Erin Estey Hertzog on Centers for Medicare & Medicaid Services (CMS)

CMMI Releases More Details on New Cell and Gene Therapy Access Model

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

2/1/2024 / Centers for Medicare & Medicaid Services (CMS) , Clinical Laboratory Testing , CMMI , Genetic Testing , Life Sciences

CMS Releases Request for Information on Medicare Advantage Data

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

1/31/2024 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Health Care Providers , Managed Care Contracts , Medicaid , Medicare , Medicare Advantage , Public Comment , Request For Information

CMS Identifies First 10 Drugs for Medicare Price Negotiation

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

8/30/2023 / Biosimilars , Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Inflation Reduction Act (IRA) , Medicare , Medicare Part D , Negotiations

CMMI Announces Medicare Dementia Care Model

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 Introduces New Multi-State Initiative Focused on Enhancing Primary Care Delivery

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

6/13/2023 / Centers for Medicare & Medicaid Services (CMS) , Children's Health Insurance Program (CHIP) , CMMI , Health Insurance , Healthcare , Medicaid , Medicare , Value-Based Care

Medicare Drug Price Negotiation Program Initial Guidance

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

3/31/2023 / Biosimilars , Centers for Medicare & Medicaid Services (CMS) , Compliance , Drug Pricing , Food and Drug Administration (FDA) , Inflation Reduction Act (IRA) , Medicare , Negotiations , New Guidance , Section 340B

Information Collection Request for Drug Price Negotiation Program Data Elements

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

3/31/2023 / Centers for Medicare & Medicaid Services (CMS) , Data Collection , Drug Pricing , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Inflation Reduction Act (IRA) , Manufacturers , Public Health Service Act , Research and Development , Revenue

HHS Issues Report Outlining Three New Drug Models for Testing by CMMI

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

OIG Technical Assistance on Part B Inflation Rebates Implementation Barriers and CMS’ Proposed Solutions in Recent Part B...

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

2/17/2023 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Inflation Reduction Act (IRA) , Medicaid Drug Rebate Program , Medicare , Medicare Part B , OIG

Erin Estey Hertzog

Foley Hoag LLP

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