In a joint publication from the Durable Medical Equipment Medicare Administrative Contractors, the Centers for Medicare & Medicaid Services (CMS) revised the coding for Healthcare Common Procedure Coding System (HCPCS) codes for articulating digits and prosthetic hands.
The revision begins by defining HCPCS code L-6026 (Transcarpal/metacarpal or partial hand disarticulation prosthesis, external power, self-suspended, inner socket with removable forearm section, electrodes and cables, two batteries, charger, myoelectric control of terminal device, excludes terminal device(s)). It says that L-6026 describes a base code for a transcarpal/metacarpal or a partial hand disarticulation, myoelectric-controlled prosthesis which includes all necessary components besides the terminal device.
According to the revision, there are five external powered terminal devices available to be used with L-6026.
- L-6715 (Terminal device, multiple articulating digit, includes motor(s), initial issue or replacement)
HCPCS code L-6715 describes one complete multiple articulating digit (finger or thumb) and the necessary motors. If more than one digit is billed, use the appropriate Units of Service (UOS) for code L-6715. With initial issue, L-6715 is only to be paired with L-6026; however, the articulating digit(s) can also be used as a “replacement digit(s)” with the use of the RB modifier as part of a prosthetic repair.
- L-6880 (Electric hand, switch or myolelectric controlled, independently articulating digits, any grasp pattern or combination of grasp patterns, includes motor(s))
HCPCS code L-6880 describes a complete terminal device that can only be used with HCPCS code L-6026 when a partial hand residual limb contains no digits. HCPCS code L-6880 has all the following characteristics:
o Includes all necessary components. This L-code describes a product that is all-inclusive. Billing of any additional features or functions used to describe a manufacturer’s terminal device is considered unbundling.
o Comprised of five (5) articulating digits and the necessary motors.
o All grasp patterns are included in the L6880 HCPCS code language. The use of HCPCS code L-6881 (Automatic grasp feature, addition to upper limb electric prosthetic terminal device) would be considered unbundling.
o All switch/myoelectric controls are included in L-6880 HCPCS code language. The use of code L6882 (Microprocessor control feature, addition to upper limb prosthetic terminal device) would be considered unbundling.
o Use of HCPCS code L-6880 is only appropriate with externally powered custom fabricated sockets such as HCPCS codes L-6026, L-6920, L-6925, L-6930, L-6935, L-6940, L-6945, L-6950, L-6955, L-6960, L-6965, L-6970, and L-6975.
o The use of HCPCS code L-6715 on initial issue will be denied as unbundling. However, the articulating digit(s) can also be used as a “replacement digit(s)” with the use of the RB modifier as part of a prosthetic repair.
o If L-6880 is under the manufacturer’s warranty, HCPCS code L-6715 as a replacement should not be billed to Medicare.
- L-7007 (Electric hand, switch or myoelectric controlled, adult)
- L-7008 (Electric hand, switch or myoelectric controlled, pediatric)
- L-7009 (Electric hook, switch or myoelectric controlled, adult)
Billing of more than one terminal device with HCPCS code L-6026 is considered incorrect coding.
HCPCS code L-7499 (upper extremity prosthesis, not otherwise specified) must not be used for the billing of any additional features or components, programming, adjustment, etc. with HCPCS codes L-6026, L-6715, L-6880, or L-7007-L-7009 as these codes are considered all-inclusive. The use of HCPCS code L-7499 on initial issue, with the any of the above HCPCS codes, is considered unbundling, according to the announcement.
CMS Repeals Reasonable and Necessary Rule
CMS rescinded the Medicare Coverage of Innovative Technology and Definition of Reasonable and Necessary (MCIT/R&N) final rule due to concerns that the provisions in the final rule may not have been sufficient to protect Medicare patients. The MCIT/R&N final rule would have granted expedited Medicare coverage for up to four years for certain Food and Drug Administration (FDA)-designated “breakthrough” devices once they received or cleared market authorization. However, the kinds of clinical studies needed for FDA market authorization might not have considered the differences in clinical profiles, complexities of medical conditions, or associated treatments of the diverse population of Medicare patients.
By overturning this rule, CMS says it can now take action that will better address those safety concerns in the future.
“Although we continue to be in favor of enhancing access to new technologies, we are mindful that they may have unknown or unexpected risks and must first ensure such technologies improve health outcomes for Medicare beneficiaries,” said Chiquita Brooks-LaSure, CMS administrator. “The Medicare program needs to implement policies that balance access and appropriate safeguards.”
CMS said it intends to explore coverage process improvements that will enhance access to innovative and beneficial medical devices in a way that will better suit the healthcare needs of people with Medicare. This will also help to establish a process in which the Medicare program covers new technologies on the basis of scientifically sound clinical evidence, with appropriate health and safety protections in place for the Medicare population.
“CMS is committed to coverage that provides an appropriate balance of support for innovation with necessary protections for Medicare patients,” said Lee Fleisher, MD, CMS chief medical officer and director for the Center for Clinical Standards and Quality (CCSQ). “Under the rule we are repealing, CMS may have covered devices without adequate evidence to demonstrate that the device would be reasonable and necessary to diagnose or treat the Medicare population for particular medical conditions.”
Devices may still be covered through claim-by-claim determinations, under one or more local coverage determinations, or a national coverage determination. CMS plans to work with the FDA, Agency for Healthcare Research and Quality, medical device manufacturers, and other stakeholders to develop an expeditious process to cover innovative devices that benefit Medicare patients, and it intends to hold at least two stakeholder public meetings in 2022.
To read the rule, visit the Federal Register.