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.
PMC on CMS' Reimbursement Policy for Chimeric Antigen Receptor T-cell Therapy
PMC on CMS' National Coverage Analysis for Blood-Based Screening Tests in Colorectal Cancer
On February 28, 2020, the Centers for Medicare & Medicaid Services (CMS) announced that the agency had begun an analysis to determine a coverage policy applicable to a single blood-based screening test in colorectal cancer. To help facilitate patient access to the many blood-based tests that underpin personalized health care strategies in oncology — as opposed to only one of these tests — PMC recommends in its comment letter that CMS focus its coverage decision more broadly "on molecular screening tests, including blood-based colorectal cancer screening assays as a group, rather than an individual company’s test."
PMC Co-Signs Statement of Support for the Strengthening Innovation in Medicare and Medicaid Act
- Letter of support co-signed by 149 organizations
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
- PMC comment letter on the revised Advancing Access to Precision Medicine Act
- PMC comment letter on the Access to Precision Medicine Advancement Act
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: 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