Insights & Analysis
There’s one constant in healthcare: change. Count on us to break down the trends so you can stay up to date. Follow our take on each piece of this deep, intertwined, and often perplexing industry to find opportunities and practical approaches to move healthcare forward.
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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On October 24, the FDA released a draft guidance describing the intended risk-based approach for regulatory actions toward homeopathic drug products marketed in the United States without the required FDA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.
Skilled Nursing Facilities Adjust to the PDPM Era
Skilled nursing facilities (SNF) nationwide continue to adapt to the Patient-Driven Payment Model (PDPM), a transformational new approach to SNF Medicare reimbursement that took effect October 1, 2019.
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
Healthcare Organizations See Reduction in ED Visits and Inpatient Admissions when Focusing on Value
Avalere worked with a healthcare organization to assess the impact of their quality improvement program over a 4-year period. The organization prepared primary and specialty care providers/practices to transition from fee-for-service (FFS) to value-based payment arrangements. Avalere’s analysis found participation in the program led to a reduction in both emergency department (ED) visits as well as inpatient (IP) admissions over the period reviewed.
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.
Avalere Publishes Manuscript on Validating Preparation for Shared Decision-Making Tool for Advanced Breast Cancer Patients
Avalere’s “Preparation for Shared Decision-Making” (PFSDM) tool aims to help patients with advanced breast cancer (ABC) feel prepared to communicate with their clinicians and engage in decision making aligned with their preferences. The validation study confirms the acceptability and usability of the tool for women with ABC.
Avalere Commentary on the 2020 National Vaccine Plan Featured in Health Affairs Blog
On December 16, Avalere policy experts, including Senior Adviser Dr. Angela Shen, published a piece in Health Affairs blog entitled “Shaping the 2020 National Vaccine Plan.” It explores the progress to date against the 2010 National Vaccine Plan (NVP), recurring challenges, and the 2020 NVP.
FDA Launches Global Platform of CURE ID Application
A new FDA resource is available to identify drug candidates for additional study and serve as a resource to shape medical decisions.
Adapting and Validating a Tool to Guide People with Stage III Non-Small Cell Lung Cancer
Avalere used a human-centered design approach to adapt a patient-centered tool to help patients prepare to make treatment decisions with their clinicians.
AI in Healthcare: 5 Areas in Which Artificial Intelligence Is Disrupting the Status Quo
The rapid expansion of artificial intelligence (AI) across healthcare holds the promise of dramatically altering not only diagnosis and treatment but also research, risk assessment, drug development, care management, and even insurance and payment systems.
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.
The Evolving EHR: Information Systems Drive Improvements in Care Quality and Decision Making, But Work Remains
Electronic health record (EHR) platforms continue to accelerate the transformation of healthcare by streamlining access to patient records, improving clinical outcomes, and fostering better decision-making at the point of care.
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.
An Opportunity for Remote Patient Monitoring as Part of Healthcare Delivery for Neurological Care
Remote patient monitoring (RPM) provides an opportunity to diagnose and treat patients facing neurological diseases. Given that multiple sclerosis (MS), Parkinson’s disease, and epilepsy require intervention from specialized care teams, effective management of these chronic neurological conditions can be supported through RPM to improve patient outcomes. Although RPM has been shown to be a complement and in some cases an alternative to office-based care, reimbursement and coverage barriers remain.
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.
Avalere Presents First Real-World Evidence on Medicare Patients’ CAR-T Experiences at ASH Press Briefing
On Saturday, December 7, Karl Kilgore discussed “Medicare Patients Receiving Chimeric Antigen Receptor T-Cell Therapy for Non-Hodgkin Lymphoma: A First Real-World Look at Patient Characteristics, Healthcare Utilization and Costs” during a press briefing at the American Society of Hematology’s Annual Meeting.
Policy Issues, Part 1: Promoting Health by Addressing Food Insecurity
Various national and local health policies aim to address food insecurity through both healthcare and community-based programs.
Digital Health is Here to Stay—Get Engaged
With increasing legislative and regulatory activity promoting adoption of digital health, interest has continued to expand in 2019.
Immunization Implications in CY 2020 MPFS Final Rule
Two decisions finalized in the CY 2020 Medicare Physician Fee Schedule (MPFS) rule have important implications for vaccine policy and access.