Federal 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 policies that affect insurance coverage, access, and consumer choice so you can see around the bend.
Featured Content
Medicare Covers More Part B Therapies for Breast Cancer than NHS England
Avalere analysis found that in 2017 and 2018, more than half (56%) of Medicare patients with breast cancer taking a medicine covered by Medicare Part B received a therapy that was not routinely covered by England’s National Health Service (NHS) or its Cancer Drug Fund (CDF).
COVID-19 Pandemic May Reduce MA Risk Scores and Payments
The COVID-19 pandemic has created significant challenges for all Americans, particularly for its most vulnerable populations, including the elderly and people with disabilities in Medicare. The Centers for Medicare & Medicaid Services (CMS) recently reported that 21% of fee-for-service (FFS) Medicare enrollees have stated they are forgoing non-COVID-19 related care due to the pandemic. Avalere conducted analyses to determine if a similar decrease in utilization is occurring in Medicare Advantage (MA) and assess the potential impact of deferred care on MA enrollees and plans.
Fewer Highly Rated MA Plans in 2021 than in 2020
On October 8, the Centers for Medicare & Medicaid Services (CMS) published their 2021 Star Ratings for Medicare Advantage (MA-PDs) and standalone Prescription Drug Plans (PDPs) on Medicare Plan Finder.
SCOTUS Overturn of the ACA May Invalidate Biosimilar Pathway
The 351(k) biosimilars pathway was legally established under the Biologics Price Competition and Innovation Act (BPCIA) provision of the Patient Protection and Affordable Care Act (ACA) of 2010. Since the passage of the ACA, 28 biosimilars have been approved by the Food & Drug Administration (FDA) along with the promulgation of policy that also applies to all biologics, including the creation of a suffix within the nonproprietary name of these products. Additionally, substantial case law has been made with respect to intellectual property pertaining to biologics. With the legality of the ACA currently under scrutiny, the future of BPCIA and biosimilars is uncertain.
Part D Senior Savings Model Participation and Premiums Vary
New Avalere analysis finds higher premiums for the enhanced standalone drug plans participating in the model.
Step Therapy Can Lead to Higher OOP Costs for Crohn’s Disease Patients
Avalere analysis finds that patients with Crohn’s disease who experience a negative outcome when required to step through a plan’s preferred product may face higher upfront out-of-pocket (OOP) costs and could increase costs to payers.
SCOTUS Ruling on ACA Could Impact Coverage and Policy Outlook
With the US Supreme Court set to hear arguments starting November 10 on California v. Texas, and Judge Amy Coney Barrett’s nomination under consideration in the Senate, questions remain regarding the future of the law.
ESRD Patient Spending Differences Between Puerto Rico and the 50 States
Avalere analysis finds End Stage Renal Disease (ESRD) spending in Puerto Rico varies substantially, and most spending is related to outpatient dialysis and inpatient services.
Avalere Statement on “Most Favored Nation” Executive Order
Yesterday, the Administration released the awaited “Most Favored Nation” Executive Order (EO), which calls for a model that would cap the price Medicare pays for select Part B and D drugs.
Fall Medicaid Outlook: Key Events to Watch
Medicaid will continue to experience considerable changes at the state and federal levels, both in terms of beneficiary demographics and the payer landscape. Stakeholders should consider how upcoming elections, policy proposals, and COVID-19 will impact benefits and payer dynamics.
CMMI Model Would Increase Gap Discounts for Non-Insulin Products
Avalere analysis finds that 51% of all drug spending for non-LIS beneficiaries using insulins and enrolled in enhanced plans in 2018 was for products not participating in the model.
MedPAC Proposes Replacement for MA Star Ratings Program
Under the Medicare Advantage (MA) Star Ratings Program, plans with 4-stars or more receive the greatest benefit from the Quality Bonus Program (QBP) in the form of higher benchmarks and bonus payments.
Charitable Assistance Covers a Small Share of Part D Non-LIS OOP Costs
As policymakers discuss ways to curb program expenditures and improve patient affordability in Medicare Part D, the role of charitable assistance in helping beneficiaries with out-of-pocket (OOP) costs has garnered interest. To understand the relationship between charitable assistance and various Part D metrics, Avalere examined Part D prescription drug claims for beneficiaries without the Low Income Subsidy (LIS) for 2014 and 2018.
Overview: Balance Billing or Surprise Medical Bill Reform
Surprise and balance billing reform efforts have been a subject of ongoing debate at the federal level.
EO on Rebate Reform Raises Key Considerations for Pharmacies
As currently written, a proposed rule on rebate reform from January 2019 may impose financial and operational challenges for pharmacies related to cash flow and new technology requirements.
Andrew E. Van Ostrand Joins Avalere Health
He brings healthcare tech, data, advocacy, and strategy experience to the firm.
Expanding LIS Subsidies Could Save Part D Beneficiaries Money
Avalere assessed the impacts of select policies to expand low-income subsidy (LIS) eligibility under Medicare Part D
Majority of API in US-Consumed Medicines is Produced in the US
New analysis of trade data finds that 54% of API, in dollars, used in domestically consumed medicines came from the US in 2019.
Proposed Medicaid Line Extension Definition Alters Rebate Calculation
The CMS proposes to define line extension under the MDRP to broadly include any product that has at least one ingredient in common with the original drug, even if it is a different dosage form. If finalized, this change would have significant implications on classification and rebate liability for a wide set of current and future products.
Comparison of Dually and Non-Dually Eligible Patients with ESRD
Dually eligible beneficiaries in Pennsylvania with end-stage renal disease (ESRD) are more often people of color and have higher costs compared to non-duals, but their utilization patterns are similar.