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.
On Aug. 7, CMS released a final national coverage determination (NCD) for Transcatheter Mitral Valve Repair (TMVR).
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.
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.
Lakshman Ramamurthy, PhD, director of FDA & Regulatory Policy at Avalere Health, has been appointed by the Centers for Medicare and Medicaid (CMS) to serve as an industry representative to the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC).
Avalere will be hosting a conference on the future of market access for diagnostics and personalized medicine.
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.
On July 28, the Medicare Board of Trustees released their 2014 report, addressing the financial health of the Medicare program.
On July 31, FDA released the details of its draft guidance regulating laboratory developed tests (LDTs).
Avalere impressions on the first FDA biosimilar filing.
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.
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.
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.
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.
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).
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.
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.
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).
On July 3, CMS released the Calendar Year (CY) 2015 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) proposed rule.
On July 3, CMS released the Calendar Year (CY) 2015 Medicare Physician Fee Schedule (MPFS) proposed rule.
