Friends of Cancer Research (Friends) has recently begun to collaborate and engage consistently with an important stakeholder in the regulatory process: the Centers for Medicare and Medicaid Services (CMS). As new, innovative treatments and products become available to patients, Friends leverages its work and expertise in drug and diagnostic development to provide CMS with recommendations to inform the agency’s work.

As Friends helps ensure patients receive the best treatments in the fastest and safest way possible across all health sectors, we provide direct comments to regulatory guidance that will impact and improve patient care. Our recent comments on guidance are included below.

2019

• Medicare Part D Proposed Rule (January 25): Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of Pocket Expenses; Proposed Rule
• CAR-T NCD (March 17): Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers
• NGS NCA (March 29): National Coverage Analysis (NCA) for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450R)
• Rebates Proposed Rule (April 8): Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees; Proposed Rule
• ReImagine Program (June 12): ReImagine HHS Accelerate Clinical Innovation Initiative
• IPPS 2020 Proposed Rule (June 24): Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the LongTerm Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2020 Rates; Proposed Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Promoting Interoperability Programs Proposed Requirements for Eligible Hospitals and Critical Access Hospitals; Proposed Rule RIN 0938–AT73
• NGS NCD (November 28): Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450R)
• Oncology Care First Model (December 13): Informal RFI on the Oncology Care First Model

2018

• NGS NCD (January 17): Proposed Decision Memo for Next Generation Sequencing for Medicare Beneficiaries with Advanced Cancer
• CAR-T NCA (June 15): National Coverage Assessment for Chimeric Antigen Receptor T-Cell Therapies
• HHS Blueprint to Lower Drug Prices (July 16): HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs;
• Medicare Part B IPI Model (December 31): International Pricing Index Model for Medicare Part B Drugs; Proposed Rule RIN 0938-AT91