        DEPARTMENT OF HEALTH AND HUMAN SERVICES
        Centers for Medicare & Medicaid Services
        42 CFR Part 423
        [CMS-4189-P]
        RIN 0938-AT94
        Medicare Program; Secure Electronic Prior Authorization for Medicare Part D

          AGENCY:
          Centers for Medicare & Medicaid Services (CMS), HHS.

          ACTION:
          Proposed rule.

          SUMMARY:
          This rule proposes a new transaction standard for the Medicare Prescription Drug Benefit program's (Part D) e-prescribing program as required by the “Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act” or the “SUPPORT for Patients and Communities Act.” Under the SUPPORT for Patients and Communities Act, the Secretary is required to adopt standards for Part D e-prescribing program to ensure secure electronic prior authorization request and response transmissions. If finalized, the proposals in this rule would amend the Part D e-prescribing regulations to require Part D plan sponsors' support of version 2017071 of the National Council for Prescription Drug Programs (NCPDP) SCRIPT standard for use in electronic Prior Authorization (ePA) transactions with prescribers regarding Part D covered drugs to Part D-eligible individuals.

          DATES:
          To be assured consideration, comments must be received at one of the addresses provided, no later than 5 p.m. on August 16, 2019.

          ADDRESSES:
          In commenting, please refer to file code CMS-4189-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
          Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):
          1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the “Submit a comment” instructions.
          2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-4189-P, P.O. Box 8013, Baltimore, MD 21244-8013.
          Please allow sufficient time for mailed comments to be received before the close of the comment period.
          3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-4189-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

          For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.

          FOR FURTHER INFORMATION CONTACT:
          Joella Roland (410) 786-7638.

        SUPPLEMENTARY INFORMATION:

          Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to view public comments.
        I. Background
        The purpose of this rule is to propose a new transaction standard for the Part D e-prescribing program. Under this proposal, Part D plan sponsors would be required to support version 2017071 of the National Council for Prescription Drug Programs (NCPDP) SCRIPT standard for four electronic Prior Authorization (ePA) transactions, and prescribers would be required to use that standard when performing ePA transactions for Part D-covered drugs they wish to prescribe to Part D-eligible individuals. Part D plans, as defined in 42 CFR 423.4, include Prescription Drug Plans (PDPs) and Medicare Advantage Prescription Drug Plans (MA-PDs); Part D sponsor, as defined in 42 CFR 423.4, means the entity sponsoring a Part D plan, MA organization offering a MA-PD plan, a PACE organization sponsoring a PACE plan offering qualified prescription drug coverage, and a cost plan offering qualified prescription drug coverage. The proposed ePA transaction standard would provide for the electronic transmission of information between the prescribing health care professional and Part D plan sponsor to inform the sponsor's determination as to whether or not a prior authorization (PA) should be granted. The NCPDP SCRIPT version 2017071 was approved in CMS 4182-F published on April 16, 2018 (83 FR 16440) effective June 15, 2018 and materials are incorporated by reference of certain publications listed in the rule as approved by the Director of the Federal Register as of June 15, 2018.
        An ePA transaction standard would allow a prescriber using an electronic prescribing (eRx) system or an electronic health record (EHR) with eRx capability to determine whether the beneficiary's plan requires a PA for a given medication. If the prescriber enters such a prescription into an eRx system, a message will be returned to the provider indicating that a PA is required. Use of the ePA transactions would then enable the prescriber to submit the information required to fulfill the terms of the PA in real time.
        A. Legislative Background
        1. Health Insurance Portability and Accountability Act of 1996 (HIPAA)
        The Health Insurance Portability and Accountability Act of 1996 (HIPAA) (Pub. L. 104-191) was enacted on August 21, 1996. Title II, Subtitle F of HIPAA requires covered entities—health plans, health care providers that conduct covered transactions, and health care clearinghouses—to use the standards HHS adopts for certain electronic transactions. The standards adopted by HHS for purposes of HIPAA are in regulations at 45 CFR part 162.
        2. Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA)
        The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) was enacted on December 8, 2003. It amended Title XVIII of the Social Security Act (the Act) by redesignating Part D as Part E and inserting a new Part D to establish a voluntary prescription drug benefit program. As part of that program, section 1860D-4(e) of Act as added by the MMA required the adoption of Part D e-prescribing standards for electronic prescriptions and prescription-related transactions between Part D plan sponsors, providers, and pharmacies. The Secretary's selection of standards is informed by the National Committee on Vital and Health Statistics (NCVHS). Under section 1860D-4(e)(4)(B) of the Act, NCVHS develops recommendations for Part D e-prescribing standards, in consultation with specified groups of organizations and entities. These recommendations are then taken into consideration when developing, adopting, recognizing, or modifying Part D e-prescribing standards. The statute further requires that the selection of standards designed, to the extent practicable, not impose an undue administrative burden on prescribers or dispensers, are compatible with standards established under Part C of title XI of the Act (the HIPAA standards), and with general health information technology standards and permit electronic exchange of drug labeling and drug listing information maintained by the Food and Drug Administration and the Library of Medicine.
        The standards adopted by CMS for purposes of the Part D e-prescribing program are in regulations at 42 CFR 423.160. Part D plan sponsors are required to support the Part D e-prescribing program transaction standards, and providers and pharmacies that conduct electronic transactions for which a program standard has been adopted must do so using the adopted standard. See the February 4, 2005 proposed rule titled “Medicare Program, E-Prescribing and the Prescription Drug Program” (70 FR 6256) for additional information about the MMA program authority.
        3. Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT for Patients and Communities Act)
        The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (Pub. L 115-271), hereinafter referred to as the “SUPPORT for Patients and Communities Act,” was enacted on October 24, 2018. Section 6062 of the SUPPORT for Patients and Communities Act amended section 1860D-4(e)(2) of the Social Security Act to require the adoption of transaction standards for the Part D e-prescribing program to ensure secure ePA request and response transactions between prescribers and part D plan sponsors no later than January 1, 2021. Such transactions are to include an ePA request transaction standard for prescribers seeking an ePA from a Part D plan sponsor for a Part D covered drug for a Part D-eligible individual, as well as an ePA response transaction standard for the Part D plan sponsor's response to the prescriber. A facsimile, a proprietary payer portal that does not meet standards specified by the Secretary or an electronic form are not treated as electronic transmissions for the purposes of ePA requests. Such standards are to be adopted in consultation with the NCPDP or other standard setting organizations the Secretary finds appropriate, as well as other stakeholders. Finally, the SUPPORT for Patients and Communities Act also authorized the adoption of ePA transaction standards for part D covered drugs for part D eligible individuals “notwithstanding” any other provision of law.
        B. Regulatory History

        In 2000, the Secretary adopted HIPAA transaction standards for the “referral certification and authorization transaction”. The term “referral certification and authorization transaction” is defined at 45 CFR 162.1301 as the transmission of any of the following: (1) A request from a health care provider to a health plan for the review of health care to obtain an authorization for the health care; (2) a request from a health care provider to a health plan to obtain authorization for referring an individual to another health care provider; and (3) a response from a health plan to a health care provider to a request described in (1) or (2). The first HIPAA standard adopted for this transaction was version 4010 of the X12 278 (65 FR 50371, August 17, 2000). In 2003, the Secretary adopted another standard, the NCPDP version 5.1, for retail pharmacy drug referral certification and authorization transactions and specified that version 4010 of the X12 278 was to be used only for dental, professional, and institutional referral certification and authorization transactions (see the February 20, 2003 Federal Register (68 FR 8398)). Still, as of 2003, the Secretary had not adopted a standard for ePA for medications specifically.
        In 2004, NCPDP formed a multi-industry, multi-Standards Development Organization (SDO) ePA Task Group to evaluate existing PA standards and promote standardized ePA, with a focus on the medication context. The Task Group considered the X12 278 standard, but determined that there were certain gaps in the X12 278 standard that made the standard difficult to use for ePA, including that the standard was unable to support attachments for PA determinations, incorporate free text in certain fields, and allow functionality for real-time messaging. As a result of these findings, the Task Group wrote a letter to the HHS Secretary stating that the X12 278 standard offered limited support for ePA and urged HHS to test new versions of the standard.
        In 2006, CMS made awards to grantees as part of a pilot to test e-prescribing standards. The participants in the pilot identified further gaps in the X12 278 standard that made it inadequate for use with medication PAs. These gaps included no mechanism for providers to request and explain reasons for deviating from standard medication dosing instructions, requiring certain fields that are not applicable to drugs, and no limit on diagnosis codes, which required clinicians to select from hundreds of options to find the appropriate code.
        After the pilot, stakeholders continued to try to improve the X12 278 standard by starting the process of adding new fields to the X12 278 standard to try to make it better able to support ePA. However, after testing the modified X12 278 standard in 2006, NCPDP determined that the improved X12 278 standard was still inadequate to support ePA, due to the inability to exchange transactions in real-time.
        On January 16, 2009, the Secretary adopted later versions of the HIPAA transaction standards, requiring NCPDP Telecommunications D.0 instead of NCPDP 5.1 and version 5010 instead of version 4010 of the X12 278 to be used for referral certification and authorization transactions (74 FR 3326) because it was determined that the X12 278 standard served the needs for non-pharmacy claims. These standards are specified at 45 CFR 162.1302(b)(2).
        However, these revised standards still have the same impediments for ePA as they still require information such as the patient diagnosis code which is not available on prescription processing and omits other information needed for ePA such as directions and dose. Further, it remains a batch standard which does not accommodate the real time nature of prescription claims.

        In the meantime, interest was once again building in the industry to develop and test alternative ePA transaction standards. NCPDP took into account its experience with previous transaction standards as it began to frame what would ultimately become its NCPDP SCRIPT ePA standard, version 2013101, which included the ability to send attachments in a standardized format. In a May 15, 2014 letter to the HHS Secretary, NCVHS stated that they had received a letter from the NCPDP recommending its SCRIPT Standard Version 2013101 standard for carrying out medication ePA transactions. (For more information see, https://ncvhs.hhs.gov/wp-content/uploads/2014/05/140515lt2.pdf.) NCVHS reported hearing from NCPDP stakeholders that NCPDP investigators tasked with reviewing the X12 278 standard for use as an ePA transaction found that the HIPAA transaction standards for PA transactions (the 278 v4010 or v5010) were not adequate to support medication PA. The standard was designed for PA of procedures/services or durable medical equipment (DME), so did not adequately accommodate the information necessary to facilitate medication PA. NCPDP also noted that X12 278 is not widely used for ePA of prescription medications as evidence of its inadequacy for this purpose.
        In response to NCVHS' May 2014 letter, we reviewed the X12 278, and found that the X12 278 standard is designed to conduct batch transactions which could not be used to support real time prescribing. For example, if a PA were to be submitted using the X12 278 standard, the PA would not accommodate a field for National Drug Codes (NDCs) and dosage information field, which are integral when evaluating medication requests. Since the X12 278 standard does not have a standard method to process ePA transactions, prescribers would have to find a place to insert NDCs and look up the codes using another source. In contrast, NCPDP SCRIPT ePA Version 2013101 and 2017 transactions are prepopulated with all NDCs and dosage information so the prescriber can choose among appropriate options.
        Another standard that we are aware of is the NCPDP Telecommunications D.0 standard. However, this standard, does not have the ability to look up and convey NDCs and dosages. The NCPDP Telecommunications D.0 standard was designed to be a standard for insurance companies to approve claims, so it does not include content fields that are relevant to ePA, such as clinical fields and beneficiary-specific information nor does it have the ability to transmit information in real time. As such it is not frequently used by prescribers because it cannot collect information needed for satisfying a medication PA.
        In our review of the standard, CMS found that the X12 278 standard is by nature a batch standard which cannot support real-time consideration of prescriptions. For example if a PA were to be submitted using the X12 278 standard, the PA would not be submitted to the plan until the following day, the plan would review it in the second day and, if all the information were correct, the approval would be conveyed back to the physician 3 days after the prescription was captured in the batching process. The reason for this is because the X12 278 is designed to batch the transactions, since this is what is optimal in the DME context. However, this is not optimal in the ePA context, since it would result in ePA transactions taking days to process. Resolution of the ePA would be further delayed if the plan needed additional information on the PA request.
        This is in contrast to the SCRIPT ePA standard, which conveys information to the plan in real time that allows the patient to access a medication subject to PA the same day that the prescription and ePA are submitted.

        In addition, X12 278 collects a standard set of information. However, PA criteria vary by medication being authorized: For some medications the plan may need to determine whether the patient had been on the same medication previously, or on another comparable medication or what the mediation is being used for, while for other medications this may not be necessary. In contrast, the SCRIPT ePA transaction requires that plans develop specific sets of questions for each drug that requires PA so that they can be answered when the ePA is submitted.
        Finally, there is an inconsistency between the types of information that are required to be submitted on a DME claim, which is what the X12 278 transaction was designed to support, and the type of information that is required to be submitted for medications. For example, the X12 278 standard requires the diagnosis to be submitted, which is not required on prescription claims, but it does not accommodate a field for National Drug Codes (NDCs) and dosage information fields that are integral when evaluating medication requests. Because the X12 278 transaction is not specifically created to process medications, prescribers would have to find a place to insert NDCs and look up the codes using another source. In contrast, the SCRIPT ePA standard is prepopulated with all NDCs and dosage information so the prescriber can chose among appropriate options.
        Despite these findings and NCPDP recommendation to NCVHS, we did not pursue proposing the NCPDP SCRIPT Standard Version 2013101 as a Part D eRx standard for medication PA transactions because it was contrary to the HIPAA requirements, which require use of the X12 278 standard. Similarly, when NCPDP wrote on May 24, 2017 to CMS to recommend the adoption of its NCPDP SCRIPT Standard Version 2017071, we were unable to consider it for the Part D e-prescribing program unless the HIPAA transaction standards for referral certifications and authorizations were modified.
        The Part D e-prescribing program's authorizing statute requires selection of Part D standards that are compatible with the HIPAA standards (see section 1860D-4(e)(4) of the Act), so we have historically ensured that our Part D e-prescribing program standards are compatible with the HIPAA transaction standards. (For additional information, see the February 4, 2005 proposed rule (70 FR 6256).)
        However, given the new authority under the SUPPORT for Patients and Communities Act, we believe we now have authority to adopt Part D eRx ePA transaction standards “notwithstanding” any other provision of law if such proposals are framed in consultation with stakeholders and the NCPDP or other standard setting organizations the Secretary finds appropriate. See section 1860D-4(e)(2)(E)(ii)(III) of the Act, as amended by section 6062 of the SUPPORT for Patients and Communities Act. We believe that this provision explicitly authorizes us to require the use of a PA standard in the Part D context that is different from the HIPAA standard, as long as it is for a Part D-covered drug prescribed to a Part D-eligible individual.
        As previously described, Part D plan sponsors are required to establish electronic prescription drug programs that comply with the e-prescribing standards that are adopted under e-prescribing program's authorizing statute. There is no requirement that prescribers or dispensers implement eRx. However, prescribers and dispensers who electronically transmit and receive prescription and certain other information regarding covered drugs prescribed for Medicare Part D-eligible beneficiaries, directly or through an intermediary, are required to comply with any applicable standards that are in effect.
        The Part D e-prescribing program currently requires providers and dispensers to utilize the NCPDP SCRIPT standard, Implementation Guide Version 10.6, which was approved November 12, 2008, for the communication of a prescription or prescription-related information for certain named transactions. However, as of January 1, 2020, we established through rulemaking that prescribers and dispensers will be required to use the NCPDP SCRIPT standard, Implementation Guide Version 2017071, which was approved by the NCPDP on July 28, 2017 to provide for the communication of prescription or prescription-related information between prescribers and dispensers for the transactions for which prior versions of the NCPDP SCRIPT standard were adopted with old named transactions, and a handful of new transactions named at § 423.160(b)(2)(iv). (For more information, see the April 16, 2018 final rule titled “Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program” (83 FR 16635 through 16638) and for a detailed discussion of the regulatory history of e-prescribing standards see the November 28, 2017 proposed rule (82 FR 56437 and 56438).)
        While not currently adopted as part of the Part D eRx standard, the NCPDP SCRIPT standard version 2017071 includes 4 transactions that would enable the prescribers to initiate medication ePA requests with Part D plan sponsors at the time of the patient's visit. These four transactions include: The PA initiation request/response, PA request/response, PA appeal request/response, and PA cancel request/response. As noted previously, historically we were unable to name the ePA transactions within the 2017071 standard as Part D e-prescribing program standards because the Part D program was previously required to adopt standards that were compatible with the HIPAA standards, and HIPAA covered entities are currently required to use the X12 278 to conduct referral certification and authorization transactions between health plans and health care providers.
        II. Proposed Adoption of the NCPDP SCRIPT Standard Version 2017071 as the Part D ePA Transaction for the Part D Program
        A. PA in the Part D Context
        All Part D plans, as defined under § 423.4, including PDPs, MA-PDs, PACE Plans offering qualified prescription drug coverage, or Cost Plans offering qualified prescription drug coverage, can use approved PA processes to ensure appropriate prescribing and coverage of Part D-covered drugs prescribed to Part D-eligible individuals. We review all proposed PA criteria as part of the formulary review process. In framing our PA policies, we encourage PDP and MA-PD sponsors to consistently utilize PA for drugs prescribed for non-Part D covered uses and to ensure that Part D drugs are only prescribed when medically appropriate. Non-Part D covered uses may be indicated when the drug is frequently covered under Parts A or B as prescribed and dispensed or administered, is otherwise excluded from Part D coverage, or is used for a non-medically accepted indication. (See Medicare Prescription Drug Manual, chapter 6, section 30.2.2.3.) Part D sponsors must submit to CMS utilization management requirements applied at point of sale, including PA.

        We may also approve PA for a drug when the Part D plan desires to manage drug utilization, such as when step therapy is required, or when it needs to establish whether the utilization is a continuation of existing treatment that should not be subject to the step therapy requirements, or to ensure that a drug is being used safely or in a cost-effective manner. Formulary management decisions must be based on scientific evidence and may also be based on pharmacoeconomic considerations that achieve appropriate, safe, and cost-effective drug therapy.

        The PA process has historically been handled via facsimile exchange of information or telephone call, and only recently via payer-specific web portals. However, there is an overall consensus among stakeholders testifying to NCVHS that there is a need for real time PA at the prescriber level for electronic prescribing. Minutes from NCVHS meetings can be accessed at https://ncvhs.hhs.gov/meetings-meeting/all-past-meetings/. We believe this would improve patient access to required medications.
        B. PA for Part D E-Prescribing
        In order to meet the SUPPORT for Patients and Communities Act's mandate to adopt an ePA transaction standard for the Part D-covered drugs prescribed to Part D-eligible individuals, CMS identified ePA transaction standards currently in use by pharmacies and prescribers. These included the X12 278 and NCPDP Telecommunications D.0 standards, the NCPDP SCRIPT standard version 2017071, and earlier versions of the NCPDP SCRIPT standard. We quickly ruled out the use of older NCPDP SCRIPT standards based on our assessment of the enhanced functionality available in the NCPDP SCRIPT version 2017071.
        We then considered the needs of the Part D program; the functionalities offered by the remaining two standards; NCVHS recommendations, stakeholder recommendations based on their experience developing, vetting, evaluating, revising, and using the standards constructed by the respective Standards Development Organizations (SDOs) including NCPDP, the burden on stakeholders to use the standard, the security offered by the standard; and the current EHR capabilities of the industry in order to estimate the potential burden each standard would impose if it were to be adopted in the Part D context. SDOs work to formulate health and safety standards based on guidelines, best practices, specifications, test methods, and/or designs.
        The X12 278 and NCPDP Telecommunications D.0 are already used as the HIPAA standards for referral certification and PA for dental, professional and institutional transactions, and retail pharmacy drugs transactions, respectively. However, the NCPDP Telecommunications D.0 standard was designed to be a standard for insurance companies to approve claims and is only used in “pharmacy to plan” transactions, so it does not include all of the content fields that are relevant to ePA nor does it have the ability to transmit information in real time. We then considered the X12 278.
        Based on review of NCPDP's testimony and the letters received from NCVHS, we found that the NCPDP and its participant organizations have concluded and presented to NCVHS via testimony at hearings that the X12 278 standard is not adequate to enable ePA in the e-prescribing context because it does not support “real-time” medication e-prescribing, meaning a prescriber seeking ePA during the patient encounter. This is due to the content logic of the standard, which does not have the technical capabilities to allow for next question logic, which allows the prescriber to determine medication alternatives and determine within minutes if the medication will be authorized or if a coverage determination is required. In addition, the fields, transaction messaging, software functioning are not standardized to include information relevant to ePA and contain mandatory questions that are unnecessary for medication PA. Unfortunately, prescribers are unable to customize these fields as needed for medication PA.

        These findings are outlined in NCPDP's 2016 written testimony to NCVHS, which is available via this web link: https://www.ncvhs.hhs.gov/wp-content/uploads/2016/01/Part-2-Attachments-NCPDP-WrittenOnly.pdf, urging the exemption of medication transactions from the X12 278 transaction standard, and its May 24, 2017 recommendation to adopt the NCPDP SCRIPT Standard Version 2017071 for ePA transactions in the HIPAA context, with a 24 month implementation time period, due to the extensive coding required by Electronic Health Records (EHRs) and Part D plans to implement the change.
        Although NCPDP's recommendation was to adopt this standard for all HIPAA transactions, the Department has not promulgated rulemaking on this point. Based on conversations with the industry, our own assessment of the standard, and under the authority provided by Congress to require the use of a standard for Part D ePA notwithstanding any other provision of law, we have concluded that the potential benefits of adopting user-friendly ePA for the Part D program outweigh any difficulties that may arise by virtue of Part D using a different standard than the rest of the industry.
        More specifically the NCPDP SCRIPT standard will support an electronic version of today's PA process by providing standardized information fields that are relevant for medication use, mandatory questions, transaction messaging, and standardized ePA data elements and vocabulary words for exchanging the PA questions and answers between prescribers and payers, while also allowing the payers to customize the wording of the questions using free form fields. Although the X12 278 standard has standard information fields, mandatory questions, transaction messaging and standardized data element and values, we believe those fields are relevant only for DME use—and would not be conducive to medication ePA. Since the X12 278 does not allow payers to customize the wording of questions, it is difficult for parties to decide how to fill out the fields. The NCPDP SCRIPT Standard was designed to support medication ePA, the standard also supports features that minimize what the prescriber is asked, creating a customized experience based on earlier answers or data pulled using automated functions from their EHR system, which would reduce the amount of time a prescriber or their staff spend reviewing and responding to the PA questions We understand that this functionality works with most EHR systems, and can be customized based on what information is requested by the plans. It additionally supports software functions that allow for automation of the collection of data required for ePA consideration from data available within most EHR systems or other PA transaction fields.
        Furthermore, unlike the X12 278, the NCPDP SCRIPT version 2017071 standard supports solicited and unsolicited models. A solicited model occurs when the prescriber notifies the payer that they wish to start the PA process to determine if an authorization is needed for the patient and their desired medication. The prescriber requests guidance as to what information will be required for an ePA request for a particular patient and medication. The payer then responds either with a description of the information required, or an indication that a PA is not required for that patient and medication. An unsolicited model can be used when the information generated in this first interchange of the solicited model is not required, where the prescriber presumes or knows that an authorization will be required based on past experience or other knowledge and they will submit the information they anticipate the payer needs.

        We found that while X12 278 uses Electronic Data Interchange (EDI) syntax, the NCPDP SCRIPT standard version 2017071 uses XML syntax. XML helps ensure security of transactions through the encryption of personal health information and through use of XML transaction processing. XML is a newer syntax that provides for an easier interaction between different formats and is more easily readable when system issues arise. By contrast, EDI is an older syntax more commonly used when there are few companies that conduct more standard interactions between each other.
        Based on this evaluation of the candidate standards, coupled with the recommendations from NCPDP, CMS concluded that the NCPDP SCRIPT standard version 2017071 is the most appropriate standard to propose for the Part D e-prescribing program.
        We recognize that this proposed rule would not change the ePA transaction standards that may be used outside of the Part D context. We do not believe that it will be problematic for plans to use one standard for Part D and another standard outside of Part D, if that is the case for the plan, because we believe that the industry is equipped to use different standards for different health plans and programs. We understand that based on our conversations with the industry, most EHRs are capable of generating transactions using more than one standard for a given transaction, and that they are programmed in a manner that would guide a prescriber to select the correct standard for a given transaction.
        Finally, we considered whether adopting the NCPDP SCRIPT Standard version 2017071 for ePA would create any difficulties if an individual had multiple forms of drug coverage or wished to pay cash for their prescription. The SUPPORT for Patients and Communities Act specifies that the adopted standard shall be applicable for ePA of covered Part D drugs being prescribed to Part D-eligible individuals. The Act requires that the drug be a Part D-covered drug, and that the patient is Part D-eligible, but it stops short of requiring that the prescribed drug be paid for by the Part D plan. Thus, even if a prescriber were to use the SCRIPT ePA to seek part D PA, the beneficiary's right to pay for the drug him or herself, or to use non-Part D coverage to pay for the drug would be unaffected. However, we note, that the prescriber would not use the SCRIPT ePA to seek ePA with non-Part D plans. We expect that their EHR's eRx function would be capable of using the appropriate HIPAA standard to seek ePA outside of the Part D context. Furthermore, where a patient has both a Part D plan and a supplementary payer the SCRIPT ePA can be used to process the SCRIPT ePA transaction in real time, with the claims processing transactions made in the usual manner if/when the prescription is filled. Thus, we believe our proposal would not be overly burdensome for the prescriber, even if beneficiaries seek to use their non-Part D coverage.
        While the prescriber can use the SCRIPT ePA for all covered Part D-covered drugs for Part D-eligible individuals, it should refrain from using the transaction if the patient were to specifically request that the Part D benefits not be accessed.
        As a result of these observations and our understanding that most of the industry is able to support NCPDP SCRIPT standards for ePA using their current EHRs, we believe that requiring plans to support and prescribers to use the NCPDP SCRIPT 2017071 ePA transactions when prescribing Part D covered drugs when they are prescribed to Part D eligible individuals would not impose an undue administrative burden on prescribers or dispensers. Therefore, based on its real time capabilities and its inherent features designed to accommodate prescriptions, we believe that the NCPDP SCRIPT standard version 2017071, which includes the following ePA transaction capabilities, would be the best available option to support ePA between prescribers and payers for Part D covered drugs prescribed to Part D-eligible individuals:

        • PAInitiationRequest and PAInitiationResponse
        • PARequest and PAResponse
        • PAAppealRequest and PAAppealResponse
        • PACancelRequest and PACancelResponse.

        If these ePA transaction proposals are finalized, they would enable the electronic presentation of ePA questions and responses using secure transactions.
        The SUPPORT for Patients and Communities Act states that the Secretary must adopt, and a Part D sponsor's electronic prescription program must implement the adopted ePA by January 1, 2021. As of January 1, 2020, plans will already be required to use the NCPDP SCRIPT 2017071 standard for certain Part D specified transactions, so we believe that giving plans an additional year to add ePA to that list of other NCPDP SCRIPT 2017071 transactions would not be overly burdensome and help ensure that the SUPPORT for Patients and Communities Act is implemented.
        We acknowledge that covered entities are required to use the X12 278 standard for ePA under HIPAA, which is different than the standard we are proposing. (See 45 CFR 162.1301.) However, the SUPPORT for Patients and Communities Act, allows us to propose the adoption of an ePA standard for Part D-covered drugs to Part D-eligible individuals notwithstanding any other provision of law. We believe that our proposal to adopt the NCPDP SCRIPT standard version 2017071 for ePA of Part D covered drugs prescribed to Part D eligible individuals is consistent with the statutory requirement to adopt technical standards for ePA transactions under the Act, which allows the Secretary to require use of standards in lieu of any other applicable standards for an electronic transmission of an ePA nothwithstanding any other provision of law.
        Therefore, we propose to add § 423.160(b)(7) which would require that Part D plans be able to support the NCPDP SCRIPT ePA standard transactions included within version 2017071 beginning on January 1, 2021, and that prescribers use that standard when conducting ePA by the same date. The proposed ePA standard applies to the following list of ePA transactions:

        • PAInitiationRequest and PAInitiationResponse
        • PARequest and PAResponse
        • PAAppealRequest and PAAppealResponse
        • PACancelRequest and PACancelResponse

        We welcome comments on the proposed adoption of the NCPDP SCRIPT standard version 2017071 eRx for these ePA transactions for Part D- covered drugs prescribed to Part D eligible individuals. We are also soliciting comments regarding the impact of these proposed transactions and the proposed effective date on industry and other interested stakeholders, including whether the implementation of a NCPDP SCRIPT standard version 2017071 ePA transaction standard for use by prescribers and plans in the Part D program would impose an additional burden on the industry as a whole. We would also be interested in hearing if implementation of the proposed transactions is a significant change for Part D sponsors which would make a January 1, 2021 implementation date as required by statute not be feasible. We also seek comment on strategies to mitigate burden in order to support successful adoption of this policy. Finally, we seek comment on any additional ways CMS can support plans as they transition to the ePA standard by the 2021 deadline.
        III. Collection of Information Requirements

        Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et seq.), we are required to provide 60-day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the PRA requires that we solicit comment on the following issues:
        • The need for the information collection and its usefulness in carrying out the proper functions of our agency.
        • The accuracy of our estimate of the information collection burden.
        • The quality, utility, and clarity of the information to be collected.
        • Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
        In this proposed rule we are soliciting public comment on each of these issues for the following sections of the rule that contain proposed “collection of information” requirements as defined under 5 CFR 1320.3(c) of the PRA's implementing regulations.
        A. Proposed Information Collection Requirements (ICRs)
        The following requirements and burden will be submitted to OMB for approval under control number 0938-0763 (CMS-R-262). Subject to renewal, the control number is currently set to expire on February 28, 2019. It was last approved on February 27, 2018, and remains active.
        This rule proposes to implement section 6062 of the SUPPORT for Patients and Communities Act, which require the adoption of technical standards for the Part D e-prescribing program that will help ensure secure ePA requests and response transactions Specifically, the proposed rule would amend the Prescription Drug Benefit program (Part D) regulations to require under § 423.160(b)(7) that Part D plan sponsors (hereinafter, “plans”) have the technical capability to support the National Council for Prescription Drug Programs (NCPDP) SCRIPT standard version 2017071 when performing electronic ePA for Part D-covered drugs prescribed to Part D-eligible individuals. While this proposed rule will not impact the PA criteria which Part D plans have in place, the electronic process will make the PA process less burdensome for plans and prescribers. Prescribers who are currently using an electronic prescribing software already have access to the ePA transactions and may generally access the proposed transactions without cost, since the eRx software includes all transactions within the NCPDP SCRIPT standard. As ePA is implemented the current system of manual processing (fax and phone calls) will be eliminated, since plans will be able to use this more appropriate standard.
        We estimate a one-time cost for plans to implement the necessary changes to support the ePA transactions within NCPDP SCRIPT standard version 2017071. After consulting with industry stakeholders, we have concluded that implementing or building the type of logic which will allow systems engineers to produce the interactive logic which the SCRIPT standard requires can vary based on how the PA criteria are currently documented, but $100,000 is the approximate average cost. The cost varies based on the size and expertise of the plan. This figure includes only the plan's internal costs including labor, initial development and programming, and systems support to transform each of its CMS-approved PA criteria from a free flowing document suitable for implementation by a clinical professional into a step-by-step document that can be adapted for use by programmers. Based on our internal data, we estimate that there are 990 plans. We estimate that only 20 percent (or 198) of the plans (990 plans × 0.20) do not have the internal ePA process that would be required to build the logic into the NCPDP SCRIPT standard's ePA transactions. In that regard we estimate a one-time implementation cost of $19,800,000 (198 plans × $100,000/plan) or $6,600,000 annually when factoring in OMB's 3-year approval period ($19.8 million/3 years). We are annualizing the one-time estimate since we do not anticipate any additional burden after the 3-year approval period expires.
        Based on our informal conversations with the industry, we believe that the ongoing cost that plans would incur to process ePA transactions range from $1.20 to $2.85 per transaction, which varies based on vendor and volume. Based on internal CMS data, for the 990 plans we estimate that 560,430 PAs are performed every year and that each authorization requires two individual transactions, one for receiving and one for responding. Using $2.03 as the average cost per transaction ([$1.20 + $2.85]/2) we estimate $4.06 per authorization ($2.03/transaction × 2 transactions/authorization). In aggregate we project an ongoing cost of $2,275,346 annually ($4.06/authorization × 560,430 authorizations) for all plans.
        With regard to current practice, the remaining 80 percent (or 792) of the plans (990 plans × 0.80) already have an automated PA process in place. Our review of their cost data indicates that they spend an average of $10.00/fax PA for 448,344 authorizations (560,430 authorizations × 0.80) at a cost of $4,483,440 (448,344 PAs × $10.00/PA). The remaining 198 plans that rely on phone or fax and individual ePA review spend an average of $25.00/manual PA for 112,086 authorizations (560,430 authorizations × 0.20) at a cost of $2,802,150 (112,086 PAs × $25.00/PA). In this regard the transaction cost for the current practice is approximately $7,285,590 ($4,483,440 + $2,802,150).
        Outside of the one-time implementation cost, the proposed changes to § 423.160(b)(7) would result in an annual savings of $5,010,244 to Part D plans ($7,285,590 current process − $2,275,346 proposed standard) for the ongoing PA requirements. When considering the one-time cost, we project an annual increase of $8,875,346 ($7,285,590 current process − $5,010,244 proposed standard savings + $6,600,000 one-time cost) for the first 3 years of OMB's approval period.
        B. Submission of PRA-Related Comments
        We have submitted a copy of this rule to OMB for its review of the rule's proposed information collection requirements and burden. The requirements are not effective until they have been approved by OMB.

        To obtain copies of the supporting statement and any related forms for the proposed collections previously discussed, please visit CMS's website at: https://www.cms.gov/Regulations-andGuidance/Legislation/PaperworkReductionActof1995/PRAListing.html, or call the Reports Clearance Office at (410) 786-1326.

        We invite public comments on the proposed information collection requirements and burden. If you wish to comment, please submit your comments electronically as specified in the DATES and ADDRESSES sections of this proposed rule and identify the rule (CMS-4189-P) and where applicable the ICR's CFR citation, CMS ID number (CMS-R-262), and OMB control number (OMB 0938-0763).
        IV. Regulatory Impact Statement
        A. Statement of Need

        This rule proposes to implement provisions of the SUPPORT for Patients and Communities Act, which require the adoption of transaction standards for the Part D program that will help ensure secure electronic PA request and response transactions. Specifically, the proposed rule would amend the Prescription Drug Benefit program (Part D) regulations to require that Part D plans sponsors have the technical capability to support the National Council for Prescription Drug Programs (NCPDP) SCRIPT standard version 2017071 when performing electronic Prior Authorization (ePA) for Part D-covered drugs prescribed to Part D-eligible individuals.
        B. Overall Impact
        We have examined the impact of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C. 804(2)), and Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30, 2017).
        Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A RIA must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This rule does not reach the economic threshold and thus is not considered a major rule.
        The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of less than $7.5 million to $38.5 million annually. Individuals and states are not included in the definition of a small entity. We are not preparing an analysis for the RFA because we have determined, and the Secretary certifies, that this proposed rule would not have a significant economic impact on a substantial number of small entities.
        In addition, section 1102(b) of the Act requires us to prepare an RIA if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act because we have determined, and the Secretary certifies, that this rule would not have a significant impact on the operations of a substantial number of small rural hospitals.
        Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2019, that threshold is approximately $154 million. This rule would have no consequential effect on state, local, or tribal governments or on the private sector.
        Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. Since this rule does not impose any costs on state or local governments, the requirements of Executive Order 13132 are not applicable.
        If regulations impose administrative costs on reviewers, such as the time needed to read and interpret this final rule, then we should estimate the cost associated with regulatory review. There are currently 750 MA contracts (which also includes PDPs), 50 State Medicaid Agencies, and 200 Medicaid Managed Care Organizations (1,000 reviewers total). We assume each entity will have one designated staff member who will review the entire rule. Other assumptions are possible and will be reviewed after the calculations.

        Using the wage information from the Bureau of Labor Statistics (BLS) for medical and health service managers (code 11-9111), we estimate that the cost of reviewing this final rule is $107.38 per hour, including fringe benefits and overhead costs (http://www.bls.gov/oes/current/oes_nat.htm). Assuming an average reading speed, we estimate that it will take approximately 12.5 hours for each person to review this final rule. For each entity that reviews the rule, the estimated cost is therefore, $1,342 (12.5 hours × $107.38). Therefore, we estimate that the total cost of reviewing this final rule is $1,342,000 ($1,342 × 1,000 reviewers).
        Note that this analysis assumed one reader per contract. Some alternatives include assuming one reader per parent entity. Using parent organizations instead of contracts will reduce the number of reviewers to approximately 500 (assuming approximately 250 parent organizations), and this will cut the total cost of reviewing in half. However, we believe it is likely that reviewing will be performed by contract. The argument for this is that a parent organization might have local reviewers; even if that parent organization has several contracts that might have a reader for each distinct geographic region, to be on the lookout for effects of provisions specific to that region.
        Executive Order 13771, titled Reducing Regulation and Controlling Regulatory Costs, was issued on January 30, 2017 (82 FR 9339, February 3, 2017). It has been determined that this rule does not impose more than a de minimis costs; and thus, is not a regulatory action for purposes of E.O. 13771.
        C. Anticipated Effects
        As stated in the previously, section 6062 of the SUPPORT for Patients and Communities Act requires the adoption of technical standards for the Part D program that will ensure secure ePA request and response transactions no later than January 1, 2021. We propose to codify requirements at § 423.160, which would require plans to support the National Council for Prescription Drug Programs (NCPDP) SCRIPT standard version 2017071 by January 1, 2021 when performing electronic ePA for Part D-covered drugs prescribed to Part D-eligible individuals. The proposed rule has the following impacts.

        Entities affected by the PA processes include pharmacies receiving ePAs from providers and filling the prescription, prescribers who use ePA, the Medicare Part D Program, Part D plans, EHR vendors who need to modify their products, and the Promoting Interoperability Programs, for any Part D prescribers in these programs. Information about what programs are included in the Medicare Promoting Interoperability Programs is available via this web link: https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/index.html?redirect=/EHRincentiveprograms.

        There are three primary aspects of the provision that could affect its cost and the amount saved. The most immediate cost comes from the one-time implementation cost for the few EHR vendors who need to need to change their programming to use two standards; the NCPDP SCRIPT standard version 2017071 for Part D ePA and the HIPAA standard for other contexts. Based on our conversations with EHR vendors, we believe that it would take the EHR vendors approximately 200 developing hours and 800 programming hours to enable the EHRs to utilize two standards.
        We also estimated what it would cost plan sponsors to implement this proposed standard. After consulting with industry stakeholders, we have concluded that implementing or building to the SCRIPT standard can vary, but $100,000 is the approximate amount. We estimate that only 20 percent of the 750 plans would have to make changes to implement their ePA process to implement the SCRIPT ePA process standard, which gives us an approximate one time implementation cost of $15 million (0.2 * 750 * $100,000).
        The ongoing cost for plans range from $1.20 to $2.85 per transaction, and vary based on vendor and volume. We estimate that 560,430 PAs are performed every year. If we estimate the average cost per transaction to be $2.03 and each PA requires two transactions, the ongoing cost of ePA would be approximately $2.27 million annually ($2.03 * 560,430 * 2).
        The anticipated costs and how they compare to current costs are as follows:

            Plans without automated PA logic
            Plans with automated PA
              processing logic

            Total

            Annual Maintenance Costs, Paper Process
            $2,302,150.00
            $3,683,440.00
            $5,985,590.00

            Annual Maintenance Costs, ePA Process

            (2,275,345.80)

            Projected Annual Savings

            3,710,244.20

        It should be noted that the $3,710,244 in cumulative plan savings would be reduced by $100,000 in the first year as plans that have not automated their PA logic move to do so.
        We believe that the savings from this rule would be primarily derived from the reduction in time it takes to process a prior-authorization as discussed previously.
        E. Alternatives Considered
        The SUPPORT for Patients and Communities Act requires the adoption of technical standards by January 1, 2021. We had considered requiring the adoption of the standard by January 1, 2020. However, we want to help ensure that plans have as much time to comply with the statutory mandate as possible.
        V. Response to Comments

        Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.

          List of Subjects in 42 CFR Part 423
          Administrative practice and procedure, Emergency medical services, Health facilities, Health maintenance organizations (HMO), Health professionals, Medicare, Penalties, Privacy, and Reporting and recordkeeping requirements.

        For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services proposes to amend 42 CFR part 423 as set forth below:

          PART 423—VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT

        1. The authority citation for part 423 is revised to read as follows:

          Authority:
          42 U.S.C. 1302, 1306, 1395w-101 through 1395w-152, and 1395hh.

        2. Section 423.160 is amended by adding paragraph (b)(7) to read as follows:

          § 423.160
           Standards for electronic prescribing.

          (b) * * *
          (7) Electronic prior authorization. Beginning January 1, 2021, Part D sponsors and prescribers must comply with the National Council for Prescription Drug Programs SCRIPT standard, Implementation Guide Version 2017071 approved July 28, 2017 (incorporated by reference in paragraph (c)(1)(vii) of this section), to provide for the communication of a prescription or related prescription-related information between prescribers and dispensers for the following transactions:
          (i) PAInitiationRequest and PAInitiationResponse
          (ii) PARequest and PAResponse
          (iii) PAAppealRequest and PAAppealResponse
          (iv) PACancelRequest and PACancelResponse

          Dated: June 11, 2019.
          Seema Verma,
          Administrator, Centers for Medicare & Medicaid Services.
          Dated: June 14, 2019.
          Alex M. Azar II,
          Secretary, Department of Health and Human Services.

      [FR Doc. 2019-13028 Filed 6-17-19; 11:15 am]
       BILLING CODE 4120-01-P


        DEPARTMENT OF COMMERCE
        National Oceanic and Atmospheric Administration
        50 CFR Part 680
        RIN 0648-AY33
        Fisheries of the Exclusive Economic Zone Off Alaska; Bering Sea and Aleutian Islands Crab Rationalization Program; Amendment 34

          AGENCY:
          National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

          ACTION:
          Notice of availability of a proposed amendment to a fishery management plan; request for comments.

          SUMMARY:
          The North Pacific Fishery Management Council submitted Amendment 34 to the Fishery Management Plan for Bering Sea/Aleutian Islands King and Tanner Crabs to NMFS for review. If approved, Amendment 34 would amend the Bering Sea and Aleutian Islands Crab Rationalization Program to exempt additional recipients of crab quota share from Gulf of Alaska Pacific cod and pollock harvest limits, called sideboards, which apply to some vessels and license limitation program licenses that are used to participate in these fisheries. The North Pacific Fishery Management Council determined that these additional recipients demonstrated a sufficient level of historical participation in Gulf of Alaska Pacific cod or pollock fisheries, and that they should be exempt from the current sideboards. This action is necessary to give these recipients an opportunity to participate in the Gulf of Alaska Pacific cod and pollock fisheries at historical levels. This action is intended to promote the goals and objectives of the Magnuson-Stevens Fishery Conservation and Management Act, the Fishery Management Plan for Bering Sea/Aleutian Islands King and Tanner Crabs, and other applicable laws.

          DATES:
          Comments on the amendment must be submitted on or before May 13, 2011.

          ADDRESSES:

          Send comments to Dr. James Balsiger, Regional Administrator, Alaska Region, NMFS, Attn: Ellen Sebastian. You may submit comments, identified by “RIN 0648-AY33,” by any one of the following methods:
          • Electronic Submissions: Submit all electronic public comments via the Federal eRulemaking Portal Web site at http://www.regulations.gov.

          • Mail: P. O. Box 21668, Juneau, AK 99802.
          • Fax: 907-586-7557.
          • Hand Delivery to the Federal Building: 709 West 9th Street, Room 420A, Juneau, AK.

          All comments received are a part of the public record. No comments will be posted to http://www.regulations.gov for public viewing until after the comment period has closed. Comments will generally be posted without change. All personal identifying information (e.g., name, address) voluntarily submitted by the commenter may be publicly accessible. Do not submit confidential business information or otherwise sensitive or protected information.
          NMFS will accept anonymous comments (enter N/A in the required fields, if you wish to remain anonymous). Attachments to electronic comments will be accepted in Microsoft Word, Excel, WordPerfect, or Adobe portable document file (pdf) formats only.

          Electronic copies of Amendment 34 to the Fishery Management Plan for Bering Sea/Aleutian Islands King and Tanner Crabs, the Environmental Assessment, the Regulatory Impact Review, and the Initial Regulatory Flexibility Analysis prepared for this action are available from http://www.regulations.gov or from the NMFS Alaska Region Web site at http://alaskafisheries.noaa.gov. The Environmental Impact Statement, Regulatory Impact Review, Final Regulatory Flexibility Analysis, and Social Impact Assessment prepared for the Crab Rationalization Program are available from the NMFS Alaska Region Web site at http://alaskafisheries.noaa.gov.

          FOR FURTHER INFORMATION CONTACT:
          Rachel Baker, 907-586-7228.

        SUPPLEMENTARY INFORMATION:

        The Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) requires that each regional fishery management council submit any fishery management plan amendment it prepares to NMFS for review and approval, disapproval, or partial approval by the Secretary of Commerce. The Magnuson-Stevens Act also requires that NMFS, upon receiving a fishery management plan amendment, immediately publish a notice in the Federal Register announcing that the amendment is available for public review and comment. This notice announces that proposed Amendment 34 to the Fishery Management Plan for Bering Sea/Aleutian Islands King and Tanner Crabs (Crab FMP) is available for public review and comment.
        The king and Tanner crab fisheries in the exclusive economic zone of the Bering Sea and Aleutian Islands (BSAI) are managed under the Crab FMP. The groundfish fisheries in the exclusive economic zone of the Gulf of Alaska (GOA) are managed under the Fishery Management Plan for Groundfish of the Gulf of Alaska. The North Pacific Fishery Management Council (Council) prepared the Crab FMP and the Fishery Management Plan for Groundfish of the Gulf of Alaska under the Magnuson-Stevens Act. Amendments 18 and 19 amended the Crab FMP to include the Bering Sea and Aleutian Islands Crab Rationalization Program (CR Program). Regulations implementing Amendments 18 and 19 were published on March 2, 2005 (70 FR 10174), and are located at 50 CFR part 680. Regulations governing GOA groundfish fisheries are located at 50 CFR part 679.
        The CR Program allocates BSAI crab resources among harvesters, processors, and coastal communities. The CR Program is a limited access privilege program for nine BSAI crab fisheries, in which participants receive exclusive harvesting and processing privileges for a portion of the total allowable catch (TAC) assigned to each crab fishery in the CR Program.
        Under the CR Program, persons received quota share (QS) based on their historical participation in one or more of the CR Program crab fisheries during a specific time period. Quota share represents an exclusive but revocable privilege to receive an annual allocation to harvest a specific percentage of the TAC from a CR Program fishery. NMFS allocated QS to eligible harvesters in 2005, prior to the first year of crab fishing under the CR Program. Each year, a person who holds crab QS and submits a timely and complete crab permit application to NMFS receives an exclusive harvest privilege for a portion of the annual TAC for that crab fishery. This harvest privilege, called individual fishing quota (IFQ), is the annual allocation of pounds of crab for harvest that represent a QS holder's percentage of the TAC. Crab QS holders may form voluntary crab harvesting cooperatives to combine and cooperatively manage their aggregate QS holdings. Each cooperative that is approved by NMFS receives the amount of cooperative IFQ yielded by the aggregate QS holdings of all of the members of the cooperative.
        The Council anticipated that crab harvesting cooperatives would significantly increase operating flexibility for crab fishermen because they could choose when and where to fish for IFQ. Crab fishermen in cooperatives also could potentially reduce costs by harvesting crab IFQs on fewer vessels during an extended season. The Council was concerned that increased flexibility for BSAI crab fishermen could give them an incentive to increase effort in other fisheries, which could economically disadvantage other participants in these fisheries.

        The Council developed sideboards to prevent Bering Sea snow crab (Chionoecetes opilio) quota share recipients from increasing their participation in GOA groundfish fisheries, particularly in the GOA Pacific cod fishery. However, in order to enable those Bering Sea snow crab quota share recipients who also had significant participation in, or dependence on, the GOA Pacific cod fishery to maintain historical participation levels, the Council exempted certain qualified vessels and license limitation program (LLP) licenses from the GOA Pacific cod sideboard.
        The CR Program's GOA groundfish sideboards were implemented in 2006. Under current regulations, CR Program sideboard limits apply to vessels that: (1) Harvest any species of GOA groundfish with the exception of sablefish harvested with fixed gear; (2) are not authorized to conduct directed fishing for pollock under the American Fisheries Act (AFA) of 1998 (Public Law 105-277, Title II of Division C); and (3) meet one or both of the following criteria: (a) Made a legal landing of Bering Sea snow crab between January 1, 1996, and December 31, 2000, that generated any amount of Bering Sea snow crab QS; or (b) are named on a GOA groundfish LLP license that was generated by the fishing history of a vessel that also generated Bering Sea snow crab QS. Vessels that meet these criteria subsequently will be referred to as “non-AFA crab vessels.” The CR Program did not establish sideboard limits for AFA vessels with historical participation in the Bering Sea snow crab fishery because these vessels are subject to GOA harvesting and processing restrictions under the AFA and in implementing regulations for the AFA (50 CFR 679.64(b)).

        The Council primarily intended GOA groundfish sideboards to restrict vessels with Bering Sea snow crab catch history. However, the Council determined that, because LLP licenses are transferable, GOA groundfish sideboard limits should also apply to GOA groundfish LLP licenses derived from vessels with catch history that also generated Bering Sea snow crab QS. The LLP was implemented in 2000 to limit the number, size, and operation type (gear designation) of vessels that may be deployed in the groundfish fisheries in the exclusive economic zone of the BSAI and GOA, and in crab fisheries in the BSAI. Regulations require, with limited exceptions, that a vessel must be named on a legible copy of a valid LLP license that is on board the vessel in order to participate in a directed fishery for LLP species. NMFS issued LLP licenses based on the catch history of a vessel in specific fisheries (i.e., a vessel's qualifying catch history generated an LLP license). The Council extended the CR Program GOA groundfish sideboards to GOA groundfish LLP licenses derived from vessels with catch history that also generated Bering Sea snow crab quota to prevent crab QS recipients from circumventing the GOA groundfish sideboards by transferring an LLP license for use on a vessel that is not subject to the sideboards. Thus, any vessel named on a GOA groundfish LLP license that was generated by the GOA groundfish catch history of a non-AFA vessel that also generated Bering Sea crab QS is subject to the CR Program GOA non-AFA groundfish sideboards, even if the vessel named on the LLP license did not have historical landings that generated Bering Sea snow crab QS.
        While most vessels and LLP licenses with catch history that generated Bering Sea snow crab QS are subject to the CR Program sideboard limits in GOA groundfish fisheries, some are exempt from the GOA Pacific cod sideboard. The Council established an exemption from the GOA Pacific cod sideboard limits for non-AFA crab vessels that demonstrated minimal participation in, or dependence on, the Bering Sea snow crab fishery and sufficient participation in, or dependence on, the GOA Pacific cod fishery from 1996 through 2000. Non-AFA crab vessels that are exempt from the GOA Pacific cod sideboard limits do not have to stop fishing for GOA Pacific cod when the sideboard limit is reached and may continue to fish as long as directed fishing for Pacific cod is open. The catch history of exempt participants is not included in the GOA Pacific cod non-AFA crab vessel sideboard limit calculations, and NMFS does not count the GOA Pacific cod catch of exempt vessels toward the non-AFA crab vessel sideboard limit.
        Each year, NMFS calculates the non-AFA crab vessel sideboard limits for GOA groundfish species. The sideboard limit is calculated as a ratio of the amount of each groundfish species retained by non-AFA crab vessels from 1996 to 2000, relative to the total retained catch of each species by all vessels during the same period. This calculation yields a fixed ratio, or percentage, that is multiplied by the annual TAC for each GOA groundfish sideboard species to determine the non-AFA crab vessel sideboard limit (in metric tons) for GOA groundfish species.
        NMFS opens directed fishing for a sideboard species for non-AFA crab vessels only when it determines that any directed fishery harvest for that species—and the incidental catch needs for that species by non-AFA crab vessels in other fisheries—would not exceed the sideboard limit. The CR Program GOA groundfish sideboard limits restrict the catch of non-AFA crab vessels in the aggregate. All targeted or incidental catch of a GOA groundfish sideboard species made by non-AFA crab vessels subject to the sideboard is deducted from the sideboard limit. NMFS closes directed fishing for vessels subject to a sideboard limit when NMFS determines that the remainder of a GOA groundfish sideboard limit is needed for incidental catch by non-AFA crab vessels in other fisheries.
        Since 2006, NMFS has determined that only Pacific cod non-AFA crab vessel sideboard limits in two GOA management areas were large enough to open a directed sideboard fishery. Although NMFS opened directed fishing for Pacific cod for non-AFA crab vessels subject to the sideboard limit, the relatively small sideboard limit amounts prompted NMFS to close directed fishing for these vessels earlier than it closed directed fishing for vessels that were not subject to sideboard limits. All other GOA sideboard species, including pollock, have been closed to directed fishing by non-AFA crab vessels subject to the CR Program groundfish sideboard limits because the sideboard limits were determined by NMFS to be insufficient to support both directed and incidental catch needs for these vessels.
        The Council was prompted to reexamine the CR Program GOA groundfish sideboard limits by non-AFA crab vessel operators who testified that some sideboard limits were too restrictive. These operators indicated that they had historically participated in GOA Pacific cod and pollock fisheries at levels that demonstrated sufficient dependence on these fisheries and had received Bering Sea crab quota share at levels that demonstrated minimal dependence on the Bering Sea snow crab fishery. Some Bering Sea snow crab QS recipients testified to the Council that the earlier closure of directed fishing for Pacific cod for non-AFA crab vessels subject to sideboard limits, as well as the complete closure of directed fishing for pollock for vessels subject to sideboard limits, represented a lost fishing opportunity for their vessels and thus, potential lost revenue from Pacific cod and pollock catch. Based on this public testimony and a review of the effects of the sideboard limits in the 2005/2006 and 2006/2007 crab fishing years, the first 2 years of the CR Program, the Council determined that the sideboard restrictions for the GOA Pacific cod and pollock fisheries should be re-examined. The Council initiated an analysis in December 2007 to examine alternatives that would expand the criteria for non-AFA crab vessels to qualify for an exemption from the Pacific cod sideboard limits and would extend a similar exemption to the pollock sideboard limits. In October 2008, the Council recommended Amendment 34 to the Crab FMP to exempt additional vessels and groundfish LLP licenses from the GOA Pacific cod and pollock sideboard limits.
        Amendment 34 would implement two actions. Action 1 would revise the GOA Pacific cod sideboard limit exemption criteria for non-AFA crab vessels. Action 2 would establish new GOA pollock sideboard limit exemption criteria for non-AFA crab vessels. NMFS estimates that, in addition to the five vessels and five groundfish LLP licenses that are currently exempt, the Council's preferred alternative for Action 1 would exempt three non-AFA crab vessels and three groundfish LLP licenses from GOA Pacific cod sideboard limits, for an estimated total of eight vessels and eight LLP licenses that would be exempt from the GOA Pacific cod sideboard. For Action 2, NMFS estimates that the Council's preferred alternative would exempt one non-AFA crab vessel and one groundfish LLP license from the GOA pollock sideboard limits. Exemptions from the sideboard harvest limits would provide an opportunity for these crab QS recipients to participate in the GOA Pacific cod and pollock fisheries at historical levels. The Council determined that the potential increased participation by these participants in GOA Pacific cod and pollock fisheries was unlikely to significantly impact other participants in these fisheries.

        The Regulatory Impact Review and Initial Regulatory Flexibility Analysis prepared for this action describes the costs and benefits of the proposed amendment (see
          ADDRESSES). All of the directly regulated entities would be expected to benefit from this action relative to the status quo because the proposed amendment would allow crab QS recipients with demonstrated dependence on GOA Pacific cod and pollock fisheries to participate in these fisheries at historical levels.

        Public comments are being solicited on proposed Amendment 34 to the Crab FMP through the end of the comment period (see
          DATES). NMFS intends to publish in the Federal Register, and seek public comment on, a proposed rule that would implement Amendment 34, following NMFS's evaluation of the proposed rule under the Magnuson-Stevens Act. Public comments on the proposed rule must be received by the end of the comment period on Amendment 34 (see
          DATES) to be considered in the approval/disapproval decision on Amendment 34. All comments received by the end of the comment period, whether specifically directed to Amendment 34 or the proposed rule, will be considered in the FMP approval/disapproval decision. To be considered, comments must be received, not just postmarked or otherwise transmitted, by the close of business on the last day of the comment period. Comments received after that date will not be considered in the approval/disapproval decision on the amendment.

          Authority:
          16 U.S.C. 1801 et seq.

          Dated: March 9, 2011.
          Emily H. Menashes,
          Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.

      [FR Doc. 2011-5854 Filed 3-11-11; 8:45 am]
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        POSTAL SERVICE
        39 CFR Part 492
        Collection of Delinquent Non-Tax Debts by Administrative Wage Garnishment

          AGENCY:
          Postal Service.

          ACTION:
          Proposed rule.

          SUMMARY:
          The United States Postal Service proposes to add a provision to its regulations in order to implement the administrative wage garnishment (AWG) provisions of the Debt Collection Improvement Act of 1996 (DCIA), and to allow the Bureau of the Fiscal Service (BFS) of the United States Treasury to collect debts owed to the Postal Service, that the Postal Service refers to BFS for collection, by AWG.

          DATES:
          Comments must be received on or before June 23, 2014.

          ADDRESSES:

          Mail or deliver written comments to Ruth Stevenson, U.S. Postal Service, 475 L'Enfant Plaza SW., Room 6416, Washington, DC 20260-1150. You may inspect and photocopy all written comments at USPS Headquarters Library, 475 L'Enfant Plaza SW., 11th Floor North, Washington, DC, by appointment only between the hours of 9 a.m. and 4 p.m., Monday through Friday. Call 1-202-268-2906 in advance for an appointment. Email comments, containing the name and address of the commenter, may be sent to: awgcomments@ usps.gov. Faxed comments are not accepted.

          FOR FURTHER INFORMATION CONTACT:
          Ruth Stevenson at (202) 268-6724.

        SUPPLEMENTARY INFORMATION:
        After providing debtors with the requisite opportunity for notice and review, the Postal Service currently may refer non-tax delinquent debts to the United States Treasury Bureau of the Fiscal Service (BFS), formerly the Financial Management Service (FMS), for centralized collection and/or offset. Among other potential collection tools, BFS may utilize Administrative Wage Garnishment (AWG) to collect delinquent debts referred to it by federal agencies. AWG allows a federal entity to enforce collection of a debt by garnishing wages the debtor receives from a non-federal (private) employer after affording the debtor with notice and certain administrative proceedings, including the right to a hearing.

        Provisions of the DCIA, codified at 31 U.S.C. 3720D, authorize Federal agencies to collect non-tax debt owed to the United States by AWG. The Treasury has also issued an implementing regulation at 31 CFR 285.11. However, before BFS may utilize AWG to collect debts that the Postal Service refers to it, the Postal Service must first implement regulations authorizing the collection of non-tax delinquent debt by AWG. The Postal Service accordingly proposes to add new part 492, containing § 492.1, to title 39 of the Code of Federal Regulations in order to authorize collection of Postal debts by AWG.
        The regulation proposed by the Postal Service provides that the Treasury regulation, 31 CFR 285.11, shall apply to AWG proceedings conducted by, or on behalf of, the Postal Service. Section 285.11 includes procedural protections, including notice requirements and hearing procedures, to allow individuals to contest the existence or amount of the debt and/or to assert that collection by garnishment would present an undue hardship prior to collection by AWG. BFS will pursue AWG on behalf of the Postal Service as part of its normal debt collection process. This includes issuing notices to debtors and garnishment orders to employers, as well as conducting required administrative hearings on behalf of the Postal Service, in accordance with the procedures contained in 31 CFR 285.11.

        AWG, which involves the garnishment of wages a debtor receives from a private employer, is a separate procedure from administrative salary offsets taken from current federal employees' salaries (including Postal employees' salaries) in order to satisfy a debt owed to the United States. See 5 U.S.C. 5514; 39 CFR part 961. It is also a distinct procedure from the garnishment of current Postal Service employee and Postal Service Rate employee salaries, as detailed in 39 CFR part 491. Accordingly, the procedures contained in these provisions are not affected by this rule. In addition, the provisions pertaining to administrative offset contained in 39 CFR part 966 are not affected by this rule. As noted, the Postal Service must afford individuals with notice and an opportunity for review prior to referring a debt to the Treasury for collection and/or administrative offset, in accordance with ELM 470-480 and/or 39 CFR part 966, if applicable. Treasury may then determine to pursue collection of the debt by AWG, after providing the debtor with any additional process or procedures required by 31 CFR 285.11.

          List of Subjects in 39 CFR Part 492
          Administrative practice and procedure, Claims, Wages.

        For the reasons stated in the preamble, the Postal Service proposes to add 39 CFR part 492 as set forth below:

          PART 492—ADMINISTRATIVE WAGE GARNISHMENT FROM NON-POSTAL SOURCES

            Authority:
             31 U.S.C. 3720D; 39 U.S.C. 204, 401, 2601; 31 CFR 285.11.

            § 492.1
            Collection of delinquent non-tax debts by administrative wage garnishment.
            (a) This section provides procedures for the Postal Service to collect money from a debtor's disposable pay by means of administrative wage garnishment, in accordance with 31 U.S.C. 3720D and 31 CFR 285.11, to satisfy delinquent nontax debt owed to the United States.
            (b) The Postal Service authorizes the United States Treasury Bureau of the Fiscal Service or its successor entity to collect debts by administrative wage garnishment, and conduct administrative wage garnishment hearings, on behalf of the Postal Service in accordance with the requirements of 31 U.S.C. 3720D and the procedures contained in 31 CFR 285.11.
            (c) The Postal Service adopts the provisions of 31 CFR 285.11 in their entirety. The provisions of 31 CFR 285.11 should therefore be read as though modified to effectuate the application of that regulation to administrative wage garnishment proceedings conducted by, or on behalf of, the U.S. Postal Service.

            Stanley F. Mires,
            Attorney, Legal Policy & Legislative Advice.

      [FR Doc. 2014-09295 Filed 4-23-14; 8:45 am]
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