2021 Panacea OPPS Final Rule Summary

2021 OPPS Final Rule Summary Summary of the Major Provisions •

OPPS Update: For CY 2021, CMS is increasing the payment rates under the OPPS by an Outpatient Department (OPD) fee schedule increase factor of 2.4 percent. This increase factor is based on the final hospital inpatient market basket percentage increase of 2.4 percent for inpatient services paid under the hospital inpatient prospective payment system (IPPS). Based on this update, CMS estimates that total payments to OPPS providers (including beneficiary cost-sharing and estimated changes in enrollment, utilization, and case-mix) for calendar year (CY) 2021 would be approximately $83.888 billion, an increase of approximately $7.541 billion compared to estimated CY 2020 OPPS payments.

CMS is continuing to implement the statutory 2.0 percentage point reduction in payments for hospitals that fail to meet the hospital outpatient quality reporting requirements by applying a reporting factor of 0.9805 to the OPPS payments and copayments for all applicable services.

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Partial Hospitalization Update: For CY 2021 OPPS/ASC final rule with comment period, CMS is maintaining the unified rate structure established in CY 2017, with a single PHP APC for each provider type for days with 3 or more services per day. CMS is using the CMHC and hospital-based PHP (HB PHP) geometric mean per diem costs, consistent with existing policy, using updated data for each provider type. Accordingly, CMS is calculating the CY 2021 PHP APC per diem rates for HB PHPs and CMHC PHPs based on updated cost and claims data. Given that the final calculated geometric mean per diem costs are much higher than the proposed cost floors, CMS is not extending the cost floors to CY 2021 and subsequent years.

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Changes to the Inpatient Only (IPO) List: For CY 2021, CMS is eliminating the IPO list over the course of 3 calendar years beginning with the removal of 266 musculoskeletal-related services. CMS is also removing 32 additional HCPCS codes from the IPO list for CY 2021 based on public comments.

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Medical Review of Certain Inpatient Hospital Admissions under Medicare Part A for CY 2021 and Subsequent Years (2-Midnight Rule): For CY 2021, CMS is finalizing a policy to exempt procedures that are removed from the inpatient only (IPO) list under the OPPS beginning on January 1, 2021 from site-of-service claim denials, Beneficiary and Family-Centered Care Quality Improvement Organization (BFCC-QIO) referrals to Recovery Audit Contractor (RAC) for persistent noncompliance with the 2-midnight rule, and RAC reviews for “patient status” (that is, site-of-service) until such procedures are more commonly billed in the outpatient setting.

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2021 OPPS Final Rule Summary •

340B-Acquired Drugs: CMS is continuing our current policy of paying an adjusted amount of ASP minus 22.5 percent for drugs and biologicals acquired under the 340B program. CMS is continuing to exempt Rural SCHs, PPS-exempt cancer hospitals and children’s hospitals from our 340B payment policy.

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Changes to the Level of Supervision of Outpatient Therapeutic Services in Hospitals and Critical Access Hospitals: For CY 2021 and subsequent years, CMS is changing the minimum default level of supervision for non-surgical extended duration therapeutic services (NSEDTS) to general supervision for the entire service, including the initiation portion of the service, for which CMS had previously required direct supervision. This is consistent with the minimum required level of general supervision that currently applies for most outpatient hospital therapeutic services. CMS is finalizing the proposed policy to permit direct supervision of pulmonary rehabilitation, cardiac rehabilitation, and intensive cardiac rehabilitation services using virtual presence of the physician through audio/video real-time communications technology subject to the clinical judgment of the supervising physician until the later of the end of the calendar year in which the PHE ends or December 31, 2021.

Updates Affecting OPPS Payments •

Payment for Blood Not Otherwise Classified (NOC) Code. CMS is finalizing the alternative proposal to make HCPCS code P9099 separately payable, assign it a status indicator of “R”, and pay the code at a rate equal to the lowest paid separately payable blood product in the OPPS, which is P9043 (Infusion, plasma protein fraction (human), 5 percent, 50 ml) with a payment rate of $7.79 per unit. CMS decided to finalize the alternative proposal, as it gives providers some payment for unclassified blood products, which is consistent with OPPS policy for other major categories of medical care where the payment rate for the unclassified service is based on the lowest-paying APC in an APC series for that category of service, while maintaining incentives for manufacturers to establish individual HCPCS codes for their new blood products in a timely manner.

Additional C-APCs for CY 2021 •

CMS created an additional level in the “Urology and Related Services” APC series and, created an additional level in the “Neurostimulator and Related Procedures” APC series.

Table 3 in the Final Rule lists the newly created C-APCs for CY 2021. Table below summarizes the changes to the APC Clinical Families UROXX and NSTIM.

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2021 OPPS Final Rule Summary

C-APC

5373 5374 5375 5376 5377 5378 5461 5462 5463 5464 5465

CY 2021 APC Group Title

Level 3 Urology and Related Services Level 4 Urology and Related Services Level 5 Urology and Related Services Level 6 Urology and Related Services Level 7 Urology and Related Services Level 8 Urology and Related Services Level 1 Neurostimulator and Related Procedures Level 2 Neurostimulator and Related Procedures Level 3 Neurostimulator and Related Procedures Level 4 Neurostimulator and Related Procedures Level 5 Neurostimulator and Related Procedures

Clinical Family UROXX UROXX UROXX UROXX UROXX UROXX NSTIM NSTIM NSTIM NSTIM NSTIM

New C-APC

*

*

Mental Health Services Composite Rate •

CMS finalized the proposed that when the aggregate payment for specified mental health services provided by one hospital to a single beneficiary on a single date of service, based on the payment rates associated with the APCs for the individual services, exceeds the maximum per diem payment rate for partial hospitalization services provided by a hospital, those specified mental health services would be paid through composite APC 8010 for CY 2021. CMS also finalized the payment rate of $260.49 for composite APC 8010 for CY 2021 at the same payment rate that was set for APC 5863, which is the maximum partial hospitalization per diem payment rate for a hospital. Under this policy, the I/OCE will continue to determine whether to pay for these specified mental health services individually, or to make a single payment at the same payment rate established for APC 5863 for all of the specified mental health services furnished by the hospital on that single date of service.

Packaging Policy for Non-Opioid Pain Management Therapies •

CMS is finalizing its proposed policy, without modification, to unpackage and pay separately at ASP+6 percent for the cost of non-opioid pain management drugs that function as surgical supplies (e.g., Exparel) when they are furnished in the ASC setting for CY 2021. They will continue to analyze the issue of access to non-opioid pain management alternatives in the OPPS and the ASC settings as part of any subsequent reviews CMS conducts under section 1833(t)(22)(A)(ii).

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2021 OPPS Final Rule Summary Clinical Diagnostic Laboratory Tests Packaging Policy •

CMS is revising the list of test codes excluded from the OPPS packaging policy to include CPT codes 81500, 81503, 81535, 81536, 81539, and 81490. They are also finalizing to exclude cancer-related protein-based MAAAs that do not currently exist, but that are developed in the future, from the OPPS packaging policy. Based on existing exclusions from OPPS packaging, when a CDLT is listed on the CLFS and meets one of the following four criteria, CMS does not pay for the test under the OPPS, but rather, CMS pays for it under the CLFS when it is: (1) the only service provided to a beneficiary on a claim; (2) considered a preventive service; (3) a molecular pathology test; or (4) an ADLT that meets the criteria of section 1834A(d)(5)(A) of the Act. Generally, when laboratory tests are not packaged under the OPPS and are listed on the CLFS, they are paid under the CLFS instead of the OPPS.

OPPS Ambulatory Payment Classification (APC) Group Policies •

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CMS finalized change in APC and status indicator for CPT code 0398T to APC 5463 from APC 1575 for CY 2021. With this change the payment is expected to decrease by $(1,264.29).

HCPCS Code

2021 Long Description

SI

APC

Payment Rate

2020 SI

2020 APC

2020 APC Rate

0398T

Magnetic resonance image guided high intensity focused ultrasound (MRgFUS), stereotactic ablation lesion, intracranial for movement disorder including stereotactic navigation and frame placement when performed

J1

5463

$ 11,236.21

S

1575

$ 12,500.50

CMS is finalizing proposal to establish C9770 (OPPS Proposed Rule C97X1 placeholder code) and assign the code to a New Technology APC based on the geometric mean cost of HCPCS code 67036. For CY 2021, HCPCS code 67036 has a geometric mean cost of $3,435.61.

HCPCS code C9770 (Vitrectomy, mechanical, pars plana approach, with subretinal injection of pharmacologic/biologic agent) will be assigned to APC 1561 (New Technology – Level 24 ($3001-$3500)) and status indicator T, with an estimated OPPS payment of $3,250.50.

HCPCS code J3398 (Injection, voretigene neparvovec-rzyl, 1 billion vector genomes) will need to be separately reported from the new HCPCS procedure code. A typical patient will receive a standard dose of 150 billion vector genomes. The biologic has an estimated OPPS

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2021 OPPS Final Rule Summary national payment amount of $2,883.20 with an approximate payment rate of $424,980 for the gene therapy.

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Bronchoscopy with Transbronchial Ablation of Lesion(s) by Microwave Energy HCPCS code C9751 will be reassigned to APC 1562 (New Technology - Level 25 ($3501-$4000)) using CMS equitable adjustment authority under section 1833(t)(2)(E) of the Act and low-volume new technology service methodology. The payment rate for C9751 will be based on the median cost of claims reported for the service since CY 2019 as the median cost is the highest estimated cost for the service, and the median provides a reasonable estimate of the midpoint cost of the three claims that have been paid for this service. The 2021 estimated payment for code C9751 is $3,750.50 which is a decrease of $(4,500.00) based on CY 2020 OPPS national estimated payment.

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Pathogen Test for Platelets/Rapid Bacterial Testing HCPCS code P9100 CMS is finalizing without modification to reassign HCPCS code P9100 from New Technology APC 1494 to clinical APC 5732 for CY 2021. The claim data showed a geometric mean cost of approximately $31 for HCPCS code P9100 based on 75 single claims (out of 2,038 total claims), which is close to the payment rate of around $33 for APC 5732. This change decreases payment for CY 2021 by $(1.66).

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V-Wave Medical Interatrial Shunt Procedure is being performed as a randomized, doubleblinded, controlled IDE study. CMS created in 2020 HCPCS code C9758 (Blinded procedure for NYHA class III/IV heart failure; transcatheter implantation of interatrial shunt or placebo control, including right heart catheterization, trans-esophageal echocardiography (TEE)/intracardiac echocardiography (ICE), and all imaging with or without guidance (for example, ultrasound, fluoroscopy), performed in an approved investigational device exemption (IDE) study) to report this procedure and is reassigning this code to New Technology APC 1590 which will reflect the cost of having this procedure and receiving the interatrial shunt one-half the time when performed. This will increase CY 2021 payment by $5,000.00.

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On July 1, 2020, CMS established HCPCS code C9760 (Non-randomized, non-blinded procedure for nyha class ii, iii, iv heart failure; transcatheter implantation of interatrial shunt or placebo control, including right and left heart catheterization, transeptal puncture, trans-esophageal echocardiography (tee)/intracardiac echocardiography (ice), and all imaging with or without guidance (for example, ultrasound, fluoroscopy), performed in an approved investigational device exemption (ide) study) to facilitate the implantation of the Corvia Medical interatrial shunt. CMS is removing “or placebo control” from the long

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2021 OPPS Final Rule Summary descriptor and is reassigning this code to New Technology APC 1592 which will cover resources and device costs. This will increase CY 2021 payment by $15,000.00.

APC Specific Policies •

Chimeric Antigen Receptor T-Cell (CAR T-Cell) Therapy (APCs 5694, 9035, 9194, and 9391) update. For CY 2021, CMS has added HCPCS code C9073 (see table below) for reporting therapeutic doses of Brexucabtagene autoleucel. The three HCPCS below include the work of harvesting, preparation for storage, and receipt and preparation of CAR-T cells for administration; therefore codes 0537T, 0538T and 0539T are not separately payable under the OPPS. HCPCS Code

2021 Long Description

SI

APC

Payment Rate

C9073

Brexucabtagene autoleucel, up to 200 million autologous anti-cd19 car positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose

G

9391

$384,190.00

Q2041

Axicabtagene ciloleucel, up to 200 million autologous anti-cd19 car positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose

G

9035

$395,380.00

Q2042

Tisagenlecleucel, up to 600 million car-positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose

G

9194

$429,813.31

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New codes 69705 and 69706 were created by the AMA and effective for use January 1, 2021. CMS finalized deletion of HCPCS code C9745 (Nasal endoscopy, surgical; balloon dilation of eustachian tube) on December 31, 2020 and has assigned CPT codes 69705 (Nasopharyngoscopy, surgical, with dilation of eustachian tube (ie, balloon dilation); unilateral) and 69706 (Nasopharyngoscopy, surgical, with dilation of eustachian tube (that is, balloon dilation); bilateral) to APC 5165.

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Health and Behavior Services (APC 5822) currently contains 16 CPT/HCPCS codes. CMS is finalizing change in payment for APC 5822 from $78.54 to $74.87 for CY 2021, which decreases payment by approximately $(3.67). CMS is also reassigning CPT codes 97151,

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2021 OPPS Final Rule Summary 97152, 97153 and 97154 from APC 5821 to APC 5822 (see table below) which means a payment increase of approximately $47.55 for CY 2021.

HCPCS 2021 Long Description Code

SI

97151

97152

97153

97155

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Behavior identification assessment, administered by a physician or other qualified health care professional, each 15 minutes of the physician's or other qualified health care professional's time face-toface with patient and/or guardian(s)/caregiver(s) administering assessments and discussing findings and recommendations, and nonface-to-face analyzing past data, scoring/interpreting the assessment, and preparing the report/treatment plan Behavior identificationsupporting assessment, administered by one technician under the direction of a physician or other qualified health care professional, face-to-face with the patient, each 15 minutes Adaptive behavior treatment by protocol, administered by technician under the direction of a physician or other qualified health care professional, face-to-face with one patient, each 15 minutes Adaptive behavior treatment with protocol modification, administered by physician or other qualified health care

APC

2020 APC

2020 APC Rate

Q3 5822

2020 Payment SI Rate $ 74.87 Q3

5821

$ 27.32

Q3 5822

$ 74.87

Q3

5821

$ 27.32

Q3 5822

$ 74.87

Q3

5821

$ 27.32

Q3 5822

$ 74.87

Q3

5821

$ 27.32

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2021 OPPS Final Rule Summary professional, which may include simultaneous direction of technician, faceto-face with one patient, each 15 minutes

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CMS finalized assignment of CPT code 0342T (Therapeutic apheresis with selective hdl delipidation and plasma reinfusion) to APC 5243 (Level 3 Blood Product Exchange and Related Services) with an estimated payment of $4,074.81. This decreases payment by an estimated $(219.35) for CY 2021. The company responsible for the PDS-2 System (HDL therapy system) will be applying for new technology payment in early 2021 since it expects FDA Humanitarian Device Exemption approval in Q4 of 2020.

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IDx-DR: Artificial Intelligence System to Detect Diabetic Retinopathy (APC 5732). The AMA CPT Editorial Panel created code 92229 (Imaging of retina for detection or monitoring of disease; point-of-care automated analysis and report, unilateral or bilateral) effective for use January 1, 2021. CMS has finalized status indicator of S and APC 5733 with an estimated national payment of $55.66. With the addition of this new code the AMA has revised CPT codes 92227 and 92228 accordingly. CPT code 92227 would be reported for remote clinical staff review and 92228 which will be reported for remote physician interpretation and report to differentiate them from the IDx-DR test.

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The AMA CPT Editorial Panel created new codes, effective for use January 1, 2021, to report percutaneous injection of allogeneic cellular and/or tissue-based products (VIA® Disc Allograft Supplementation). The new codes (0627T – 0630T) and the CMS CY 2021 payment information is found in the table below:

HCPCS Code 0627T

Place holder Codes 0X32T

0628T

0X33T

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2021 Long Description

SI

APC

Payment Rate

Percutaneous injection of allogeneic cellular and/or tissue-based product, intervertebral disc, unilateral or bilateral injection, with fluoroscopic guidance, lumbar; first level Percutaneous injection of allogeneic cellular and/or tissue-based product, intervertebral disc, unilateral or bilateral injection, with fluoroscopic guidance, lumbar; each additional level (List

J1

5115

$ 12,314.76

N

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2021 OPPS Final Rule Summary separately in addition to code for primary procedure)

0629T

0X34T

0630T

0X37T

Percutaneous injection of allogeneic cellular and/or tissue-based product, intervertebral disc, unilateral or bilateral injection, with CT guidance, lumbar; first level Percutaneous injection of allogeneic cellular and/or tissue-based product, intervertebral disc, unilateral or bilateral injection, with CT guidance, lumbar; each additional level (List separately in addition to code for primary procedure)

J1

5115

$ 12,314.76

N

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Medical Physics Dose Evaluation (APC 5611). New CPT code 76145 (Medical physics dose evaluation for radiation exposure that exceeds institutional review threshold, including report (medical physicist/dosimetrist)) will be effective January 1, 2021 and is assigned to APC 5611 (Level 1 Therapeutic Radiation Treatment Preparation) with an estimated payment rate of $126.87. This was previously listed as 7615X placeholder code in the proposed rule submitted by the AMA CPT Editorial Panel.

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Neurostimulator and Related Procedures (APCs 5461 through 5465). CMS finalized with modification the reassignment of CPT code 0587T to APC 5462 and CPT code 0588T to APC 5461. With this change, the payments for both Category III codes increase for CY 2021 by approximately $5,535.63 and $3,013.53, respectively. See table below for long descriptors and summary of CMS payment information.

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2021 OPPS Final Rule Summary HCPCS 2021 Long Description Code 0587T Percutaneous implantation or replacement of integrated single device neurostimulation system including electrode array and receiver or pulse generator, including analysis, programming, and imaging guidance when performed, posterior tibial nerve 0588T Revision or removal of integrated single device neurostimulation system including electrode array and receiver or pulse generator, including analysis, programming, and imaging guidance when performed, posterior tibial nerve

SI

APC

J1

Payment Rate 5462 $6,160.68

2020 2020 SI APC T 5442

2020 APC Rate $ 625.05

J1

5461

T

$

$3,275.30

5441

261.77

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For CY 2021 CMS has assigned status indicator E1 for AMA created code 0632T (Percutaneous transcatheter ultrasound ablation, nerves innervating the pulmonary arteries, including right heart catheterization, radiological supervision and interpretation and pulmonary artery angiography) to report procedures performed with the TIVUS system. The system was approved by the FDA for a Category B (Nonexperimental / investigational) Investigational Device Exemption (IDE) for the device to be used in a clinical study/trial. To date, CMS has not established approval of Medicare coverage for the Category B IDE study for the TIVUS™ system.

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CMS has created for CY 2021 four new HCPCS codes (see table below) for lithotripsyenhanced balloon catheter procedures in the peripheral vasculature using the IVL system and has assigned these codes to existing clinical APCs that contain existing codes

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2021 OPPS Final Rule Summary C9764, C9765, C9766 and C9767. With addition of the new HCPCS codes, CMS is revising the descriptions for the existing codes so that these descriptors indicate peripheral IVL procedures performed in lower extremity artery(ies) except tibial/perioneal since the new codes will be reported when the IVL procedure is performed in the tibial/peroneal artery(ies).

HCPCS Code C9764

C9765

C9766

C9767

C9772

C9773

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2021 Long Description

SI

APC

Payment Rate

Revascularization, endovascular, open or percutaneous, lower extremity artery(ies), except tibial/peroneal; with intravascular lithotripsy, includes angioplasty within the same vessel(s), when performed Revascularization, endovascular, open or percutaneous, lower extremity artery(ies), except tibial/peroneal; with intravascular lithotripsy, and transluminal stent placement(s), includes angioplasty within the same vessel(s), when performed Revascularization, endovascular, open or percutaneous, lower extremity artery(ies), except tibial/peroneal; with intravascular lithotripsy and atherectomy, includes angioplasty within the same vessel(s), when performed Revascularization, endovascular, open or percutaneous, lower extremity artery(ies), except tibial/peroneal; with intravascular lithotripsy and transluminal stent placement(s), and atherectomy, includes angioplasty within the same vessel(s), when performed Revascularization, endovascular, open or percutaneous, tibial/peroneal artery(ies), with intravascular lithotripsy, includes angioplasty within the same vessel (s), when performed Revascularization, endovascular, open or percutaneous, tibial/peroneal artery(ies); with intravascular lithotripsy, and transluminal stent placement(s), includes angioplasty within the same vessel(s), when performed

J1

5192

$

4,956.84

J1

5193

$

10,042.94

J1

5193

$

10,042.94

J1

5194

$

16,064.00

J1

5193

$

10,042.94

J1

5194

$

16,064.00

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2021 OPPS Final Rule Summary C9774

C9775

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Revascularization, endovascular, open or percutaneous, tibial/peroneal artery(ies); with intravascular lithotripsy and atherectomy, includes angioplasty within the same vessel (s), when performed Revascularization, endovascular, open or percutaneous, tibial/peroneal artery(ies); with intravascular lithotripsy and transluminal stent placement(s), and atherectomy, includes angioplasty within the same vessel (s), when performed

J1

5194

$

16,064.00

J1

5194

$

16,064.00

Remote Physiological Monitoring Services, Virtual Check-In, E-visits, Telephone E/M, and Medication Management Services update. In the 2021 OPPS Final Rule, CMS includes in Table 34 two new placeholder codes G20X2 and G20X0. These are addressed in more detail in the 2021 MPFS Final Rule. CMS created three new HCPCS (G2250, G2251, G2252) codes for Communication Technology-Based Services (CTBS) which are all assigned status indicator A (Services furnished to a hospital outpatient that are paid under a fee schedule or payment system other than OPPS). Codes G2250 and G2251 are finalized to allow billing of other CTBS by certain NPPs (LCSW, clinical psychologists), consistent with the scope of these practitioners’ benefit categories that can be billed by practitioners who cannot independently bill for E/M services. This will also allow rehabilitative therapists (PT, OT, ST) to use HCPCS codes G2250 and G2251 along with existing codes G2061, G2062, and G2063 which are designated as “sometimes therapy” services. When billed by a private practice PT, OT, or SLP, the codes would need to include the corresponding GO, GP, or GN therapy modifier to signify that the CTBS are furnished as therapy services furnished under an OT, PT, or SLP plan of care. The primary difference in new codes G2250 and G2251 versus G2010 and G2012 is the new HCPCS codes are not associated with an outpatient evaluation and management (E/M) visit and the existing codes are associated with an E/M visit. CMS created HCPCS code G2252 to be used on an interim basis in 2021 (during the COVID-19 PHE). This code is specifically created for physicians and other qualified healthcare professionals who can report outpatient E/M services. This code is used when the professional conducts an “audio-only” discussion with the patient and the purpose of the call is not related to an E/M service or procedure.

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2021 OPPS Final Rule Summary HCPCS Place Code holder Codes G2250 G20X0

G2251 G20X2

G2252

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2021 Long Description

SI

Remote assessment of recorded video and/or images submitted by an established patient (e.g., store and forward), including interpretation with follow-up with the patient within 24 business hours, not originating from a related service provided within the previous 7 days nor leading to a service or procedure within the next 24 hours or soonest available appointment Brief communication technology-based service, e.g. virtual checkin, by a qualified health care professional who cannot report evaluation and management services, provided to an established patient, not originating from a related service provided within the previous 7 days nor leading to a service or procedure within the next 24 hours or soonest available appointment; 5-10 minutes of medical discussion Brief communication technology-based service, e.g. virtual checkin, by a physician or other qualified health care professional who can report evaluation and management services, provided to an established patient, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 11-20 minutes of medical discussion

A

A

A

Medicare Telehealth Update. CMS has finalized two new HCPCS codes G2211 and G2212 that are a permanent addition to Medicare Telehealth services. While these codes are assigned to status indicator “N” in the 2021 OPPS Final Rule Addendum B, the following summarization is taken from the 2021 MPFS Final Rule. HCPCS codes G2211 and G2212 are intended to be used as add-on codes to the office/outpatient evaluation and management (O/O E/M) services and are, by definition, part of the O/O E/M services with which they are billed; they cannot be billed with any other codes.

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G2211 - Visit complexity inherent to evaluation and management associated with medical care services that serve as the continuing focal point for all needed health care services and/or with medical care services that are part of ongoing care related to a patient’s single, serious condition or a complex condition. (Add-on code, list separately in addition to office/outpatient evaluation and management visit, new or established)

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2021 OPPS Final Rule Summary •

G2212 - Prolonged office or other outpatient evaluation and management service(s) beyond the maximum required time of the primary procedure which has been selected using total time on the date of the primary service; each additional 15 minutes by the physician or qualified healthcare professional, with or without direct patient contact (List separately in addition to CPT codes 99205, 99215 for office or other outpatient evaluation and management services) (Do not report G2212 on the same date of service as 99354, 99355, 99358, 99359, 99415, 99416). (Do not report G2212 for any time unit less than 15 minutes))

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2021 OPPS Final Rule Summary

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2021 OPPS Final Rule Summary •

For 2021, Tympanostomy Using an Automated Tube Delivery System (APC 5163) CPT code 0583T (Tympanostomy (requiring insertion of ventilating tube), using an automated tube delivery system, iontophoresis local anesthesia) has been finalized with status indicator J1 and an estimated national payment of $1,352.79. The manufacturer reported a cost of about $1,400 for the device (e.g., TULA).

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CMS is finalizing Urology and Related Services (APCs 5371 through 5378) CPT codes 53440 and 0548T for reassignment to APC 5377, and finalizing without modification to reassign CPT codes 54416, 53444, 54410, 54411, 54401, 54405, 53447, and 53445 to APC 5378. See table below for estimated payment impacts: HCPCS Code 53440 53444 53445 53447 54400 54401 54405 54410 54411 54416 54417

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Short Descriptor Male sling procedure Insert tandem cuff Insert uro/ves nck sphincter Remove/replace ur sphincter Insert semi-rigid prosthesis Insert self-contd prosthesis Insert multicomp penis pros Remove/replace penis prosth Remov/replc penis pros comp Remv/repl penis contain pros Remv/replc penis pros compl Tprnl balo cntnc dev bi

SI APC

Payment Rate J1 5377 $11,488.02

2020 APC 5376

2020 APC Rate $ 8,067.93

PAYMENT DIFF 3,420.09

J1 5378

$18,258.35

5377

$ 17,573.96

684.39

J1 5378

$18,258.35

5377

$ 17,573.96

684.39

J1 5378

$18,258.35

5377

$ 17,573.96

684.39

J1 5377

$11,488.02

5377

$ 17,573.96

(6,085.94)

J1 5378

$18,258.35

5377

$ 17,573.96

684.39

J1 5378

$18,258.35

5377

$ 17,573.96

684.39

J1 5378

$18,258.35

5377

$ 17,573.96

684.39

J1 5378

$18,258.35

5377

$ 17,573.96

684.39

J1 5378

$18,258.35

5377

$ 17,573.96

684.39

J1 5377

$11,488.02

5377

$ 17,573.96

(6,085.94)

J1 5377

$11,488.02

5376

$

8,067.93

3,420.09

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2021 OPPS Final Rule Summary

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CMS is deleting code C9747 (Ablation of prostate, transrectal, high intensity focused ultrasound (hifu), including imaging guidance) effective December 31, 2020 with addition of the AMA CPT code 55880 (Ablation of malignant prostate tissue, transrectal, with high intensity-focused ultrasound (HIFU), including ultrasound guidance) for 2021. The new code is assigned to APC 5375 with an estimated national payment amount of $4,413.90 for a minimal increase in reimbursement.

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CMS is finalizing Venous Mechanical Thrombectomy (APC 5193) CPT code 37187 (Percutaneous transluminal mechanical thrombectomy, vein(s), including intraprocedural pharmacological thrombolytic injections and fluoroscopic guidance) reassignment of APC to 5193 which means an estimated increase in national payment of $ 5,089.03.

OPPS Pass-Through Payment for Devices •

CUSTOMFLEX® ARTIFICIALIRIS (HCPCS code C1839) is being finalized to receive pass-through payment. The manufacturer indicated the cost is $7,700 (Fiber Free and Fiber models). The AMA created several Category III codes that became effective for use July 1, 2020 o 0616T Insertion of iris prosthesis, including suture fixation and repair or removal of iris, when performed; without removal of crystalline lens or intraocular lens, without insertion of intraocular lens o 0617T with removal of crystalline lens and insertion of intraocular lens o 0618T with secondary intraocular lens placement or intraocular lens exchange

•

EXALT™ Model D Single-Use Duodenoscope (HCPCS code C1748) is being finalized to receive pass-through payment. The manufacturer indicated the cost is $2,930 for the sterile, singleuse, flexible duodenoscope used to examine the duodenum and perform endoscopic retrograde cholangiopancreatography (ERCP) procedures. HCPCS code for the device may be reported with endoscopic CPT codes 43260-43265 or 43274-43278 where applicable.

•

BAROSTIM NEO™ is being finalized to receive pass-through payment. CMS has created HCPCS code C1825 (Gen, neuro, carot sinus baro) which becomes effective for use January 1, 2021. The manufacturer indicated the cost is $35,000 for the system (generator, neurostimulator and a lead). This device HCPCS code may be reported with existing Category III CPT codes 0266T-0271T as applicable. Code 0266T (Implantation or

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2021 OPPS Final Rule Summary replacement of carotid sinus baroreflex activation device; total system (includes generator placement, unilateral or bilateral lead placement, intra-operative interrogation, programming, and repositioning, when performed) would be used for insertion or removal/replacement of the entire system.

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Cook Medical’s Hemospray® Endoscopic Hemostat (Hemospray) is being finalized to receive pass-through payment. CMS has created HCPCS code C1052 (Hemostatic agent, gi, topic) which becomes effective for use January 1, 2021. The manufacturer indicated the cost is $2,500 for the hemostatic agent and a delivery system. The new code would be reported in addition to the applicable CPT code where endoscopic hemostasis is performed: HCPCS Short Descriptor

•

43227

Esophagoscopy control bleed

43255

Egd control bleeding any

44366

Small bowel endoscopy

44378

Small bowel endoscopy

44391

Colonoscopy for bleeding

45334

Sigmoidoscopy for bleeding

45382

Colonoscopy w/control bleed

Stryker’s SpineJack® Expansion Kit (hereinafter referred to as the SpineJack® system) is being finalized to receive pass-through payment. CMS has created HCPCS code C1062 (Intravertebral fx aug impl) which becomes effective for use January 1, 2021. The manufacturer indicated the cost is $5,623 for the implantable fracture reduction system, which is indicated for use in the reduction of painful osteoporotic vertebral compression fractures (VCFs) and is intended to be used in combination with Stryker VertaPlex and VertaPlex High Viscosity (HV) bone cement. The device HCPCS code is expected to be reported in addition to CPT code 22513 (Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device (eg, kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, inclusive of all imaging guidance; thoracic).

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2021 OPPS Final Rule Summary Addition of New Service Categories for Hospital Outpatient Department (OPD) Prior Authorization Process •

For 2021, CMS has finalized the addition of two categories of codes because they have seen an increase in reported cases over the last several years. The two new categories are Cervical Fusion with Disc Removal (CPT codes 22551 and 22552) and Implanted Spinal Neurostimulators (63650, 63685 and 63688). (a)(2) The following service categories comprise the list of hospital outpatient department services requiring (a) Cervical Fusionprior withauthorization Disc Removal.beginning for service dates on or after July 1, 2021: (b) Implanted Spinal Neurostimulators.

Code 22551

(i) Cervical Fusion with Disc Removal Fusion of spine bones with removal of disc at upper spinal column, anterior approach, complex, initial

22552

Fusion of spine bones with removal of disc in upper spinal column below second vertebra of neck , anterior approach, each additional interspace

Code 63650 63685 63688

(ii) Implanted Spinal Neurostimulators Implantation of spinal neurostimulator electrodes, accessed through the skin Insertion or replacement of spinal neurostimulator pulse generator or receiver Revision or removal of implanted spinal neurostimulator pulse generator or receiver

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2021 OPPS Final Rule Summary Other AMA & CMS Updates Related to COVID-19 PHE Medicare Part B Payment for COVID-19 Vaccines and Certain Monoclonal Antibodies during the Public Health Emergency Code

CPT Short Descriptor

91300 SARSCOV2 VAC 30MCG/0.3ML IM 0001A ADM SARSCOV2 30MCG/0.3ML 1ST

0002A ADM SARSCOV2 30MCG/0.3ML 2ND

91301 SARSCOV2 VAC 100MCG/0.5ML IM 0011A ADM SARSCOV2 100MCG/0.5ML1ST

0012A ADM SARSCOV2 100MCG/0.5ML2ND

Labeler Name Pfizer

Vaccine/Procedure Name Pfizer-Biontech Covid-19 Vaccine Pfizer Pfizer-Biontech Covid-19 Vaccine Administration – First Dose Pfizer Pfizer-Biontech Covid-19 Vaccine Administration – Second Dose Moderna Moderna Covid-19 Vaccine Moderna Moderna Covid-19 Vaccine Administration – First Dose Moderna Moderna Covid-19 Vaccine Administration – Second Dose

Payment Allowance $0.010* $16.940**

$28.390**

$0.010* $16.940**

$28.390**

* Since we anticipate that providers, initially, will not incur a cost for the product, CMS will update the payment allowance at a later date. Providers should not bill for the product if they received it for free. ** These rates will also be geographically adjusted for many providers. Certain settings utilize other payment methodologies, such as payment based on reasonable costs.

The AMA will be updating the new Appendix Q for the CPT code set which current contains the CPT codes listed in the table above. The link to the current Appendix Q is provided here: https://www.ama-assn.org/system/files/2020-11/covid-19-immunizations-appendix-qtable.pdf

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2021 OPPS Final Rule Summary Payment Allowances and Effective Dates for COVID-19 Monoclonal Antibodies and their Administration during the Public Health Emergency: • •

Q0239 and M0239 became effective for use 11/10/2020 Q0243 and M0243 became effective for use 11/21/2020

Code

CPT Short Descriptor

Q0239

bamlanivimab-xxxx

M0239 bamlanivimab-xxxx infusion

Q0243

casirivimab and imdevimab

M0243 casirivi and imdevi infusion

Labeler Name Eli Lilly

Vaccine/Procedure Name Injection, bamlanivimab, 700 mg Eli Lilly Intravenous infusion, bamlanivimabxxxx, includes infusion and post administration monitoring Regeneron Injection, casirivimab and imdevimab, 2400 mg Regeneron intravenous infusion, casirivimab and imdevimab includes infusion and post administration monitoring

Payment Allowance $0.010*

$309.600***

$0.010*

$309.600***

* Since we anticipate that providers, initially, will not incur a cost for the product, CMS will update the payment allowance at a later date. Providers should not bill for the product if they received it for free. *** Medicare will pay a rate of $309.60 for many providers. These rates will also be geographically adjusted for many providers. Certain settings utilize other payment methodologies, such as payment based on reasonable costs.

Source: CMS COVID-19 Vaccines and Monoclonal Antibodies https://www.cms.gov/medicare/medicare-part-b-drug-average-sales-price/covid-19-vaccinesand-monoclonal-antibodies

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