Federal & State Policy
As the largest, single US healthcare payer, the government plays a dominant role in shaping the healthcare marketplace. Our experts track, interpret, and model federal and state policies that affect insurance coverage, access, and consumer choice so you can see around the bend.
Featured Content
Nearly 60 Percent of New Medicare Advantage Plans Are Sponsored by Healthcare Providers
A new analysis from Avalere Health finds that hospitals and health systems are increasingly taking risk for the cost of Medicare patients and the quality of the care they receive.
Federal Government Underpays Medicare Advantage Plans for Enrollees with Multiple Diseases
A new analysis by Avalere finds that the Centers for Medicare and Medicaid Services (CMS) underpay Medicare Advantage (MA) plans for the costs of treating individuals with multiple chronic conditions.
Proposed Exchange Standardized Benefit Designs Expand First-Dollar Coverage for Services and Drugs
As the government considers rules for 2017 insurance plans offered through exchanges, a new analysis by Avalere finds that proposed 2017 benefit designs could increase coverage of certain services and drugs, while lowering out-of-pocket costs for many consumers.
Webinar: How to Develop Compassionate Use Policies
FDA oversees access to investigational treatments by eligible patients (compassionate use) through its expanded access program. But how do you decide whether to give these patients the unapproved treatments they seek?
Webinar: Medicare Advantage Star Ratings: CMS Proposes Changes
Recently, stakeholders have raised concerns around whether the current star rating methodology appropriately adjusts for the socioeconomic impacts on quality ratings.
New Study Analyzes FDA Advisory Committees’ Trends in First Three Years of Current User Fee Era
The U.S. Food and Drug Administration's (FDA) Advisory Committee (AdComm) process remains a source of significant uncertainty for medical product manufacturers, despite FDA's guidelines in the Code of Federal Regulations (C.F.R.)1 and in guidance.2 While the AdComm process is generally the same across Centers,3 each AdComm is unique and subject to the expertise and opinions of individual panel members, opinions voiced during the public comment period, and challenges exclusive to each new product or indication.
Podcast: Compassionate Use
When life sciences companies consider whether to allow compassionate use—access to unapproved investigational treatments outside of clinical trials—there are no easy answers. Brenda Huneycutt gleans insight from Arthur Caplan, PhD, and Alison Bateman-House, PhD, from the New York University Langone Medical Center Division of Medical Ethics on some of the many questions that life sciences companies should ask themselves before implementing a compassionate use policy.
Webinar: FDA’s Regulation of Laboratory Developed Tests—Where Do We Go Next?
The FDA has shown growing interest in regulating laboratory developed tests (LDTs) to ensure their safety and effectiveness.
MACRA and the Promise of Better Patient/Family Engagement in Post-SGR World
The story of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) actually begins in the previous millennium. In 1997, when the Congress passed the Balanced Budget Act, it ushered in the era of the Sustainable Growth Rate (SGR) formula. In theory, the SGR payment adjustment would raise or lower physician reimbursement each year based on spending relative to the target SGR. The caveat, however, was that Congress had the authority to suspend or adjust this benchmark, a "patch" that they regularly deployed through a "doc fix" for nearly two decades.
Where Are the States Going on Payment and Delivery Reform? Tracking SIM Grant Developments
Believing that states are productive incubators of innovation, the Center for Medicare & Medicaid Innovation (CMMI) launched a State Innovation Model (SIM) grant program in 2013 to encourage state-by-state testing of innovative payment and delivery models.
Business Education for Healthcare Innovation
The healthcare delivery system is one of the most complex businesses in the country.
An Analysis of the Impact of Breakthrough Therapies on Government Spending
To evaluate public program spending on new medications in the drug development pipeline, Avalere projected the fiscal impact of 10 FDA breakthrough therapies to Medicare, Medicaid, and the health insurance exchanges created by the Affordable Care Act (ACA).
Upcoming Managed Care Regulation Will Impact Plans Serving 46M Medicaid Beneficiaries
Over the past four years, enrollment in Medicaid managed care has increased by 48 percent, with 46 million beneficiaries now receiving coverage through these plans. The government will soon update regulations that direct the plans providing this coverage.
Two Seasoned Healthcare Professionals Join Avalere
Lisa Latts, MD, and Rick Smith join Avalere's team.
Webinar: Expanded Access and Right-to-Try Legislation: Can We Find a Balance Between Competing Interests?
Providing patient access to investigational treatments outside of clinical trials is once again in the spotlight of media scrutiny. Earlier this year, social and popular media attention pressured one company to provide an investigational treatment to a young cancer patient. Then, states began debating and passing “Right to Try” bills to set up a new pathway to allow access to investigational drugs.
Avalere Health Names Lindy Hinman its New Senior Vice President of Health Plans and Managed Care
Avalere Health announced today that Lindy Hinman will be re-joining the company as senior vice president, leading its Health Plans and Managed Care Practice.
Podcast: The Emerging Initiative of 21st Century Cures
Even during these gridlocked times in Congress, certain healthcare initiatives are getting through the cracks; one of these such initiatives is 21st Century Cures.
HHS Report Finds Carrier Participation in Exchanges Will Grow 25 Percent
On September 23, HHS released a new report that finds the number of issuers participating in the 2015 exchange market will grow by 25 percent when compared to 2014.
Podcast: What’s to Come in MolDx?
Meet Kathy Hughes who leads our Molecular Diagnostics team and has successfully advised device, diagnostics and pharmaceutical companies on optimal market access strategies for over a decade. Kathy addresses key evidentiary developments in the diagnostics space, and what she sees as the future of this evolving field.
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).