide, assisted suicide, mercy killing, or homicide under any State law, and the bill expressly exempts actions taken pursuant to the bill from the provisions of N.J.S.2C:11-6, which makes it a crime to purposely aid a person in committing suicide. Nothing in the bill is to be construed to authorize a physician or other person to end a patient's life by lethal injection, active euthanasia, or mercy killing.
The bill amends section 1 of P.L.1991, c.270 (C.2A:62A-16), which establishes a “duty to warn” when a health care professional believes that a patient intends to carry out physical violence against the patient’s own self or against another person, in order to specify that that “duty to warn” provisions are not applicable when a qualified terminally ill patient requests medication under the bill.
The bill requires a patient’s attending physician to notify the patient of the importance of taking the prescribed medication in the presence of another person and in a non-public place. The bill specifies that, if any governmental entity incurs costs as a result of a patient’s self-administration of medication in a public place, the governmental entity will have a claim against the patient’s estate to recover those costs, along with reasonable attorney fees.
The bill authorizes attending physicians, if registered with the federal Drug Enforcement Administration, to dispense requested medication, including ancillary medication designed to minimize discomfort, directly to the patient. Otherwise, with the patient’s written consent, the attending physician may transmit the prescription to a pharmacist, who will be required to dispense the medication directly to the patient, to the attending physician, or to an expressly identified agent of the patient. Medication prescribed under the bill may not be dispensed by mail or other form of courier. Not later than 30 days after the dispensation of medication under the bill, the health care professional who dispensed the medication will be required to file a copy of the dispensing record with the Division of Consumer Affairs (DCA) in the Department of Law and Public Safety.
Any medication prescribed under the bill, which the patient chooses not to self-administer, is required to be disposed of by lawful means. Not later than 30 days after the patient’s death, the attending physician will be required to transmit documentation of the patient’s death to the DCA. The DCA is required, to the extent practicable, to coordinate the reporting of dispensing records and records of patient death with the process used for the reporting of prescription monitoring information. The DCA will be required to annually prepare and make available on its Internet website a statistical report of information collected pursuant to the bill’s provisions; information made available to the public will not include personal or identifying information.
A health care facility’s existing policies and procedures will be required, to the maximum extent possible, to govern actions taken by health care providers pursuant to the bill. Any action taken by a health care professional or facility to carry out the provisions of the bill is to be voluntary. If a health care professional is unable or unwilling to participate in a request for medication under the bill, the professional will be required to refer the patient to another health care provider and provide the patient’s medical records to that provider.
Laurie A. Clark
Laurie Clark is NJAOPS’ government affairs and legislative counsel. She is also president of LegisServe, a Governmental Affairs Agency located in Princeton, NJ.
© 2018 New Jersey Association of Osteopathic Physicians and Surgeons
The Journal is the official magazine of the New Jersey Association of Osteopathic Physicians and Surgeons (NJAOPS). NJAOPS is the sixth largest state affiliate of the American Osteopathic Association. NJAOPS represents the interests of more than 4,700 active osteopathic physicians, residents, interns and medical students. Founded in 1901, NJAOPS is one of the most active medical associations in New Jersey with 12 county societies.