June 26, 2019
UPDATE (July 15, 2019): Recent rulings by the U.S. Courts of Appeals for the Fourth and Ninth Circuits, as well as the U.S. District Court for the District of Maine, currently give the [...]
May 28, 2019
The Office for Civil Rights (OCR) recently reinterpreted the HIPAA penalty structure to reduce the maximum annual penalty amounts: When a covered entity does not know about the violation Reduced annual amount [...]
May 23, 2019
WASHINGTON, DC (May 23, 2019) – Feldesman Tucker Leifer Fidell LLP (FTLF) is proud to have authored a new amicus brief in support of Medicaid beneficiaries in Philbrick, et al. v. Azar in [...]
April 29, 2019
On March 4, 2019, the U.S. Department of Health and Human Services (HHS) issued a final rule revising its Title X family planning regulations, which have an effective date of May 3, 2019. [...]
April 29, 2019
As health centers enhance their substance use disorder (SUD) services, including developing and expanding medication assisted treatment (MAT) services to respond to the opioid crisis, they should be aware that adding staff [...]
April 26, 2019
Last week, the Department of Justice (DOJ) announced the arrest of 60 individuals for allegedly participating in illegal prescribing and distributing opioids and other narcotics and for their participation in various health [...]
April 8, 2019
Covered entities in the 340B Discount Drug Program now can verify that drug manufacturers are charging them no more than the “ceiling price” for a given drug. On Monday, April 1, the [...]
April 4, 2019
Last Monday, March 25, 2019, the U.S. Department of Health and Human Services (“HHS”) Office of the Inspector General (“OIG”) issued a report addressing vulnerabilities in HHS’s implementation of its Small Business Innovation [...]
March 4, 2019
Today, the U.S. Department of Health and Human Services (HHS) published a final rule, Compliance With Statutory Program Integrity Requirements, dramatically revising the Title X family planning program regulations. The proposed rule (published [...]
February 13, 2019
On January 31, 2019, the Trump Administration announced proposed changes to safe harbor protections under the Anti-Kickback Statute (AKS), which could impact the pharmaceutical market and indirectly the 340B Discount Drug Program. [...]