Is the Transparency Rule on Its Way Out? And Other Federal Updates

CMS Scales Back Part of the Transparency Rule

The Centers for Medicare & Medicaid Services ("CMS") issued its annual proposed Hospital Inpatient Prospective Payment Systems. Under the proposed rule, CMS seeks to repeal the requirement that acute care hospitals report median payer-specific negotiated rates with Medicare Advantage insurers, which was finalized in 85 FR 58432. This has created some excitement in the industry that CMS may be pulling back its transparency rules.

New OIG Advisory Opinion on Ambulatory Surgery Centers and the One-Third Test

On April 29, 2021, the Health and Human Services Office of Inspector General ("OIG") issued Advisory Opinion 21-02. The Advisory Opinion addresses a proposed arrangement involving a health system, certain orthopedic surgeons and neurosurgeons employed by that health system, and a management company seeking to invest in an ambulatory surgery center ("ASC").

New York Lifts Immunity, CMS Updates and Proposed Rules

Governor Cuomo Signs Law Lifting Liability Protections for Health Facilities

Governor Cuomo recently signed S5177 into law, repealing the Treatment Protection Act, which prevented health care facilities, like nursing homes and hospitals, as well as their administrators and executives, from being held accountable for harm in connection with their treatment of patients with COVID‑19. 

New Jersey Legislation Update

Every year, New Jersey proposes dozens of statutes that impact health care. The statutes in this post have already passed both the State Senate and Assembly and are on their way to become law unless vetoed by the Governor, with the exception of one statute that has already been approved and is now law.  

New Jersey Proposes New Statute on PBMs, CMS Expands Coverage for COVID-19 Testing and More

New Jersey’s Proposed Pharmacy Benefits Manager Licensure and Regulation Act

This bill, A5410, first introduced to the New Jersey Assembly on March 1, 2021, provides for the licensure of pharmacy benefits managers ("PBM"). Under the bill, the Commissioner of Banking and Insurance is to create the application for a license to operate in New Jersey as a PBM and establish the accompanying licensing, fees, application, financial standards, and reporting requirements of PBMs.

New Jersey and Federal Legislation and Regulatory Update

New Jersey recently approved several statutes that reinstated the tax exemption for non-profit hospitals, with some caveats, and changed the standard for trauma care. On the federal side, several federal courts enjoined the “most favored nation” payment model rule and The Department of Health and Human Services (“HHS”) issued a notification of enforcement discretion relaxing HIPAA when it comes to arranging for COVID-19 vaccination appointments.

Proposed Changes to New Jersey’s Out-of-Network Transparency Act

A bill, S3458, is currently being proposed in the State Senate. This proposed statute amends the arbitration provisions of the Out-of-Network Consumer Protection, Transparency, Cost Containment and Accountability Act. Besides increasing the time frames for when parties can attempt to reach a settlement before initiating arbitration, the proposed statute eliminates the requirement that the final offers submitted by the insurer and provider be more than $1,000 apart.

New Opioid and COVID-19 Reporting Developments

New Proposed Rules Limit Prescribing, Administering, or Dispensing Controlled Dangerous Substances

The New Jersey State Board of Dentistry, New Jersey Board of Nursing, and New Jersey State Board of Optometrists (collectively, the “Boards”) each released a proposed rule aimed at addressing New Jersey’s ongoing opioid epidemic and further increasing the public availability of the overdose‑reversal drug, naloxone. 

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.