Federal Register/Vol. 85, No. 28/Tuesday, February
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7666 Federal Register / Vol. 85, No. 28 / Tuesday, February 11, 2020 / Rules and Regulations DEPARTMENT OF HEALTH AND determines, on the basis of prior would be grandfathered into the prior HUMAN SERVICES payment experience, are frequently authorization program until the subject to unnecessary utilization and to implementation of the first Required Centers for Medicare & Medicaid develop a prior authorization process Prior Authorization List published Services for these items. subsequent to this rule, to avoid the In the December 30, 2015 final rule administrative and stakeholder burdens 42 CFR Part 414 (80 FR 81674) titled ‘‘Medicare Program; associated with the termination of the [CMS–6080–N3] Prior Authorization Process for Certain current prior authorization program and Durable Medical Equipment, the implementation of a revised Medicare Program; Update to the Prosthetics, Orthotics, and Supplies,’’ program created under this rule. This Required Prior Authorization List of we implemented section 1834(a)(15) of rule also maintained the process Durable Medical Equipment, the Act by establishing an initial Master established in the December 30, 2015, Prosthetics, Orthotics, and Supplies List (called the Master List of Items final Rule that when items are placed on (DMEPOS) Items That Require Prior Frequently Subject to Unnecessary the Required Prior Authorization List, Authorization as a Condition of Utilization) of certain DMEPOS that the we would inform the public of those Payment Secretary determined, on the basis of DMEPOS items on the Required Prior prior payment experience, are Authorization List in the Federal AGENCY: Centers for Medicare & frequently subject to unnecessary Register with no less than 60 days’ Medicaid Services (CMS), HHS. utilization and by establishing a prior notice before implementation, and post ACTION: Update to list and phases. authorization process for these items. notification on the CMS website (84 FR On November 8, 2019, CMS published 60753). SUMMARY: This document announces the a final rule (84 FR 60648) titled The Required Prior Authorization List continuation of prior authorization for ‘‘Medicare Program; End-Stage Renal specified in § 414.234(c)(1) is selected 45 Healthcare Common Procedure Disease Prospective Payment System, from the Master List (as described in Coding System (HCPCS) codes on the Payment for Renal Dialysis Services § 414.234(b)), and those selected items Required Prior Authorization List of Furnished to Individuals with Acute require prior authorization as a DMEPOS Items that require prior Kidney Injury, End-Stage Renal Disease condition of payment. Additionally, we authorization as a condition of payment, Quality Incentive Program, Durable stated that CMS may elect to limit the as well as the addition of six HCPCS Medical Equipment, Prosthetics, prior authorization requirement to a codes to this list. Prior authorization for Orthotics and Supplies (DMEPOS) Fee particular region of the country if claims the additional codes will be Schedule Amounts, DMEPOS data analysis shows that unnecessary implemented in two phases. Competitive Bidding Program (CBP) utilization of the selected item(s) is DATES: Phase one of implementation is Amendments, Standard Elements for a concentrated in a particular region. effective on May 11, 2020. Phase two of DMEPOS Order, and Master List of The purpose of this document is to implementation is effective on October DMEPOS Items Potentially Subject to a inform the public that all 45 Power 8, 2020. Face-to-Face Encounter and Written Mobility Device (PMD) and Pressure FOR FURTHER INFORMATION CONTACT: Tara Order Prior to Delivery and/or Prior Reducing Support Services (PRSS) Bramhall, (410) 786–8256. Erica Ross, Authorization Requirements.’’ Through HCPCS codes currently on the Required (410) 786–7480. this rule we harmonized the lists of Prior Authorization List will continue to SUPPLEMENTARY INFORMATION: DMEPOS items created by former rules be subject to the requirements of prior and established one ‘‘Master List of authorization (see 81 FR 93636, 83 FR I. Background DMEPOS Items Potentially Subject to 25947, and 84 FR 16616). In addition, Sections 1832, 1834, and 1861 of the Face-To-Face Encounter and Written we are updating the Required Prior Social Security Act (the Act) establishes Orders Prior to Delivery and/or Prior Authorization List to include six Lower that the provision of durable medical Authorization Requirements’’ (the Limb Prosthetic (LLP) HCPCS codes. To equipment, prosthetics, orthotics, and ‘‘Master List’’). This rule was effective assist stakeholders in preparing for supplies (DMEPOS) are covered benefits January 1, 2020. implementation of the prior under Part B of the Medicare program. authorization program, we are providing II. Provisions of the Document Section 1834(a)(15) of the Act 90 days’ notice. authorizes the Secretary to develop and In the November 8, 2019, final rule The following six HCPCS codes for periodically update a list of DMEPOS (84 FR 60648), we stated that the items LLPs are added to the Required Prior items and supplies that the Secretary currently subject to prior authorization Authorization List: HCPCS Description L5856 ......................... Addition to lower extremity prosthesis, endoskeletal knee-shin system, microprocessor control feature, swing and stance phase, includes electronic sensor(s), any type. L5857 ......................... Addition to lower extremity prosthesis, endoskeletal knee-shin system, microprocessor control feature, swing phase only, includes electronic sensor(s), any type. L5858 ......................... Addition to lower extremity prosthesis, endoskeletal knee-shin system, microprocessor control feature, stance phase only, includes electronic sensor(s), any type. L5973 ......................... Endoskeletal ankle foot system, microprocessor controlled feature, dorsiflexion and/or plantar flexion control, includes power source. L5980 ......................... All lower extremity prostheses, flex foot system. L5987 ......................... All lower extremity prosthesis, shank foot system with vertical loading pylon. We believe prior authorization of LLPs will help further our program and abuse, while also protecting access these six additional HCPCS codes for integrity goals of reducing fraud, waste, to care. LLPs have been identified by VerDate Sep<11>2014 15:44 Feb 10, 2020 Jkt 250001 PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 E:\FR\FM\11FER1.SGM 11FER1 khammond on DSKJM1Z7X2PROD with RULES Federal Register / Vol. 85, No. 28 / Tuesday, February 11, 2020 / Rules and Regulations 7667 CMS’ Comprehensive Error Rate Testing medical review and communicate a Executive Orders 12866 and 13563 (CERT) program as one of the top 20 decision that provisionally affirms or direct agencies to assess all costs and DMEPOS service types with improper non-affirms the request. benefits of available regulatory payments over the past several years.1 We will issue specific prior alternatives and, if regulation is The 2018 Medicare Fee-for-Service authorization guidance in subregulatory necessary, to select regulatory Supplemental Data reported over $46 communications, including final approaches that maximize net benefits million in projected improper payments timelines customized for the DMEPOS (including potential economic, for LLPs.2 Additionally, the Office of item subject to prior authorization, for environmental, public health and safety Inspector General (OIG) has previously communicating a provisionally affirmed effects, distributive impacts, and reported that Medicare has or non-affirmed decision to the equity). A regulatory impact analysis inappropriately paid for LLPs that did requester. In the December 30, 2015 (RIA) must be prepared for major rules not meet certain Medicare final rule (80 FR 81692), we stated that with economically significant effects requirements.3 this approach to final timelines provides ($100 million or more in any 1 year). These codes will be subject to the flexibility to develop a process that This document does not reach the requirements of the prior authorization involves fewer days, as may be economic threshold and, thus, is not program for certain DMEPOS items as appropriate, and allows us to safeguard considered a major rule. outlined in § 414.234. We will beneficiary access to care. If at any time The RFA requires agencies to analyze implement a prior authorization we become aware that the prior options for regulatory relief of small program for the six newly added codes authorization process is creating barriers entities. For purposes of the RFA, small for LLPs in two phases. This phased-in to care, we can suspend the program. entities include small businesses, approach will allow us to identify and For example, we will review questions nonprofit organizations, and small resolve any unforeseen issues by using and complaints from consumers and governmental jurisdictions. Most a smaller claim volume in phase one providers that come through regular hospitals and most other providers and before nationwide implementation sources such as 1–800–Medicare. suppliers are small entities, either by occurs in phase two. In phase one of The updated Required Prior nonprofit status or by having revenues implementation, which begins on the Authorization list is available in the of less than $7.5 million to $38.5 date specified in the DATES section, we download section of the following CMS million in any one year. Individuals and will limit the prior authorization website: