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4 Jun 2019, 10:35 am
In addition, the HHS Centers for Medicare & Medicaid Services, working in conjunction with HHS-OIG, are taking steps to increase accountability and decrease the presence of fraudulent providers. * * * [read post]
4 Jun 2019, 7:54 am
HHS had claimed that the APA’s exception for interpretive rules applied to its payment change that included Part C patients in the formula. [read post]
1 Jun 2019, 7:05 am
Moving boldly to restore a standard of truth, the Department of Health and Human Services (HHS) just issued a proposed rule that would remove “gender identity” from the definition of sex in the nondiscrimination provisions of the Affordable Care Act (ACA). [read post]
30 May 2019, 2:16 pm
Final Report – Updates, Gaps, Inconsistencies, and Recommendations: “Patients with acute and chronic pain in the United States face a crisis because of significant challenges in obtaining adequate care, resulting in profound physical, emotional, and societal costs. [read post]
30 May 2019, 12:50 pm
On May 24, 2019, the Department of Health and Human Services (HHS) proposed a new rule that would maintain vigorous civil rights enforcement and revise certain provisions that a federal court has said are likely unlawful. [read post]
30 May 2019, 8:30 am
Henry McMaster asked Trump’s HHS for a waiver from the regulation. [read post]
29 May 2019, 9:17 am
These are: Failure to provide the Secretary of Health and Human Services (HHS) with records and compliance reports; cooperate with complaint investigations and compliance reviews; and permit access by the Secretary to information, including protected health information (PHI), pertinent to determining compliance. [read post]
29 May 2019, 8:11 am
The relevant HHS regulation is 45 CFR §46.102 (l)(1), which specifically excludes: Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected. [read post]
29 May 2019, 7:36 am
In the report, GAO reviewed the actions of five agencies (Army, Navy, DOE, HHS, and VA) to determine their consideration of a contractor’s federal tax debts before awarding contracts. [read post]
27 May 2019, 12:03 pm
Last week the Department oj Health and Human Services issued a proposed rule (full text) that would eliminate protections against discrimination in health care where the discrimination is on the basis of gender identity or termination of pregnancy. [read post]
24 May 2019, 10:46 pm
Department of Health and Human Services (“HHS”) announced its collection of a $3 million settlement payment from a radiology provider that also allowed hackers to breach its electronic protected health information (ePHI) by failing to conduct and respond to HIPAA-required risk assessments, OCR’s announcement late yesterday of the MIE Agreement makes clear that HIPAA entities need to tighten their HIPAA risk assessment, documentation and other compliance practices. [read post]
24 May 2019, 11:30 am
It even suggested in the HHS comments that sharing space with trans people violates the rights of non-transgender people. [read post]
24 May 2019, 7:05 am
Food and Drug Administration’s (FDA) Department of Health and Human Services (HHS) announced via the Federal Register the availability of a draft guidance for industry titled “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations. [read post]
23 May 2019, 9:30 pm
Department of Health and Human Services (HHS) over a new rule that seeks to strengthen health care providers’ ability to refuse to perform abortions or other procedures under federal conscience laws. [read post]
22 May 2019, 12:04 pm
UK pharmaceutical giant Mallinckrodt filed suit against the US Department of Health and Human Services (HHS) and Centers for Medicare & Medicaid (CMS) on Tuesday to defend profitability of their drug, Acthar Gel Injection (Acthar). [read post]
20 May 2019, 11:00 pm
Department of Health & Human Services ("HHS"). [read post]
20 May 2019, 11:00 pm
Department of Health & Human Services ("HHS"). [read post]
15 May 2019, 8:26 am
So far, the rules have not been extended to radio or online, but HHS says that they will monitor advertising to see if future additions are warranted. [read post]
9 May 2019, 9:56 am
Physicians, pharmacists and pharmacies, prescription benefit management companies and other health industry participants should begin preparing for new questions and other responsibilities likely to arise from the Department of, Health and Human Services(“HHS”) Medicare and Medicaid Programs; Regulation to Require Drug Pricing Transparency Final Rule (the “Rule”) announced on Wednesday, May 8 and scheduled for […] [read post]
9 May 2019, 8:06 am
Consequently, HHS says ODPD will not require a manufacturer that simply adds price information to a direct-to-consumer advertisement as required by § 403.1202 of the Rule unless the price information explicitly or implicitly incorporates safety or efficacy information about the drug, or makes express or implied claims about the safety or efficacy of the drug. [read post]
