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20 May 2020, 10:00 pm
With just days left until provider attestations are due related to acceptance of CARES Act Provider Relief Funds, the US Department of Health and Human Services (HHS) recently updated its FAQs providing some additional clarity, and potentially confusion, surrounding the acceptance of Relief Funds from its initial tranche $30 billion of General Distribution payments. [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]
20 May 2020, 10:00 pm
With just days left until provider attestations are due related to acceptance of CARES Act Provider Relief Funds, the US Department of Health and Human Services (HHS) recently updated its FAQs providing some additional clarity, and potentially confusion, surrounding the acceptance of Relief Funds from its initial tranche $30 billion of General Distribution payments. [read post]
22 Jul 2020, 12:30 am
Department of Health and Human Services has announced they will begin analyzing trends in the use of add-on testing, such as respiratory pathogen panel (RPP), allergy, and genetic testing, in order to locate patterns in billing that may indicate fraud. [read post]
19 Apr 2021, 10:00 pm
Given the significant push to vaccinate the public since the start of 2021, the increasing availability of vaccines, and the need to recruit additional personnel to administer vaccinations, the secretary of the US Department of Health and Human Services (HHS) has again amended its declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to accommodate some workforce barriers that had not been previously contemplated. [read post]
25 Oct 2020, 10:00 pm
The US Department of Health and Human Services (HHS) issued two welcome announcements on October 22 relating to the CARES Act Relief Fund Provider Relief Fund (PRF). [read post]
12 Oct 2022, 10:00 pm
On October 3, the Office of Inspector General (OIG) of the US Department of Health and Human Services issued a report titled “UPICs Hold Promise to Enhance Program Integrity Across Medicare and Medicaid, But Challenges Remain. [read post]
3 Sep 2010, 11:09 am
After a long delay, the US Department of Health & Human Services published the 2010 federal poverty guidelines on August 3, 2010 in the Federal Register. [read post]
22 Apr 2021, 10:00 pm
In a not-so-unexpected turn of events, the Biden-Harris administration’s Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) rescinded a notice issued by the Trump administration’s HHS days before leaving office exempting seven glove types from 510(k) premarket notification and proposing to do the same for 84 other devices ranging from gowns to ventilators. [read post]
11 Mar 2004, 1:25 am
The government's General Accounting Office ruled Wednesday that a series of ads from the Bush administration's Department of Health and Human Services outlining benefits of the recent legislative changes to Medicare law were legally permissible and not instances of using taxpayer funds for political purposes. [read post]
22 Apr 2021, 10:00 pm
In a not-so-unexpected turn of events, the Biden-Harris administration’s Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) rescinded a notice issued by the Trump administration’s HHS days before leaving office exempting seven glove types from 510(k) premarket notification and proposing to do the same for 84 other devices ranging from gowns to ventilators. [read post]
30 Jul 2019, 5:32 am
The US Department of Health and Human Services (HHS) projects the number of Americans in need of long-term care (LTC) by 2020 to be roughly 12 million with nearly half those seniors exhibiting some form of dementia. [read post]
5 Oct 2009, 3:21 pm
On October 1, the Departments of Health and Human Services (HHS), Labor, and Treasury issued an interim final rule with request for comments implementing Title I of the Genetic Information Nondiscrimination Act of 2008 (GINA). [read post]
22 Apr 2021, 10:00 pm
In a not-so-unexpected turn of events, the Biden-Harris administration’s Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) rescinded a notice issued by the Trump administration’s HHS days before leaving office exempting seven glove types from 510(k) premarket notification and proposing to do the same for 84 other devices ranging from gowns to ventilators. [read post]
10 Jun 2021, 10:00 pm
In a May 27 Federal Register notice, the US Department of Health and Human Services (HHS) announced the reinstatement of the Unapproved Drugs Initiative, the FDA’s compliance policy governing marketed unapproved drugs. [read post]
13 Apr 2007, 10:29 am
[JURIST] The US Senate Committee on Finance [official website] has approved a bill which would provide the Secretary of the Department of Health and Human Services [official website] the authority to negotiate drug prices on behalf of Medicare [JURIST news archive] beneficiaries with drug manufacturers, insurers and pharmacies. [read post]
25 Jul 2024, 10:00 pm
At the end of last year, the US Department of Health and Human Services Office of Inspector General (OIG) issued an Advisory Opinion (AO 23-11, the Opinion) in which OIG approved an arrangement where a medical device manufacturer would provide up to $2,000 in subsidies to Medicare beneficiaries for cost sharing obligations as part of the beneficiary’s participation in a clinical trial. [read post]
25 Jul 2024, 10:00 pm
At the end of last year, the US Department of Health and Human Services Office of Inspector General (OIG) issued an Advisory Opinion (AO 23-11, the Opinion) in which OIG approved an arrangement where a medical device manufacturer would provide up to $2,000 in subsidies to Medicare beneficiaries for cost sharing obligations as part of the beneficiary’s participation in a clinical trial. [read post]
25 Jul 2024, 10:00 pm
At the end of last year, the US Department of Health and Human Services Office of Inspector General (OIG) issued an Advisory Opinion (AO 23-11, the Opinion) in which OIG approved an arrangement where a medical device manufacturer would provide up to $2,000 in subsidies to Medicare beneficiaries for cost sharing obligations as part of the beneficiary’s participation in a clinical trial. [read post]
25 Jul 2024, 10:00 pm
At the end of last year, the US Department of Health and Human Services Office of Inspector General (OIG) issued an Advisory Opinion (AO 23-11, the Opinion) in which OIG approved an arrangement where a medical device manufacturer would provide up to $2,000 in subsidies to Medicare beneficiaries for cost sharing obligations as part of the beneficiary’s participation in a clinical trial. [read post]
