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.
CMS Appoints Lakshman Ramamurthy as Industry Representative to MEDCAC
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).
The Three Rs of Diagnostics and Personalized Medicine: Regulatory, Research, and Reimbursement
Avalere will be hosting a conference on the future of market access for diagnostics and personalized medicine.
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On July 31, FDA released the details of its draft guidance regulating laboratory developed tests (LDTs).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.
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.