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
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
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 December 7, the White House announced “New Actions to Lower Health Care and Prescription Drug Costs by Promoting Competition,” which included “a proposed framework for agencies on the exercise of march-in rights on...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
The GUIDE Model is an eight-year model that will test an alternative payment for participants that delivers key supportive services to people with dementia, including comprehensive, person-centered assessments and care plans,...more
8/4/2023
/ Biden Administration ,
Caregivers ,
Centers for Medicare & Medicaid Services (CMS) ,
Dementia ,
Executive Orders ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Long-Term Care ,
Medicare ,
New Guidance
CMMI was established to test innovative payment and service delivery models expected to reduce expenditures and preserve or enhance care quality under Medicare, Medicaid, and the Children’s Health Insurance Program. Over the...more
On March 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued an initial guidance regarding the Medicare Drug Price Negotiation Program (Negotiation Program) established by the Inflation Reduction Act of 2022...more
On March 21, 2023, CMS published in the Federal Register the Information Collection Request (ICR) Form, as required by the Paperwork Reduction Act, for Negotiation Data Elements under Sections 11001 and 11002 of the Inflation...more
On February 14, 2023, and in response to Executive Order 14087 (“Lowering Prescription Drug Costs for Americans”), the Secretary of Health and Human Services (HHS) issued a report announcing the selection of three models that...more
2/22/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Fee-for-Service ,
Food and Drug Administration (FDA) ,
Inflation Reduction Act (IRA) ,
Medicaid ,
Medicare ,
Medicare Part B ,
Medicare Part D
On February 7, 2023, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published a report entitled, “Technical Assistance Brief: Implementation of Inflation-Indexed Rebates for Part B Drugs.” ...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
On October 13, 2022, CMS announced it will extend the Bundled Payments for Care Improvement Advanced Model (BPCI Advanced) for two years, with the opportunity for new entities to join the model beginning in 2024. CMS also...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
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
June 27, 2022 Key Takeaways: Late last week, the Supreme Court released its opinion in Becerra v. Empire Health Foundation, a case that involves the complex but important question regarding how to calculate the Medicare and...more
Bracing for the inevitable end of the COVID-19 Public Health Emergency (PHE), CMS has begun issuing voluminous guidance to states on unwinding Medicaid’s continuous enrollment requirement without precipitating a calamitous...more