Policy

Policy

Reimbursement

Background

If the health care system is to secure the full benefits of personalized medicine, it must provide full and fair reimbursement for new technologies, products and services, based on market principles to the greatest extent possible. The reimbursement system — both governmental and private payers — must have coverage and payment policies that support the timely adoption of new personalized medicine technologies, including both diagnostics and therapeutics.

Since 2004, PMC's call to action is to monitor, evaluate, and contribute to the debate to ensure that personalized medicine is properly integrated into reimbursement systems in the years ahead.

2021

PMC Co-Signs Letter to Delay Changes to Clinical Laboratory Fee Schedule (CLFS)

National Government Services' Proposed Local Coverage Determination on Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasms

CMS' Proposed Medicare Coverage of Innovative Technology (MCIT) Pathway for Breakthrough Devices and Definition of “Reasonable and Necessary”

PMC on the Most Favored Nation (MFN) Drug Pricing Model

CMS' Payments for CAR T-Cell Therapy (IPPS Proposed Rule for FY 2022)

Telehealth in Medicare After the Coronavirus Public Health Emergency

2020

PMC on CMS' National Coverage Analysis/Determination for Blood-Based Screening Tests in Colorectal Cancer

PMC on PalmettoGBA's Proposed Local Coverage Determination (MolDX) for Minimal Residual Disease Testing for Cancer

Changes to CMS' "Laboratory Date of Service Policy"

PMC on CMS' Reimbursement Policy for Chimeric Antigen Receptor T-cell Therapy

PMC Co-Signs Statement of Support for the Strengthening Innovation in Medicare and Medicaid Act

  • Letter of support co-signed by 149 organizations
    March 2020

2019

PMC on CMS' Oncology Care First (OCF) Payment Model

To "reduce program expenditures" while "preserving or enhancing the quality of care for Medicare beneficiaries," the Centers for Medicare and Medicaid Services (CMS)' Oncology Care First (OCF) payment model seeks to establish a voluntary program that offers an alternative to the traditional fee-for-service reimbursement framework. In its response to CMS' informal request for information about the OCF model, PMC reminds CMS that personalized medicine can improve the quality of health care and encourage health care providers to make better use of health care dollars by identifying the patients who are most likely to respond to certain medications.

CMS: Coverage of Next Generation Sequencing for Medicare Beneficiaries with Advanced Cancer

PMC Supports the Ending the Diagnostic Odyssey Act

PMC Supports the Advancing Access to Precision Medicine Act

  • PMC letter of support for the Advancing Access to Precision Medicine Act
    September 2019
    • PMC comment letter on the revised Advancing Access to Precision Medicine Act
      February 2018
    • PMC comment letter on the Access to Precision Medicine Advancement Act
      July 2017

PMC Co-Signs Statement of Support for the Access to Genetic Counselor Services Act

  • Statement of support organized by National Society of Genetic Counselors
    August 2019

CMS: Medicare Hospital Inpatient Prospective Payment System Proposed Rule for FY 2020

CMS: Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancer

2018

CMS: International Pricing Index Model for Medicare Part B Drugs

CMS: Calendar Year 2019 Medicare Clinical Laboratory Fee Schedule Preliminary Determinations

HHS: Step Therapy for Part B Drugs in Medicare Advantage (MA)

Trump Administration/HHS: Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs

CMS: Medicare Hospital Inpatient Prospective Payment System Proposed Rule for FY 2019

CMS: Medicare National Coverage Analysis for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancer

2017

CMS: Innovation Center New Direction

2016

CMS' 2016 Preliminary Gapfill Payment Determinations

CMS' Part B Drug Payment Model Proposal

2015

CMS PAMA Payment System

Oncology Care Model at CMS

2014

Fair and Rational Payment for Molecular Diagnostic Tests

Reimbursement for Personalized Medicine Diagnostics

Centers for Medicare and Medicaid Services (CMS) Specialty Practitioner Payment Models

2013

Centers for Medicare and Medicaid Services (CMS) Molecular Diagnostics Gapfill Payment Amounts

Centers for Medicare and Medicaid Services (CMS) Guidance Regarding Coverage and Evidence Development

2011

PMC and Bridgehead International Issue Brief on European Reimbursement

2010

PMC and Boston Healthcare Issue Brief on Reimbursement in the U.S.

2006

PMC Payer Principles

2005

Secretary's Advisory Committee on Genetics, Health and Society: Reimbursement Report

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