By Michael D.I. Siget, JD, MPA, PAMED’s Legislative & Regulatory Counsel
The General Assembly Passes Several Bills That Will Impact Physicians Statewide
On Nov. 2, 2016, Gov. Wolf signed four bills into law that will impact physicians statewide. In addition, two bills of significance to PAMED members did not reach the Governor's desk. Below are highlights of those bills.
Act 122 – Opioid limits in emergency departments
Act 122, sponsored by Rep. Rosemary M. Brown, will limit the prescribing of an opioid to an individual seeking treatment in certain settings to no more than a quantity sufficient to treat that individual for up to seven days. Those settings include an emergency department, an urgent care center, or a patient in observation status at a hospital.
Act 122 does contain an exception that allows a health care practitioner to prescribe more than a seven-day supply to treat a patient's acute medical condition or if it is deemed necessary for the treatment of pain associated with a cancer diagnosis or for palliative care. In order to go beyond the seven-day limit, a health care practitioner must document in the individual's medical record that a non-opioid alternative was not appropriate to treat the medical condition.
Regardless of the amount prescribed, a health care practitioner under these settings is prohibited from writing a prescription that allows for a refill for an opioid drug product.
Other parts of the bill require:
- A health care practitioner under these settings to refer an individual for treatment if the individual is believed to be at risk for substance abuse while seeking treatment.
- A health care practitioner under these settings to query the Prescription Drug Monitoring Program (PDMP) system to determine whether a patient may be under treatment with an opioid drug product by another health care practitioner. This requirement does not apply to any medication provided to a patient in the course of treatment while undergoing care in an ED.
Health care practitioners who violate the provisions of this bill are subject to licensure sanctions by the appropriate state board, although practitioners who comply with the provisions of this bill are presumed to be acting in good faith and will have immunity from civil liability.
Act 122 takes effect on Jan. 1, 2017.
Act 124 – Revisions to the PDMP law
Act 124, sponsored by Sen. Gene Yaw, will amend the Achieving Better Care by Monitoring All Prescriptions Program (ABC-MAP) law, better known as the PDMP law. Act 124 contains several major revisions to the PDMP law, including:
- Requiring dispensers to query the PDMP system before dispensing an opioid or benzodiazepine prescribed to a patient under certain circumstances.
- Requiring prescribers to query the PDMP system each time a patient is prescribed an opioid or benzodiazepine. However, querying is not required if a patient has been admitted to a licensed health care facility or is in observation status in a licensed health care facility after the initial query as long as the patient remains admitted to the licensed health care facility or remains in observation status in a licensed health care facility.
- Requiring an individual applying for an initial license or certification issued by a licensing board to be a dispenser or prescriber, to complete, within the first 12 months after obtaining the initial license or certification, four hours of education, with those hours being at least two hours of education in pain management or identification of addiction and at least two hours of education in the practices of prescribing or dispensing of opioids.
- Requiring dispensers or prescribers applying for the renewal of a license or certification to complete at least two hours of continuing education in pain management, identification of addiction or the practices of prescribing or dispensing of opioids.
The education indicated above is not in addition to the 100-credit CME requirement for physicians but rather is part of the 100-credit CME requirement. In addition, prescribers who don't have their own DEA number and who do not use the registration number of another person or entity as permitted by law to prescribe controlled substances is exempt from this CME requirement.
Act 124 takes effect on Jan. 1, 2017.
Act 125 – Opioid prescribing for minors
Act 125, sponsored by Sen. Gene Yaw, will limit the number of opioids that may be prescribed to a minor to no more than a seven-day supply unless a prescriber determines that more than a seven-day supply is needed to stabilize the minor's acute medical condition.
For that exception to apply, the prescriber is required to document the acute medical condition in the minor's record with the prescriber and indicate the reasons why a non-opioid alternative is not appropriate to address the minor's acute medical condition. There is also an exception if the prescription is for management of pain associated with cancer, for use in palliative or hospice care, or for management of chronic pain not associated with cancer.
There is a 72-hour dosage limit if an authorized adult (as opposed to a parent or guardian) is in charge of the minor child.
Before prescribing an opioid for the first time to a prescriber, a prescriber is required to do the following:
- Assess whether the minor has taken or is currently taking prescription drugs for treatment of a substance use disorder.
- Discuss with the minor and the minor's parent, guardian, or with an authorized adult certain specified risks and dangers.
Act 125 will require the Department of State's Bureau of Professional and Occupational Affairs, in consultation with the licensing boards, to create a standardized form for prescribers to use to obtain written consent from a minor's parent, guardian, or authorized adult, in order to prescribe an opioid to that minor.
Violations of this bill may subject a prescriber to administrative sanctions by the appropriate licensing board.
Act 125 takes effect immediately with respect to the requirement for the licensing boards to create a standardized form. Once the standardized form is developed and published, the remainder of the act will take effect.
Act 126 – Opioid Education and voluntary non-opioid directive
Act 126, sponsored by Sen. Thomas H. Killion, will require the licensing boards to implement curriculum regarding safe prescribing practices for controlled substances containing opioids. This curriculum may be offered by medical schools, medical training facilities, dental schools, and other providers.
This education will not be mandated as a graduation requirement but will instead be left up to each educational institution to determine whether it will be required for graduation.
Act 126 will also allow a patient to sign a form prohibiting the prescribing or administering of a controlled substance containing an opioid to that patient. Guidelines for the implementation of this form will be drafted by the Department of Health.
A practitioner who recklessly or negligently fails to comply with a patient's voluntary non-opioid directive may be subject to a licensure sanction by the applicable state board.
Act 126 takes effect immediately.
Bills that did not become law
Two bills that would have impacted physicians did not get passed by the full General Assembly prior to its adjournment. HB 1698, introduced by Rep. Doyle Heffley, would have provided insurance coverage for abuse deterrent opioids (ADOs).
While PAMED supported the original version of the bill, PAMED did object to a late amendment that was put in the bill that would have required the Department of Health to create mandatory prescribing guidelines for ADOs. In addition, the amendment would have required the Department of Health to create educational materials to explain the risks of all opioids, not just ADOs.
Prescribers would have been required to distribute these materials to all patients when prescribing opioids. While PAMED supported the original concept of this bill, it objected to these two amendments, particularly with requiring prescribers to distribute one-size-fits-all educational materials to patients.
PAMED argued that physicians were better positioned to discuss opioids with their patients and many physicians already provided materials to their patients.
Finally, SB 717, introduced by Sen. Pat Vance, would have given CRNPs more independent practicing authority. PAMED opposed this bill and argued keeping the physician-led medical team in place. While it passed the Senate, it was not considered by the House prior to its adjournment.
Any bill that did not become law by the end of the legislative session will need to be re-introduced when the new legislative session starts in January.