PARA HealthCare Analytics Weekly eJournal January 27, 2021

January 27, 2021

PARA

WeeklyeJOURNAL NEWS FOR HEALTHCARE DECISION MAKERS Claims Guidance Page 15

Page 23 Im por t an t COVID In f or m at ion Page 51

Im plan t able Def ibr illat or s Page 38

- OPPS Pack agin g - Ziopatch Coding - Billin g For Oxygen An d Pu lse Oxim et r y - Omnibus Bill Strips G2211 Payment - 900 Wor ds Abou t PTT - CMS IPPS Pricer

FAST LINKS

- CM S " M ost Favor ed Nat ion" St opped By Feder al Cou r t - Billing And Coding For COVID-19 Vaccines - M LNCon n ect s New slet t er - MedLearns

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Administration: Pages 1-66 HIM /Coding Staff: Pages 1-66 Providers: Pages 2,4,15,18,23,38 Oncology: Page 2 Cardiology: Pages 4,5,38 Pulmonology: Page 3 1 Respiratory Care: Pages 5,52

Wh y Is Th is Nu m ber Im por t an t ?

Page 34

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COVID Guidance: Pages 47,51 Price Transparency: Pages 8,21 Finance: Pages 8,21 California Providers: Page 23 Pharmacy: Page 41 Laboratory: Pages 55,59 DM E: Page 57

© 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: January 27, 2021

OPPS PACKAGING

I am doing a financial analysis of our Cancer Center's recurring accounts. I am trying to separate each date of service as if it were billed separately, and not on a recurring account. I am having trouble finding guidance on exactly which status indicators get packaged with each other. I know if the claim has a code with status indicator J1 or J2, the reimbursement for most charges will be packaged into the reimbursement for the code with J1 or J2.

I also know that Q4 will be packaged with Q1, if on the same claim. I was hoping you could provide me with a chart that provides this information or a place with PARA that I can type in several CPTÂŽ /HCPCS and see which ones have separate reimbursement and which ones get packaged.

For example, I have a claim with 96372 (SI - Q1), and J1447 (SI-K). If the claim only has these two codes, what would the reimbursement be? Any guidance or advice is greatly appreciated.

Answer: Please use the ?Quick Claim Evaluator? on the Calculator tab. Enter the string of HCPCS in the Code field on the left, select ?Quick Claim?, and submit:

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PARA Weekly eJournal: January 27, 2021

OPPS PACKAGING

The results will return with the packaging indicated:

Additionally, there is a key to the OPPS Status Indicators in the lower left corner of the Calculator tab ? it is outlined in red in the first screen shot above.

By the way, repeater claims have one particularly tricky twist ? any status Q1 provided on any date of service will be ?packaged? to any other payable line on the same claim, regardless of the date of service of the payable line.

The payment packaging instructions appear on page 12 of the 2020 Integrated Outpatient Claim Editor (IOCE) CMS Specifications V21.0.R1): https://www.cms.gov/apps/aha/license.asp?file=/files/zip/january-2020-ioce-r1-re-release.zip 5.4.1 Processing Procedures with Status Indicators of Q1 and Q2Effective January 1, 2017 (v18.0), conditional APC assignment and packaging discussed in this section for procedures with SI = Q1 or Q2 are executed across the claim if multiple service dates are present, and not by individual date of service. References noted as processed by day are to be considered for claims with From Dates prior to January 1, 2017. Procedure codes with SI of Q1 or Q2 are packaged when they appear with other specified services on the same day or claim; however, they may be assigned to a payable SI and APC and paid separately if there are no other specified services on the same day or claim. Procedures with SI = Q1 are packaged in the presence of any payable procedure code with SI of S, T, or V (and through version 15.3, SI = X). Procedures with SI = Q2 are packaged only in the presence of payable codes with SI = T or effective with version 16.0, J1. The SI is changed from Q1 or Q2 to N for packaging if present with other payable services, or to the standard SI and APC specified for the code when separately payable. If there are multiple Q1 or Q2 procedures on a specific date or claim and no service with which the codes would be packaged on the same date or claim, the Q1/Q2 code assigned to the APC with the highest payment rate is paid and all other codes are packaged. If a procedure with SI = Q1 or Q2 has been previously packaged (SI = N) prior to the execution of the conditional APC processing logic, the packaged Q1 or Q2 is ignored from the selection as the service with the highest paying APC payment rate. Additionally, procedures with SI = Q1 or Q2 that are packaged with SI = N under conditional APC processing logic are not evaluated in any subsequent processing (e.g. composite or comprehensive APC processing).

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PARA Weekly eJournal: January 27, 2021

ZIOPATCH CODING

At our last monthly call we were told that 0296T for Ziopatch would not be active in 2021.

WE are looking at codes 93242 or 93246, depending on time. Are these correct? We were also wondering about 93229. If you could give us your input on this we would appreciate it!

Answer: The manufacturer of ZioPatch offers two models ? the ZioXT for plain ECG recording, the ZioAT for mobile telemetry: https://www.irhythmtech.com/providers/zio-service/zio-monitors Therefore the appropriate code appears to hinge on which model is used.

As we explained during our meeting, in its 2021 update, the AMA discontinued CPT® 0296T - EXTERNAL ELECTROCARDIOGRAPHIC RECORDING FOR MORE THAN 48 HOURS UP TO 21 DAYS BY CONTINUOUS RHYTHM RECORDING AND STORAGE; RECORDING (INCLUDES CONNECTION AND INITIAL RECORDING).

The AMA refers providers to see CPT®s 93242 and 93246 for extended ECG recording in 2021: 93242 - EXTERNAL ELECTROCARDIOGRAPHIC RECORDING FOR MORE THAN 48 HOURS UP TO 7 DAYS BY CONTINUOUS RHYTHM RECORDING AND STORAGE; RECORDING (INCLUDES CONNECTION AND INITIAL RECORDING) 93246 - EXTERNAL ELECTROCARDIOGRAPHIC RECORDING FOR MORE THAN 7 DAYS UP TO 15 DAYS BY CONTINUOUS RHYTHM RECORDING AND STORAGE; RECORDING (INCLUDES CONNECTION AND INITIAL RECORDING) Attached PARA's paper discussing this coding update for 2021.

93229 reports mobile telemetry; here?s the code description: 93229 - EXTERNAL MOBILE CARDIOVASCULAR TELEMETRY WITH ELECTROCARDIOGRAPHIC RECORDING, CONCURRENT COMPUTERIZED REAL TIME DATA ANALYSIS AND GREATER THAN 24 HOURS OF ACCESSIBLE ECG DATA STORAGE (RETRIEVABLE WITH QUERY) WITH ECG TRIGGERED AND PATIENT SELECTED EVENTS TRANSMITTED TO A REMOTE ATTENDED SURVEILLANCE CENTER FOR UP TO 30 DAYS; TECHNICAL SUPPORT FOR CONNECTION AND PATIENT INSTRUCTIONS FOR USE, ATTENDED SURVEILLANCE, ANALYSIS AND TRANSMISSION OF DAILY AND EMERGENT DATA REPORTS AS PRESCRIBED BY A PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROFESSIONAL Using the general information available on the ZioPatch website, we?re not able to verify whether the ZioPatch AT model permits all the functions described in the mobile telemetry code. Please ask the department?s cardiology staff to examine the functionality of the patch in light of the CPT® code requirements to verify whether the ZioPatch meets the test.

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PARA Weekly eJournal: January 27, 2021

BILLING FOR OXYGEN AND PULSE OXIMETRY MONITORING

Th e deliver y of oxygen t o a pat ien t in a bed (in pat ien t or ou t pat ien t ) m ay be ch ar ged as a n on -st er ile su pply u sin g r even u e code 0271 pr ovided t h at t h e docu m en t at ion su ppor t s bot h t h e m edical n ecessit y an d t h e r ecor d of t h e ph ysician?s or der f or oxygen t h er apy.

The charges may be applied as follows: - Oxygen can be charged hourly, per shift, or per day - Oxygen is not charged if the patient is on a ventilator oxygen is considered within the ventilator management charge - When a humidifier is added for higher-flow oxygen, the humidifier is not separately charged, it is considered incidental to the charge for oxygen High Flow: Some hospitals bill a higher charge for high-flow oxygen therapy, as it requires not only more oxygen gas but more expensive supplies. High-flow oxygen supplies should not be separately charged.

Oxygen supplies, including inexpensive masks, nasal cannulas, and tubing, fall into the category of bulk supplies which are not separately billable. PARA does not recommend billing the high flow therapy nasal cannula system separately; charge auditors hired by insurance companies will deny any line item with the word ?tubing? or ?canula?.

(For more information, refer to the PARA document ?Billing for Supplies? at https://apps.parahcfs.com/pde/documents/PARA_BillingForSupplies.pdf.)

Pulse Oximetry may be separately charged only when it is specifically appropriate to the care of an individual patient on the order of a physician. For example, if all patients undergoing anesthesia for surgery are concurrently monitored for oxygen saturation via pulse oximetry, the pulse oximetry charge should not be separately charged as it is incidental to the surgical/anesthesia procedure charges.

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PARA Weekly eJournal: January 27, 2021

BILLING FOR OXYGEN AND PULSE OXIMETRY MONITORING

Note that the Medicare APC status for 94760 and 94761 is ?N?, not separately reimbursed:

When pulse oximetry is routinely performed in the ED as the ?4th? vital sign, it is considered the customary standard of care, and not a separately billable line. The nursing resource should be captured in the following charges for general nursing services: - ED level charge - ICU room charge - Daily ventilator charge - Oxygen charge Disposable probe covers for pulse oximetry are not chargeable in addition to the charge for pulse oximetry.

The cost of the supply is considered incidental to the charge for the monitoring service.

There are a number of articles in the PDE Calculator CPTÂŽ Assistant discussing pulmonary function testing.

To review these articles, enter the HCPCS code in the Calculator Report Selection.

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PARA Weekly eJournal: January 27, 2021

BILLING FOR OXYGEN AND PULSE OXIMETRY MONITORING

The Calculator query will return all CPT Assistant® documents which reference the codes in the query shown here:

Each document is available for review by clicking the links at right.

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PARA Weekly eJournal: January 27, 2021

THE COM PLIANCE GUIDE

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2021 8

PARA Weekly eJournal: January 27, 2021

There is still time to achieve readiness for the critical Price Transparency Rule.

PARA can help.

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PARA Weekly eJournal: January 27, 2021

THE CLOCK IS TICKING DATES, RULES & REGS The CMS final rule (CMS-1717-F2) aims to make hospital price information readily available to patients, so they can compare costs and make more informed healthcare decisions. Meeting the deadline and maintaining compliance will be no small endeavor for providers. Complying with the mandate will be a large undertaking that requires multi-disciplinary coordination. PARA HealthCare Analytics and HFRI can help navigate the dates, the rules and the regulations.

REQUIREMENT #1

By Jan u ar y 1, 2021, h ospit als ar e r equ ir ed t o be in com plian ce w it h t h e Hospit al Pr ice Tr an spar en cy r equ ir em en t s set f or t h in t h e CY 2020 Hospit al Ou t pat ien t PPS Policy Ch an ges (CM S-1717-FS).

REQUIREMENT #2 A com pr eh en sive m ach in e-r eadable f ile t h at in clu des t h e specif ic st an dar d ch ar ges f or all h ospit al it em s an d ser vices.

REQUIREMENT #3 A con su m er -f r ien dly display t h at in clu des t h e st an dar d ch ar ges f or at least 300 "sh oppable" ser vices t h at ar e gr ou ped w it h ch ar ges f or an cillar y ser vices t h at ar cu st om ar ily pr ovided by t h e 10 h ospit al.

PARA Weekly eJournal: January 27, 2021

SOLUTIONS FOR HOSPITALS THE PARA PTT 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 letter of the law, both CMS requirements in a fully customizable manner.

Providers will need to publish both machine-readable format files and the patient facing price estimator is a value-add service for enhancing price transparency.

PARA will use the CMS Extract file embedded in the Price Transparency Tool tab via the PARA Dat a Edit or to build the shoppable items/bundles.

This can be done by the hospital, coupled with PARA?s guidance to ensure all primary procedures are linked to its customarily paired ancillary services.

Turnaround time for the Pr ice Tr an spar en cy Tool is 60 days from submission of completed data.

There is no limit at this time on how many clients PARA can assist with the CMS?2021 price transparency requirements as we are constantly monitoring workload and innovating our automation to support the data mining need for this initiative.

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PARA Weekly eJournal: January 27, 2021

FROM <THIS, TO THIS> TAKING CONSUMERS FROM THE STONE AGE TO THE DIGITAL AGE

M EET THE T EAM

Violet Ar ch u let -Ch iu

San dr a LaPlace

Ran di Br an t n er

Senior Account Executive

Account Executive

Vice President of Analytics

varchuleta@para-hcfs.com

splace@para-hcfs.com

rbrantner@hfri.net

800.999.3332 x219

800.999.3332 x 225

719.308.0883

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PARA Weekly eJournal: January 27, 2021

CAPABILITIES AND SERVICES To ensure consumers will be able to browse for healthcare services in the same way they shop for other goods and services online, hospitals partner with PARA Healt h Car e An alyt ics, an HFRI company that has been providing hospitals and health systems with pricing, reimbursement, coding, and contract management services since 1985.

PARA works closely with clients to deploy robust and accurate pricing capabilities for area healthcare consumers. The PARA solution includes a patient-facing estimator engineered to deliver user-friendly, procedure-level estimates reflecting patients?specific coverage limits.

Providing consumers with the ability to effectively shop for healthcare services is essential as more employers transition to high-deductible health plans.

Peter Ripper, CEO of PARA Healt h Car e An alyt ics, has led his team to design a solution that will provide meaningful, easy-to-understand information for healthcare consumers.

With the healthcare providers facing a range of new financial pressures due to the COVID-19 pandemic, PARA has pushed to ensure that the critical but complex transparency rule can be implemented in a timely, cost-effective and consumer-friendly manner. We look forward to helping other systems who may be struggling to achieve price transparency.

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PARA Weekly eJournal: January 27, 2021

WATCH YOUR HOSPITAL'S BRIGHT FUTURE UNFOLD With The Help Of Our Price Transparency Tool

PRESS HERE

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PARA Weekly eJournal: January 27, 2021

INACCURATE CLAIM REJECTIONS FOR PROLIA J0897

Several PARA clients have reported that claims for Prolia, J0897, rejected in the Medicare FISS system with an error that indicates that J0897 must be billed on a home health claim type, TOB 34X.According to the error, TOB 131 is not acceptable.This is an inaccurate rejection.

A Medicare transmittal which expanded access to osteoporosis drugs through Home Health agencies (CR 11846) inadvertently triggered a change to the claims processing system which has resulted in the rejection of the HCPCS for a common osteoporosis therapeutic injection, Prolia, on Medicare Part A outpatient claims.The problem has been reported in more than one Medicare Administrative Contractor jurisdiction, indicating the problem may have been duplicated nationwide.

MAC NGS published an update Friday, January 22, 2021 which explains thatproviders should hold claims until CMS resolves the issue. http://view.email.ngsmedicare.com/?qs=acd6bffa6144bf03a81c2e2e633bd7e4740f1d96e97fd81f982d 747bc0419583724df63765ef2460bccec21bea9bbf84a8019c3db72adb4c3d06a75a2c5a8dc45bf59c5c 49552d781c49d5fc0dc67c34

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PARA Weekly eJournal: January 27, 2021

INACCURATE CLAIM REJECTIONS FOR PROLIA J0897

As mentioned in the NGS notice, in addition to Prolia, the error also affects J3111 (brand name Evenity) and the HCPCS for unclassified biologics, J3590.

The generic name for Prolia is denosumab, reported using HCPCS J0897. J0897 has long been payable under Medicare?s OPPS reimoutpatient hospital billing; it is a status K (separately payable) drug:

The change request also generated rejections for Status G (pass-through drugs) brand name osteoporosis drugs Evenity or Tymlos, reported using J3111 injection, romosozumab-aqqg, 1mg The change request which triggered the error, (CR11846 effective 1/1/2021) added wording to the Medicare Claims Processing Manual, Chapter 10 ? Home Health Agency Billing. Although the change made no mention of outpatient hospital claims, it was somehow misinterpreted to have the effect of limiting access to these drugs.

R10274CP (cms.gov)

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PARA Weekly eJournal: January 27, 2021

INACCURATE CLAIM REJECTIONS FOR PROLIA J0897

Some MACs publish LCDs which set out the medical necessity osteoporosis drugs. Providers should refer to limitations of coverage for osteoporosis HCPCS codes ICD-10 codes that support medical necessity and the billing and coding articles offered by the provider?s regional MAC. Two LCD links are provided here: CGS published the following Article instructing providers to report that J0897 with the non-chemotherapy administration codes: Local Coverage Article for Billing and Coding: Complex Drug Administration Coding (cms.gov)

NGS provides a Local Coverage Article from NGS applicable to Illinois, Minnesota, Wisconsin, Connecticut, New York, etc. specific to Prolia: Local Coverage Article for Billing and Coding: Denosumab (Prolia ? , Xgeva ? ) (cms.gov)

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PARA Weekly eJournal: January 27, 2021

OMNIBUS BILL STRIPS G2211 PAYMENT, INCREASES OTHER PRO FEES

he recently enacted Consolidated Appropriations Act of 2021 (the Act) stalled Medicare?s ambitious plan to transfer a larger slice of the Medicare reimbursement pie to primary care physicians at the expense of reimbursement to specialists.In fact, the Act increases reimbursement to most physicians under the Medicare Physician Fee Schedule by 3.75%.

The means by which Medicare had planned to transfer higher reimbursement to primary care physicians was through paying two add-on codes, G2211 and G2212, with office visit codes (99202-99215.)In order to pay higher rates on office visits, Medicare was set to reduce reimbursement on most non-office visit services by around 10%.

The Act places a moratorium on CMS to keep it from paying HCPCS G2211, for ?complexity inherent to E/M Visits? when billed together with office visit CPTÂŽ codes 99202 through 99215. The moratorium will remain in effect until 2024, while other provisions in the Act will increase physician payments in general by 3.75% over the rates paid in 2020.While Medicare claims systems may not reject professional fee claims reporting G2211 in the New Year, the code will not be reimbursed, according to the Act. To illustrate the increase in reimbursement that G2211 had promised, when billed together with 99213, G2211 represented an increase of 17% to 25% in Medicare reimbursement on 99213, depending on whether the professional fee was facility-based:

While reporting G2211 will be an unrewarding exercise in 2021, new HCPCS G2212 remains valid and payable.G2212, which is an add-on code for prolonged time at 15-minute increments in performing a high-complexity E/M (99205 or 99215) will be valid in 2021, although it will not be reported as frequently as G2211 would have been.

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PARA Weekly eJournal: January 27, 2021

OMNIBUS BILL STRIPS G2211 PAYMENT, INCREASES OTHER PRO FEES

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

Here are the key points for professional planning to report new HCPCS code G2212: - G2212 is intended to be used in lieu of 99417 on Medicare professional fee claims.The CPT® explanation of time required for 99417 above the minimum time range for an E/M was unacceptable to CMS; the new HCPCS G2212 clarifies the time required to ensure that the 15-minute increment is above the maximum time threshold for the E/M codes 99205 and 99215 - In order to remain true to the principle that all patients should be charged the same, PARA recommends reporting G2212 to Medicare, and 99417 to non-Medicare payers. To ensure consistency in billing practices, providers should charge either code only after the maximum time range of CPT® 99205 or 99215 was reached - Reimbursement per unit of G2212 will differ slightly in the facility vs. non-facility setting: Non-facility @ .97 RVU x $32.41 = $31.37; Facility @ .93 x $32.41 = $30.14 (this may change if G2212 is subject to the 3.75% increase referenced in the Act.) The documented time required to report units G2212 must be the full 15-minute increment. Do not report G2212 for a partial period, even if that partial period is more than half the 15 minutes

A link and pertinent excerpts from the Act are provided below: https://rules.house.gov/sites/democrats.rules.house.gov/files/BILLS-116HR133SA-RCP-116-68.pdf Showing the text of the Consolidated Appropriations Act, 2021 SEC. 101. SUPPORTING PHYSICIANS AND OTHER PROFESSIONALS IN ADJUSTING TO M EDICARE PAYM ENT CHANGES DURING 2021.

(continued next page)

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PARA Weekly eJournal: January 27, 2021

OMNIBUS BILL STRIPS G2211 PAYMENT, INCREASES OTHER PRO FEES

(a) IN GENERAL.? Section 1848 of the Social Security Act (42 U.S.C. 1395w?4) is amended by adding at the end the following new subsection: ??(t) SUPPORTING PHYSICIANS AND OTHER PROFESSIONALS IN ADJUSTING TO MEDICARE PAYMENT CHANGES DURING 2021.? ??(1) IN GENERAL.? In order to support physicians and other professionals in adjusting to changes in payment for physicians?services during 2021, the Secretary shall increase fee schedules under subsection (b) that establish payment amounts for such services furnished on or after January 1, 2021, and before January 1, 2022, by 3.75 percent. ?

SEC. 113. M ORATORIUM ON PAYM ENT UNDER THE M EDICARE PHYSICIAN FEE SCHEDULE OF THE ADD ON CODE FOR INHERENTLY COM PLEX EVALUATION AND M ANAGEM ENT VISITS. (a)IN GENERAL.? The Secretary of Health and Human Services may not, prior to January 1, 2024, make payment under the fee schedule under section 1848 of the Social Security Act (42 U.S.C. 1395w?4) for services described by Healthcare Common Procedure Coding System (HCPCS) code G2211(or any successor or substantially similar code), as described in section II.F. of the final rule filed by the Secretary with the Office of the Federal Register for public inspection on December 2, 2020, ?

The American Medical Association posted a review of the key provisions of the Act on its website at the following link ? an excerpt is provided: https://www.ama-assn.org/delivering-care/patient-support-advocacy/congress-provides-reliefmedicare-payment-passes-surprise

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PARA Weekly eJournal: January 27, 2021

900 WORDS ABOUT THE PRICE TRANSPARENCY TOOL

900 WordsAbout

PTT

Healthcare consumerism is in the spotlight as we closed out 2020, and the Centers for Medicare and Medicaid Services (CMS) moved forward with implementing Hospital Price Transparency requirements on January 1st, 2021.

Beginning on that date, each hospital operating in the US is required to provide publicly accessible standard charge information online for the items and services they offer.The information must be provided in two ways, and PARA has created the solution to readily to meet these requirements and empower Patients to make meaningful comparisons in a consumer-friendly, intuitive manner.

At its core, these requirements are intended to allow Patients to view and compare the prices for healthcare services across different hospitals.

The CMS Requirements CMS requires the hospital charge information be available in two ways.

The first approach is through a Comprehensive machine-readable file of all items and services.This downloadable file should be categorized by payer and include the following information: - Gross Charges (chargemaster price) - Discounted Cash Prices (self-pay/cash price) - Payer-Specific Negotiated Charges (hospital negotiated price by third-party payer) - De-identified Minimum Negotiated Charges (lowest third-party payer negotiated price) - De-identified Maximum Negotiated Charges (highest third-party payer negotiated price) The second method is a display of 300 shoppable services in a consumer-friendly format.These shoppable services are common tests and procedures performed at the hospital including any additional charges usually associated with the procedure.The required data points are the same as the previous files.

Ideally, though not required, this second requirement should include an internet-based price estimator tool that allows consumers to determine an accurate Patient out-of-pocket cost estimate through integration of co-payment and deductible information. Overall, CMS hopes these requirements will further the availability of publicly accessible pricing data to better compare services across health care settings towards the benefit of the consumer.

The Challenges These requirements present challenges when it comes the sheer data mining and payer contract analytics required to deliver on the mandates.Some hospitals and consulting firms have relied on the use of rate-averaging to determine the payer-specific negotiated rates. This is usually accomplished through analysis of 837/835 Electronic Data Interchange (EDI) data to calculate the average charge and average payment at the payer level.

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PARA Weekly eJournal: January 27, 2021

900 WORDS ABOUT THE PRICE TRANSPARENCY TOOL

However, the CMS Final Rule outlines that the definition of Payer Specific Negotiated Charge as the charge the hospital has negotiated with a third-party payer. In PARA?s experience, there is approximately a 40% error rate in the 835 EDI remit data, so it is not a reliable source for determining the negotiated payment rate. The final rule clearly states that the Payer Specific Negotiated Charge refers to the charge that the hospital has negotiated with the third-party payer,not the payment received.

Additionally, CMS is requiring that the hospital list the tax ID number on the names of the downloadable files which has significance in the agency?s ability to mine and audit the data. It is PARA?s opinion that CMS will have the capability to compare this data to Medicare reimbursement and adjust rates accordingly.If a facility relies on the use of 835 remit data, they may inadvertently understate their third-party reimbursement values, which may result in a reduction in Medicare rates.

Therefore, PARA relies on the actual language from payer contracts to determine the negotiated rates as mandated in the requirements. 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 HFMA Article on the topic, this detailed approach could cost a hospital several hundred thousand dollars to contract with a consulting firm.

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, comprehensive solution out there today.

The Solution The consumer expects 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 Hospital Partners in making meaningful comparisons in a consumer-friendly, intuitive manner.

The team at PARA HealthCare Analytics 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.

According to Peter Ripper, CEO of PARA HealthCare Analytics, ?The President?s Executive Order in June 2019 promoted increased availability of meaningful pricing information for Patients.The key word here is meaningful.Therefore, since the release of the CMS requirements, we?ve focused on creating an approach to these obligations that would lessen confusion for Patients and support the hospital in fulfilling the mandates. With a healthcare environment riddled with various pressures including thin operating margins, health plan competition, and a shortage of resources due to a pandemic, PARA has done the heavy lifting to deliver the best solution possible for our Hospital Partners.?

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PTT

PARA Weekly eJournal: January 27, 2021

CALIFORNIA PROVIDERS: MEDI-CAL UPDATES FOR 2021

For the month of January 2021, Medi-Cal is implementing the following changes: - New codes / Modifiers - Replacement codes - Discontinued codes - Updated codes to specific Medi-Cal Programs - Updated restrictions to codes - Updated rates - ICD-10 update The following services have been detailed in the associated Bulletins: - Allied Health (ACU, AUD, CHR, DME, MTR, OAP, PSY) - Medical Services (GM) / Obstetrics (OB) - Inpatient / Outpatient (AID, CAH, DIA, Adult Day Care, EAP, HER, HOM, HOS, IPS, LEA, MSSP, REH) - Long Term Care - Pharmacy - Vision Care - Family PACT The information contained in this article can be found at the following link: https://files.medi-cal.ca.gov/pubsdoco/bulletins/artfull/cah202101.aspx

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PARA Weekly eJournal: January 27, 2021

CALIFORNIA PROVIDERS: MEDI-CAL UPDATES FOR 2021

Providers: All Medi-Cal Participating Providers Alert: CY2021 1st Quarter HCPCS Updates: The CY 2021 1st Quarter HCPCS updates are effective as of January 01, 2021, however due to COVID-19, Medi-Cal is not able to implement the updates at this time.

Providers are asked not to use the CY 2021 1st Quarter HCPCS codes on claims submitted for Medi-Cal or Presumptive Eligibility for Pregnant Women (PE4PW) until notified in a future Medi-Cal update.

Providers: All Medi-Cal Participating Providers Update: COVID-19 Testing Codes 87636, 87637 and 87811: Effective for dates of service on or after October 06, 2020, the reimbursement rates for 87636, 87637 and 87811 are being updated.

The codes are exempt from the 10% payment reductions as outlined in the California W&I Code section 14105.192.

There is no action required from providers at this time. An Erroneous Payment Correction (EPC) will be implemented to correct impacted claims.

Providers: Pharmacy Suppliers Termination: Monthly Six (6) Prescription Limit and Pharmacy Co-Pay ? On May 13, 2020 DHCS issued a temporary waiver to suspend the monthly six (6) prescription limits per beneficiary due to the COVID-19 pandemic.

Effective January 01, 2021, this waiver is now permanent for all Medi-Cal Program beneficiaries. In addition, under the CY2020 Budget Health Omnibus Trailer Bill (AB80/SB102) the one (1) dollar co-pay was permanently eliminated.

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PARA Weekly eJournal: January 27, 2021

CALIFORNIA PROVIDERS: MEDI-CAL UPDATES FOR 2021

Providers: Audiology and Hearing Aids, Durable Medical Equipment, Pharmacy, Orthotics and Prosthetics, Therapies New Medi-Cal Benefit ? Effective for dates of service on or after December 01, 2020, HCPCS code E1639 has been added to the Medi-Cal Program as a new benefit.

Providers seeking reimbursement, documentation must indicate the recipient does not have access to a scale and meets one of the following criteria: - Recipient is enrolled in the Medi-Cal Diabetes Prevention Program, and/or - Recipient is pregnant, and/or - Recipient has a medical condition that requires on-going monitoring of weight from home

Providers: Audiology and Hearing Aids, Durable Medical Equipment, Orthotics and Prosthetics, Pharmacy New: TENS Units and NMES Devices are Non-Taxable ? Effective retroactively for dates of service on or after April 01, 2015, the following table indicates specific Transcutaneous Nerve Stimulators (TENS) and Neuromuscular Electrical Stimulators (NMES), HCPCS that are non-taxable under the Medi-Cal Program.

No action is required by Providers at this time. An EPC will reprocess impacted claims.

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PARA Weekly eJournal: January 27, 2021

CALIFORNIA PROVIDERS: MEDI-CAL UPDATES FOR 2021

Providers: Durable Medical Equipment, Pharmacy, Orthotics and Prosthetics, Therapies Update: Frequency limits to Disposable Collection and Storage Bags for Breast Milk ? Effective for dates of service on or after February 01, 2021, HCPCS code K1005 frequency limits have been updated to 120 bags per infant without a Treatment Authorization Request (TAR).

However, additional requests for bags over the 120 limit per infant, will require an approved TAR. Provider?s requesting additional bags, use the infant?s Medi-Cal ID on the TAR. If the infant?s Medi-Cal approval has not been processed, Provider?s may use the mother?s Medi-Cal ID. 26

PARA Weekly eJournal: January 27, 2021

CALIFORNIA PROVIDERS: MEDI-CAL UPDATES FOR 2021

Providers: Chronic Dialysis Clinics, Clinics and Hospitals, General Medicine, Obstetrics CLIA-Waived 87428 and 87811 ? The following tests are considered to be Clinical Laboratory Improvement Amendments (CLIA)- waived when performed with a CLIA-waived test kit.

These codes may be submitted with the QW modifier.

No action is required from providers, Medi-Cal will issue an EPC to reprocess impacted claims

Providers: Chronic Dialysis Clinics, Clinics and Hospitals, General Medicine, Obstetrics, Pharmacy, Rehabilitation Clinics New: Teprotumumab-trbw (J3241) ? Effective for dates of service on or after October 01, 2020, Teprotumumab-trbw J3241 is now a Medi-Cal benefit.

An approved TAR is required for reimbursement under the Medi-Cal Program.

Claims submitted for Medi-Cal reimbursement prior to the effective date of this new benefit will be reprocessed. No action is required by providers at this time.

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PARA Weekly eJournal: January 27, 2021

CALIFORNIA PROVIDERS: MEDI-CAL UPDATES FOR 2021

Providers: Chronic Dialysis, Clinics and Hospitals, General Medicine, Obstetrics, Rehabilitation Clinics, Pharmacy Updates: Policy Updates for Injection HCPCS J0490, J1335, and J2182 ? Effective for dates of service on or after February 01, 2021, Medi-Cal has updated the reimbursement policies for the following codes.

Providers: Clinics and Hospitals, General Medicine, Obstetrics, Rehabilitation Clinics, Chronic Dialysis Clinics, Pharmacy Updates: Billing Policy for Lanreotide (J1930) ? Effective for dates of service on or after February 01, 2021, the billing policy for HCPCS J1930 has been updated to delete the Approved TAR requirements.

An Approved TAR is no longer required for providers seeking reimbursement for J1930.

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PARA Weekly eJournal: January 27, 2021

CALIFORNIA PROVIDERS: MEDI-CAL UPDATES FOR 2021

Providers: Clinics and Hospitals, General Medicine, Obstetrics, Pharmacy, Rehabilitation Clinics Terminated Medi-Cal Benefit G0396, G0397 and G2011 ? Effective for dates of service on or after February 01, 2021, HCPCS G0396, G0397 and G2011 are NO LONGER Medi-Cal benefits and will not be reimbursed to Medi-Cal Participating Providers.

Providers: Clinics and Hospitals, General Medicine, Obstetrics Update for Preventive Medicine Services 99385 and 99395 ? Effective for dates of service on or after February 01, 2021, CPTÂŽ codes 99385 and 99395 reimbursement policy has been updated to reflect age limits.

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PARA Weekly eJournal: January 27, 2021

CALIFORNIA PROVIDERS: MEDI-CAL UPDATES FOR 2021

Providers: All Medi-Cal Participating providers Update Policy: Billing Immune Globulins ? On October 06, 2020, DHCS published an update article, which is been updated at this time to remove Xembify from the list of immune globulins billable with CPT® code 90284.

The preferred biological billing codes listed in the table below have effective dates of service on or after October 01, 2019. For reimbursement, providers must submit claims for the listed CPT codes using the corresponding HCPCS codes shown in the table below: Providers may continue to bill for Gammagard liquid, Gammaked, Gammunex-C and Cutaquig using CPT code 90284.

Cuvitru must be billed with J1555 and Hizentra with J1559 Processes for Rebilling and Payment Correction of Rho (D) Immune Globulins for Dates of Service on or after October 01, 2019 to August 31, 2020. This process applies to providers who billing with CPT® codes and were denied or underpaid: Providers that previously submitted claims with CPT® codes 90384 and 90385 and had claims that were denied: - Re-bill with the corresponding J codes as indicated in the table - It is not necessary to submit an approved TAR - Medi-Cal will reprocess and reimburse at the full Medi-Cal established rate that is available - If re-bill is submitted beyond the 6-month billing limitation, timeliness of the re-bill will be waived Providers that previously submitted claims with CPT® codes 90384 and 90385 and were reimbursed only the injection administration fee of $4.46 should complete the following: - Submit a Claims Inquiry Form (CIF) to void the claim billed with the CPT® code - There are no time restrictions on this process - When completing the CIF, providers must enter the information exactly as it appears on the Remittance Advice Details (RAD) to ensure the claim is located within the Medi-Cal processing system - Re-bill using the corresponding J-code as indicated in the table for the appropriate reimbursement following the void of the previous claim - It is not necessary to submit an approved TAR - Medi-Cal will reprocess and reimburse at the full Medi-Cal established rate that is available - If re-bill is submitted beyond the 6-month billing limitation, timeliness of the re-bill will be waived

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PARA Weekly eJournal: January 27, 2021

CALIFORNIA PROVIDERS: MEDI-CAL UPDATES FOR 2021

Providers: All Medi-Cal Hospice Providers Update: Annual Hospice Reimbursement Rates ? Effective for dates of service on or after October 01, 2020, DHCS has updated the Medi-Cal reimbursement rates for the CY2020 thru CY2021. Rate update includes daily and hourly hospice rates for routine home care, continuous home care, inpatient respite care, general inpatient care and service intensity add-on for all hospice providers.

Providers should bill using the new hospice rates. No action is required by providers for claims submitted and reimbursed at the old rates, DHCS will implement EPC to adjust all impacted claims. Providers can review rates posted on the Hospice Care page of the DHCS website. https://www.dhcs.ca.gov/services/medi-cal/Pages/Hospice.aspx Providers: Long Term Care Update: Temporary COVID-19 Increase for Distinct Part Adult Sub-acute (DPASA) Rates: A rate increase has been authorized under Section 7.4 of the COVID-19 SPA 20-0024 and a waiver under Section 1135 of the Social Security Act. This revised rate is effective as of August 01, 2020, is the 2020-2021 annual rate increased by 10%. Providers will be notified in a separate letter of their facility rates.

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PARA Weekly eJournal: January 27, 2021

CMS IPPS PRICER NOW LINKED TO THE PDE CALCULATOR

PARA is pleased to announce a new link on the Calculator page to Medicare?s Web-Based pricing tool:

The new CMS Web Pricer is a big improvement over previous ?PC Pricer? software ? it can be used for Inpatient Prospective Payment System (DRG) reimbursement, and Inpatient Rehab Facility reimbursement. There are plans to add other CMS reimbursement programs in the future.

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PARA Weekly eJournal: January 27, 2021

CMS IPPS PRICER NOW LINKED TO THE PDE CALCULATOR

Many hospitals subject to Medicare?s Inpatient Prospective Payment System (IPPS) DRG reimbursement will find the CMS IPPS Web-Based Pricer tool to be helpful in validating appropriate payment for inpatient stays. This is particularly important in identifying the cost outlier on high-dollar cases, and in checking whether Medicare managed care payers, when obligated to pay Medicare equivalent rates for inpatient care, are appropriately reimbursing hospitals under DRG methodology.

In the past, CMS offered its ?IPPS PC Pricer? software package, which was cumbersome COBOL-based software that often required the assistance of local IT support to load and execute properly.

The new ?Web Pricer? for IPPS is a big leap forward over the old version. The entire program is web based, requiring no software download. Navigation is much improved, although there?s one caveat ? the IPPS pricer requires a ?Review Code?, which is explained in a special note on the introductory page: Inpatient PPS PC Pricer | CMS

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PARA Weekly eJournal: January 27, 2021

5

Th e t op 5 f in an cial ch allen ges f acin g h ospit als in 2021.

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PARA Weekly eJournal: January 27, 2021

The Top 5 Financial Challenges As Ident ified

By Our Expert s Movinginto 2021, the financial pressuresplaced on hospitalsand health systemscontinuesto mount. Understandingthese pressuresis the first step in beingable to successfully addressand mitigate these challenges. Here are the top 5 challengesasidentified by our experts.

1. Price Transparency The responsibility for dramatically increasing consumer access to pricing information will continue.

2. The Impact Of PAMA Regulat ions Compliance with the Protecting Access to Medicare Act will place heightened pressure on financial resources.

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PARA Weekly eJournal: January 27, 2021

3. Ongoing COVID-19 Treat ment Expenses Adapting to dramatic changes in treatment modalities during the public health emergency will change the delivery of healthcare, and therefore the cost.

4. Payer Cont ract Negot iat ions Now that payer-negotiated rates have been made public, payers will create a contract negotiation environment unfavorable to hospitals.

5. The Survival Of Small Hospit als The financial demands placed on smaller hospitals will send these hospitals looking for partnerships with larger health systems.

Navigat ing t hese issues requires a t hought ful part ner wit h t he experience and financial gravit as t o make a difference.

That's where we come in.

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PARA Weekly eJournal: January 27, 2021

ABOUT THE TOP 5

The advent of t he public healt h em ergency relat ed t o COVID-19 dram at ically alt ered t he healt hcare landscape.

The sheer cost of grappling wit h t he pandem ic, t he drop in volum e of elect ive procedures and t he result ing loss of revenue have pushed som e hospit als t o t he brink of insolvency.

THEPARA EDGE When hospitals partner with PARA HealthCare Analytics, a number of services are brought to bear.

These vital services include Accounts Receivable Recovery; Charge Master Review; Claim Review; Market Based Pricing; Pharmacy Pricing Analysis; Physician Practice Pricing Analysis, and more.

Through the use of the industry-leading PARA Data Editor, partner hospitals can quickly and easily ascertain best practices for coding and billing.

Range of expertise among PARA consultants, each with an average of 21 years' healthcare experience, provides hospitals with the edge needed to more readily compete in a changing healthcare landscape.

Bu t PARA an d HFRI h ave ideas t o h elp.

That 's why our expert s have ident ified t he t op 5 challenges t hey believe hospit als will face in 2021.

But bet t er st ill, we've also developed st rat egies t o address t hese issues and help hospit als t hrive.

THEPOWEROF HFRI HFRI is altering the hospital AR landscape by delivering unparalleled speed, scalability and accuracy to the insurance AR management process.

Through HFRI's proprietary intelligent automation and powerful process engineering, hospitals are able to resolve all claims, regardless of size or age, thereby dramatically improving cash flow.

In addition, HFRI specialists collaborate with the teams from partner hospitals to assist with denial management and to identify root causes that will help prevent denials from occurring in the first place.

HFRI's scalable, client-specific solutions allow hospitals to systematically address problem claims across the full AR spectrum.

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PARA Weekly eJournal: January 27, 2021

CMS CLARIFIES IMPLANTABLE DEFIBRILLATOR ICD-10 CODING

Providers who offer automatic cardiac defibrillator (C1882) procedures should ensure the HIM department is aware of a new MLN article released on January 9, 2021 regarding ICD-10 coding which supports medical necessity requirements.The new article stresses the importance of recording ICD-10 codes for heart failure to meet the requirements of medical necessity, even if the symptoms of heart failure have been managed successfully.A link and excerpts are provided below: https://www.cms.gov/files/document/se20006.pdf

?The current requirements for reporting heart failure codes (ICD-10 diagnosis codes I50.21, I50.22, I50.23, I50.41, I50.42, and I50.43) for patients with ischemic or non-ischemic cardiomyopathy are based on NCD language, which specifically adds this requirement. ? ?CMS believes that perhaps some have misinterpreted correct coding principles with respect to the use of these codes. CMS agrees that patients do not have to have ?active heart failure? to qualify for an Automatic Implantable Cardioverter Defibrillator (AICD) but they also do not have to have ?active heart failure? in order to append one of these codes.? ?

This clarification is particularly important in light of the nationwide Recovery Audit Contractor issue, approved on October 6, 2020, which authorized RACs to examine whether medical necessity requirements were met for inpatient implantable defibrillator claims.Defibrillator claims are usually fairly high cost, due to the expense of the implantable device; failure to meet medical necessity on these cases can represent a large sum that includes out-of-pocket costs to the provider for the device itself.

RAC auditors will focus on inpatient defibrillator cases performed after National Coverage Determination 20.4 became effective on February 15, 2019.In addition to requirements related to patient condition as represented on the claim by ICD10 codes, the NCD requires a formal ?shared decision making visit? between the patient and the physician prior to the procedure.If that visit was not conducted, reimbursement will be recouped in full. Since inpatient ICD cases are typically reimbursed at between $30,000 and $90,000, the threat is significant.

A link and an excerpt from the approved issue announcement on the CMS website: https://www.cms.gov/node/1439781 Issue Name: 0195-Implantable Automatic Defibrillator- Inpatient Procedure: Medical Necessity and Documentation Requirements MAC Jurisdiction: All A/B MACs Description: The implantable automatic defibrillator is an electronic device designed to detect and treat life-threatening tachyarrhythmias. The device consists of a pulse generator and electrodes for sensing and defibrillating. Medical documentation will be reviewed for medical necessity to validate that implantable automatic cardiac defibrillators are used only for covered indications.

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PARA Weekly eJournal: January 27, 2021

CMS CLARIFIES IMPLANTABLE DEFIBRILLATOR ICD-10 CODING

PARA clients can identify the number of inpatient cases at risk of audit by using the CMS Claims Database on the PARA Data Editor. Search inpatient claims for DRGs 222, 223, 224, 225, 226, and 227:

The National Coverage Determination for Implantable Automatic Defibrillators (NCD 20.4) became effective February 15, 2019.The NCD is available on the CMS Coverage Database at the link below: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=110&ncdver =4&DocID=20.4&bc=gAAAAAIAAAAA&

The NCD requires that most patients receiving an initial ICD placement must first attend a ?formal shared decision making visit? with their doctor prior to the ICD placement procedure.If the ICD is placed without the required prerequisite visit, Medicare will not cover the procedure.Since payment is not predicated upon submitting the visit documentation in advance, many hospitals have been billing ICD cases and receiving substantial payments while unaware that the cases did not meet medical necessity.

In addition to other coverage requirements, the shared decision-making visit applies to the following categories of patients who may be considering an implantable ICD procedure: - Patients with a prior MI and a measured Left Ventricular Ejection Fraction (LVEF) <0.30 - Patients who have severe, ischemic, dilated cardiomyopathy but no personal history of sustained VT or cardiac arrest due to VF, and have NYHA Class II or III heart failure, LVEF <35% - Patients who have severe, non-ischemic, dilated cardiomyopathy but no history of cardiac arrest or sustained VT, NYHA Class II or III heart failure, LVEF <35%, been on optimal medical therapy for at least three months - Patients with documented, familial or genetic disorders with a high risk of life-threathening tachyarrhythmias (sustained VT or VF, to include, but not limited to, long QT syndrome or hypertrophic cardiomyopathy

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PARA Weekly eJournal: January 27, 2021

CMS CLARIFIES IMPLANTABLE DEFIBRILLATOR ICD-10 CODING

However, the shared decision-making visit is not required for patients with a personal history of sustained Ventricular Tachyarrhythmia (VT) or cardiac arrest due to Ventricular Fibrillation (VF), or patients that have had an ICD previously and require an ICD replacement procedure.

The formal shared decision-making encounter must occur between the patient and a physician or qualified non-physician practitioner using an evidence-based decision tool on ICDs prior to initial ICD implantation. The Colorado Program for Patient Centered Decisions offers such a tool at the following website: https://patientdecisionaid.org/icd/

Hospitals would be well served to ensure that ICD-10 coding is appropriate and evidence of the shared decision-making visit is on file prior to performing an implantable defibrillator procedure for a Medicare beneficiary for both inpatient and outpatient cases.

The procedure is costly due to the expensive purchased implants ? lost revenue for these procedures is more than benign because the significant cost of the implanted defibrillator device itself is at risk.

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PARA Weekly eJournal: January 27, 2021

CMS "MOST FAVORED NATION" STOPPED BY FEDERAL COURT

As expected, legal challenges to Medicare?s new ?Most Favored Nation? drug payment rule will delay Medicare?s announced implementation date of 1/ 1/ 2021, and may put the program on ice indefinitely.

The ruling vacates the MFN rule until CMS completes the ordinary administrative procedure of a notice and comment period before implementing the new payment scheme.That means the new rule could not become effective until at least 60 days after the comment period ends on January 26, 2021.

Meanwhile, President-elect Biden has announced that he will issue a memo to stop or postpone actions taken by the Trump administration that have not gone into effect by Inauguration Day, January 20, 2021.

The order from the US District Court of Northern California is particularly stinging; excerpts are provided below: https://innovation.cms.gov/media/document/mfn-ca-50-order-prelim-injunct 2. Likelihood of success on the merits. The plaintiffs have demonstrated that they are very likely? indeed virtually certain? to prevail on their claim that the government violated the APA?s notice and comment requirements. As Judge Blake explains, the government?s argument that the good cause exception applies is flimsy; complying with the notice and comment requirements here would not interfere with the agency?s ability to carry out its mission, or cause real harm to life, property, or public safety. See California v. Azar, 911 F.3d 558, 575-77 (9th Cir. 2018); East Bay Sanctuary Covenant v. Trump, 950 F.3d 1242, 1278 (9th Cir. 2020).

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PARA Weekly eJournal: January 27, 2021

CMS "MOST FAVORED NATION" STOPPED BY FEDERAL COURT

This would be true even if the government had not delayed so long in adopting the rule, but it is especially true in light of those delays. See Azar, 911 F.3d at 577; Chamber of Commerce v.

Department of Homeland Security, 2020 WL 7043877, at *7-9 (N.D. Cal. Dec. 1, 2020).

In fact, it seems obvious? based on both common sense and the way the interim final rule is written? that the reasons the government offers for dispensing with the notice and comment requirements are contrived. The real reason is that the current presidential administration is in its waning days and would not have time to enact the policy if it adhered to these requirements. While there?s nothing unlawful per se about rushing to enact policy in the final days of a presidential administration (indeed, it?s a time-honored tradition), executive Case 3:20-cv-08603-VC Document 50 Filed 12/28/20 Page 2 of 4 3 branch officials may not circumvent clear legal requirements in the eleventh hour to achieve goals they couldn?t accomplish in the normal course. ? Scope of relief. For the reasons explained by Judge Blake, the only appropriate relief is to vacate the interim final rule pending completion of the notice and comment process.?

The rates at which the 50 drugs subject to the ?Most Favored Nation? pricing were to be paid were released on the MFN website and in an updated OPPS Addendum B (released without notice) on the OPPS Final Rule webpage late in December.While the reduced reimbursement in 2021 is not as drastic as feared (all but 11 drugs were reduced by 1% or less), it remains to be seen whether the CMS claims processing system can comply with the court ruling and reverse course to implement the old payment methodology with such little notice.The irony of their dilemma is not lost on providers.

The incoming Biden administration has not announced a position on the MFN rule.Considering that the program has unleashed harsh criticism from both providers and Big Pharma, the new administration is not expected to embrace this controversial last-minute directive from the previous administration.

Here is a link and an excerpt from the Most Favored Nation webpage, announcing the legal action: https://innovation.cms.gov/innovation-models/most-favored-nation-model

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PARA Weekly eJournal: January 27, 2021

CMS "MOST FAVORED NATION" STOPPED BY FEDERAL COURT

The Most Favored Nation Rule was published on November 27 2020.The objective of the program is to implement one of President Trump?s executive orders to reduce the cost of prescription drugs.The surprising new rule, which would have cut reimbursement to hospitals and physician practices for 50 expensive drugs, did not follow the usual regulatory process.There was no proposed rule, the regulation went straight to ?final rule with a comment period?, citing the Medicare beneficiary?s need for less expensive drugs during the pandemic as the basis of this exercise of regulatory authority.While the rule would cut reimbursement to providers, it has no effect on the cost of the drugs to providers, which would likely be forced to absorb the difference between cost and the new reimbursement rates.

Under the ?Most Favored Nation? Innovation Model, CMS selected 50 of its highest expenditure drugs to be reimbursed to OPPS hospitals and physicians nationwide at the ?MFN? price ? the lowest price paid for that drug among certain other developed nations, such as Australia, Canada, Germany, France, the United Kingdom, Italy, Spain, and Japan (among others.)

Under the new rule, reimbursement in 2021 would have been 75% of the Average Sales Price in the USA, and 25% the Most Favored Nations price.Over 4 years, the Average Sales Price would have been gradually eliminated, and the MFN price will become 100% of the reimbursement rate.

In late December, CMS listed the new rates on its Innovation website in the ?technical documents? section: https://innovation.cms.gov/innovation-models/most-favored-nation-model

In concert with the MFN pricing file release, CMS released an updated OPPS Addendum B, without a notice to indicate that the file was corrected from the previous version. The new MFN rates replace the 2020 OPPS rates for the MFN drugs.

Only 11 drugs were reduced more than 1% by the MFN price, as rounded to the penny: (See CHART next page)

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PARA Weekly eJournal: January 27, 2021

CMS "MOST FAVORED NATION" STOPPED BY FEDERAL COURT

Under the MFN reimbursement scheme, providers claiming reimbursement for one of the 50 MFN drugs would have reported the established drug HCPCS code and appropriate units, as usual, but an additional claim line reporting anew add-on HCPCS, M1145 would trigger an ?add-on? payment of $148.73 ?per dose.?

Although the reimbursement for M1145 is set at $148.73, some hospitals intended to report it at a charge of $0.01 in order to ensure that claims to Medicare do not report a materially higher rate of charges for the same drug. Under OPPS, reimbursement for M1145 should process at $148.73 even for a nominal charge that is less that the reimbursement amount.

The new MFN reimbursement method applies only to outpatient claims paid under OPPS and professional fee claims which include MFN drugs, but does not apply to Critical Access Hospitals, Cancer centers, children?s hospitals, hospitals paid on the basis of reasonable costs, and a few other excepted provider types. CMS projects that in general, physician practices will be better off under the per-dose add-on payment approach than hospital outpatient departments, and single specialty practices will be better off than multi-specialty practices.

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PARA Weekly eJournal: January 27, 2021

CMS "MOST FAVORED NATION" STOPPED BY FEDERAL COURT

Since the rule takes effect 1/1/2021, providers had very little time to develop a workflow to capture the add-on HCPCS code M1145, or to have that HCPCS code added to the EHR system dictionary.

The ?Per dose? add-on HCPCS M1145 is described in the following excerpt from the Final Rule: https://www.federalregister.gov/documents/2020/11/27/2020-26037/most-favored-nation-mfn-model

?? MFN participants will be required to submit a separate claim line using a new model-specific HCPCS code (M1145, MFN drug add-on, per dose) to bill for and receive the alternative add-on payment amount for each dose of an MFN Model drug that is billed on the claim. The MFN participant will indicate in the units field of the claim line with HCPCS code M1145 the number of doses of a separately payable MFN Model drug that are billed on the claim. To do so, the MFN participant will count the number of claim lines with a HCPCS code that is included on the applicable MFN Model Drug HCPCS Codes List (based on the date of service),including all claim lines when the number of billing units necessary to indicate the dosage given exceeds the character size of the units field and the claim has more than one claim line for such MFN Model drug (we note that this is expected to be a rare situation), and excluding the number of claim lines billed with the JW modifier. This approach will allow the Medicare claims processing system to apply the alternative add-on payment amount for each dose, and not apply beneficiary cost-sharing to the alternative add-on payment amount. MFN participants will still bill for wastage as they otherwise would, using a separate claim line and the JW modifier, and the payment for such claim lines will be based on the MFN Drug Payment Amount (the alternative add-on payment amount is not applicable to such claim lines).

A link and an excerpt from the CMS Innovation Center webpage is provided below: Most Favored Nation Model | CMS Innovation Center

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PARA Weekly eJournal: January 27, 2021

CMS "MOST FAVORED NATION" STOPPED BY FEDERAL COURT

Although this program is referred to by CMS as a ?Model?, participation in the reimbursement scheme was to be mandatory for many Part B providers, including physicians, suppliers, and outpatient hospitals which are paid under OPPS.The rule did not apply to drugs administered during an inpatient stay (specifically, Part B-only inpatient claims are excluded), DME claims,and ESRD PPS claims.There was also a limitation on the MFN Drug Payment Amount that will apply to certain claims submitted by 340B covered entities.

In the first year of the MFN model, 2021, CMS planned to blend the lowest price paid for the same drug among economically similar countries (the MFN price) into its reimbursement rates ? the 2021 rate was to be a blend of 25% MFN Price and 75% of the Average Sales Price.Over four years, the reimbursement would increase the portion paid at the MFN rate, culminating in 100% of the MFN Price.

The full text of the Interim Final Rule (RIN 0938-AT91) is available at the link below ? we have included a few excerpts: https://innovation.cms.gov/media/document/mfn-ifc-rule ?Drug acquisition costs in the U.S. exceed those in Europe, Canada, and Japan, according to an October 2018 ASPE analysis of Medicare Part B physician administered drugs. This finding was generally consistent with the existing evidence base as described in the HHS analysis?s background section, which found peer-reviewed literature on this topic to be relatively limited and dated, but with similar findings of higher drug prices in the U.S. compared to other countries. The HHS analysis compared U.S. drug acquisition costs for a set of Medicare Part B physician-administered drugs to acquisition costs in 16 other developed economies? Austria, Belgium, Canada, Czechia, Finland, France, Germany, Greece, Ireland, Italy, Japan, Portugal, Slovakia, Spain, Sweden, and the United Kingdom (UK). The main analysis in the HHS report focused on 27 drugs accounting for 64 percent of total Medicare Part B drug spending in 2016.Among the 27 drugs included in the analysis, acquisition costs in the U.S. were 1.8 times higher than in comparator countries.? ?

Comments on the Final Rule will be accepted until January 26, 2021, at the following electronic address: http://www.regulations.gov Follow the "Submit a comment" instructions.) Commenters may also submit comments via regular mail and express or overnight mail; the addresses are found on pages 2 and 3 of the final rule.

PARA will publish updates on the MFN rule as more information comes to light.

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PARA Weekly eJournal: January 27, 2021

BILLING AND CODING FOR COVID-19 VACCINES

On Fri day, December 18, 2020 the FDA approved the M oderna COVID-19 vacci ne for use under an Emergency Use Authori zati on (EUA).Thi s vacci ne joi ns the Pfi zer product whi ch was provi ded EUA on December 11, 2020.

Under the CARES Act, Medicare will provide beneficiaries COVID-19 vaccine administration with no cost-sharing to beneficiaries under Part B coverage.

Initially, providers will not incur a cost for the drug product as they will be distributed through government agencies.Providers should not bill for the drug when they receive it at no cost.CMS states it will establish COVID-19 drug product allowances, which will be based on reasonable costs (or, for physician offices, 95% of Average Wholesale Prices), later. Effective immediately after the FDA approves vaccinations for EUA, providers may report the COVID-19 administration code based on the type of vaccine and the which dose is provided.

(PARA note: Report administration code 00001A or 0002A)

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PARA Weekly eJournal: January 27, 2021

BILLING AND CODING FOR COVID-19 VACCINES

(PARA note: Report administration code 00001A or 0002A)

*Per the The Medicare Claims Processing Manual Chapter 32 - Billing Requirements for Special Services section 67.2 providers should not bill for drugs when they receive it at no cost. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c32.pdf#

In anticipation of the EUA approval of the COVID-19 vaccine that is currently in development by AstraZeneca and the University of Oxford, the AMA CPTÂŽ code set for the vaccine product and administration.Like both the Pfizer and Moderna vaccines, administration code will be reported based whether it is the first or the second dose.

The effective date for these codes will follow the EUA approval.The codes are provided on the following page.

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PARA Weekly eJournal: January 27, 2021

BILLING AND CODING FOR COVID-19 VACCINES

(PARA note: Report administration code 00001A or 0002A)

*Per the The Medicare Claims Processing Manual Chapter 32 - Billing Requirements for Special Services section 67.2 providers should not bill for drugs when they receive it at no cost.

The AMA provides instructions for coding the administration of the COVID-19 vaccines through the following document: https://www.ama-assn.org/system/files/2020-11/covid-vaccine-long-descriptors.pdf

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PARA Weekly eJournal: January 27, 2021

BILLING AND CODING FOR COVID-19 VACCINES

CMS created a resource page to provide COVID-19 vaccine policies and guidance for providers, state programs and beneficiaries: https://www.cms.gov/covidvax

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PARA Weekly eJournal: January 27, 2021

COVID-19 UPDATED JANUARY 27, 2021

PARA Healt h Car e An alyt ics con t in u es t o u pdat e COVID-19 codin g an d billin g in f or m at ion based on f r equ en t ly ch an gin g gu idelin es r egu lat ion s f r om CM S an d payer s.

All codin g m u st be su ppor t ed by m edical docu m en t at ion .

Updat es f r om t h e pr eviou s ver sion of t h is COVID-19 paper ar e in dicat ed in r ed, an d t est t ables ar e u pdat ed.

ICD-10-CM Of f icial Codin g an d Repor t in g Gu idelin es f or Cor on avir u s, m ay be dow n loaded f r om t h e lin k below :

https://apps.para-hcfs.com/para/Documents/COVID-19%20(Updated%2001-27-2021).pdf

Download the full 31-page update dated January 27, 2021, by clicking the link above or the document to the right.

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PARA Weekly eJournal: January 27, 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, Jan u ar y 21, 2021 Com plian ce -

Hospital IPPS: FAQs on Market-Based MS-DRG Relative Weights MLN Web-Based Training: Complete Training & Save Certificates by January 31 Intensity-Modulated Radiation Therapy: Comparative Billing Report in January 2020 MIPS Extreme & Uncontrollable Circumstances Exception Application: Deadline February 1 Give Flu Shots through January & Beyond

Com plian ce -

SNF 3-Day Rule: Bill Correctly

Even t s -

COVID-19 Listening Sessions with CMS Office of Minority Health ? January 22, 26, & 28 Physicians, Nurses & Allied Health Professionals Open Door Forum ? January 27

Claim s, Pr icer s, & Codes -

ESRD Facilities: Machine Reported Dialysis Treatment Time on the 072X Bill Type Therapy Claims: Reprocessing Dates of Service from January 1 through February 15 Home Health RAP Workaround

M LN M at t er sÂŽ Ar t icles -

Implementation of Changes in the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) and Payment for Dialysis Furnished for Acute Kidney Injury (AKI) in ESRD Facilities for Calendar Year (CY) 2021 ? Revised

M u lt im edia -

Quality Reporting Programs: From Data Elements to Quality Measures Web-Based Training Section M: Assessment and Coding of Pressure Ulcers & Injuries Web-Based Training

View this edition as PDF (PDF)

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PARA Weekly eJournal: January 27, 2021

There were TWO new or revised MedLearns released this week.

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

2

FIND ALL THESE MEDLEARNS IN THE ADVISOR TAB OF THE PDE

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PARA Weekly eJournal: January 27, 2021

The link to this MedLearn MM11871

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PARA Weekly eJournal: January 27, 2021

The link to this MedLearn MM12080

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PARA Weekly eJournal: January 27, 2021

There were NINE new or revised Transmittals released this week.

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

9

FIND ALL THESE TRANSMITTALS IN THE ADVISOR TAB OF THE PDE

56

PARA Weekly eJournal: January 27, 2021

The link to this Transmittal R10565CP

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PARA Weekly eJournal: January 27, 2021

The link to this Transmittal R10576OTN

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PARA Weekly eJournal: January 27, 2021

The link to this Transmittal R10575CP

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PARA Weekly eJournal: January 27, 2021

The link to this Transmittal R10577DEMO

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PARA Weekly eJournal: January 27, 2021

The link to this Transmittal R10559CP

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PARA Weekly eJournal: January 27, 2021

The link to this Transmittal R10567PI

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PARA Weekly eJournal: January 27, 2021

The link to this Transmittal R10560PI

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PARA Weekly eJournal: January 27, 2021

The link to this Transmittal R10564CP

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PARA Weekly eJournal: January 27, 2021

The link to this Transmittal R10562CP

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PARA Weekly eJournal: January 27, 2021

Creating results through our experience and automated processes.

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719.308.0883 Randi Brant ner Vice President of Analytics 719.308.0883 rbrantner@hfri.net