LSHC Horizons Brochure 2024 - Flipbook - Page 92
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | United States
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Medicare and HCT/P skin substitute products: Uncertainty persists as the
Medicare agency eyes sweeping changes to coverage and reimbursement
The Medicare program continues to explore
comprehensive changes to its policies
surrounding human cells, tissues, and cellular
and tissue-based (HCT/P) skin substitute
products. In recent years, the Centers for
Medicare & Medicaid Services (CMS) and its
Medicare contractors have considered (but
ultimately not finalized) sweeping changes both
to coverage and reimbursement for this class of
regenerative medicines.
Most recently, this past summer, three
Medicare contractors issued Local Coverage
Determinations (LCDs) that would have
imposed dramatic coverage restrictions on skin
substitutes—including limiting the frequency
with which they could be administered.
Further, in policy articles associated with
the LCDs, the contractors designated certain
HCT/Ps as categorically non-covered, while
permitting coverage of other, similarly
situated products.
These LCDs and their associated coverage
restrictions had originally been scheduled
to take effect on 1 October 2023, but were
ultimately withdrawn following widespread
criticism from industry and patients. In
addition to procedural irregularities, the
LCDs included restrictions that appeared
inconsistent with the scientific principles under
which these products function, as well as the
FDA regulatory framework surrounding HCT/
Ps. For example, the LCDs drew a seemingly
arbitrary distinction between similarly situated
HCT/P skin substitute products based on
James Huang
Partner
Washington, D.C.
whether a given product acted as “scaffolding”,
while failing to recognize that all appropriately
applied, sheet-based HCT/Ps necessarily act
as a form of scaffold. Likewise, the contractors’
LCDs appeared to misunderstand the purpose
and function of the advisory letters issued by
the FDA’s Tissue Reference Group for HCT/Ps.
Although these most recent coverage
restrictions are currently withdrawn, there
continues to be great uncertainty surrounding
how HCT/P skin substitute products will
be covered and paid in future years. Even
following the withdrawal of the recent LCDs,
CMS and its contractors have continued to
signal strong interest in reworking the policies
governing these products. Following the
withdrawal of the summer LCDs, the Medicare
contractors have stated they intend to publish
new proposed LCDs “in the near future”.
Similarly, CMS has—for multiple years—
solicited comment on potentially sweeping
changes to the payment policies surrounding
skin substitutes, including ending separate
payment for skin substitute products furnished
in physician offices.
Industry should continue closely to monitor
for new developments impacting Medicare
coverage and reimbursement of skin
substitutes. Scrutiny surrounding skin
substitutes has dramatically increased in recent
years, and the agency has a strong interest
in rethinking its approaches to how these
technologies are covered and paid.
Randy J. Prebula
Partner
Washington, D.C.
Beth L. Roberts
Partner
Washington, D.C.
