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.
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.
Changes to CMS' "Laboratory Date of Service Policy"
- PMC's comment letter about policy options that could slow the delivery of personalized medicine strategies in clinical settings by complicating Medicare billing for diagnostic tests and placing unnecessary administrative burdens on physicians.
(submitted September 2019)
- PMC's previous comment letter
(submitted September 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
CMS: Medicare Hospital Inpatient Prospective Payment System Proposed Rule for FY 2020
CMS: Coverage of Next Generation Sequencing for Medicare Beneficiaries with Advanced Cancer
CMS: Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancer
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
CMS: Innovation Center New Direction
CMS' 2016 Preliminary Gapfill Payment Determinations
CMS' Part B Drug Payment Model Proposal
CMS PAMA Payment System
Oncology Care Model at CMS
Fair and Rational Payment for Molecular Diagnostic Tests
Reimbursement for Personalized Medicine Diagnostics
Centers for Medicare and Medicaid Services (CMS) Specialty Practitioner Payment Models
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
PMC and Bridgehead International Issue Brief on European Reimbursement
PMC and Boston Healthcare Issue Brief on Reimbursement in the U.S.
PMC Payer Principles
Secretary's Advisory Committee on Genetics, Health and Society: Reimbursement Report