Articles and Blogs

On Thursday, June 20, 2024, the United States District Court for the Northern District of Texas (“the Court”) issued a ruling in a case that could have significant implications for enforcement of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). The case, which was brought by the American Hospital Association (“AHA”), the... READ MORE

On February 8, 2024, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights and the Substance Abuse and Mental Health Services Administration (“SAMHSA”) issued a Final Rule that modified the “Confidentiality of Substance Use Disorder Patient Records” regulated by 42 CFR Part 2 (“Part 2”). The Final Rule was published... READ MORE

On October 5, 2023, the Office of Research Integrity (“ORI”) of the Department of Health and Human Services (“HHS”) issued a Notice of Proposed Rulemaking intended to update the Public Health Service (“PHS”) Policies on Research Misconduct, last revised in 2005 (the “Proposed Rule”). The Proposed Rule would significantly impact how research institutions handle allegations... READ MORE

The Department of Health and Human Services (“HHS”) proposed a rule that would require HHS components to inform the public when issuing a “guidance document” and to clarify the document’s legal impact. The new procedures also create a process for “any interested party” to petition HHS to review guidance documents that go too far... READ MORE

Update: On November 6, 2019, a federal judge sitting in the Southern District of New York voided the U.S. Department of Health and Human Services Final Conscience Rule set to take effect November 22, 2019. For more information, click here. Update: This blog article was originally posted on May 20, 2019, and it stated... READ MORE

More Changes Ahead for 340B The Human Resources and Services Administration (“HRSA”) released a final rule delaying the effective date of implementation and enforcement of the previously issued final rule implementing the 340B Drug Discount Program. The delayed rule, which was originally published on January 5, 2017, established the methodology for calculating the 340B... READ MORE

On October 12, 2011, the U.S. Department of Justice unsealed an indictment charging Matthew Kolodesh a/k/a Matvei Kolodech, with conspiracy to defraud Medicare of more than $14 million.  According to the indictment, Kolodesh’s business, Home Care Hospice, Inc. (HCH), located in Philadelphia, PA, submitted Medicare claims for approximately $14.3 million dollars for patients who... READ MORE