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.
2022
PMC Co-Signs Letter of Support for Legislation That Would Enhance Patients' Experiences With Personalized Medicine by Enabling Medicare Reimbursement for Genetic Counselors
PMC Comment Letter Explains How Medicare Advantage Plans Can Better Promote Beneficiaries' Access to Personalized Medicine
PMC Comment Letter Explains How Centers for Medicare and Medicaid Services Can Advance Personalized Medicine Through Quality Measures Included in CY 2023 Physician Fee Schedule
Medicare Payments for CAR T-Cell Therapy (IPPS Proposed Rule for FY 2023)
To Help Protect Medicare Coverage of Genetic Testing for Cancer Patients, PMC Pens Letter to CMS on Proposed Discontinuation of ICD-10 NOS Reimbursement Codes
PMC Co-Signs Letter to Facilitate Broad-Based Access to Telehealth After the Pandemic Without Face-to-Face Visit Requirements for Ordering High-Cost Laboratory Tests
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