Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-April Through June 2019, 39323-39338 [2019-17025]

Download as PDF Federal Register / Vol. 84, No. 154 / Friday, August 9, 2019 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Solicitation of Nominations for Appointment to the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHACHSPT) ACTION: Notice. The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the CHACHSPT. The CHACHSPT consists of 18 experts in fields associated with public health; epidemiology; laboratory practice; immunology; infectious diseases; drug abuse; behavioral science; health education; healthcare delivery; state health programs; clinical care; preventive health; medical education; health services and clinical research; and healthcare financing, who are selected by the Secretary of the U.S. Department of Health and Human Services (HHS). DATES: Nominations for membership on the CHACHSPT must be received no later than August 31, 2019. Packages received after this time will not be considered for the current membership cycle. ADDRESSES: All nominations should be mailed to 1600 Clifton Road NE, Mailstop: E07, Atlanta, GA 30329–4027, emailed (recommended) to zkr7@ cdc.gov, or faxed to (404) 639–8317. FOR FURTHER INFORMATION CONTACT: Margie Scott-Cseh, Committee Management Specialist, CDC, 1600 Clifton Road NE, Mailstop: E07, Atlanta, GA 30329–4027, (404) 639–8317, zkr7@ cdc.gov. SUPPLEMENTARY INFORMATION: The CDC/ HRSA Advisory Committee on HIV and STD Prevention and Treatment shall advise the Director, CDC, and the Administrator and Associate Administrator for HIV/AIDS, HRSA, regarding objectives, strategies, policies, and priorities for HIV and STD prevention and treatment efforts including surveillance of HIV infection, AIDS, STDs, and related behaviors; epidemiologic, behavioral, health services, and laboratory research on HIV/AIDS and STD; identification of policy issues related to HIV/STD professional education, patient healthcare delivery, and prevention services; agency policies about prevention of HIV/AIDS and other STDs, treatment, healthcare delivery, and research and training; strategic issues influencing the ability of CDC khammond on DSKBBV9HB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:34 Aug 08, 2019 Jkt 247001 and HRSA to fulfill their missions of providing prevention and treatment services; programmatic efforts to prevent and treat HIV and STDs; and support to the agencies in their development of responses to emerging health needs related to HIV and other STDs. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee’s objectives. Nominees will be selected based on expertise in the fields of HIV/ AIDS, Viral Hepatitis and STD prevention, control and treatment. Experts in the disciplines of public health; epidemiology; laboratory practice; immunology; infectious diseases; drug abuse; behavioral science; health education; healthcare delivery; state health programs; clinical care; preventive health; medical education; health services and clinical research; and healthcare financing. Federal employees will not be considered for membership. Members may be invited to serve for up to four-year terms. Selection of members is based on candidates’ qualifications to contribute to the accomplishment of CHACHSPT objectives. The U.S. Department of Health and Human Services policy stipulates that committee membership be balanced in terms of points of view represented, and the committee’s function. Appointments shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, gender identity, HIV status, disability, and cultural, religious, or socioeconomic status. Nominees must be U.S. citizens, and cannot be full-time employees of the U.S. Government. Current participation on federal workgroups or prior experience serving on a federal advisory committee does not disqualify a candidate; however, HHS policy is to avoid excessive individual service on advisory committees and multiple committee memberships. Committee members are Special Government Employees (SGEs), requiring the filing of financial disclosure reports at the beginning and annually during their terms. CDC reviews potential candidates for CHACHSPT membership each year, and provides a slate of nominees for consideration to the Secretary of HHS for final selection. HHS notifies selected candidates of their appointment near the start of the term in December 1, 2020, or as soon as the HHS selection process is completed. Note that the need for different expertise varies from year to year and a candidate who is not selected in one year may be reconsidered in a subsequent year. SGE PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 39323 Nominees must be U.S. citizens, and cannot be full-time employees of the U.S. Government. Candidates should submit the following items: D Current curriculum vitae, including complete contact information (telephone numbers, mailing address, email address) D At least one letter of recommendation from person(s) not employed by the U.S. Department of Health and Human Services. (Candidates may submit letter(s) from current HHS employees if they wish, but at least one letter must be submitted by a person not employed by an HHS agency (e.g., CDC, NIH, FDA, etc.). Nominations may be submitted by the candidate him- or herself, or by the person/organization recommending the candidate. The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Kalwant Smagh, Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2019–17064 Filed 8–8–19; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–9117–N] Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—April Through June 2019 Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. AGENCY: This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from April through June 2019, relating to the Medicare and Medicaid programs and other programs administered by CMS. FOR FURTHER INFORMATION CONTACT: It is possible that an interested party may need specific information and not be able to determine from the listed information whether the issuance or regulation would fulfill that need. SUMMARY: E:\FR\FM\09AUN1.SGM 09AUN1 39324 Federal Register / Vol. 84, No. 154 / Friday, August 9, 2019 / Notices concerning each of the addenda published in this notice. I. Background statements necessary to administer and oversee the programs efficiently. Section 1871(c) of the Act requires that we publish a list of all Medicare manual instructions, interpretive rules, statements of policy, and guidelines of general applicability not issued as regulations at least every 3 months in the Federal Register. khammond on DSKBBV9HB2PROD with NOTICES The Centers for Medicare & Medicaid Services (CMS) is responsible for administering the Medicare and Medicaid programs and coordination and oversight of private health insurance. Administration and oversight of these programs involves the following: (1) Furnishing information to Medicare and Medicaid beneficiaries, health care providers, and the public; and (2) maintaining effective communications with CMS regional offices, state governments, state Medicaid agencies, state survey agencies, various providers of health care, all Medicare contractors that process claims and pay bills, National Association of Insurance Commissioners (NAIC), health insurers, and other stakeholders. To implement the various statutes on which the programs are based, we issue regulations under the authority granted to the Secretary of the Department of Health and Human Services under sections 1102, 1871, 1902, and related provisions of the Social Security Act (the Act) and Public Health Service Act. We also issue various manuals, memoranda, and VerDate Sep<11>2014 16:34 Aug 08, 2019 Jkt 247001 II. Format for the Quarterly Issuance Notices This quarterly notice provides only the specific updates that have occurred in the 3-month period along with a hyperlink to the full listing that is available on the CMS website or the appropriate data registries that are used as our resources. This is the most current up-to-date information and will be available earlier than we publish our quarterly notice. We believe the website list provides more timely access for beneficiaries, providers, and suppliers. We also believe the website offers a more convenient tool for the public to find the full list of qualified providers for these specific services and offers more flexibility and ‘‘real time’’ accessibility. In addition, many of the PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 websites have listservs; that is, the public can subscribe and receive immediate notification of any updates to the website. These listservs avoid the need to check the website, as notification of updates is automatic and sent to the subscriber as they occur. If assessing a website proves to be difficult, the contact person listed can provide information. III. How To Use the Notice This notice is organized into 15 addenda so that a reader may access the subjects published during the quarter covered by the notice to determine whether any are of particular interest. We expect this notice to be used in concert with previously published notices. Those unfamiliar with a description of our Medicare manuals should view the manuals at https:// www.cms.gov/manuals. Dated: July 26, 2019. Kathleen Cantwell, Director, Office of Strategic Operations and Regulatory Affairs. BILLING CODE 4120–01–P E:\FR\FM\09AUN1.SGM 09AUN1 EN09AU19.076</GPH> Consequently, we are providing contact persons to answer general questions khammond on DSKBBV9HB2PROD with NOTICES VerDate Sep<11>2014 Jkt 247001 PO 00000 Frm 00067 Fmt 4703 Addendum 1: Medicare and Medicaid Manual Instructions (April through June 2019) The CMS Manual System is used by CMS program components, partners, providers, contractors, Medicare Advantage organizations, and State Survey Agencies to administer CMS programs. It offers day-to-day operating instructions, policies, and procedures based on statutes and regulations, guidelines, models, and directives. In 2003, we transformed the CMS Program Manuals into a web user-friendly presentation and renamed it the CMS Online Manual System. Sfmt 4725 E:\FR\FM\09AUN1.SGM 09AUN1 How to Obtain Manuals The Internet-only Manuals (IOMs) are a replica of the Agency's official record copy. Paper-based manuals are CMS manuals that were officially released in hardcopy. The majority of these manuals were transferred into the Internet-only manual (10M) or retired. Pub 15-1, Pub 15-2 and Pub 45 arc exceptions to tlris rule and arc still active paper-based manuals. The remaining paper-based manuals arc for reference purposes only. If you notice policy contained in the paper-based manuals that was not transferred to the 10M, send a message via the CMS Feedback tool. Those wishing to subscribe to old versions of CMS manuals should contact the National Technical Information Service, Department of Commerce, 5301 Shawnee Road, Alexandria, VA 22312 Telephone (703-605-6050). You can download copies of the listed material free of charge at: https://cms.gov/manuals. arrangements to transfer material to a local library not designated as an FDL. Contact any library to locate the nearest FDL. This information is available at https://www.gpo.gov/libraries/ In addition, individuals may contact regional depository libraries that receive and retain at least one copy of most federal government publications, either in printed or microfilm form, for use by the general public. These libraries provide reference services and interlibrary loans; however, they are not sales outlets. Individuals may obtain information about the location of the nearest regional depository library from any library. CMS publication and transmittal numbers are shown in the listing entitled Medicare and Medicaid Manual Instructions. To help FDLs locate the materials, use the CMS publication and transmittal numbers. For example, to find the manual for Updates to Publication (Pub.) 100-01, Medicare General Information, Eligibility, and Entitlement, Chapter 6, Disclosure of Information Disclosure of Information, use (CMS-Pub. 100-01) Transmittal No. 123. Addendum I lists a unique CMS transmittal number for each instruction in our manuals or program memoranda and its subject number. A transmittal may consist of a single or multiple instruction(s). Often, it is necessary to use information in a transmittal in conjunction with information currently in the manual. For the purposes of this quarterly notice, we list only the specific updates to the list of manual instructions that have occurred in the 3-month period. This information is available on our website at www.cms.gov/Manuals. Transmittal 123 I Updates to Publication (Pub.) 100-01, Medicare General Information, Eligibility. and Entitlement, Chapter 6, Disclosure oflnformation Disclosure None 214 215 How to Review Transmittals or Program Memoranda Those wishing to review transmittals and program memoranda can access this information at a local Federal Depository Library (FDL). Under the FDL program, government publications are sent to approximately 1,400 designated libraries throughout the United States. Some FDLs may have Manual/Subject/Publication Number 216 National Coverage Determination (NCD90.2): Next Generation Sequencing (NGS) National Coverage Determination (NCD90.2): Next Generation Sequencing (NGS) Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instructions Federal Register / Vol. 84, No. 154 / Friday, August 9, 2019 / Notices 16:34 Aug 08, 2019 Publication Dates for the Previous Four Quarterly Notices We publish this notice at the end of each quarter reflecting information released by CMS during the previous quarter. The publication dates of the previous four Quarterly Listing of Program Issuances notices are: August 13,2018 (83 FR 40043), November 2, 2018 (83 FR 55174) February 19, 2019 (84 FR 4805) and April29, 2019 (84 FR 18040). We are providing only the specific updates that have occurred in the 3-month period along with a hyperlink to the website to access this information and a contact person for questions or additional information. 39325 EN09AU19.077</GPH> khammond on DSKBBV9HB2PROD with NOTICES 39326 VerDate Sep<11>2014 4273 4275 Jkt 247001 4276 4277 4278 PO 00000 Frm 00068 Fmt 4703 Sfmt 4725 E:\FR\FM\09AUN1.SGM 4279 4280 09AUN1 4281 Dismissal Letters Model Dismissal Notices Processing Requests to Vacate Dismissals Medicare Redetermination l\otice (For Partly or Fully Unfavorable Redeterminations Effect of the Redetermination Effectuation of the Redetermination Decision Reconsideration - T11e Second Level of Appeal Filing a Request for a Reconsideration MAC Responsibilities -General QIC Case File Preparation QIC Jurisdictions Effectuation of Reconsiderations Administrative Law Judge (ALJ) Hearing or Attorney Adjudicator Review at Office of Medicare Hearings and Appeals (OMHA)- The Third Level of Appeal Requests for an ALJ Hearing Forwarding Requests to OMHA Review and Effectuation of OMHA Decisions Effectuation Time Limits & Responsibilities Duplicate OMHA Decisions Payment oflnterest on OMHA Decisions Departmental Appeals Doard- Appeals Council- T11e fourth Level of Appeal Recommending Agency Referral ofOMHA Decisions or Dismissals Requests for Case Files District Court Review - The Fifth Level of Appeal Requests for U.S. District Court Review by a Party Work:load Data Analysis Execution of Workload Prioritization Workload Priorities Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instructions Update to Pub. I 00-04. Chapter II Hospice Election Periods and Benefit Periods in Medicare Systems Data Required on the Institutional Claim to AlB MAC (HHH Administrative Activities Hospice Attending Physician Services Independent Attending Physician Services Care Plan Oversight Processing Professional Claims for Hospice Beneficiaries Billing and Payment for Services Unrelated to Terminal Illness Coinsurance on Inpatient Respite Care Update to Chapter 28 in Publication (Pub.) I 00-04 to Provide Language-Only Changes for the 'lew Medicare Card Project Beneficiary Insurance Assignment Selection Consolidation of the Claims Crossover Process Coordination of Benefits Agreement (COBA) Detailed Error Report Notification Process Coordination of Benefits Agreement (CORA) ASC Xl2 s:n Coordination of Federal Register / Vol. 84, No. 154 / Friday, August 9, 2019 / Notices 16:34 Aug 08, 2019 EN09AU19.078</GPH> 4274 Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instructions Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instructions Quarterly Update for the Temporary Gap Period of the Durable Medical Equipmenl, Proslhelics, Orlholics and Supplies (DMEPOS) Compelilive Bidding Program (CBP)- July 2019 Indian Health Services (IHS) Hospital Payment Rates for Calendar Year 2019 New Waived Tests Pub. I 00-04, Chapter 29 -Appeals of Claims Decisions -Revisions CMS Decisions Subject to the Administrative Appeals Process Who May Appeal Steps in the Appeals Process: Overview Where to Appeal Time Limits for Filing Appeals & Good Cause for Extension of the Time Limit for Filing Appeals Good Cause Conditions and Examples That May Establish Good Cause for Late Filing by Beneficiaries Conditions and Examples That May Establish Good Cause for Late Filing by Providers, Physicians, or Other Suppliers Good Cause- Administrative Relief Following a Disaster Procedures to Follow When a Party Fails to Establish Good Cause Amount in Controversy General Requirements Principles for Determining Amount in Controversy Aggregation of Claims to Meet the Amount in Controversy Who May Be an Appointed or Authorized Representative How to Make and Revoke an Appointment When and Where to Submit the Appointment Rights and Responsibilities of a Representative Curing a Defective Appointment of Representative Incapacitation or Death of Beneficiary How to Make and Revoke a Transfer of Appeal Rights Where to Submit the Transfer of Appeal Rights Rights of the Assignee of Appeal Rights Curing a Defective Transfer of Appeal Rights Medicare Secondary Payer (MSP) Specific Limitations or Additional Requirements with Respect to the Appointment of Representatives Inclusion and Consideration of Evidence of Fraud and/or Abuse Claims Where There is Evidence That Items or Services Were Not Furnished or Were Not Furnished as Billed Responsibilities of Adjudicators Leller Formal Fraud and Abuse Investigations Appeal Decision Involving Multiple Beneficiaries Filing a Request for Redetermination Time Limit for Filing a Request for Redetermination The Redetermination Dismissals khammond on DSKBBV9HB2PROD with NOTICES VerDate Sep<11>2014 4283 4284 Jkt 247001 4285 4286 PO 00000 4287 Frm 00069 4288 4289 Fmt 4703 4290 4291 Sfmt 4725 4292 4293 E:\FR\FM\09AUN1.SGM 4294 4295 4296 4297 4298 4299 4300 4301 4302 4303 4304 4305 4306 09AUN1 4307 430g 4309 4310 4311 4312 Coordination of HH PPS Claims With Inpatient Claim Types Exhibit: Chart Summarizing the Etfects of RAP/Claim Actions on the HH PPS Episode File Request for Anticipated Payment (RAP HH PPS Claims !III PPS Claims When No RAP is Submitted- ''No-RAP" LUPAs Input/Output Record Layout Decision Logic Used by the Pricer on RAPs Decision Logic Used by the Pricer on Claims Annual Updates to the HH Pricer Update to the Internet Only Manual (!OM) Publication (Pub.) 100.04, Chapter 4 Payment for CRNA Pass-Through Services Quarterly Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instructions Medicare Physician Fee Schedule Database (MPFSDB) File Record Layout MPFSDB Record Layout MPFSDB File Record Layout and Field Descriptions Re-implementation of the AMCC Lab Panel Claims Payment System Logic Automated Test Listing Organ or Disease Oriented Panels Claims Processing Requirements for Panel and Profile Tests Laboratory Tests Utilizing Automated Equipment Ilistory Display Special Processing Considerations Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instructions Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instructions Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instructions Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code Claim Status Category and Claim Status Codes Update Annual Updates to the Prior Authorization/Pre-Claim Review Federal Holiday Schedule Tables for Generating Reports Quarterly Heallhcare Common Procedure Coding System (HCPCS) Drug/Biological Code Changes- July 2019 Update Instructions for Downloading the Medicare ZIP Code Files for October 2019 Implementation of the Medicare Performance Adjustment (MPA) for the Maryland Total Cost of Care (.\1D TCOC) Model Documentation of Medical Necessity of the Ilome Visit; and Physician Management Associated with Superficial Radiation Treatment Home Services (Codes 99341 · 99350) Physician Management Associated with Superficial Radiation Treatment Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instructions Home Health (HH) Patient-Driven Groupings Model (PDGM) ·Additional Federal Register / Vol. 84, No. 154 / Friday, August 9, 2019 / Notices 16:34 Aug 08, 2019 4282 Benefits (COB) Mapping Requirements as of July 2012 l\ational Council for Prescription Drug Programs (NCPDP) Version D.O Coordination of Benefits (COB) Requirements Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instructions Documentation of Evaluation and Management Services of Teaching Physicians Evaluation and Management (E/M) Services File Conversions Related to the Spanish Translation of the Healthcare Common Procedure Coding System (HCPCS) Descriptions Quarterly Update to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) Update to Chapter 21 in Publication (Pub.) 100-04to Provide Language-Only Changes for the New Medicare Card Project Specitlcations for Section 1: Summary (Page 1) Specifications for Content Variations of Spanish MSNs Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instructions Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instructions Issued to a specitic audience, not posted to Intemet/Intranet due to Confidentiality of Instructions Medicare Summary Notice (MSN) Changes to Assist Beneficiaries Enrolled in the Qualified Medicare Beneficiary (QMB) Program Qualified Medicare Beneficiary (QMB) Program Issued to a specific audience, not posted to Intemet/Intranet due to Contldentiality of Instructions Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instructions Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instructions Home Health (HH) Patient-Driven Groupings Model (PDGM)- Additional Manual Instructions Home Health Prospective Payment System (HH PPS) Consolidated Billing Responsibilities of Home Health Agencies Responsibilities of Providers/Suppliers of Services Subject to Consolidated Billing Home health Consolidated Billing Edits in Medicare Systems Therapy Editing Other Editing Related to Home Health Consolidated Billing Only Request for Anticipated Payment (RAP) Received and Services Fall Within 60 Days after RAP Start Date l\ o RAP Received and Therapy Services Rendered in the Home Eligibility Query to Determine Status CWF Response to Inquiry Timeliness and Limitations of CWF Responses 1\ational Home Health Prospective Payment Episode History File Opening and Length of HH PPS Episodes/Periods of Care Closing, Adjusting and Prioritizing HH PPS Episodes/Periods of Care Based on RAPs and HHA Claim Activity Other Editing for HH PPS Episodes 39327 EN09AU19.079</GPH> khammond on DSKBBV9HB2PROD with NOTICES 39328 VerDate Sep<11>2014 Jkt 247001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4725 E:\FR\FM\09AUN1.SGM 4314 4315 09AUN1 4316 4317 4318 4319 4320 EN09AU19.080</GPH> Drug/Biological Code Changes- July 2019 Update July Quarterly Update for 2019 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule 4322 Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instructions 4323 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instructions 4324 Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instructions 4325 Medicare Part A Skilled Nursing Facility (SNF) Prospective Payment System (PPS) Pricer Update FY 2020 4326 Qumterly Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment 4327 July 2019 Integrated Outpatient Code Editor (I/OCE) Specifications Version 20.2 ; t i\+\>+· ;;11.~<,>.),'\ ,.{i\ '>II' llcl'l'i •~);.;:~:: ~\1,\t:::;),+Ji ; ''~"''· :\ 4321 None ~? ~r:;: 312 313 314 315 i''\+2 1 +tl!j1 +'' '" iii!'i~~~t~;0.\i. Updates to Medicare Financial Management Manual Chapter 4, Section 5050.6 Extended Repayment Schedules Establishing an Extended Repayment Schedule (ERS)- (formerly known as an Extended Repayment Plan (ERP)) ERS Required Documentation --Physician is a Sole Proprietor ERS Required Documentation- Provider is an Entity Other Thm1 a Sole Proprietor ERS Approval Process Sending the ERS Request to the Regional Office (RO) Monitoring an Approved Extended Repayment Schedule (ERS) and Reporting Requirements Requests from Terminated Providers or Debts that are Pending Referral to Department of Treasury Notice of 'lew Interest Rate for Medicare Overpayments and Underpayments -3rd Qtr Notification for FY 2019 Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instmctions Update to Publication (Pub.) 100-06 to Provide Language-Only Changes for the New Medicare Card Project Demand Letter Contents Recovery From the Beneficiary Beneficiary Wishes to Refund in Instalhnents Bankruptcy Forms Tennination of Collection Action- Beneficiary Overpayments Collection of Fee-for-Service Payments Made During Periods of Medicare Advantage (MA) Enrollment Treasury Cross-Servicing Dispute Resolution Exhibit 20- Procedures for Reporting Currently Not Collectible (CNC) Debt Receiving and Processing Unsolicited!V oluntary Refund Checks When Identifying Information is Provided Receiving and Processing Unsolicited/Voluntary Reftmd Checks When Identifying Information is not Provided Federal Register / Vol. 84, No. 154 / Friday, August 9, 2019 / Notices 16:34 Aug 08, 2019 4313 Manual Instructions Adjustments of Episode Payment- Validation of HIPPS Home Health Prospective Payment System (HH PPS) Consolidated Billing Responsibilities of Home Health Agencies Responsibilities of Providers/Suppliers of Services Subject to Consolidated Billing Ilome health Consolidated Dilling Edits in Medicare Systems Therapy Editing Other Editing Related to Home Health Consolidated Billing Only Request for Anticipated Payment (RAP) Received and Services Fall Within 60 Days after RAP Start Date l\o RAP Received and Therapy Services Rendered in the Home Eligibility Query to Detem1ine Status CWI' Response to Inquiry Timeliness and Limitations of CWF Responses l\ational Home Health Prospective Payment Episode History File Opening and Length of HH PPS Episodes/Periods of Care Closing, Adjusting and Prioritizing HH PPS Episodes/Periods of Care Based on RAPs and HHA Claim Activity Other Editing for HH PPS Episodes Coordination of HH PPS Claims With Inpatient Claim Types Medicare Secondary Payment (MSP) and the HH PPS Episodes File Exhibit: Chart Summarizing the Effects of RAP/Claim Actions on the HH PPS Episode File Request for Anticipated Payment (RAP) HH PPS Claims HH PPS Claims When No RAP is Submitted- ''No-RAP" LUPAs Billing for Nonvisit Charges Inpul/Output Record Layout Decision Logic Used by the Pricer on RAPs Decision Logic Used by the Pricer on Claims Annual Updates to the HH Pricer July 2019 Update of the Hospital Outpatient Prmpective Payment System (OPPS) July 2019 Integrated Outpatient Code Editor (I/OCE) Specifications Version 20.2 Ammal (2020) Update of the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instructions Implement Operating Rules- Phase III Electronic Remittance Advice (ERA) Electronic Funds Transfer (EFT): Committee on Operating Rules for Information Exchange (CORE) 360 Uniform Use of Claim Adjustment Reason Codes (CARC), Remittance Advice Remark Codes (RARC) and Claim Adjustment Group Code (CAGC) Rule - Update from Council for Affordable Quality Healthcare (CAQH) CORE Issued to a specific audience, not posted to Intcmct/Intranct due to Confidentiality of Instructions July 2019 Update ofthe Ambulatory Surgical Center (ASC) Pavment System Quarterly Healthcare Common Procedure Coding System (HCPCS) khammond on DSKBBV9HB2PROD with NOTICES VerDate Sep<11>2014 Jkt 247001 PO 00000 Frm 00071 317 Fmt 4703 I i~,~~il{c;;,'\':\'\1:.''') 188 Sfmt 4725 E:\FR\FM\09AUN1.SGM 189 190 Relationship Between the Transplant CoPs and Hospital CoPs Tennination of Organ Transplant Programs Options letter for transplant program inactive at 12 months ! : ;,;it~~;~',-s' \~;:~ii\1;8 :;~~-;:" 872 873 S74 875 876 ;(''*'" !is\''~S ~ :(<!'' : ;~,~'21~ 09AUN1 Revisions to the State Operations Manual (SOM 100-07) Chapter 2, The Certification Process, Chapter 3, Additional Program Activities, and Chapter 4, Program Administration and Fiscal Management Outcome and Assessment Infonnation Set (Oasis) Requirementsi2202.9B Right to See, Review, and Request Changes Documentation Guide List- Tennination for Noncompliance With §§1866(b)(2)(A) and (C)/3028B- Additional Documentation- Charging for Covered Services and/or Refusing to Refund Incorrect Collections Budget and Financial Report Files- Records to be Retained/4802K. Supplementary Medical Insurance (SMI) General Enrollment Period (GEP) Records (N1-440-95-1, Item 10) Budget and Financial Report Files- Records to be Retained/4802K. Supplementary Medical Insurance (SMI) General Enrollment Period (GEP) Records (N1-440-95-1, Item 10) Updates to the State Operations Manual (SOM) Chapters 2, 3 and 9 to add Instructions for Organ Transplant Programs. Organ Transplant Programs Definitions Regulatory Background Request for Medicare Approval of an Organ Transplant Program Survey and Approval Procedures for Organ Transplant Programs Types of Surveys and Related Guidance Determining Level of Detlciency for Clinical J::xperience (Volume) and Outcome Requirements Standards: Post-Survev Activities Transmission of Program Approval Information Mitigating Factors '8.77 .c;s'z:!l• ',~;.: :t ;,;;,,~\Y.t~\:;i Updates to Immunosuppressive Guidance Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instructions Issued to a specitlc audience, not posted to lntemet/lntranet due to Confidentiality of Instructions Updates to Immunosuppressive Guidance--Exceptions Update to Publication (Pub.) 100-08 to Provide Language-Only Changes for the New Medicare Card Project Sources of Data for ZPICs Overview of Prepayment and Postpayment Reviews Maintaining Provider Information Denial Types Prior Authorization Procedural Requirements Program Integrity Security Requirements Medical Review for Program Integrity Purposes Contact Center Operations MAC Complaint Screening Referrals to the UP! C Guidelines for Incentive Reward Program Complaint Tracking Documentation of Identity Theft and Compromised Medicare beneficiary Identifiers in the FID Worksheets Providing Sample Infonnation to the CERT Review Contractor Medicare Diabetes Prevention Program (MDPP) Suppliers Independent Diagnostic Testing Facility (IDTF) Standards Claims against Surety Bonds Reactivations- Miscellaneous Policies Update to Publication (Puh.) 100-0S to Provide Language-Only Changes for the New Medicare Card Project Sources of Data for ZPICs Overview of Prepayment and Postpayment Reviews Maintaining Provider Information Denial Types Prior Authorization Procedural Requirements Program Integrity Security Requirements Review for Program Integrity Purposes Contact Center Operations MAC Complaint Screening Referrals to the UPIC Guidelines for Incentive Reward Program Complaint Tracking Worksheets Providing Sample Information to the CERT Review Contractor Medicare Diabetes Prevention Program (MDPP) Suppliers Independent Diagnostic Testing Facility (IDTF) Standards Claims against Surety Bonds Federal Register / Vol. 84, No. 154 / Friday, August 9, 2019 / Notices 16:34 Aug 08, 2019 316 Overpayment Refund Form Recording Savings Section B - Cause of Overpayments Recording Savings Rody of Report Section I - Redeterminations Processing CMS-838 Claims Adjustments Completing the CMS-838 Exhibit II: Medicare Credit Balance Report Detail Page Updates to Medicare Financial Management Manual Chapter 4, Section 20 and 20 .I Demand Letters Demand Letters !\umber of Demand Letters INITIAL DEMAND LETTER- NON-935 INITIAL DEMAND LETTER- 935 Initial Demand Letter- Cost Reports Filed Initial Demand Letter- Unfiled Cost Report Intent to Refer Letter- Non 935 Intent to Refer Letter- 935 Cnfiled Cost Reports Onlv Issued to a specific audience, not posted to Intemet/Intranet due to f'cmfi<1cntinlity of Instructions 39329 EN09AU19.081</GPH> khammond on DSKBBV9HB2PROD with NOTICES 39330 VerDate Sep<11>2014 878 880 Jkt 247001 SS1 882 S81 884 PO 00000 S85 Frm 00072 886 887 Fmt 4703 888 889 Sfmt 4725 1'.'. 30 E:\FR\FM\09AUN1.SGM 31 ~ii',;;~, ·•·i;~~:>. ..,.. :~:;::,;ti•;·t~>> :•ii>;•,_i:t 09AUN1 None ·• ., 'l:' .•: %\i:.;~;;l:: :·:c:;:;;1·~;:• • · "• ' (::;siis:":i; Update to Publication (Pub.) 100-18 to Provide Language-Only Changes and URL Location Updates for the New Medicare Card P~oject ": ,.....~1~'::;r'::c "''';•:.•;;,:;;;~~;:.,•::.:i•:t:•: ..::••i•c.•::.··.·i Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instructions 225 Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instructions 226 Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instructions Next Generation ACO Model- Demo Code Placement 227 :~,\~~;•;;~;'~5?,•::?0\ . ,:;,;;~;.,, :;;\.;2' ,::z;~.:s•:, z'·'ili;~;K:',"·l·(·;~ User CR: .\i!CS- Add Date to NU Screen for Health Insurance Claim Number 2275 (HICN) Changes Update to Claim Processing Logic to Allow 53 Automated Development 2276 System (ADS) Messages (Three Header and 50 Claim Lines) 2277 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity of Instructions 2278 Implementation of the Skilled Nursing Facility (SNF) Patient Driven Payment Model (PDP.\1) 2279 Direct Mailing Notification to the Medicare Administrative Contractors (MACs) Regarding Clinical Laboratory Fee Schedule (CLFS) 2280 MAC Reporting of Issuance of Compliance Letters to Specific Providers and Suppliers Regarding Inappropriate Billing of Qualified Medicare Beneficiaries (Qlv!Bs) for Medicare Cost-Sharing 2281 Implementation to Exchange the list of Electronic Medical Documentation Requests (eMDR) for Registered Providers via the Electronic Submission of Medical Documentation (esMD) System 2282 Direct Mailing Notification to the Medicare Administrative Contractors (MACs) Regarding Clinical Laboratory Fee Schedule (CLFS) Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity 2283 of Instructions 2284 Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instructions 2285 Common Working File (CWF) to Medicare Beneficiary Database (MBD) Extract File Changes to send all Hospice periods to Support HIP AA Eligibility Transaction System (HETS) Issued to a specific audience, not posted to Internet/Intranet due to 2286 Confidentiality of Instmctions 2287 Health Insurance Portability and Accountability Act (HIP AA) Electronic Data Interchange (EDI) Front End Updates for October 2019 2288 User CR: FISS- Develop Enhanced Claims Search Reporting in FISS -Phase 2289 User CR: FISS Update RPTMEDRl to Provide Medical Policy Parameters (MP P) Status 2290 User CR: ViPS Medicare System (VMS)- "\Jew Standard Paper Remittance (SPR) Files for Use on Durable Medical Equipment Medicare Administrative .. l'·':l""ii.<\i EN09AU19.082</GPH> \iy;<;i 224 Update to Publication (Pub.) 100-14to Provide Language-Only Change for the New Medicare Card Project CMS-Uirected Changes (Notifications) to the Network Patient Database Processing Fonn CMS-2728-U3 CMS ESRD Forms Data Discrepancies and Data Corrections Coordination of Additional Renal Related Information Additional Considerations Acronyms/Medicare ESRD Network Organizations List of Commonly Used Acronyms fii•.·;~~i \~j}; -~~·,;};~;;i_:i;':ii ;,•(1\ 19 Update to Publication (Pub.) 100-10 to Provide Language-Only Changes for the New Medicare Card Project t::•;:Ji';. 10 0~1:;.;;;;~;'.:::..?5 '\ .~i~i}y~~~t~~...,. :;;s;~·: ·:;~1i;! None QIO Manual Chapter 16- "Healthcare Quality Improvement Program" Quality Improvement Interventions Developing and Spreading Successful Interventions Documenting and Disseminatino- Results Update to Publication (Pub.) 100-10 to Provide Language-Only Changes for The New Medicare Card Project 1.;.:,\i~~ ~':".;c''~ 32 None ~~~::;:''-;::;;• .. Federal Register / Vol. 84, No. 154 / Friday, August 9, 2019 / Notices 16:34 Aug 08, 2019 879 Reactivations- Miscellaneous Policies Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instructions Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instructions Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality oflnstruclion Update to Chapter 15 of Publication (Pub.) 100-0S Local Coverage Determinations (LCDs) Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instructions Update to Exhibit 46.2, 46.3, 46.4, and 46.5 in Publication (Pub.) 100-08 DME MAC Unified Post-payment ADR Sample Letter Recovery Audit Contractor (RAC) Unified Postpayment ADR Sample Letter CERT Unified Post-payment ADR Sample Letter SMRC Postpayment ADR Sample Letter Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instructions Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instructions Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instructions Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instructions Issued to a specific audience, not posted to Intcmct/Intranct due to Confidentiafity of Instructions khammond on DSKBBV9HB2PROD with NOTICES VerDate Sep<11>2014 2291 2293 2294 Jkt 247001 2295 PO 00000 2297 2296 2298 Frm 00073 2299 2300 2301 Fmt 4703 2302 Sfmt 4725 2303 2304 E:\FR\FM\09AUN1.SGM 2305 2306 2307 2308 09AUN1 2309 2310 2311 2312 2313 2314 2315 2316 2317 Interface Changes Related to New Return Code Field Updates Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instructions Mobile Personal Identity Verification (PIV) Station Pilot Project Fiscal Intermediary Shared System (FISS) Enhancement of PC Print Billing Software Mobile Personal Identity Verification (PIV) Station Pilot Project ';'i '~...?:; \':.s;';~'(;'.~~~;i None '''''"•' .,,., ..,.. None Addendum II: Regulation Documents Published in the Federal Register (April through June 2019) Regulations and Notices Regulations and notices arc published in the daily Federal Register. To purchase individual copies or subscribe to the Federal Register, contact GPO at www.gpo.gov/fdsys. When ordering individual copies, it is necessary to cite either the date of publication or the volume number and page number. The Federal Register is available as an online database through GPO Access. The online database is updated by 6 a.m. each day the Federal Register is published. The database includes both text and graphics from Volume 59, Number 1 (January 2, 1994) through the present date and can be accessed at https://www.gpoaccess.gov/fr/. The following website https://www.archives.gov/federal-register/ provides information on how to access electronic editions, printed editions, and reference copies. This information is available on our website at: https://www.cms.gov/quarterlyproviderupdates/downloads/Regs2Q19QPU.pdf For questions or additional information, contact Terri Plumb (410-786-4481 ). Addendum III: CMS Rulings (April through June 2019) CMS Rulings arc decisions of the Administrator that serve as precedent final opinions and orders and statements of policy and interpretation. They provide clarification and interpretation of complex or ambiguous provisions of the law or regulations relating to Medicare, Medicaid, Utilization and Quality Control Peer Review, private health insurance, and related matters. Federal Register / Vol. 84, No. 154 / Friday, August 9, 2019 / Notices 16:34 Aug 08, 2019 2292 Contractors (DME MAC) Web Portals User CR: FISS- Expand Number of Archived Claims That May Be Retrieved per Cycle User CR: FISS- Analysis Only- Enhancement to Allow MACs to Copy VSAM Files from One Region to Another to Reduce File Maintenance Systems Changes to Allow IPPS-Excluded Hospitals to Operate IPPSExcluded Units FISS Integrated Outpatient Code Editor (IOCE) Claim Retum Buffer Interface Changes Related to New Return Code Field Updates Archiving and Retrieving of the Integrated Outpatient Code Editor (1/0CE) for Processing Claims Updating Fiscal Intermediary Shared System (FISS) for Pricing Drugs at Different Rates Depending on Provider Type Modifications to the National Coordination of Benefits Agreement (COBA) Crossover Process Intemational Classification of Diseases, lOth Revision (ICD-1 0) and Other Coding Revisions to National Coverage Determination (NCDs) Implementation of the Skilled Nursing Facility (SNF) Patient Driven Payment Model (PDP\1) Reporting the Patient Relationship Categories and Codes User CR: \1CS- Update the RB55 Job to Include Processing of Additional Fields on the Procedure Code File Implementation to Send Pre-Pay Electronic Medical Documentation Requests (eMDR) to Participating Providers via the Electronic Submission of \1edical Documentation (esMD) System Shared System Enhancement 2018: Rewrite Fiscal Intermediary Shared System (FISS) module FSSB6001, Common Working File (CWF) Unsolicited Response Function Automatic Transmission of the Prepayment File to the Recovery Audit Contractor (RAC) Data Warehouse (DW) Implementation to Send Post-Pay Electronic Medical Documentation Requests (eMDR) to Participating Providers via the Electronic Submission of Medical Documentation (esMD) System Analysis for First Coast Service Options (FCSO) and Novitas for the CMS Enterprise Identitv Management OKT A/Saviynt Migration Additional Processing Instructions to Update the Standard Paper Remit (SPR) New CWF Edit for Part A Outpatient \1edicare Advantage (MA), Health Maintenance Organization (HMO) New Overpayment Field Established within the YiPS Medicare System (VMS) for Healthcare Integrated General Ledger Accounting System (HIGLAS) Reporting Viable Information Processing Systems (ViPS) Medicare Systems (VMS) Changes to Accommodate National Provider Identifier Associations Analysis and Development Bills Pending Reports to Assist Medicare Administrative Contractors (MACs) with Monthly Status Report (lv!SR) Issued to a specific audience, not posted to Intemet/ Intranet due to Sensitivity of Instructions FISS Integrated Outpatient Code Editor (IOCE) Claim Retum Buffer 39331 EN09AU19.083</GPH> khammond on DSKBBV9HB2PROD with NOTICES 39332 VerDate Sep<11>2014 Jkt 247001 PO 00000 Frm 00074 Fmt 4703 Sfmt 4725 E:\FR\FM\09AUN1.SGM Addendum IV: Medicare National Coverage Determinations (April through June 2019) Addendum IV includes completed national coverage determinations (NCDs), or reconsiderations of completed NCDs, from the quarter covered by this notice. Completed decisions arc identified by the section of the NCD Manual (NCDM) in which the decision appears, the title, the date the publication was issued, and the effective date of the decision. An NCD is a determination by the Secretary for whether or not a particular item or service is covered nationally under the Medicare Program (title XVIII of the Act), but does not include a determination of the code, if any, that is assigned to a particular covered item or service, or payment determination for a particular covered item or service. The entries below include information concerning completed decisions, as well as sections on program and decision memoranda, which also announce decisions or, in some cases, explain why it was not appropriate to issue an NCD. Information on completed decisions as well as pending decisions has also been posted on the CMS website. For the purposes of this quarterly notice, we are providing only the specific updates that have occurred in the 3month period. For the purposes of this quarterly notice, we are providing only the specific updates to national coverage determinations (NCDs), or reconsiderations of completed NCDs published in the 3-month period. This information is available at www.cms.gov/medicare-coverage-database/. For questions or additional information, contact Wanda Belle, MP A (410-786-7491) Title 09AUN1 '!ext Generation Sequencing (NGS) for 'v!edicare Beneficiaries with Advanced Cancer NCDM Section NCD90.2 Transmittal Number Issue Date 215 04/10/2019 Effective Date 02/15/2018 Addendum V: FDA-Approved Category B Investigational Device Exemptions (IDEs) (April through June 2019) (Inclusion of this addenda is under discussion internally.) EN09AU19.084</GPH> Addendum VI: Approval Numbers for Collections of Information (April through June 2019) All approval numbers are available to the public at Reginfo.gov. Under the review process, approved information collection requests are assigned OMB control numbers. A single control number may apply to several related information collections. This information is available at www.reginfo.gov/public/do/PRAMain. For questions or additional information, contact William Parham (410-786-4669). Addendum VII: Medicare-Approved Carotid Stent Facilities, (April through June 2019) Addendum VII includes listings of Medicare-approved carotid stent facilities. All facilities listed meet CMS standards for performing carotid artery stenting for high risk patients. On March 17, 2005, we issued our decision memorandum on carotid artery stenting. We determined that carotid artery stenting with embolic protection is reasonable and necessary only if performed in facilities that have been determined to be competent in performing the evaluation, procedure, and follow-up necessary to ensure optimal patient outcomes. We have created a list of minimum standards for facilities modeled in part on professional society statements on competency. All facilities must at least meet our standards in order to receive coverage for carotid artery stenting for high risk patients. For the purposes of this quarterly notice, we are providing only the specific updates that have occurred in the 3-month period. This information is available at: https://www. ems. gov/MedicareApprovedFacilitie/CASF/list asp#TopOfPage For questions or additional information, contact Sarah Fulton, MHS (410-786-2749). Facility Provider Number Adventist Health White Memorial 050103 11720 Cesar E. Chavez Avenue Los Angeles, CA 90033 Sentara Rockingham Medical Center I 1780694372 12010 Health Campus Drive Harrisonbul]h VA 22801 Clinch Valley Medical Center I 1871534297 6801 Gov. G. C. Peery Highway Richlands, VA 24641 Catholic Medical Center I 1528150273 100 McGregor Street Manchester, NH 03102 Effective Date I State 04/09/2019 CA 04/23/2019 VA 05/14/2019 VA 05/14/2019 NH Federal Register / Vol. 84, No. 154 / Friday, August 9, 2019 / Notices 16:34 Aug 08, 2019 The rulings can be accessed at uuv.1nn' w .c;m~. !;;U'• nu,;!GmduLm~ For questions or additional information, contact Tiffany Lafferty (410-786-7548). khammond on DSKBBV9HB2PROD with NOTICES VerDate Sep<11>2014 Jkt 247001 Brookdale University Hospital Medical Center One Brookdale Plaza BrooklynNY 11212 Deaconess Hospital Inc. -The Heart Hospital at Deaconess Gateway 4007 Gateway Boulevard Newburg, IN 47630 PO 00000 Frm 00075 Fmt 4703 Sfmt 4725 E:\FR\FM\09AUN1.SGM Provider Number 330233 Effective Date State Facility 05/14/2019 NY 150082 05/14/2019 IN FROM: MedCentral Health System TO: OhioHealth Mansfield Hospital 335 Glessner Avenue Mansfield, OH 44903 FROM: Riverside Methodist Hospital TO: OhioHealth Riverside Methodist Hospital 3535 Olentangy River Road Columbus, OH 43214 FROM: Grant Medical Center TO: OhioHealth Grant Medical Center Ill S. Grant Avenue Columbus, OH 43215 FROM: Central Baptist Hospital TO: Baptist Health Lexington 1740 Nicholasville Road Lexington, KY 40503 FROM: St Joseph's Mercy Health Center TO: CHI St. Vincent Hospital Hot Springs 300 Werner Street Hot Springs, AR 71903 FROM: Mercy Medical Center TO: Mercy Hospital of Northwest Arkansas 2710 Rife Medical Lane Rogers, AR 72758 ;~'i\~s} 1i~'i;~~;,:1h'~i ll{;;~;~~~\··\ ~j}c~····• 09AUN1 100109 100068 100319 100046 04/30/2012 07/20/2005 07/18/2013 07/07/2005 FL FL FL FL 100007 06/07/2005 FL 670034 06/04/2010 TX 230117 04/12/2005 MI 010006 05/05/2005 AL Effective Date State 11129/2005 OH 360006 04/20/2005 OH 360017 01/04/2006 OH 180103 04/27/2005 KY 040026 05/26/2005 AR 040010 01/07/2011 AR Addendum VIII: American College of Cardiology's National Cardiovascular Data Registry Sites (April through June 2019) The initial data collection requirement through the American College of Cardiology's National Cardiovascular Data Registry (ACCNCDR) has seiVed to develop and improve the evidence base for the use of ICDs in certain Medicare beneficiaries. The data collection requirement ended with the posting of the final decision memo for Implantable Cardioverter Defibrillators on February 15, 2018. For questions or additional infmmation, contact Sarah Fulton, MHS (410-786-2749). 39333 FROM: Florida Hospital Heart Heartland Medical Center Sebring TO: AdventHealth Sebring 4200 Sun 'n Lake Boulevard Sebring, FL 33872 FROM: Florida Hospital Memorial Medical Center TO: AdventHealth Daytona Beach 301 Memorial.\i!edical Parkway Daytona Beach, FL 32117 FROM: Florida Hospital Wesley Chapel TO: AdventHealth Wesley Chapel 2600 Bruce B. Downs Boulevard Wesley Chapel, FL 33544 FROM: Florida Hospital Zephyrhills TO: AdventHealth Zephyrhills 7050 Gall Boulevard Zephyrhills, FL 33541-1399 FROM: Florida Hospital Orlando TO: AdventHealth Orlando 60 1 East Rollins Street Orlando, FL 32803 FROM: Scott & White Healthcare -Round Rock TO: Scott & White HospitalRound Rock 302 University Boulevard Round Rock, TX 78665 FROM: Borgess Medical Center TO: Ascension Borgess Hospital 1521 Gull Road Kalamazoo, MI 49048 FROM: Eliza Coffee Memorial Hospital TO: North Alabama Medical Center P.O. Box 818 Florence, AL 35630 Provider Number 360118 Federal Register / Vol. 84, No. 154 / Friday, August 9, 2019 / Notices 16:34 Aug 08, 2019 EN09AU19.085</GPH> Facility khammond on DSKBBV9HB2PROD with NOTICES 39334 VerDate Sep<11>2014 Jkt 247001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4725 E:\FR\FM\09AUN1.SGM Addendum X: List of Special One-Time Notices Regarding National Coverage Provisions (April through June 2019) There were no special one-time notices regarding national coverage provisions published in the 3-month period. This information is available at www.cms.hhs.gov/coverage. For questions or additional information, contact JoAnna Baldwin, MS (410-786 7205). 09AUN1 Addendum XI: National Oncologic PET Registry (NOPR) (April through June 2019) Addendum XI includes a listing of National Oncologic Positron Emission Tomography Registry (NOPR) sites. We cover positron emission tomography (PET) scans for particular oncologic indications when they are performed in a facility that participates in the NOPR. In January 2005, we issued our decision memorandum on positron emission tomography (PET) scans, which stated that CMS would cover PET scans for particular oncologic indications, as long as they were perfmmed in the context of a clinical study. We have since recognized the National Oncologic PET Registry as one of these clinical studies. Therefore, in order for a beneficiary to receive a Medicare-covered PET scan, the beneficiary must receive the scan in a facility that participates in the registry. There were no additions, deletions, or editorial changes to the listing of National Oncologic Positron Emission Tomography Registry (NOPR) in the 3-month period. This information is available at https://www. ems. gov/MedicareApprovedF acilitie/NOPR/list. asp#T opOfPage. For questions or additional information, contact Stuart Caplan, RN, MAS (410-786-8564 ). Addendum XII: Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities (April through June 2019) Addendum XII includes a listing of Medicare-approved facilities that receive coverage for ventricular assist devices (VADs) used as destination therapy. All facilities were required to meet our standards in order to receive coverage for VADs implanted as destination therapy. On October 1, 2003, we issued our decision memorandum on VADs for the clinical indication of destination therapy. We determined that VADs used as destination therapy are reasonable and necessary only if performed in facilities that have been determined to have the experience and infrastructure to ensure optimal patient outcomes. We established facility standards and an application process. All facilities were required to meet our standards in order to receive coverage for VADs implanted as destination therapy. For the purposes of this quarterly notice, we are providing only the specific updates to the list of Medicare-approved facilities that meet our standards that have occurred in the 3-month period. This information is available at https://www. ems. gov/MedicareApprovedF acilitie!VAD/list.asp#TopOfPage. For questions or additional information, contact David Dolan, JD, (410-786-3365). Facility ',·,it~:,">' '~~·~;; St. Joseph's Hospital Provider Number Date of Initial Certification Date of Recertification 100075 02/28/2019 FL 220163 02/06/2019 !viA t;i~\~~,;:: State •:t•.Y'<.•;~~~ 3001 W Dr. Martin Luther King Jr Boulevard Tampa, FL 33614 Other information: DNV GL Certificate #t 285554-2019-V AD Ulv!ass lv!emoriallv!edical Center SS Lake Avenue North Worcester, !viA 01655 Federal Register / Vol. 84, No. 154 / Friday, August 9, 2019 / Notices 16:34 Aug 08, 2019 EN09AU19.086</GPH> Addendum IX: Active CMS Coverage-Related Guidance Documents (April through June 2019) CMS issued a guidance document on November 20, 2014 titled "Guidance for the Public, Industry, and CMS Staff: Coverage with Evidence Development Document". Although CMS has several policy vehicles relating to evidence development activities including the investigational device exemption (IDE), the clinical trial policy, national coverage determinations and local coverage determinations, this guidance document is principally intended to help the public understand CMS' s implementation of coverage with evidence development (CED) through the national coverage determination process. The document is available at https://www. ems. gov/medicare-coverage-database/details/medicarecoverage-document-details.aspx?MCDid=27. There are no additional Active CMS Coverage-Related Guidance Documents for the 3-month period. For questions or additional information, contact JoAnna Baldwin, MS (410-786-7205). khammond on DSKBBV9HB2PROD with NOTICES VerDate Sep<11>2014 Facility Provider Number Jkt 247001 PO 00000 Other information: DNV GL Certificate #: 595753-2019-V AD OHSU 3181 SW Sam Jackson Park Road Portland, OR 97239 Frm 00077 Other information: DNV GL Certificate#: 575469-2019-V AD Dignity Health 150 West Thomas Rd. Phoenix, AZ 85013 Date of Recertification 100248 04/04/2019 FL 380009 05117/2019 OR 030024 05/08/2019 AZ Fmt 4703 Other information: Joint Commission ID # 9494 1,~~ ,,,:))~\ ~ ' t!tt~tt:a®: ~;:::~ ;~,; Sfmt 4725 Brigham and Women's Hospital 75 Francis Street Boston, MA 02115 E:\FR\FM\09AUN1.SGM 09AUN1 Other information: Joint Conm1ission ID #: 5503 V AD Previous Re-certification Dates: 2008-ll-04: 2010-12-09: 2012-12-07: 2014-11-07: 201612-13 I'lorida Hospital 601 East Rollins Street Orlando, FL 32803 Other information: Joint Conm1ission ID #: 6873 V AD Previous Re-certification Dates: 2014-10-07: 2016-11-15 UCSF Medical Center 505 Pamassus Avenue San Francisco, CA 94143 State 220l10 100007 01/09/2004 11/09/2016 .•\;.~ 02/27/2019 01/30/2019 ,.,, ~-,x~:~t_,,; MA I'L Facility V AD Previous Re-certification Dates: 2014-ll-04: 2016-12-06 FROM: Tacoma GeneralAllenmore Hospital TO: Mnlticare Tacoma General Hospital 315 Martin Luther King Jr. Way Tacoma, WA 98405 Other information: Joint Commission ID #: 9649 V AD Previous Re-certification Dates: 2012-11-14; 2014-1118; 2016-12-06 Fresno Community Hospital and Medical Center 2823 Fresno Street Fresno, CA 93721 Other information: Joint Commission ID #: 9832 Abbott Northwestern Hospital 800 East 38th Street Minneapolis, MN 55407 Other information: Joint Commission ID #: 8149 V AD Previous Re-certification Dates: 2012-11-29; 2014-1118; 2016-12-06 JFK Medical Center 5301 South Congress Avenue Atlantis, FL 33462 Other information: Joint Commission ID #: 6836 Mercy Medical Center 1111 6th Avenue Des Moines, IA 50314 050454 10116/2012 01/30/2019 CA Pro-.ider Number Date of Initial Certification Date of Recertification State 500129 11/04/2010 02/06/2019 WA 050060 12/14/2016 02/13/2019 CA 240057 ll/17/2010 02/13/2019 MN 100080 01/25/2017 03/06/2019 FL 160083 01/15/2015 03/27/2019 IA Federal Register / Vol. 84, No. 154 / Friday, August 9, 2019 / Notices 16:34 Aug 08, 2019 Other information: Joint Commission ID # 5640 Largo Medical Center 201 14th Street SW Largo, FL 33770 Date of Initial Certification Other information: Joint Commission ID #: 8248 V AD Previous Re-certification Dates: 2017-02-14 Other Information: Joint Conm1ission ID li: 10095 39335 EN09AU19.087</GPH> khammond on DSKBBV9HB2PROD with NOTICES 39336 VerDate Sep<11>2014 Facility Jkt 247001 Other information: Joint Conm1ission ID #: 6024 VAD Previous Re-certification Dates: 2017-01-24 Henry Ford Hospital 2799 W Grand Boulevard Detroit, MI 48202 PO 00000 Frm 00078 Fmt 4703 Other information: Joint Conm1ission ID #: 7485 VAD Previous Re-certification Dates: 2008-10-30; 2010-1021; 2012-11-06; 2014-10-28; 2016-12-20 Intermountain Medical Center 5121 South Cottonwood Street Murry, UT 84157 Sfmt 4725 E:\FR\FM\09AUN1.SGM Other information: Joint Conm1ission ID #: 9540 VAU Previous Re-certitlcation Dates: 2008-10-31; 2010-1207; 2012-12-11; 2014-12-16; 2017-01-24 210051 460010 Date of Initial Certification 12118/2014 01/06/2004 10/23/2003 Date of Recertification 03/06/2019 03/13/2019 03/13/2019 State Facility PA Yale- New Haven Hospital 20 York Street New Haven, CT 06510 MT UT Other information: Joint Commission ID #: 5677 V AD Previous Re-certification Dates: 2013-01-15; 2014-1216: 2017-02-28 FROM: Lorna Linda University Medical Center and Children's Hospital TO: Lorna Linda University Medical Center 11234 Anderson Street Lorna Linda, CA 92354 Other information: Joint Commission ID # 9898 Previous Re-certification Dates: 2014-01-23; 2016-02-24 University of Colorado Hospital Authority 12605 E 16th Avenue Aurora, CO 80045-2545 Other information: Joint Commission ID # 9384 Previous Re-certification Dates: 2008-07-23; 2010-08-17; 201208-10; 2014-07-22; 2016-07-26 Beth Israel Deaconess Medical Center 330 Brookline Avenue Boston, MA 02215 09AUN1 Other information: Joint Commission ID # 5501 Presbyterian Medical Center of the UPHS 51 North 39th Street Philadelphia, PA 19104 Other information: Joint Commission ID # 6145 Previous Re-certification Dates: 2012-11-07; 2014-12-09; 201703-21 EN09AU19.088</GPH> Pro'>ider Number 070022 Date of Initial Certification 02/04/2011 Date of Recertification 05/22/2019 State 050327 02/17/2012 04/1112018 CA 060024 11/06/2003 07/17/2018 co 220086 06/23/2017 05/22/2019 PA 390223 10/11/2011 04/17/2019 PA CT Federal Register / Vol. 84, No. 154 / Friday, August 9, 2019 / Notices 16:34 Aug 08, 2019 St. Luke's Hospital 801 Ostrum Street Bethlehem, PA 18015 Provider Number 390049 khammond on DSKBBV9HB2PROD with NOTICES VerDate Sep<11>2014 Facility Frm 00079 Fmt 4703 Sfmt 4725 Other information: Joint Connnission ID # 186313 Previous Re-certification Dates: 2013-01-29; 2015-02-24; 201702-14 University of Colorado Hospital Authority 12605 E 16th Ave. Aurora, CO 80045-2545 Date of Initial Certification 11126/2003 Date of Recertification 04/24/2019 FL 280011 02/02/2011 04/17/2019 NE 060024 11/06/2003 07/18/2018 State co E:\FR\FM\09AUN1.SGM Other information: Joint Connnission ID # 9384 Previous Re-certification Dates: 2008-07-23; 2010-08-17; 201208-10; 2014-07-22; 2016-07-26 09AUN1 Addendum XIII: Lung Volume Reduction Surgery (LVRS) (April through June 2019) Addendum XIII includes a listing of Medicare-approved facilities that are eligible to receive coverage for lung volume reduction surgery. Until May 17, 2007, facilities that participated in the National Emphysema Treatment Trial were also eligible to receive coverage. The following three types of facilities are eligible for reimbursement for Lung Volume Reduction Surgery (L VRS): • National Emphysema Treatment Trial (NETT) approved (Beginning 05/07/2007, these will no longer automatically qualify and can qualify only with the other programs); • Credentialed by the Joint Commission (formerly, the Joint Commision on Accreditation of Healthcare Organizations (JCAHO)) under their Disease Specific Certification Program for L VRS; and • Medicare approved for lung transplants. Only the first two types are in the list. For the purposes of this quarterly notice, there arc no specific updates to the listing of facilities for lung volume reduction surgery published in the 3-month period. This information is available at www.cms.gov/MedicareApprovedFacilitie/L VRS/list.asp#TopOfPage. For questions or additional information, contact Sarah Fulton, MHS (410-786-27 49). Addendum XIV: Medicare-Approved Bariatric Surgery Facilities (April through June 2019) Addendum XIV includes a listing of Medicare-approved facilities that meet minimum standards for facilities modeled in part on professional society statements on competency. All facilities must meet our standards in order to receive coverage for bariatric surgery procedures. On February 21, 2006, we issued our decision memorandum on bariatric surgery procedures. We determined that bariatric surgical procedures are reasonable and necessary for Medicare beneficiaries who have a body-mass index (BMI) greater than or equal to 35, have at least one co-morbidity related to obesity and have been previously unsuccessful with medical treatment for obesity. This decision also stipulated that covered bariatric surgery procedures are reasonable and necessary only when performed at facilities that are: (1) certified by the American College of Surgeons (ACS) as a Levell Bariatric Surgery Center (program standards and requirements in effect on February 15, 2006 ); or (2) certified by the American Society for Bariatric Surgery (ASBS) as a Bariatric Surgery Center of Excellence (ESCOE) (program standards and requirements in effect on February 15, 2006). There were no additions, deletions, or editorial changes to Medicare-approved facilities that meet CMS' minimum facility standards for bariatric surgery that have been certified by ACS and/or ASMBS in the 3-month period. This infonnation is available at www. ems. gov/MedicareApprovedF acilitie/B SF/list.asp#TopOfPage. For questions or additional information, contact Sarah Fulton, MHS (410-786-27 49). Federal Register / Vol. 84, No. 154 / Friday, August 9, 2019 / Notices Jkt 247001 Other information: Joint Connnission ID # 6804 Previous Re-certification Dates: 2008-11-18; 20 11-02-08; 201302-12; 2015-01-27; 2017-02-14 'lehraska Medical Center 4350 Dewey Avenue Omaha, NE 68198-7400 PO 00000 16:34 Aug 08, 2019 FROM: Shands at the University of Florida TO: Shands Teaching Hospitals & Clinics, Inc. 1600 SW Archer Rd. Gainesville, FL 32608 Provider Number 10113 39337 EN09AU19.089</GPH> khammond on DSKBBV9HB2PROD with NOTICES 39338 This information is available on our website at www. ems. gov/MedicareApprovedF acilitie/PETDT/list.asp#TopOfPage. For questions or additional information, contact Stuart Caplan, RN, MAS (410-786-8564). PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 E:\FR\FM\09AUN1.SGM 09AUN1 Federal Register / Vol. 84, No. 154 / Friday, August 9, 2019 / Notices Jkt 247001 [FR Doc. 2019–17025 Filed 8–8–19; 8:45 am] 16:34 Aug 08, 2019 BILLING CODE 4120–01–C VerDate Sep<11>2014 EN09AU19.090</GPH> Addendum XV: FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials (April through June 2019) There were no FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials published in the 3-month period.

Agencies

[Federal Register Volume 84, Number 154 (Friday, August 9, 2019)]
[Notices]
[Pages 39323-39338]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17025]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9117-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--April Through June 2019

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

ACTION: Notice.

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SUMMARY: This quarterly notice lists CMS manual instructions, 
substantive and interpretive regulations, and other Federal Register 
notices that were published from April through June 2019, relating to 
the Medicare and Medicaid programs and other programs administered by 
CMS.

FOR FURTHER INFORMATION CONTACT: It is possible that an interested 
party may need specific information and not be able to determine from 
the listed information whether the issuance or regulation would fulfill 
that need.

[[Page 39324]]

Consequently, we are providing contact persons to answer general 
questions concerning each of the addenda published in this notice.
[GRAPHIC] [TIFF OMITTED] TN09AU19.076

I. Background

    The Centers for Medicare & Medicaid Services (CMS) is responsible 
for administering the Medicare and Medicaid programs and coordination 
and oversight of private health insurance. Administration and oversight 
of these programs involves the following: (1) Furnishing information to 
Medicare and Medicaid beneficiaries, health care providers, and the 
public; and (2) maintaining effective communications with CMS regional 
offices, state governments, state Medicaid agencies, state survey 
agencies, various providers of health care, all Medicare contractors 
that process claims and pay bills, National Association of Insurance 
Commissioners (NAIC), health insurers, and other stakeholders. To 
implement the various statutes on which the programs are based, we 
issue regulations under the authority granted to the Secretary of the 
Department of Health and Human Services under sections 1102, 1871, 
1902, and related provisions of the Social Security Act (the Act) and 
Public Health Service Act. We also issue various manuals, memoranda, 
and statements necessary to administer and oversee the programs 
efficiently.
    Section 1871(c) of the Act requires that we publish a list of all 
Medicare manual instructions, interpretive rules, statements of policy, 
and guidelines of general applicability not issued as regulations at 
least every 3 months in the Federal Register.

II. Format for the Quarterly Issuance Notices

    This quarterly notice provides only the specific updates that have 
occurred in the 3-month period along with a hyperlink to the full 
listing that is available on the CMS website or the appropriate data 
registries that are used as our resources. This is the most current up-
to-date information and will be available earlier than we publish our 
quarterly notice. We believe the website list provides more timely 
access for beneficiaries, providers, and suppliers. We also believe the 
website offers a more convenient tool for the public to find the full 
list of qualified providers for these specific services and offers more 
flexibility and ``real time'' accessibility. In addition, many of the 
websites have listservs; that is, the public can subscribe and receive 
immediate notification of any updates to the website. These listservs 
avoid the need to check the website, as notification of updates is 
automatic and sent to the subscriber as they occur. If assessing a 
website proves to be difficult, the contact person listed can provide 
information.

III. How To Use the Notice

    This notice is organized into 15 addenda so that a reader may 
access the subjects published during the quarter covered by the notice 
to determine whether any are of particular interest. We expect this 
notice to be used in concert with previously published notices. Those 
unfamiliar with a description of our Medicare manuals should view the 
manuals at https://www.cms.gov/manuals.

    Dated: July 26, 2019.
Kathleen Cantwell,
Director, Office of Strategic Operations and Regulatory Affairs.
BILLING CODE 4120-01-P

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[FR Doc. 2019-17025 Filed 8-8-19; 8:45 am]
 BILLING CODE 4120-01-C

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