2019 Clinic Government Patients 
PEMBlog
JUNE 14, 2023
Government. Boarding of Mentally Ill Patients in Emergency Departments: American Psychiatric Association Resource Document. 2019 Jul 22;20(5):690-695. Characteristics, Clinical Care, and Disposition Barriers for Mental Health Patients Boarding in the Emergency Department. 10.1542/peds.2022-057383 West J Emerg Med.
FDA Law
AUGUST 4, 2022
Recognizing that this out-of-pocket cost still represents a significant financial barrier for many patients, Pfizer proposed a Direct Copay Assistance Program for Medicare Part D beneficiaries using tafamidis. On June 27, 2019, Pfizer sought an OIG advisory opinion to ensure that its proposal would not run afoul of federal law.
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FDA Law
OCTOBER 10, 2022
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the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.
FDA Law
AUGUST 29, 2021
The federal government does its own version of rebranding with each change in administration. The memorandum cites the 2019 Supreme Court decision, Kisor v. clinical testing of implanted brain computer interface devices for patients with paralysis or amputation), enforcement (e.g., Wilkie , 139 S.
FDA Law
SEPTEMBER 29, 2021
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.
FDA Law
MARCH 1, 2023
By way of background, FDA first proposed using a QMM rating in its 2019 Report on Drug Shortages and Potential Solutions. On November 2, 2022, the FDA’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee held a meeting on CDER’s QMM Program.
FDA Law
JANUARY 6, 2022
Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. His job was governed by an employment contract that contained both salary provisions and restrictive covenants.
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