Last month, the U.S. Food and Drug Administration (the “FDA”) announced in a Declaratory Order the resolution of the shortage of semaglutide injection products Wegovy and Ozempic (the “February Declaratory Order”). On March...more
3/21/2025
/ Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Regulatory Authority ,
Regulatory Requirements
As we previewed last year regarding SB 184 and the establishment of the California Office of Health Care Affordability (OHCA), California now has taken a significant regulatory step aimed at restraining growth in health care...more
On April 4, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued the contract year 2025 (CY2025) Medicare Advantage and Part D final rule (the “Final Rule”). In addition to finalizing its CY2025 proposed rule,...more
4/16/2024
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Beneficiaries ,
Biosimilars ,
Brokers ,
Centers for Medicare & Medicaid Services (CMS) ,
Chronic Care Managment (CCM) ,
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Final Rules ,
Health Care Providers ,
Medicare Advantage ,
Medicare Advantage Organizations (MAOs) ,
Medicare Part C ,
Medicare Part D ,
Mental Health ,
Policies and Procedures ,
Reporting Requirements ,
Supplemental Benefits ,
Third-Party
On November 6, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released the contract year 2025 proposed rule for Medicare Advantage (“MA”) organizations and Part D sponsors (the “Proposed Rule”). The Proposed...more
As we anticipated in our previous blog article, the Office of Health Care Affordability (OHCA) made revisions to its proposed regulations following the public workshop hosted by the California Department of Health Care Access...more
The Office of Inspector General (“OIG”) within the U.S. Department of Health and Human Services (“HHS”) is responsible for detecting and preventing fraud, waste, and abuse in federal health care programs. The OIG has...more
The White House recently announced that the COVID-19 national emergency and public health emergency (PHE) declarations will end on May 11, 2023. These declarations have been in place since the beginning of the COVID-19...more
3/14/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Home Health Care ,
Hospice ,
Hospitals ,
Long Term Care Facilities ,
Medicaid ,
Public Health Emergency ,
Reasonable Expectation of Coverage ,
Regulatory Requirements ,
Rural Health Care Providers ,
Telehealth ,
Vaccinations ,
Virus Testing ,
Waivers
Introduction On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023 (the “Act”). The Act provides for nearly $1.7 trillion in funding across a range of domestic initiatives, including certain...more
1/6/2023
/ Consolidated Appropriations Act (CAA) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Healthcare ,
Hospitals ,
Medicaid ,
Medicare ,
New Legislation ,
Physician Medicare Reimbursements ,
Rulemaking Process ,
Telehealth