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FDA Finalizes Guidance on Communications Regarding Unapproved Uses of Medical Products

In January 2025, the US Food and Drug Administration (FDA) finalized its 2023 revised draft guidance Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more

DEA Telemedicine Update

The Drug Enforcement Administration (DEA), in concert with other federal agencies, has taken various steps in the past few months to strengthen a practitioner’s ability to prescribe controlled substances via telemedicine, a...more

New Jersey Regulatory Update Part II - February 2025

We continue our New Jersey Regulatory Update with this Part II, which focuses on regulations that were finalized in the second half of 2024 and impact healthcare. For example, as a continuation of price transparency efforts,...more

New Jersey Regulatory Update Part I - January 2025

Below is Part I of our New Jersey Regulatory Update focusing on regulations that were finalized in 2024 by various New Jersey agencies that impact healthcare. The final regulations range from additional transparency...more

New Jersey Statutory Year-End Review

Compared to previous years, the New Jersey Legislature passed a limited number of statutes impacting health care in 2024. It was a slow start to 2024, but activity picked up in the last six months of the calendar year. Once...more

Nursing Home Update

The federal government has made a variety of changes to federal requirements aimed at improving the quality of care at long-term care facilities across the country. In May 2024, the United States Department of Health and...more

Is the Qui Tam A Sham?: Federal Judge Finds Qui Tam Enforcement of False Claims Act Unconstitutional

A recent federal court decision has the potential to significantly impact the future of False Claims Act (FCA) lawsuits initiated by whistleblowers and to upend the FCA. In United States of America ex rel. Clarissa Zafirov v....more

CMS Proposes Further Changes to Medicare Overpayment Rule

The Centers for Medicare & Medicaid Services (CMS) recently published a proposed rule, 89 FR 61596, that revives portions of a 2022 proposal to amend the Medicare Overpayment Rule. The 2024 proposed rule comes after...more

Washington DC Removes Collaboration Requirements for CRNAs

Certified registered nurse anesthetists (CRNAs) in Washington, DC can now practice without a collaborating physician following the DC legislature’s recent passing of Bill B25-0545, also known as the Health Occupations...more

CMS Adopts New Age-Friendly Hospital Measure for Care of Older Adults for CY 2025 Reporting

The Centers for Medicare & Medicaid Services (CMS) has adopted an age-friendly quality hospital measure in its most recent final rule addressing prospective payment systems, policy changes, and quality program requirements...more

More Roadblocks For Information Blocking: HHS Finalizes Rule Establishing Disincentives for Hospitals, Clinicians, and ACOs

On July 31, 2024, the Department of Health and Human Services (HHS) final rule, 89 FR 54662, establishing disincentives for certain healthcare providers that have committed information blocking, will become effective. This...more

New Jersey Statutory Update Part II

Below is Part II of our New Jersey Statutory update. As you can see from the below, several statutes were passed imposing requirements on health insurance payers, including new requirements for prior authorization request and...more

New Jersey Regulatory Update Part II

Part II of our New Jersey Regulatory Update further identifies proposed and adopted regulations that may impact healthcare providers, from additional financial transparency rules impacting facilities to rules attempting to...more

Federal Rule to Establish Minimum Staffing Requirements for Long-Term Care Facilities

The contentious “Nursing Home Minimum Staffing Rule,” which sets minimum staffing requirements for federally funded long-term care facilities throughout the U.S., was finalized on April 22, 2024. The rule was initially...more

HHS Issues Final Rule Strengthening HIPAA Protections for Reproductive Healthcare

On April 22, 2024, the Department of Health and Human Services (HHS) announced a Final Rule titled HIPAA Privacy Rule to Support Reproductive Health Care Privacy. The Final Rule strengthens the Health Insurance Portability...more

Payment Flexibilities and New Legislation Introduced Regarding Healthcare Cyberattacks

For the past month or longer, many providers have reported a significant impact on their revenue cycle due to the cyberattack on Change Healthcare, LLC. In light of that impact, the Centers for Medicare & Medicaid Services...more

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