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 Confirms Widespread Generic-Drug Equivalency Testing Program
FDA has now confirmed that the first widespread generic-drug equivalency testing program was initiated last September (without public notice).
CMS Physician Compare Website Publishes Quality Data for the First Time
On Feb. 21, CMS enhanced the Physician Compare website to include the addition of quality measures to indicate the performance achieved on a set number of specific metrics.
FDA Releases Final Guidance on Pre-Submission Program for Medical Devices
On Feb. 18, FDA released guidance outlining how an applicant can obtain FDA feedback on a potential or planned medical device submission reviewed by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER), including the Pre-Submission (formerly pre-Investigational Device Exemption (pre-IDE)) program.
First Coast Once Again Awarded the Part A/B Medicare Administrative Contract for Jurisdiction N
Last week, CMS awarded First Coast Service Options, Inc. (First Coast) the contract for the administration of Medicare Part A and Part B fee-for-service claims in Jurisdiction N, which encompasses Florida, Puerto Rico, and the U.S. Virgin Islands.
Medicare Advantage and Part D Plans See Enrollment Increase with Payment and Policy Changes on the Horizon
A new Avalere Health analysis finds that enrollment in Medicare Advantage (MA) plans grew substantially in 2014 versus 2013.
Report Finds More Than $1.3 Billion in Potential Savings Through Diabetes Prevention Legislation
An Avalere Health study commissioned by the American Diabetes Association, YMCA of the USA (YMCA), in collaboration with the American Medical Association (AMA) focusing on HR 962/S 452, The Medicare Diabetes Prevention Act (MDPA), found that if enacted, the bill would save the Federal Government $1.3 billion over 10 years, and would also dramatically reduce diabetes among Medicare beneficiaries.
Big Data Continues to Shape Healthcare in 2014
There is a rapid expansion of large and diverse data sets -- what is more commonly referred to as Big Data - as a result of the digitization of clinical and research data.
Creating a PAC Scorecard to Foster Acute-Post-Acute Relationships
In this week's edition of McKnight's Long-Term Care News & Assisted Living, Avalere's Anne Tumlinson wrote a guest post based on acute care and post-acute care relationships moving into 2014.
NCQA Releases 2015 HEDIS Measures for Public Comment; Proposes Eight New Measures Addressing Use of Antipsychotics and Cancer Screenings
On Feb. 19, the National Committee for Quality Assurance (NCQA) released its 2015 Healthcare Effectiveness Data and Information Set (HEDIS) for public comment, proposing eight new measures, proposing changes to seven existing measures, and retiring two measures.
Consumers Likely Face High Out-Of-Pocket Costs for Specialty Drugs In Exchange Plans
In most exchange plans, consumers will face paying a percentage of the costs-known as coinsurance-rather than fixed-dollar copayments for many specialty medications used to treat rare and complex diseases.
USPSTF Recommends Against Screening for Carotid Artery Stenosis in Asymptomatic Adults, Reaffirming Its 2007 Recommendation
On Feb. 18, the United States Prevention Services Task Force (USPSTF) released for public comment a draft recommendation statement, "Screening for Carotid Artery Stenosis."
USPSTF Recommends Against Screening for Carotid Artery Stenosis in Asymptomatic Adults, Reaffirming Its 2007 Recommendation
On Feb. 18, the United States Prevention Services Task Force (USPSTF) released for public comment a draft recommendation statement, "Screening for Carotid Artery Stenosis."
GAO and FDA Release Separate Reports on Drug Shortages; Disagreement Over Number of Ongoing Drug Shortages
On Feb. 10, the Government Accountability Office (GAO) released a report discussing the results of its drug shortages analysis, and reported that although the total number of ongoing drug shortages continues to increase, new drug shortages decreased in 2012.
NICE Publishes the First Medtech Innovation Briefings (MIB), Its Newest Product to Support Decision-Making
On Feb. 4, the United Kingdom's National Institute for Health and Care Excellence (NICE) published their first Medtech Innovation Briefings (MIB), providing objective information on device and diagnostic technologies to aid local decision-making by clinicians and policymakers.
State Exchange Enrollment Widely Variable Compared to Projections
New Avalere analysis finds that while nationwide exchange enrollment has reached 55 percent of projections, state progress varies dramatically.
CMS Opens NCA on Lung Cancer Screening with LDCT and Schedules MEDCAC for April 30
On Feb. 10, CMS opened a national coverage analysis (NCA) on the use of lung cancer screening with Low-Dose Computed Tomography (LDCT) devices.
7.4M Medicare Beneficiaries Could Be Affected By Proposed Meaningful Differences Policy
A Medicare proposed rule change limiting the number of prescription drug plans (PDPs) that insurers may offer in the Part D market could require 39 percent of all enhanced plans to be eliminated in 2016.
AHRQ White Paper Offers Payer Perspectives on How to Improve the Usability of AHRQ’s Comparative Effectiveness Reviews for Decision Making
On Feb. 3, the Agency for Healthcare Research and Quality (AHRQ) released a white paper that provides payer perspectives on how to improve the usability of reports produced by AHRQ's Effective Health Care (EHC) program.
OIG Report Finds Contract Pharmacy Arrangements “Create Complications” in the Administration of the 340B Program
On Feb. 4, the Office of the Inspector General (OIG) released a report describing select covered entities' contract pharmacy arrangements and their oversight to prevent diversion of 340B purchased drugs to ineligible patients, and to prevent duplicate discounts through Medicaid.
MAP Releases Final 2014 Pre-Rulemaking Report, Providing Recommendations on Measures for 20 Federal Programs
On Feb. 3, the Measures Application Partnership (MAP) released its final pre-rulemaking report, providing recommendations on the adoption of new measures in more than 20 federal public reporting and payment programs, including clinician programs (e.g., Physician Quality Reporting System, Physician Compare) and facility programs (e.g., Inpatient Quality Reporting System (IQR), Hospital Acquired Conditions Payment Reduction Programs).