On April 4, 2025, the Centers for Medicare & Medicaid Services (“CMS”) released the contract year (“CY”) 2026 final rule for the Medicare Advantage (“MA”) program, Medicare Prescription Drug Benefit Program (“Part D”),...more
4/18/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Final Rules ,
Healthcare ,
Healthcare Reform ,
Medicare ,
Medicare Advantage ,
Medicare Part D ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Requirements
President Trump was sworn into office on Monday, promising swift action on several fronts. There is already a new Federal Trade Commission (“FTC”) Chair, Andrew Ferguson, with former FTC Chair Lina Khan expected to step down...more
1/23/2025
/ Acquisitions ,
Antitrust Division ,
Competition ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Healthcare ,
Merger Controls ,
Mergers ,
Pharmaceutical Industry ,
Private Equity
On November 26, 2024, the Centers for Medicare & Medicaid Services (“CMS”) released the contract year 2026 proposed rule for the Medicare Advantage (“MA”) program, Medicare Prescription Drug Benefit Program (“Part D”),...more
12/17/2024
/ Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Medicare ,
Medicare Advantage ,
Medicare Part D ,
Medicare Payment Reform ,
Mental Health Parity Rule ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Rules ,
Transparency
Over two years into the post-Dobbs era, women’s health is taking center stage in the presidential election. In Dobbs v. Jackson, the Supreme Court overturned protections relating to abortion established in Roe v. Wade. Since...more
10/7/2024
/ Abortion ,
Dobbs v. Jackson Women’s Health Organization ,
Health Care Providers ,
Healthcare ,
Legislative Agendas ,
Political Candidates ,
Pregnancy ,
Presidential Elections ,
Reproductive Healthcare Issues ,
SCOTUS ,
State Bans
In a decision joined by all nine justices, the Supreme Court preserved the Food and Drug Administration’s (“FDA’s”) regulatory approval of mifepristone, ensuring continued access to the widely-used abortion medication across...more
On April 29, 2024, the U.S. Department of Labor (the “DOL”) issued a final rule (the “Final Rule”) rescinding the 2018 Association Health Plan rule (“2018 AHP Rule”), thereby marking a return to the more rigid pre-2018...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 Department of Health and Human Services (HHS) and the Department of Justice (DOJ) recently released its “Health Care Fraud and Abuse Control Program Annual Report for Fiscal Year 2022” (the “Report”), highlighting...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
Nearly three months after hearing oral arguments, a divided Fifth Circuit panel issued its decision in Alliance for Hippocratic Medicine v. FDA, upholding the U.S. Food and Drug Administration’s (“FDA”) underlying approval of...more
For a brief moment in time last April, the U.S. Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, was curtailed. Just days after a Texas federal judge’s ruling suspended...more
6/16/2023
/ Abortion ,
Class Action ,
Department of Justice (DOJ) ,
Dobbs v. Jackson Women’s Health Organization ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Pharmaceutical Industry ,
Planned Parenthood of Southeastern Pennsylvania v Casey ,
Prescription Drugs ,
Roe v Wade ,
SCOTUS ,
Texas
In February, when the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) delivered two annual reports to Congress for the 2021 calendar year as mandated by the HITECH Act, several notable...more
The U.S. Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, has been curtailed following dueling federal court decisions in Texas and Washington. Just days after a Texas...more
4/17/2023
/ Abortion ,
Department of Justice (DOJ) ,
Dobbs v. Jackson Women’s Health Organization ,
Executive Branch ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Patient Access ,
Pregnancy ,
Prescription Drugs ,
Reproductive Healthcare Issues ,
State and Local Government
On December 21, 2022, the Department of Health and Human Services (“HHS”) issued a proposed rule aimed at advancing health equity and mitigating health disparities while minimizing administrative burden...more