By Mike Siget
Regulatory Update - August 2017
Department of Health
Department of State
Department of Health
Achieving Better Care by Monitoring All Prescriptions Program (PDMP)
The Department of Health has not yet issued proposed regulations to support the implementation of the prescription drug monitoring program: Achieving Better Care by Monitoring All Prescriptions Programs (ABC-MAP).
Four new pieces of legislation were enacted in November 2016 and most of the provisions took effect Jan. 1, 2017. PAMED published an extensive FAQ document regarding the new legislation and how it effects the PDMP law.
The Independent Regulatory Review Commission approved the regulations in October 2016. The Department of Health published the approved regulations on March 4, 2017. The regulations take effect on Aug. 1, 2017. PAMED published information relating to the changes that take effect on Aug. 1.
Health Care Worker ID Badge Regulations
On June 1, 2015, the remaining provisions of the Photo Identification Tag legislation went into effect. Even though the remainder of the law related to titles and their precise placement on the badge did not go into effect until June 1, 2015, many of the health care practitioners affected by the law (particularly physicians and employees in private physician practices) have been in compliance with all components of the law since it passed in 2011.
The Department of Health anticipated the release of proposed regulations in 2015; however, that did not happen. PAMED will continue to track the development and release of this regulation.
Medical Marijuana Regulations
On June 25, 2016, the Department of Health issued temporary regulations regarding the safe harbor provision contained in the medical marijuana law. The safe harbor provision authorizes parents, legal guardians, caregivers, or spouses of a minor to bring medical marijuana from another state into the Commonwealth without violating the law.
The Department of Health created a Safe Harbor Physician Form to be completed by an authorized person named above and a Pennsylvania-licensed physician. This form must be submitted to the Department of Health in order for the authorized person to receive a safe harbor letter from the Department of Health.
This letter will enable the authorized person to administer medical marijuana to the minor named in the Safe Harbor Physician Form.
The safe harbor regulations expire on May 17, 2018, or upon the Department of Health's publication in the Pennsylvania Bulletin that the Commonwealth's medical marijuana program has been implemented, whichever comes first.
In recent months, the Department of Health has issued temporary regulations relating to growers/processers, dispensers, laboratories, physicians and research. PAMED submitted comments to the Department of Health concerning its proposed temporary regulations relating to physicians.
PAMED anticipates that the next regulations that will be issued will be proposed regulations seeking to formally implement the Act.
PAMED has participated in an internal workgroup developed by the Department of Health to revise the Department's hospital regulations. The Department's hospital regulations were promulgated in 1982 and have not been extensively updated since then. The Department is seeking to overhaul these regulations due to significant changes that have occurred relating to hospitals since that time.
PAMED anticipates that the Department will issue proposed regulations sometime before the end of the year. One major area of concern for PAMED includes medical staff revisions to include practitioners other than physicians and dentists. PAMED will have more information on these regulations they are issued as proposed regulations.
Department of State
The State Board of Osteopathic Medicine plans to issue proposed regulations regarding the internship requirement for osteopathic licensure. The Board is concerned about the unification of a single GME accreditation system and that the Board’s current regulations allow for completion of an AOA-approved internship. As the AOA will cease doing so after the unification is finalized, members of the Board want to update its regulations to reaffirm its position that an internship in certain rotations is required prior to licensure.
The State Board of Medicine plans to issue proposed regulations to clarify the requirements for the use and delegation of the use of medical lasers. The proposed rule will bring the Board's regulations in line with the majority of other states with regulations related to these devices.
Child Abuse Reporting Requirements
The State Board of Medicine and the Osteopathic Board of Medicine plan to issue regulations to update the Board’s existing rules regarding the mandatory reporting of suspected child abuse pursuant to the recent amendments to the Child Protective Services Law (CPSL).
Osteopathic Prescribing Regulations
The State Board of Osteopathic Medicine plans to issue proposed regulations to outline the minimum acceptable standards of practice that an osteopathic physician or physician assistant licensed by the Board must follow when prescribing, administering or dispensing controlled substances or one specific additional drug which shares serious potential for addiction and abuse (butalbital).
The State Board of Dentistry plans to issue proposed regulations updating the standards for administration of general anesthesia, deep sedation, moderate sedation, minimal sedation and nitrous oxide/oxygen analgesia in dental offices to conform to and adopt the current standards used by the dental profession.
The State Board of Pharmacy issued proposed regulations pertaining to compounding drugs on March 11, 2017. PAMED submitted comments on these regulations focused on whether these regulations will apply to physicians who compound drugs in the office setting. The State Board will review all comments submitted and respond to them when it issues its final regulations. Final regulations are due by April 2019.
Compounding Regulations – http://www.pabulletin.com/secure/data/vol47/47-10/427.html
Public Health Dental Hygiene Practitioners – New item
The State Board of Dentistry is in the planning stages of drafting updates to its regulations relating to public health dental hygiene practitioners. Under current regulations, these practitioners may perform certain dental hygiene services without the supervision of a dentist in specified practice settings such as health care facilities, correctional facilities, free and reduced-fee nonprofit health clinics and older adult daily living centers.
There are several proposals to revise these regulations. First, the proposal would clarify the definition of a "health care facility" to include specified facilities regulated by the Department of Health and include services provided by a health care facility to patients in their places of residence or other independent living environment. Second, the term "personal care homes" would be changed to "facility" to include facilities regulated by the Department of Human Services.
Finally, an additional paragraph would be added to permit these practitioners to practice in an office or clinic of a physician who is licensed by the State Board of Medicine or the State Board of Osteopathic Medicine. These regulations are internal drafts and may be revised in successive drafts. PAMED will continue to monitor these drafts and provide notice when they are formally published as proposed regulations.
As these regulations are only in the internal drafting stage, it is unknown when they will be formally published, but they would likely not be published until sometime in 2018 at the earliest.