A recently issued federal court opinion confirmed that certain pre-COVID era prescribing restrictions are back in place. In July 2023, a nonprofit advocacy group, Community Oncology Alliance, filed suit against the U.S. Department of Health and Human Services (HHS) regarding provisions of the Stark Law. Stark prohibits physicians from referring Medicare and Medicaid patients to…

The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) imposed a $240,000 civil monetary penalty against Providence Medical Institute in connection with a ransomware attack that revealed vulnerabilities in the Institute’s systems and potential HIPAA violations.

The Institute was the victim of a series of ransomware attacks in 2018 that compromised…

On October 20, 2024, several significant consumer protection laws will go into effect, directly affecting healthcare providers throughout New York State. Introduced through the FY 2025 Executive Budget, these new laws reshape how providers must handle patient consent to pay for medical services and the use of credit cards for payment.

Separate Consent for Payment…

In our previous article, we described the due diligence process, including what a buyer would look for in your practice. Once due diligence is under way, the next step is the purchase agreement, which is usually prepared by the buyer’s attorney.

A purchase agreement is the main document for the transaction and describes its…

As previously discussed here, Johnson & Johnson (J&J) recently announced its intention to change its 340B Drug Pricing Program discount available to disproportionate share hospital (DSH) Covered Entities on purchases of STELARA and XARELTO. However, the Health Resources and Services Administration (HRSA) notified J&J that its rebate model was contrary to the 340B statute…

Three Connecticut dental practices, together with their owners, have agreed with the U.S. Attorney’s Office for the District of Connecticut to pay $1.7 million to settle allegations that the practices violated federal and Connecticut False Claims Acts and the federal Anti-Kickback Statute. This and other recent settlements seem to be suggesting that a crackdown on…

On August 23, Johnson & Johnson (J&J) announced changes to its 340B Drug Pricing Program discount available to disproportionate share hospital (DSH) Covered Entities on purchases of two of J&J’s most popular drugs, STELARA and XARELTO.

As of October 15, J&J will make a 340B discount on these drugs available through a rebate. According to…

An article in the September issue of Healthcare Risk Management’s HIPAA Regulatory Alert, “Hospital Terminates Employees for Allowing Another to Do Their Jobs,” discussed a recent incident at Mass General Brigham in Somerville, MA. Upon investigation, the hospital discovered that two employees inappropriately allowed a third person, who was not a hospital…

The U.S. Attorney’s Office for the Southern District of Texas announced on August 20 that National Interventional Radiology Partners PLLC (NIRP) and its founder and CEO will pay $8,884,091 to the United States to resolve alleged violations of the federal False Claims Act (FCA) and Anti-Kickback Statute. NIRP and Dr. Andrew Gomes allegedly illegally paid…