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8/25/2021 1 Update on 2022 Outpatient PPS and Physician Fee Schedule Proposed Rules August 26, 2021 Welcome Jaime Welcher Education Program Manager California Hospital Association 1 2

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8/25/2021

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Update on 2022 Outpatient PPS and Physician Fee Schedule Proposed Rules

August 26, 2021

Welcome

Jaime Welcher

Education Program Manager

California Hospital Association

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Questions

CALIFORNIA HOSPITAL ASSOCIATION 3

There will be time at the end to address questions.

Please submit them throughout the presentation in the Q & A box usually found at the bottom of your Zoom screen.

Welcome! Today’s Speakers

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Chad MulvanyVice President, Federal Policy

Chad Mulvany is responsible for providing leadership on federal hospital reimbursement issues and contributes on other federal regulatory matters. Based in CHA’s Washington, DC Office, Chad collaborates with CHA’s vice president, federal policy, CHA’s senior vice president, federal relations, CHA issue managers and national hospital associations on analysis and policy development for advocacy purposes.

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Welcome! Today’s Speakers

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Megan HowardVice President, Federal Policy

As Vice President, Federal Policy for CHA, Megan Howard is responsible for providing leadership on federal regulatory issues related to health care finance, quality and patient safety, and hospital and post-acute provider related issues. Also based in CHA’s Washington, DC office, Megan works with Chad, CHA issue managers and national hospital associations on analysis and policy development for advocacy purposes.

Agenda

CALIFORNIA HOSPITAL ASSOCIATION 6

Outpatient Prospective Payment System (OPPS) Proposed Rule

• OPPS Payment and Policy Updates

• 340B Updates

• Inpatient-Only (IPO) List

• Rural Emergency Hospital

• Radiation Oncology Model

• Price Transparency

• Outpatient Quality Reporting Program

• Additional Requests for Comment

Physician Fee Schedule (PFS) Proposed Rule

• PFS Conversion Factor• Rural Health Clinic (RHC)

Payment• Evaluation/Management Services• Medicare Shared Savings

Program• Telehealth• Appropriate Use Criteria (AUC)• Quality Payment Program

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Overview/How to Comment

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• On July 23, the Centers for Medicare & Medicaid Services (CMS) published the calendar year (CY) 2022 PFS proposed rule.

• On August 4, CMS published the CY 2022 OPPS proposed rule.

• Comments due to CMS by 2 p.m. (PT) on:

✓ September 13 for the PFS proposed rule

✓ September 17 for the OPPS proposed rule

• Submit comments online at regulations.gov

✓ Search “CMS-1751-P” for PFS

✓ Search “CMS-1753-P” for OPPS

• CHA summaries are available: PFS and OPPS

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Outpatient Prospective Payment SystemKey Provisions

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OPPS: Key Proposed Changes

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• Use CY 2019 claims and fiscal year (FY) 2018 cost report data to set the CY 2022 payment rates due to the effect of the COVID–19 public health emergency (PHE).

• Reverse the elimination of the IPO list and add back in services removed in CY 2021.

• Create a universal low volume Ambulatory Payment Classification (APC) policy.

• Continue the reduction in payment to 340B hospitals for separately payable Part B drugs.

• Amend price transparency requirements, increasing penalties for non-compliance.• Make changes to the radiation oncology model.

• Update the requirements for the Hospital Outpatient Quality Reporting (OQR) Program.

The proposed rule includes policies that will:

The increase in OPPS spending due only to changes in the 2022 OPPS proposed rule is estimated to be approximately $1.35 billion.

Proposed OPPS Conversion Factor update

CALIFORNIA HOSPITAL ASSOCIATION 10

The proposed OPPS conversion factor increases 2% over the prior year.

Final

CY 2021

Proposed

CY 2022

Percent

Change

OPPS Conversion Factor $82.797 $84.457 +2.00%

Proposed CY 2022 Update Factor Component Value

Market Basket (MB) Update +2.5%

Affordable Care Act (ACA)–Mandated Productivity MB

Reduction–0.2 percentage points (PPT)

Wage Index BN Adjustment +0.12%

Pass–through Spending/Outlier BN Adjustment –0.38%

Cancer Hospital BN Adjustment +0.00%

Overall Proposed Rate Update +2.04%

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Impact on California Hospitals

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Payments to California hospitals are projected to increase by $124m.

Source: CHA DataSuite, August 2021

OPPS Outlier Payments

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• This is an increase compared to the current threshold of $5,300.

• Outlier payments are proposed to continue to be paid at 50% of the amount by

which the hospital’s cost exceeds 1.75 times the APC payment amount when

both the 1.75 multiplier threshold and the fixed–dollar threshold are met.

• Similar to prior years, CMS is targeting outlier payments to equal 1% of total

OPPS payments.

CMS uses CY 2019 claims to calculate a proposed CY 2022 outlier fixed–dollar

threshold of $6,100.

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Claims Used for Rate-Setting

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• CMS believes 2020 outpatient utilization has been significantly affected by the

COVID-19 PHE, as it did for the FY 2022 inpatient prospective payment system

(IPPS) proposed rule.

• CMS’ analysis of the issue in the CY 2022 OPPS proposed rule is nearly identical

to the analysis provided in the FY 2022 IPPS proposed rule.

• CMS also proposes to extend pass-through payment for up to four quarters for 21 drugs, and one device whose pass-through status was scheduled to expire in CY 2022 (Table 38, pg. 42192).

CMS proposes using 2019 outpatient claims and FY 2018 hospital cost report data to set the OPPS relative weights for 2022.

Wage Index

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• Labor related share remains at 60%.

• For non-IPPS hospitals paid under the OPPS for 2022, CMS proposes continuing its past policies of assigning the wage index that would be applicable if the hospital were paid under the IPPS and allowing the hospital to qualify for the out-migration adjustment.

• For Community Mental Health Centers (CMHC), CMS proposes continuing to calculate the wage index by using the post-reclassification IPPS wage index based on the core-based statistical area (CBSA) where the CMHC is located.

Similar to prior years, CMS proposes to use the FY 2022 IPPS post-reclassified wage index for the CY 2022 OPPS.

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Comprehensive Ambulatory Payment Classification (C-APC)

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• The treatment is a Food and Drug Administration (FDA)-approved (or indicated in the

“Criteria for Issuance of Authorization”) drug or biological product (which could include

a blood product) authorized to treat COVID–19.

• The emergency use authorization for the drug or biological product must authorize the

use of the product in the outpatient setting or not limit its use to the inpatient setting

or be approved by the FDA to treat COVID–19 disease and not limit its use to the

inpatient setting.

This is in effect from the effective date of the interim final rule (November 2, 2020) with

comment period (IFC) until the end of the pandemic.

CMS continues its exclusion for new COVID–19 treatments meeting certain criteria from C-APC packaging.

Any New COVID–19 Treatment Meeting the Following Criteria Is Separately Payable:

Payment for Drugs, Biologicals, and Radiopharmaceuticals

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• CMS proposes a packaging threshold of $130.

• Separately payable drugs and biological products without pass–through status and not acquired under the 340B program are paid wholesale acquisition cost (WAC) plus 3% instead of WAC plus 6%.

• CMS proposes to continue to pay for therapeutic radiopharmaceuticals with pass–through payments status as well as blood clotting factors, based on ASP plus 6%.

• Pass–through status will expire by December 31, 2021, for 25 drugs and biologicals listed in Table 27 (page 42118 of the proposed rule) and by December 31, 2022, for 26 drugs and biologicals listed in Table 28 (page 42121 of the proposed rule).

• CMS also proposed to continue/establish pass–through status in CY 2022 to 46 others, shown in Table 29 (page 42124 of the proposed rule).

Drugs, biologicals, and radiopharmaceuticals above the packaging threshold will continue to be paid at average sales price (ASP) plus 6%.

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Drugs Acquired Under 340B

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• The 340B adjustment applies to drugs priced based on WAC and average wholesale price.

• CMS proposes to continue paying for drugs priced under WAC at WAC minus 22.5%, while those acquired under average wholesale price (AWP) pricing are paid at 69.46% of AWP.

• Proposed Exemptions: Critical access hospitals (CAHs), sole community hospitals (SCHs), children’s hospitals, and PPS–exempt cancer hospitals will receive drug payments based on ASP plus 6% if finalized.

• Modifier “JG” is used by non–exempt hospitals to report separately payable drugs that were acquired through the 340B program, and thus paid the reduced rate.

• Modifier “TB” is used by hospitals exempt from the 340B payment adjustment to report separately payable drugs that were acquired through the 340B program.

CMS proposes continuing to pay ASP minus 22.5% for separately payable drugs and biologicals acquired under the 340B program.

Payment for Off-Campus PBD Clinic Visits

CALIFORNIA HOSPITAL ASSOCIATION 18

• These excepted PBDs continue to bill HCPCS code G0463 with modifier “PO”.

CMS is proposing to continue to apply a 60% reduction to the OPPS rate for excepted off–campus provider-based departments (PBDs) for basic clinic services in CY 2022.

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Inpatient-Only (IPO) List

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• CMS proposes reinstating the 266 musculoskeletal services and 32 other Healthcare Common Procedure Coding System (HCPCS) codes that were removed in CY 2021.

• CMS proposes codifying in regulation the five criteria to determine if a procedure or service should be removed from the IPO list.

• CMS solicits comments on services that were removed in CY 2021 and should remain off the list but are proposed to be reinstated for CY 2022.

CMS proposes to halt the elimination of the IPO list.

2-Midnight Rule for IPO List

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• In the CY 2020 OPPS final rule, CMS established a two–year exemption from

medical review activities, including referrals to recovery audit contractors

(RACs), site–of–service claim denials, and RAC reviews for “patient status” for

procedures removed from the IPO list for CY 2020 and forward.

• In the CY 2021 OPPS rule, CMS finalized an indefinite exemption from medical

review activities for procedures removed from the IPO list on or after

January 1, 2021.

CMS proposes rescinding the indefinite exemption period and reinstating the two–year exemption from medical review activities for procedures removed from the IPO list beginning on or after January 1, 2021.

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Pass-Through Payments: Devices

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There are currently 11 device categories eligible for pass–through payment:

*CMS proposes to continue to provide separate payment for C1823 through 2022.

Table 17: Expiration of Transitional Pass-Through Payments for Certain Devices

HCPCS

CodesLong Descriptor

Effective

Date

Pass-Through

Expiration Date

C1823 Generator, neurostimulator (implantable),

nonchargeable, with transvenous sensing and

stimulation leads

1/1/2019 12/31/2021*

C1824 Generator, cardiac contractility modulation

(implantable)

1/1/2020 12/31/2022

C1982 Catheter, pressure-generating, one-way valve,

intermittently occlusive

1/1/2020 12/31/2022

C1839 Iris prosthesis 1/1/2020 12/31/2022

C1734 Orthopedic/device/drug matrix for opposing bone-

to-bone or soft tissue-to bone (implantable)

1/1/2020 12/31/2022

Pass-Through Payments: Devices (cont.)

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There are currently 11 device categories eligible for pass–through payment:

Table 17: Expiration of Transitional Pass-Through Payments for Certain Devices

HCPCS

CodesLong Descriptor

Effective

Date

Pass-Through

Expiration Date

C2596 Probe, image-guided, robotic, waterjet ablation. 1/1/2020 12/31/2022

C1748 Endoscope, single-use (that is, disposable), upper GI,

imaging/illumination device (insertable).

7/1/2020 6/30/2023

C1052 Hemostatic agent, gastrointestinal, topical. 1/1/2021 12/31/2023

C1062 Intravertebral body fracture augmentation with

implant .

1/1/2021 12/31/2023

C1825 Generator, neurostimulator (implantable)

nonchargeable with carotid sinus baroreceptor

simulation lead(S).

1/1/2021 12/1/2023

C1761 Catheter, transluminal intravascular lithotripsy,

coronary.

7/1/2021 6/30/2024

*CMS proposes to continue to provide separate payment for C1823 through 2022.

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Device Intensive Procedures

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CMS proposes assigning an offset percentage based on CY 2020 data for the 11

procedures, if available, instead of the proposed CY 2019 data.

Proposed 2022 Device Offset Percentages Using 2020 Claims Data

HCPCS Code Code Descriptor

0266T Implantation or replacement of carotid sinus baroflex activation device; total system.

0414T Removal and replacement of cardiac contractility modulation system pulse generator.

0511T Removal and reinsertion of sinus tarsi implant.

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, posterior tibial nerve.

0600T Ablation, irreversible electroporation; 1 or more tumors per organ, imaging guidance,

percutaneous.

0614T Removal and replacement of substernal implantable defibrillator pulse generator.

66987 Extracapsular cataract replacement with insertion of intraocular lens prosthesis,

complex.

66988 Extracapsular cataract replacement with insertion of intraocular lens prosthesis, manual

or mechanical technique.

Device Intensive Procedures (cont.)

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CMS proposes assigning an offset percentage based on CY 2020 data for the 11

procedures, if available, instead of the proposed CY 2019 data.

Proposed 2022 Device Offset Percentages Using 2020 Claims Data

HCPCS Code Code Descriptor

C9757 Laminectomy (hemilaminectomy), with decompression of nerve

roots.

C9765 Revascularization, endovascular, open or percutaneous, lower

extremity artery(ies), except tibial/peroneal; with intravascular

lithotripsy, and transluminal stent placement, including angioplasty

when performed.

C9767 Revascularization, endovascular, open or percutaneous, lower

extremity artery(ies), except tibial/peroneal; with intravascular

lithotripsy, and transluminal stent placement, and atherectomy,

including angioplasty when performed.

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Sole Community Hospital (SCH) Adjustment

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• This includes services and procedures paid under the OPPS, excluding separately payable drugs and biologicals, devices paid under the pass-through payment policy, and items paid at charges reduced to costs.

• The adjustment is budget neutral and is applied before calculating outliers and copayments.

• CMS is proposing to maintain this for future years until data supports a change to the adjustment.

CMS proposes to continue applying a 7.1% payment adjustment to all SCHs.

Cancer Hospital Adjustment

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• CMS adjusts payments so the hospital’s target payment–to–cost ratio (PCR) after the additional payments is equal to the weighted average PCR for the other OPPS hospitals.

• Due to the COVID–19 PHE, CMS is holding the target PCR equal to that of CY 2021.

• Since this is the same target PCR as CY 2021, CMS proposed a 0% adjustment to the CY 2022 conversion factor to account for this policy.

CMS proposes continuing providing payment increases to the 11 hospitals

identified as exempt cancer hospitals.

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Partial Hospitalization Program (PHP) Services

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• CMS proposes a cost floor equal to the per diem cost finalized in CY 2021 for both CHMC-

and hospital–based PHPs.

• CMS is proposes using CY 2019 claims and cost report data for rate setting.

• CMS proposes to continue to make outlier payments to CMHCs for 50% of the amount by

which the cost for the PHP service exceeds 3.4 times the highest CMHC PHP APC payment

rate implemented for that calendar year.

The table below compares the final CY 2021 and proposed CY 2022 PHP rates:

Final

Payment

Rate

2021

Proposed

Payment

Rate 2022

Percent

Change

APC 5853: Partial Hospitalization (3+ services) for

CMHCs$139.75 $143.42 +2.6%

APC 5863: Partial Hospitalization (3+ services) for

Hospital-Based PHPs$260.49 $267.31 +2.6%

Beneficiary Co-Insurance for Colorectal Cancer Screening

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Beginning January 1, 2022, the Consolidated Appropriations Act (CAA) of 2021 reduces coinsurance for screening colonoscopies if tissue is removed as a result of the test.

• Patients are still responsible for 20% of the associated coinsurance if services are furnished as a diagnostic service.

• Providers must continue to report HCPCS modifier “PT” to indicate a planned screening service converted to a diagnostic service.

• All surgical services furnished on the same date as a planned screening colonoscopy could be viewed as part of this policy for the purposes of determining the coinsurance required of Medicare beneficiaries.

YearMedicare

Payment %

Beneficiary

Coinsurance

%

2022 80 20

2023 through

202685 15

2027 through

202990 10

2030 and

subsequent

years

100 0

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Rural Emergency Hospital (REH)- Background

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The CAA of 2021 establishes REHs as a new provider type starting January 1, 2023.

• REHs provide emergency department services, observation care, and potentially other medical and health services on an outpatient basis.

• REHs must not provide inpatient services (except skilled-nursing facility services in a distinct unit).

• CAHs and rural hospitals with fewer than 50 beds are eligible to convert to an REH.

• REHs will be paid at the OPPS rate plus 5%.

• REHs will also receive a monthly payment based on the excess of the total amount paid to all CAHs in 2019 over the estimated total amount that would have been paid to CAHs in 2019 if payment were made for inpatient, outpatient, and SNF services under the PPS.

REH – Request For Information

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CMS seeks comment on the health and safety standards, payment policies, enrollment, health equity, and quality measures and reporting requirements.

• Type and scope of services offered, including what outpatient medical and health

services should be considered as eligible services.

• Health and safety standards, including licensure and conditions of participation.

• How REHs can help address social needs in rural areas and if there are additional

factors to consider for specific populations.

• Quality measures, including quality reporting requirements, specification of measures,

and public reporting of data.

• Payment provisions, including what payment reporting issues should be considered

when estimating payments under prospective payment systems for service furnished.

• Enrollment process, such as the steps and timing for conversion to an REH.

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No Significant Changes Proposed

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• Blood and Blood Products• Composite APCs• Device Edit Policy• Adjustment to OPPS Payment for No Cost/Full Credit and Partial Credit Devices• High/Low-Cost Threshold for Packaged Skin Substitutes (Table 32 – pg. 42139)

The proposed rule does not include significant changes in the following areas for CY 2022.

Radiation Oncology (RO) Model – Proposed Changes

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Topic Finalized Policy per the IFC Proposed Policy Modifications*

RO Model

performance period

4.5 years, beginning on July 1, 2021, and

ending on December 31, 2025.

5 years, beginning on January 1, 2022,

and ending on December 31, 2026.

Quality Measure dataQM reporting delayed until PY3, for data

from PY2.

RO participants will submit QM data

starting in PY2 for PY1.

Clinical Data Element

dataCDE reporting beginning in PY2.

RO participants will submit CDE data

starting in PY1.

*See proposal in the CY 2022 OPPS/ASC Payment System NPRM.

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RO Model – Proposed Changes (cont.)

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Topic Finalized Policy per the IFC Proposed Policy Modifications*

RO participant

exclusions

HOPDs that participate in or are

identified as eligible to participate in

the PARHM are excluded from the

RO Model.

Only HOPDs that participate in the PARHM are

excluded from the RO Model.

RO Model exclusion for HOPDs participating in the

Community Transformation track of the CHART

Model.

Low volume

opt-out policy

A new TIN or CCN that results from a merger,

acquisition, or other business relationship is not

eligible for the low volume opt-out if the entities

involved have furnished 20 or more episodes of RT

services as a combined total across all CBSAs selected

for participation in the most recent year with claims

data available.

EUC policy . Added Extreme and Uncontrollable Circumstances

Policy.

*See proposal in the CY 2022 OPPS/ASC Payment System NPRM.

RO Model – Proposed Changes (cont.)

CALIFORNIA HOSPITAL ASSOCIATION 34*See proposal in the CY 2022 OPPS/ASC Payment System NPRM

Topic Finalized Policy per the IFC Proposed Policy Modifications*

Included modalities Includes brachytherapy Excludes brachytherapy

Baseline period

Baseline period for the national base rate updated to be the

most

recent 3-year period, where the last year of the baseline period

is three years before the calendar year in which the model

performance period begins.

Baseline period will be used to establish separate PC and TC

national base rates for each of the included cancer types, the

participant-specific historical experience adjustments for the

model performance period, and the participant-specific case

mix adjustments for PY1.

Discount ratePC: 3.75%

TC: 4.75%

PC: 3.5%

TC: 4.5%

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RO Model – Proposed Changes (cont.)

CALIFORNIA HOSPITAL ASSOCIATION 35

Topic Finalized Policy per the IFC Proposed Policy Modifications*

Individual practitioner changes

notification deadline

Within 30 days of receiving

the IPLBy the QPP snapshot date

*See proposal in the CY 2022 OPPS/ASC Payment System NPRM.

RO Model – Proposed Changes (cont.)

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Topic Finalized Policy per the IFC Proposed Policy Modifications*

True-Up

Reconciliation

Timing

CMS will conduct the PY1 true-up reconciliation as

early as August 2023, and the PY2 true-up

reconciliation as early as August 2024, and so forth.

CMS will conduct the true-up reconciliation as early as

August of the CY following an initial reconciliation for a PY.

Under the proposed rule, reconciliation would start in 2023

and true-up would start in 2024.

RO Model

Requirements

All eligible clinicians participating in the RO Model

have the opportunity to become QPs or Partial QPs

based on meeting the relevant payment or patient

count thresholds, and thereby exempt from the MIPS

reporting requirements and payment adjustment for

the relevant year. Those that do not meet Model

requirements would not be eligible for Advanced APM

payments.

Track One and Track Two designations for Professional and

Dual participants based on compliance, as well as Technical

participants.

Incomplete

Episodes

Exception for when traditional Medicare ceases to be

the primary payer for an RO beneficiary after the TC

of the RO episode has been initiated but before all

included RT services in the RO episode have been

furnished, in which case each RO participant would be

paid only the first installment of the episode payment.

For all incomplete episodes, including when the RO

beneficiary ceases to have traditional FFS Medicare before

all included RT services in the RO episode have been

furnished, CMS would reconcile the episode payment for

the PC and TC that was paid to the RO participant(s) with

what the FFS payments would have been for those RT

services using no-pay claims.

*See proposal in the CY 2022 OPPS/ASC Payment System NPRM.

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Hospital Price Transparency

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• Under the Hospital Price Transparency final rule, CMS requires all hospitals post price information on their website to comply with two specific requirements:

✓ Post gross charges, payer-specific negotiated rates, the de-identified minimum and maximum negotiated rates, and the cash discount price for all items and services on a website in a machine-readable format.

✓ Post information for 300 “shoppable” services (70 CMS-specified and 230 hospital-selected) in a “consumer-friendly manner,” OR provide an Internet-based price estimator tool for common shoppable services.

• In response to what CMS deems as high rates of noncompliance with the requirements — which were effective January 1, 2021 — CMS proposes to increase the maximum civil monetary penalty (CMP) (currently $300/day) using a scaling factor to establish the CMP amount for a noncompliant hospital.

• CMS proposes to use the noncompliant hospital’s number of beds as specified in hospital cost report data as the scaling factor to establish CMP amounts.

Hospital Price Transparency - Proposed CMPs

CALIFORNIA HOSPITAL ASSOCIATION 38

*The above amounts would be adjusted annually beginning in 2023 using the multiplier determined by the Office of Management and Budget for adjusting CMPs.

Number of Beds Penalty Applied Per DayTotal Maximum Penalty for a

Full Calendar Year of Non-compliance

30 or less $300 per hospital $109,500 per hospital

31 up to 550 $310 - $5,500 per hospital (number of beds x 10)

$113,150 – $2,007,500 per hospital

Greater than 550 $5,500 per hospital $2,007,500 per hospital

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Hospital Price Transparency

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• Machine-Readable File: CMS proposes to specify that the hospital must ensure that standard charge information is easily accessible, without barriers, including but not limited to ensuring the information is accessible to automated searches and direct file downloads through a link posted on a publicly available website.

• Shoppable Services and Price Estimator Tool: CMS clarifies that price estimator tools must be “tailored to individuals’ circumstances” to satisfy requirements as an alternative to posting shoppable services price information.

✓ Hospital must provide real-time individualized out-of-pocket estimates that combine hospital standard charge information with the individual’s benefit information directly from the insurer or provide the self-pay amount.

• Requests for Comment for Future Rulemaking:

✓ Best practices for price estimators

✓ Standardization of machine-readable file

✓ Expectations for plain language descriptions of shoppable services

✓ Recognizing “exemplar” hospitals

Hospital Outpatient Quality Reporting (OQR) Program –Proposed Changes to Measure Set

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CY Payment Determination

Proposed New Measures CY Payment Determination

Proposed Measure Removals

CY 2023 Breast Screening Recall Rates CY 2025 Fibrinolytic Therapy Received Within 30 Minutes of Emergency Department Arrival (OP-2)

CY 2024 COVID-19 Vaccination Coverage Among Health Care Personnel

Median Time to Transfer to Another Facility for Acute Coronary Intervention (OP-3)CY 2025

(Voluntary)/CY 2026 (Mandatory)

ST-Segment Elevation Myocardial Infarction (STEMI) eCQM

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COVID-19 Vaccination Coverage among Healthcare Personnel (HCP) Measure

CALIFORNIA HOSPITAL ASSOCIATION 41

• Proposed measure would track the percentage of healthcare personnel (HCP) who receive a complete COVID-19 vaccination.✓ Detailed measure specifications available on CDC’s website

✓ For OQR Program, CMS clarifies that acute care facilities would count all HCP working in all inpatient or outpatient units that share a hospital’s CMS Certification Number (CCN), regardless of a unit’s size or type.

• CMS proposes to require an initial data reporting of January 1, 2022, through December 31, 2021, for the CY 2024 payment year.

• Hospitals would submit measure data using the National Health Safety Network’s (NHSN) standard data submission requirements via the CDC/NHSN web-based surveillance system.

• CMS would publicly report the CDC-calculated vaccination coverage rates on a quarterly basis on Care Compare.

• CMS has finalized this measure for the inpatient quality reporting (IQR) program, SNF QRP, and inpatient rehabilitation facility QRP beginning with FFY 2023 payment determination.

Hospital OQR Program – Modifications to Previously Adopted Measures

CALIFORNIA HOSPITAL ASSOCIATION 42

CMS also proposes modifications to two previously adopted – but delayed – measures:

• Cataracts: Improvement in Patient’s Visual Function within 90 Days Following Cataract Surgery (OP-31): CMS proposes to require mandatory reporting through the CMS web-based tool beginning with the 2023 reporting year/2025 payment determination.

• Outpatient and Ambulatory Surgery Consumer Assessment of Healthcare Providers and Systems (OAS CAHPS) Survey-Based Measures (OP-37a-e): CMS proposes a voluntary reporting for the 2023 reporting period/2025 payment determination, and mandatory reporting beginning with the 2024 reporting period/2026 payment determination.

✓ CMS proposes to add two web-based data collection modes for the 2023 reporting period/2025 payment determination.

✓ CMS proposes a low-volume exception that would apply to hospitals with fewer than 60 survey-eligible patients during the calendar year just prior to the data collection period.

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Additional OQR Program Proposals

CALIFORNIA HOSPITAL ASSOCIATION 43

• CMS proposes several changes to electronic clinical quality measures (eCQMs) reporting to align with IQR and Promoting Interoperability Program requirements.

• CMS proposes changes to the OQR data validation process beginning with the 2022 reporting period/2024 payment to further align the OQR Program with the hospital IQR Program.

• CMS seeks comments for future rulemaking:

✓ Measures to assess quality of care for services whose delivery is shifting from inpatient to outpatient settings.

✓ Adoption of a Hospital-Level Risk-Standardized Patient Reported Outcomes Measure Following Elective Primary Total Hip and/or Total Knee Arthroplasty specified for the outpatient setting.

• CMS continues its focus on health equity seeking comment on:

✓ Stratification of certain measure hospital-specific reports by dual eligibility and race and ethnicity.

✓ Hospital collection of standardized demographic information.

Requests for Information: dQMs and Safe Use of Opioids eCQM

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• CMS continues to requests input into the agency’s planning for transformation to a fully digital quality enterprise by 2025, posing numerous questions grouped into three categories:

✓ Definition of digital quality measures (dQMs).

✓ Potential role of Fast Healthcare Interoperability Resources (FHIR)-based standards, including transitioning to FHIR-based quality reporting through APIs for existing eCQMs.

✓ How dQMs could support alignment across public and private quality measurement efforts.

• Under both the hospital IQR and Promoting Interoperability programs, hospitals are required to report three self–select eCQMs and the Safe Use of Opioids eCQM beginning with the 2022 reporting period.

✓ CMS seeks feedback on whether reporting the Safe Use of Opioids eCQM should be required or self–selected by hospitals as part of the available eCQM measure set.

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Request for Comment on Maintaining COVID-19 PHE Flexibilities

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CMS seeks comment on permanently extending several temporary policies intended to address the COVID-19 PHE:

• Mental Health Services Furnished Remotely by Hospital Staff to Beneficiaries in their homes.

• Direct Supervision by Interactive Communications Technology.

• Payment for COVID-19 Specimen Collection in HOPDs.

Questions

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Physician Fee ScheduleKey Provisions

Physician Fee Schedule – Conversion Factor

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CMS proposes a slight decrease in PFS payment rates of 0.14% in CY 2022 .

• The actual change from the final CY 2021 conversion factor of $34.89 to the proposed CY 2022 conversion factor of $33.58 is a decrease of $1.31, or 3.89%.

• This reflects the expiration of the one-time 3.75% payment increase to the conversion factor included in the CAA of 2021, a zero-percent update factor as required by MACRA and a budget-neutrality adjustment.

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RHC Modernization Act

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• Definition of Existing RHCs: “Existing” RHCs that are provider-based to hospitals under 50 beds must have either:

1. Been enrolled in Medicare as of December 31, 2020; or2. Submitted an application for enrollment in Medicare that was received no

later than December 31, 2020.

• Medical economic index: the proposed inflation factor for 2022 is 1.8 precent. CMS will likely update this in the final rule based on more recent data if it is available.

• Base year: The proposed rule clarified that if an RHC does not have a calendar year cost report, the 2020 reasonable cost per visit will be from the cost report that ends in 2020.

The CAA of 2021 capped the all-inclusive rate for existing RHCs that are provider-based to hospitals with less than 50 beds for services provided after April 1, 2021.

Payment for Therapy Services

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• CMS proposes polices to implement requirements that the agency identifies and pays 85% of the otherwise applicable Part B payment amount for physical therapy and occupational therapy services furnished in whole or in part by physical therapist assistants (PTAs) and occupational therapy assistants (OTAs), for dates of service on and after Jan. 1, 2022.

• In previous rulemaking, CMS defined “in whole or in part” via de minimis standard and established modifiers (CQ/CO) to identify these claims.

• CMS proposes to clarify:

✓ Modifiers would apply if PTA /OTA furnishes 8 or more minutes of a timed unit of service, regardless of the minutes of service provided by the PT/OT.

✓ Modifiers would NOT apply if PT/OT provides 8 or more minutes of service, regardless of the minutes of service provided by the PTA/OTA.

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Evaluation & Management (E/M) Split Billing

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• Definition: CMS proposes to define a split (or shared) visit as an E/M visit in the

facility setting that is performed in part by both a physician and a non-physician

practitioner (NPP) who are in the same group. CMS proposes to define facility

setting as an institutional setting in which “incident to” payment is prohibited.

• New and established patients; initial and subsequent visits: CMS proposes to modify

existing policy to allow physicians and NPPs to bill for split (or shared) visits for

both new and established patients and for both initial and subsequent visits.

• Substantive portion: CMS proposes to define the “substantive portion” of the split

(or shared) visit as more than half of the total time spent by the physician and non-

physician practitioner performing the visit.

CMS includes the following proposals related to split (or shared) visits:

E/M Split Billing (cont.)

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• Qualifying activities: CMS includes in the rule a list of activities that it proposes

to count toward total time for purposes of determining the substantive portion

of the visit.

• Claim identification: CMS proposes to create a modifier to describe split (or

shared) visits that providers would be required to append to claims for these

visits.

• Critical care services: The agency proposes to allow critical care visits to be

furnished as split (or shared) visits and delineates a unique list of qualifying

activities as well as other policies specific to split (or shared) critical care.

CMS includes the following proposals related to split (or shared) visits:

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Critical Care Split Billing

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• Concurrent Care: CMS proposes to allow critical care services to be furnished as

concurrent care if medically necessary and not duplicative. Concurrent care is

defined as more than one physician or qualified NPP furnishing services to the

same patient on the same day.

• Global Surgical Period: CMS also proposes to bundle critical care visits with

procedure codes that have a global surgical period.

CMS proposes to adopt the Current Procedural Terminology (CPT) Professional Codebook definition of critical care that delineates where, when and by whom critical care services may be delivered.

Physician Self Referral - Clarifications

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• The two-step analysis will apply to any unbroken chain of financial relationships in

which the compensation paid under the arrangement closest to the physician (or

immediate family member) is for anything other than services personally performed by

the physician.

• CMS proposes to define personally performed services to “not include services that are

performed by any person other than the physician (or immediate family member),

including, but not limited to, the referring physician’s (or immediate family member’s)

employees, independent contractors, group practice members, or persons supervised

by the physician (or the immediate family member).”

• CMS views all compensation as unit-based; as such, an underlying unit may be a

discrete item, a unit of service, a unit of time or a unit that results from combining

different types of units into a single unit used to calculate the compensation.

CMS proposes to clarify the “streamlined” two-step analysis of physician compensation

arrangements that was finalized in 2020.

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Medicare Shared Savings Program (MSSP): Quality Reporting

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CMS proposes a longer phase-in of the requirement to report the APM Performance Pathway (APP) performance measure set.

• For CY 2022 PY, Accountable Care Organizations (ACOs) permitted to report either the current MSSP measures via the CMS web interface, or the MIPS APP set.

• For CY 2023, ACOs that report the web interface measure set also would be required to report at least one measure from the APP measure set.

Performance Year (PY)

Web Interface Option APP Measure Option

2022 • Report the ten web interface measures.✓ Three measures* do not have

performance benchmarks, but must still be reported.

• Report the CAHPS for MIPS survey.

• Be scored on the two APP. administrative claims measures (i.e. hospital wide unplanned readmissions for multiple chronic conditions).

• Report the three APP MIPS CQM/eCQM measures:✓ Diabetes Hemoglobin

HbA1c Poor control (MIPS quality ID# 001).

✓ Preventative care and screening: Screening for depression and follow up plan (MIPS quality ID# 134).

✓ Controlling high blood pressure (MIPS quality ID# 236).

• Report CAHPS for MIPS survey.• Be scored on the two APP claims

based measures.2023 Same as 2022, except:

• Report at least one APP MIPS cQM/eCQM measure.

Same as 2022.

MSSP: Quality Standard

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CMS proposes to delay the increase of the minimum quality standard from the 30th to the 40th percentile until the CY 2024 performance year.

Performance Year Web Interface Option APP Measure Option

2022 ACO meets all data reporting and submission requirements and achieves quality performance score at or above 30

thpercentile of

all MIPS quality category scores.

ACO meets all APP data reporting requirements and achieves a quality performance score on at least one APP measure that is at or above the 30

thpercentile benchmark score for

the measure.

2023 Same as 2022 Same as 2022

2024 Not available ACO meets all APP data reporting requirements and achieves a quality performance score at or above the 40

thpercentile of all MIPS quality

category scores.

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MSSP: Beneficiary Attribution

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CMS proposes adding the following additional codes to the definition of primary care services for Performance Year 2022:

• Chronic care management code 99X21*.

• Principal care management codes 99X22, 99X23, 99X24 and 99X25*.

• Prolonged office or other E/M service HCPCS code G2212.

• Communication Technology-Based Service (CTBS) HCPCS code G2252 (for a prolonged virtual check-in that can be provided via audio-only connection)*.

CMS also proposes to continue allowing telephone E/M codes (99441 through 99443) to be used for beneficiary assignment until they are no longer be payable under Medicare telehealth policies.

* If CPT/HCPCS codes in question are finalized through this rule as proposed.

MSSP: Reduced Repayment Mechanism

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CMS believes repayment mechanisms are larger than necessary and makes the following proposals to reduce them.

• Changing the methodology used to calculate the repayment mechanism amount, lowering the required amount.

• Changing the methodology to more clearly specify the assigned population used as a multiplier in annually recalculating the repayment mechanism amount.

• Allowing ACOs already in two-sided participation agreements a one-time opportunity to decrease the amount of their repayment mechanism.

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MSSP: Reduced Application Burden

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CMS proposes to modify three provisions of its application requirements.

• Instead of being mandatory, CMS proposes that prior participation disclosure requirements are required only at the request of the agency during the application process.

• CMS proposes removing provisions requiring an ACO to submit sample ACO participant agreements during the application process.

• CMS proposes removing provisions requiring an ACO to submit an executed agreement for each ACO participant at the time of its initial application or participation agreement renewal process.

MSSP: Benchmark Request for Information (RFI)

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Stakeholders have expressed concerns that the MSSP benchmarking methodology penalizes efficient ACOs. The proposed rule discusses ideas to respond to those concerns and requests feedback.

• CMS describes an approach to benchmarking per-capita risk-adjusted regional fee-for-service (FFS) expenditures for all assignable beneficiaries in an ACO’s regional service area (a) as a weighted average of the FFS expenditures for the ACO’s assigned beneficiaries (b) and the assignable beneficiaries in the region who are not actually assigned to the ACO (c).

• A simulation of this approach found that the average increase in the updated benchmark by quintile ranged from 0.1% to 1.4%, although some ACOs saw decreases in their benchmarking amounts.

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MSSP: Benchmark RFI (cont.)

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CMS seeks comment on several issues related to the use of regional FFS expenditures in benchmarks, including:

• CMS’ approach or alternative approaches to calculating regional FFS expenditures without including an ACO’s assigned beneficiaries.

• Whether market penetration should be considered in benchmark calculations and what constitutes heavy penetration in the ACO’s regional service area.

• Possible unintended consequences that could result from removing an individual ACO’s assigned beneficiaries from regional calculations.

• Whether removal of an ACO’s assigned beneficiaries from regional FFS calculations brings about a need to remove ACO assigned beneficiaries from other MSSP financial calculations.

• Other approaches to calculating benchmarks that would reduce the influence of an ACO’s assigned beneficiaries on regional expenditure calculations.

MSSP: Risk Adjustment RFI

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CMS also requests comment on issues related to its risk adjustment methodology, including:

• Approaches to improving the risk adjustment methodology and specifically for ACOs with medically-complex, high-cost beneficiaries.

• Approaches to risk adjustment that would balance the need for accurate and complete coding, while protecting against incentivizing coding intensity initiatives by ACO participants and ACO providers/suppliers.

• Alternate approaches that would increase the cap on an ACO’s risk score growth in relation to risk score growth in the ACO’s regional service area.

• Potential interactions between policies to remove assigned beneficiaries from the assignable beneficiary population used to calculate regional FFS expenditures and growth rates and policies addressing regional risk score growth.

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Medicare Telehealth Services

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• In CY 2021, CMS finalized a new “Category 3” list of Medicare telehealth services to describe services added temporarily during the COVID-19 PHE for which there is clinical benefit when furnished via telehealth, but for which there is not yet sufficient evidence to consider the services as permanent additions under Category 1 or Category 2 criteria.

• CMS proposes to retain all services added to the Medicare telehealth services list on a Category 3 basis until the end of CY 2023.

• CMS also seeks comment on whether any of the services added to the Medicare telehealth list for coverage and payment during the PHE that were not extended on a temporary Category 3 basis in the CY 2021 PFS final rule should now be added to the Medicare telehealth list under Category 3.

✓ These services are identified in Table 11 of the proposed rule.

Medicare Telehealth Services – Table 11 Services

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Medicare Telehealth – Mental Health Services

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• The Consolidated Appropriations Act (CAA) waived the Medicare geographic restrictions and added the patient’s home as a permissible originating site for telehealth services furnished for the purpose of diagnosis, evaluation or treatment of a mental health disorder, effective for services furnished on or after the end of the COVID-19 PHE.

• CMS proposes to require providers conduct an in-person, non-telehealth service within six months prior to initial mental health telehealth service, and at least once every six months thereafter.

✓ CMS seeks comment on whether the required in-person, non-telehealth service could be furnished by another physician or practitioner of the same specialty and same subspecialty within the same group as the physician or practitioner who furnishes the telehealth service.

• CMS proposes to revise its regulatory definition of “interactive. telecommunications system” to permit the use of audio-only communications technology for mental health services under certain conditions when provided to beneficiaries located in their home.

Medicare Telehealth Services and Other Communications Technology-Based Services

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• Direct Supervision: During the COVID-19 PHE, CMS allowed providers to satisfy “direct supervision” requirements for diagnostic tests, physicians’ services and some hospital outpatient services through virtual presence, using real-time audio/video technology, and finalized this policy through the later of the end of the calendar year in which the PHE ends or Dec. 31, 2021. CMS seeks comment on whether it should make this flexibility permanent or if it should temporarily continue it beyond the current timeframe.

• Extended Virtual Check-in: CMS proposes to permanently adopt coding and payment for HCPCS code G2252, extended virtual check-in provided using any form of synchronous communication technology, including audio-only communication.

• Remote Therapeutic Monitoring (RTM): CMS provides several clarifications on RTM services, including that it believes RTM codes are “incident to” services and therefore cannot be billed independently by physical therapists and other practitioners who are not physicians or NPPs.

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Appropriate Use Criteria (AUC) for Advanced Diagnostic Imaging Services

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• The Protecting Access to Medicare Act (PAMA) of 2014 required CMS to create a program promoting use of AUC for advanced diagnostic imaging.

• Restricts payment to furnishing professional for claims that indicate that ordering professional consulted with qualified a clinical decision support mechanism (CDSM).

• Applies only in “applicable settings”: Hospital outpatient departments, physician offices, ambulatory surgical centers, and independent diagnostic testing facilities.

✓ Outpatient department of a critical access hospital is not an applicable setting.

• The AUC program has operated under an “educational and testing” period since Jan. 1, 2020.

✓ In response to the COVID-19 PHE, CMS extended the educational and operational testing period through 2021.

AUC for Advanced Diagnostic Imaging Services (cont.)

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• CMS proposes to delay the payment penalty phase of the AUC program to Jan. 1, 2023 — or the first of the January that follows the end of the PHE —whichever is later.

✓ CMS clarifies that stakeholders may continue to attest to a significant hardship under the AUC program due to extreme and uncontrollable circumstances related to the PHE and that such an attestation may be used as needed throughout the PHE.

• CMS proposes and seeks comment on several additional policies related to implementation of the AUC payment penalty phase.

✓ Modified orders

✓ Claims processing edits and modifiers

✓ Denial vs return of claims that fail AUC processing edits

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Additional PFS COVID-19 PHE Related Policies

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• Clinical Lab Fee Schedule: Lab Specimen Collection and Travel Allowance

✓ During COVID-19 PHE, CMS established a revised policy to pay independent labs for specimen collection for COVID-19 testing at an increased rate of $23-$25 (from the current rate of $3-$5).

✓ CMS expects this policy to end with the PHE but seeks comment on considerations for specimen collection for COVID testing beyond the PHE.

• Expansion of Coverage for Pulmonary Rehabilitation

✓ CMS proposes to expand coverage of outpatient pulmonary rehab services to beneficiaries with “severe manifestations” of COVID-19.

o CMS proposes to define “severe manifestations” as patients requiring hospitalization in the ICU or otherwise who experience continuing symptomatology, including respiratory dysfunction, for at least 4 weeks post discharge.

Quality Payment Program

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• CMS proposes several changes to Merit-based Incentive Payment System (MIPS) thresholds and categories:✓ Performance threshold

✓ Quality data completeness threshold

✓ Removal of 3-point floor for certain measures

✓ Five new episode-based cost measures

✓ Updated Improvement Activities inventory

✓ Changes to complex patient bonus

✓ Changes to Promoting Interoperability program generally aligned with hospital program

• CMS proposes to implement 7 voluntary MIPS Value Pathways beginning CY 2023:✓ Rheumatology, stroke care and prevention, heart disease, chronic disease management,

lower extremity joint repair, emergency medicine, anesthesia.

✓ Organizes each MIPS category’s reporting requirements around particular treatments, specialties or other priorities.

Additional information available in CMS Fact Sheet

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Questions

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Closing Comments and Next Steps

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Contact

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Please contact us if you have questions we were not able to address today.

Chad MulvanyVP, Federal Policy(202) [email protected]

Megan HowardVP, Federal Policy(202) [email protected]

Thank You

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Thank you for participating in today’s webinar.

A recording of the program will be sent to each attendee within two weeks.

For education questions, contact:

[email protected]

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