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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Avalere Analysis: WellPoint, Blues Capture Greatest Percentage of 2014 Exchange Market Share
A new analysis from Avalere Health finds that in 12 of 15 states where complete data on market share of the health insurance exchanges are available, WellPoint or independent Blue Cross Blue Shield plans captured the greatest percentage of covered lives.
CMS Released Final Rule with Modifications to the 2014 EHR Incentive Program
On Friday, Aug. 29, CMS issued the Modifications to the Medicare and Medicaid Electronic Health Record (EHR) Program final rule, following CMS' notice of proposed rulemaking (NPRM) issued on May 20.
HHS Finalizes Re-Enrollment and Annual Eligibility Redeterminations Rule for Exchange Participation and Insurance Affordability Programs, Finalizing Most Provisions as Proposed
On Sept. 2, HHS released a final rule on re-enrollment and annual eligibility redeterminations for health insurance exchanges, simultaneously releasing guidance for issuers on discontinuation and renewal notices.
Avalere Health Releases Report on Improving Access to Clinical Trial Data
A new report from Avalere Health explores the potential public health consequences of increased clinical trial data transparency.
Avalere Analysis: ‘Copper Plan’ Alternative Would Lower Premiums 18%
In an analysis funded by the Council for Affordable Health Coverage, Avalere Health estimated the cost savings resulting from a new, less-expensive tier of insurance coverage, if legislation were to permit it.
FDA Receives First Biosimilar Application for a Monoclonal Antibody
On August 11, Celltrion announced the completion of their 351(k) filing procedure to FDA on Aug. 8, for its Remicade (infliximab) biosimilar product, Remsima (infliximab).
Notable Success for Parallel Review Program, but Uncertainty about Program’s Future
On Aug. 11, Cologuard became the first technology to receive a simultaneous FDA approval and proposed Medicare national coverage determination (NCD) through the FDA-CMS Parallel Review program.
CMS Finalizes Its Decision to Cover TMVR under CED
On Aug. 7, CMS released a final national coverage determination (NCD) for Transcatheter Mitral Valve Repair (TMVR).
CMS Releases FY15 IPPS Final Rule; Policies Continue to Focus on Transparency and Quality
On Aug. 4, CMS released the Fiscal Year (FY) 2015 Inpatient Prospective Payment Systems (IPPS) final rule. The rule made important changes to quality reporting programs and clarifies criteria for hospital inpatient admissions, in addition to its regular payment policies.
Few Medicare Beneficiaries Receive Comprehensive Medication Review Services
A new analysis from Avalere Health finds that less than half of all Medicare prescription drug (Part D) enrollees eligible for medication therapy management (MTM) programs receive these services. Under Medicare rules, the Centers for Medicare & Medicaid Services (CMS) requires all Part D plans to provide MTM services to beneficiaries who meet certain criteria and have high drug utilization.
Part D Average Bid Decreased for the Fifth Straight Year, Average Part D Premiums Stable
On July 31, CMS released Calendar Year (CY) 2015 regional and national benchmarks that help determine beneficiary premiums in Medicare Part D, including the regional low-income subsidy (LIS) amounts.
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.