CENTERS FOR MEDICARE &
MEDICAID SERVICES (CMS) Special
Edition – Tuesday, October 27, 2020
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New CMS Proposals Streamline Medicare
Coverage, Payment, and Coding for Innovative New Technologies and Provide
Beneficiaries with Diabetes Access to More Therapy Choices
Durable Medical Equipment (DME) proposed rule
would reduce administrative burden for new innovative technologies On October 27, under the leadership of
President Trump, CMS proposed new changes to Medicare Durable Medical
Equipment, Prosthetics, Orthotic Devices, and Supplies (DMEPOS) coverage and
payment policies. This rule would provide more choices for beneficiaries with
diabetes, while streamlining the process for innovators in getting their
technologies approved for coverage, payment, and coding by Medicare. The proposed rule would expand the
interpretation regarding when external infusion pumps are appropriate for use
in the home and can be covered as DME under Medicare Part B, increasing
access to drug infusion therapy services in the home. The proposed rule also
drastically reduces administrative burdens – such as complicated government
coverage, payment, and coding processes – that block innovators from getting
their products to Medicare beneficiaries in a timely manner. This action
aligns with President Trump’s Executive Order on Protecting and Improving
Medicare for Our Nation’s Seniors. “With the policies outlined in this proposed
rule, innovators have a much more predictable path to understanding the kinds
of products that Medicare will pay for,” said CMS Administrator Seema Verma.
“For manufacturers, bringing a new product to market will mean they can get a
Medicare payment amount and billing code right off the bat, resulting in
quicker access for Medicare beneficiaries to the latest technological
advances and the most, cutting-edge devices available. It’s clearly a win-win
for patients and innovators alike.” Due to administrative constraints, the
process for making Medicare benefit classifications, pricing determinations,
and creating billing codes for DMEPOS used to routinely take up to 18 months
to complete. Last year, CMS changed this process through sub-regulatory
guidance to reduce that timeframe to six months in many cases, and is now
proposing to establish a streamlined process for coding, coverage, and
payment in regulation. Under this accelerated process, benefit classification
and pricing decisions could happen on the same day the billing codes used for
payment of new items take effect, which would facilitate seamless coverage
and payment for new DMEPOS and services. If finalized, this proposed rule
would allow innovators to bring their products to Medicare beneficiaries
quicker giving them more choices and increased access to the latest,
cutting-edge devices. If finalized, this proposed rule will also
expand Medicare coverage and payment for Continuous Glucose Monitors (CGMs)
that provide critical information on blood glucose levels to help patients
with diabetes manage their disease. Currently, CMS only covers therapeutic
CGMs or those approved by the FDA for use in making diabetes treatment
decisions, such as changing one's diet or insulin dosage based solely on the
readings of the CGM. CMS is proposing to classify all CGMs (not
just limited to therapeutic CGMs) as DME and establish payment amounts for
these items and related supplies and accessories. CGMs that are not approved
for use in making diabetes treatment decisions can be used to alert
beneficiaries about potentially dangerous glucose levels while they sleep and
that they should further test their glucose levels using a blood glucose
monitor. With one in every three Medicare beneficiaries having diabetes, this
proposal would give Medicare beneficiaries and their physicians a wider range
of technology and devices to choose from in managing diabetes. This proposal
will improve access to these medical technologies and empower patients to
make the best health care decisions for themselves. In addition, the proposed rule would expand
classification of external infusion pumps under the DME benefit making home
infusion of more drugs possible for beneficiaries. An external infusion pump
is a medical device used to deliver fluids such as nutrients or medications
into a patient’s body in a controlled manner. The proposal would expand
classification of external infusion pumps as DME in cases where assistance
from a skilled home infusion therapy supplier is necessary for safe infusion
in the home, allowing beneficiaries more choices to get therapies at home
instead of traveling to a health care facility. Lastly, in the proposed rule, CMS proposes to
continue to pay higher amounts to suppliers for DMEPOS items and services
furnished in rural and non-contiguous areas to encourage suppliers to provide
access and choices for beneficiaries living in those areas. CMS is making
this proposal based on previous stakeholder feedback that indicate unique
challenges and higher costs for providing for DMEPOS items for beneficiaries
in rural and remote areas. For More Information: Like our newsletter? Have
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