
Federal Policy
As the largest, single US healthcare payer, the government plays a dominant role in shaping the healthcare marketplace. Our experts track, interpret, and model federal policies that affect insurance coverage, access, and consumer choice so you can see around the bend.

Recent Federal Rule Could Undermine Some Patient Support Programs
The Center for Medicare & Medicaid Services (CMS) recently issued its proposed Notice of Benefit and Payment Parameters (NBPP) for the 2021 plan year. The proposed rule would significantly expand commercial payer flexibility to not count manufacturer copay support toward deductibles or out-of-pocket (OOP) maximums.
OOP Costs for MS Drugs Are Substantially Higher for Non-Employer-Based Part D Plans
Employer Group Waiver Plans (EGWPs) have lower out-of-pocket (OOP) costs for multiple sclerosis (MS) drugs than beneficiaries enrolled in other types of Part D plans.
CMS Proposal May Increase Obstacles for State-Mandated Benefits
In the Notice of Benefit and Payment Parameters (NBPP) for the 2021 plan year, CMS questioned whether states were appropriately deciding if the state was required to defray the premium impacts of new benefit mandates added since 2011. CMS proposes requiring states to report on and justify defrayal decisions for all state benefit mandates.
Patient Costs Among Medicare Part D Users of Mental Health Drugs
According to a new analysis from Avalere, Medicare Part D beneficiaries who are taking mental health drugs and do not receive low-income cost-sharing support are responsible for a higher share of the cost of mental health drugs (46%) than for non-mental health drugs (23%).
5 High Impact Areas in the MA Advance Notice & Proposed Rule
This month, the Centers for Medicare & Medicaid Services (CMS) proposed changes to Medicare Advantage (MA) through the annual Advance Rate Notice and Proposed Rule. These proposals impact MA in many ways, including changes to quality bonus payments, network adequacy requirements, coverage of End Stage Renal Disease (ESRD), plans targeting dual eligibles, and supplemental benefit offerings. Stakeholders should examine each of these areas closely as they respond to CMS.
CMS Proposes Allowing Part D Plans to Implement a New Preferred Specialty Tier
Implementation of a preferred specialty tier could have various impacts on Part D plans’ formulary and benefit designs and could affect manufacturer contracting strategies.
For the First Time, a Majority of Generic Drugs Are on Non-Generic Tiers in Part D
According to a new analysis from Avalere, Medicare Part D plans place generic prescription drugs on non-generic tiers 53% of the time in 2020.
What to Watch for in this Week’s Call Letter and Proposed MA-PD Rule
CMS is set to release its annual proposed changes to Medicare Advantage (MA) this week. Some of the topics that may be addressed include End-Stage Renal Disease (ESRD), network adequacy requirements, payment to MA plans that offer the hospice benefit, and the MA quality bonus program.
Variation in Generic Substitution Rates Among Part D Plans
New analysis from Avalere finds 52% of Part D plans achieve generic substitution1 rates above 75%.
Device Regulation Modernization Efforts Continue to Accelerate
The Food and Drug Administration’s (FDA) efforts to modernize medical device oversight in the agency’s Center for Devices and Radiological Health (CDRH) have continued with the release of multiple draft and final guidances in 2019, as well as a plan for additional releases in 2020.
CMMI’s Financial Impact on Medicare Spending Challenging to Project (Updated)
CMMI’s impact on Medicare spending has not reached earlier projections by the Congressional Budget Office (CBO), demonstrating the difficulty in projecting savings from untested and future unknown alternative payment models
CMS RADV White Paper Outlines Potentially Significant Program Changes
CMS is considering changes to its commercial market Risk Adjustment Data Validation (RADV) program to improve the accuracy of risk adjustment transfers and to increase stability and predictability for issuers. This follows issuer experiences with the 2017 RADV process in which some issuers saw substantial, unforeseen changes to their risk adjustment transfers. These RADV changes have the potential to impact issuer participation and premiums in future years depending on the direction (positive or negative) and magnitude of those transfers.
USMCA Compromise Drops Key Biologics Exclusivity Provisions
The replacement to North American Free Trade Agreement (NAFTA), the United States-Mexico-Canada Agreement, was originally proposed to increase biologics exclusivity in Mexico and Canada to 10 years. As part of the Administration’s compromise with the House of Representatives, these provisions have been removed from the amended version that was recently agreed to by the US, Mexico, and Canada. While exclusivity in the US remains unchanged at 12 years, that it is not increased for Canada and Mexico may impact market entry for biologics ex-US.
Assessment of Regulatory Proposal to Eliminate the FFS Adjuster from Medicare Advantage Plan Audits
In a recent post on the RISE website, Sean Creighton examines the methodology and evidence behind CMS’s proposal to eliminate the Fee-for-Service (FFS) Adjuster from Risk Adjustment Data Validation (RADV) audit methodology.
2020 Exchange Plan Networks Are the Most Restrictive Since 2014
Restrictive network plans comprise over 75% of the exchange market.
Medicare Advantage Plans May Be Paid Below Actual ESRD Patients’ Costs in Large Metropolitan Areas in 2021
Avalere analysis finds that payment to Medicare Advantage (MA) plans for end-stage renal disease (ESRD) patients in highly populated regions may be significantly below actual patient costs.
Medicare Advantage Beneficiaries Will Again See a Jump in Supplemental Benefit Offerings in 2020
Medicare Advantage (MA) plans continue expanding coverage of supplemental benefits following administration’s policy changes from a year ago.
More Practices Would Receive a Novel Therapy Adjustment in Medicare’s New Oncology Care First Model
New Avalere analysis finds that practices currently participating in the Oncology Care Model (OCM) would be more likely to receive a Novel Therapy Adjustment (NTA) in the newly proposed Oncology Care First (OCF) Model.
Webinar: Get the 411 on Healthcare Consulting
Are you interested in a career in healthcare consulting? Are you passionate about solving the challenges of the healthcare system? Avalere Health, a leading healthcare consulting firm, held an informational webinar on November 18 to provide information about the company and our Associate Immersion Program.
Affordable Patient Access to PCSK9 Inhibitors Remains Challenging Across Part D Plans in 2020
Avalere analysis finds that, despite substantial list price decreases across the PCSK9 inhibitor class, out-of-pocket costs for the majority of 2020 Part D beneficiaries remain significant