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5 Jan 2021, 10:00 pm
The US Department of Health and Human Services Office of Inspector General (OIG) recently issued important updates to its Anti-Kickback Statute (AKS) safe harbor rules that provide additional legal protections and flexibilities, in particular with regard to value-based enterprise (VBE) arrangements. [read post]
30 Nov 2020, 10:00 pm
In an apparent effort to combat prescription drug shortages and price spikes, the US Department of Health and Human Services (HHS) recently announced the forthcoming termination of FDA’s Unapproved Drugs Initiative (UDI). [read post]
16 Nov 2015, 6:32 am
Department of Health and Human Services, Justice Clarence Thomas issued a dissent, in which Justice Antonin Scalia joined, from the denial of certiorari. [read post]
9 Dec 2010, 9:59 pm
By James DeGiulio -- On August 2, patients with the rare Fabry disease petitioned the Department of Health and Human Services to exercise the "march-in" powers under the federal Bayh-Dole Act, and issue an open license to use patents needed to manufacture Genzyme's enzyme replacement drug Fabrazyme (see "Genzyme's Manufacturing Issues with Fabrazyme Prompt Patients to Petition HHS Secretary to Exercise Bayh-Dole "March-in"… [read post]
29 Mar 2017, 1:00 pm
According to the Michigan Department of Health and Human Services, between Aug. 1, 2016, and March 21, 2017, there have been a shocking 107 cases of lab-confirmed Hepatitis A in the state, though the spike in cases seems to be centered on areas around Detroit, including Macomb, Oakland, and Wayne counties. [read post]
13 Jan 2021, 10:00 pm
The US Department of Health and Human Services (HHS) issued a Final Rule on January 12, 2021 on Transparency and Fairness in Civil Administrative Enforcement Actions that amends 45 CFR Part I to set forth rules for appropriate reliance on guidance documents and requirements to give fair notice of relevant agency positions before taking a civil enforcement action that relies on any such position. [read post]
13 Jan 2014, 11:30 am
A November 21, 2013 report published by the Office of the Inspector General (OIG) concluded that The Department of Health & Human Services (HHS) Office for Civil Rights (OCR) is not fully enforcing the HIPAA Security Rule and layed out recommendations for the OCR to implement. [read post]
7 Aug 2013, 9:51 am
The Department of Health and Human Services (HHS) Office of Inspector General (OIG) has issued its monthly Recovery Act Oversight report for June 2013. [read post]
13 Jan 2021, 10:00 pm
The US Department of Health and Human Services (HHS) issued a Final Rule on January 12, 2021 on Transparency and Fairness in Civil Administrative Enforcement Actions that amends 45 CFR Part I to set forth rules for appropriate reliance on guidance documents and requirements to give fair notice of relevant agency positions before taking a civil enforcement action that relies on any such position. [read post]
25 Jan 2011, 9:55 pm
By James DeGiulio -- In December 2009, the Department of Health and Human Services denied a petition filed by U.S. [read post]
21 Nov 2022, 1:15 pm
In a move that previously would have been unthinkable, policymakers have even called upon the Department of Health and Human Services to exercise a mechanism known as Bayh-Dole “march-in” rights, to break the patents on drugs that the private sector has spent billions developing, in order to lower their prices. [read post]
30 Nov 2020, 10:00 pm
In an apparent effort to combat prescription drug shortages and price spikes, the US Department of Health and Human Services (HHS) recently announced the forthcoming termination of FDA’s Unapproved Drugs Initiative (UDI). [read post]
7 Nov 2013, 4:05 am
Department of Health and Human Services, (filed 11/6/2013). [read post]
23 Sep 2014, 9:19 am
Department of Health and Human Services, 8th Cir., Sept. 8, 2014). [read post]
21 Nov 2022, 1:15 pm
In a move that previously would have been unthinkable, policymakers have even called upon the Department of Health and Human Services to exercise a mechanism known as Bayh-Dole “march-in” rights, to break the patents on drugs that the private sector has spent billions developing, in order to lower their prices. [read post]
13 Dec 2006, 7:58 am
The lawsuit states that the nurse called the Department of Health and Human Services to report nursing home neglect to a patient who had broken his hip. [read post]
4 Dec 2012, 7:52 am
Department of Health and Human Services (HHS) "will be able to open our doors" on Oct. 1, 2013." [read post]
18 Jun 2009, 11:00 pm
On June 8, 2009, the Office of Inspector General (the “OIG”) of the Department of Health and Human Services (“DHHS”) released its Semiannual Report to Congress (the “Report”). [read post]
19 Apr 2013, 10:23 am
Department of Health and Human Services Office of Inspector General (OIG) released its updated Provider Self-Disclosure Protocol (SDP), under which providers may report and settle potential liability under the civil monetary penalty law. [read post]
20 Dec 2016, 9:00 am
In a recent report, the Department of Health and Human Services Office of Inspector General (OIG) found that hospices are not always meeting two key coverage requirements for the Medicare hospice benefit: (1) that beneficiaries sign an election statement and (2) that a physician certifies that the beneficiary is terminally ill. [read post]
