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.
FDA Releases Final Guidance on Qualification Process for Drug Development Tools
On Jan. 6, FDA released final guidance outlining the qualification process for drug development tools (DDTs).
Proposed MA/Part D Rule Significantly Scales Back Protected Classes Policy for Plan Year 2015 and Beyond
On Jan. 6, CMS released a proposed rule seeking to implement key policy changes to the MA and Part D programs for Contract Year (CY) 2015.
Final Budget Act Allows Time for Full SGR Repeal in Q1 2014; Establishes a 0.5 Percent Update Factor for Physician Payment Through the End of March
On Dec. 26, President Obama signed into law a two-year budget resolution that reduces budget uncertainties through fiscal year (FY) 2015.
Brenda Huneycutt to Moderate FDA Panel at the 2014 Biotech Showcase in San Francisco
Join Avalere's Brenda Huneycutt, FDA Policy & Regulatory Strategy Practice, who will be moderating a panel with Avalere's Jenny Gaffney and other leading experts at the Biotech Showcase in San Francisco on Tuesday, January 14th at 8am, titled "FDA: where it's going and how it affects biotech."
Exchange Enrollment Steadily Increasing as IT Problems Addressed
On Dec. 1, the Administration re-launched Healthcare.gov after largely resolving the IT problems that plagued the site for the first two months of open enrollment.
Analysis: Exchange Formulary Structure More Similar To Part D Than Employer Coverage
An analysis from Avalere Health finds that most individuals in exchanges will face formularies with four or five cost-sharing tiers that commonly use coinsurance techniques for top-tier medications.
ACO Educational Series – Leveraging Specialty Pharmacy in Accountable Care Organizations
Join Avalere, Armada and SPAARx for an educational series that examines the potential role of specialty pharmacies within Accountable Care Organizations (ACOs).
CMS Codifies Enrollment Deadline Delay
On Dec. 12, CMS released an interim final rule (IFR) codifying recently announced changes that permit consumers to enroll in health insurance coverage through an exchange as late as Dec. 23 for coverage effective Jan. 1, 2014.
1.99 Million Individuals Have Been Determined Eligible for Medicaid or CHIP Since Oct. 1
As of Dec. 11, 1.99 million individuals were determined or assessed eligible for Medicaid or the Children's Health Insurance Program (CHIP).
Analysis: Consumer Deductibles Vary Significantly Across Exchange Plans
NEWS RELEASE: An analysis by Avalere Health finds that consumers who enroll in exchange plans will, on average, face dramatically different deductibles based on the metallic level plan (i.e., bronze, silver, gold, platinum).
CMS and ONC Propose One-Year Meaningful Use Extension
On Dec. 6, CMS and the Office for the National Coordinator for Health Information Technology (ONC) proposed a one-year extension for Stage 2 of Meaningful Use for eligible providers who began attesting in 2011 or 2012.
Analysis: Dec. 23 Exchange Coverage Deadline Crucial For High-Need Enrollees
An analysis by Avalere Health addresses key issues faced by various high-need groups that must enroll in exchanges by Dec. 23 to secure coverage by Jan. 1, 2014, including those facing individual market cancellations, individuals in high-risk pools, some Medicaid beneficiaries and uninsured HIV/AIDS patients.
Analysis: Despite Subsidies, Chronically Ill Individuals Will Be Underinsured In Exchanges
NEWS RELEASE: An analysis from Avalere Health finds that most individuals in exchanges who reach their maximum out-of-pocket (OOP) cap will be underinsured, despite reduced OOP caps for those below 250 percent of poverty. The Commonwealth Fund[1] defines underinsurance as OOP costs[2] greater than 10 percent of income for those earning more than twice the poverty level and OOP costs greater than 5 percent of income for those earning less than twice the poverty level.
FDA Solicits Comments on Draft Guidances Regarding Compounding Facilities
On Nov. 27, FDA released three draft guidances on the regulation of compounding pharmacies following the enactment of the Drug Quality and Security Act (DQSA).
Release: Study Shows Medicare Receives Lower Rates For Clinical Laboratory Services
NEWS RELEASE -- Today Avalere Health, a private data analysis firm, released a study that refutes past claims that commercial plans pay lower rates for lab services than Medicare. Instead, the study found that Medicare rates are almost always lower than average rates paid by private plans.
Notice of Benefit and Payment Parameters 2015 Proposed Rule
On Nov. 25, HHS released the Proposed Notice of Benefit and Payment Parameters for 2015 that provides technical details and policy parameters related to the advance payments of the premium tax credits (APTC), cost-sharing reductions (CSRs) and premium stabilization programs.
CMS Postpones SHOP Online Enrollment Until 2015 Plan Year
On Nov. 27, CMS announced a yearlong delay of online enrollment for small business employers seeking health insurance through the federally-facilitated small business health options program (FF-SHOP).
Avalere Identifies Three Ways To Reduce Post-Acute Care Spending
Nowhere are there more opportunities for savings than in post-acute care (PAC) settings.
CMS to Phase In Drug Utilization Payment Cut in Final ESRD Rule; Net Update to Base Rate 0.0% in CY 2014
On Nov. 22, CMS released its final Calendar Year (CY) 2014 End Stage Renal Disease (ESRD) PPS rule, finalizing a 2014 base per treatment rate of $239.02, reduced slightly from $240.36 in CY 2013.
FDA Issues Warning Letter to 23andMe Genomic Service; Other LDTs on the Radar?
On Nov. 22, FDA issued a warning letter to 23andMe, Inc., asking them to immediately discontinue the marketing of their saliva collection kit and Personal Genome Service (PGS) Kit.