On January 5, 2017, the U.S. Department of Health and Human Services (“HHS”) Health Resources and Services Administration (“HRSA”) issued a Final Rule implementing the 340B Drug Pricing Program Ceiling Price policy and Civil Monetary Penalty (“CMP”) standards, including the knowledge requirement related to overcharging …
By David C. Gibbons & Jeffrey N. Wasserstein – On March 16, 2016, the Feinstein Institute for Medical Research, located in Manhasset, New York, (“Feinstein”) entered into an agreement with the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) to pay $3.9 …
By Jeffrey N. Wasserstein – Either Senator Lamar Alexander (R-Tenn) reads the FDA Law Blog, or great minds truly think alike. On February 20, 2014, Senator Alexander wrote to Secretary of Health and Human Services (HHS) Kathleen Sebelius asking her to clarify HHS’s position regarding patient …
By Jeffrey N. Wasserstein & Jennifer M. Thomas – Yesterday, the Department of Health and Human Services (HHS), announced a final rule (published in the Federal Register on February 6, 2014 – here) amending the Department’s Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations, and the …
By Jeffrey N. Wasserstein & Alexander J. Varond – Last week, ahead of the September 23, 2013 compliance deadline for its HITECH final rule (also referred to as the “Omnibus Final Rule”), the Department of Health and Human Services issued guidance entitled “The HIPAA Privacy …
By Jeffrey N. Wasserstein and Alexander J. Varond – On September 11, 2013, Adheris, Inc. (“Adheris”) and the Department of Health and Human Services (“HHS”) filed a joint motion requesting the suspension of Adheris’s motion for a preliminary injunction seeking to prohibit HHS from enforcing its …
By Jeffrey N. Wasserstein & Alexander J. Varond – Several months ago, when HHS released the final HITECH rule, we noted that several of the provisions represented a sea change from prior practice (see our previous post here). Well, the seas have gotten rougher and …
By Jeffrey N. Wasserstein – On January 17, 2013, the Office for Civil Rights of the U.S. Department of Health and Human Services announced the issuance of its much anticipated (and long-awaited) final rule (in prepublication form) relating to the modification to the HIPAA Privacy, Security …
By Ben Wolf* and Jeff Wasserstein – Justice Kennedy delivered the opinion of the Supreme Court in today’s 6-3 decision in Sorrell v. IMS Healthcare Inc. (Docket No. 10-779). This decision strikes down a Vermont law prohibiting the sale, disclosure, and use of pharmacy records that reveal …
By Jeffrey N. Wasserstein – On July 8, 2010, the Office for Civil Rights of the U.S. Department of Health and Human Services announced the issuance of its long-awaited proposed rule (in prepublication form) relating to the modification to the HIPAA Privacy, Security and Enforcement Rules under …
By Susan Matthees and Jeff Wasserstein – Although the stimulus bill that President Obama recently signed into law received significant attention for its economic implications, less noticed was Title XIII of the stimulus bill, entitled the "Health Information Technology for Economic and Clinical Health Act" or …
