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.
Lower Inpatient Hospital Expenditures Drive Improved Medicare Solvency
On July 28, the Medicare Board of Trustees released their 2014 report, addressing the financial health of the Medicare program.
FDA Releases Long-Awaited Guidance on Laboratory Developed Tests
On July 31, FDA released the details of its draft guidance regulating laboratory developed tests (LDTs).
Analysis: First FDA Biosimilar Filing
Avalere impressions on the first FDA biosimilar filing.
HRSA Stands Behind Its Interpretation of the 340B Orphan Drug Exclusion After District Court Vacates the Agency’s Final Rule
The Health Resources and Services Administration (HRSA) has issued an "interpretive rule" that reflects the same interpretation of the 340B orphan drug exclusion as the agency included in the July 2013 orphan drug final rule, before the rule was vacated by the U.S. District Court for D.C. in May 2014.
U.S. Court of Appeals for D.C. Rules Against Government, Says Tax Credits Are Not Available in Federally Facilitated Exchanges
On July 22, the U.S. Court of Appeals for the D.C. Circuit issued a 2-1 ruling in Halbig v. Burwell, deciding contrary to lower courts and striking down the IRS's regulations allowing consumers to receive subsidies for insurance purchased on federally facilitated exchanges.
U.S. Court of Appeals for D.C. Rules Against Government, Says Tax Credits Are Not Available in Federally-Facilitated Exchanges
On July 22, the U.S. Court of Appeals for the D.C. Circuit issued a 2-1 ruling in Halbig v. Burwell, deciding contrary to lower courts and striking down the IRS's regulations allowing consumers to receive subsidies for insurance purchased on federally-facilitated exchanges.
Avalere Health Insurance Exchange Map
On July 22, the U.S. Court of Appeals for the D.C. Circuit ruled contrary to lower courts and struck down the IRS's regulations allowing consumers to receive subsidies for insurance purchased on federally-facilitated exchanges.
Upcoming Federal Court Decision Could Mean Premium Increases for Nearly 5 Million Americans
The Halbig v. Burwell case before the U.S. District Court of Appeals could negatively impact millions of Americans who are benefiting from the Affordable Care Act (ACA).
Paying for the High Cost of Care
This July, Avalere's Tanisha Carino and Scott Gottlieb published a paper on AEI.org, discussing the ways in which medical research for major diseases continues to advance, while simultaneously making cures more expensive upfront.
MolDX May Be the Norm, but Is It the Future?
With over 16,000 genetic tests already on the market and thousands more in development, stakeholders cannot ignore the rapidly evolving field of personalized medicine.
Avalere Observations on a Potential Approach to Essential Health Benefits
The Affordable Care Act (ACA) requires health plans in the individual and small group markets-both inside and outside exchanges-to offer essential health benefits (EHB).
CY 2015 OPPS/ASC Proposed Rule Makes Refinements to Last Year’s Significant Changes to the Outpatient Payment System
On July 3, CMS released the Calendar Year (CY) 2015 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) proposed rule.
CY 2015 MPFS Proposed Rule Details Chronic Care Management Payment, Increases Transparency of Code Revaluations, Continues Implementation of Quality Programs
On July 3, CMS released the Calendar Year (CY) 2015 Medicare Physician Fee Schedule (MPFS) proposed rule.
CMS Proposes Flat Payment and New Quality Measures for Dialysis Facilities
In the Calendar Year (CY) 2015 End Stage Renal Disease (ESRD) Prospective Payment System (PPS) proposed rule released on July 2, CMS proposes a 2015 base per treatment rate of $239.33, up slightly from $239.02 in CY 2014.
CVS Caremark Announces New Partnerships with Medicare ACOs to Reduce Drug Spending
On June 27, CVS Caremark announced partnerships with seven additional Medicare accountable care organizations (ACOs) to improve pharmacy care and reduce drug spending for beneficiaries enrolled in CVS' SilverScript Medicare Prescription Drug Plan (PDP).
NCQA Releases New Technical Specifications for the 2015 Edition of HEDIS
NCQA has released new technical specifications for the 2015 version of Health Effectiveness Data and Information Set (HEDIS) to include four new measures, changes to seven measures, the retirement of two measures and minimal changes to various other measures.
Supreme Court Hobby Lobby Decision Limits Contraception Coverage Mandate
In a 5-4 ruling on June 30, the U.S. Supreme Court issued a majority opinion on Burwell v. Hobby Lobby Stores, Inc., holding that the contraceptive mandate violates the Religious Freedom Restoration Act (RFRA) as applied to closely held, for-profit corporations.
Addressing Sustainability and Informatics Challenges for Clinical Data Registries
In the spring 2014 edition of the Journal of Health Information Management (JHiM), Avalere's Chris Boone published an article addressing modern-day challenges to clinical data registries (CDR).
Exchange Plan Renewals: Many Consumers Face Sizeable Premium Increases in 2015 Unless They Switch Plans
New analysis from Avalere Health finds that many consumers in exchange plans who receive federal assistance to reduce their monthly premiums will face substantial premium increases unless they switch insurance plans in 2015.
Differences in FDA Communication Practices Result in Increased Review Times for Devices
As the medical device industry prepares for the next round of user fee negotiations, manufacturer representatives must consider the importance of FDA's approval process transparency, and regular interactive communication.

