Medicare Program; Updates to the Master List of Items Potentially Subject to Face-to-Face Encounter and Written Order Prior To Delivery and/or Prior Authorization Requirements; Updates to the Required Face-to-Face and Written Order Prior To Delivery List; and Updates to the Required Prior Authorization List

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Centers for Medicare & Medicaid Services</SUBAGY> <CFR>42 CFR Parts 410 and 414</CFR> <DEPDOC>[CMS-6095-N]</DEPDOC> <SUBJECT>Medicare Program; Updates to the Master List of Items Potentially Subject to Face-to-Face Encounter and Written Order Prior To Delivery and/or Prior Authorization Requirements; Updates to the Required Face-to-Face and Written Order Prior To Delivery List; and Updates to the Required Prior Authorization List</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS). <HD SOURCE="HED">ACTION:</HD> Updates to the Master List of Items Potentially Subject to Face-To-Face Encounter and Written Order Prior to Delivery and/or Prior Authorization Requirements (the “Master List”) and updates to the Required Face-to-Face and Written Order Prior to Delivery List and the Required Prior Authorization List. <SUM> <HD SOURCE="HED">SUMMARY:</HD> This document announces the updated Healthcare Common Procedure Coding System (HCPCS) codes on the Master List. It also announces updates to the HCPCS codes on the Required Face-to-Face and Written Order Prior to Delivery List and the Required Prior Authorization List. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> Implementation of updates to the Master List and the Required Face-to-Face and Written Order Prior to Delivery List are effective on August 12, 2024. Required prior authorization of newly added lumbar-sacral orthoses and lower limb orthoses is effective nationwide on August 12, 2024. Prior authorization of newly added osteogenesis stimulators will be implemented in two phases, with phase 1 including one State per Durable Medical Equipment Medicare Administrative Contractor (DME MAC) jurisdiction on August 12, 2024. The States included in phase 1 are California, Florida, Ohio, and Pennsylvania. Phase 2 will include all remaining U.S. States and territories not included in phase 1, effective on November 12, 2024. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> For information related to the Master List or Required Prior Authorization List, contact Susan Billet, (410) 786-1062; Emily Calvert, (410) 786-4277; Justin Carlisle, (410) 786-4265; Stephanie Collins, (410) 786-0959; or Jessica Martindale, (410) 786-1558. For information related to the Required Face-to-Face Encounter and Written Order Prior to Delivery List, contact Jennifer Phillips, (410) 786-1023; Misty Whitaker, (410) 786-4975; Olufemi Shodeke, (410) 786-1649; or Cristine Egan, (410) 786-8088. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> On November 8, 2019, the Centers for Medicare & Medicaid Services (CMS) published a final rule titled, “Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule Amounts, DMEPOS Competitive Bidding Program (CBP) Amendments, Standard Elements for a DMEPOS Order, and Master List of DMEPOS Items Potentially Subject to a Face-to-Face Encounter and Written Order Prior to Delivery and/or Prior Authorization Requirements” (the November 2019 final rule) (84 FR 60648). The rule became effective January 1, 2020, harmonizing the lists of DMEPOS items created by former rules and establishing one “Master List of DMEPOS Items Potentially Subject to Face-to-Face Encounter and Written Orders Prior to Delivery and/or Prior Authorization Requirements” (the “Master List”). The Master List serves as a library of items, that have been identified as potential vulnerabilities to the Trust Fund based on criteria outlined in 42 CFR 414.234(b), from which items may be selected to be placed on either the Required Face-to-Face Encounter and Written Orders Prior to Delivery List (the “F2F/WOPD List”) and/or Required Prior Authorization List under the authority provided under sections 1834(a)(1)(E)(iv), 1834(a)(11)(B), and 1834(a)(15) of the Act. Only those items that are selected and announced via <E T="04">Federal Register</E> notice are subject to such regulatory conditions of payment. The November 2019 final rule provided that the <E T="04">Federal Register</E> notice would be for a period of no less than 60 days. It also clarified that certain items (that is, power mobility devices) require a face-to-face encounter per statute and would remain on both the Master List and the F2F/WOPD List, indefinitely. The November 2019 final rule information related to face-to-face encounters, written orders prior to delivery, and 5-element order/prescription for specified DMEPOS items was codified in 42 CFR 410.38. The information in the November 2019 final rule related to the creation and maintenance of the Master List is codified at 42 CFR 414.234. The November 2019 final rule also includes information related to the prior authorization process, as initially outlined in the December 30, 2015 final rule titled “Medicare Program; Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, and Supplies” (80 FR 81674). The Master List was last updated in 2022 and currently includes 439 items. In 2022 and 2023, CMS published the first and second iterations of the Required Face-to-Face Encounter and Written Orders Prior to Delivery List, respectively. There are currently 63 items on the list, including 46 power mobility devices that were included per statute. The Required Prior Authorization List was last updated in 2022 and currently includes 62 items. All the lists discussed in this notice are available on the <E T="03">cms.gov</E> website. <HD SOURCE="HD1">II. Provisions of the Document</HD> This document serves to update three separate lists. First, it provides an update to the Master List. Next, this document updates the items included on the Required Face-to-Face and Written Order Prior to Delivery List. Finally, this document updates items included on the Required Prior Authorization List. <HD SOURCE="HD2">A. Master List</HD> The Master List includes items that appear on the DMEPOS Fee Schedule and meet one of the following criteria, as stated in 42 CFR 414.234(b)(1): • Have an average purchase fee of $500 or greater that is adjusted annually for inflation, or an average monthly rental fee schedule of $50 or greater that is adjusted annually for inflation, or items identified as accounting for at least 1.5 percent of Medicare expenditures for all DMEPOS items over a recent 12-month period, that are also— ++ Identified in a Government Accountability Office (GAO) or Department of Health and Human Services Office of Inspector General (OIG) report that is national in scope and published in 2015 or later as having a high rate of fraud or unnecessary utilization; or ++ Listed in the 2018 or subsequent year Comprehensive Error Rate Testing (CERT) Medicare Fee-for-Service Supplemental Improper Payment Data report as having a high improper payment rate. • Any items with at least 1,000 claims and $1 million in payments during a recent 12-month period that are determined to have aberrant billing patterns and lack explanatory contributing factors (for example, new technology or coverage policies that may require time for providers and suppliers to be educated on billing policies). Items with aberrant billing patterns would be identified as those items with payments during a 12-month timeframe that exceed payments made during the preceding 12-months by the greater of— ++ Double the percent change of all DMEPOS claim payments for items that meet the previous claim and payment criteria, from the preceding 12-month period; or ++ Exceeding a 30 percent increase in payments for the items from the preceding 12-month period. • Any items statutorily requiring a face-to-face encounter, a written order prior to delivery, or prior authorization. In the regulation at § 414.234 (b)(2) and the November 2019 final rule noted previously, the maintenance process of the Master List is described as follows: • The Master List will be updated annually, and more frequently as needed (for example, to address emerging billing trends), and to reflect the thresholds specified in the regulations. • Items on the DMEPOS Fee Schedule that meet the payment threshold criteria set forth in § 414.234(b)(1) are added to the list when the item is also listed in the CERT Medicare Fee-for-Service Supplemental Improper Payment Data report published after 2020, or in an OIG or GAO report published after 2020, and items not meeting the cost thresholds (originally set at $500 for purchases and $50 for rentals and adjusted for inflation) may still be added based on findings of aberrant billing patterns. • Items are removed from the Master List 10 years after the date the item was added, unless the item was identified in an OIG report, GAO report, or having been identified in the CERT Medicare Fee for Service Supplemental Improper Payment Data report as having a high improper payment rate, within the 5-year period preceding the anticipated date of expiration. • Items are removed from the list sooner than 10 years if the purchase amount drops below the payment threshold. • Items already on the Master List that are identified on a subsequent OIG, GAO, or CERT report will remain on the list for 10 years from the publication date of the new report. • Items on the Master List are updated when the HCPCS codes representing an item have been discontinued and cross walked to an equivalent item. • We will notify the public of any additions and deletions from the Master List by posting a notification in the <E T="04">Federal Register</E> and on the CMS Prior Authorization website a ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 56k characters. 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