LCD

Enteral Nutrition LCD

Revision Effective Date: 01/01/2024

COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:

• Added: “and document an affirmative response” to language that pertains to contact with the beneficiary or caregiver/designee for DMEPOS products supplied as refills
• Revised: “approaching exhaustion” to “expected to end” in regard to existing supplies
• Revised: “Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date.” to “Contact with the beneficiary or designee regarding refills must take place no sooner than 30 calendar days prior to the expected end of the current supply.”
• Revised: “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product.” to “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the expected end of the current supply.”

12/14/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates to refill requirement information per CMS Final Rule CMS-1780-F.

LCD

External Breast Prostheses LCD

Revision Effective Date: 01/01/2024

COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:

• Added: “and document an affirmative response” to language that pertains to contact with the beneficiary or caregiver/designee for DMEPOS products supplied as refills
• Revised: “approaching exhaustion” to “expected to end” in regard to existing supplies
• Revised: “Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date.” to “Contact with the beneficiary or designee regarding refills must take place no sooner than 30 calendar days prior to the expected end of the current supply.”
• Revised: “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product.” to “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the expected end of the current supply.”

12/14/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates to refill requirement information per CMS Final Rule CMS-1780-F.

LCD

External Infusion Pumps LCD

Revision Effective Date: 01/01/2024

COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:

• Added: “and document an affirmative response” to language that pertains to contact with the beneficiary or caregiver/designee for DMEPOS products supplied as refills
• Revised: “approaching exhaustion” to “expected to end” in regard to existing supplies
• Revised: “Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date.” to “Contact with the beneficiary or designee regarding refills must take place no sooner than 30 calendar days prior to the expected end of the current supply.”
• Revised: “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product.” to “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the expected end of the current supply.”

12/14/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates to refill requirement information per CMS Final Rule CMS-1780-F.

LCD

Glucose Monitors LCD

Revision Effective Date: 01/01/2024

COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:

• Added: “and document an affirmative response” to language that pertains to contact with the beneficiary or caregiver/designee for DMEPOS products supplied as refills
• Revised: “approaching exhaustion” to “expected to end” in regard to existing supplies
• Revised: “Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date.” to “Contact with the beneficiary or designee regarding refills must take place no sooner than 30 calendar days prior to the expected end of the current supply.”
• Revised: “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product.” to “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the expected end of the current supply.”

12/14/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates to refill requirement information per CMS Final Rule CMS-1780-F.

LCD

Immunosuppressive Drugs LCD

Revision Effective Date: 01/01/2024

COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:

• Added: “and document an affirmative response” to language that pertains to contact with the beneficiary or caregiver/designee for DMEPOS products supplied as refills
• Revised: “approaching exhaustion” to “expected to end” in regard to existing supplies
• Revised: “Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date.” to “Contact with the beneficiary or designee regarding refills must take place no sooner than 30 calendar days prior to the expected end of the current supply.”
• Revised: “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product.” to “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the expected end of the current supply.”

12/14/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates to refill requirement information per CMS Final Rule CMS-1780-F

LCD

Intravenous Immune Globulin LCD

Revision Effective Date: 01/01/2024

COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:

• Added: “and document an affirmative response” to language that pertains to contact with the beneficiary or caregiver/designee for DMEPOS products supplied as refills
• Revised: “approaching exhaustion” to “expected to end” in regard to existing supplies
• Revised: “Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date.” to “Contact with the beneficiary or designee regarding refills must take place no sooner than 30 calendar days prior to the expected end of the current supply.”
• Revised: “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product.” to “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the expected end of the current supply.”

12/14/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates to refill requirement information per CMS Final Rule CMS-1780-F.

LCD

Lower Limb Prostheses LCD

Revision Effective Date: 10/01/2023

HCPCS CODES:

• Added: HCPCS code L5991

12/14/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates per CMS HCPCS coding determinations.

PA

Lower Limb Prostheses PA

Revision Effective Date: 10/01/2023

CODING GUIDELINES:

• Added: “PROSTHETIC CONNECTORS”
• Added: HCPCS code L5991 coding guideline information
• Added: “L5614” to the HCPCS codes listed in reference to addition codes for exoskeletal knee-shin systems
• Added: HCPCS code L5845 coding guideline information
• Added: HCPCS code L5848 coding guideline information
• Revised: HCPCS code L5982 coding guideline information, to include “Motion of this product is separate from any similar incidental prosthetic foot/ankle motions."
• Revised: HCPCS code L5984 coding guideline information, to include “Motion of this product is separate from any similar incidental prosthetic foot/ankle motions."

12/14/2023: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

LCD

Nebulizers LCD

Revision Effective Date: 01/01/2024

COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:

• Added: “and document an affirmative response” to language that pertains to contact with the beneficiary or caregiver/designee for DMEPOS products supplied as refills
• Revised: “approaching exhaustion” to “expected to end” in regard to existing supplies
• Revised: “Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date.” to “Contact with the beneficiary or designee regarding refills must take place no sooner than 30 calendar days prior to the expected end of the current supply.”
• Revised: “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product.” to “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the expected end of the current supply.”

12/14/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates to refill requirement information per CMS Final Rule CMS-1780-F.

LCD

Negative Pressure Wound Therapy Pumps LCD

Revision Effective Date: 01/01/2024

COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:

• Added: “and document an affirmative response” to language that pertains to contact with the beneficiary or caregiver/designee for DMEPOS products supplied as refills
• Revised: “approaching exhaustion” to “expected to end” in regard to existing supplies
• Revised: “Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date.” to “Contact with the beneficiary or designee regarding refills must take place no sooner than 30 calendar days prior to the expected end of the current supply.”
• Revised: “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product.” to “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the expected end of the current supply.”

12/14/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates to refill requirement information per CMS Final Rule CMS-1780-F.

LCD

Oral Anticancer Drugs LCD

Revision Effective Date: 01/01/2024

COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:

• Added: “and document an affirmative response” to language that pertains to contact with the beneficiary or caregiver/designee for DMEPOS products supplied as refills
• Revised: “approaching exhaustion” to “expected to end” in regard to existing supplies
• Revised: “Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date.” to “Contact with the beneficiary or designee regarding refills must take place no sooner than 30 calendar days prior to the expected end of the current supply.”
• Revised: “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product.” to “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the expected end of the current supply.”

12/14/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates to refill requirement information per CMS Final Rule CMS-1780-F.

LCD

Oral Antiemetic Drugs (Replacement for Intravenous Antiemetics) LCD

Revision Effective Date: 01/01/2024

COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:

• Added: “and document an affirmative response” to language that pertains to contact with the beneficiary or caregiver/designee for DMEPOS products supplied as refills
• Revised: “approaching exhaustion” to “expected to end” in regard to existing supplies
• Revised: “Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date.” to “Contact with the beneficiary or designee regarding refills must take place no sooner than 30 calendar days prior to the expected end of the current supply.”
• Revised: “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product.” to “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the expected end of the current supply.”

12/14/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates to refill requirement information per CMS Final Rule CMS-1780-F.

LCD

Osteogenesis Stimulators LCD

Revision Effective Date: 01/01/2024

COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:

• Added: “and document an affirmative response” to language that pertains to contact with the beneficiary or caregiver/designee for DMEPOS products supplied as refills
• Revised: “approaching exhaustion” to “expected to end” in regard to existing supplies
• Revised: “Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date.” to “Contact with the beneficiary or designee regarding refills must take place no sooner than 30 calendar days prior to the expected end of the current supply.”
• Revised: “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product.” to “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the expected end of the current supply.”

12/14/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates to refill requirement information per CMS Final Rule CMS-1780-F.

LCD

Ostomy Supplies LCD

Revision Effective Date: 01/01/2024

COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:

• Added: “and document an affirmative response” to language that pertains to contact with the beneficiary or caregiver/designee for DMEPOS products supplied as refills
• Revised: “approaching exhaustion” to “expected to end” in regard to existing supplies
• Revised: “Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date.” to “Contact with the beneficiary or designee regarding refills must take place no sooner than 30 calendar days prior to the expected end of the current supply.”
• Revised: “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product.” to “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the expected end of the current supply.”

12/14/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates to refill requirement information per CMS Final Rule CMS-1780-F.

LCD

Parenteral Nutrition LCD

Revision Effective Date: 01/01/2024

COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:

• Added: “and document an affirmative response” to language that pertains to contact with the beneficiary or caregiver/designee for DMEPOS products supplied as refills
• Revised: “approaching exhaustion” to “expected to end” in regard to existing supplies
• Revised: “Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date.” to “Contact with the beneficiary or designee regarding refills must take place no sooner than 30 calendar days prior to the expected end of the current supply.”
• Revised: “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product.” to “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the expected end of the current supply.”

SUMMARY OF EVIDENCE:

• Removed: Summary of evidence information, due to not being applicable to the non-discretionary changes

ANALYSIS OF EVIDENCE (RATIONALE FOR DETERMINATION):

• Removed: Analysis of evidence information, due to not being applicable to the non-discretionary changes

12/14/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates to refill requirement information per CMS Final Rule CMS-1780-F.

LCD

Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea LCD

Revision Effective Date: 01/01/2024

COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:

• Added: “and document an affirmative response” to language that pertains to contact with the beneficiary or caregiver/designee for DMEPOS products supplied as refills
• Revised: “approaching exhaustion” to “expected to end” in regard to existing supplies
• Revised: “Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date.” to “Contact with the beneficiary or designee regarding refills must take place no sooner than 30 calendar days prior to the expected end of the current supply.”
• Revised: “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product.” to “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the expected end of the current supply.”

12/14/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates to refill requirement information per CMS Final Rule CMS-1780-F.

LCD

Respiratory Assist Devices LCD

Revision Effective Date: 01/01/2024

COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:

• Added: “and document an affirmative response” to language that pertains to contact with the beneficiary or caregiver/designee for DMEPOS products supplied as refills
• Revised: “approaching exhaustion” to “expected to end” in regard to existing supplies
• Revised: “Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date.” to “Contact with the beneficiary or designee regarding refills must take place no sooner than 30 calendar days prior to the expected end of the current supply.”
• Revised: “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product.” to “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the expected end of the current supply.”

SUMMARY OF EVIDENCE:

• Removed: Summary of evidence information, due to not being applicable to the non-discretionary changes

ANALYSIS OF EVIDENCE (RATIONALE FOR DETERMINATION):

• Removed: Analysis of evidence information, due to not being applicable to the non-discretionary changes

12/14/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates to refill requirement information per CMS Final Rule CMS-1780-F.

PA

Standard Documentation Requirements for All Claims Submitted to DME MACs PA

Revision Effective Date: 01/01/2024

MEDICAL RECORD DOCUMENTATION:

• Revised: Supplier produced records by replacing “Supplier-produced records, even if signed by the treating practitioner, and attestation letters (e.g. letters of medical necessity) are deemed not to be part of a medical record for Medicare payment purposes.” with “Supplier prepared statements and physician attestations by themselves do not provide sufficient documentation of medical necessity, even if signed by the ordering physician.” as clarification

REFILL DOCUMENTATION REQUIREMENTS:

• Removed: “either a written document received from the beneficiary or a contemporaneous written record of a phone conversation/contact between the supplier and beneficiary”
• Added: “individualized to the beneficiary (i.e., the beneficiary or their caregiver/designee affirms the need for refill) and documented in the record. Medicare does not prescribe the mode of communication used to gather the information. For example, the refill request communication may be performed via automated text messaging or email as long as each required aspect of the refill request is captured.” as clarification
• Added: “Documentation of affirmative response indicating a need for refill” based on CMS Final Rule CMS-1780-F
• Removed: “For consumable supplies i.e., those that are used up (e.g., ostomy or urological supplies, surgical dressings, etc.) the supplier must assess the quantity of each item that the beneficiary still has remaining to document that the amount remaining will be nearly exhausted on or about the supply anniversary date.” based on CMS Final Rule CMS-1780-F
• Removed: “For non-consumable supplies i.e., those more durable items that are not used up but may need periodic replacement (e.g., PAP and RAD supplies) the supplier must assess whether the supplies remain functional, providing replacement (a refill) only when the supply item(s) is no longer able to function. The supplier must document the functional condition of the item(s) being refilled in sufficient detail to demonstrate the cause of the dysfunction that necessitates replacement (refill).” based on CMS Final Rule CMS-1780-F

12/14/2023: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

LCD

Suction Pumps LCD

Revision Effective Date: 01/01/2024

COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:

• Added: “and document an affirmative response” to language that pertains to contact with the beneficiary or caregiver/designee for DMEPOS products supplied as refills
• Revised: “approaching exhaustion” to “expected to end” in regard to existing supplies
• Revised: “Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date.” to “Contact with the beneficiary or designee regarding refills must take place no sooner than 30 calendar days prior to the expected end of the current supply.”
• Revised: “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product.” to “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the expected end of the current supply.”

12/14/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates to refill requirement information per CMS Final Rule CMS-1780-F.

LCD

Surgical Dressings LCD

Revision Effective Date: 01/01/2024

COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:

• Added: “and document an affirmative response” to language that pertains to contact with the beneficiary or caregiver/designee for DMEPOS products supplied as refills
• Revised: “approaching exhaustion” to “expected to end” in regard to existing supplies
• Revised: “Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date.” to “Contact with the beneficiary or designee regarding refills must take place no sooner than 30 calendar days prior to the expected end of the current supply.”
• Revised: “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product.” to “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the expected end of the current supply.”

12/14/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates to refill requirement information per CMS Final Rule CMS-1780-F.

LCD

Tracheostomy Care Supplies LCD

Revision Effective Date: 01/01/2024

COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:

• Added: “and document an affirmative response” to language that pertains to contact with the beneficiary or caregiver/designee for DMEPOS products supplied as refills
• Revised: “approaching exhaustion” to “expected to end” in regard to existing supplies
• Revised: “Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date.” to “Contact with the beneficiary or designee regarding refills must take place no sooner than 30 calendar days prior to the expected end of the current supply.”
• Revised: “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product.” to “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the expected end of the current supply.”

12/14/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates to refill requirement information per CMS Final Rule CMS-1780-F.

LCD

Transcutaneous Electrical Nerve Stimulators (TENS) LCD

Revision Effective Date: 01/01/2024

COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:

• Added: “and document an affirmative response” to language that pertains to contact with the beneficiary or caregiver/designee for DMEPOS products supplied as refills
• Revised: “approaching exhaustion” to “expected to end” in regard to existing supplies
• Revised: “Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date.” to “Contact with the beneficiary or designee regarding refills must take place no sooner than 30 calendar days prior to the expected end of the current supply.”
• Revised: “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product.” to “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the expected end of the current supply.”

12/14/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates to refill requirement information per CMS Final Rule CMS-1780-F.

LCD

Urological Supplies LCD

Revision Effective Date: 01/01/2024

COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:

• Added: “and document an affirmative response” to language that pertains to contact with the beneficiary or caregiver/designee for DMEPOS products supplied as refills
• Revised: “approaching exhaustion” to “expected to end” in regard to existing supplies
• Revised: “Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date.” to “Contact with the beneficiary or designee regarding refills must take place no sooner than 30 calendar days prior to the expected end of the current supply.”
• Revised: “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product.” to “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the expected end of the current supply.”

12/14/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates to refill requirement information per CMS Final Rule CMS-1780-F.