        ENVIRONMENTAL PROTECTION AGENCY
        40 CFR Part 52
        [EPA-R04-OAR-2012-0237; FRL-9757-2]
        Approval and Promulgation of Implementation Plans; Tennessee; Interstate Transport Infrastructure Requirements (Prevention of Significant Deterioration) for the 2008 8-Hour Ozone National Ambient Air Quality Standards

          AGENCY:
          Environmental Protection Agency (EPA).

          ACTION:
          Supplemental proposed rule.

          SUMMARY:

          EPA is proposing to conditionally approve the State Implementation Plan (SIP) submission, submitted by the State of Tennessee through the Tennessee Department of Environment and Conservation (TDEC). This proposal pertains to the Clean Air Act (CAA) requirements pertaining to prevention of significant deterioration (PSD) (concerning the PM2.5 increments) for the for the 2008 8-hour ozone national ambient air quality standards (NAAQS) infrastructure SIPs. The CAA requires that each state adopt and submit a SIP for the implementation, maintenance, and enforcement of each NAAQS promulgated by EPA, which is commonly referred to as an “infrastructure” SIP. TDEC certified that the Tennessee SIP contains provisions that ensure the 2008 8-hour ozone NAAQS are implemented, enforced, and maintained in Tennessee (hereafter referred to as “infrastructure submission”). EPA is proposing to supplement the earlier proposed approval related to sections related to prevention of significant deterioration (PSD) (concerning the PM2.5 increments) by proposing conditional approval of the State's infrastructure submission based upon a October 4, 2012, commitment by the State to submit a SIP revision to address current deficiencies in these sections. EPA is proposing to conditionally approve these sections related to PSD because the current Tennessee SIP does not include provisions to fully comply with the requirements of these sections. All of the other required infrastructure elements for the 2008 8-hour ozone NAAQS are being addressed in a separate rulemaking.

          DATES:
          Written comments must be received on or before December 24, 2012.

          ADDRESSES:
          Submit your comments, identified by Docket ID No. EPA-R04-OAR-2012-0237, by one of the following methods:
          1. www.regulations.gov: Follow the on-line instructions for submitting comments.
          2. Email: R4-RDS@epa.gov.

          3. Fax: (404) 562-9019.
          4. Mail: “EPA-R04-OAR-2012-0237,” Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960.
          5. Hand Delivery or Courier: Lynorae Benjamin, Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Such deliveries are only accepted during the Regional Office's normal hours of operation. The Regional Office's official hours of business are Monday through Friday, 8:30 to 4:30, excluding federal holidays.

            Instructions: Direct your comments to Docket ID No. EPA-R04-OAR-2012-0237. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at
            www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit through www.regulations.gov or email, information that you consider to be CBI or otherwise protected. The www.regulations.gov Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to EPA without going through www.regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA's public docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.

            Docket: All documents in the electronic docket are listed in the www.regulations.gov index. Although listed in the index, some information is not publicly available, i.e., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically in www.regulations.gov or in hard copy at the Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you contact the person listed in the FOR FURTHER INFORMATION CONTACT section to schedule your inspection. The Regional Office's official hours of business are Monday through Friday, 8:30 to 4:30, excluding federal holidays.

          FOR FURTHER INFORMATION CONTACT:

          Nacosta C. Ward, Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. The telephone number is (404) 562-9140. Ms. Ward can be reached via electronic mail at ward.nacosta@epa.gov.

          Table of Contents

            I. Background
            II. What elements are required under sections 110(a)(1) and (2)?
            III. Scope of Infrastructure SIPs
            IV. What is EPA's analysis of how tennessee addressed sections 110(a)(2)(C), prong 3 of 110(a)(2)(D)(i), and 110(a)(2)(J) “infrastructure” provisions?
            V. Proposed Action
            VI. Statutory and Executive Order Reviews

          I. Background

          On March 27, 2008, EPA promulgated a new NAAQS for ozone based on 8-hour average concentrations. EPA revised the level of the 8-hour standard to 0.075 parts per million (ppm). See 77 FR 16436. Pursuant to section 110(a)(1) of the CAA, states are required to submit SIPs meeting the requirements of section 110(a)(2) within three years after promulgation of a new or revised NAAQS. Section 110(a)(2) requires states to address basic SIP requirements, including emissions inventories, monitoring, and modeling to assure attainment and maintenance of the NAAQS. States were required to submit such SIPs for the 2008 8-hour ozone NAAQS to EPA no later than March 2011.
          Midwest Environmental Defense and Sierra Club submitted a complaint on November 20, 2011, related to EPA's failure to issue findings of failure to submit related to the infrastructure requirements for the 2008 8-hour ozone NAAQS. On December 13, 2011, and March 6, 2012, Midwest Environmental Defense and Sierra Club submitted amended complaints for failure to promulgate prevention of significant deterioration (PSD) regulations within two years and failure to approve or disapprove SIP submittals, and to remove claims regarding states that have submitted SIPs for the 2008 8-hour ozone NAAQS, respectively. Tennessee was among the states named in the November 2011 complaint, and the December 2011 and March 2012 amended complaints. Specifically, the plaintiffs claim that EPA has failed to perform its mandatory duty by not approving in full, disapproving in full, or approving in part and disapproving in part Tennessee's 2008 ozone infrastructure SIP addressing sections 110(a)(2)(A)-(H) and (J)-(M) by no later than April 19, 2011.
          Tennessee's infrastructure submission was received by EPA on October 19, 2009, for the 2008 8-hour ozone NAAQS. The submission was determined to be complete on April 19, 2010. On July 3, 2012, Tennessee submitted a letter to EPA withdrawing the portion of its October 19, 2009, SIP submission that purported to address the requirements related to section 110(a)(2)(D)(i)(I) interstate transport. On August 22, 2012, EPA proposed approval of Tennessee's 2008 8-hour ozone infrastructure SIP, with the exception of section 110(a)(2)(D)(i)(I).1

            See 77 FR 50651. The proposed approval included sections 110(a)(2)(C), 110(a)(2)(D)(i)(II), and 110(a)(2)(J); however, it was subsequently found that Tennessee's SIP did not contain all of the requisite provisions in its SIP necessary to fully approve these elements. The deficient portion of Tennessee's SIP pertains to PM2.5 PSD increments.

              1 Section 110(a)(2)(D)(i)(I) for the 2008 8-hour ozone NAAQS will be addressed through a separate rulemaking.

          On October 4, 2012, Tennessee submitted a request for conditional approval of sections 110(a)(2)(C), 110(a)(2)(D)(i)(II) with respect to the PSD requirements (hereafter referred to as prong 3 of 110(a)(2)(D)(i)),2

             and 110(a)(2)(J) to address the SIP deficiencies concerning PM2.5 PSD increments for these elements. Today's action proposes conditional approval for these sections based upon a commitment by Tennessee to submit the necessary SIP revisions to address PM2.5 PSD increments for the 2008 8-hour ozone NAAQS.

              2 Section 110(a)(2)(D)(i) includes four requirements referred to as prongs 1 through 4. Prongs 1 and 2 are provided at section 110(a)(2)(D)(i)(I); prongs 3 and 4 are provided at section 110(a)(2)(D)(i)(II).

          II. What elements are required under sections 110(a)(1) and (2)?

          Section 110(a) of the CAA requires states to submit SIPs to provide for the implementation, maintenance, and enforcement of a new or revised NAAQS within three years following the promulgation of such NAAQS, or within such shorter period as EPA may prescribe. Section 110(a) imposes the obligation upon states to make a SIP submission to EPA for a new or revised NAAQS, but the contents of that submission may vary depending upon the facts and circumstances. In particular, the data and analytical tools available at the time the state develops and submits the SIP for a new or revised NAAQS affects the content of the submission. The contents of such SIP submissions may also vary depending upon what provisions the state's existing SIP already contains. In the case of the 2008 8-hour ozone NAAQS, states typically have met the basic program elements required in section 110(a)(2) through earlier SIP submissions in connection with the 1997 8-hour ozone NAAQS.
          More specifically, section 110(a)(1) provides the procedural and timing requirements for SIPs. Section 110(a)(2) lists specific elements that states must meet for “infrastructure” SIP requirements related to a newly established or revised NAAQS. As mentioned above, these requirements include SIP infrastructure elements such as modeling, monitoring, and emissions inventories that are designed to assure attainment and maintenance of the NAAQS. The requirements that are the subject of this proposed rulemaking are listed below.3

              3 Two elements identified in section 110(a)(2) are not governed by the three year submission deadline of section 110(a)(1) because SIPs incorporating necessary local nonattainment area controls are not due within three years after promulgation of a new or revised NAAQS, but rather due at the time the nonattainment area plan requirements are due pursuant to section 172. These requirements are: (1) Submissions required by section 110(a)(2)(C) to the extent that subsection refers to a permit program as required in part D Title I of the CAA; and (2) submissions required by section 110(a)(2)(I) which pertain to the nonattainment planning requirements of part D, Title I of the CAA. Today's proposed rulemaking does not address infrastructure elements related to section 110(a)(2)(I) or the nonattainment planning requirements of 110(a)(2)(C).

          • 110(a)(2)(A): Emission limits and other control measures.
          • 110(a)(2)(B): Ambient air quality monitoring/data system.
          • 110(a)(2)(C): Program for enforcement of control measures.4

              4 This rulemaking only addresses requirements for this element as they relate to attainment areas.

          • 110(a)(2)(D): Interstate transport.5

              5 Today's proposed rulemaking does not address element 110(a)(2)(D)(i)(I) (Interstate Transport) for the 2008 8-hour ozone NAAQS. Interstate transport requirements were formerly addressed by Tennessee consistent with the Clean Air Interstate Rule (CAIR) for the 1997 8-hour ozone NAAQS. On December 23, 2008, CAIR was remanded by the D.C. Circuit Court of Appeals, without vacatur, back to EPA. See North Carolina v. EPA, 531 F.3d 896 (D.C. Cir. 2008). Prior to this remand, EPA took final action to approve Tennessee's SIP revision, which was submitted to comply with CAIR. See 72 FR 46388 (August 20, 2007). In so doing, Tennessee's CAIR SIP revision addressed the interstate transport provisions in section 110(a)(2)(D)(i)(I) for the 1997 8-hour ozone NAAQS. In response to the remand of CAIR, EPA has promulgated a new rule to address interstate transport. See 76 FR 48208 (August 8, 2011) (the Transport Rule). That rule was recently vacated by the D.C. Circuit Court of Appeals. As a result of both the remand of CAIR and vacatur of the Transport Rule, Tennessee has not yet made a submission to address interstate transport. EPA's action on element 110(a)(2)(D)(i)(I) for the 2008 8-hour ozone NAAQS will be addressed in a separate action.

          • 110(a)(2)(E): Adequate resources.
          • 110(a)(2)(F): Stationary source monitoring system.
          • 110(a)(2)(G): Emergency power.
          • 110(a)(2)(H): Future SIP revisions.
          • 110(a)(2)(I): Areas designated nonattainment and meet the applicable requirements of part D.6

              6 This requirement was inadvertently omitted from EPA's October 2, 2007, memorandum entitled “Guidance on SIP Elements Required Under Section 110(a)(1) and (2) for the 1997 8-Hour Ozone and PM2.5 National Ambient Air Quality Standards,” but as mentioned above is not relevant to today's proposed rulemaking.

          • 110(a)(2)(J): Consultation with government officials; public notification; and PSD and visibility protection.
          • 110(a)(2)(K): Air quality modeling/data.
          • 110(a)(2)(L): Permitting fees.
          • 110(a)(2)(M): Consultation/participation by affected local entities.
          III. Scope of Infrastructure SIPs
          EPA notes that this rulemaking does not address four substantive issues that are not integral to the state's infrastructure SIP submission. These four issues are: (i) Existing provisions related to excess emissions during periods of start-up, shutdown, or malfunction at sources (SSM), that may be contrary to the CAA and EPA's policies addressing such excess emissions; (ii) existing provisions related to “director's variance” or “director's discretion” that purport to permit revisions to SIP approved emissions limits with limited public process or without requiring further approval by EPA, that may be contrary to the CAA (director's discretion); (iii) existing provisions for minor source new source review (NSR) programs that may be inconsistent with the requirements of the CAA and EPA's regulations that pertain to such programs (minor source NSR); and, (iv) existing provisions for PSD programs that may be inconsistent with current requirements of EPA's “Final NSR Improvement Rule,” 67 FR 80186 (December 31, 2002), as amended by 72 FR 32526 (June 13, 2007) (NSR Reform).

          Instead, EPA has indicated that it has other authority to address any such existing SIP defects in other rulemakings, as appropriate. A detailed rationale for why these four substantive issues are not part of the scope of infrastructure SIP rulemakings can be found in EPA's June 11, 2012, proposed rule entitled, “Approval and Promulgation of Implementation Plans; Tennessee 110(a)(1) and (2) Infrastructure Requirements for the 1997 and 2006 Fine Particulate Matter National Ambient Air Quality Standards” in the section entitled, “Scope of Infrastructure SIPs” (See 77 FR 34306). It can also be found in EPA's August 22, 2012, proposed rule entitled, “Approval and Promulgation of Implementation Plans; Tennessee 110(a)(1) and (2) Infrastructure Requirements for the 2008 8-Hour Ozone Matter National Ambient Air Quality Standards” in the section entitled, “Scope of Infrastructure SIPs.” See 77 FR 50651.
          IV. What is EPA's analysis of how Tennessee addressed sections 110(a)(2)(C), prong 3 of 110(a)(2)(D)(i), and 110(a)(2)(J) “infrastructure” provisions?
          In this action, EPA is proposing to conditionally approve Tennessee's infrastructure SIP for the following infrastructure sections for the 2008 8-hour ozone NAAQS: (1) Section 110(a)(2)(C) to include a program in the SIP that regulates the modification and construction of any stationary source as necessary to assure that the NAAQS are achieved, (2) prong 3 of section 110(a)(2)(D)(i) to include adequate provisions prohibiting any source or other type of emissions activity within the State from emitting any air pollutant in amount which will interfere with measure required to be include in the applicable SIP for any State necessary to prevent significant deterioration, and (3) section 110(a)(2)(J) to include a program in the SIP that regulates the modification and construction of any stationary source as necessary to assure that the NAAQS are achieved.

          There are four revisions to the Tennessee SIP that are necessary to meet the requirements of infrastructure requirements of sections 110(a)(2)(C), prong 3 of 110(a)(2)(D)(i), and 110(a)(2)(J). These four revisions are related to (1) the Ozone Implementation NSR Update (November 29, 2005, 70 FR 71612), (2) the “Prevention of Significant Deterioration and Title V Greenhouse Gas Tailoring Rule” (June 3, 2010, 75 FR 31514), (3) the NSR PM2.5 Rule (May 16, 2008, 73 FR 28321), and (4) the portion of the final rulemaking entitled “Final Rule Prevention of Significant Deterioration (PSD) for Particulate Matter Less Than 2.5 Micrometers (PM2.5)—Increments, Significant Impact Levels (SILs) and Significant Monitoring Concentration (SMC): Final Rule” that relates to the PM2.5 PSD increments requirements (hereafter referred to as the PM2.5 PSD Increment-SILs-SMC Rule (only as it relates to PM2.5 PSD Increments) (75 FR 64864).

          Tennessee's Ozone Implementation NSR Update revision was submitted by TDEC on May 28, 2009, and approved by EPA on February 7, 2012. See 77 FR 6016. Tennessee submitted its Greenhouse Gas (GHG) Tailoring Rule, to EPA on January 11, 2012, and EPA approved it on February 28, 2012. See 77 FR 11744. Tennessee submitted its NNSR requirements related to the implementation of the NSR PM2.5 Rule on July 29, 2011, and EPA approved this revision on July 30, 2012. See 77 FR 44481. On October 4, 2012, Tennessee submitted a letter to EPA requesting conditional approval of specific enforceable measures related to 110(a)(2)(C), prong 3 of 110(a)(2)(D)(i), and 110(a)(2)(J) concerning the October 20, 2010, PSD PM2.5 Increments, SILs and SMC Rule because Tennessee's SIP does not currently contain provisions to address requirements associated with PM2.5 increments. Tennessee's October 4, 2012, letter to EPA contained a schedule and commitment to provide the necessary SIP revision to address its SIP deficiencies related to the PM2.5 increments. Today's conditional approval applies only to the PM2.5 increments portion of the PM2.5 Increments, SILs and SMC Rule. The PM2.5 Increments, SILs and SMC Rule provided additional regulatory requirements under the PSD program regarding the implementation of the PM2.5 NAAQS for NSR by specifically establishing PM2.5 increments pursuant to section 166(a) of the CAA to prevent significant deterioration of air quality in areas meeting the NAAQS. The letter can be accessed at www.regulations.gov using Docket ID No. EPA-R04-OAR-2012-0237. The four SIP revisions outlined above 7
             address the requisite requirements of sections 110(a)(2)(C), prong 3 of 110(a)(2)(D)(i), and 110(a)(2)(J) and are necessary for approval of these infrastructure requirements.

              7 (1) EPA's approval of Tennessee's PSD/NSR regulations which address the Ozone Implementation NSR Update requirements, (2) EPA's approval of Tennessee's PSD GHG Tailoring Rule revisions which addresses the thresholds for GHG permitting applicability in Tennessee, (3) EPA's approval of Tennessee's NSR PM2.5 Rule, which adopts required federal PSD and NNSR permitting provisions governing the implementation of the NSR program for PM2.5 as promulgated in the NSR PM2.5 Rule, and (4) EPA's proposed conditional approval of Tennessee's PSD PM2.5 Increments, SILs, and SMC rulemaking to the extent it addresses the PM2.5 Increments portion of the PM2.5 PSD Increment-SILs-SMC Rule..

          In accordance with section 110(k)(4) of the CAA, EPA is proposing to conditionally approve these sections based upon a commitment from Tennessee that the State will submit a SIP revision addressing the increments associated with the PM2.5 PSD Increment-SILs-SMC Rule (only as it relates to PM2.5 Increments) to EPA for approval within one year from EPA's final conditional approval action. In its October 4, 2012, letter, TDEC committed to adopt the above-specified provisions and submit them to EPA for incorporation into the SIP by no later than one year from the publication date of EPA's final conditional approval action for that requirement. Failure by the State to adopt these provisions and submit them to EPA for incorporation into the SIP within one year from the effective date of EPA's final conditional approval action would result in this proposed conditional approval being treated as a disapproval. Should that occur, EPA would provide the public with notice of such a disapproval in the Federal Register.8

              8 EPA notes that pursuant to section 110(k)(4), a conditional approval is treated as a disapproval in the event that a State fails to comply with its commitment. Notification of this disapproval action in the Federal Register is not subject to public notice and comment.

          As a result of Tennessee's formal commitment to correct the deficiency contained in the Tennessee SIP pertaining to PM2.5 PSD increments, EPA is proposing to conditionally approve sections 110(a)(2)(C), prong 3 of 110(a)(2)(D)(i), and 110(a)(2)(J) requirements consistent with section 110(k)(4) of the Act.
          V. Proposed Action

          As described above, EPA is proposing to conditionally approve Tennessee's infrastructure submissions pertaining to sections 110(a)(2)(C), prong 3 of 110(a)(2)(D)(i), 110(a)(2)(J) related to PSD, provided to EPA on October 4, 2012, as addressing the infrastructure requirements for the 2008 8-hour ozone NAAQS. Specifically, this conditional approval is based upon Tennessee's commitment that TDEC will provide the necessary SIP revision to address its SIP deficiencies related to the October 20, 2010, final rulemaking related to PSD PM2.5 Increments. EPA is proposing to conditionally approve Tennessee's SIP submission consistent with section 110(k)(4) of the CAA.
          VI. Statutory and Executive Order Reviews

          Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this proposed action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:
          • Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

          • Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

          • Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);
          • Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
          • Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
          • Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
          • Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
          • Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
          • Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

          In addition, this proposed rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the State, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

            List of Subjects in 40 CFR Part 52
            Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.

            Authority:
            42 U.S.C. 7401 et seq.

            Dated: November 21, 2012.
            A. Stanley Meiburg,
            Acting Regional Administrator, Region 4.

      [FR Doc. 2012-29107 Filed 11-30-12; 8:45 am]
      BILLING CODE 6560-50-P


        DEPARTMENT OF HEALTH AND HUMAN SERVICES
        Centers for Medicare & Medicaid Services
        42 CFR Chapter IV
        [CMS-4183-N]
        Medicare Program; Listening Session Regarding the Implementation of Certain Medicare Part D Provisions in the Comprehensive Addiction and Recovery Act of 2016 (CARA)

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

          ACTION:
          Notice of meeting.

          SUMMARY:

          This document announces a listening session to solicit input from stakeholders regarding our implementation of section 704 of the Comprehensive Addiction and Recovery Act of 2016 (CARA), which includes provisions to permit Part D sponsors to establish drug management programs for at-risk beneficiaries under which Part D sponsors may limit such beneficiaries' access to frequently abused drugs to certain prescribers and pharmacies.

          Medicare beneficiaries with Part A or Part B, advocacy groups representing Medicare beneficiaries, physicians, pharmacists, and other clinicians (particularly other lawful prescribers of controlled substances), retail pharmacies, plan sponsors, entities delegated by plan sponsors (such as pharmacy benefit managers), biopharmaceutical manufacturers, and other interested parties are invited to participate. The Listening Session will be held via teleconference and is open to the public.

          DATES:

            Meeting Date: The Listening Session announced in this document will be held via teleconference on Monday, November 14, 2016 from 1 p.m. to 4 p.m., Eastern Standard Time (e.s.t.).

            Deadline for Submitting a Request for Special Accommodations: Individuals planning to participate in the teleconference who have a condition that requires special assistance or accommodations are asked to submit their requests as specified in the ADDRESSES section of this document no later than 5:00 p.m., e.s.t Tuesday, November 1, 2016.

            Deadline for Meeting Registration: Individuals may register online at https://www.cms.gov/Outreach-and-Education/training/CTEO/Upcoming_Current_events.html. or by phone by contacting the person listed in the FOR FURTHER INFORMATION CONTACT section of this document by 1 p.m. e.s.t., Monday, November 14, 2016.

            Deadline for Submission of Written Comments or Statements: Written comments or statements on the topics listed in section II.A. of this document may be sent via mail or electronically to the address specified in the ADDRESSES section of this document and must be received by 5 p.m. e.s.t., Friday, December 2, 2016.

          ADDRESSES:

            Meeting Location: The Listening Session will be held via teleconference only.

            Meeting Registration: Persons interested in participating in the teleconference must register by completing the online registration. Online registration is available via the CMS Compliance Training, Education & Outreach—Upcoming/Current Events Web site: https://www.cms.gov/Outreach-and-Education/training/CTEO/Upcoming_Current_events.html.

            Requests for Special Accommodations: Individuals who require special accommodations should send a request via email to CTEO@cms.hhs.gov.

            Written Comments or Statements: Any interested party may send written comments or statements by mail to Attn: Chad Buskirk, Centers for Medicare & Medicaid Services, Mail Stop C1-24-23, 7500 Security Boulevard, Baltimore, MD 21244-1850 or by email to PARTDPOLICY@cms.hhs.gov.

          FOR FURTHER INFORMATION CONTACT:
          Chad Buskirk, 410-786-1630. News Media Representatives must contact our Public Affairs Office at (202) 690-6145.

        SUPPLEMENTARY INFORMATION:
        I. Background
        Section 704 of the Comprehensive Addiction and Recovery Act of 2016 (CARA) (Pub. L. 114-198) includes provisions to permit Part D sponsors to establish drug management programs for at-risk beneficiaries under which Part D sponsors may limit such beneficiaries' access to frequently abused drugs to certain prescribers and pharmacies. Section 704(g)(2)(A) of CARA requires the Secretary of Health and Human Services to convene stakeholders for input regarding specific topics in sufficient time for the Secretary to take such input into account in promulgating regulations to implement the relevant provisions. Stakeholders include Medicare beneficiaries with Part A or Part B, advocacy groups representing Medicare beneficiaries, physicians, pharmacists, and other clinicians (particularly other lawful prescribers of controlled substances), retail pharmacies, plan sponsors, entities delegated by plan sponsors (such as pharmacy benefit managers), and biopharmaceutical manufacturers.
        II. Listening Session Topics and Format
        A. Listening Session Topics
        Section 704 of CARA is the basis for the listening session and provides the information for which we are soliciting stakeholder input. The first topic is found in section 704(a) of CARA and the nine other topics are from the listing in section 704(g)(2)(B) of CARA. Therefore, we are soliciting feedback from stakeholders and other interested parties on the following 10 topics:
        • The clinical guidelines that indicate misuse or abuse of frequently abused drugs. Section 704(a) of CARA refers to such clinical guidelines and requires the Secretary to develop such guidelines in consultation with Part D sponsors and other stakeholders.
        • The anticipated impact of drug management programs for at-risk beneficiaries under section 1860D-4(c)(5) of the Social Security Act (the Act) on cost-sharing and ensuring accessibility to prescription drugs for enrollees in prescription drug plans (PDPs), and MA-PD plans who are at-risk beneficiaries for prescription drug abuse (as defined in section 1860D-4(c)(5)(C) of the Act).
        • The use of an expedited appeals process under which such an enrollee may appeal the enrollee's identification as an at-risk beneficiary for prescription drug abuse (similar to the processes established under the Medicare Advantage program that allow an automatic escalation to external review of claims submitted under Part C).
        • The types of enrollees that should be treated as exempted individuals, as described in section 1860D-4(c)(5)(C)(ii) of the Act.
        • The manner in which terms and definitions should be applied, such as the use of clinical appropriateness in determining whether an enrollee is an at-risk beneficiary for prescription drug abuse as defined in section 1860D-4(c)(5)(C) of Act.
        • The information to be included in the notices described in section 1860D-4(c)(5)(B) of Act and the standardization of such notices.
        • The responsibility for the implementation of the program of the PDP sponsor (or Medicare Advantage organization) that establishes a drug management program for at-risk beneficiaries under section 1860D-4(c)(5) of the Act.
        • Notices for plan enrollees at the point of sale that would explain why an at-risk beneficiary has been prohibited from receiving a prescription at a location outside of the designated pharmacy.
        • Evidence-based prescribing guidelines for opiates.
        • The sharing of claims data under Parts A and B of title XVIII of the Act with Part D sponsors.
        B. Listening Session Format
        Stakeholders and other interested parties will be convened by teleconference for this listening session. The session will begin with teleconference logistics and an overview of objectives for the session. The remainder of the session will be devoted to receiving input on the 10 topics specified in section II.A. of this document. Time allotted for each topic will be limited.
        III. Registration Instructions

        Persons interested in participating the teleconference must register by completing the on-line registration via the CMS Compliance Training, Education & Outreach—Upcoming/Current Events Web site: https://www.cms.gov/Outreach-and-Education/training/CTEO/Upcoming_Current_events.html by the deadline specified in the DATES section of this document. You will receive a registration confirmation with the dial-in information to participate in the listening session.

        Individuals requiring special accommodations should refer to the DATES and ADDRESSES section of this document.

          Dated: October 7, 2016.
          Andrew M. Slavitt,
          Acting Administrator, Centers for Medicare & Medicaid Services.

      [FR Doc. 2016-25806 Filed 10-21-16; 4:15 pm]
       BILLING CODE 4120-01-P