PARA HealthCare Analytics Weekly eJournal September 1, 2021 by CorroHealth

September 1, 2021

PARA

WeeklyeJOURNAL NEWS FOR HEALTHCARE DECISION MAKERS No Ph ysician Or der Equ als Hef t y Fin es Page 23

AUC Deadlin e Delayed Page 7

Rescin din g M ost Favor ed Nat ion St at u s Page 4 - E/ M Dow n codin g - Lab PAMA RHC Related - ACTEM RA Updat e: CM S HCPCS Q0249 Tocilizu m ab - Price Transparency: High Stakes - Rever sin g IPO List s

FAST LINKS

- EUA Amended To Add Another Dose Of COVID Vaccines - FDA Au t h or izes Tocilizu m ab Rx - Working With BC/BS - Pu lm on ar y Reh ab Cover age For COVID-19

Administration: Pages 1-41 HIM /Coding Staff: Pages 1-41 Providers: Pages 2,3,5,16,17,27 Emergency Dept: Pages 2,23 Laboratory: Pages 3,7,21,31 COVID Treatment: Pages 5,19,21 1 Compliance: Pages 7,12,23,31

New FDA Appr oval Page 15 -

Quality M gmt: Page 24 Imaging: Page 9 Pulmonology: Page 27 PDE Training: Page 30 Hospice Care: Page 38 Telehealth: Page 38 ASCs: Page 17

PARA Weekly eJournal: September 1, 2021

EM DOWNCODING

Daily, we are seeing payers downcode all of our E&M codes. This includes, Workers' Compensation, Kaiser and Blue Cross. We have several claims denied. Everything is billed electronically, so no medical record is sent. However, once they downcode, we are uploading records. That seems so time consuming. Can you suggest a better way? Answer: Many payers have adopted a reimbursement policy which entitles them to adjust the E/M level paid on an emergency department visit. United, for example, implemented a new policy effective July 1, 2021 which examines most claims reporting 99284 or 99285 on the basis of only the data on the claim ? i.e. patient demographics, ICD-10 codes, and the extent of diagnostic procedures performed. They use an algorithm developed by United?s subsidiary, Optum ? here?s the website advertising this product to other health plans: https://www.optum.com/business/solutions/health-plans/claims-payment-accuracy/claims -coding-solution.html Some clients have taken the time to appeal the down-coded claims with medical records, which has at times been successful. Each facility will need to weigh the cost of the appeal in light of the level of reimbursement at stake. We suspect that payors are betting that it will not be worth your time in generating an appeal ? and any money the payor shaves off provider reimbursement drops right to the bottom line profit of the insurer. For contracted payers, the boilerplate language of the facility contract likely requires the hospital to comply with all the payor?s policies, existing and future. Unless hospitals are more discriminating about entering into contractual obligations which enable the payer to change the basic terms of reimbursement unilaterally via ?policy?, they will continue to be plagued with reimbursement cuts, limited only by the imagination and nerve of the contracted payer. Furthermore, with the implementation of the new regulations under the No Surprises Act in January 2022, we may find that even non-contracted emergency department claims will be down-coded aggressively, since the hospital will be legally prohibited from billing the beneficiary for any amount the health plan doesn?t pay. Under the ?No Surprises? law, there is little leverage that hospitals will have in regard to emergency department reimbursement. If the hospital wishes to dispute a payor?s rate of reimbursement, their sole recourse is arbitration ? an expensive and time-consuming effort that could completely backfire. The regulations implementing the No Surprises Act for reimbursement dispute resolution will be published before the end of 2020, but the provisions of the law do not encourage providers to press disputes. In most commercial arbitration proceedings, each party absorbs half the cost of the independent arbiter and each party absorbs the expenses of their own legal counsel. Under No Surprises, the arbiter will award legal fees to the prevailing party. In other words, if the arbitrator disagrees with the hospital?s position and decides in favor of the payor?s rate of reimbursement, the hospital will owe the legal expenses for its own counsel, the costs incurred in hiring the independent arbiter, and the costs of legal counsel representing the payor. Those expenses could easily add up to thousands of dollars, consequently we would expect that most hospitals will not find it worthwhile to dispute the payment rate determined by the payer. If you are interested in learning more about the No Surprises Act?s arbitration provisions, The National Law Review offers an excellent article that summarizes the arbitration rules at this link: https://www.natlawreview.com/article/federal-no-surprises-act-and-its-arbitration-provisions 2

PARA Weekly eJournal: September 1, 2021

LAB PAMA RHC RELATED

If an RHC that shares a TIN with a major hospital, but has a unique NPI, collects a lab specimen that is sent to the hospital outpatient lab department (patient never presents in person to the hospital lab), is that part of the 141 requirement? The specimen was collected by the major hospital, but it was collected within the RHC part of that major hospital and not the outpatient department of that hospital. Can you help? Answer: Thank you for clarifying that the RHC is provider based. The following excerpts from the Medicare Claims Processing Manual states the provider bills for tests provided in its Lab to their MAC under the host provider?s bill type, which in your case is TOB 13X. Only payment data from non-patient services reported on TOB 14X are required to be reported by hospital ?outreach? laboratories. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c16.pdf#

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c09.pdf#

PARA Weekly eJournal: September 1, 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

PARA Weekly eJournal: September 1, 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

PARA Weekly eJournal: September 1, 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

PARA Weekly eJournal: September 1, 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.

PARA Weekly eJournal: September 1, 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.

PARA Weekly eJournal: September 1, 2021

APPROPRIATE USE COMPLIANCE DEADLINE DELAYED

The following list was posted on August 30, 2021:

PARA Weekly eJournal: September 1, 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.

PARA Weekly eJournal: September 1, 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 11

PARA Weekly eJournal: September 1, 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

$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.

PARA Weekly eJournal: September 1, 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.

PARA Weekly eJournal: September 1, 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 14

PARA Weekly eJournal: September 1, 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

PARA Weekly eJournal: September 1, 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

PARA Weekly eJournal: September 1, 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.

PARA Weekly eJournal: September 1, 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

PARA Weekly eJournal: September 1, 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

PARA Weekly eJournal: September 1, 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

PARA Weekly eJournal: September 1, 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:

PARA Weekly eJournal: September 1, 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.

PARA Weekly eJournal: September 1, 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

PARA Weekly eJournal: September 1, 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 24

PARA Weekly eJournal: September 1, 2021

FIVE TIPS TO WORKING WITH BLUE CROSS/BLUE SHIELD OF ILLINOIS

A health insurance company as prominent as Blue Cross Blue Shield (BCBS), having over 62 million members across all 50 states, provides high potential for revenue generating opportunities for any hospital Central Billing Office (CBO). According to the 2020 census, there are 12.8 million people living in the state of Illinois with 80 percent of that population enrolled with BCBS of Illinois. Based on these statistics, that would suggest that 10.2 million residents in Illinois are enrolled for healthcare coverage through BCBS. In terms of a business perspective on a revenue standpoint, BCBS of Illinois coverage should always be a high focus for any facility solely for the revenue aspect when patients are seen. Tip 1: Understanding your EDI clearinghouse All hospitals throughout Illinois should have an intimate understanding of what is required from front-end registration to denial management to streamline revenue as best as possible for this large number of insured individuals with one carrier. BCBS of Illinois requires the use of an insurance web portal or clearinghouse, so it is important to understand the range of products that portal provides. This will help maximize efficiency and avoid unnecessary denials to keep aging clean and healthy for this large volume carrier. Tip 2: Checking eligibility ? the key to clean claims On a front-end/registration point of view, utilizing running eligibility is a simple starting point to ensure your claims are being sent to the appropriate address. Whether a patient?s coverage is through an Independent Practice Association (IPA), Managed Care Organization (MCO), Labor Fund, Federal or traditional BCBS, checking eligibility is the first step to avoid any unnecessary submissions or claim status inquiry attempts. Tip 3: Utilizing AIM to help decrease denials After eligibility is confirmed and the patient?s benefits based on the services have been provided, utilizing the AIM portal within the insurance web portal is another excellent tool for preauthorization purposes. The AIM portal allows you to look up the services a patient is scheduled to receive and verify if that specific CPT® code requires a preauthorization. As a vendor, the most common denials we see with our hospitals are specifically from the clinical denial aspect. This denial category would pertain to no authorization, medical necessity, level of care, and length of stay. With utilizing the AIM portal, this will provide an opportunity to minimize no authorization denials with a simple check if the scheduled services require an authorization or not. If your facility is not aware of this, please reach out to your provider representative to provide you this information. On a medical necessity standpoint, you may also utilize the AIM portal to initiate a peer-to-peer review for level of care or length of stay denials in efforts to overturn these denials received. 25

PARA Weekly eJournal: September 1, 2021

FIVE TIPS TO WORKING WITH BLUE CROSS/BLUE SHIELD OF ILLINOIS

Tip 4: Improving follow-up efficiency and accuracy Follow-up efficiency and accuracy is also important when dealing with this high-volume carrier. With roughly 10.2 million members, traditional BCBS of Illinois receives enormous amounts of calls a day regarding claim status inquires. Using an insurance web portal?s claim status tool for all claim status inquires prior to calling can help reduce unnecessary calls. This tool provides the opportunity to capture all key and necessary information needed to grasp a rough understanding of all claim status inquires. There may be times that the information captured may not be sufficient in terms of a progressive standpoint to verify if recent submitted disputes or documents are under review. Utilizing the CIR, or Claim Inquiry Resolution tool, is another effective way to verify an updated status of documents or disputes submitted, which is provided with a reference number for tracking purposes to ensure all inquiries are answered in a timely manner. Utilizing this tool helps reduce call volumes along with decreased hold times. Not only will this tool assist the efficiency of any CBO staff member but will also help vendors as well. Tip 5: Understanding contractual reimbursement agreements Some believe that BCBS pays at 100% of billed charges when in fact that is not the case. Typically, what happens is that it appears payments are paid in full within an Electronic Medical Records (EMR) system but in reality, the contractual adjustment is applied on the back end through the UPP Program. The Uniform Payment Program (UPP) in a sense is the contractual reimbursement solely for BCBS and individual facilities. The UPP discount can range from 25 percent to 70 percent based on services provided or the facility in general. It is encouraged to speak to your provider representative or your internal contract management department if you do not have a clear understanding of the discount BCBS of Illinois has with your facility. Streamlining BCBS accounts In conclusion, BCBS of Illinois provides countless opportunities to streamline this book of business with your CBOs and your vendors to help improve efficiencies which in turn will increase your revenue. Accurately utilizing all tools that BCBS and an insurance web portal provide is another opportunity to decrease denial volumes thus reduce aging. Any specific questions you may have, it is highly encouraged to reach out to your provider representative that will allow you to make your CBO and vendors more successful.

PARA Weekly eJournal: September 1, 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:

PARA Weekly eJournal: September 1, 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. 28

PARA Weekly eJournal: September 1, 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. 29

Updat ed An d Revised Au gu st 17, 2021

PARA Weekly eJournal: September 1, 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 30

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 1, 2021

JULY 2021 LAB PAMA ISSUES

TI M E

LIKE SANDS THROUGH THE HOURGLASS, THE TIME TO COMPLY IS RUNNING OUT.

LAB PAM A

DETAILED GUIDANCE BOOKLET TIM ELINES AND REQUIREM ENTS

Pr icin g | Codin g | Reim bu r sem en t | Com plian ce 31

PARA Weekly eJournal: September 1, 2021

Introduction

Congress instructed Medicare to set its rates under the Clinical Lab Fee Schedule at the weighted median of private payer rates.

BACKGROUND

PAMA stands for Pr ot ect in g Access t o M edicar e Act of 2014 and was published by The White House Office of Management and Budget to modify the Medicare reimbursement rate methodology for lab services.

In doing so, Congress hoped to ensure Medicare did not overcompensate providers for lab services, protecting the Medicare program by saving money while compensating providers at a defensible rate of reimbursement per laboratory diagnostic test. .

PARA Weekly eJournal: September 1, 2021

Private payer rate reporting is required of so-called ?Applicable laboratories.? A hospital lab likely qualifies as an ?Applicable Laboratory? if it earned more than $12,500 in reimbursement from Medicare for ?outreach? lab services billed on the 014X (non-patient services) type of bill and paid between January 1 and June 30, 2019. Although there are several tests, the revenue threshold test is the most pivotal determination as it pertains to hospital laboratories.

Wh at 's An Applicable Lab? Hospital Labs Serving:

- Inpatients - Outpatients - Non-Patients (?Outreach?)

Physician Office Labs Performing: - Point of Care/Traditional Tests - Provider-Performed Microscopy - Pathologists?Practices Independent Labs Performing:

- Standard Tests - Drug Abuse Testing - Molecular Diagnostics 33

A CLIA certified laboratory that bills Medicare Part B under it?s own NPI or under the hospital?s NPI And received the majority of the payments for non-patient services (TOB 14X) paid by Medicare in the first 6 months of 2019 under the CLFS or MPFS (a given for hospital outreach labs) And received more than $12,500 in payments from Medicare for TOB 14X services between 1/1/19 and 6/30/19

PARA Weekly eJournal: September 1, 2021

Hospital laboratories which offer ?outreach laboratory? services process specimens collected by another provider without actually seeing the patient in person. Such ?specimen only? testing is submitted to Medicare and non-Medicare payers on the 014X (non-patient services) Type of Bill (TOB.)

JUST THE FACTS, PLEASE

PAMA requires CMS to set the rates paid under its Clinical Lab Fee Schedule at the weighted median rate of payment that private payers pay for each specimen-only lab test. Consequently, CMS must compel certain ?applicable laboratories?, including certain hospitals and physician clinics, to periodically report the payment rates each provider received for non-patient lab services billed to commercial and managed care payers. CMS will use data collected from the first six month of 2019 to set the Clinical Lab Fee Schedule (CLFS) rates for 2023 through 2025. The current CLFS rates, which many providers complain are too low, were calculated from data submitted by a small number of national and regional labs in 2016. Going forward, more providers of non-patient laboratory services will be required to report payment rates to be used in calculating the CLFS. CMS efforts to communicate the data reporting requirement have been muddled with excruciating detail, causing the requirement to be widely misunderstood. In an effort to clarify the requirement as the deadline for reporting approaches, CMS published a ten-page ?summary? document and a new FAQ on April 20, 2021, at the links on the next page. 34

PARA Weekly eJournal: September 1, 2021

https://www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/ClinicalLabFeeSched/Downloads/ CY2019-CLFS-PrivatePayor-RateBased-Summary.pdf https://www.cms.gov/files/document/frequently-asked -questions-cy-2021-clfs.pdf Hospitals which received more than $12,500 in Medicare revenues for non-patient lab services paid between 1/1/209 and 6/20/2019, will likely meet the definition of an ?applicable laboratory?, which triggers the requirement to report private payer rates early next year. Applicable laboratories must report each CLFS CPT® , each payment rate, and the quantity of times each rate was paid for a non-patient service billed to commercial and Medicare or Medicaid managed care payers; reports must be submitted online through the CMS PAMA reporting website in early 2022.Failure of an applicable laboratory to report carries a risk of substantial penalties. While data was initially collected from a few national lab providers in 2016, Medicare has expanded the definition of ?Applicable Laboratories? since then to include certain hospitals and physician practices. Payment reporting requirement is burdensome and confusing, but PARA can help you determine whether your facility qualifies as an ?applicable lab? and in preparing the data for submission.

THE COST OF NON-COM PLIANCE

PARA Weekly eJournal: September 1, 2021

?We are revising the certification and CMP (Civil Monetary Penalties) policies in the final rule to require that the accuracy of the data be certified by the President, CEO, or CFO of the reporting entity, or an individual who has been designated to sign for, and who reports directly to such an officer.

CURRENT CM P $10,017 Per Day

PARA Weekly eJournal: September 1, 2021

PARA has developed a 30-minute online presentation that can help keep you compliant with PAMA laboratory rate and reporting requirements. It's vital information for all clinical laboratories.

Click t he m on it or t o w at ch .

Th en con t act you r PARA Accou n t Execu t ive f or det ails. Ran di Br an t n er

San dr a LaPlace

Violet Ar ch u let -Ch iu

Vice President of Analytics

Account Executive

Senior Account Executive

rbrantner@hfri.net

splace@para-hcfs.com

varchuleta@para-hcfs.com

719.308.0883

800.999.3332 x 225

800.999.3332 x219

PARA Weekly eJournal: September 1, 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, Au gu st 26, 2021

New s

Impact of the PHE on Telehealth: Comparative Billing Report in August COVID-19 Monoclonal Antibody EUA Updates: Casirivimab & Imdevimab

Even t s -

FY 2022 Hospice Final Rule: What Hospices Need to Know Webinar ? August 31

Pu blicat ion s -

Health Care Code Sets: ICD-10 ? RevisedView this edition as PDF (PDF)

PARA Weekly eJournal: September 1, 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.

FIND ALL THESE MEDLEARNS IN THE ADVISOR TAB OF THE PDE

PARA Weekly eJournal: September 1, 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.

FIND ALL THESE TRANSMITTALS IN THE ADVISOR TAB OF THE PDE

PARA Weekly eJournal: September 1, 2021

The link to this Transmittal R10986OTN