article thumbnail

Supreme Court Finds CMS’ Reduction of Medicare Hospital Outpatient Payment Rates for 340B Hospitals was Not Authorized by Statute

FDA Law Blog

Kirschenbaum — In 2017, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule to significantly decrease the rate the government will reimburse 340B hospitals in 2018 for outpatient prescription drugs from average sales price (“ASP”) plus 6% to ASP minus 22.5%. By Faraz Siddiqui & Alan M. 52494 (Nov.

article thumbnail

Agitation Podcast Series Episode 3: Pharmacologic management of agitated children

PEMBlog

Government. 2019 Mar;20(2):409-418. Epub 2019 Feb 19. 2019 May;20(3):537. 2019 Jul;20(4):688-689. Department of Health and Human Services (HHS) as part of an award (U07MC37471) totaling $3M with 0 percent financed with nongovernmental sources. West J Emerg Med. doi: 10.5811/westjem.2019.1.41344. 2019.1.41344.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Agitation Podcast Series Episode 1: Differentiating organic versus psychiatric causes of agitation and altered mental status

PEMBlog

Government. Pediatr Radiol 2019; 49:240. 2019 Mar;20(2):409-418. 2019 Mar;20(2):409-418. Epub 2019 Feb 19. 2019 May;20(3):537. 2019 Jul;20(4):688-689. Department of Health and Human Services (HHS) as part of an award (U07MC37471) totaling $3M with 0 percent financed with nongovernmental sources.

article thumbnail

Approaches for Quelling Stigma related to COVID-19

BMJ

8 For example, prestigious medical schools and hospitals could use official WeChat accounts to share information and news with the general public. Many Chinese expressed their disapproval of the many untrusted sources of information online while demonstrating a high level of trust towards the central government.

article thumbnail

The 340B Showdown: HRSA Proceeds Towards Enforcement Despite Litigation

FDA Law Blog

Department of Health and Human Services (“HHS”), which reported that discounted purchases totaled $38 billion in 2020, a 27% increase compared to 2019. Manufacturers may choose not to participate in this program, but the federal government will not reimburse for their outpatient drugs under Medicaid or Medicare Part B if they do not.

article thumbnail

Corporate Liability from Employee Diversion: Costly on Many Fronts

FDA Law Blog

This matter is the latest in a recent string of large monetary settlements between the government and health care providers involving employee diversion. 18, 2020) ; Press Release, DOJ, Former Nurse at Danville Hospital Sentenced for Tampering with Prescription Opioid Drugs, Making False Statements (Feb. 4, 2022).

article thumbnail

The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

FDA Law Blog

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Interpretation of Statutory Criteria Under the Final Guidance. Medical information about a patient.

Clinic 52