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|Notices or Amendments|
Notice of Changes or Amendments that Impact NPs
Below are notices that will directly and significantly impact nurse practitioners:
Department of Health | 48 Pa.B. 7712 | Amendments to Charges for Medical Records
Summary: The Pennsylvania Department of Health (Department) provided notice that a health care provider or facility is allowed to charge a fee in response to a request for medical charts or records. The Secretary of Health (Secretary), has the authority to adjust annually the amounts which may be charged by the health care provider or facility based on the most recent changes in the Consumer Price Index reported annually by the Bureau of Labor Statistics of the United States Department of Labor. For the annual period of October 31, 2017, through October 31, 2018, the Consumer Price Index was 2.5%. Therefore, effective January 1, 2019, the Department provided the fees that may be charged by a health care facility or health care provider in response to a request for production of medical charts or records. Questions or inquiries concerning this notice should be sent to the Department of Health, Office of Legal Counsel, Room 825, Health and Welfare Building, 625 Forster Street, Harrisburg, PA 17120, (717) 783-2500.
Department of Health | 48 Pa.B. 6629 | Rescheduling of Epidiolex and Generic Verisons from Schedule I to Schedule V
Summary: The Department of Health (Department) provided notice that the Secretary of Health (Secretary) of the Department is issuing this final order rescheduling certain drug products that have been approved by the United States Food and Drug Administration (FDA) and that contain cannabidiol (CBD) in Schedule V of The Controlled Substance, Drug, Device and Cosmetic Act (act) (35 P.S. §§ 780-101—780-144). This final order places in Schedule V certain FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1% tetrahydrocannabinols—specifically Epidiolex and any generic versions of the same formulation that might be approved by the FDA in the future. Significantly, however, the bulk cannabis material used to make the Epidiolex formulation (as opposed to the FDA-approved drug product in finished dosage form) will remain in Schedule I of the act. Under section 3 of the act, the rescheduling of a controlled substance to a lower schedule may take effect upon publication in the Pennsylvania Bulletin. 35 P.S. § 780-103(c)(1) because under section 3 of the act, the Secretary shall control all substances listed in Schedules I—V of the act. Thus, under section 3(c) of the act, if the Secretary finds that the health and safety of the public will not be adversely affected, the Secretary is authorized to reschedule any substance to coincide with Federal law, including the CSA (Pub.L. No. 91-513, 84 Stat. 1236; 21 U.S.C.A. §§ 801 et seq.), regulations promulgated under 21 CFR Chapter 2 (relating to drug enforcement administration, Department of Justice) or any Federal judicial order. 35 P.S. § 780-103(c)(1). The rescheduling of a controlled substance to a lower schedule may take effect upon publication in the Pennsylvania Bulletin. Id.
Hence, based upon the DEA's September 28, 2018, final order rescheduling the Epidiolex formation (and any future FDA-approved generic versions of such formulation made from cannabis), the Secretary is exercising her authority to reschedule the Epidiolex formation from Schedule I to Schedule V under the act. Specifically, this order places FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1% tetrahydrocannabinols in Schedule V. The rescheduling of the Epidiolex formation (and any future FDA-approved generic versions of such formulation made from cannabis) to a lower schedule may take effect upon publication in the Pennsylvania Bulletin. 35 P.S. § 780-103(c)(1). The Department plans to promulgate a conforming amendment to 28 Pa. Code § 25.72 through final rulemaking with proposed rulemaking omitted.