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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.

Matt Kazan

What to Watch for in Medicare Advantage Policy in the Coming Months

As the Centers for Medicare & Medicaid Services (CMS) consider what, if any, changes to propose to Medicare Advantage (MA) through fall rulemaking, stakeholders should consider where the Biden adminstration’s priorities may differ from the previous administration’s. Topics that may be addressed—either in regulation or via legislation—include health equity, supplemental benefit flexibility, star ratings, payment and risk adjustment, and end-stage renal disease (ESRD).

Andrew Van Ostrand

New Data-Sharing and Interoperability Mandates Create New Challenges

Digital health will continue to be a focus under recently confirmed Secretary Becerra‘s leadership at the Department of Health and Human Services. As the Biden administration looks to enforce compliance across a range of data interoperability and price transparency rules, as well as usher in new Food & Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) coverage policies for medical technologies and digital health tools, the industry is responding with a range of innovations.

Joanna Young

OPPS 340B Policy Reversal Lowers Hospital Payment and Increases Copays

A new analysis from Avalere estimates the impact of reverting back to the Calendar Year (CY) 2017 Medicare Outpatient Prospective Payment System (OPPS) payment policy that reimbursed all separately payable drugs at average sales price (ASP) plus 6%. Key findings suggest beneficiary cost sharing for separately payable drugs at 340B OPPS hospitals would increase by $472.8 million. Also, 82% of all OPPS hospitals—specifically 89% of rural, 80% of urban, and 49% of 340B hospitals—would see net total payment decreases.

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.

Zachary Zalewski

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.

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