A federal judge in D.C. recently ruled in favor of the U.S. Health Resources and Services Administration (“HRSA”), an administrative agency under the U.S. Department of Health and Human Services (“HHS”), by finding that drug...more
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
On July 18, 2024, the Massachusetts Senate passed S. 2871, An Act Enhancing the Health Care Market Review Process (the Bill), to increase oversight of healthcare transactions involving private equity firms, real estate...more
Only two months after California’s cost and market impact review (CMIR) regime began to require notice of certain healthcare-related transactions, the Office of Health Care Affordability (OHCA) has already proposed several...more
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
/ Agents ,
Beneficiaries ,
Biosimilars ,
Brokers ,
Centers for Medicare & Medicaid Services (CMS) ,
Chronic Care Managment (CCM) ,
Compensation ,
Competition ,
Fair Market Value ,
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
“The American people deserve to know that the insurance companies receiving more than $700B annually in taxpayer funds are working to ensure you receive effective, high-quality care. Remember, you have rights and options to...more
In the final days of November, the Office of Health Care Affordability (OHCA) published three updates related to its proposed regulations regarding the review of certain healthcare transactions in California:
1. the...more
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
As we previewed in our previous blog article, the California Department of Health Care Access and Information (“HCAI”) hosted a public workshop on August 15, 2023 for in-person and virtual attendees to make comments and pose...more
As the nation prepares for the upcoming 2024 elections, the consequences of the U.S. Supreme Court’s ruling in Dobbs v. Jackson continues to be a significant topic of discussion in numerous states. Since that decision and our...more
8/9/2023
/ Abortion ,
Dobbs v. Jackson Women’s Health Organization ,
Healthcare ,
Legislative Agendas ,
New Legislation ,
Patient Access ,
Pregnancy ,
Regulatory Agenda ,
Reproductive Healthcare Issues ,
SCOTUS ,
State Legislatures
Industry stakeholders have been eagerly waiting for the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Secretary of HHS to provide more clarity on federal information blocking...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