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30 Nov 2020, 7:54 am
Pharma and bioscience companies in particular must monitor spending; avoid overlap; and save interim HHS and industry guidance to protect themselves from future SEC enforcement rules. [read post]
30 Nov 2020, 7:24 am
HHS has repeatedly stated that it plans for COVID-19 vaccines to have no out-of-pocket costs for patients. [read post]
30 Nov 2020, 6:10 am
On November 16, 2020, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a special fraud alert targeting remuneration associated with speaking arrangements paid for by pharmaceutical and medical device companies. [read post]
30 Nov 2020, 2:00 am
Rev. (2021, Forthcoming): This Article describes how the Department of Health and Human Services (HHS) has used fiscal waiver authorities — delegated power... [read post]
28 Nov 2020, 9:03 pm
The entire program is housed under and managed by HHS/ODPHP and includes 355 core (or measurable) objectives as well as developmental and research objectives. [read post]
27 Nov 2020, 9:39 am
The inspector general’s office of the giant federal Health and Human Services (HHS) agency has warned drug- and medical device-makers that these pandemic-paused marketing shams should not resume. [read post]
25 Nov 2020, 1:32 pm
On November 20, 2020, in a joint effort, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) and the Centers for Medicare & Medicaid Services (“CMS”) issued final rules to revise and modernize the Physician Self-Referral Law (“Stark Law”), Anti-Kickback Statute (“AKS”) and Civil Monetary Penalties Law (“CMP”). [read post]
23 Nov 2020, 10:00 pm
Powerfully illustrating the efforts of the US Department of Health and Human Services (HHS) to transform the US healthcare system to a value-based model, the Office of the Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) have finalized rules that will alter critical healthcare fraud and abuse regulations to remove or diminish obstacles to value-based enterprises that meaningfully embrace patient care coordination. [read post]
23 Nov 2020, 10:00 pm
Powerfully illustrating the efforts of the US Department of Health and Human Services (HHS) to transform the US healthcare system to a value-based model, the Office of the Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) have finalized rules that will alter critical healthcare fraud and abuse regulations to remove or diminish obstacles to value-based enterprises that meaningfully embrace patient care coordination. [read post]
23 Nov 2020, 10:00 pm
Powerfully illustrating the efforts of the US Department of Health and Human Services (HHS) to transform the US healthcare system to a value-based model, the Office of the Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) have finalized rules that will alter critical healthcare fraud and abuse regulations to remove or diminish obstacles to value-based enterprises that meaningfully embrace patient care coordination. [read post]
23 Nov 2020, 10:00 pm
Powerfully illustrating the efforts of the US Department of Health and Human Services (HHS) to transform the US healthcare system to a value-based model, the Office of the Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) have finalized rules that will alter critical healthcare fraud and abuse regulations to remove or diminish obstacles to value-based enterprises that meaningfully embrace patient care coordination. [read post]
23 Nov 2020, 10:00 pm
Powerfully illustrating the efforts of the US Department of Health and Human Services (HHS) to transform the US healthcare system to a value-based model, the Office of the Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) have finalized rules that will alter critical healthcare fraud and abuse regulations to remove or diminish obstacles to value-based enterprises that meaningfully embrace patient care coordination. [read post]
23 Nov 2020, 10:00 pm
Powerfully illustrating the efforts of the US Department of Health and Human Services (HHS) to transform the US healthcare system to a value-based model, the Office of the Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) have finalized rules that will alter critical healthcare fraud and abuse regulations to remove or diminish obstacles to value-based enterprises that meaningfully embrace patient care coordination. [read post]
23 Nov 2020, 4:20 pm
The Department of Health and Human Services (HHS) released complementary rules this past Friday, November 20, 2020, to modernize and clarify the regulations that interpret the Physician Self-Referral Law (the Stark Law) and the federal Anti-Kickback Statute. [read post]
23 Nov 2020, 3:51 pm
In a press release accompanying the final rules, HHS Secretary Alex Azar touted the final rules as “regulatory reforms [that] will mean better care, including innovative arrangements with digital technology that may help patients receive care during the COVID-19 pandemic. [read post]
22 Nov 2020, 3:47 am
Jane LambertIntellectual Property Enterprise Court (HH Judge Melissa Clarke) Communisis Plc v The TALL Group of Companies Ltd and others [2020] EWHC 3089 (IPEC) (17 Nov 2020)This was a claim for patent infringement and a counterclaim for revocation on grounds of obviousness and excluded matter. [read post]
20 Nov 2020, 4:25 pm
In October 20, 2020 guidance, the he FDA provided they may issue an Emergency Use Authorization once the FDA determines certain statutory requirements have been met: The chemical, biological, radiological, or nuclear (CBRN) agent referred to in the March 27, 2020 EUA declaration by the Secretary of HHS (SARS-CoV-2) can cause a serious or life-threatening disease or condition. [read post]
19 Nov 2020, 12:32 pm
The Corrective Action Plan orders the implementation of additional HIPAA policies and procedures, reporting requirements, training, and the submission of annual reports to HHS. [read post]
19 Nov 2020, 12:32 pm
The Corrective Action Plan orders the implementation of additional HIPAA policies and procedures, reporting requirements, training, and the submission of annual reports to HHS. [read post]
19 Nov 2020, 12:32 pm
The Corrective Action Plan orders the implementation of additional HIPAA policies and procedures, reporting requirements, training, and the submission of annual reports to HHS. [read post]
