Last Updated: May 11, 2020
In the latest issue of the Pennsylvania Bulletin (Vol. 50 No. 19), Governor Wolf's office released its regulatory agenda for the first half of 2020. All agencies under the jurisdiction of the Governor are required semi-annually to publish an agenda of regulations under development or consideration.
A few of the items on the Governor's agenda may be of particular relevance to Pennsylvania physicians, including updates to the state’s hospital and long-term care facility regulations as well as updates to State Board of Medicine regulations and the State Board of Osteopathic Medicine’s prescribing rules and fee provisions. These updates are discussed below.
Health Facilities and Hospitals/Long Term Care Facilities Updates (Department of Health)
The Department of Health (DOH) plans to update regulations regarding hospitals and long-term care facilities. The hospital regulations have not been extensively updated since their promulgation in 1982, and the long-term care facilities regulations were last updated in 1999. These updates will reflect the recommendations of two Secretary of Health commissioned task forces to review regulations governing the aforementioned facilities.
Both proposed updates to the health facilities and hospital regulations and proposed updates to the long-term care facility regulations are currently slated to be published by November 2020. Note though that the expected publishing dates on these regulations have changed several times over the past few Regulatory Agendas released.
Updates to the hospital regulations could include allowing each hospital to determine which health care practitioners may be part of that hospital’s medical staff and permitting CRNAs to administer anesthesia without being under the supervision of an anesthesiologist or other physician. The Pennsylvania Medical Society (PAMED) opposes medical staff membership changes and opposes authorizing CRNAs to administer anesthesia without physician supervision. In the event that the hospital regulations include these provisions, PAMED will actively oppose these changes and submit comments in opposition. PAMED will alert its members of these proposed changes and recommend that members submit comments as well.
Communicable and Noncommunicable Diseases Revisions (Department of Health)
DOH will update its reportable disease regulations (28 Pa. Code, Chapter 27
) to include: additional and emerging diseases, new laboratory tests, and changes to exclusion policies for individuals with evidence of disease. Changes will allow for alignment with national standards and improve disease surveillance, investigation and response efforts.
Screening and Follow-up for Diseases of the Newborn (Department of Health)
DOH will publish proposed regulations to revise and update the newborn screening regulations (28 Pa. Code, Chapter 28
) to include additional diseases, changes to policies and reporting requirements. Critical congenital heart defects in accordance with the Newborn Child Pulse Oximetry Screening Act
and hearing screening in accordance with the Infant Hearing, Education, Assessment, Reporting, and Referral Act
will be added to the regulations.
Electronic Prescribing of Controlled Substances (Department of Health)
Act 96 of 2018 amends Pennsylvania’s Controlled Substance, Drug, Device and Cosmetic Act to provide for the required use of electronic prescribing for scheduled II—V controlled substances, including provisions for exemptions and penalties. Per Act 96 the Department of Health will promulgate regulations necessary to implement the requirements of the Act.
A PAMED resource on Act 96 compliance can be accessed here.
Medical Marijuana Program (Department of Health)
DOH plans to promulgate proposed permanent regulations to update existing temporary regulations to the Medical Marijuana program.
Access PAMED’s resources on Pennsylvania’s medical marijuana program here.
Prescribing Rules (State Board of Osteopathic Medicine)
The State Board of Osteopathic Medicine plans to propose rules setting forth the minimum acceptable standards of practice that an osteopathic physician or physician assistant licensed by the Board must follow when prescribing, administering, or dispensing drugs.
Licensure Fees (State Board of Osteopathic Medicine)
In March 2020, the State Board of Osteopathic Medicine published proposed regulations seeking to increase both application fees and licensure fees for practitioners under the authority of the Board.
PAMED submitted comments, including questions concerning how the fees would be implemented over the proposed three-cycle licensure period. In May 2020, the Independent Regulatory Review Commission (IRRC) published it comments on the proposed regulations reiterating PAMED’s concerns. For more information on PAMED and IRRC’s comments, click here.
Practitioners of Oriental Medicine Regulations (State Board of Medicine)
In accordance with Governor Wolf’s recommendation for occupational licensure reform, the State Board of Medicine will revise regulations relating to Practitioners of Oriental Medicine to reflect the application of herbal therapy for acupuncturists.
Naturopathic Doctors (State Board of Medicine)
The proposed rulemaking will amend the State Board of Medicine's regulations to implement the Naturopathic Doctor Registration Act, Act 128 of 2016
, which provides for the registration of naturopathic doctors.
Examinations (State Board of Medicine)
The State Board of Medicine will publish proposed regulations to reflect changes made by the National Board of Medical Examiners to the United States Medical Licensing Examination (USMLE) regarding limitations on the number and timing of attempts an applicant may take the various USMLE parts. The proposed rulemaking will also remove the detailed descriptions of the FLEX and Federation of State Medical Boards (FSMB) licensing examinations which are no longer offered.
Administration of Injectable Medications, Biologicals and Immunizations (State Board of Pharmacy)
Act 8 of 2015
lowered the age of patients (to nine years of age and older, with parental consent) to whom pharmacists may administer flu vaccinations to. This Act also established that licensed pharmacy interns are permitted to administer immunizations under the direct, immediate, and personal supervision of a licensed pharmacist (who is actively authorized to administer injectables, biologicals, and immunizations by the State Board of Pharmacy). The State Board of Pharmacy will update its regulations to reflect these statutory changes.
Anesthesia Regulations (State Board of Dentistry)
The State Board of Dentistry will publish 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.
Public Health Dental Hygiene Practitioners (State Board of Dentistry)
In March of 2019, the State Board of Dentistry published proposed regulations that expand the practice sites that public health dental hygiene practitioners (PHDHPs) may perform dental hygiene services without the supervision of a dentist. Note these expanded sites include physician offices. PAMED submitted comments seeking clarification on how these proposals could affect physicians.
Click here for a summary of the proposed regulations and PAMED’s comments.
Act 41 Regulations (Bureau of Professional and Occupational Affairs)
Act 41 of 2019
requires all licensing boards and commissions under the Bureau of Professional and Occupational Affairs to draft regulations for the implementation of Act 41 to include methods of determining competency and terms of provisional licenses. A PAMED resource on Act 41 can be accessed here
A full listing of the Governor's regulatory agenda, including agency contacts, can be found here. Agency contacts can be contacted for more information regarding regulations and the procedure for submitting comments.
For a comprehensive list and description of regulatory items that PAMED is tracking, please visit PAMED's Regulatory Update.
PAMED will continue to monitor the promulgation of new regulations, comment on proposed rules and regulations on behalf of PAMED members and share all updates with PAMED members and provide information to members on how they may submit comments.