Health Law Informer

On October 29, 2020, Governor Wolf signed House Bill 81 into law, creating new minimum education and certification requirements for central service technicians and surgical technicians working in the Commonwealth, and regulating the practice of surgical technology. The Act will take effect on December 28, 2020.

Central Service Technicians

The Act defines central service technicians (“Central Tech”) as “an individual who provides the services of inspecting, assembling, decontamination, preparation, packaging and sterilization of reusable medical instruments or devices.” Under the Act, a health care facility cannot employ or otherwise contract for the services of a Central Tech unless the individual has successfully passed a nationally accredited central service exam for central service technicians and holds and maintains either a certified registered central service technician or a certified sterile processing and distribution technician credential. Currently employed health care facility Central Techs and contracted Central Techs are grandfathered from the requirements, but any Central Tech that is considered a new employee must meet the minimum requirements within 18 months from the date of hire. Techs must complete 10 hours of annual continuing education. The Act directs the Department of Health (“DOH”) to promulgate regulations necessary to implement the Act’s requirements, and grants the DOH general oversight.

In 2018, Governor Tom Wolf signed a multitude of bills into law that significantly impact Pennsylvania health care providers. Compliance deadlines for these new laws vary. Implementing any new policies or procedures often takes longer than anticipated, so we strongly recommend taking steps to determine whether your organization is out of compliance. While not all-encompassing, the following laws represent those of particular significance:

Act 90 – Anatomical Gifts: this act represents a significant update to Pennsylvania’s anatomical gift law. Additions include a new section addressing specific requirements around vascularized composite allograft donation, an update to the statutory list of designated health care representative decision makers, and new medical record documentation requirements.

On June 22, 2018 Governor Wolf signed HB 2477 (“Amendment”) into law breathing new life into Chapter 20 of the Medical Marijuana Act (“Act”), the country’s first-of-its-kind law for cannabis research. This follows Commonwealth Court Judge Patricia McCullough’s May 22, 2018 issuance of a preliminary injunction halting the Department of Health’s (“DOH”) implementation of the Act’s Chapter 20 regulations. Chapter 20 of the Act governs the registration and operation of clinical registrants, the certification of academic clinical research centers (“ACRC”), and partnerships between clinical registrants and ACRCs for research purposes. A clinical registrant is a grower/processor and dispensary that will have a contractual relationship with an ACRC. An ACRC is an accredited medical school in the Commonwealth of Pennsylvania that “operates or partners with an acute care hospital licensed within this Commonwealth.” As of May this year, DOH had already certified eight medical schools as ACRCs under the Act. Continue reading…

On August 18, 2016, the Secretary of Pennsylvania’s Department of Health (“DOH”), Dr. Karen Murphy, announced that the DOH has posted draft temporary regulations (“Regulations”) focusing on the 25 medical marijuana grower/processor permits that will become available under Pennsylvania’s Medical Marijuana Act (“Act”) that was passed last April.

The Regulations state the general application requirements for medical marijuana organizations, which requirements include detailed information about principals and financial backers of such organizations. Medical marijuana organizations include not just grower/processors, but also clinical registrants and dispensaries. The application requirements also contain a clear commitment to foster diversity. The Regulations establish procedures for promoting and ensuring that medical organizations foster diversity through participation of diverse groups in all aspects of the medical organization’s operations. This includes but is not limited to requiring each organization to have a diversity plan. Diverse groups are defined under the Regulations as “disadvantaged business[es], minority-owned business[es], women-owned business[es], service-disabled veteran-owned small business[es] or veteran-owned small business[es] that ha[ve] been certified by a third-party certifying organization.”

The Regulations also contain specific requirements for grower/processor permits. Application forms for permits will be posted on the DOH website in the future. Among the requirements is that a grower/processor notify DOH within six months of being issued an initial permit that it is ready, willing and able to begin production.

The Regulations prohibit executive level employees of the Commonwealth and their immediate family members from being employed by or holding an interest in medical marijuana organizations while employed by the Commonwealth and for one year thereafter.

The Regulations are not final and are open for public comment until August 26, 2016.

Although Pennsylvania joins 23 other states and the District of Columbia to legalize medical marijuana, marijuana is still classified as a Schedule I controlled substance by the U.S. Drug Enforcement Agency, and as such it remains a crime under federal law to grow, sell and/or use marijuana. Any content contained herein is not intended to provide legal advice in connection with the violation of any state or federal law.  Although the Act provides for the legalization of medical marijuana in the Commonwealth of Pennsylvania, one should obtain legal advice with respect to any such compliance issues.

Stay tuned for details regarding an upcoming Cozen O’Connor webinar on these Regulations.

For more information about the Regulations or the Act, contact Chris Raphaely, J. Nicole Martin or another member of Cozen O’Connor’s Cannabis Industry Team.

On April 17, 2016, Governor Wolf signed Act 16 of 2016, making Pennsylvania the 24^th state (plus the District of Columbia) to legalize marijuana for medical use. The full text of the act is available here.

Physicians, not surprisingly, will play a vital role in making medical marijuana available to Pennsylvanians, while ensuring patient safety in the process.  This is what they should know about Act 16: Continue reading…