PARA HealthCare Analytics Weekly eJournal September 8, 2021

September 8, 2021

PARA

WeeklyeJOURNAL NEWS FOR HEALTHCARE DECISION MAKERS Fin d Ou t Wh y Zer o Is A Good Nu m ber Page 25

Clar if yin g PAM A Repor t in g

Ou t pat ien t Th er apy Billin g Page 2

Page 20

- COVID-On ly Test in g - CMS Proposes Rescinding Most Favored Nation Model - ACTEM RA Updat e: CM S HCPCS Q0249 Tocilizu m ab - Webinar: Zero Balance Insurance AR

FAST LINKS

- Appr opr iat e Use Com plian ce Deadlin e Delayed - Pfizer COVID Vaccine Ar e You Rollin g - CM S Rever sin g IPO Th e Dice On Pr ice List An d ASC CPL - EUA Amended Tr an spar en cy?

- FDA To Wit h dr aw EUA Page 17 On COVID PCR Test

- Administration: Pages 1-44 - HIM /Coding Staff: Pages 1-44 - Providers: Pages 2,7,12,30,34,35,36 - COVID Treatment: Pages 7,9,22,29,30,32,38 - Finance: Pages 8,11,251

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PAM A: Pages 12,20 Price Transparency: Page 17 Laboratory: Page 20 Pharmacy: Pages 22,29 Emergency Dept: Page 34 Imaging: Page 35 Pulmonology: Page 36

© PARA Healt h Car e An alyt ics an HFRI Company CPT® is a r egist er ed t r adem ar k of t h e Am er ican M edical Associat ion

PARA Weekly eJournal: September 8, 2021

OUTPATIENT THERAPY BILLING

We need help with outpatient therapy billing. There are lots of nuances that we have never had to learn before.

We are wondering if there was any assistance from PARA, either through the articles in the eJournal or anything else we could use to study about billing outpatient PT, OT and ST, including Medicare and Medicaid requirements?

Can you help with some resources?

Answer: PARA has papers and resources for outpatient therapy service billing.

Attached are several of our articles. The papers can be found on the PDE under the Advisor tab. Enter a key word or phrase to pull up potentially relevant articles. Please note that using one key word may garner more information while using a longer phrase may exclude relevant articles. Also note the issue date to make sure you have the most recent information.

On February 9, 2018, the Bipartisan Budget Act of 2018 (BBA of 2018) (Public Law 115-123) was signed into law. This law included two provisions related to Medicare payment for outpatient therapy services including physical therapy (PT), speech-language pathology (SLP), and occupational therapy (OT) services: - Section 50202 of the BBA of 2018 repeals application of the Medicare outpatient therapy caps and its exceptions process while adding limitations to ensure payment for appropriate therapy services - Section 53107 of the BBA of 2018 relates to the payment of OT and PT services furnished by therapy assistants 2

PARA Weekly eJournal: September 8, 2021

OUTPATIENT THERAPY BILLING

Through section 50202 of the BBA of 2018, the law preserves the former therapy cap amounts as thresholds above which claims must include the KX modifier as a confirmation that services are medically necessary as justified by appropriate documentation in the medical record. For CY 2021 this KX modifier threshold amount is: - $2,110 for PT and SLP services combined, and - $2,110 for OT services Section 53107 of the BBA of 2018 additionally requires CMS, using a new modifier, to make payment at a reduced rate for PT and OT services that are furnished in whole or in part by physical therapist assistants (PTAs) and occupational therapy assistants (OTAs).

Payment for these services is at 85 percent of the otherwise applicable Physician Fee Schedule payment amount/rate for the service, effective January 1, 2022. For CY 2019, CMS created two payment modifiers as follows: - CQ modifier: PT services furnished in whole or in part by PTAs and - CO modifier: OT services furnished in whole or in part by OTAs For CY 2020, CMS established a de minimis standard for such services?meaning that portions of a service furnished by the PTA/OTA independent of the physical therapist/ occupational therapist, as applicable, that do not exceed 10 percent of the total service are not subject to the payment reduction; while portions of a service furnished by the PTA/OTA independent of the therapist that exceed 10 percent of the total service must be reported with the CQ/CO modifier, alongside of the corresponding GP/GO therapy modifier.

Portions of services provided by the PTA/OTA together with the physical therapist/occupational therapist are counted as services provided by physical and occupational therapist.

For more information about other outpatient therapy payment policies, please see the Medicare Claims Processing Manual, Chapter 5 (PDF) For applicable coverage policies for therapy services, please refer to the Medicare Benefit Policy Manual, Sections 220 and 230 of Chapter 15 (PDF) and Chapter 12 (PDF) for PT, OT, and SLP services in Comprehensive Outpatient Rehabilitation Facilities.

PT/OT/ST are among the services that must be reported on a repetitive bill.

These excerpts from the Medicare Claims Processing Manual illustrate how repetitive services must be billed and how to handle non-repetitive services during that same time frame.

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PARA Weekly eJournal: September 8, 2021

OUTPATIENT THERAPY BILLING

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PARA Weekly eJournal: September 8, 2021

OUTPATIENT THERAPY BILLING

We have also attached a paper concerning wound therapy in the event the rehab therapists are performing this service within the scope of their state license. The hospital can bill a facility fee for outpatient wound care procedures performed by wound care staff, without direct supervision of the ordering provider, if they meet all the following guidelines: - Wound care staff (rehab therapist or nurse) is working within the scope of their state license - There is an order for the procedure from an MD/PA/NP who is guiding the patient?s treatment plan - The provider is available for general supervision when not physically present during the procedure - The procedure occurs in a hospital outpatient department The attached paper includes a list of common billable services as copied below:

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PARA Weekly eJournal: September 8, 2021

OUTPATIENT THERAPY BILLING

Another good resource is the American Physical therapy Association. They have a lot of guidance papers ? available to their members only. American Physical Therapy Association | APTA

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PARA Weekly eJournal: September 8, 2021

COVID-ONLY TESTING

Our lab manager asks the following question: The CDC will not be reapplying for EUA status for COVID only testing after 12/31/2021. They recommend a multiplex for SARS and FLU together. Have you heard if the COVID-only test will no longer be covered by insurance? Do we need to remove COVID-only from our in-house menu?

Answer: We revisited the FDA announcement, and offer the following clarification: the FDA will revoke the Emergency Use Authorization for one of the COVID-19 tests the CDC has been distributing to public health laboratories, the ?CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel.? Introduced in February 2020, that test is not commercially available to hospitals, it has been distributed only to state, tribal, local, and territorial government-supported public health laboratories.

After 1/1/2022, those entities must use one of the many FDA-authorized alternatives. Therefore, the EUA that will be termed at year end will not be relevant to commercially available COVID-19 tests (which are available under a separate Emergency Use Authorization).

The tests offered under other ?individual? EUA?s which hospitals have been using (and bill for) will continue to be available, and no change in coverage by Medicare and other payors is anticipated. There are a large number of commercially available COVID-only PCR tests that have been granted EUA status; the EUA?s are not impacted by the FDA announcement regarding the CDC test.

You can find a list of the RT-PCR tests which are commercially available on the FDA website here: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use -authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2#imft1

Public health laboratories and testing sites that have been using the CDC 2019-nCoV RT-PCR assay should select and begin their transition to another FDA-authorized COVID-19 test. CDC encourages laboratories to transition to a multiplexed method that can facilitate detection and differentiation of SARS-CoV-2 and influenza viruses 7

PARA Weekly eJournal: September 8, 2021

CMS PROPOSES RESCINDING MOST FAVORED NATION MODEL

On Au gu st 6, 2021, CM S pr oposed r escin din g t h e Novem ber 2020 M ost Favor ed Nat ion s In n ovat ion M odel (M FN). Pu blic com m en t per iod en ds on Oct ober 12, 2021.

Several states challenged this Medicare drug payment rule which had an implementation date of January 1, 2021. Injunctions and court orders in the U.S. District Courts delayed the start date based on the need for further rulemaking.

The rule, which was intended to reduce drug prescription costs, significantly cut reimbursement to hospitals and physician practices for 50 of the highest expenditure Medicare Part B drugs, as selected by CMS.The regulations bypassed usual regulatory processes by including it in a Final Rule with Comment Period.

Under the MFN model, OPPS hospitals and physician reimbursement would be phased into the MFN price, which is the lowest price paid for that drug among certain other developed nations, such as Canada, Germany, France, United Kingdom, Italy, and Japan (among others).

The Background, Regulation and Notice for the August 2021 MFN are available through the following link: https://innovation.cms.gov/innovation-models/most-favored-nation-model

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PARA Weekly eJournal: September 8, 2021

ACTEMRA UPDATE: CMS HCPCS Q0249 TOCILIZUMAB

THIS UPDATE INFORMS READERS OF NEW HCPCS Q0249 The FDA Emergency Use Authorization (EUA) for tocilizumab (Actemra®) in treating hospitalized patients with COVID-19 is limited to administration of the drug via IV therapy.

The previously established HCPCS J3262 is inappropriate for reporting IV tocilizumab used under the EUA. CMS created HCPCS Q0249 (short descriptor: Tocilizumab for covid-19) on June 24, 2021, in order to allow facilities to report the drug on Part B only inpatient claims, and claims for hospitalized patients under observation (Inpatient services billed on the TOB 11X do not require HCPCS codes.)

HCPCS for subcutaneous tocilizumab, J3262, is not appropriate when reporting IV administration. https://www.cms.gov/outreach-and-educationoutreachffsprovpartprogprovider-partnershipemail-archive/2021-07-22-mlnc#_Toc77687195

On June 24, 2021, the FDA issued an Emergency Use Authorization (EUA) for treatment of COVID-19 in hospitalized patients with the drug tocilizumab (Actemra): https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-andpolicy-framework/emergency-use-authorization#coviddrugs

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PARA Weekly eJournal: September 8, 2021

ACTEMRA UPDATE: CMS HCPCS Q0249 TOCILIZUMAB

The ICD-10 codes for reporting tocilizumab on an inpatient claim are XW033H5 and XW043H5:

The subcutaneous version of Acetmra® is not authorized for use in treating COVID-19 patients.The FDA Fact Sheet for Healthcare Providers: Emergency Use Authorization for Actemra® (tocilizumab) states: https://www.fda.gov/media/150321/download

Some clients have inquired about shortages of Actemra®; the FDA suggests contacting the drug manufacturer for assistance:

The customer service phone line for Genentech is(800) 551-2231, available M-F 6:00 am (5:00 am) Pacific time, according to the Genentech website: https://www.gene.com/contact-us/call-us

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PARA Weekly eJournal: September 8, 2021

WEBINAR: ZERO BALANCE INSURANCE AR

Wat ch t h is f r ee w ebin ar t o lear n w h y h ospit als m ay be leavin g m on ey on t h e t able.

Click the webinar icon.

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PARA Weekly eJournal: September 8, 2021

APPROPRIATE USE COMPLIANCE DEADLINE DELAYED

In con sider at ion of t h e im pact t h at COVID-19 h as on pr act it ion er s, pr ovider s an d ben ef iciar ies, CM S is pr oposin g t o delay t h e paym en t pen alt y ph ase of t h e appr opr iat e u se cr it er ia (AUC) pr ogr am u n t il Jan u ar y 1, 2023, or t h e Jan u ar y 1 f ollow in g t h e en d of t h e PHE f or COVID-19.

The list of imaging HCPCS services affected by the AUC, which will require the use of a Clinical Decision Support Mechanism (CDSM) tool, is available on the PARA Data Editor; search the Advisor tab with the keyword ?AUC? in the summary field, then click on the hyperlink to the right of that Advisor:

In 2019, CMS announced that calendar year 2020 would serve as a ?test and educate? period during which providers billing for advanced imaging studies are required to report whether the ordering physician consulted a clinical decision support mechanism. The requirement to report the informational codes is currently in effect, but Medicare will not yet impose penalties for failure to report, or for incorrect reporting. (The requirement does not apply to Critical Access Hospitals).

The AUC program was authorized by the Protecting Access to Medicare Act of 2014 (PAMA) to promote the use of AUC and decrease the number of inappropriate advanced diagnostic imaging services provided to Medicare beneficiaries.

Ordering physicians (or clinical staff acting at the physician?s direction) will consult the AUC using a clinical decision support mechanism (CDSM). The CDSM is an interactive, electronic tool that is either stand-alone or integrated into an electronic health record (EHR).

When queried, it provides a response indicating that the advanced diagnostic imaging service is appropriate, not appropriate or not applicable for the patient. The AUC requirements apply to advanced diagnostic imaging services (CT, PET, MRI, and Nuclear Medicine) provided in physician offices, hospital outpatient departments (including emergency departments), ambulatory surgical centers, and independent diagnostic testing facilities.

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PARA Weekly eJournal: September 8, 2021

APPROPRIATE USE COMPLIANCE DEADLINE DELAYED

CMS released an MLN Matters article in July 2019 that includes the imaging HCPCS codes, the G-codes for the CDSMs, and AUC modifiers. mm11268 (cms.gov) There are a few exceptions to the requirement to consult the CDSM, which are: - Emergencies - Inpatient advanced diagnostic imaging services - Ordering physician meets hardship exception - Hardship exceptions include: - Insufficient internet access - EHR or CDSM vendor issues - Extreme and uncontrollable circumstances If an exception exists, the physician will include it with the order and the furnishing physician will report the corresponding modifier on the claim.

After the physician has consulted the CDSM and ordered the advanced diagnostic imaging service, the following data will be sent, with the order, to the provider completing the imaging service: - The CDSM consulted by the ordering physician.

- Whether the service adhered to the applicable AUC, did not adhere to the applicable AUC, or whether no criteria in the CDSM were applicable to the patient?s clinical scenario.

- The National Provider Identifier (NPI) of the ordering physician.

CMS maintains a list of qualified CDSMs on its website at Clinical Decision Support Mechanisms | CMS.

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PARA Weekly eJournal: September 8, 2021

APPROPRIATE USE COMPLIANCE DEADLINE DELAYED

The following list was posted on August 30, 2021:

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PARA Weekly eJournal: September 8, 2021

APPROPRIATE USE COMPLIANCE DEADLINE DELAYED

Medicare also released eight new modifiers to be appended to the imaging HCPCS when an advanced diagnostic imaging is billed. The modifiers indicate the clinician?s use (or non-use) and compliance with a CDSM when ordering advanced diagnostic images.

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PARA Weekly eJournal: September 8, 2021

APPROPRIATE USE COMPLIANCE DEADLINE DELAYED

The excerpt below illustrates the mandatory reporting for a CT of the head billed to Medicare on a UB04:

The following is the workflow for meeting the AUC requirements: - The physician sees a Medicare beneficiary and plans to order an advanced diagnostic imaging service - The physician (or clinical staff under the direction of the physician) consults the AUC for the proposed advanced diagnostic imaging service through a CDSM. The CDSM can be integrated into the EHR or a separate portal - If a hardship exception exists, the physician will include it with the order - The CDSM will search for and present the AUC relevant to the patient?s condition - The CDSM response will indicate if the proposed advanced diagnostic imaging service: - adheres to the AUC, or - does not adhere to the AUC, or - if there is no applicable AUC - If it adheres to the AUC, the physician will proceed with the order - If it does not adhere, the physician must decide to order a different imaging service or proceed with the proposed service despite it not adhering to the AUC - The physician orders the advanced diagnostic imaging service and includes with the order: - the CDSM queried, and - the AUC response, and - the physician?s NPI - The rendering provider furnishes the imaging service to the patient - The rendering provider reports in the professional and institutional claims: - HCPCS G-code associated with the CDSM, and - The applicable AUC modifier, and - the ordering physician?s NPI The outcome of this program will be to analyze the ordering practices of the physicians and determine any outliers. PAMA calls for identification on an annual basis of no more than five percent of the total number of ordering physicians who are outliers. The use of two years of data is required for this analysis.

Data collected during the education and testing period will not be used when identifying outliers.

Outliers will be determined based on low adherence to applicable AUC or comparison to other ordering physicians. Physicians who are found to be outliers will be required to complete prior authorizations for advanced diagnostic imaging services.

The following clinical areas will be the focus of the analysis of outliers: - Coronary artery disease (suspected or diagnosed) - Suspected pulmonary embolism - Headache (traumatic and non-traumatic) - Hip pain - Low back pain - Shoulder pain (to include suspected rotator cuff injury) - Cancer of the lung (primary or metastatic, suspected or diagnosed) - Cervical or neck pain 16

PARA Weekly eJournal: September 8, 2021

PRICE TRANSPARENCY COMPLIANCE: THE STAKES JUST GOT HIGHER

CM S ju st r aised t h e st akes on Pr ice Tr an spar en cy com plian ce.

Don't r oll t h e dice on t h e n ew civil m on et ar y pen alt ies.

On May 3, 2021, the American Hospital Association (AHA) released a M ember Advisory regarding noncompliance with the Centers for Medicare & Medicaid Services?(CMS) Hospital Price Transparency requirements.In it, they note that CMS has launched proactive audits of hospital websites and have evaluated complaints presented to CMS by consumers.

According to the publication, CMS started with auditing larger acute care hospitals and have now expanded their examination of random hospitals.The first set of warning letters were issued the week of April 19th.However, CMS has indicated that they will not announce the list of hospitals that have received warning letters but will publish the identities of the hospitals that remain non-compliant and receive a monetary penalty if they have not addressed the issues within 90 days.

Nu m ber Of Hospit al Beds

M axim u m An n u al Civil M on et ar y Pen alt y

<30

$109,500

50

$182,500

100

$365,000

200

$730,000

300

$1,095,000

400

$1,460,000

500

$1,825,000

550+

$2,007,500

The PARA Price Transparency Solution is so effective, that clients are indemnified from any civil monetary penalty.

There's no risk with PARA.

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PARA Weekly eJournal: September 8, 2021

PRICE TRANSPARENCY COMPLIANCE: THE STAKES JUST GOT HIGHER

The July 19, 2021 mlnconnects Special Edition states that CMS is updating the civil monetary penalty amount.The current minimum civil monetary penalty of $300/day would apply to smaller hospitals with less than 30 patient beds.However, for hospitals with more than 30 beds, the penalty will be $10/bed/day, not to exceed a maximum daily dollar amount of $5,500. ?Under this proposed approach, for a full calendar year of noncompliance, the minimum total penalty amount would be $109,500 per hospital, and the maximum total penalty amount would be $2,007,500 per hospital.? [mln connects Special Edition] PARA HealthCare Analytics, an HFRI Company, is among the leaders in supporting hospitals in achieving readiness for CMS Price Transparency regulations, which will help consumers make more informed healthcare purchasing decisions.

To ensure consumers will be able to browse for healthcare services in the same way they shop for other goods and services online, PARA has developed robust and accurate pricing capabilities for area healthcare consumers. The PARA solution includes a patient-facing estimator that delivers user-friendly, procedure-level estimates reflecting patients?specific coverage limits and is updated quarterly for the facility.

As a reminder, the CMS Hospital Price Transparency rule requires that hospitals publish detailed pricing information online to help consumers make accurate cost comparisons for a range of treatments and procedures.

The rule contains two types of price transparency requirements: - Hospitals must post their entire array of standard charges online in a machine-readable file that is easily accessible from their public website - Hospitals must publish a document listing pricing for 300 specific shoppable healthcare services.

Of these 300 items, 70 have been pre-defined by CMS, while the remaining 230 can be selected at the discretion of the hospital.

For both requirements, a range of different price categories must be shown, including gross charges, payer-specific negotiated rates, self-pay discounted rates, and de-identified minimum and maximum negotiated charges. The files also must contain any ancillary charges that are customarily included for the specific shoppable service, such as the costs associated with additional related procedures, tasks, allied services, supplies, or drugs, as well as any professional fees billed separately from the facility bill.

These requirements present challenges when it comes the sheer data mining and payer contract analytics required to deliver on the mandates.

PARA?s payer contract models accommodate a variety of settlement methodologies by patient type including MS-DRG, APR-DRG, EAPG, ASC Levels, APC packaging, and percent of charge, among others.

For a typical hospital with a 10,000-line chargemaster, seven patient types, and 20 payer contracts, this could mean 1.4M calculations needed to fulfill the mandate.According to an HFM A Article on the topic, this detailed approach could cost a hospital several hundred thousand dollars to contract with a consulting firm.

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PARA Weekly eJournal: September 8, 2021

PRICE TRANSPARENCY COMPLIANCE: THE STAKES JUST GOT HIGHER However, PARA's Price Transparency Tool, which uses the actual payer contract language as outlined in the CMS requirements to make those millions of calculations, costs under $30,000 in the first year, with nominal (under $3,000) quarterly maintenance fees thereafter. It is the most cost-effective and comprehensive solution out there today.

Consumers expect to shop for healthcare the same way they shop for other goods and services and healthcare providers must be ready to meet that need.

Therefore, PARA HealthCare Analytics, an HFRI Company, has partnered with hospitals across the nation to empower them in providing this required information in a consumer-friendly, intuitive manner.

The team at PARA believes that price transparency and Patient Price Estimators are a useful and important component of healthcare consumerism and have spent the past year preparing for the release of these requirements. In speaking with hospital associations, clients, and business vendor groups, we are finding that we are one of the only vendors who can completely satisfy, to the spirit and letter of the law, both CMS requirements in a fully customizable manner.

To f in d ou t m or e abou t ou r solu t ion , please con t act on e of ou r exper t s.

San dr a LaPlace

Violet Ar ch u let -Ch iu

Account Executive

Senior Account Executive

splace@para-hcfs.com

varchuleta@para-hcfs.com

800.999.3332 x 225

800.999.3332 x219 19

PARA Weekly eJournal: September 8, 2021

PAMA REPORTING CLARIFIED FOR "NON-PATIENT SPECIMEN" CLAIMS

PARA r eceived clar if icat ion on w h et h er h ospit als m u st r epor t paym en t r at es an d volu m es f or lab t est s t h at w er e per f or m ed on a n on -pat ien t basis, bu t billed on a 13X or 85X Type of Bill.

For the first time, Medicare will require certain hospitals which meet the definition of an ?Applicable Laboratory? to report payments made by commercial insurers for non-patient laboratory services.The reports are due in the first quarter of 2022.

The central qualifying criteria for hospitals is whether the entity was paid more than $12,500 by Medicare in the period January 1 through June 30, 2019.The data that must be reported are allowable payment rates made by commercial payers per lab CPT® code, and the frequency of times each hospital has been paid each separate rate.

The rates of commercial payments to be reported are limited to those paid for ?non-patient services?, which should be reported on the 14X Type of Bill (TOB.) However, several hospitals have asked PARA whether payments made for non-patient services, but which were billed on another TOB (such as 13X or 85X), should be reported.

We turned to Medicare?s Clinical Fee Schedule Inquiries email address (CLFS_Inquiries@cms.hhs.gov) for clarification on this point.

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PARA Weekly eJournal: September 8, 2021

PAMA REPORTING CLARIFIED FOR "NON-PATIENT SPECIMEN" CLAIMS

In an email sent on August 12, 2021, the CLFS Fee Schedule Inquiries email responded: ?We apologize for the delay in responding. If a CLIA-certified hospital outreach laboratory that bills Medicare Part B under the hospital?s NPI meets the requirements of an applicable laboratory, the reporting entity reports identifiable applicable information attributed to non-hospital patients. That is, for a hospital outreach laboratory that bills under the hospital?s NPI, the reporting entity reports private payor data that can be distinguished from testing performed for hospital patients.?

PARA interprets this reply to mean that CMS expects hospitals to report private payer lab rates for non-patient specimen testing whether or not the claim was submitted on TOB 14x, so long as the hospital can affirm that the testing qualified as a non-patient service. In other words, only the specimen was registered.

CMS offers a description of a ?non-patient? service in Chapter 16 of the Medicare Claims Processing Manual: https://www.cms.gov/Regulations -and-Guidance/Guidance/ Manuals/Downloads/clm104c16.pdf# Non-Patient (Referred) Laboratory Specimen- A non-patient is defined as a beneficiary that is neither an inpatient nor an outpatient of a hospital, but that has a specimen that is submitted for analysis to a hospital and the beneficiary is not physically present at the hospital.

All hospitals (including Maryland waiver hospitals and CAHs) bill non-patient lab tests on TOB 14X. They are paid under the clinical laboratory fee schedule at the lesser of the actual charge, the fee schedule amount, or the NLA (including CAH and MD Waiver hospitals). Part B deductible and coinsurance do not apply.

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PARA Weekly eJournal: September 8, 2021

PFIZER COVID VACCINE COMIRNATY GRANTED FULL FDA APPROVAL

On August 23, 2021, the FDA approved licensing of the Pfizer COVID-19 vaccine. Marketed as Comirnaty (COVID-19 Vaccine, mRNA), the vaccine approval covers coronavirus prevention for ages 16 and older.

An Emergency Use Authorization (EUA) remains in place for ages 12 through 15.The EUA also covers a third dose for solid organ transplant recipients and those with immunocompromised conditions.

The FDA offers a Fact Sheet through the following link: https://www.fda.gov/media/144413/download

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PARA Weekly eJournal: September 8, 2021

CMS REVERSING IPO LIST AND ASC CPL IN 2022 OPPS PROPOSED RULE

In the 2022 OPPS proposed rule, CMS proposes to reverse two of the 2021 policies that some hospital stakeholders had opposed; the phase-out of the inpatient-only (IPO) list and relaxing criteria for adding services to the ambulatory surgical center covered-procedures list (ASC CPL.) A copy of the proposed rule is available on the Advisor tab of the PARA Data Editor; search ?2022?:

Inpatient only-- The 298 inpatient-only procedures that were being phased out under the 2021 OPPS rule would be added back to the IPO list under the 2022 OPPS proposed rule. CMS will be soliciting further comments on whether they should maintain the longer-term objective of eliminating the IPO list or maintain the IPO list but continue to systematically scale the list back. CMS also proposes to shorten the exemption from medical review activities for services removed from the IPO list to two years.

CY 2022 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Proposed Rule (CMS-1753-P) | CMS

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PARA Weekly eJournal: September 8, 2021

CMS REVERSING IPO LIST AND ASC CPL IN 2022 OPPS PROPOSED RULE

Ambulatory surgical center covered-procedures-- CMS is proposing to reinstate the ASC CPL criteria that was in effect in CY 2020 and remove 258 of the 267 procedures that were added to the ASC CPL in CY 2021. CMS is requesting comments on whether any of the 258 procedures meet the CY 2020 criteria they are proposing to reinstate.

They are also proposing to change the notification process adopted in CY 2021 to a nomination process, under which stakeholders could nominate procedures they believe meet the requirements to be added to the ASC CPL. The formal nomination process would begin in CY 2023.

In addition to the IPO list and ASC CPL changes, the proposed rule addresses the health equity gap and fighting the Covid-19 PHE. The rule will also be promoting safe, effective, and patient-centered healthcare through proposals that affect the newly established Rural Emergency Hospital provider type, partial hospitalization programs, and the Radiation Oncology Model.

The new rule also includes proposals to encourage transparency in health systems. PARA HealthCare Analytics, a leader in supporting hospitals in achieving readiness for CMS Price Transparency regulations, will be following these proposals closely.

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PARA Weekly eJournal: September 8, 2021

ZERO-BALANCE CLAIMS REVIEW -- A WHITE PAPER FROM HFRI

E C N A L BA s w e i v e R ms Cl ai

A CRITICAL BACKSTOP FOR AR MANAGEMENT STRATEGIES

As payer rules and coding have become more complex and internal pressures mount to keep accounts receivable (AR) days low, denial rates and resulting write-offs have continued to climb for most hospitals.

Between 2011 and 2017, denial volume soared by nearly 80 percent for the average hospital.1 The financial impact of these late or foregone collections is significant. Even though 90 percent of denials are preventable, and two-thirds are recoverable, 65 percent of claim denials are never corrected and resubmitted for reimbursement.2 A recent survey of hospital executives found that 30 percent of facilities had bad debt of between $10 million and $50 million.3

AR STRATEGIES FOR AGED ACCOUNTS Today, in the wake of often-severe cash flow problems triggered by the COVID-19 pandemic and other operational and regulatory challenges, a growing number of hospitals are partnering with third parties to implement comprehensive AR management strategies that can help reduce denials and ensure facilities collect every dollar they?re entitled to.

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PARA Weekly eJournal: September 8, 2021

ZERO-BALANCE CLAIMS REVIEW -- A WHITE PAPER FROM HFRI

These integrated approaches typically incorporate both internal and external elements: Hospital billing staff focus exclusively on the newest claims, then turn over unpaid balances to specialists at specific aging intervals.

Relying on external experts to pursue low-dollar, high-volume claims is often the most cost-effective way to optimize collections and minimize write-offs, since it frees up staff to concentrate on fresher, higher-dollar claims.

Pre-write-off insurance collection experts well-versed in health plan policies can provide an additional safeguard to help prevent legitimate claims, regardless of age or size, from going uncollected. A comprehensive approach will help organizations obtain hard collectible dollars from the full spectrum of aged accounts, including pre-write off claims and even from closed balance accounts.

BOOSTING CASH FLOW WITH ZERO-BALANCE REVIEWS OF CLOSED BALANCE ACCOUNTS One critical element in a comprehensive AR management strategy is a zero-balance claims review.

Zero-balance reviews are essentially forensic audits of written-off claims. Thorough, closed-balance reviews can validate claims integrity and maximize contractual revenue for all payers. They are designed to assess whether the factors that initially caused a payer?s denial can be mitigated to secure retroactive reimbursement.

While some may assume that pursuing old write-offs isn?t likely to be productive, experts skilled at identifying common mistakes that frequently result in denials can recover up to one percent of a hospitals total net patient revenue. For large hospitals and health systems that may generate hundreds of millions of dollars annually, this can translate into a significant amount of found revenue.

FOUR STEPS TO IMPROVING COLLECTIONS THROUGH AN EXTERNAL ZERO-BALANCE REVIEW Most healthcare systems or organizations typically don?t have the time, resources or expertise to conduct in-depth reviews of denied or unpaid aged claims. External reviews consequently can provide the extra scrutiny needed to potentially capture revenue from denied, underpaid and unpaid claims. Zero-balance reviews of closed balance accounts performed by an experienced partner represent a final safety net at the end of the revenue cycle management process, again freeing up staff to concentrate on fresher, higher-dollar claims.

Here are the four primary steps that should be included in a zero-balance review:

1. Scrutinize contracts Specialists review all payer contractual agreements to identify areas of underpayment risk. This process is conducted in conjunction with hospital contracting staff and attorneys to help clarify the facility?s expectations or intent with respect to specific contract provisions. Not infrequently, specialists identify ambiguous language that leaves the facility vulnerable to underpayments or common reimbursement methodologies that can be exploited by payers to reduce reimbursement.

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PARA Weekly eJournal: September 8, 2021

ZERO-BALANCE CLAIMS REVIEW -- A WHITE PAPER FROM HFRI

Not infrequently, specialists identify ambiguous language that leaves the facility vulnerable to underpayments or common reimbursement methodologies that can be exploited by payers to reduce reimbursement. Contract problems sometimes can be as simple as a grammatical error or word choice: A clause that should have included ?and?instead of ?or,?or vice versa, depending on the anticipated scenario, can lead to reoccurring underpayments. Language like this may be causing significant underpaid revenue unbeknownst to revenue cycle staff.

Experts also flag any coding changes that may have occurred since the contract was executed to ensure updates have been made and reimbursements continue to be paid at appropriate levels.

2. Evaluate discharge files After the contract review is completed, zero-balance specialists download a full set of discharge files for a specific timeframe, usually two full years of data for all payers, including Medicare, Medicare Advantage, Medicaid, Medicaid HMO, and commercial carriers. STAT Revenue, the zero-balance division of HFRI, processes the data files through a proprietary application that has been custom-programed with each payer?s contract specifications. This process produces an independent payment analysis that isn?t reliant on the hospital?s contractual expected amounts to identify both underpayments and areas where the hospital?s model may be deficient or inaccurate. Given the inherent limitations of existing billing platforms in calculating complex reimbursements? such as payments due from a secondary payer or more accurate outpatient coding? greater accuracy is usually achieved.

3. Perform an in-depth, 360-degree review Once the subset of closed accounts is identified for potential additional revenue, an in-depth review is performed to pressure-test the integrity of the claim and the subsequent reimbursement. This step relies on the external team?s collective experience to research each claim and maximize the revenue potential unique to that claim and payer, focusing on industry changes, coding best practices, and the contractual intent for each hospital. When accounts are verified through this review as underpaid, STAT Revenue?s experts work with the payers to deliver the additional revenue to the hospital?s bottom line.

4. Recommend improvements From this extensive review process and subsequent trend analysis, recommendations can be made about how hospitals can optimize collections through implementation of coding best practices for specific procedures or drugs. One example: a hospital may not be billing properly for expensive new drugs that are FDA-approved but do not have an HCPCS code assigned.

Medicare and most commercial payers have specific, often complex requirements for reimbursing for unclassified drugs, and external experts can help in resubmitting claims with this correct coding to achieve proper reimbursement.

In addition to flagging coding mistakes, the zero-balance claims analysis also identifies payer deficiencies, whether they?re one-off events or reoccurring, systemic issues. Working withing appropriate contractual claim and appeal submission timeframes, STAT Revenue will work with the hospital staff to resubmit corrected claims to the payer, and, in instances when the payer is at fault, bring the problem to the attention of provider relations and help prepare for arbitration if necessary

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PARA Weekly eJournal: September 8, 2021

ZERO-BALANCE CLAIMS REVIEW -- A WHITE PAPER FROM HFRI

A SECOND SET OF EYES The zero-balance review can produce immediate benefits, in terms of recovered reimbursement on written-off claims, as well as longer-term reductions in inaccurate coding, denials and write-offs. Working in partnership with hospital staff, experts identify process improvements and help implement staff training to reduce and eliminate denial root causes.

Ultimately, zero-balance reviews provide expert oversight to scrutinize the all-important denial arena.

This can help produce lasting solutions that improve collections while ensuring optimal compliance. Amid the current challenges in healthcare, this capability helps hospitals not only collect every dollar they are owed, but also allows them to focus on other, equally pressing areas of operations. HFRI can help you progress toward the goal of zero-percent write-offs through our comprehensive AR solutions. We?re able to resolve all claims, regardless of size or age quickly, and conduct zero-balance claims reviews and root cause analysis to ensure you?re collecting every dollar you deserve.

Contact us today to learn more.

For more information, be sure to watch the recorded webinar ?Zero Balance Insurance AR: Learn how most hospitals are leaving money on the table.?

1 Kelly Gooch, ?4 ways hospitals can lower claim denial rates,? Becker?s Hospital CFO Report, Jan. 5, 2018.

2 Chris Wyatt, ?Optimizing the Revenue Cycle Requires a Financially Integrated Network,? HFMA, July 7, 2015.

3 ?Bad Debt Exceeds $10M at a Third of Organizations, But Lack of Confidence Exists in How Much is Recoverable,? Cision PR Newswire. June 19, 2018.

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PARA Weekly eJournal: September 8, 2021

EUA AMENDED TO ADD ANOTHER DOSE OF COVID VACCINES

On August 12, 2021, the FDA announced in a press release that they amended the EUA for the Pfizer and Moderna COVID-19 vaccines.The amendment allows solid organ transplant recipients and individuals diagnosed with conditions considered immunocompromised to receive an additional dose of the vaccines. The FDA also states that, at this time, fully vaccinated people do not need an additional dose.

People with immunocompromised conditions are more vulnerable to COVID-19 and other infections.The FDA evaluated data and determined that an additional COVID-19 vaccine may protect this small, vulnerable group of people.

The announcement also recommends that if an immunocompromised person is exposed to or contracts COVID-19, they should consult a healthcare provider to determine if they may need monoclonal antibody therapy.

The AMA provided the following HCPCS codes in response to the amended EUA: https://www.ama-assn.org/press-center/press-releases/ama-announces-cpt-code-set-ready-thirddoses-covid-19-vaccines

Medicare will cover the additional doses with approximately $40 administration fee as they have the first and second COVID-19 vaccine doses. https://www.cms.gov/newsroom/news-alert/people-medicare-who-are-immunocompromisedwould-be-able-receive-additional-covid-19-dose-no-cost

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PARA Weekly eJournal: September 8, 2021

EUA AMENDED TO ADD ANOTHER DOSE OF COVID VACCINES

The August 12, 2021 FDA announcement is available through the following link: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fdaauthorizes-additional-vaccine-dose-certain-immunocompromised

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PARA Weekly eJournal: September 8, 2021

FDA TO WITHDRAW EUA ON COVID PCR TEST DECEMBER 31, 2021

On July 21, 2021, the CDC announced it will withdraw its Emergency Use Authorization (EUA) request for the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel after December 31, 2021.

The advanced notice allows laboratories to adopt and prepare to use an alternative FDA approved test.

The 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel detects only COVID-19.The CDC suggests laboratories begin using a multiplex assay that can detect both COVID-19 and influenza, which will be save time and laboratory resources as we enter flu season. https://www.cdc.gov/csels/dls/locs/2021/07-21-2021-lab-alert-Changes_CDC_ RT-PCR_SARS-CoV-2_Testing_1.html

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PARA Weekly eJournal: September 8, 2021

FDA AUTHORIZES TOCILIZUMAB RX FOR INPATIENT COVID-19

On Ju n e 24, 2021, t h e FDA issu ed an Em er gen cy Use Au t h or izat ion (EUA) f or t r eat m en t of COVID-19 in h ospit alized pat ien t s w it h t h e dr u g t ocilizu m ab (Act em r a ® ):

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization#coviddrugs

The ICD-10 codes for reporting tocilizumab on an inpatient claim are XW033H5 and XW043H5:

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PARA Weekly eJournal: September 8, 2021

FDA AUTHORIZES TOCILIZUMAB RX FOR INPATIENT COVID-19

PARA Data Editor users may find the NDC?s and HCPCS assigned to Tocilizumab on the Calculator tab by searching ?tocilizumab? or ?Actemra? using the ?NDC to J-Code Crosswalk? report:

As of July 29, 2021, the ICD10 codes for Tocilizumab are not on the list of codes qualifying an inpatient claim for enhanced DRG reimbursement under Medicare?s ?New COVID-19 Treatments Add-On Payment? program (NCTAP). https://www.cms.gov/medicare/covid-19/new-covid-19-treatments-add-payment-nctap

If and when CMS adds the ICD10 codes for tocilizumab to the NCTAP program, PARA will update this article.

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PARA Weekly eJournal: September 8, 2021

CHECK PHYSICIAN ORDER ON OBSERVATION CLAIMS

The Health and Human Services Office of the Inspector General (OIG) recently publicized a self-disclosed recoupment from a Virginia facility which had charged for observation care when there was no physician order to support the service, and/or when the service was not supported as medically necessary: https://oig.hhs.gov/fraud/enforcement/sentara-healthcare-agreed-to-pay-43-million-for-allegedlyviolating-the-civil-monetary-penalties-law-by-submitting-improper-claims-for-observation-services/

PARA reminds facilities that observation may be reported only if: - ·There is a physician order for observation care in the medical record - ·The service is medically necessary - ·Observation begins on the date and time of the physician order - ·All units of observation care should be reported on only one line on the claim (not by DOS) - ·Observation time must be reduced for the period of time a patient is undergoing another closely monitored, billable service (such as an imaging procedure) - ·Observation may not be charged retroactively PARA offers a comprehensive paper on billing for observation at the following link: https://apps.para-hcfs.com/para/Documents/Observation_Charging_Billing_Compliance_ and_Reimbursement_January_2016_Update_edited.pdf

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PARA Weekly eJournal: September 8, 2021

CMS PROPOSES CHANGES TO HOSPITAL QUALITY MEASURES

Within the 2022 OPPS Proposed Rule, CMS has proposed two new quality measures for hospitals which, if adopted, will factor into OPPS reimbursement rates for the individual hospitals in future years.

The full proposed rule has been published in the Federal Register publication at the link below: https://www.federalregister.gov/documents/2021/08/04/2021-15496/medicare-programhospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment Newly proposed measures include: - For payment determinations in calendar year 2024 -- COVID-19 Vaccination Coverage Among Health Care Personnel (HCP); the measure data will begin with the CY 2022 Reporting Period, but the results will be reflected in the CY 2024 Payment Determination.The COVID-19 Vaccination Coverage Among HCP measure will track COVID-19 vaccination coverage in non-LTC facilities including outpatient hospitals.The numerator for the HCP measure is the number of HCP eligible to work in at the hospital for at least 1 day during a certain week (self-selected per quarter) and who received a complete COVID-19 vaccination. The discussion of this measure begins on page 1509 of the proposed rule: https://www.federalregister.gov/d/2021-15496/p-1509 - For payment determinations in CY 2023: Breast Screening Recall Rates?which measures the percentage of Medicare beneficiaries for whom a traditional mammography or Digital Breast Tomosynthesis (DBT) screening study was performed that was then followed by a diagnostic mammography, DBT, ultrasound of the breast, or magnetic resonance imaging (MRI) of the breast in an outpatient or office setting on the same day or within 45 calendar days of the index image.

Data will be used from July 1, 2020 through June 30, 2021, and annually July 1 through June 30 thereafter.CMS intend for this measure to move facilities toward the 5 to 12 percent range of recall rates.The discussion of this measure begins on page 1581 of the proposed rule: https://www.federalregister.gov/d/2021-15496/p-1581 CMS also proposes to remove two measures beginning with the 2023 reporting period and 2025 payment determination: - OP-2 (Fibrinolytic Therapy Received Within 30 Minutes Of ED Arrival) And - OP-3 (Median Time To Transfer To Another Facility For Acute Coronary Intervention) The proposed quality measures to be removed are discussed beginning on page 1501: https://www.federalregister.gov/ d/2021-15496/p-1501 35

PARA Weekly eJournal: September 8, 2021

PULMONARY REHAB COVERAGE FOR CHRONIC COVID-19 PROPOSED In the 2022 Medicare Physician Fee Schedule (MPFS) Proposed Rule, CMS indicates it intends to expand coverage of outpatient pulmonary rehabilitation (PR) to include beneficiaries experiencing persistent respiratory symptoms after being hospitalized with COVID-19.

As specified in 42 CFR 410.47, Medicare currently covers pulmonary rehab services for patients with moderate to very severe Chronic Obstructive Pulmonary Disease (COPD).

The 2022 MPFS proposed rule would add pulmonary rehab coverage for Medicare beneficiaries who have been diagnosed with severe manifestations of COVID?19, defined as requiring hospitalization in the ICU or otherwise, and who experience continuing symptomatology, including respiratory dysfunction, for at least 4 weeks post discharge.

In clarifying the definition of persistent respiratory symptoms, the CDC uses the term post-COVID conditions to describe health issues that persist more than four weeks after first being infected with the causative virus.

Similarly, the National Institute for Health and Care Excellence (NICE), the Scottish Intercollegiate Guidelines Network (SIGN), and the Royal College of General Practitioners (RCGP) have jointly used four weeks to differentiate the acute symptoms of COVID. Based on the information from the CDC, NICE, SIGN, and RCGP, CMS considers COVID?19 to be chronic when symptoms persist for more than 4 weeks.

Symptoms include dyspnea, depression, and anxiety which can impair physical function and cause incapacitation.The clarification can be found on page 155 in the Federal Register, Vol. 86, No. 139, published, Friday, July 23, 2021.

A link to a PDF file with the full proposed rule is available on the PARA Data Editor Advisor tab; search ?2022? in the summary field:

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PARA Weekly eJournal: September 8, 2021

CMS REMOVES CERTAIN NCDS -- DEFERS COVERAGE TO MACS

In an MLN dated August 2, 2021, CMS announced that effective January 1, 2021, it has removed several older National Coverage Determinations (NCDs) that may have become obsolete or unnecessary.The agency has deferred coverage decisions on the services previously addressed in these NCDs to the judgement of the MACs. MACs may decide to cover services previously covered, or to continue non-coverage as previously established in the NCD. https://www.cms.gov/files/document/mm12254.pdf

The 2021 Payment Policies under the Medicare Physician Fee Schedule and other Part B services were published in the Federal Register on December 28, 2021 ? a pertinent excerpt is provided: https://www.govinfo.gov/content/pkg/FR-2020-12-28/pdf/2020-26815.pdf#page=326 J. Removal of Selected National Coverage Determinations In the CY 2021 PFS proposed rule (85 FR at 50255), we proposed to use the notice and comment rulemaking to identify and remove older NCDs that we believed no longer contained clinically pertinent and current information or no longer reflected current medical practice. ? Instead, in the absence of an NCD, the coverage determinations for those items and services would be made by Medicare Administrative Contractors (MACs).

We also noted that if the previous NCD barred coverage for an item or service under title XVIII (that is, national noncoverage NCD), a MAC would now be able to cover the item or service if the MAC determined that such action was appropriate under the statute. Removing a national non-coverage NCD may permit access to technologies that may be beneficial for some uses.

We explained that as the scientific community continues to conduct research producing new evidence, the evidence base we previously reviewed may have evolved to support other policy conclusions. In the proposed rule, we also described the circumstances that we had used in determining whether an older NCD should be removed.

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PARA Weekly eJournal: September 8, 2021

COVID-19 UPDATE PARA Healt h Car e An alyt ics continues to update COVID-19 coding and billing information based on frequently changing guidelines and regulations from CMS and payers. All coding must be supported by medical documentation.

Download the updated Guidebook by clicking here.

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Updat ed An d Revised Au gu st 17, 2021

PARA Weekly eJournal: September 8, 2021

Expanded PDE Training Sessions Available PARA offers nationwide overview training on the PARA Data Editor each week. And, due to increased demand, we are expanding the training schedule to include sessions that focus on the two most frequently used modules with the PDE. Sessions on Charge Quote and the Calculator will now be offered on Tuesdays (Charge Quote) and Thursdays (Calculator) at the following times: Tuesdays: 11:00 am Pacific Daylight Time Thursdays: 8:00 am Pacific Daylight Time Regular PDE Training Sessions: Wednesdays at 11:00 am PDT and Fridays at 8:00 am PDT

I nterested?

Please contact one of the following experts for a session key.

Mary McDonnell: 800.999.3332, ext 216 mmcdonnell@para-hcs.com Violet Archuleta-Chiu: 800.999.3332, ext 219 varchuleta@para-hcfs.com Sandra LaPlace: 800.999.3332, ext 225 slaplace@para-hcfs.com Gail Langord: 800.999.3332, ext 426 glangford@para-hcs.com Randi Brantner: 800.999.3332, ext 215 rbrantner@para-hcfs.com 39

If you can't make any of these sessions, but would still like to attend, please contact Mary McDonnell for options.

PARA Weekly eJournal: September 8, 2021

MLN CONNECTS

PARA invites you to check out the mlnconnects page available from the Centers For Medicare and Medicaid (CMS). It's chock full of news and information, training opportunities, events and more! Each week PARA will bring you the latest news and links to available resources. Click each link for the PDF!

Th u r sday, Sept em ber 2, 2021

New s -

Ambulance Prior Authorization Model Implementation Dates In Response to Hurricane Ida PHE, CMS Announces Support for Provider Enrollment Activities Resume in October Hospice Quality Reporting Program: Public Reporting Key Dates DME Suppliers: Payment for Respiratory Equipment Affected by Healthy Aging: Recommend Services for Your Patients

Residents of Louisiana & Mississippi

Recent Recall

Com plian ce -

DMEPOS Standard Written Order Requirements

Claim s, Pr icer s, & Codes -

HCPCS Level II Application Submission: Launch of MEARISTM HCPCS Level II Application Submission Deadlines

M LN M at t er s® Ar t icles -

International Classification of Diseases, 10th Revision Coverage Determination (NCDs) ? January 2022

Pu blicat ion s -

Medicare Provider Enrollment ? Revised

View this edition as PDF (PDF)

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(ICD-10) and Other Coding Revisions to National

PARA Weekly eJournal: September 8, 2021

There were 0 new or revised MedLearns released this week.

To go to the full Transmittal document simply click on the screen shot or the link.

0

FIND ALL THESE MEDLEARNS IN THE ADVISOR TAB OF THE PDE

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PARA Weekly eJournal: September 8, 2021

There was ONE new or revised Transmittals released this week.

To go to the full Transmittal document simply click on the screen shot or the link.

1

FIND ALL THESE TRANSMITTALS IN THE ADVISOR TAB OF THE PDE

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PARA Weekly eJournal: September 8, 2021

The link to this Transmittal R10993DEMO

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PARA Weekly eJournal: September 8, 2021

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