FOOD SAFETY & INFECTIOUS DISEASES
New Reimbursement Limits on Respiratory Viral,
GIP Panels: Will They Impact Detection, Surveillance of Foodborne
and Respiratory Diseases?
By Kristy Kubota, MPH, manager, PulseNet and Anna Tate, MPH, senior specialist, Respiratory Diseases
Gastrointestinal Pathogen Panel Palmetto
Local Coverage Determination
GIP testing limited to up to five bacterial
pathogens: Salmonella, Campylobacter,
Shigella, Cryptosporidium, and STEC
(O157 and non O157). If Clostridium
difficile colitis is of concern, the contractor
will cover up to 11 targets if Clostridium
difficile is one of the organisms tested.
Salmonella
Since 2013, several manufacturers have
received FDA clearance of culture-
independent diagnostic tests (CIDTs)
for the detection of viral, bacterial and
parasitic agents involved in an array of
respiratory and enteric diseases. While
there is inherent utility of CIDT panels
for both clinical management and public
health surveillance, adoption of CIDTs
presents new challenges and warrants
careful scientific consideration within
a jurisdiction. Moreover, manufacturers
have added new analytes to these panels
over time, sometimes without clearly
demonstrating added benefit or clinical
utility.
Antiquated reimbursement policies
focused on per-analyte fees are not
well adapted. Since the Centers for
Medicare and Medicaid Services (CMS)
and private insurance entities regulate
clinical laboratories’ billing, they
ultimately determine which diseases and
conditions are covered (i.e., reimbursed)
under national and local purviews. This
was notable in several recent coverage
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LAB MATTERS Winter 2019
determinations for respiratory viral and
foodborne gastrointestinal pathogen (GIP)
panels. 1. Expand coverage for respiratory
viral assays when determined to be
clinically warranted
Proposed Reimbursement
of NAATs: Local Coverage
Determinations 2. Consider per-panel (rather than
per-pathogen) reimbursement
In 2017 and 2018, a number of Medicare
Administrative Contractors (MACs) issued
molecular diagnostic (MolDX) draft local
coverage determinations (dLCDs) for
reimbursement of both respiratory viral
and GIP panels identified by the most
common type of CIDT–multiplex nucleic
acid amplification tests (NAATs). Draft
LCDs for viral respiratory panels were
issued across multiple reimbursement
jurisdictions, indicating a non-coverage
policy. Similarly, draft LCD proposals for
GIP panels limited coverage to just five
bacterial targets.
In response to these dLCDs, APHL joined
partner organizations to submit letters
during the public open comment period
urging MACs to:
3. Consider the public health impact
when making LCDs concerning
pathogens of public health significance
4. Expand GIP panel coverage to the
top 90-95% of foodborne infections
considered medically necessary for
therapeutic decision-making.
Impact of Final Ruling on Clinical
and Public Health Labs
In September 2018, one of these MACs,
Palmetto, issued a response to public
comments, citing that respiratory
viral panels do not meet Medicare’s
“reasonable and necessary” criteria and
that public health surveillance testing
does not qualify as a Medicare benefit. In
October 2018, Palmetto issued final LCDs
for respiratory viral panels, allowing for
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