Vicarious Liability Claims and Affidavits of Merit

In Haviland v. Lourdes Med. Ctr. of Burlington County, Inc., the Appellate Division addressed, in a matter of first impression, whether an Affidavit of Merit (“AOM”) is required for vicarious liability claims against a licensed facility for the alleged negligence of an employee, where the Affidavit of Merit Statute (the “Statute”), N.J.S.A. 2A:53A-26-29, applies to the licensed facility, but not the employee.  

Regulatory Update, Including Changes to HIPAA and Opioid Treatment

HHS Proposes Changes to HIPAA/HITECH Privacy Rule

The United States Department of Health and Human Services (“HHS”) issued its Notice of Proposed Rule Making (“Proposed Rule”) to modify the Standards for the Privacy of Individually Identifiable Health Information (“Privacy Rule”) under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH Act”). 

Federal Update, Including a New HIPAA Safe Harbor

HIPAA Safe Harbor Bill Becomes Law, Providing Protections to Entities That Have Taken Appropriate Safeguards 

On January 5, 2021, H.R. 7898 became law. The law benefits covered entities and business associates that are subject to the Health and Human Services ("HHS") investigations as a result of a security incident but have taken steps to document their compliance with the HIPAA Security Rule and other standardized security practices.

NJ Proposes Changes to Office-Based Surgery and Other Regulations

NJ Board of Medical Examiners Proposes to Substantially Change Regulation Governing Surgery in the Office Setting

The New Jersey Board of Medical Examiners (“BME”) has proposed a new rule that replaces the phrase “minor surgery” with “minor procedure” and further expands the definition of “special procedure.”  The purpose of these changes is to remove restrictions relating to where and by whom abortion care may be provided, and regulates abortions like other office-based surgical and special procedures.   By making these changes, however, the proposed rule expands who and where minor procedures may be performed. 

Five Recent OIG and HHS Advisory Opinions

The Office of Inspector General (“OIG”) issued four advisory opinions at the end of 2020 addressing gift cards and paying for expenses, among other issues. With regard to all of these requests, the OIG analyzed whether the proposed arrangements in these requests would constitute grounds for the imposition of sanctions under the Social Security Act (the “Act”) and the federal anti‑kickback statute (the “Anti-Kickback Statute”).

NJ Passes Statute Similar to the 2018 Federal EKRA

The New Jersey Senate and Assembly recently passed A2280, which operates similar to the federal statute, Eliminating Kickbacks in Recovery Act (“EKRA”). Similar to EKRA, A2280 criminalizes certain payments for referral of patients to substance use disorder treatment facilities. Specifically, the bill makes it a crime of the fourth degree for a person to knowingly make or receive a payment or otherwise furnish or receive any fee, commission, or rebate to any person in connection with the referral of patients to substance use treatment disorder facilities regulated by the Division of Mental Health and Addiction Services in the Department of Human Services.

Nursing Home and Pharmacy Litigation Update

Nursing Homes May Seek Payment Based on Agreement to Apply for Medicaid

On November 23, 2020, the Appellate Division held that a law preventing a nursing home from requiring a third‑party guarantee of payment as a condition of admission does not bar a claim by a nursing home against the children of a resident who signed an admission agreement pledging to apply for Medicaid on the resident’s behalf. Pine Brook Care Ctr. v. D'Alessandro, A‑3197‑18T1, 2020 WL 6852609 (N.J. Super. Ct. App. Div. Nov. 23, 2020).

The New Federal Out-of-Network Statute

As part of the recently enacted Consolidated Appropriations Act, 2021 (the “Appropriations Act”), the federal government did not only provide relief to stem the effects of the COVID-19 pandemic, but it also adopted the No Surprises Act.

The No Surprises Act (the “Act”) does not become effective until January 1, 2022, and, for those providers who practice in New Jersey, the Act operates similar to New Jersey’s Out‑of‑Network Consumer Protection, Transparency, Cost Containment and Accountability Act (the “NJ OON Act”). 

New Federal Regulations, Provider Relief Fund Reporting Requirements Update, and New CMS Model for Dual-Eligible Beneficiaries

This post covers the numerous new final rules that were issued by the federal government toward the end of 2020. In addition, the Department of Health and Human Services (“HHS”) updated its reporting requirements for the Provider Relief Fund, and the Centers for Medicare & Medicaid Services (“CMS”) issued a new model that covers those beneficiaries with dual eligibility for Medicare and Medicaid.

New Jersey Legislative Update

Throughout this year, the New Jersey Legislature has passed numerous bills that impact health care providers in the State. Over the past month, the Legislature continued to do so with the passage of several bills as noted in this post.