Since 1984, the “Chevron doctrine” had served as the bedrock of many regulatory actions by the U.S. Department of Health and Human Services (HHS) and other federal agencies. Under the doctrine, courts followed a two-step...more
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 April 10, 2024, the Centers for Medicare & Medicaid Services (CMS) published the fiscal year (FY) 2025 Medicare Hospital Inpatient Prospective Payment Systems (IPPS) Proposed Rule, an annual rulemaking that broadly...more
On February 2, 2024, the “gang of six”—a bipartisan group of six senators who have traditionally championed reforms to the 340B program1 —introduced a discussion draft of a bill that would modify the program that provides...more
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 Friday, November 3, 2023, the U.S. District Court for the District of South Carolina issued a long-awaited decision in Genesis Health Care, Inc. v. Becerra—a case dating back to 2017 contesting HRSA’s definition of...more
This morning the Centers for Medicare & Medicaid Services (CMS) published, for the first time, a list of drugs subject to price negotiation under the Inflation Reduction Act’s (IRA) Medicare Drug Price Negotiation program....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
On November 29, 2022, the Health Resources and Services Administration (“HRSA”) published a notice of proposed rulemaking (“Proposed Rule”)[1] to implement an Administrative Dispute Resolution (“ADR”) process for resolving...more
12/7/2022
/ Comment Period ,
Covered Entities ,
Dispute Resolution ,
Drug Pricing ,
HRSA ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Proposed Rules ,
Section 340B
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
Over the last two weeks we have seen a flurry of activity from U.S. District Courts across the country in the ongoing contract pharmacy disputes between pharmaceutical manufacturers and HRSA, the agency responsible for...more
On November 6, 2021, the Fifth Circuit Court of Appeals temporarily blocked enforcement of the OSHA vaccination-or-testing rule. Citing “grave statutory and constitutional issues” with the rule, a three-judge panel issued the...more
11/8/2021
/ Anti-Discrimination Policies ,
Appeals ,
Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Civil Rights Act ,
Coronavirus/COVID-19 ,
Enforcement ,
Equal Employment Opportunity Commission (EEOC) ,
Health Care Providers ,
Healthcare Workers ,
Interim Final Rules (IFR) ,
Order to Stay ,
OSHA ,
Religious Exemption ,
Title VII ,
Vaccinations ,
Virus Testing
On October 13th our friends over at STAT broke the news [sorry, Paywall] about a “warranty” pilot program from Pfizer that offers both patients and health plans (including Medicare Part D plans) the opportunity to receive a...more
10/15/2021
/ Alternative Payment Models (APM) ,
Centers for Medicare & Medicaid Services (CMS) ,
Medicaid ,
Medicare Part D ,
Patients ,
Pfizer ,
Pharmaceutical Industry ,
Pilot Programs ,
Prescription Drug Coverage ,
State Health Plans ,
Value-Based Purchasing
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
This just in – as previously discussed, on January 4, 2021 CMS Administrator Seema Verma sent a letter (available here) to State Medicaid Directors requesting they sign a Letter of Agreement “as soon as possible” establishing...more
A quick, timely update for our reader. As reported in our previous posts on the recently approved Tennessee waiver, in likely anticipation of the Biden Administration withdrawing the newly approved, but controversial waiver,...more
Now that we have had the chance to read and meditate on the historic Medicaid waiver approved on Friday January 8th, giving Tennessee permission from the Federal government to fundamentally alter Medicaid’s traditional...more
1/12/2021
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Essential Health Benefits ,
Health Insurance ,
Manufacturers ,
Medicaid ,
Medicare Part D ,
Medication-Assisted Treatment (MAT) ,
Prescription Drugs ,
Rebates ,
Section 340B ,
Waivers
...On Friday January 8th, in the final days of the Trump Administration, CMS announced approval of a first-in-the-nation waiver that would permit Tennessee to transition from Medicaid’s longstanding, open-ended financing...more
In a historic presidential election that began during the COVID-19 pandemic and ended with record voter turnout and mail-in ballots, former Vice President Joseph Biden of Delaware was declared the 46th president of the United...more
On November 10, 2020, the U.S. Supreme Court held oral arguments in California v. Texas (Dkt. No. 19-840), a case in which the Trump administration and several Republican-led states have asked the Court to strike down the...more