West Virginia Bill Seeks to Regulate Parity and Out-of-State
Providers
On February 10, 2021, members of the West Virginia Legislature
introduced
Senate Bill 1 ( SB1 ) which seeks to regulate the use
of telemedicine in the state. If passed, the proposed bill would
require the Public Employees Insurance Agency, Medicaid and
specified insurance plans to cover telehealth services at the same
rate as in-person healthcare, starting July 1, 2021. The bill would
also permit healthcare providers who are licensed in other states
to provide telehealth services in West Virginia.
Like many other states during the public health emergency, in an
effort to reduce the potential exposure to the COVID-19 virus, West
Summary Takeaways:
Payment misalignment in Medicare FFS for Substance Use Disorder
(SUD) treatment as the subject of potential legislative and/or
regulatory reforms
New opportunities for investor-backed behavioral health
platforms in Medicare Advantage and other value-based
arrangements
New possible focus areas for health plans with expertise in
Medicaid managed care to expand into Medicare managed care models
for SUD treatment
The opioid epidemic has been further fueled by the COVID-19
pandemic and a recently published report by the Legal Action Center
(entitled Medicare Coverage of Substance Use Disorder Care:
A Landscape Review of Benefit Coverage, Service Gaps, and a Path to
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Sunday, February 28, 2021, was Rare Disease Day. With so much
focus on COVID-19 throughout 2020, it s important to recognize
the continued work done in rare disease drug development by
sponsors and FDA throughout 2020. In addition, a number of policies
implemented in response to COVID-19 are expected to have a positive
impact on rare disease drug development going forward. Yet, the
lasting nature of these policies, post-pandemic, remains uncertain,
creating an opportunity for rare disease drug sponsors to be
proactive in engaging with regulatory authorities and the patient
VISTITAN (
Allergan Inc v Alberta (Justice and
Solicitor General), 2021 ABCA 32.
Alberta Health concluded that VISTITAN was interchangeable with
LUMIGAN RC on the basis that LUMIGAN RC had previously been listed
as interchangeable with another Allergan bimatoprost product with
the same concentration as
VISTITAN:
LUMIGAN (
0.03%
bimatoprost).
On judicial review (reported
here), the reviewing Court agreed that Alberta Health s
decision was unreasonable, but the judicial review was nonetheless
dismissed as not pertaining to the most final or recent decision on
interchangeability. The Court concluded that Allergan ought to have
sought judicial review of Alberta Health s later decision on
Allergan s resubmission for LUMIGAN RC, which the Court
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Historically pharmaceutical companies turned to contract
manufacturers for achieving efficiencies in cost, capacity and
time-to-market, or to obtain specific expertise not available
in-house. However, the increment in outsourcing of manufacture is
driven, at least in part, by the fact that contract manufacturers
have increasingly developed innovative proprietary processes and
implemented technology that may well surpass that available at the
pharmaceutical client s own facilities. Moreover, nowadays few
pharmaceuticals are made in dedicated plants and key intermediates
and active compounds can be made in general-purpose plants.