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.
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).
Avalere will be hosting a conference on the future of market access for diagnostics and personalized medicine.
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.
In a 5-4 ruling on June 30, the U.S. Supreme Court issued a majority opinion on Burwell v. Hobby Lobby Stores, Inc., holding that the contraceptive mandate violates the Religious Freedom Restoration Act (RFRA) as applied to closely held, for-profit corporations.
On April 7, CMS finalized their Calendar Year (CY) 2015 capitation rates, methodological changes to rates and risk models, and other payment and program policies for Medicare Advantage (MA) and Part D plans.
In this podcast, Matt Eyles, Executive Vice President of Health Plans and Providers, gives a short preview of his upcoming MHPA presentation, Medicaid Premium Assistance Programs: Opportunities and Challenges for States and Plans.