On May 21, 2024, the United States Court of Appeals for the District of Columbia Circuit (“D.C. Circuit”) issued its decision in United Therapeutics Corporation v. Carole Johnson, et al./Novartis Pharmaceuticals v. Carole...more
5/24/2024
/ Appeals ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Healthcare ,
Healthcare Reform ,
HRSA ,
Life Sciences ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B
On April 8, 2024, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited favorable Advisory Opinion (AO 24-02) for a charitable patient assistance program (PAP) focused on rare...more
5/13/2024
/ Advisory Opinions ,
Anti-Kickback Statute ,
Cost-Sharing ,
Department of Health and Human Services (HHS) ,
Inflation Reduction Act (IRA) ,
Manufacturers ,
Medicare Part D ,
OIG ,
Patients ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Requirements
On January 30, 2024, CMS published in the Federal Register an RFI to seek input from the public regarding increased public releases of MA data to improve transparency in the program. CMS stated responses to this RFI may be...more
On January 30, 2023, the United States Court of Appeals for the Third Circuit issued its decision in Sanofi Aventis U.S. LLC v. United States Department of Health and Human Services, enjoining the United States Department of...more
On August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022 (IRA). The drug pricing provisions in Subtitle B of Title I of the IRA, entitled “Prescription Drug Pricing Reform,” enact government...more
The 340B program requires drug manufacturers to offer outpatient pharmaceuticals to statutorily defined covered entities (including certain hospitals and certain federal grantees, such as federally qualified health centers)...more
On July 25, 2022, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released a long-awaited proposed rule on Section 1557 of the Affordable Care Act (ACA), the nondiscrimination protections...more
7/29/2022
/ Affordable Care Act ,
Biden Administration ,
Bostock v Clayton County Georgia ,
Civil Rights Act ,
Department of Health and Human Services (HHS) ,
Dobbs v. Jackson Women’s Health Organization ,
Gender Discrimination ,
Medicare Part B ,
Non-Discrimination Rules ,
OCR ,
Proposed Rules ,
Regulatory Reform ,
Reproductive Healthcare Issues ,
Sex Discrimination ,
Telehealth ,
Trump Administration
On September 9, 2021, President Biden unveiled his administration’s plan to combat the recent COVID-19 surge across the United States, referred to by the administration as the “Path out of the Pandemic.” The plan, in...more
9/13/2021
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Labor (DOL) ,
Employer Mandates ,
Executive Orders ,
Federal Contractors ,
Healthcare Workers ,
OSHA ,
Vaccinations ,
Workplace Safety
On April 22, 2021 the Tennessee Justice Center and the National Health Law Program, representing thirteen (13) aggrieved Medicaid beneficiaries in the state of Tennessee, filed suit in the U.S. District Court for the District...more
While CMS has been relatively quiet as of late from a public-facing perspective as it waits for new political leadership to arrive (including newly announced CMS Administrator, Chiquita Brooks-LaSure), a recent review by your...more
On Friday, November 20, 2020, 60 calendar days prior to the inauguration of President-Elect Biden, the Trump administration released three rulemakings with significant implications for life sciences companies and healthcare...more
11/30/2020
/ Anti-Kickback Statute ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Life Sciences ,
OIG ,
Pharmaceutical Industry ,
Rulemaking Process ,
Stark Law ,
Trump Administration
On October, 1, 2020, the U.S. Department of Health and Human Services (HHS) announced the availability of an additional $20 billion in relief funding for providers – including specifically for behavioral health providers and...more
10/19/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Federal Grants ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Medicare ,
Provider Relief Fund ,
Relief Measures ,
Terms and Conditions
On November 19, 2019, CMS announced key results from the 2019 HHS Agency Financial Report, which generally provides fiscal and high-level performance data for HHS for the reporting period of October 1, 2018 through September...more
11/25/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Eligibility ,
Federal Contractors ,
Fee-for-Service ,
Financial Reporting ,
Health Care Providers ,
Managed Care Contracts ,
Medicaid ,
Medicare ,
PERM ,
Proposed Rules ,
Regulatory Agenda
On June 13, 2019, the Internal Revenue Service (IRS), Department of Labor and Department of Health and Human Services (HHS) issued a new regulation that is intended to increase the use of tax-favored health reimbursement...more
Excerpt:
I. Introduction -
In February of 2019, the Department of Health and Human Services’ Office of Inspector General (HHS-OIG) issued a Proposed Rule that, if adopted, would upend the current prescription drug...more
In February of 2019, the Department of Health and Human Services’ Office of Inspector General (HHS-OIG) issued a Proposed Rule that, if adopted, would upend the current prescription drug rebate system. According to HHS-OIG,...more
I. Introduction -
In May 2018, the Department of Health and Human Services (HHS) introduced a “Blueprint” and Request for Information setting forth proposed actions and policies as a means to purportedly help lower...more
On November 13, 2017, a group of hospital trade associations (the American Hospital Association, the Association of American Medical Colleges, and America’s Essential Hospitals), along with two health system providers, filed...more