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July 2, 2018 Regulatory Developments

Here are the most recent health care related regulatory developments as published in the New Jersey Register on July 2, 2018:

  • On July 2, 2018, at 50 N.J.R. 1468(a), the State Board of Pharmacy issued a proposal to amend the regulations regarding the effective date for complying with Chapter 800 of the United States Pharmacopoeia/National Formulary (USP 800), which sets forth standards for compounding antineoplastic agents (i.e., anti-tumor) and other hazardous substances. The Board is, therefore, proposing to amend the effective date for pharmacies to meet the requirements of USP 800 from July 1, 2018, to the official (effective) date of General Chapter 800 which is currently December 1, 2019.

  •  On July 2, 2018, at 50 N.J.R. 1494(a), the Department of Health issued a notice of readoption of N.J.A.C. 8:31B, Hospital Financial Reporting, which was scheduled to expire June 29, 2018. The readopted rules includes technical amendments to the existing rule and will be in effect for a period of seven years.

  •  On July 2, 2018, at 50 N.J.R. 1500(a), the Department of Law and Public Safety, Division of Consumer Affairs issued a notice of adoption of amendments to the Prescription Monitoring Program. The program is now accessible to certified medical assistants, registered dental assistants and licensed mental health practitioners. The rule adoption gives the Division authority to review the PMP information submitted by a pharmacy permit holder. The rule adoption also amends recordkeeping requirements and names non-compliance with the PMP regulations as grounds for professional misconduct.

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Frank R. Ciesla, Giordano Law Firm Health Care Litigation Health Care Fraud and Abuse Tax Health & Hospital Law
Of Counsel

Mr. Ciesla is Chair Emeritus of the firm's Health Care Law Practice Area. His practice is primarily devoted to Health Care and Government Contracts Law. He counsels clients on legal developments facing healthcare providers in the modern health care environment. Firm clients include hospitals, nursing homes, physicians and physician groups, individual practice associations, home health agencies, ambulance carriers and industry-wide associations.

Mr. Ciesla advises such clients on business structures, mergers and consolidations, joint ventures, reorganization of health care providers...

732-741-3900
Beth Christian, Giordano Law firm, Health Care Attorney,Health Care Fraud and Abuse, Cannabis Law, Non-Profit Law
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Ms. Christian's practice is devoted to Health Care Law and legal issues facing Health Care facilities licensed professionals and non-profit organizations. She has over twenty years of experience counseling clients on legal issues facing the modern health care and non-profit communities.

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Anjali Baxi, Giordano Halleran Law Firm, Healthcare Attorney, New Jersey health Law,Cannabis Law,Government Affairs,Business Transactions, Health Care Law Regulation, Medicare and NJ Medicaid Enrollment
Counsel

Anjali has been practicing law for 15 years, mainly focused on health care transactional and regulatory matters. She prepares and reviews LOIs, purchase agreements and other transaction documents for health care providers needed for the business transfer and necessary for the transfer of NJDOH and NJDHS licenses and provider numbers. She also reviews agreements required for the day to day operations of health care facilities.

She has counseled skilled nursing, assisted living, adult medical day care, outpatient facility clients and hospitals regarding NJDOH regulatory requirements,...

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Ari G. Burd, Shareholder, Giordano Law Firm, Labor & Employment, Cannabis Law, Health Care
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Ari devotes his time to assisting and defending employers with regard to traditional employment issues. He frequently counsels employers for compliance with New Jersey laws and has extensive transactional and litigation experience.

Ari has litigated employment matters throughout the state, having made appearances in almost every Superior Court in New Jersey, as well as before both Federal District Courts in New Jersey and the Federal and State Courts in New York.  These actions have involved a diverse range of claims such as wrongful discharge, discrimination, harassment,...

732-741-3900