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

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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: https://www.cms.gov/Research- states are not included in the definition requirement to one state in each of the Statistics-Data-and-Systems/Monitoring- of a small entity. We are not preparing four DME Medicare Administrative Programs/Medicare-FFS-Compliance- an analysis for the RFA because we have Contractors (MAC) geographic Programs/DMEPOS/Prior- determined, and the Secretary certifies, jurisdictions as follows: California, Authorization-Process-for-Certain- that this document will not have a Michigan, Pennsylvania, and Texas. In Durable-Medical-Equipment-Prosthetic- significant economic impact on a phase two, which begins on the date Orthotics-Supplies-Items.html. substantial number of small entities. specified in the DATES section of this In addition, section 1102(b) of the Act III. Collection of Information document, we will expand the program requires us to prepare an RIA if a rule Requirements to the remaining states in all four DME may have a significant impact on the MAC jurisdictions. The prior This document announces the operations of a substantial number of authorization program for the 45 codes continuation of prior authorization for small rural hospitals. This analysis must currently subject to the DMEPOS prior 45 HCPCS codes, and the addition of six conform to the provisions of section 604 authorization requirement will remain HCPCS codes for LLPs on the Required of the RFA. For purposes of section in place uninterrupted in all states. Prior Authorization List and does not 1102(b) of the Act, we define a small Prior to furnishing the item to the impose any new information collection rural hospital as a hospital that is beneficiary and submitting the claim for burden under the Paperwork Reduction located outside of a Metropolitan processing, a requester must submit a Act of 1995. However, there is an Statistical Area for Medicare payment prior authorization request. The request information collection burden regulations and has fewer than 100 must include evidence that the item associated with this program that is beds. We are not preparing an analysis complies with all applicable Medicare currently approved under OMB control for section 1102(b) of the Act because coverage, coding, and payment rules. number 0938–1293 which expires we have determined, and the Secretary Consistent with § 414.234(d), such March 31, 2022. certifies, that this action will not have evidence must include the order, a significant impact on the operations of IV. Regulatory Impact Statement relevant information from the a substantial number of small rural beneficiary’s medical record, and We have examined the impact of this hospitals. relevant supplier-produced action as required by Executive Order Section 202 of the Unfunded documentation. After receipt of all 12866 on Regulatory Planning and Mandates Reform Act of 1995 also applicable required Medicare Review (September 30, 1993), Executive requires that agencies assess anticipated documentation, CMS or one of its Order 13563 on Improving Regulation costs and benefits before issuing any review contractors will conduct a and Regulatory Review (January 18, rule whose mandates require spending 2011), the Regulatory Flexibility Act in any one year of $100 million in 1995 1 https://www.cms.gov/Research-Statistics-Data- (RFA) (September 19, 1980, Pub. L. 96– dollars, updated annually for inflation. and-Systems/Monitoring-Programs/Medicare-FFS- 354), section 1102(b) of the Act, section In 2019, that threshold is approximately Compliance-Programs/CERT/CERT-Reports.html 202 of the Unfunded Mandates Reform ?DLSort=0&DLEntries=10&DLPage=1&DLSortDir $154 million. This action will have no =descending. Act of 1995 (March 22, 1995; Pub. L. consequential effect on state, local, or 2 https://www.cms.gov/Research-Statistics-Data- 104–4), Executive Order 13132 on tribal governments or on the private and-Systems/Monitoring-Programs/Medicare-FFS- Federalism (August 4, 1999), the sector. Compliance-Programs/CERT/Downloads/2018 Congressional Review Act (5 U.S.C. Executive Order 13132 establishes MedicareFFSSuplementalImproperPayment Data.pdf. 804(2)), and Executive Order 13771 on certain requirements that an agency 3 https://oig.hhs.gov/oei/reports/oei-02-10- Reducing Regulation and Controlling must meet when it promulgates a 00170.pdf. Regulatory Costs (January 30, 2017). proposed rule (and subsequent final

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rule) that imposes substantial direct elimination of existing costs associated In accordance with the provisions of requirement costs on state and local with at least two prior regulations.’’ Executive Order 12866, this document governments, preempts state law, or OMB’s interim guidance, issued on was reviewed by the Office of otherwise has federalism implications. April 5, 2017, https:// Management and Budget. Since this action does not impose any www.whitehouse.gov/sites/ Dated: November 5, 2019. costs on state or local governments, the whitehouse.gov/files/omb/memoranda/ requirements of Executive Order 13132 2017/M-17-21-OMB.pdf, explains that Seema Verma, are not applicable. for Fiscal Year 2017 the above Administrator, Centers for Medicare & Executive Order 13771, titled requirements only apply to each new Medicaid Services. Reducing Regulation and Controlling ‘‘significant regulatory action that Editorial note: This document was Regulatory Costs, was issued on January imposes costs.’’ It has been determined received for publication by the Office of the 30, 2017 and requires that the costs that this document is not a ‘‘significant Federal Register on February 5, 2020. associated with significant new regulatory action’’ and thus does not regulations ‘‘shall, to the extent trigger the aforementioned requirements [FR Doc. 2020–02644 Filed 2–7–20; 11:15 am] permitted by law, be offset by the of Executive Order 13771. BILLING CODE 4120–01–P

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