Summer 2019: Policy Changes Hold Potential to Reshape Healthcare Landscape
I’m Charline Shan, Vice President, Access Experience Team, editor of All Access, I hope to bring you noteworthy and groundbreaking news to Precision for Value’s bimonthly newsletter by sharing the latest payer insights brought to you by our team of ex-payers.
As we head into the lazy days of summer, the Administration is feverishly passing guidance to drive the agenda of President Trump’s American Patient First Blueprint. The policies aim to drive patient affordability and reduce federal spending, and directly impact manufacturers and payers in varying degrees. But with pushback from various industry stakeholders and a court ruling, some of the policies are dead in the water or on hold. Todd Edgar assesses the impact of the White House reverting their push to sunset rebates in government-sponsored programs; Kellie Rademacher examines CMS’s guidance on copay accumulators in health care exchanges; Erin Lopata, the newest member of AET, reviews the FDA guidance on biosimilar interchangeability; and Jeremy Schafer shares with us the effect on the court ruling that blocks drug prices in DTC advertisements.
Drop me a note if you’d like to talk to me or any of our Access Experience Team members about securing greater access for your treatment. Until then, enjoy your reading!
Warm Regards,
Charline Shan
Charline Shan, RPh, MPH
Vice President, Access
Experience Team
EMAIL CHARLINE
All Access is a bimonthly newsletter that features key insights from our team of former payers, intended specifically for market access leaders. It is published by Precision for Value.
Guest Editor
Charline Shan
Executive Editor
Louis Landon
Contributors
Andrew Cournoyer
Ryan Cox
Dan Danielson
Todd Edgar
Dominic Galante
Ami Gopalan
Joe Honcz
Louis Landon
Elizabeth Oyekan
Jeremy Schafer
Erin Lopata
Kellie Rademacher
Rebate Safe Harbor Proposal Evolution
With the Trump Administration’s recent withdrawal of their proposal to modify the rebate safe harbor, what do manufacturers need to know in preparing for the future? Todd Edgar reviews the history of the proposal and offers some advice.
CMS Guidance Accepts Use of Copay Accumulator Programs in Healthcare Exchanges
The CMS has announced that individual markets, small and large group, and self-insured group health plans will be allowed to implement copay accumulator programs starting in 2020. What does this mean for market access? Kellie Rademacher provides an overview.
The Latest on Biosimilar Interchangeability
In May 2019, the FDA released guidance to clarify the level of evidence required from manufacturers to support interchangeability between a biosimilar and the reference product. Erin Lopata explains how this may impact stakeholders, and how price and utilization could be influenced by increased competition in the biologics market.
Drug Pricing Transparency: Planning for the Future
The HHS final rule requiring inclusion of price into all televised DTC for pharmaceuticals reimbursable under Medicare/Medicaid that have a cost greater than $35 per month was to begin this July, but manufacturers may have won a reprieve with an initial court ruling that HHS overstepped its bounds. Jeremy Schafer takes a look at the implications of this ruling, the proposed new policy, and how manufacturers can mitigate some of the risks.