February 25, 2021
Proposed Local Coverage Determinations (LCDs) Released for Comment – Enteral Nutrition, Oral Appliances for Obstructive Sleep Apnea, Parenteral Nutrition, Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea, and Respiratory Assist Devices
The Centers for Medicare and Medicaid Services (CMS) assigned to the Durable Medical Equipment Medicare Administrative Contractors (DME MACs) the task of developing LCDs for Durable Medical Equipment, Prostheses, Orthoses, and Supplies (DMEPOS). The DME MACs are proposing five LCDs as described below:
- Enteral Nutrition (DL38955) – Proposed LCD for enteral nutrition.
- Oral Appliances for Obstructive Sleep Apnea (DL33611) – Removed language related to home sleep testing devices. The DME MAC LCD will defer to the CMS NCD 240.4.1 and the A/B MAC.
- Parenteral Nutrition (DL38953) – Proposed LCD for parenteral nutrition.
- Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea (DL33718) – Removed language related to home sleep testing devices. The DME MAC LCD will defer to the CMS NCD 240.4.1 and the A/B MAC.
- Respiratory Assist Devices (DL33800) – Removed language related to home sleep testing devices. The DME MAC LCD will defer to the CMS NCD 240.4.1 and the A/B MAC.
Stakeholders may read the details of the proposed LCDs posted on the Medicare Coverage Database by referencing the LCD ID number in the search field. The entire proposed LCD should be completely reviewed prior to the submission of written comments.
We are soliciting comments on these proposed LCDs from clinicians, manufacturers, suppliers, and other stakeholders who care for Medicare beneficiaries. You should be very specific in your comments, and if possible, offer suggestions that may address your concerns. You should provide an evidence-based rationale for your comments, and attach any full-text references from the published clinical literature (e.g. peer-reviewed journals, clinical society guidelines, etc.) that were not included in the bibliography of the proposed LCDs. We encourage a written response regardless of your agreement or disagreement with the proposed LCDs.
All comments will be collected at a single point of contact for each proposed LCD. Comments that address more than one proposed LCD should be submitted to each LCD email address for which comments are being made. Do not include any protected health information (PHI) or personally identifiable information (PII). Please submit your comments electronically to the DME MACs at the email addresses below no later than Saturday, April 10, 2021 at 5 pm ET.
Enteral Nutrition (DL38955): ENTLCDComments@cgsadmin.com
Oral Appliances for Obstructive Sleep Apnea (DL33611): OAOSARecon@noridian.com
Parenteral Nutrition (DL38953): PENRecon@noridian.com
Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea (DL33718): PAPLCDComments@cgsadmin.com
Respiratory Assist Devices (DL33800): RADRecon@noridian.com
Suppliers and clinicians are cautioned not to make any changes based upon the information contained in a proposed LCD, as the revisions posed in a proposed LCD may be further revised or otherwise updated based upon the comments received. When all comments have been reviewed, revisions will be considered. A “Response to Comments” document will be published with the final LCDs. The final LCDs will be published in the CMS Medicare Coverage Database and accessible on individual DME MAC websites, allowing for a minimum 45-day notice period before the final LCDs are effective.
*IMPORTANT: The DME MACs will host open meetings to further solicit input from stakeholders for each of the proposed LCDs. These meetings will take place on March 30, 2021. For details regarding participation in the open meetings, refer to the Open Meeting Announcement articles posted at https://www.cgsmedicare.com/jc/coverage/tracking.html.
Refer to each DME MAC web site for additional information, including access to the proposed LCDs.
Thank you for your participation in our policy development process.
Smitha M. Ballyamanda, MD, CAQSM |
Stacey V. Brennan, MD, FAAFP |
Robert D. Hoover, Jr., MD, MPH, FACP |
Peter J. Gurk, MD, CPE, CHCQM |