Model Overview -
CMS as Negotiator -
Under the model, CMS will negotiate OBAs with participating manufacturers, which will tie pricing for SCD treatments to whether the therapy improves health outcomes for people with...more
As we’ve discussed in previous alerts (here and here), after the Supreme Court’s Dobbs decision, which eliminated the federal constitutional right to abortion and returned the question of abortion regulation to the states,...more
We’ve written recently about the process that states are undertaking to begin to wind down the Medicaid enrollment expansion that was necessitated by the enactment of the Families First Coronavirus Response Act in March of...more
12/12/2023
/ Beneficiaries ,
Centers for Medicare & Medicaid Services (CMS) ,
Consolidated Appropriations Act (CAA) ,
Corrective Action Plans (CAPs) ,
Eligibility ,
Enrollment ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Medicaid ,
New Rules
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
At the onset of the COVID pandemic in March of 2020, Congress made an important policy decision: continued access to health coverage was crucial, especially because, at the time, it was uncertain how the economy would...more
9/19/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Consolidated Appropriations Act (CAA) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Due Process ,
Enrollment ,
Families First Coronavirus Response Act (FFCRA) ,
Health Insurance ,
Public Health ,
Redeterminations ,
SCOTUS ,
State Medicaid Programs
Today’s post provides an important update on the Supreme Court case Health & Hospital Corporation of Marion County (HHC) v. Talevski. As readers will remember, our blog has been following this case since it made its way to...more
6/13/2023
/ 42 U.S.C. §1983 ,
Federal Nursing Home Reform Act (FNHRA) ,
Health Care Providers ,
Healthcare ,
Medicaid ,
New Regulations ,
Nurses ,
Patient Access ,
Patient Rights ,
SCOTUS ,
Spending Clause ,
Talevski vs. Health and Hospital Corporation of Marion County
In the first week of 2023, the Biden administration announced two actions centered on expanding access to medication abortion. The first involves a policy change by the FDA regarding the ability of retail pharmacies to...more
1/13/2023
/ Abortion ,
Biden Administration ,
Department of Justice (DOJ) ,
Food and Drug Administration (FDA) ,
New Legislation ,
Patient Access ,
Pharmaceutical Industry ,
Pharmacies ,
Policy Statement ,
Pregnancy ,
Reproductive Healthcare Issues ,
State and Local Government
In eliminating the federal constitutional right to abortion, the United States Supreme Court’s July 24, 2022 decision, Dobbs v. Jackson Women’s Health Organization, returned the question of abortion regulation to the “people...more
Following the Supreme Court’s decision in Dobbs, one federal law, the Emergency Medical Treatment and Labor Act (EMTALA), has become a focal point in the Biden administration’s efforts to challenge state attempts to restrict...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
Hello readers! Today’s post focuses on a topic we’ve touched on a few times in the past – Medicaid drug formularies.
Back in December 2021, the state of Oregon released a draft Medicaid waiver proposal that caught the...more
3/1/2022
/ 1115 Waivers ,
Centers for Medicare & Medicaid Services (CMS) ,
Food and Drug Administration (FDA) ,
Managed Care Contracts ,
MDRP ,
Medicaid ,
Oregon ,
Patients ,
Prescription Drugs ,
Proposed Legislation ,
State and Local Government ,
Waivers
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
Due to the COVID-19 pandemic, most people have spent considerably more time at home over the past year. For many, this meant long hours of Netflix binging, crossword puzzles, and the occasional zoom happy hour. But for some...more
On January 28th, President Biden issued an “Executive Order on Strengthening Medicaid and the Affordable Care Act.” The E.O. states that the Biden Administration will promote policies that “protect and strengthen Medicaid and...more
2/1/2021
/ Affordable Care Act ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Final Rules ,
Medicaid ,
Open Enrollment ,
SCOTUS ,
Secretary of HHS ,
Trump Administration
Donald Trump extended two directives restricting the admission of certain immigrants and nonimmigrants to the U.S. Specifically, Presidential Proclamation (PP) 10014 restricting the admission of first-time immigrants and PP...more
1/6/2021
/ Advisory Opinions ,
Compliance ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Enforcement Actions ,
Final Rules ,
Health Care Providers ,
Manufacturers ,
Medicaid ,
OGC ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B
On November 9, 2020, the Centers for Medicare and Medicaid Services (“CMS”) announced it finalized the Medicaid and Children’s Health Insurance Program (“CHIP”) Managed Care final rule (“2020 final rule”). According to CMS,...more
We are back again with another 340B post. The 340B program has recently been a regular feature on the blog in the context of ongoing litigation discussed here and here. Today, we wanted to provide readers the details of an...more
9/24/2020
/ Covered Entities ,
Drug Pricing ,
GAO ,
HRSA ,
Manufacturers ,
Medicaid ,
New Guidance ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B
On August 4th, CMS released a proposed rule titled Treatment of Medicare Part C Days in the Calculation of a Hospital’s Medicare Disproportionate Patient Percentage (DPP). We’ve written before about the Medicaid...more
8/23/2020
/ Administrative Procedure Act ,
Azar v Allina Health Services ,
Centers for Medicare & Medicaid Services (CMS) ,
DSH ,
Medicaid ,
Medicare Advantage ,
Medicare Part A ,
Medicare Part C ,
NPRM ,
Public Comment ,
Rulemaking Process ,
SCOTUS