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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 proposed rule would reduce administrative burden for new
innovative technologies Today, under the leadership of President Trump, the Centers for
Medicare & Medicaid Services (CMS), is proposing 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. Today’s 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, today’s 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 Food and Drug Administration (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
healthcare 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 healthcare 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 a fact sheet on the CY 2021 proposed rule (CMS-1738-P),
please visit: https://www.cms.gov/newsroom/fact-sheets/medicare-cy-2021-durable-medical-equipment-prosthetics-orthotics-and-supplies-dmepos-policy-issues. Download the proposed rule at: https://www.cms.gov/files/document/cms-1738-p-dmepos.pdf. ### Get CMS news at cms.gov/newsroom, sign up for CMS news via email
and follow CMS on Twitter CMS Administrator @SeemaCMS and @CMSgov |
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Tuesday, October 27, 2020
New CMS Proposals Streamline Medicare Coverage, Payment, and Coding for Innovative New Technologies and Provide Beneficiaries with Diabetes Access to More Therapy Choices
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