Federal & State 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 and state policies that affect insurance coverage, access, and consumer choice so you can see around the bend.
Featured Content
FDA’s Priorities and Approach for Homeopathic Drug Products
On October 24, the FDA released a draft guidance describing the intended risk-based approach for regulatory actions toward homeopathic drug products marketed in the United States without the required FDA approval. The FDA has not approved a single homeopathic product thus far. The agency is currently restructuring its enforcement and regulatory priorities in this space.
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.
Impact of H.R.3 Scenarios on Federal Spending and Drug Manufacturer Revenues
Scenario analysis of varying levels of negotiation under H.R.3 (as released on September 19) finds that the bill could reduce federal spending by $790B to $1,055B and decrease manufacturer revenues by $1,125B to $1,520B for CY 2020–2029.
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
Where We Stand with Generic Drug Approvals and Authorized Generics in 2019
Patient access to high-quality, low-cost generic drugs continues to increase, due to a record number of generic approvals by the FDA in fiscal year 2019.
Policy and Market Access Trends in Kidney Care
A shifting policy landscape and emerging market forces could introduce significant disruption in the kidney care space in the coming years. Understanding the risks and opportunities that these changes may present will be critical for patients, providers, payers, and manufacturers alike.
2019 State Elections: What to Watch in Healthcare Policy
Healthcare policy remains a top priority for both voters and policymakers in 2019 and has been a key part of campaign platforms.
Free Exchange Plan Options Are Available to Many Low-Income Consumers for 2020
New analysis from Avalere finds that over 96% of counties with exchanges operated by HealthCare.gov have free plan options for low-income consumers.
State-Run Reinsurance Programs Reduce ACA Premiums by 16.9% on Average
Continuing analysis from Avalere finds that state reinsurance programs reduce individual market premiums by 16.9% on average in their first year, relative to estimated premiums without reinsurance.
5 Key Trends from the 2020 CMS Star Ratings Report
Join Avalere experts on our webinar on October 29, 2019, to unpack CMS’ 2020 Star Ratings and look at what’s to come for 2021.
Bolstering Patient Access: FDA’s Project Orbis Attains First Joint International Drug Approval
New call center also supports investigational requests.
