Justia Department Of Health And Human Services Centers For Medicare & Medicaid Services Medicare Program: Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Revisions of Organ Procurement Organizations Conditions of Coverage; Prior Authorization Process and Requirements for Certain Covered Outpatient Department Services; Potential Changes to the Laboratory Date of Service Policy; Changes to Grandfathered Children's Hospitals-Within-Hospitals; Notice of Closure of Two Teaching Hospitals and Opportunity To Apply for Available Slots; Correction, 224-230 [2019-28364]

Medicare Program: Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Revisions of Organ Procurement Organizations Conditions of Coverage; Prior Authorization Process and Requirements for Certain Covered Outpatient Department Services; Potential Changes to the Laboratory Date of Service Policy; Changes to Grandfathered Children's Hospitals-Within-Hospitals; Notice of Closure of Two Teaching Hospitals and Opportunity To Apply for Available Slots; Correction, 224-230 [2019-28364]

Download as PDF 224 Federal Register / Vol. 85, No. 2 / Friday, January 3, 2020 / Rules and Regulations through Broadcast Notices to Mariners (BNMs), Local Notices to Mariners (LNMs), and/or Marine Safety Information Bulletins (MSIBs) as appropriate. Dated: December 23, 2019. R. Tamez, Captain, U.S. Coast Guard, Captain of the Port Sector Lower Mississippi River. [FR Doc. 2019–28190 Filed 12–30–19; 4:15 pm] BILLING CODE 9110–04–P I. Background In FR Doc. 2019–24138 of November 12, 2019 (84 FR 61142), there were a number of technical and typographical errors that are identified and corrected by the Correction of Errors section below. The corrections in this correction document are effective as if they had been included in the document that appeared in the November 12, 2019 issue of the Federal Register. Accordingly, the corrections are effective January 1, 2020. DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Parts 405, 410, 412, 414, 416, 419, and 486 [CMS–1717–CN] RIN 0938–AT74 Medicare Program: Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Revisions of Organ Procurement Organizations Conditions of Coverage; Prior Authorization Process and Requirements for Certain Covered Outpatient Department Services; Potential Changes to the Laboratory Date of Service Policy; Changes to Grandfathered Children’s HospitalsWithin-Hospitals; Notice of Closure of Two Teaching Hospitals and Opportunity To Apply for Available Slots; Correction Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Final rule; correction. AGENCY: This document corrects technical errors that appeared in the final rule with comment period that appeared in the November 12, 2019, issue of the Federal Register titled ‘‘Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Revisions of Organ Procurement Organizations Conditions of Coverage; Prior Authorization Process and Requirements for Certain Covered Outpatient Department Services; Potential Changes to the Laboratory Date of Service Policy; Changes to Grandfathered Children’s HospitalsWithin-Hospitals; Notice of Closure of Two Teaching Hospitals and Opportunity to Apply for Available Slots.’’ DATES: jbell on DSKJLSW7X2PROD with RULES SUMMARY: VerDate Sep<11>2014 16:16 Jan 02, 2020 Effective date: This correcting document is effective January 1, 2020. Applicability date: The corrections in this correcting document are applicable on and after January 1, 2020. FOR FURTHER INFORMATION CONTACT: Elise Barringer via email Elise.barringer@cms.hhs.gov or at (410) 786–9222. SUPPLEMENTARY INFORMATION: Jkt 250001 II. Summary of Errors A. Summary of Errors in the Preamble 1. Hospital Outpatient Prospective Payment System (OPPS) Corrections On page 61162, we inadvertently omitted a discussion of the reestablishment of ComprehensiveAmbulatory Payment Classification (C– APC) 5495 (Level 5 Intraocular Procedures) in the description of additional C–APCs that are finalized for calendar year (CY) 2020. Therefore, we are correcting the final rule with comment period to add this description. On page 61182, we are correcting the standard wage index conversion factor budget neutrality adjustment from 0.9990 to 0.9991, which also results in the overall wage index budget neutrality factor changing from 0.9981 to 0.9982. This correction is necessary because some of the CY 2020 wage indexes used for calculating budget neutrality were based on the incorrect assignment of a rural wage index rather than the rural floor. We note that this affected both the conversion factor, which changes from $80.784 to $80.793, as well as all CY 2020 OPPS payment rates included in the final rule with comment period that are based on that OPPS conversion factor. Therefore, on page 61420, we are correcting the full and reduced conversion factors based on the previously described change to the standard wage index budget neutrality adjustment. This change in the OPPS conversion factor and payments also slightly affects the OPPS impact table, with relative increases and decreases based on assignment of the correct wage index PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 and the corresponding increase in the OPPS conversion factor. As a result, on pages 61474 through 61478, we are correcting the impact table and accompanying preamble text based on the corrected payment rates, which are being updated in this correction notice. We note that there was also an error in the impact file, in which wage indexes that did not include the 5 percent cap on wage index decreases relative to 2019 (as described in the CY 2020 OPPS final rule with comment period (84 FR 61184 through 61188)) were incorrectly displayed as being the final CY 2020 wage indexes. This correction notice corrects these wage indexes in a revised impact file accompanying the correction notice. On page 61194, we are correcting the reporting ratio. On page 61195, we are correcting the CY 2020 example of the supporting calculations for both the full and reduced national unadjusted payment rates that will apply to certain outpatient items and services performed by hospitals that meet and that fail to meet the Hospital Outpatient Quality Reporting (OQR) Program requirements. On page 61196, we are correcting the beneficiary copayment amount calculated for APC 5071 and the national unadjusted payment rate for APC 5071. We also are correcting the reporting ratio for hospitals that failed to meet hospital OQR program requirements. These corrections are necessary because of the correction to the wage index budget neutrality adjustment and the corresponding change to the OPPS conversion factor. On page 61184, we are correcting the preamble language that incorrectly states the difference between passthrough spending in 2019 and passthrough spending in 2020 as being a difference of 0.88 percentage points. Instead, the difference in pass-through spending in 2019 and 2020 is 0.74 percentage point, which is the difference between the 0.14 percent of total 2019 OPPS spending for passthrough drugs, biologicals, and devices and 0.88 percent of total 2020 OPPS spending for pass-through drugs, biologicals, and devices. We note that this inaccuracy was limited to the preamble language, and did not affect the calculated CY 2020 OPPS payment rates included elsewhere in the final rule with comment period. On pages 61296 and 61336, we incorrectly referred to the CUSTOMFLEX® ARTIFICIALIRIS as ARTIFICIALIris®. We are correcting the final rule with comment period to refer to the device by the correct name: CUSTOMFLEX® ARTIFICIALIRIS. E:\FR\FM\03JAR1.SGM 03JAR1 jbell on DSKJLSW7X2PROD with RULES Federal Register / Vol. 85, No. 2 / Friday, January 3, 2020 / Rules and Regulations On page 61306, we are correcting Table 41, ‘‘Drugs and Biologicals with Pass-Through Payment Status during CY 2020’’. We are removing records for HCPCS codes C9407 (Iodine i-131 iobenguane, diagnostic, 1 millicurie) and C9408 (Iodine i-131 iobenguane, therapeutic, 1 millicurie). We are adding a record for HCPCS code A9590 (Iodine i-131, iobenguane, 1 millicurie). This change was made because HCPCS codes C9407 and C9408 will no longer be active as of December 31, 2019. Both of these codes are being replaced by HCPCS code A9590. In the final rule, CMS mistakenly left the records for C9407 and C9408 in Table 41 and did not include the record for A9590. On page 61313, we incorrectly stated that ASP data from the first quarter of CY 2019 was used to calculate payment rates in the CY 2020 proposed rule. We are correcting the final rule with comment period to refer to the data that was used to calculate payment rates in the CY 2020 proposed rule: ASP data from the fourth quarter of 2018. On page 61313, we incorrectly stated that ASP data from the third quarter of CY 2019 were used to calculate payment rates in the CY 2020 final rule with comment period. We are correcting the final rule with comment period to refer to the data that was used to calculate payment rates in the CY 2020 final rule with comment period: ASP data from the second quarter of CY 2019. On page 61320, we are correcting an incorrect description of the final CY 2020 policy regarding the payment of non pass-through biosimilars acquired under the 340B Program. We stated that we were finalizing our proposal, which was to continue to pay non pass-through biosimilars acquired under the 340B Program at the biosimilar’s ASP minus 22.5 percent of the biosimilar’s ASP, not minus 22.5 percent of the reference product’s ASP. On page 61337, we are correcting our estimate of the cost of drugs and biologicals recently made eligible for pass-through payment and continuing on pass-through payment status for at least one quarter in CY 2020. The cost estimate was misstated in the preamble text of the final rule. The correct estimated cost is $425.6 million, not $339.6 million. On pages 61448 through 61450, we incorrectly labeled and referenced the table ‘‘Proposed List of Outpatient Services That Would Require Prior Authorization’’ as Table 38. We are correcting the document to use the correct number, which is Table 64. On pages 61456 and 61457, we incorrectly labeled and referenced the table as ‘‘Table 64—Proposed List of VerDate Sep<11>2014 16:16 Jan 02, 2020 Jkt 250001 Outpatient Services That Would Require Prior Authorization.’’ We are correcting the document to use the correct number, which is Table 65, as well as the correct title which states ‘‘Final’’ rather than ‘‘Proposed’’ and removes the word ‘‘Would’’. The corrected table reads: ‘‘Table 65—Final List of Outpatient Services That Require Prior Authorization.’’ We also inadvertently omitted two additional botulinum toxin injection codes, J0586 and J0588, as noted on page 61456. Therefore, we are adding these codes to Table 65—Final List of Outpatient Services That Require Prior Authorization. On pages 61458 through 61463, we inadvertently included an earlier iteration of the section titled ‘‘Summary of the Public Comments and Responses to Comments on the Proposed Rule’’. We are removing this language. On page 61464, we erroneously included Table 65, which is identical to the Table 38, which is corrected to be numbered correctly as Table 64 above. We are removing the table. 2. Ambulatory Surgical Center (ASC) Payment System Corrections On page 61381, we inadvertently omitted a comment and response regarding the temporary office-based designation of CPT code 64624. We are correcting the document to include this comment and response. On page 61384, as a result of the correction to the OPPS conversion factor, we are correcting the ASC device offset amount for CPT code 22869 from ‘‘$8,383.12’’ to ‘‘$8,384.05.’’ On page 61388, as a result of the correction to the OPPS conversion factor, we are correcting ASC payment rate for total knee arthroplasty, CPT code 27447, from ‘‘$8,609.17’’ to ‘‘$8,609.82’’, and the ASC coinsurance from ‘‘$1,721.83’’ to ‘‘$1,721.96’’. Additionally, in that same sentence, we are correcting the OPPS payment rate for total knee arthroplasty from ‘‘$11,899.39’’ to ‘‘$11,900.71’’. On page 61409, we inadvertently omitted a discussion of the final ASC conversion factors for ASCs that meet the quality requirements and ASCs who failed to meet the quality requirements in the description of updated ASC conversion factors for CY 2020. Therefore, we are adding this text. B. Summary of Errors and Corrections to the OPPS and ASC Addenda Posted on the CMS Website 1. OPPS Addenda Posted on the CMS Website In Addendum B of the CY 2020 OPPS/ASC final rule with comment PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 225 period, HCPCS codes 99487, 99489, and 99490 were incorrectly assigned to status indicator ‘‘B’’ to indicate that another more appropriate code should be reported. However, the HCPCS codes that CMS considered more appropriate, HCPCS codes G2059, G2060, and G2057, respectively, were not adopted for implementation in CY 2020. Therefore, these codes were mistakenly assigned status indicator ‘‘B’’ and in Addendum B (Final OPPS Payment by HCPCS Code for CY 2020), we corrected the following: • CPT code 99487 (Cmplx chron care w/o pt vsit): We made a typographical error in the status indicator and APC assignments. Specifically, we are correcting the status indicator from ‘‘B’’ to ‘‘S’’, and the APC assignment to APC 5822 (Level 2 Health and Behavior Services). • CPT code 99489 (Cmplx chron care addl 30 min): We made a typographical error in the status indicator assignment. Specifically, we are correcting the status indicator from ‘‘B’’ to ‘‘N’’. • CPT code 99490 (Chron care mgmt srvc 20 min): We made a typographical error in the status indicator and APC assignments. Specifically, we are correcting the status indicator from ‘‘B’’ to ‘‘S’’, and the APC assignment to APC 5822 (Level 2 Health and Behavior Services). In Addendum C (Final HCPCS Codes Payable Under the 2020 OPPS by APC), we corrected the following: • CPT code 99487 (Cmplx chron care w/o pt vsit) was added to APC 5822 (Level 2 Health and Behavior Services). • CPT code 99490 (Chron care mgmt srvc 20 min) was added to APC 5822 (Level 2 Health and Behavior Services). In Addendum P in the spreadsheet in the tab titled ‘‘2020 FR Device Intensive List,’’ we inadvertently included CPT code 86891 (Autologous blood op salvage) in the list. HCPCS 86891 was not proposed as a device-intensive procedure for CY 2020. It is appropriate to remove HCPCS 86891 from the device-intensive list because it is a lab code for ‘‘processing and storage of blood unit or component’’ and is not reported with a device code. We have removed this procedure from the list as this procedure does not meet the criteria for device-intensive status. To view the corrected CY 2020 OPPS status indicators, APC assignments, relative weights, payment rates, copayment rates, device-intensive status, and short descriptors for Addendum A, B, C, and P that resulted from the technical corrections described in this correcting document, we refer readers to the Addenda and supporting files that are posted on the CMS website E:\FR\FM\03JAR1.SGM 03JAR1 226 Federal Register / Vol. 85, No. 2 / Friday, January 3, 2020 / Rules and Regulations jbell on DSKJLSW7X2PROD with RULES at: https://www.cms.gov/Medicare/ Medicare-Fee-for-Service-Payment/ HospitalOutpatientPPS/. Select ‘‘CMS–1717–CN’’ from the list of regulations. All corrected Addenda for this correcting document are contained in the zipped folder titled ‘‘2020 OPPS Final Rule Addenda’’ at the bottom of the page for CMS–1717–CN. 2. ASC Payment System Addenda Posted on the CMS Website The ASC device intensive methodology calculated estimated device cost based on OPPS payment rates. As a result of the correction to the OPPS conversion factor, we corrected the payment rates for device-intensive surgical procedures in Addendum AA. In addition, we corrected the following in Addendum BB: • CPT code 78431: Updated the payment rate from $1,137.28 to $1,137.15. • CPT code 78432: Updated the payment rate from $1,389.95 to $1,389.79. • CPT code 78433: Updated the payment rate from $1,389.95 to $1,389.79. • HCPCS code J7331: Added to Addendum BB with a payment rate of $6.13. • HCPCS code J7332: Added to Addendum BB with a payment rate of $25.18. HCPCS codes J7331 and J7332 were listed in the OPPS Addendum B of the CY 2020 OPPS/ASC final rule but were inadvertently omitted from ASC Addendum AA. Since pricing information was not available at the time the final rule was developed, both HCPCS codes received the payment indicator Y5 (Nonsurgical procedure/ item not valid for Medicare purposes because of coverage, regulation and/or statute; no payment made) and were mistakenly omitted from the addendum. We are correcting this omission now with updated pricing information. These codes have been flagged with comment indicator N1 in Addendum BB of the CY 2020 OPPS/ASC correction notice to indicate that we have assigned the codes an interim ASC payment indicator of K2 for CY 2020. We intend to invite public comments in the CY 2021 OPPS/ASC proposed rule on the interim ASC payment indicator for these codes that we intend to finalize in the CY 2021 OPPS/ASC final rule with comment period. To view the corrected final CY 2020 ASC payment indicators, payment weights, payment rates, and multiple procedure discounting indicator for Addendum AA and BB that resulted from these technical corrections, we VerDate Sep<11>2014 16:16 Jan 02, 2020 Jkt 250001 refer readers to the Addenda and supporting files on the CMS website at: https://www.cms.gov/Medicare/ Medicare-Fee-for-Service-Payment/ ASCPayment/ASC-Regulations-andNotices.html. Select ‘‘CMS–1717–CN’’ from the list of regulations. All corrected ASC addenda for this correcting document are contained in the zipped folder entitled ‘‘Addendum AA, BB, DD1, DD2, and EE’’ at the bottom of the page for CMS–1717–CN. III. Waiver of Proposed Rulemaking, 60-Day Comment Period, and Delay in Effective Date Under 5 U.S.C. 553(b) of the Administrative Procedure Act (APA), the agency is required to publish a notice of the proposed rulemaking in the Federal Register before the provisions of a rule take effect. Similarly, section 1871(b)(1) of the Act requires the Secretary to provide for notice of the proposed rulemaking in the Federal Register and provide a period of not less than 60 days for public comment. In addition, section 553(d) of the APA, and section 1871(e)(1)(B)(i) of the Act mandate a 30day delay in effective date after issuance or publication of a rule. Sections 553(b)(B) and 553(d)(3) of the APA provide for exceptions from the notice and comment and delay in effective date APA requirements; in cases in which these exceptions apply, section 1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the Act provide exceptions from the notice and 60-day comment period and delay in effective date requirements of the Act as well. Section 553(b)(B) of the APA and section 1871(b)(2)(C) of the Act authorize an agency to dispense with normal rulemaking requirements for good cause if the agency makes a finding that the notice and comment rulemaking process are impracticable, unnecessary, or contrary to the public interest. In addition, both section 553(d)(3) of the APA and section 1871(e)(1)(B)(ii) of the Act allow the agency to avoid the 30-day delay in effective date where such delay is contrary to the public interest and agency includes a statement of support. We believe that this correcting document does not constitute a rule that would be subject to the notice and comment or delayed effective date requirements. This document corrects technical and typographic errors in the preamble, addenda, payment rates, and tables included or referenced in the CY 2020 OPPS/ASC final rule with comment period but does not make substantive changes to the policies or payment methodologies that were adopted in the final rule with comment PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 period. As a result, this correcting document are intended to ensure that the information in the CY 2020 OPPS/ ASC final rule with comment period accurately reflects the policies adopted in that document. In addition, even if this were a rulemaking to which the notice and comment procedures and delayed effective date requirements applied, we find that there is good cause to waive such requirements. Undertaking further notice and comment procedures to incorporate the corrections in this document into the final rule with comment period or delaying the effective date would be contrary to the public interest because it is in the public’s interest for providers to receive appropriate payments in as timely a manner as possible, and to ensure that the CY 2020 OPPS/ASC final rule with comment period accurately reflects our methodologies and policies as of the date they take effect and are applicable. Furthermore, such procedures would be unnecessary, as we are not altering our payment methodologies or policies, but rather, we are simply correctly implementing the policies that we previously proposed, received comment on, and subsequently finalized. This correcting document is intended solely to ensure that the CY 2020 OPPS/ASC final rule with comment period accurately reflects these payment methodologies and policies. For these reasons, we believe we have good cause to waive the notice and comment and effective date requirements. IV. Correction of Errors In FR Doc. 2019–24138 of November 12, 2019 (84 FR 61142), make the following corrections: 1. On page 61162, column 1, first partial paragraph, in line 15, add the following text: ‘‘As discussed in section III.D.16 of this final rule with comment period, we are also re-establishing C– APC 5495 (Level 5 Intraocular Procedures) for CY 2020 based on need for a Level 5 for the Intraocular Procedures C–APC clinical family.’’ 2. On page 61182, column 3, second partial paragraph, a. In line 14, the figure ‘‘0.9981’’ is corrected to read ‘‘0.9982’’. b. In line 16, the figure ‘‘0.9990’’ is corrected to read ‘‘0.9991’’. 3. On page 61184, column 1, second full paragraph, a. In line 9, the figure ‘‘$80.784’’ is corrected to read ‘‘$80.793’’. b. In line 17, the figure ‘‘0.9981’’ is corrected to read ‘‘0.9982’’. c. In line 18, the figure ‘‘0.88 percentage point’’ is corrected to read ‘‘0.74 percentage point’’. E:\FR\FM\03JAR1.SGM 03JAR1 Federal Register / Vol. 85, No. 2 / Friday, January 3, 2020 / Rules and Regulations d. In line 22, the figure ‘‘$80.784’’ is corrected to read ‘‘$80.793’’. 4. On page 61194, column 2, third full paragraph, line 23, the figure ‘‘0.980’’ is corrected to read ‘‘0.981’’. 5. On page 61195, column 2, a. Second full paragraph, (1) In line 17, the figure ‘‘$609.94’’ is corrected to read ‘‘$610.01’’. (2) In line 21, the figure ‘‘$598.35’’ is corrected to read ‘‘$598.42’’. b. Third full paragraph, (1) In line 7, the figure ‘‘$470.84’’ is corrected to read ‘‘$470.91’’. (2) In line 8, the figure ‘‘$609.94’’ is corrected to read ‘‘$610.01’’. (3) In line 11, the equation ‘‘$461.90 (.60 * $598.35 * 1.2866)’’ is corrected to read ‘‘$461.95 (.60 * $598.42 * 1.2866)’’. CY 2019 HCPCS code CY 2020 HCPCS code C9407 ............ C9407 C9408 ............ C9408 (4) In line 14, the equation ‘‘$243.98 (.40 * $609.94)’’ is corrected to read ‘‘$244.00 (.40 * $610.01)’’. (5) In line 17, the equation ‘‘$239.34 (.40 * $598.35)’’ is corrected to read ‘‘$239.37 (.40 * $598.42)’’. (6) In lines 21 and 22, the equation ‘‘$714.82 ($470.84 + $243.98)’’ is corrected to read ‘‘$714.91 ($470.91 + $244.00)’’. (7) In lines 24 and 25, the equation ‘‘$701.24 ($461.90 + $239.34)’’ is corrected to read ‘‘$701.32 ($461.95 + $239.37)’’. 6. On page 61196, column 3, a. First full paragraph, labeled ‘‘Step 1’’, (1) In line 5, the figure ‘‘$121.99’’ is corrected to read ‘‘$122.01’’. (2) In line 8, the figure ‘‘$609.94’’ is corrected to read ‘‘$610.01’’. CY 2020 status indicator Long descriptor Iodine i-131 iobenguane, diagnostic, 1 millicurie. Iodine i-131 iobenguane, therapeutic, 1 millicurie. 227 b. Second to last paragraph, labeled ‘‘Step 4’’, in line 5, the figure ‘‘0.980’’ is corrected to read ‘‘0.981’’. 7. On page 61296, column 3, last paragraph, a. In line 5, ‘‘ARTIFICIALIris®’’ is corrected to read ‘‘CUSTOMFLEX® ARTIFICIALIRIS’’. b. In line 7, ‘‘ARTIFICIALIris®’’ is corrected to read ‘‘CUSTOMFLEX® ARTIFICIALIRIS’’. c. In line 12, ‘‘ARTIFICIALIris®’’ is corrected to read ‘‘CUSTOMFLEX® ARTIFICIALIRIS’’. 8. On page 61306, Table 41—Drugs and Biologicals With Pass-Through Status During CY 2020, is corrected by— a. Removing the following rows: CY 2020 APC Pass-through payment effective date Pass-through payment end date G 9184 01/01/2019 12/31/2021 G 9185 01/01/2019 12/31/2021 b. Adding the following row in alphabetical and numerical order: CY 2019 HCPCS code CY 2020 HCPCS code jbell on DSKJLSW7X2PROD with RULES C9407 and C9408 .......... A9590 Iodine i-131, iobenguane, 1 millicurie. 9. On page 61313, a. Column 1, first full paragraph, in line 4, the words ‘‘first quarter of CY 2019’’ are corrected to read ‘‘fourth quarter of CY 2018’’. b. Column 3, first full paragraph, in lines 5 and 6, the words ‘‘third quarter of CY 2019’’ are corrected to read ‘‘second quarter of CY 2019’’. 10. On page 61320, column 1, first partial paragraph, in lines 1 through line 7, remove the text ‘‘We also are finalizing our proposal to pay non passthrough biosimilars acquired under the 340B Program at the biosimilar’s ASP minus 22.5 percent of the reference product’s ASP, in accordance with section 1833(t)(14)(A)(iii)(II) of the Act.’’ and replace with the text ‘‘We also are finalizing our proposal to pay non passthrough biosimilars acquired under the 340B Program at the biosimilar’s ASP minus 22.5 percent of the biosimilar’s ASP, in accordance with section 1833(t)(14)(A)(iii)(II) of the Act.’’ VerDate Sep<11>2014 16:16 Jan 02, 2020 Jkt 250001 CY 2020 status indicator Long descriptor G 9185 11. On page 61336, column 3, first full paragraph, a. In line 9, ‘‘ARTIFICIALIris®’’ is corrected to read ‘‘CUSTOMFLEX® ARTIFICIALIRIS’’. b. In line 18, ‘‘ARTIFICIALIris®’’ is corrected to read ‘‘CUSTOMFLEX® ARTIFICIALIRIS’’. 12. On page 61337, column 1, in the last two lines of the first partial paragraph, the figure ‘‘$399.6 million’’ is corrected to read ‘‘$425.6 million’’. 13. On page 61381, column 3, first full paragraph, a. In lines 1 and 2, remove the text ‘‘We did not receive any public comments on our proposal.’’ and add the following text: Comment: One commenter requested that CPT code 64624 (Destruction by neurolytic agent, genicular nerve branches, including imaging guidance, when performed) be assigned a payment indicator for CY 2020 of ‘‘G2’’—Non office-based surgical procedure added in CY 2008 or later; payment based on PO 00000 Frm 00021 Fmt 4700 CY 2020 APC Sfmt 4700 Pass-through payment effective date 01/01/2019 Pass-through payment end date 12/31/2021 OPPS relative payment weight. The commenter argued that the RVS Relative Update Committee (RUC) (a committee of volunteer physicians that advise Medicare on the valuation of services paid under the Medicare Physician Fee Schedule) survey responders reported performing genicular nerve ablation in a facility 65 percent of the time and that ‘‘G2’’ is the more accurate payment indicator for the CPT code, similar to CPT code 64625 (Radiofrequency ablation, nerves innervating the sacroiliac joint, with image guidance (that is, gluoroscopy or computed tomography)) which is assigned a payment indicator of ‘‘G2’’ for CY 2020. Response: We appreciate the commenter’s suggestion. While we agree that RUC survey responders reported performing this procedure 35 percent of the time in a physician’s office setting, CPT code 64624 is a new code effective Jan 1, 2020. The service is currently reported using CPT code 64640 E:\FR\FM\03JAR1.SGM 03JAR1 228 Federal Register / Vol. 85, No. 2 / Friday, January 3, 2020 / Rules and Regulations (Destruction by neurolytic agent; other peripheral nerve or branch). When we looked at the previous procedure codes CPT 77002 and 64640, we found that the volume would surpass the 50 percent office-based threshold. Additionally, CPT code 64640 is assigned an office-based payment indicator for CY 2020 of ‘‘P3’’—Officebased surgical procedure added to ASC list in CY 2008 or later with MPFS nonfacility PE RVUs; payment based on MPFS nonfacility PE RVUs. Therefore, we are finalizing our proposal to assign CPT code 64624 a temporary officebased designation of ‘‘P3’’ for CY 2020. b. In line 2, delete the word ‘‘Therefore’’. c. In line 3, capitalize the word ‘‘we’’. 14. On page 61384, column 3, first full paragraph, a. In line 6, the figure ‘‘$8,383.12’’ is corrected to read ‘‘$8,384.05’’. b. In line 23, the figure ‘‘$8,383.12’’ is corrected to read ‘‘$8,384.05’’. 15. On page 61388, column 1, third full paragraph, a. In line 23, the figure ‘‘$8,609.17’’ is corrected to read $8,609.82’’ and the ASC coinsurance from ‘‘$1,721.83’’ to ‘‘$1,721.96’’. b. In line 25, the figure ‘‘$11,899.39’’ is corrected to read ‘‘$11,900.71’’. 16. On page 61409, column 2, a. End of the second full paragraph, after the words, ‘‘. . . determine the CY 2020 ASC payment rates.’’ add the following sentences: ‘‘The ASCQR Program affected payment rates beginning in CY 2014 and, under this program, there is a 2.0 percentage point reduction to the update factor for ASCs that fail to meet the ASCQR Program requirements. We are finalizing our proposal to utilize the hospital inpatient market basket update of 3.0 percent reduced by 2.0 percentage points for ASCs that do not meet the quality 20. On page 61450, ‘‘Table 38— Proposed List of Outpatient Services That Would Require Prior Authorization’’ is corrected to read ‘‘Table 64—Proposed List of Outpatient Services That Would Require Prior Authorization’’. 21. On page 61456, third column, second full paragraph, line 11, ‘‘Table 64’’ is corrected to read ‘‘Table 65’’. 22. On page 61457, a. The table titled ‘‘Table 64— Proposed List of Outpatient Services That Would Require Prior Authorization’’ is corrected to read: ‘‘Table 65—Final List of Outpatient Services That Require Prior Authorization.’’ b. In numerical order, add rows for botulinum toxin injection codes J0586 and J0588 after the rows for codes J0585 and J0587, respectively, as follows: reporting requirements and then subtract the 0.4 percentage point MFP adjustment. Therefore, we are applying a 0.6 percent MFP-adjusted hospital market basket update factor to the CY 2019 ASC conversion factor for ASCs that do not meet the quality reporting requirements. b. After the second full paragraph and before the section titled ‘‘3. Display of Final CY 2020 ASC Payment Rates,’’ add the following paragraph: ‘‘For CY 2020, we are adjusting the CY 2019 ASC conversion factor ($46.532) by the proposed wage index budget neutrality factor of 1.0001 in addition to the MFP-adjusted hospital market basket update factor of 2.6 percent discussed above, which results in a final CY 2020 ASC conversion factor of $47.747 for ASCs meeting the quality reporting requirements. For ASCs not meeting the quality reporting requirements, we are adjusting the CY 2019 ASC conversion factor ($46.532) by the proposed wage index budget neutrality factor of 1.0001 in addition to the quality reporting/MFP-adjusted hospital market basket update factor of 0.6 percent, which results in a final CY 2020 ASC conversion factor of $46.816.’’ 17. On page 61420, column 1, second full paragraph, a. In line 4, the figure ‘‘80.784’’ is corrected to read ‘‘80.793’’. b. In line 8, the figure ‘‘79.250’’ is corrected to read ‘‘79.257’’. 18. On page 61448, a. Column 2, first full paragraph, in line 4, ‘‘Table 38’’ is corrected to read ‘‘Table 64’’. b. Column 3, second full paragraph, (1) In line 3, ‘‘(Table 38)’’ is corrected to read ‘‘(Table 64)’’. (2) In line 17, ‘‘Table 38’’ is corrected to read ‘‘Table 64’’. 19. On page 61449, column 3, last paragraph, in line 1, ‘‘Table 38’’ is corrected to read ‘‘Table 64’’. Code (ii) Botulinum toxin injection J0586 .......... J0588 .......... Injection, abobotulinumtoxina. Injection, incobotulinumtoxin a. 23. On pages 61458 through 61463, remove the section titled, ‘‘4. Summary of Public Comments and Responses to Comments on the Proposed Rule’’ in its entirety. 24. On page 61464, remove Table 65 in its entirety. 25. On page 61474, a. Column 2, first full paragraph, in line 19, the figure ‘‘$80.784’’ is corrected to read ‘‘$80.793’’. b. Column 3, second full paragraph, in line 6, the figure ‘‘1.5’’ is corrected to read ‘‘1.6’’. 26. On page 61475 through 61478, Table 68—Estimated Impact of the CY 2020 Changes for the Hospital Outpatient Prospective Payment System, is corrected to read as follows: jbell on DSKJLSW7X2PROD with RULES TABLE 68—ESTIMATED IMPACT OF THE CY 2020 CHANGES FOR THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM ALL PROVIDERS * .................................................................... ALL HOSPITALS (excludes hospitals held harmless and CMHCs) ................................................................................. URBAN HOSPITALS ................................................................ LARGE URBAN (GT 1 MILL.) ........................................... OTHER URBAN (LE 1 MILL.) ........................................... RURAL HOSPITALS ................................................................. SOLE COMMUNITY .......................................................... OTHER RURAL ................................................................. BEDS (URBAN) ........................................................................ 0–99 BEDS ........................................................................ 100–199 BEDS .................................................................. VerDate Sep<11>2014 16:16 Jan 02, 2020 Jkt 250001 PO 00000 Number of hospitals APC recalibration (all changes) New wage index and provider adjustments (1) (2) (3) All budget neutral changes (combined cols 2 and 3) with market basket update Existing off-campus provider based department visits policy All changes (4) (5) (6) 3,732 0.0 0.1 2.7 ¥0.6 1.3 3,625 2,849 1,471 1,378 776 365 411 ........................ 973 822 0.0 0.1 0.0 0.1 ¥0.5 ¥0.5 ¥0.6 ........................ 0.4 ¥0.1 0.1 0.0 ¥0.2 0.2 0.7 0.7 0.7 ........................ 0.1 0.0 2.7 2.7 2.4 3.0 2.8 2.8 2.7 ........................ 3.2 2.5 ¥0.6 ¥0.5 ¥0.4 ¥0.6 ¥0.6 ¥0.7 ¥0.5 ........................ ¥0.4 ¥0.5 1.3 1.3 1.2 1.4 1.1 0.9 1.3 ........................ 1.9 1.2 Frm 00022 Fmt 4700 Sfmt 4700 E:\FR\FM\03JAR1.SGM 03JAR1 229 Federal Register / Vol. 85, No. 2 / Friday, January 3, 2020 / Rules and Regulations TABLE 68—ESTIMATED IMPACT OF THE CY 2020 CHANGES FOR THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM—Continued 200–299 BEDS .................................................................. 300–499 BEDS .................................................................. 500+ BEDS ........................................................................ BEDS (RURAL) ......................................................................... 0–49 BEDS ........................................................................ 50–100 BEDS .................................................................... 101–149 BEDS .................................................................. 150–199 BEDS .................................................................. 200+ BEDS ........................................................................ REGION (URBAN) .................................................................... NEW ENGLAND ................................................................ MIDDLE ATLANTIC ........................................................... SOUTH ATLANTIC ............................................................ EAST NORTH CENT ......................................................... EAST SOUTH CENT ......................................................... WEST NORTH CENT ........................................................ WEST SOUTH CENT ........................................................ MOUNTAIN ........................................................................ PACIFIC ............................................................................. PUERTO RICO .................................................................. REGION (RURAL) .................................................................... NEW ENGLAND ................................................................ MIDDLE ATLANTIC ........................................................... SOUTH ATLANTIC ............................................................ EAST NORTH CENT ......................................................... EAST SOUTH CENT ......................................................... WEST NORTH CENT ........................................................ WEST SOUTH CENT ........................................................ MOUNTAIN ........................................................................ PACIFIC ............................................................................. TEACHING STATUS ................................................................ NON-TEACHING ............................................................... MINOR ............................................................................... MAJOR ............................................................................... DSH PATIENT PERCENT ........................................................ 0 ......................................................................................... GT 0–0.10 .......................................................................... 0.10–0.16 ........................................................................... 0.16–0.23 ........................................................................... 0.23–0.35 ........................................................................... GE 0.35 .............................................................................. DSH NOT AVAILABLE ** ................................................... URBAN TEACHING/DSH ......................................................... TEACHING & DSH ............................................................ NO TEACHING/DSH ......................................................... NO TEACHING/NO DSH ................................................... DSH NOT AVAILABLE2 .................................................... TYPE OF OWNERSHIP ........................................................... VOLUNTARY ..................................................................... PROPRIETARY ................................................................. GOVERNMENT ................................................................. CMHCs ...................................................................................... All budget neutral changes (combined cols 2 and 3) with market basket update Existing off-campus provider based department visits policy All changes Number of hospitals APC recalibration (all changes) New wage index and provider adjustments (1) (2) (3) (4) (5) (6) 444 390 220 ........................ 342 267 87 43 37 ........................ 134 335 461 456 165 179 491 208 373 47 ........................ 21 53 119 120 150 96 145 49 23 ........................ 2,469 781 375 ........................ 13 274 256 558 1,117 931 476 ........................ 1,038 1,344 12 455 ........................ 1,981 1,182 462 41 0.0 0.1 0.1 ........................ ¥0.9 ¥0.6 ¥0.6 ¥0.2 ¥0.1 ........................ ¥0.3 0.0 0.1 ¥0.1 0.2 0.3 0.4 0.0 0.3 1.0 ........................ ¥0.5 ¥0.6 ¥0.8 ¥0.5 ¥0.5 ¥0.3 ¥0.6 ¥0.3 ¥0.6 ........................ ¥0.1 0.1 0.0 ........................ 2.5 1.0 0.0 0.1 ¥0.1 ¥0.1 2.0 ........................ 0.1 0.1 2.5 1.8 ........................ 0.0 0.4 ¥0.1 1.4 0.0 0.3 ¥0.1 ........................ 1.2 0.9 0.9 0.8 ¥0.5 ........................ ¥2.0 0.1 ¥0.1 ¥0.2 0.8 1.2 0.2 ¥0.2 0.5 17.8 ........................ ¥1.3 ¥0.1 0.9 ¥0.2 1.2 1.5 1.1 2.4 0.7 ........................ 0.3 0.2 ¥0.2 ........................ 0.5 0.0 0.0 0.0 0.2 0.1 0.4 ........................ 0.0 0.1 0.5 0.2 ........................ 0.1 0.2 0.3 0.5 2.6 3.0 2.6 ........................ 2.9 2.9 2.9 3.3 2.0 ........................ 0.3 2.7 2.5 2.3 3.6 4.1 3.2 2.4 3.4 22.0 ........................ 0.7 1.9 2.7 1.9 3.3 3.9 3.0 4.8 2.7 ........................ 2.8 2.9 2.4 ........................ 5.6 3.6 2.6 2.7 2.8 2.6 5.1 ........................ 2.7 2.8 5.7 4.7 ........................ 2.6 3.2 2.8 4.6 ¥0.5 ¥0.5 ¥0.7 ........................ ¥0.3 ¥0.7 ¥0.6 ¥0.9 ¥0.6 ........................ ¥1.0 ¥0.4 ¥0.5 ¥0.7 ¥0.2 ¥0.6 ¥0.5 ¥0.5 ¥0.5 0.0 ........................ ¥1.9 ¥1.0 ¥0.2 ¥0.7 ¥0.2 ¥0.8 ¥0.3 ¥0.3 ¥1.0 ........................ ¥0.4 ¥0.6 ¥0.8 ........................ 0.0 ¥0.3 ¥0.5 ¥0.4 ¥0.6 ¥0.6 ¥0.4 ........................ ¥0.7 ¥0.3 0.0 ¥0.3 ........................ ¥0.6 ¥0.2 ¥0.7 0.0 1.3 1.5 1.1 ........................ 1.5 0.9 1.2 1.3 0.7 ........................ ¥1.3 1.5 1.3 0.8 2.6 1.7 1.9 0.7 2.1 20.9 ........................ ¥1.8 0.2 1.7 0.5 2.3 1.1 2.0 1.1 1.0 ........................ 1.6 1.3 0.9 ........................ 4.4 2.3 1.2 1.4 1.2 1.2 4.2 ........................ 1.1 1.6 4.8 4.0 ........................ 1.1 2.1 1.3 3.7 jbell on DSKJLSW7X2PROD with RULES Column (1) shows total hospitals and/or CMHCs. Column (2) includes all final CY 2020 OPPS policies and compares those to the CY 2019 OPPS. Column (3) shows the budget neutral impact of updating the wage index by applying the FY 2020 hospital inpatient wage index and the non-budget neutral frontier adjustment. The rural SCH adjustment continues our current policy of 7.1 percent so the budget neutrality factor is 1. The budget neutrality adjustment for the cancer hospital adjustment is 0.9999 because in CY 2020 the target payment-to-cost ratio is higher than the CY 2019 PCR target (0.89) Column (4) shows the impact of all budget neutrality adjustments and the addition of the 2.6 percent OPD fee schedule update factor (hospital market basket percentage increase of 3.0 percent reduced by 0.4 percentage point for the productivity adjustment). Column (5) shows the additional impact of the policy to pay clinic visits for nonexcepted providers under the otherwise applicable payment system. We note that we are completing the 2-year phase-in so the amount of the reduction will be the full difference in CY 2020 (or payment at 40 percent of the OPPS rate). Column (6) shows the additional adjustments to the conversion factor resulting from a change in the pass-through estimate, and adding estimated outlier payments. Note that previous years included the frontier adjustment in this column, but we have moved the frontier adjustment to Column 3 in this table. These 3,732 providers include children and cancer hospitals, which are held harmless to pre-BBA amounts, and CMHCs. ** Complete DSH numbers are not available for providers that are not paid under IPPS, including rehabilitation, psychiatric, and long-term care hospitals. VerDate Sep<11>2014 16:16 Jan 02, 2020 Jkt 250001 PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 E:\FR\FM\03JAR1.SGM 03JAR1 230 Federal Register / Vol. 85, No. 2 / Friday, January 3, 2020 / Rules and Regulations 27. On page 61478, column 3, first partial paragraph, in line 8, the figure ‘‘4.5’’ is corrected to read ‘‘4.6’’. Dated: December 19, 2019. Ann C. Agnew, Executive Secretary to the Department, Department of Health and Human Services. [FR Doc. 2019–28364 Filed 12–30–19; 4:15 pm] BILLING CODE 4120–01–P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 54 [WC Docket No. 18–89, PS Docket Nos. 19– 351, 19–352; FCC 19–121; FRS 16315] Protecting Against National Security Threats to the Communications Supply Chain Through FCC Programs; Huawei Designation; ZTE Designation Federal Communications Commission. ACTION: Final rule. AGENCY: In this document, the Federal Communications Commission (Commission) adopts a rule that prospectively prohibits the use of Universal Service Fund (USF or the Fund) funds to purchase or obtain any equipment or services produced or provided by a covered company posing a national security threat to the integrity of communications networks or the communications supply chain. In doing so, the Report and Order initially designates Huawei Technologies Company (Huawei) and ZTE Corporation (ZTE) as covered companies for purposes of the rule and establish a process for designating additional covered companies in the future. To support the Commission’s future efforts to protect the communications supply chain, the Information Collection Order (Order) directs the Wireline Competition Bureau (WCB) and Office of Economics and Analytics (OEA), in coordination with USAC, to conduct an information collection to determine the extent to which potentially prohibited equipment exists in current networks and the costs associated with removing such equipment and replacing it with equivalent equipment. DATES: Effective January 3, 2020. FOR FURTHER INFORMATION CONTACT: For further information, please contact John Visclosky, Competition Policy Division, Wireline Competition Bureau, at John.Visclosky@fcc.gov. SUPPLEMENTARY INFORMATION: This is a summary of the Commission’s Report and Order and Order in WC Docket No. jbell on DSKJLSW7X2PROD with RULES SUMMARY: VerDate Sep<11>2014 16:16 Jan 02, 2020 Jkt 250001 18–89 and PS Docket Nos. 19–351 and 19–352, adopted November 22, 2019 and released November 26, 2019. The full text of this document is available for public inspection during regular business hours in the FCC Reference Information Center, Portals II, 445 12th Street SW, Room CY–A257, Washington, DC 20554 or at the following internet address: https:// docs.fcc.gov/public/attachments/FCC19-121A1.pdf . The Further Notice of Proposed Rulemaking that was adopted concurrently with this Report and Order and Order is published elsewhere in the Federal Register. Comments on the initial designations of Huawei and ZTE as covered companies are due on or before February 3, 2020. Pursuant to sections 1.415 and 1.419 of the Commission’s rules, 47 CFR 1.415, 1.419, interested parties may file comments on or before the dates indicated on the first page of this document. Comments may be filed using the Commission’s Electronic Comment Filing System (ECFS). See Electronic Filing of Documents in Rulemaking Proceedings, 63 FR 24121 (1998). Interested parties may file comments, identified by PS Docket No. 19–351 for the Huawei final designation proceeding or PS Docket No. 19–352 for the ZTE final designation proceeding, by any of the following methods: D Electronic Filers: Comments may be filed electronically using the internet by accessing the ECFS: https:// www.fcc.gov/ecfs/. D Paper Filers: Parties who choose to file by paper must file an original and one copy of each filing. If more than one docket or rulemaking number appears in the caption of this proceeding, filers must submit two additional copies for each additional docket or rulemaking number. Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission’s Secretary, Office of the Secretary, Federal Communications Commission. • All hand-delivered or messengerdelivered paper filings for the Commission’s Secretary must be delivered to FCC Headquarters at 445 12th St. SW, Room TW–A325, Washington, DC 20554. The filing hours are 8:00 a.m. to 7:00 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes and boxes must be disposed of before entering the building. • Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9050 PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 Junction Drive, Annapolis Junction, MD 20701. • U.S. Postal Service first-class, Express, and Priority mail must be addressed to 445 12th Street SW, Washington, DC 20554. People with Disabilities: To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an email to fcc504@fcc.gov or call the Consumer & Governmental Affairs Bureau at 202–418–0530 (voice), 202– 418–0432 (tty). Comments and reply comments must include a short and concise summary of the substantive arguments raised in the pleading. Comments and reply comments must also comply with section 1.49 and all other applicable sections of the Commission’s rules. The Commission directs all interested parties to include the name of the filing party and the date of the filing on each page of their comments and reply comments. All parties are encouraged to use a table of contents, regardless of the length of their submission. I. Introduction 1. In today’s increasingly connected world, safeguarding the security and integrity of America’s communications infrastructure has never been more important. Broadband networks have transformed virtually every aspect of the U.S. economy, enabling the voice, data, and internet connectivity that fuels all other critical industry sectors— including our transportation systems, electrical grid, financial markets, and emergency services. And with the advent of 5G—the next generation of wireless technologies, which is expected to deliver exponential increases in speed, responsiveness, and capacity—the crucial and transformative role of communications networks in our economy and society will only increase. It is therefore vital that the Commission protects these networks from national security threats. 2. The Commission has taken a number of targeted steps to protect the nation’s communications networks from potential security threats. In this document, the Commission builds on these efforts, consistent with concurrent Congressional and Executive Branch actions, and ensure that the public funds used in the Commission’s USF funds are not used in a way that undermines or poses a threat to our national security. Specifically, in the Report and Order, the Commission adopts a rule that prospectively prohibits the use of USF funds to purchase or obtain any equipment or services produced or provided by a E:\FR\FM\03JAR1.SGM 03JAR1

Agencies

[Federal Register Volume 85, Number 2 (Friday, January 3, 2020)]
[Rules and Regulations]
[Pages 224-230]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-28364]


=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 405, 410, 412, 414, 416, 419, and 486

[CMS-1717-CN]
RIN 0938-AT74


Medicare Program: Changes to Hospital Outpatient Prospective 
Payment and Ambulatory Surgical Center Payment Systems and Quality 
Reporting Programs; Revisions of Organ Procurement Organizations 
Conditions of Coverage; Prior Authorization Process and Requirements 
for Certain Covered Outpatient Department Services; Potential Changes 
to the Laboratory Date of Service Policy; Changes to Grandfathered 
Children's Hospitals-Within-Hospitals; Notice of Closure of Two 
Teaching Hospitals and Opportunity To Apply for Available Slots; 
Correction

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

ACTION: Final rule; correction.

-----------------------------------------------------------------------

SUMMARY: This document corrects technical errors that appeared in the 
final rule with comment period that appeared in the November 12, 2019, 
issue of the Federal Register titled ``Changes to Hospital Outpatient 
Prospective Payment and Ambulatory Surgical Center Payment Systems and 
Quality Reporting Programs; Revisions of Organ Procurement 
Organizations Conditions of Coverage; Prior Authorization Process and 
Requirements for Certain Covered Outpatient Department Services; 
Potential Changes to the Laboratory Date of Service Policy; Changes to 
Grandfathered Children's Hospitals-Within-Hospitals; Notice of Closure 
of Two Teaching Hospitals and Opportunity to Apply for Available 
Slots.''

DATES: 
    Effective date: This correcting document is effective January 1, 
2020.
    Applicability date: The corrections in this correcting document are 
applicable on and after January 1, 2020.

FOR FURTHER INFORMATION CONTACT: Elise Barringer via email 
[email protected] or at (410) 786-9222.

SUPPLEMENTARY INFORMATION: 

I. Background

    In FR Doc. 2019-24138 of November 12, 2019 (84 FR 61142), there 
were a number of technical and typographical errors that are identified 
and corrected by the Correction of Errors section below. The 
corrections in this correction document are effective as if they had 
been included in the document that appeared in the November 12, 2019 
issue of the Federal Register. Accordingly, the corrections are 
effective January 1, 2020.

II. Summary of Errors

A. Summary of Errors in the Preamble

1. Hospital Outpatient Prospective Payment System (OPPS) Corrections
    On page 61162, we inadvertently omitted a discussion of the re-
establishment of Comprehensive-Ambulatory Payment Classification (C-
APC) 5495 (Level 5 Intraocular Procedures) in the description of 
additional C-APCs that are finalized for calendar year (CY) 2020. 
Therefore, we are correcting the final rule with comment period to add 
this description.
    On page 61182, we are correcting the standard wage index conversion 
factor budget neutrality adjustment from 0.9990 to 0.9991, which also 
results in the overall wage index budget neutrality factor changing 
from 0.9981 to 0.9982. This correction is necessary because some of the 
CY 2020 wage indexes used for calculating budget neutrality were based 
on the incorrect assignment of a rural wage index rather than the rural 
floor. We note that this affected both the conversion factor, which 
changes from $80.784 to $80.793, as well as all CY 2020 OPPS payment 
rates included in the final rule with comment period that are based on 
that OPPS conversion factor. Therefore, on page 61420, we are 
correcting the full and reduced conversion factors based on the 
previously described change to the standard wage index budget 
neutrality adjustment.
    This change in the OPPS conversion factor and payments also 
slightly affects the OPPS impact table, with relative increases and 
decreases based on assignment of the correct wage index and the 
corresponding increase in the OPPS conversion factor. As a result, on 
pages 61474 through 61478, we are correcting the impact table and 
accompanying preamble text based on the corrected payment rates, which 
are being updated in this correction notice. We note that there was 
also an error in the impact file, in which wage indexes that did not 
include the 5 percent cap on wage index decreases relative to 2019 (as 
described in the CY 2020 OPPS final rule with comment period (84 FR 
61184 through 61188)) were incorrectly displayed as being the final CY 
2020 wage indexes. This correction notice corrects these wage indexes 
in a revised impact file accompanying the correction notice.
    On page 61194, we are correcting the reporting ratio. On page 
61195, we are correcting the CY 2020 example of the supporting 
calculations for both the full and reduced national unadjusted payment 
rates that will apply to certain outpatient items and services 
performed by hospitals that meet and that fail to meet the Hospital 
Outpatient Quality Reporting (OQR) Program requirements. On page 61196, 
we are correcting the beneficiary copayment amount calculated for APC 
5071 and the national unadjusted payment rate for APC 5071. We also are 
correcting the reporting ratio for hospitals that failed to meet 
hospital OQR program requirements. These corrections are necessary 
because of the correction to the wage index budget neutrality 
adjustment and the corresponding change to the OPPS conversion factor.
    On page 61184, we are correcting the preamble language that 
incorrectly states the difference between pass-through spending in 2019 
and pass-through spending in 2020 as being a difference of 0.88 
percentage points. Instead, the difference in pass-through spending in 
2019 and 2020 is 0.74 percentage point, which is the difference between 
the 0.14 percent of total 2019 OPPS spending for pass-through drugs, 
biologicals, and devices and 0.88 percent of total 2020 OPPS spending 
for pass-through drugs, biologicals, and devices. We note that this 
inaccuracy was limited to the preamble language, and did not affect the 
calculated CY 2020 OPPS payment rates included elsewhere in the final 
rule with comment period.
    On pages 61296 and 61336, we incorrectly referred to the 
CUSTOMFLEX[supreg] ARTIFICIALIRIS as ARTIFICIALIris[supreg]. We are 
correcting the final rule with comment period to refer to the device by 
the correct name: CUSTOMFLEX[supreg] ARTIFICIALIRIS.

[[Page 225]]

    On page 61306, we are correcting Table 41, ``Drugs and Biologicals 
with Pass-Through Payment Status during CY 2020''. We are removing 
records for HCPCS codes C9407 (Iodine i-131 iobenguane, diagnostic, 1 
millicurie) and C9408 (Iodine i-131 iobenguane, therapeutic, 1 
millicurie). We are adding a record for HCPCS code A9590 (Iodine i-131, 
iobenguane, 1 millicurie). This change was made because HCPCS codes 
C9407 and C9408 will no longer be active as of December 31, 2019. Both 
of these codes are being replaced by HCPCS code A9590. In the final 
rule, CMS mistakenly left the records for C9407 and C9408 in Table 41 
and did not include the record for A9590.
    On page 61313, we incorrectly stated that ASP data from the first 
quarter of CY 2019 was used to calculate payment rates in the CY 2020 
proposed rule. We are correcting the final rule with comment period to 
refer to the data that was used to calculate payment rates in the CY 
2020 proposed rule: ASP data from the fourth quarter of 2018.
    On page 61313, we incorrectly stated that ASP data from the third 
quarter of CY 2019 were used to calculate payment rates in the CY 2020 
final rule with comment period. We are correcting the final rule with 
comment period to refer to the data that was used to calculate payment 
rates in the CY 2020 final rule with comment period: ASP data from the 
second quarter of CY 2019.
    On page 61320, we are correcting an incorrect description of the 
final CY 2020 policy regarding the payment of non pass-through 
biosimilars acquired under the 340B Program. We stated that we were 
finalizing our proposal, which was to continue to pay non pass-through 
biosimilars acquired under the 340B Program at the biosimilar's ASP 
minus 22.5 percent of the biosimilar's ASP, not minus 22.5 percent of 
the reference product's ASP.
    On page 61337, we are correcting our estimate of the cost of drugs 
and biologicals recently made eligible for pass-through payment and 
continuing on pass-through payment status for at least one quarter in 
CY 2020. The cost estimate was misstated in the preamble text of the 
final rule. The correct estimated cost is $425.6 million, not $339.6 
million.
    On pages 61448 through 61450, we incorrectly labeled and referenced 
the table ``Proposed List of Outpatient Services That Would Require 
Prior Authorization'' as Table 38. We are correcting the document to 
use the correct number, which is Table 64.
    On pages 61456 and 61457, we incorrectly labeled and referenced the 
table as ``Table 64--Proposed List of Outpatient Services That Would 
Require Prior Authorization.'' We are correcting the document to use 
the correct number, which is Table 65, as well as the correct title 
which states ``Final'' rather than ``Proposed'' and removes the word 
``Would''. The corrected table reads: ``Table 65--Final List of 
Outpatient Services That Require Prior Authorization.'' We also 
inadvertently omitted two additional botulinum toxin injection codes, 
J0586 and J0588, as noted on page 61456. Therefore, we are adding these 
codes to Table 65--Final List of Outpatient Services That Require Prior 
Authorization.
    On pages 61458 through 61463, we inadvertently included an earlier 
iteration of the section titled ``Summary of the Public Comments and 
Responses to Comments on the Proposed Rule''. We are removing this 
language.
    On page 61464, we erroneously included Table 65, which is identical 
to the Table 38, which is corrected to be numbered correctly as Table 
64 above. We are removing the table.
2. Ambulatory Surgical Center (ASC) Payment System Corrections
    On page 61381, we inadvertently omitted a comment and response 
regarding the temporary office-based designation of CPT code 64624. We 
are correcting the document to include this comment and response.
    On page 61384, as a result of the correction to the OPPS conversion 
factor, we are correcting the ASC device offset amount for CPT code 
22869 from ``$8,383.12'' to ``$8,384.05.''
    On page 61388, as a result of the correction to the OPPS conversion 
factor, we are correcting ASC payment rate for total knee arthroplasty, 
CPT code 27447, from ``$8,609.17'' to ``$8,609.82'', and the ASC 
coinsurance from ``$1,721.83'' to ``$1,721.96''. Additionally, in that 
same sentence, we are correcting the OPPS payment rate for total knee 
arthroplasty from ``$11,899.39'' to ``$11,900.71''.
    On page 61409, we inadvertently omitted a discussion of the final 
ASC conversion factors for ASCs that meet the quality requirements and 
ASCs who failed to meet the quality requirements in the description of 
updated ASC conversion factors for CY 2020. Therefore, we are adding 
this text.

B. Summary of Errors and Corrections to the OPPS and ASC Addenda Posted 
on the CMS Website

1. OPPS Addenda Posted on the CMS Website
    In Addendum B of the CY 2020 OPPS/ASC final rule with comment 
period, HCPCS codes 99487, 99489, and 99490 were incorrectly assigned 
to status indicator ``B'' to indicate that another more appropriate 
code should be reported. However, the HCPCS codes that CMS considered 
more appropriate, HCPCS codes G2059, G2060, and G2057, respectively, 
were not adopted for implementation in CY 2020. Therefore, these codes 
were mistakenly assigned status indicator ``B'' and in Addendum B 
(Final OPPS Payment by HCPCS Code for CY 2020), we corrected the 
following:
     CPT code 99487 (Cmplx chron care w/o pt vsit): We made a 
typographical error in the status indicator and APC assignments. 
Specifically, we are correcting the status indicator from ``B'' to 
``S'', and the APC assignment to APC 5822 (Level 2 Health and Behavior 
Services).
     CPT code 99489 (Cmplx chron care addl 30 min): We made a 
typographical error in the status indicator assignment. Specifically, 
we are correcting the status indicator from ``B'' to ``N''.
     CPT code 99490 (Chron care mgmt srvc 20 min): We made a 
typographical error in the status indicator and APC assignments. 
Specifically, we are correcting the status indicator from ``B'' to 
``S'', and the APC assignment to APC 5822 (Level 2 Health and Behavior 
Services).
    In Addendum C (Final HCPCS Codes Payable Under the 2020 OPPS by 
APC), we corrected the following:
     CPT code 99487 (Cmplx chron care w/o pt vsit) was added to 
APC 5822 (Level 2 Health and Behavior Services).
     CPT code 99490 (Chron care mgmt srvc 20 min) was added to 
APC 5822 (Level 2 Health and Behavior Services).
    In Addendum P in the spreadsheet in the tab titled ``2020 FR Device 
Intensive List,'' we inadvertently included CPT code 86891 (Autologous 
blood op salvage) in the list. HCPCS 86891 was not proposed as a 
device-intensive procedure for CY 2020. It is appropriate to remove 
HCPCS 86891 from the device-intensive list because it is a lab code for 
``processing and storage of blood unit or component'' and is not 
reported with a device code. We have removed this procedure from the 
list as this procedure does not meet the criteria for device-intensive 
status.
    To view the corrected CY 2020 OPPS status indicators, APC 
assignments, relative weights, payment rates, copayment rates, device-
intensive status, and short descriptors for Addendum A, B, C, and P 
that resulted from the technical corrections described in this 
correcting document, we refer readers to the Addenda and supporting 
files that are posted on the CMS website

[[Page 226]]

at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/. Select ``CMS-1717-CN'' from the list 
of regulations. All corrected Addenda for this correcting document are 
contained in the zipped folder titled ``2020 OPPS Final Rule Addenda'' 
at the bottom of the page for CMS-1717-CN.
2. ASC Payment System Addenda Posted on the CMS Website
    The ASC device intensive methodology calculated estimated device 
cost based on OPPS payment rates. As a result of the correction to the 
OPPS conversion factor, we corrected the payment rates for device-
intensive surgical procedures in Addendum AA. In addition, we corrected 
the following in Addendum BB:
     CPT code 78431: Updated the payment rate from $1,137.28 to 
$1,137.15.
     CPT code 78432: Updated the payment rate from $1,389.95 to 
$1,389.79.
     CPT code 78433: Updated the payment rate from $1,389.95 to 
$1,389.79.
     HCPCS code J7331: Added to Addendum BB with a payment rate 
of $6.13.
     HCPCS code J7332: Added to Addendum BB with a payment rate 
of $25.18.
    HCPCS codes J7331 and J7332 were listed in the OPPS Addendum B of 
the CY 2020 OPPS/ASC final rule but were inadvertently omitted from ASC 
Addendum AA. Since pricing information was not available at the time 
the final rule was developed, both HCPCS codes received the payment 
indicator Y5 (Nonsurgical procedure/item not valid for Medicare 
purposes because of coverage, regulation and/or statute; no payment 
made) and were mistakenly omitted from the addendum. We are correcting 
this omission now with updated pricing information. These codes have 
been flagged with comment indicator N1 in Addendum BB of the CY 2020 
OPPS/ASC correction notice to indicate that we have assigned the codes 
an interim ASC payment indicator of K2 for CY 2020. We intend to invite 
public comments in the CY 2021 OPPS/ASC proposed rule on the interim 
ASC payment indicator for these codes that we intend to finalize in the 
CY 2021 OPPS/ASC final rule with comment period.
    To view the corrected final CY 2020 ASC payment indicators, payment 
weights, payment rates, and multiple procedure discounting indicator 
for Addendum AA and BB that resulted from these technical corrections, 
we refer readers to the Addenda and supporting files on the CMS website 
at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ASCPayment/ASC-Regulations-and-Notices.html. Select ``CMS-1717-CN'' 
from the list of regulations. All corrected ASC addenda for this 
correcting document are contained in the zipped folder entitled 
``Addendum AA, BB, DD1, DD2, and EE'' at the bottom of the page for 
CMS-1717-CN.

III. Waiver of Proposed Rulemaking, 60-Day Comment Period, and Delay in 
Effective Date

    Under 5 U.S.C. 553(b) of the Administrative Procedure Act (APA), 
the agency is required to publish a notice of the proposed rulemaking 
in the Federal Register before the provisions of a rule take effect. 
Similarly, section 1871(b)(1) of the Act requires the Secretary to 
provide for notice of the proposed rulemaking in the Federal Register 
and provide a period of not less than 60 days for public comment. In 
addition, section 553(d) of the APA, and section 1871(e)(1)(B)(i) of 
the Act mandate a 30-day delay in effective date after issuance or 
publication of a rule. Sections 553(b)(B) and 553(d)(3) of the APA 
provide for exceptions from the notice and comment and delay in 
effective date APA requirements; in cases in which these exceptions 
apply, section 1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the Act provide 
exceptions from the notice and 60-day comment period and delay in 
effective date requirements of the Act as well. Section 553(b)(B) of 
the APA and section 1871(b)(2)(C) of the Act authorize an agency to 
dispense with normal rulemaking requirements for good cause if the 
agency makes a finding that the notice and comment rulemaking process 
are impracticable, unnecessary, or contrary to the public interest. In 
addition, both section 553(d)(3) of the APA and section 
1871(e)(1)(B)(ii) of the Act allow the agency to avoid the 30-day delay 
in effective date where such delay is contrary to the public interest 
and agency includes a statement of support.
    We believe that this correcting document does not constitute a rule 
that would be subject to the notice and comment or delayed effective 
date requirements. This document corrects technical and typographic 
errors in the preamble, addenda, payment rates, and tables included or 
referenced in the CY 2020 OPPS/ASC final rule with comment period but 
does not make substantive changes to the policies or payment 
methodologies that were adopted in the final rule with comment period. 
As a result, this correcting document are intended to ensure that the 
information in the CY 2020 OPPS/ASC final rule with comment period 
accurately reflects the policies adopted in that document.
    In addition, even if this were a rulemaking to which the notice and 
comment procedures and delayed effective date requirements applied, we 
find that there is good cause to waive such requirements. Undertaking 
further notice and comment procedures to incorporate the corrections in 
this document into the final rule with comment period or delaying the 
effective date would be contrary to the public interest because it is 
in the public's interest for providers to receive appropriate payments 
in as timely a manner as possible, and to ensure that the CY 2020 OPPS/
ASC final rule with comment period accurately reflects our 
methodologies and policies as of the date they take effect and are 
applicable.
    Furthermore, such procedures would be unnecessary, as we are not 
altering our payment methodologies or policies, but rather, we are 
simply correctly implementing the policies that we previously proposed, 
received comment on, and subsequently finalized. This correcting 
document is intended solely to ensure that the CY 2020 OPPS/ASC final 
rule with comment period accurately reflects these payment 
methodologies and policies. For these reasons, we believe we have good 
cause to waive the notice and comment and effective date requirements.

IV. Correction of Errors

    In FR Doc. 2019-24138 of November 12, 2019 (84 FR 61142), make the 
following corrections:
    1. On page 61162, column 1, first partial paragraph, in line 15, 
add the following text: ``As discussed in section III.D.16 of this 
final rule with comment period, we are also re-establishing C-APC 5495 
(Level 5 Intraocular Procedures) for CY 2020 based on need for a Level 
5 for the Intraocular Procedures C-APC clinical family.''
    2. On page 61182, column 3, second partial paragraph,
    a. In line 14, the figure ``0.9981'' is corrected to read 
``0.9982''.
    b. In line 16, the figure ``0.9990'' is corrected to read 
``0.9991''.
    3. On page 61184, column 1, second full paragraph,
    a. In line 9, the figure ``$80.784'' is corrected to read 
``$80.793''.
    b. In line 17, the figure ``0.9981'' is corrected to read 
``0.9982''.
    c. In line 18, the figure ``0.88 percentage point'' is corrected to 
read ``0.74 percentage point''.

[[Page 227]]

    d. In line 22, the figure ``$80.784'' is corrected to read 
``$80.793''.
    4. On page 61194, column 2, third full paragraph, line 23, the 
figure ``0.980'' is corrected to read ``0.981''.
    5. On page 61195, column 2,
    a. Second full paragraph,
    (1) In line 17, the figure ``$609.94'' is corrected to read 
``$610.01''.
    (2) In line 21, the figure ``$598.35'' is corrected to read 
``$598.42''.
    b. Third full paragraph,
    (1) In line 7, the figure ``$470.84'' is corrected to read 
``$470.91''.
    (2) In line 8, the figure ``$609.94'' is corrected to read 
``$610.01''.
    (3) In line 11, the equation ``$461.90 (.60 * $598.35 * 1.2866)'' 
is corrected to read ``$461.95 (.60 * $598.42 * 1.2866)''.
    (4) In line 14, the equation ``$243.98 (.40 * $609.94)'' is 
corrected to read ``$244.00 (.40 * $610.01)''.
    (5) In line 17, the equation ``$239.34 (.40 * $598.35)'' is 
corrected to read ``$239.37 (.40 * $598.42)''.
    (6) In lines 21 and 22, the equation ``$714.82 ($470.84 + 
$243.98)'' is corrected to read ``$714.91 ($470.91 + $244.00)''.
    (7) In lines 24 and 25, the equation ``$701.24 ($461.90 + 
$239.34)'' is corrected to read ``$701.32 ($461.95 + $239.37)''.
    6. On page 61196, column 3,
    a. First full paragraph, labeled ``Step 1'',
    (1) In line 5, the figure ``$121.99'' is corrected to read 
``$122.01''.
    (2) In line 8, the figure ``$609.94'' is corrected to read 
``$610.01''.
    b. Second to last paragraph, labeled ``Step 4'', in line 5, the 
figure ``0.980'' is corrected to read ``0.981''.
    7. On page 61296, column 3, last paragraph,
    a. In line 5, ``ARTIFICIALIris[supreg]'' is corrected to read 
``CUSTOMFLEX[supreg] ARTIFICIALIRIS''.
    b. In line 7, ``ARTIFICIALIris[supreg]'' is corrected to read 
``CUSTOMFLEX[supreg] ARTIFICIALIRIS''.
    c. In line 12, ``ARTIFICIALIris[supreg]'' is corrected to read 
``CUSTOMFLEX[supreg] ARTIFICIALIRIS''.
    8. On page 61306, Table 41--Drugs and Biologicals With Pass-Through 
Status During CY 2020, is corrected by--
    a. Removing the following rows:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                           Pass-through    Pass-through
      CY 2019 HCPCS code         CY 2020 HCPCS        Long descriptor          CY 2020 status indicator     CY 2020 APC       payment       payment end
                                     code                                                                                 effective date       date
--------------------------------------------------------------------------------------------------------------------------------------------------------
C9407.........................           C9407  Iodine i-131 iobenguane,     G                                      9184      01/01/2019      12/31/2021
                                                 diagnostic, 1 millicurie.
C9408.........................           C9408  Iodine i-131 iobenguane,     G                                      9185      01/01/2019      12/31/2021
                                                 therapeutic, 1 millicurie.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    b. Adding the following row in alphabetical and numerical order:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                           Pass-through    Pass-through
          CY 2019 HCPCS code             CY 2020 HCPCS      Long descriptor           CY 2020 status        CY 2020 APC       payment       payment end
                                             code                                       indicator                         effective date       date
--------------------------------------------------------------------------------------------------------------------------------------------------------
C9407 and C9408.......................           A9590  Iodine i-131,            G                                  9185      01/01/2019      12/31/2021
                                                         iobenguane, 1
                                                         millicurie.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    9. On page 61313,
    a. Column 1, first full paragraph, in line 4, the words ``first 
quarter of CY 2019'' are corrected to read ``fourth quarter of CY 
2018''.
    b. Column 3, first full paragraph, in lines 5 and 6, the words 
``third quarter of CY 2019'' are corrected to read ``second quarter of 
CY 2019''.
    10. On page 61320, column 1, first partial paragraph, in lines 1 
through line 7, remove the text ``We also are finalizing our proposal 
to pay non pass-through biosimilars acquired under the 340B Program at 
the biosimilar's ASP minus 22.5 percent of the reference product's ASP, 
in accordance with section 1833(t)(14)(A)(iii)(II) of the Act.'' and 
replace with the text ``We also are finalizing our proposal to pay non 
pass-through biosimilars acquired under the 340B Program at the 
biosimilar's ASP minus 22.5 percent of the biosimilar's ASP, in 
accordance with section 1833(t)(14)(A)(iii)(II) of the Act.''
    11. On page 61336, column 3, first full paragraph,
    a. In line 9, ``ARTIFICIALIris[supreg]'' is corrected to read 
``CUSTOMFLEX[supreg] ARTIFICIALIRIS''.
    b. In line 18, ``ARTIFICIALIris[supreg]'' is corrected to read 
``CUSTOMFLEX[supreg] ARTIFICIALIRIS''.
    12. On page 61337, column 1, in the last two lines of the first 
partial paragraph, the figure ``$399.6 million'' is corrected to read 
``$425.6 million''.
    13. On page 61381, column 3, first full paragraph,
    a. In lines 1 and 2, remove the text ``We did not receive any 
public comments on our proposal.'' and add the following text:
    Comment: One commenter requested that CPT code 64624 (Destruction 
by neurolytic agent, genicular nerve branches, including imaging 
guidance, when performed) be assigned a payment indicator for CY 2020 
of ``G2''--Non office-based surgical procedure added in CY 2008 or 
later; payment based on OPPS relative payment weight. The commenter 
argued that the RVS Relative Update Committee (RUC) (a committee of 
volunteer physicians that advise Medicare on the valuation of services 
paid under the Medicare Physician Fee Schedule) survey responders 
reported performing genicular nerve ablation in a facility 65 percent 
of the time and that ``G2'' is the more accurate payment indicator for 
the CPT code, similar to CPT code 64625 (Radiofrequency ablation, 
nerves innervating the sacroiliac joint, with image guidance (that is, 
gluoroscopy or computed tomography)) which is assigned a payment 
indicator of ``G2'' for CY 2020.
    Response: We appreciate the commenter's suggestion. While we agree 
that RUC survey responders reported performing this procedure 35 
percent of the time in a physician's office setting, CPT code 64624 is 
a new code effective Jan 1, 2020. The service is currently reported 
using CPT code 64640

[[Page 228]]

(Destruction by neurolytic agent; other peripheral nerve or branch). 
When we looked at the previous procedure codes CPT 77002 and 64640, we 
found that the volume would surpass the 50 percent office-based 
threshold. Additionally, CPT code 64640 is assigned an office-based 
payment indicator for CY 2020 of ``P3''--Office-based surgical 
procedure added to ASC list in CY 2008 or later with MPFS nonfacility 
PE RVUs; payment based on MPFS nonfacility PE RVUs. Therefore, we are 
finalizing our proposal to assign CPT code 64624 a temporary office-
based designation of ``P3'' for CY 2020.
    b. In line 2, delete the word ``Therefore''.
    c. In line 3, capitalize the word ``we''.
    14. On page 61384, column 3, first full paragraph,
    a. In line 6, the figure ``$8,383.12'' is corrected to read 
``$8,384.05''.
    b. In line 23, the figure ``$8,383.12'' is corrected to read 
``$8,384.05''.
    15. On page 61388, column 1, third full paragraph,
    a. In line 23, the figure ``$8,609.17'' is corrected to read 
$8,609.82'' and the ASC coinsurance from ``$1,721.83'' to 
``$1,721.96''.
    b. In line 25, the figure ``$11,899.39'' is corrected to read 
``$11,900.71''.
    16. On page 61409, column 2,
    a. End of the second full paragraph, after the words, ``. . . 
determine the CY 2020 ASC payment rates.'' add the following sentences: 
``The ASCQR Program affected payment rates beginning in CY 2014 and, 
under this program, there is a 2.0 percentage point reduction to the 
update factor for ASCs that fail to meet the ASCQR Program 
requirements. We are finalizing our proposal to utilize the hospital 
inpatient market basket update of 3.0 percent reduced by 2.0 percentage 
points for ASCs that do not meet the quality reporting requirements and 
then subtract the 0.4 percentage point MFP adjustment. Therefore, we 
are applying a 0.6 percent MFP-adjusted hospital market basket update 
factor to the CY 2019 ASC conversion factor for ASCs that do not meet 
the quality reporting requirements.
    b. After the second full paragraph and before the section titled 
``3. Display of Final CY 2020 ASC Payment Rates,'' add the following 
paragraph:
    ``For CY 2020, we are adjusting the CY 2019 ASC conversion factor 
($46.532) by the proposed wage index budget neutrality factor of 1.0001 
in addition to the MFP-adjusted hospital market basket update factor of 
2.6 percent discussed above, which results in a final CY 2020 ASC 
conversion factor of $47.747 for ASCs meeting the quality reporting 
requirements. For ASCs not meeting the quality reporting requirements, 
we are adjusting the CY 2019 ASC conversion factor ($46.532) by the 
proposed wage index budget neutrality factor of 1.0001 in addition to 
the quality reporting/MFP-adjusted hospital market basket update factor 
of 0.6 percent, which results in a final CY 2020 ASC conversion factor 
of $46.816.''
    17. On page 61420, column 1, second full paragraph,
    a. In line 4, the figure ``80.784'' is corrected to read 
``80.793''.
    b. In line 8, the figure ``79.250'' is corrected to read 
``79.257''.
    18. On page 61448,
    a. Column 2, first full paragraph, in line 4, ``Table 38'' is 
corrected to read ``Table 64''.
    b. Column 3, second full paragraph,
    (1) In line 3, ``(Table 38)'' is corrected to read ``(Table 64)''.
    (2) In line 17, ``Table 38'' is corrected to read ``Table 64''.
    19. On page 61449, column 3, last paragraph, in line 1, ``Table 
38'' is corrected to read ``Table 64''.
    20. On page 61450, ``Table 38--Proposed List of Outpatient Services 
That Would Require Prior Authorization'' is corrected to read ``Table 
64--Proposed List of Outpatient Services That Would Require Prior 
Authorization''.
    21. On page 61456, third column, second full paragraph, line 11, 
``Table 64'' is corrected to read ``Table 65''.
    22. On page 61457,
    a. The table titled ``Table 64--Proposed List of Outpatient 
Services That Would Require Prior Authorization'' is corrected to read: 
``Table 65--Final List of Outpatient Services That Require Prior 
Authorization.''
    b. In numerical order, add rows for botulinum toxin injection codes 
J0586 and J0588 after the rows for codes J0585 and J0587, respectively, 
as follows:

------------------------------------------------------------------------
               Code                    (ii) Botulinum toxin injection
------------------------------------------------------------------------
J0586............................  Injection, abobotulinumtoxina.
J0588............................  Injection, incobotulinumtoxin a.
------------------------------------------------------------------------

    23. On pages 61458 through 61463, remove the section titled, ``4. 
Summary of Public Comments and Responses to Comments on the Proposed 
Rule'' in its entirety.
    24. On page 61464, remove Table 65 in its entirety.
    25. On page 61474,
    a. Column 2, first full paragraph, in line 19, the figure 
``$80.784'' is corrected to read ``$80.793''.
    b. Column 3, second full paragraph, in line 6, the figure ``1.5'' 
is corrected to read ``1.6''.
    26. On page 61475 through 61478, Table 68--Estimated Impact of the 
CY 2020 Changes for the Hospital Outpatient Prospective Payment System, 
is corrected to read as follows:

                        Table 68--Estimated Impact of the CY 2020 Changes for the Hospital Outpatient Prospective Payment System
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                            All budget
                                                                                                              neutral     Existing  off-
                                                                                APC          New wage         changes         campus
                                                             Number of     recalibration     index and       (combined       provider       All changes
                                                             hospitals     (all changes)     provider      cols 2 and 3)       based
                                                                                            adjustments     with market     department
                                                                                                           basket update  visits  policy
                                                                     (1)             (2)             (3)             (4)             (5)             (6)
--------------------------------------------------------------------------------------------------------------------------------------------------------
ALL PROVIDERS *.........................................           3,732             0.0             0.1             2.7            -0.6             1.3
ALL HOSPITALS (excludes hospitals held harmless and                3,625             0.0             0.1             2.7            -0.6             1.3
 CMHCs).................................................
URBAN HOSPITALS.........................................           2,849             0.1             0.0             2.7            -0.5             1.3
    LARGE URBAN (GT 1 MILL.)............................           1,471             0.0            -0.2             2.4            -0.4             1.2
    OTHER URBAN (LE 1 MILL.)............................           1,378             0.1             0.2             3.0            -0.6             1.4
RURAL HOSPITALS.........................................             776            -0.5             0.7             2.8            -0.6             1.1
    SOLE COMMUNITY......................................             365            -0.5             0.7             2.8            -0.7             0.9
    OTHER RURAL.........................................             411            -0.6             0.7             2.7            -0.5             1.3
BEDS (URBAN)............................................  ..............  ..............  ..............  ..............  ..............  ..............
    0-99 BEDS...........................................             973             0.4             0.1             3.2            -0.4             1.9
    100-199 BEDS........................................             822            -0.1             0.0             2.5            -0.5             1.2

[[Page 229]]

 
    200-299 BEDS........................................             444             0.0             0.0             2.6            -0.5             1.3
    300-499 BEDS........................................             390             0.1             0.3             3.0            -0.5             1.5
    500+ BEDS...........................................             220             0.1            -0.1             2.6            -0.7             1.1
BEDS (RURAL)............................................  ..............  ..............  ..............  ..............  ..............  ..............
    0-49 BEDS...........................................             342            -0.9             1.2             2.9            -0.3             1.5
    50-100 BEDS.........................................             267            -0.6             0.9             2.9            -0.7             0.9
    101-149 BEDS........................................              87            -0.6             0.9             2.9            -0.6             1.2
    150-199 BEDS........................................              43            -0.2             0.8             3.3            -0.9             1.3
    200+ BEDS...........................................              37            -0.1            -0.5             2.0            -0.6             0.7
REGION (URBAN)..........................................  ..............  ..............  ..............  ..............  ..............  ..............
    NEW ENGLAND.........................................             134            -0.3            -2.0             0.3            -1.0            -1.3
    MIDDLE ATLANTIC.....................................             335             0.0             0.1             2.7            -0.4             1.5
    SOUTH ATLANTIC......................................             461             0.1            -0.1             2.5            -0.5             1.3
    EAST NORTH CENT.....................................             456            -0.1            -0.2             2.3            -0.7             0.8
    EAST SOUTH CENT.....................................             165             0.2             0.8             3.6            -0.2             2.6
    WEST NORTH CENT.....................................             179             0.3             1.2             4.1            -0.6             1.7
    WEST SOUTH CENT.....................................             491             0.4             0.2             3.2            -0.5             1.9
    MOUNTAIN............................................             208             0.0            -0.2             2.4            -0.5             0.7
    PACIFIC.............................................             373             0.3             0.5             3.4            -0.5             2.1
    PUERTO RICO.........................................              47             1.0            17.8            22.0             0.0            20.9
REGION (RURAL)..........................................  ..............  ..............  ..............  ..............  ..............  ..............
    NEW ENGLAND.........................................              21            -0.5            -1.3             0.7            -1.9            -1.8
    MIDDLE ATLANTIC.....................................              53            -0.6            -0.1             1.9            -1.0             0.2
    SOUTH ATLANTIC......................................             119            -0.8             0.9             2.7            -0.2             1.7
    EAST NORTH CENT.....................................             120            -0.5            -0.2             1.9            -0.7             0.5
    EAST SOUTH CENT.....................................             150            -0.5             1.2             3.3            -0.2             2.3
    WEST NORTH CENT.....................................              96            -0.3             1.5             3.9            -0.8             1.1
    WEST SOUTH CENT.....................................             145            -0.6             1.1             3.0            -0.3             2.0
    MOUNTAIN............................................              49            -0.3             2.4             4.8            -0.3             1.1
    PACIFIC.............................................              23            -0.6             0.7             2.7            -1.0             1.0
TEACHING STATUS.........................................  ..............  ..............  ..............  ..............  ..............  ..............
    NON-TEACHING........................................           2,469            -0.1             0.3             2.8            -0.4             1.6
    MINOR...............................................             781             0.1             0.2             2.9            -0.6             1.3
    MAJOR...............................................             375             0.0            -0.2             2.4            -0.8             0.9
DSH PATIENT PERCENT.....................................  ..............  ..............  ..............  ..............  ..............  ..............
    0...................................................              13             2.5             0.5             5.6             0.0             4.4
    GT 0-0.10...........................................             274             1.0             0.0             3.6            -0.3             2.3
    0.10-0.16...........................................             256             0.0             0.0             2.6            -0.5             1.2
    0.16-0.23...........................................             558             0.1             0.0             2.7            -0.4             1.4
    0.23-0.35...........................................           1,117            -0.1             0.2             2.8            -0.6             1.2
    GE 0.35.............................................             931            -0.1             0.1             2.6            -0.6             1.2
    DSH NOT AVAILABLE **................................             476             2.0             0.4             5.1            -0.4             4.2
URBAN TEACHING/DSH......................................  ..............  ..............  ..............  ..............  ..............  ..............
    TEACHING & DSH......................................           1,038             0.1             0.0             2.7            -0.7             1.1
    NO TEACHING/DSH.....................................           1,344             0.1             0.1             2.8            -0.3             1.6
    NO TEACHING/NO DSH..................................              12             2.5             0.5             5.7             0.0             4.8
    DSH NOT AVAILABLE2..................................             455             1.8             0.2             4.7            -0.3             4.0
TYPE OF OWNERSHIP.......................................  ..............  ..............  ..............  ..............  ..............  ..............
    VOLUNTARY...........................................           1,981             0.0             0.1             2.6            -0.6             1.1
    PROPRIETARY.........................................           1,182             0.4             0.2             3.2            -0.2             2.1
    GOVERNMENT..........................................             462            -0.1             0.3             2.8            -0.7             1.3
CMHCs...................................................              41             1.4             0.5             4.6             0.0             3.7
--------------------------------------------------------------------------------------------------------------------------------------------------------
Column (1) shows total hospitals and/or CMHCs.
Column (2) includes all final CY 2020 OPPS policies and compares those to the CY 2019 OPPS.
Column (3) shows the budget neutral impact of updating the wage index by applying the FY 2020 hospital inpatient wage index and the non-budget neutral
  frontier adjustment. The rural SCH adjustment continues our current policy of 7.1 percent so the budget neutrality factor is 1. The budget neutrality
  adjustment for the cancer hospital adjustment is 0.9999 because in CY 2020 the target payment-to-cost ratio is higher than the CY 2019 PCR target
  (0.89)
Column (4) shows the impact of all budget neutrality adjustments and the addition of the 2.6 percent OPD fee schedule update factor (hospital market
  basket percentage increase of 3.0 percent reduced by 0.4 percentage point for the productivity adjustment).
Column (5) shows the additional impact of the policy to pay clinic visits for nonexcepted providers under the otherwise applicable payment system. We
  note that we are completing the 2-year phase-in so the amount of the reduction will be the full difference in CY 2020 (or payment at 40 percent of the
  OPPS rate).
Column (6) shows the additional adjustments to the conversion factor resulting from a change in the pass-through estimate, and adding estimated outlier
  payments. Note that previous years included the frontier adjustment in this column, but we have moved the frontier adjustment to Column 3 in this
  table.
These 3,732 providers include children and cancer hospitals, which are held harmless to pre-BBA amounts, and CMHCs.
** Complete DSH numbers are not available for providers that are not paid under IPPS, including rehabilitation, psychiatric, and long-term care
  hospitals.


[[Page 230]]

    27. On page 61478, column 3, first partial paragraph, in line 8, 
the figure ``4.5'' is corrected to read ``4.6''.

    Dated: December 19, 2019.
Ann C. Agnew,
Executive Secretary to the Department, Department of Health and Human 
Services.
[FR Doc. 2019-28364 Filed 12-30-19; 4:15 pm]
BILLING CODE 4120-01-P

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