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16 Sep 2020, 5:36 am
The order also directs HHS to develop and implement a similar test payment model for Part D prescription drugs but does not impose a timeline on HHS to do so. [read post]
15 Sep 2020, 7:19 pm
“The Centers for Disease Control and Prevention (CDC) and the US Department of Health and Human Services (HHS), in collaboration with agencies throughout the federal government, are initiating the National Wastewater Surveillance System (NWSS) in response to the COVID-19 pandemic. [read post]
15 Sep 2020, 4:05 pm
HHS (D D.C.) -- ruling that HHS performed reasonable search for records pertaining to plaintiff'-prisoner’s former nursing homes and that agency properly withheld third-party records pursuant to Exemption 6. [read post]
14 Sep 2020, 10:00 pm
Our FDA team recently posted a LawFlash about the US Department of Health and Human Services (HHS) August 19 announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, in which it stated that the FDA would not require premarket review of laboratory developed tests (LDTs) without notice-and-comment rulemaking. [read post]
14 Sep 2020, 10:00 pm
Our FDA team recently posted a LawFlash about the US Department of Health and Human Services (HHS) August 19 announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, in which it stated that the FDA would not require premarket review of laboratory developed tests (LDTs) without notice-and-comment rulemaking. [read post]
14 Sep 2020, 10:00 pm
Our FDA team recently posted a LawFlash about the US Department of Health and Human Services (HHS) August 19 announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, in which it stated that the FDA would not require premarket review of laboratory developed tests (LDTs) without notice-and-comment rulemaking. [read post]
14 Sep 2020, 10:00 pm
Our FDA team recently posted a LawFlash about the US Department of Health and Human Services (HHS) August 19 announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, in which it stated that the FDA would not require premarket review of laboratory developed tests (LDTs) without notice-and-comment rulemaking. [read post]
14 Sep 2020, 10:00 pm
Our FDA team recently posted a LawFlash about the US Department of Health and Human Services (HHS) August 19 announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, in which it stated that the FDA would not require premarket review of laboratory developed tests (LDTs) without notice-and-comment rulemaking. [read post]
14 Sep 2020, 10:00 pm
Our FDA team recently posted a LawFlash about the US Department of Health and Human Services (HHS) August 19 announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, in which it stated that the FDA would not require premarket review of laboratory developed tests (LDTs) without notice-and-comment rulemaking. [read post]
14 Sep 2020, 12:02 pm
In that order, the president instructed HHS to take actions to end kickbacks, pass on insulin and epinephrine savings to the medically disadvantaged, allow states to implement drug importation plans, and enact other reforms. [read post]
14 Sep 2020, 8:40 am
Department of Health and Human Services (HHS) to repeal and revise certain provisions of the 2016 Rule through a new Rule, a ... [read post]
14 Sep 2020, 8:28 am
The virus is “deadly stuff,” but we can no longer trust the CDC, HHS, or our President to tell us the truth about it. [read post]
14 Sep 2020, 6:45 am
Looked at somewhat differently, the modicum of national consensus necessary to sustain the administrative state today is likely to sorely test the patience of progressive interests looking to the EPA for a concerted assault on climate change, and to the Justice Department for a decisive assault on systemic racism, and to HHS for more comprehensive social supports. [read post]
14 Sep 2020, 5:07 am
Despite the timeline given by HHS, many hospitals and other healthcare providers have reported that after the 120-day timeline given by HHS had passed, CMS had not yet begun recoupment. [read post]
10 Sep 2020, 6:23 pm
This summer, HHS also entered agreements to advance domestic manufacturing capabilities, such as with Texas A&M’s Center for Innovation in Advanced Development and Manufacturing, which is at least partially reserved for the Novavax recombinant-protein vaccine candidate. [read post]
9 Sep 2020, 6:22 am
HHS has subdivided the PRF into various allocations and distributions. [read post]
8 Sep 2020, 7:30 am
The Human Rights Campaign challenged the HHS rule on behalf of two transgender women, who sought a nationwide injunction to prevent its implementation. [read post]
7 Sep 2020, 10:43 am
*** The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the issuance of an Order under Section 361 of the Public Health Service Act to temporarily halt residential evictions to prevent the further spread of COVID-19. [read post]
6 Sep 2020, 7:27 am
The so-called “gag rule” was promulgated by HHS last year, and would prohibit the use of Title X funds “to perform, promote, refer for, or support abortion as a method of family planning. [read post]
6 Sep 2020, 7:01 am
Though HHS has slowly started to explore how to deepen its involvement in CVE (or terrorism and targeted violence prevention), it would no doubt face challenges in entering a new space. [read post]
