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

Published date03 January 2020
Citation85 FR 224
Record Number2019-28364
SectionRules and Regulations
CourtCenters For Medicare & Medicaid Services
Federal Register, Volume 85 Issue 2 (Friday, January 3, 2020)
[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: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html. 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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