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.
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.
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.
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.
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?
Recently, stakeholders have raised concerns around whether the current star rating methodology appropriately adjusts for the socioeconomic impacts on quality ratings.
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.
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.
The FDA has shown growing interest in regulating laboratory developed tests (LDTs) to ensure their safety and effectiveness.
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.
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.
The healthcare delivery system is one of the most complex businesses in the country.
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).
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.
Lisa Latts, MD, and Rick Smith join Avalere's team.
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 announced today that Lindy Hinman will be re-joining the company as senior vice president, leading its Health Plans and Managed Care Practice.
Even during these gridlocked times in Congress, certain healthcare initiatives are getting through the cracks; one of these such initiatives is 21st Century Cures.
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.
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.
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).