PARA HealthCare Analytics Weekly eJournal June 23, 2021

June 23, 2021

PARA

WeeklyeJOURNAL NEWS FOR HEALTHCARE DECISION MAKERS

Updat ed An d Expan ded Gu idan ce On Billin g & Codin g f or COVID-19 Page 26

Im por t an t New OPPS Updat es Page 12 Billin g For PAs Page 2 - CM S Clar if ies Pu lm on ar y, Car diac Reh ab Requ ir em en t s - CMS Offers New Lab PAMA Reporting Summary & FAQ - M on oclon al AB Th er apy In Th e Hom e

FAST LINKS

- CMS Price Transparency Compliance Update In t r avascu lar - Con ver t in g In pat ien t Lit h ot r ipsy M edicar e Claim s For Page 35 Ou t pat ien t Paym en t s - Medicare COVID-19 Vaccines In The Home

- Administration: Pages 1-44 - HIM /Coding Staff: Pages 1-44 - Providers: Pages 2,3,8,10,17,26,32,38 - Physician Assistants: Page 2 - Pulmonology: Page 3 1 - Laboratory: Pages 8,15,35,39,43

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Cardiology: Page 3 Compliance: Page 8 COVID Therapy: Pages 10,14,32 OPPS: Page 12 Imaging: Page 17 COVID Billing: Page 26 DM E: Page 36

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

PARA Weekly eJournal: June 23, 2021

PA BILLING

Currently we bill MD, NP, CRNA and LCSW. Are we allowed to bill for PAs? My understanding is that PAs can only be billed when they assist in surgery or incident to a physician. What guidance can you offer?

Answer: Professional services of a Physician Assistant are reimbursed by Medicare, although there may be some commercial plans that do not accept PA services on a pro-fee form.

A critical access hospital may bill the professional fees for Physician Assistants (PAs). Append modifier GF for services performed in the hospital setting; here's a link and an excerpt from the Medicare Claims Processing Manual which instructs Method II hospitals to append modifier GF to codes performed by a Nurse Practitioner, a Clinical Nurse Specialist, or a Physician Assistant: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c04.pdf

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PARA Weekly eJournal: June 23, 2021

CMS CLARIFIES PULMONARY, CARDIAC REHAB REQUIREMENTS

CM S r ecen t ly u pdat ed lan gu age in t h e M edicar e Claim s Pr ocessin g M an u al t o clar if y t h e cover age r equ ir em en t s f or car diac an d pu lm on ar y r eh ab pr ogr am s. Th e n ew lan gu age is in r espon se t o t h e f in din gs of an au dit pu blish ed by t h e Of f ice of t h e In spect or Gen er al (OIG) on M ay 13, 2021.

While many of the updates are minor language changes, the requirement that an ?individualized treatment plan must be established, reviewed, and signed by a physician every 30 days? has been added to the Claims Manual for cardiac rehab and intensive cardiac rehab.The requirements for pulmonary rehab went a little further with the addition of ?The individualized treatment plan must be established, reviewed, and signed by a physician, who is involved in the patient?s care and has knowledge related to his or her condition, every 30 days.?

An OIG report published in May, 2021 found that CMS regulatory requirements related to Medicare outpatient cardiac and pulmonary rehabilitation services did not contain sufficient information to ensure that claims for these services met Medicare coverage requirements.The report is available at the link below: Medicare Claims Processing Manual (cms.gov)

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PARA Weekly eJournal: June 23, 2021

CMS CLARIFIES PULMONARY, CARDIAC REHAB REQUIREMENTS

CMS was advised of the report findings prior to the publication, and pro-actively made adjustments to the Medicare Claims Processing Manual in March of 2021 to further clarify conditions of coverage.The updates to the Claims Manual, Chapter 4, in regard to cardiac rehab, intensive cardiac rehab, and pulmonary rehab programs is in red font in the excerpts below: Medicare Claims Processing Manual (cms.gov) 140.2 ? Car diac Reh abilit at ion Pr ogr am Ser vices Fu r n ish ed On or Af t er Jan u ar y 1, 2010 (Rev. 10573; Issued: 03-24- 2021; Effective: 01-01-2010; Implementation: 04-26-2021) As specified at 42 CFR 410.49, Medicare covers cardiac rehabilitation program services for beneficiaries who have experienced one or more of the following: -

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An acute myocardial infarction within the preceding 12 months; A coronary artery bypass surgery; Current stable angina pectoris; Heart valve repair or replacement; Percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting; A heart or heart-lung transplant; Stable, chronic heart failure defined as patients with left ventricular ejection fraction of 35 percent or less and New York Heart Association (NYHA) class II to IV symptoms despite being on optimal heart failure therapy for at least 6 weeks, on or after February 18, 2014; or Other cardiac conditions as specified through a national coverage determination (NCD).

Cardiac rehabilitation programs must include all of the following: Physician-prescribed exercise each day cardiac rehabilitation items and services are furnished.

Cardiac risk factor modification, including education, counseling, and behavioral intervention, tailored to patients?individual needs.

Psychosocial assessment.

Outcomes assessment.An individualized treatment plan detailing how components are utilized for each patient. The individualized treatment plan must be established, reviewed, and signed by a physician every 30 days.

Cardiac rehabilitation items and services must be furnished in a physician?s office or a hospital outpatient setting. All settings must have a physician immediately available and accessible for medical consultations and emergencies at all times items and services are being furnished under the program.

This provision is satisfied if the physician meets the requirements for direct supervision for physician office services as specified at 42 CFR 410.26 and for hospital outpatient services as specified at 42 CFR 410.27.As specified at 42 CFR 410.49(f)(1), cardiac rehabilitation program sessions are limited to a maximum of 2 1-hour sessions per day for up to 36 sessions over up to 36 weeks with the option for an additional 36 sessions over an extended period of time if approved by the Medicare contractor.

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PARA Weekly eJournal: June 23, 2021

CMS CLARIFIES PULMONARY, CARDIAC REHAB REQUIREMENTS

140.3 ? In t en sive Car diac Reh abilit at ion Pr ogr am Ser vices Fu r n ish ed On or Af t er Jan u ar y 1, 2010 (Rev. 10573; Issued: 03-24- 2021; Effective: 01-01-2010; Implementation: 04-26-2021) As specified at 42 CFR 410.49, Medicare covers intensive cardiac rehabilitation program services for beneficiaries who have experienced one or more of the following: -

An acute myocardial infarction within the preceding 12 months; A coronary artery bypass surgery; Current stable angina pectoris; Heart valve repair or replacement; Percutaneous transluminal coronary angioplasty or coronary stenting; A heart or heart-lung transplant.

- Stable, chronic heart failure defined as patients with left ventricular ejection fraction of 35 percent or less and New York Heart Association (NYHA) class II to IV symptoms despite being on optimal medical therapy for at least 6 weeks, on or after February 9, 2018; or - Other cardiac conditions as specified through a national coverage determination (NCD).

The NCD process may also be used to specify non-coverage of a cardiac condition for ICR if coverage is not supported by clinical evidence.

Intensive cardiac rehabilitation programs must include all of the following: - Physician-prescribed exercise each day cardiac rehabilitation items and services are furnished.

- Cardiac risk factor modification, including education, counseling, and behavioral intervention, tailored to patients?individual needs.

- Psychosocial assessment.

- Outcomes assessment.

- An individualized treatment plan detailing how components are utilized for each patient.

The individualized treatment plan must be established, reviewed, and signed by a physician every 30 days.

A list of approved intensive cardiac rehabilitation programs, identified through the national coverage determination process, will be posted to the CMS Web site and listed in the Federal Register.

In order to be approved, a program must demonstrate through peer-reviewed, published research that it has accomplished one or more of the following for its patients: - Positively affected the progression of coronary heart disease - Reduced the need for coronary bypass surgery - Reduced the need for percutaneous coronary interventions

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PARA Weekly eJournal: June 23, 2021

CMS CLARIFIES PULMONARY, CARDIAC REHAB REQUIREMENTS

An intensive cardiac rehabilitation program must also demonstrate through peer-reviewed published research that it accomplished a statistically significant reduction in 5 or more of the following measures for patients from their levels before cardiac rehabilitation services to after cardiac rehabilitation services: -

Low density lipoprotein Triglycerides Body mass index Systolic blood pressure Diastolic blood pressure The need for cholesterol, blood pressure, and diabetes medications

Intensive cardiac rehabilitation items and services must be furnished in a physician?s office or a hospital outpatient setting. All settings must have a physician immediately available and accessible for medical consultations and emergencies at all times items and services are being furnished under the program. This provision is satisfied if the physician meets the requirements for direct supervision for physician office services as specified at 42 CFR 410.26 and for hospital outpatient services as specified at 42 CFR 410.27.

As specified at 42 CFR 410.49(f)(2), intensive cardiac rehabilitation program sessions are limited to 72 1-hour sessions, up to 6 sessions per day, over a period of up to 18 weeks. ?

140.4 ? Pu lm on ar y Reh abilit at ion Pr ogr am Ser vices Fu r n ish ed On or Af t er Jan u ar y 1, 2010 (Rev. 10573; Issued: 03-24- 2021; Effective: 01-01-2010; Implementation: 04-26-2021) As specified in 42 CFR 410.47, Medicare covers pulmonary rehabilitation for beneficiaries with moderate to very severe COPD (defined as GOLD classification II, III and IV), when referred by the physician treating the chronic respiratory disease.

Pulmonary rehabilitation includes all of the following components: - Physician-prescribed exercise. Some aerobic exercise must be included in each pulmonary rehabilitation session - Education or training closely and clearly related to the individual?s care and treatment which is tailored to the individual?s needs, including information on respiratory problem management and, if appropriate, brief smoking cessation counseling - Psychosocial assessment - Outcomes assessment -An individualized treatment plan detailing how components are utilized for each patient.The individualized treatment plan must be established, reviewed, and signed by a physician, who is involved in the patient?s care and has knowledge related to his or her condition, every 30 days.

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PARA Weekly eJournal: June 23, 2021

CMS CLARIFIES PULMONARY, CARDIAC REHAB REQUIREMENTS

Pulmonary rehabilitation items and services must be furnished in a physician?s office or a hospital outpatient setting. All settings must have the necessary cardio-pulmonary, emergency, diagnostic, and therapeutic life-saving equipment accepted by the medical community as medically necessary to treat chronic respiratory disease.

All settings must have a physician immediately available and accessible for medical consultations and emergencies at all time when services are being provided under the program.

This provision is satisfied if the physician meets the requirements for direct supervision for physician office services as specified at 42 CFR 410.26 and for hospital outpatient services as specified at 42 CFR 410.27.

As specified at 42 CFR 410.47(f), pulmonary rehabilitation program sessions are limited to a maximum of 2 1-hour sessions per day for up to 36 sessions, with the option for an additional 36 sessions if approved by the Medicare contractor, based on medical necessity.

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PARA Weekly eJournal: June 23, 2021

CMS OFFERS NEW LAB PAMA REPORTING SUMMARY, FAQ 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.) The Protecting Access to Medicare Act (PAMA) requires CMS to set the rates paid under its Clinical Lab Fee Schedule at the weighted median rate of payment that private payors 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 below and on the next page. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/ CY2019-CLFS-PrivatePayor-RateBased-Summary.pdf

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PARA Weekly eJournal: June 23, 2021

CMS OFFERS NEW LAB PAMA REPORTING SUMMARY, FAQ

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 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.

Reach out now to your PARA Account Executive for more information on whether your facility is required to report, and to learn about the Lab PAMA reporting support PARA offers to its clients.

Reach Out To One Of Our Experts. See Below.

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

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PARA Weekly eJournal: June 23, 2021

MEDICARE COVID-19 MONOCLONAL AB THERAPY IN THE HOME For services on or after May 6, 2021, Medicare established administration codes for providers that furnishCOVID-19 monoclonal antibody (MAB) infusions to beneficiaries in a patient?s home or residence.COVID-19 MAB therapy may be administered under an FDA Emergency Use Authorization (EUA) for treatment of mild-to-moderate COVID-19 adults (and certain pediatric patients) who are at high risk for progressing to severe COVID-19 which may require hospitalization.

Medicare considers a patient?s permanent residence: - Home or residence that has been made provider-based to a hospital during the PHE - Temporary lodging (hotel, motel, homeless shelter) - Intermediate facility (ICF), nursing facility or skilled nursing facility (SNF) when it is the beneficiary?s permanent residence (not temporary or post-acute) Medicare provides a higher payment of approximately $750 (geographically adjusted) when a provider charges one of the following codes:

Medicare reminds providers in traditional healthcare settings to continue to report M0243 or M0245 when applicable.Sotrovimab (M0247) was also added to the FDA EUA approved COVID-19 MABs on May 26, 2021.

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PARA Weekly eJournal: June 23, 2021

MEDICARE COVID-19 MONOCLONAL AB THERAPY IN THE HOME

A facility interested in providing COVID-19 MAB therapy during the Public Health Emergency may do so by appendingmodifier PNto the service performed at the patient's home. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/ MLNMattersArticles /Downloads/SE18002.pdf ?CMS expects the PN modifier to be reported with each non-excepted line item and service including those for which payment will not be adjusted, such as separately payable drugs, clinical laboratory tests, and therapy services; with reporting required beginning on January 1, 2017.?

There is no cost-sharing (copayments, coinsurance or deductibles) for Medicare patients receiving monoclonal antibody treatments for COVID-19.

Additional information may be found through the following websites: https://www.cms.gov/ files/document/ COVID-19-toolkit -issuers -MA-plans.pdf

https://www.cms.gov/medicare/ covid-19/monoclonal-antibody-covid-19-infusion

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PARA Weekly eJournal: June 23, 2021

JULY 1, 2021 OPPS UPDATE

On Ju n e 11, 2021, CM S issu ed Tr an sm it t al R10825CP w it h M LN, ?Ju ly 2021 Updat e of Hospit al Ou t pat ien t Paym en t Syst em (OPPS).? https://www.cms.gov/files/document/mm12316.pdf

PARA will advise chargemaster clients by email of any line items in the hospital CDM that require an update because of a deleted HCPCS code; we will also provide a replacement HCPCS where available.

Clients are encouraged to upload a current CDM at least quarterly to take full advantage of PARA support.

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PARA Weekly eJournal: June 23, 2021

JULY 1, 2021 OPPS UPDATE

The following summarizes the OPPS updates effective July 1, 2021.

- COVID-19 Vaccine Novavax codes will become effective once the FDA approves under an Emergency Use Authorization (EUA):

- Monoclonal Antibody Therapy - Bamlanivimab - The FDA revoked the EUA for the monoclonal antibody therapy bamlanivimab on April 16, 2021, when administered alone. CMS deleted HCPCS codes M0239 and Q0239 from the July 2021 Integrated Outpatient Code Editor (I/OCE).

- APC Change - Effective May 6, 2021, monoclonal antibody codes M0243 and M0245 moved from APC 5694 (Level 4 Drug Administration) with a payment rate of $310.75 to APC 1506 (New Technology - Level 6) with a payment rate of $450.

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PARA Weekly eJournal: June 23, 2021

JULY 1, 2021 OPPS UPDATE

- COVID-19 MAB in Home ? M0244 and M0246, effective May 6, 2021, assigned for monoclonal antibody therapy services provided in the home or residence.These are assigned APC 1509 ((New Technology - Level 9) with a payment rate of $750.

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PARA Weekly eJournal: June 23, 2021

JULY 1, 2021 OPPS UPDATE

- Proprietary Laboratory Analysis (PLA) Changes ? Effective July 1, 2021, CMS provided 7 new PLA codes.

- 31 New CPT® Category III Codes ? Effective July 1, 2021, CMS adds codes 0640T through 0670T.

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PARA Weekly eJournal: June 23, 2021

JULY 1, 2021 OPPS UPDATE - 31 New CPT® Category III Codes ? Effective July 1, 2021, CMS adds codes 0640T through 0670T.

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PARA Weekly eJournal: June 23, 2021

JULY 1, 2021 OPPS UPDATE - 31 New CPT® Category III Codes ? Effective July 1, 2021, CMS adds codes 0640T through 0670T.

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PARA Weekly eJournal: June 23, 2021

JULY 1, 2021 OPPS UPDATE - 31 New CPT® Category III Codes ? Effective July 1, 2021, CMS adds codes 0640T through 0670T.

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PARA Weekly eJournal: June 23, 2021

JULY 1, 2021 OPPS UPDATE

- Devices - New Pass-Through Category ? Pass-through devices, in accordance with section 1833(t)(6)(B) of the Social Security Act are eligible for at least 2, but not more than 3 years.Pass-through device costs are deducted from the pass-through payments. Effective July 1, 2021, CMS created an additional transitional pass-through payment for C1761 (Cath, trans intra litho/coro) which was not described by previous device categories - Device Offset from Payment ?Because the cost associated with catheter C1761 is not included in APC 5193 (Level 3 Endovascular Procedures), CMS will not deduct the device offset. Report C1761 with one of the following procedures that are assigned APC 5193: - 92928 (Percutaneous transcatheter placement of intracoronary stent(s), with coronary angioplasty when performed; single major coronary artery or branch) - C9600 (Percutaneous transcatheter placement of drug eluting intracoronary stent(s), with coronary angioplasty when performed; single major coronary artery or branch)

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PARA Weekly eJournal: June 23, 2021

JULY 1, 2021 OPPS UPDATE

- Drug, Biologicals and Radiopharmaceuticals - Nine New HCPCS codes assigned for pass-through status:

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PARA Weekly eJournal: June 23, 2021

JULY 1, 2021 OPPS UPDATE

- Six HCPCS Pass-Through status ending June 30, 2021 ? Status indicator changing from G (pass-through) to K (paid under OPPS; separate APC payment):

- Five New HCPCS Effective July 1, 2021 ? Because of a late correction to HCPCS A9593 (Gallium ga-68 psma-11, diagnostic, (ucsf), 1 millicurie) and A9594 (Gallium ga-68 psma-11, diagnostic, (ucla), 1 millicurie), these codes are in the I/OCE with a status indicator of G (pass-through) but with a zero-dollar payment for July 1, 2021 ? September 30, 2021.CMS will make a retroactive correction to a status indicator N when they publish the October 2021 Quarterly OPPS Update. Below are the 5 new drugs, biologicals, and radiopharmaceutical HCPCS codes:

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PARA Weekly eJournal: June 23, 2021

JULY 1, 2021 OPPS UPDATE

- Manual Adjudication Status Change Effective July 1, 2021?

- Updates on Drugs and Biologicals with payments based on Average Sales Price (ASP): - Most non pass-through, non 340B Program = ASP +6% of reference product for biosimilars - Non pass-through, acquired through 340B Program = ASP ? 22.5 percent of 340B acquired biosimilar - Single payment of ASP + 6 percent for pass-through to provide payment for the acquisition cost and pharmacy overhead costs - Based on OPPS/ASC final rule comments, values for many drugs and biologicals changed based on sales price from third quarter CY 2020.The full updated list will be available at the July 2021 update of OPPS Addendum A and B: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ HospitalOutpatientPPS/Addendum-A-and-Addendum-B-Updates

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Restated ASP Methodology Payment Rates -Quarterly retroactive correction to some drugs and biological payment rates will be available on the first date of the quarter at the following CMS website:

https://www.cms.gov/medicaremedicare-fee-service-paymenthospitaloutpatientppsopps -restated-payment-rates/july-2021-update-hospital-outpatient-prospectivepayment-system-opps

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PARA Weekly eJournal: June 23, 2021

JULY 1, 2021 OPPS UPDATE

- Skin Substitutes ? CMS reassigned one skin substitute from the low-cost skin substitute to the high-cost skin substitute effective July 1, 2021:

- New Procedure HCPCS Code - Vaginal Colpopexy By Sacrospinous Ligament Fixation:

- OPPS Pricer Changes ? Added APC 2033 (Cath, trans intra litho/coro) and added payment adjustment flag 2 to fields received from the I/OCE - Coverage Determination - CMS reminds us that HCPCS codes and payment rates demonstrate how services, products, or procedures may pay if covered by Medicare.To determine coverage, consult the local MAC for HCPCS code coverage limitations.

References: Transmittal 10825 July 2021 Update of the Hospital OPPS: https://www.cms.gov/files/document/r10825CP.pdf#page=20 July 2021 Addendum A and B Updates: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS /Addendum-A-and-Addendum-B-Updates

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PARA Weekly eJournal: June 23, 2021

CMS PRICE TRANSPARENCY COMPLIANCE UPDATE

On M ay 3, 2021, t h e Am er ican Hospit al Associat ion (AHA) r eleased a M em ber Advisor y r egar din g n on com plian ce w it h t h e Cen t er s f or M edicar e & M edicaid Ser vices?(CM S) Hospit al Pr ice Tr an spar en cy r equ ir em en t s. In it , t h ey n ot e t h at CM S h as lau n ch ed pr oact ive au dit s of h ospit al w ebsit es an d h ave evalu at ed com plain t s pr esen t ed t o CM S by con su m er s.

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.

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.

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PARA Weekly eJournal: June 23, 2021

CMS PRICE TRANSPARENCY COMPLIANCE UPDATE

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 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 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, 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 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, ?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.?

PARA has done the heavy lifting to deliver the best solution possible for our Hospital Partners.

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

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PARA Weekly eJournal: June 23, 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.

Updat ed Ju n e 15, 2021

Download the updated Guidebook by clicking here.

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PARA Weekly eJournal: June 23, 2021

CONVERTING INPATIENT MEDICARE CLAIMS FOR OUTPATIENT PAYMENTS

Is you r billin g syst em au t om at ically dr oppin g r even u e code 0360 (oper at in g r oom ) ch ar ges f r om Type of Bill 12X? If so, r ead on .

There are important differences in Medicare reimbursement for services provided during inpatient stay which are converted to an outpatient claim due to medical necessity, as opposed to billing an inpatient account on an outpatient claim because the patient has no Part A coverage. Billers who don?t understand the difference could cost the hospital valuable reimbursement.

Inpatient operating room HCPCS codes (revenue code 036X)are not reimbursed on TOB 120 if the Medicare beneficiary has no Part A coverage.However, they are payable if the 12X claim is submitted for a beneficiary who is eligible for Part A benefits, but the inpatient stay was deemed not medically necessary.

In 2014, Medicare changed its policy to permit reimbursement of inpatient surgery charges in revenue code 0360 reported on an outpatient claim which converted inpatient charges from a stay which did not meet medically necessary criteria: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/ Downloads/MM8445.pdf

Sometimes a Medicare beneficiary?s inpatient claim is ineligible for coverage because the inpatient level of care was deemed not medically necessary.In some cases, an audit by the MAC, a RAC, or a QIO may find the documentation does not support an inpatient level of care, and therefore the inpatient claim is denied, but the hospital is permitted to submit an outpatient claim for the individual services instead.

In other cases, the hospital?s own utilization management team may identify the case after the patient has been discharged ? but before the claim has been submitted (Condition Code 44.) When an inpatient claim is converted to an outpatient claim due to failure to meet inpatient criteria, medically necessary services provided during the inpatient stay, including services in revenue code 0360, are generally eligible for reimbursement under Medicare Part B. 27

PARA Weekly eJournal: June 23, 2021

CONVERTING INPATIENT MEDICARE CLAIMS FOR OUTPATIENT PAYMENTS

In the circumstance that an inpatient stay was deemed not medically necessary, the hospital may submit: - A TOB 13X claim for outpatient services rendered within the 72-hour periodpriorto admission as an inpatient, and - A TOB 12X claim for services rendered after admission to inpatient status, but submitted for outpatient reimbursement due to failure to meet medical necessity ? with the exception of charges in certain revenue codes (the list of excluded revenue codes is provided on page 5.)The 12X claims are always re-bills, after a denied claim or a TOB 110 claim is submitted for the denied or self-denied inpatient stay.These claims should report occurrence span code M1 and condition code W2 (along with other detailed billing requirements explained in the Medicare Claims Processing Manual.)

Two Medicare manuals set out the coverage and billing requirements, the Benefits manual and the Claims Processing Manual.Excerpts on the following pages explain the reimbursement provisions for inpatient services that are not payable under Part A due to medical necessity.

The Medicare Benefits Policy Manual discusses coverage: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c06.pdf# Medicare Benefits Policy Manual, Chapter 6 10.1 - Reasonable and Necessary Part A Hospital Inpatient Claim Denials (Rev. 182, Issued: 03-21-14, Effective: 10-01-13, Implementation: 04-21-14) If a Medicare Part A claim for inpatient hospital services is denied because the inpatient admission was not reasonable and necessary, or if a hospital determines under 42 CFR §482.30(d) or §485.641 after a beneficiary is discharged that the beneficiary?s inpatient admission was not reasonable and necessary, and if waiver of liability payment is not made, the hospital may be paid for the following Part B inpatient services that would have been reasonable and necessary if the beneficiary had been treated as a hospital outpatient rather than admitted as an inpatient, provided the beneficiary is enrolled in Medicare Part B: - Part B services paid under the outpatient prospective payment system (OPPS), excluding observation services and hospital outpatient visits that require an outpatient status. Hospitals that are excluded from payment under the OPPS are instead paid under their alternative payment methodology (e.g., reasonable cost, all inclusive rate, or Maryland waiver) for the services that are otherwise payable under the OPPS - The following services excluded from OPPS payment, that are instead paid under the respective Part B fee schedules or prospectively determined rates for which payment is made for these services when provided to hospital outpatients: - Physical therapy services, speech-language pathology services, and occupational therapy services (see chapter 15, §§220 and 230 of this manual, ?Covered Medical and Other Health Services,?)

- Ambulance services.

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PARA Weekly eJournal: June 23, 2021

CONVERTING INPATIENT MEDICARE CLAIMS FOR OUTPATIENT PAYMENTS

- Prosthetic devices, prosthetic supplies, and orthotic devices paid under the DMEPOS fee schedule (excludes implantable prosthetic devices (other than dental) which replace all or part of an internal body organ (including colostomy bags and supplies directly related to colostomy care) and replacement of such devices) - Durable medical equipment supplied by the hospital for the patient to take home, except durable medical equipment that is implantable - Certain clinical diagnostic laboratory services - Screening and diagnostic mammography services - Annual wellness visit providing personalized prevention plan services Hospitals may also be paid under Part B for services included in the payment window prior to the point of inpatient admission for outpatient services treated as inpatient services (see Pub. 100-04, Medicare Claims Processing Manual, Chapter 4, §10.12, ?Payment Window for Outpatient Services Treated as Inpatient Services?), including services requiring an outpatient status. The hospital can only bill for services that it provided directly or under arrangement in accordance with Part B payment rules.

Outpatient therapeutic services furnished at an entity that is wholly owned or wholly operated by the hospital and is not part of the hospital (such as a physician?s office), may not be billed by the hospital to Part B. Reference labs may be billed only if the referring laboratory does not bill for the laboratory test (see Pub. 100-04, Medicare Claims Processing Manual, Chapter 16, §40.1, ?Laboratories Billing for Referred Tests?). The services billed to Part B must be reasonable and necessary and must meet all applicable Part B coverage and payment conditions. Claims for Part B services submitted following a reasonable and necessary Part A claim denial or hospital utilization review determination must be filed no later than the close of the period ending 12 months or 1 calendar year after the date of service (see Pub. 100-04, Medicare Claims Processing Manual, Chapter 1, §70 ?Time Limitations for Filing Part A and Part B Claims?). See Pub. 100-04, Medicare Claims Processing Manual, chapter 4, §240 for required bill types.

The Medicare Claims Processing Manual provides billing instructions, including a list of revenue codes that are EXCLUDED from Part B coverage. Revenue code 0360 is not excluded: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c04.pdf Medicare Claims Processing Manual, Chapter 4 -- Part B Hospital (Including Inpatient Hospital Part B and OPPS) 240.1 - Editing Of Hospital Part B Inpatient Services: Reasonable and Necessary Part A Hospital Inpatient Denials (Rev. 4394, Issued: 09-13-19, Effective: 10-01-13, Implementation: 10-15-19)When inpatient services are denied as not medically necessary or a provider submitted medical necessity denial utilizing occurrence span code ?M1?, and the services are furnished by a participating hospital, Medicare pays under Part B for physician services and the non-physician medical and other health services provided in Pub. 100-02, Medicare Benefit Policy Manual, Chapter 6, §10.1, ?Reasonable and Necessary Part A Hospital Inpatient Claim Denials.?

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PARA Weekly eJournal: June 23, 2021

CONVERTING INPATIENT MEDICARE CLAIMS FOR OUTPATIENT PAYMENTS

A hospital may also be paid for Part B inpatient services if it determines under Medicare's utilization review requirements that a beneficiary should have received hospital outpatient rather than hospital inpatient services, and the beneficiary has already been discharged from the hospital (commonly referred to as hospital self-audit).

If the hospital already submitted a claim to Medicare for payment under Part A, the hospital would be required to adjust its Part A claim (to make the provider liable) prior to submitting a claim for payment of Part B inpatient services. Whether or not the hospital had submitted a claim to Part A for payment, we require the hospital to submit a Part A claim indicating that the provider is liable under section 1879 of the Act for the cost of the Part A services. The hospital could then submit an inpatient claim for payment under Part B for all services that would have been reasonable and necessary if the beneficiary had been treated as a hospital outpatient rather than admitted as a hospital inpatient, except where those services specifically require an outpatient status.

A hospital part B inpatient services claim billed when a reasonable and necessary part A hospital inpatient was denied must be billed with: - A condition code ?W2? attesting that this is a rebilling and no appeal is in process - ?A/B REBILLING? in the treatment authorization field, and - The original, denied inpatient claim (CCN/DCN/ICN) number NOTE: Providers submitting an 837I are instructed to place the appropriate Prior Authorization code above into Loop 2300 REF02 (REF01 = G1) as follows: REF*G1*A/B REBILLING~ For DDE or paper Claims, "A/B Rebilling" will be added in FL 63.

NOTE: Providers submitting an 837I are instructed to place the DCN in the Billing Notes loop 2300/NTE in the format: NTE*ADD*ABREBILL12345678901234~ For DDE or paper Claims, Providers are instructed to use the word "ABREBILL" plus the denied inpatient DCN/CCN/ICN shall be added to the Remarks Field (form locator #80) on the claim using the following format: "ABREBILL12345678901234". (The numeric string (12345678901234) is meant to represent original claim DCN/ICN numbers from the inpatient denial.)

Not Allowed Revenue Codes: The claims processing system shall set edits to prevent payment on Type of Bill 012x for claims containing the revenue codes listed in the table below.

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PARA Weekly eJournal: June 23, 2021

CONVERTING INPATIENT MEDICARE CLAIMS FOR OUTPATIENT PAYMENTS

Here?s the next section of the Claims Processing Manual, which sets out the excluded revenue codes for inpatient services converted to an outpatient claim because the beneficiary has no Part A coverage, and is eligible for Part B only: 240.2 - Editing Of Hospital Part B Inpatient Services: Other Circumstances in Which Payment Cannot Be Made under Part A (Rev. 4394, Issued: 09-13-19, Effective: 10-01-13, Implementation: 10-15-19) When Medicare pays under Part B for the limited set of non-physician medical and other health services provided in Pub. 100-02, Medicare Benefit Policy Manual, chapter 6, §10.2 (that is, when furnished by a participating hospital to an inpatient of the hospital who is not entitled to benefits under Part A, has exhausted his or her Part A benefits, or receives services not covered under Part A), ?

Not Allowed Revenue Codes

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PARA Weekly eJournal: June 23, 2021

MEDICARE COVID-19 VACCINES IN THE HOME

Ef f ect ive Ju n e 8, 2021, M edicar e w ill pay pr ovider s cu r r en t ly eligible t o bill f or COVID-19 vaccin e adm in ist r at ion (e.g., ph ysician s, ph ar m acies, n on -ph ysician pr act it ion er s, an d h ospit als) an addit ion al $35 per COVID-19 vaccin e dose w h en pr ovided in t h e pat ien t ?s h om e t o a M edicar e ben ef iciar y w h o h as is h ar d-t o-r each or h as dif f icu lt y leavin g h om e.

M0201 COVID-19 vaccine home administration may be reported with the COVID-19 administration code when the sole purpose of the healthcare home visit was to administer the vaccine. This add-on payment raises the total provider reimbursement to approximately $75 (which amount includes the $40 reimbursement for the specific vaccine administration.)

When a provider administers the COVID-19 vaccine to multiple people in the same home during the same visit, the provider may report M0201 (COVID-19 vaccine home admin) only once but should report all COVID-19 vaccine dose-specific administration codes.

The provider does not have to certify the patient is "homebound" (as defined by federal statute) but should document in the beneficiary's medical record the barrier(s) to receiving the vaccine outside the home.Medicare provides examples of instances when the M0201 is appropriate: - When a patient seldom leaves home, if at all, as it requires considerable difficulty and effort - When a patient is more susceptible to contracting COVID-19 due to a current medical condition - When a patient is disabled, has transportation issues, communication barriers, or caregiving challenges that make it difficult to get a vaccine outside of the home - When a patient faces clinical, socioeconomic or geographical barriers in settings other than their home

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PARA Weekly eJournal: June 23, 2021

MEDICARE COVID-19 VACCINES IN THE HOME

A facility interested in providing COVID-19 vaccines during the Public Health Emergency may do so by appending modifier PN to the service performed at the patient's home. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/ MLNMattersArticles/Downloads/SE18002.pdf ?CMS expects the PN modifier to be reported with each non-excepted line item and service including those for which payment will not be adjusted, such as separately payable drugs, clinical laboratory tests, and therapy services; with reporting required beginning on January 1, 2017.?

On professional fee claims, Medicare Administrative Contractor Novitas indicates HCPCS M0201 is billable only in the following places of service: 04, 06, 09, 12, 13, 14, 16, 19, 22, 33, 54, 55, 56, and 60. https://www.novitas-solutions.com/webcenter/portal/MedicareJH/pagebyid?contentId=00243903 Place of Service Codes 04 ? Homeless shelter 06 ? Indian Health Service Provider-based facility 09 -Prison/Correctional facility 12 ? Home 13 ? Assisted living facility 14 ? Group home 16 ? Temporary lodging 19 ? Off campus outpatient hospital 22 ? On campus outpatient hospital 33 ? Custodial care 54 ? ICF/Individuals with intellectual disabilities 55 ? Residential substance abuse treatment facilities 56 ? Psychiatric residential treatment centers 60 ? Mass immunization centers Independent and provider-based RHCs do not include charges for vaccine or administration for COVID-19 on a claim, reimbursement is made at the time of cost settlement.

Medicare provides additional information through the paper found through the following link: https://www.cms.gov /files/document/ vaccine-home.pdf 33

PARA Weekly eJournal: June 23, 2021

PAM A HELP IS HERE

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 h e sign s t o w at ch .

Th en con t act you r PARA Accou n t Execu t ive f or m or e in f or m at ion .

Our amazingguides.

Ran di Br an t n er

San dr a LaPlace

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Vice President of Analytics

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719.308.0883

800.999.3332 x 225

800.999.3332 x219

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PARA Weekly eJournal: June 23, 2021

NEW HCPCS ADDED 7-1-2021 FOR INTRAVASCULAR LITHOTRIPSY DEVICE

Shockwave Medical, Inc. introduced a new device, Shockwave C2Coronary Intravascular Lithotripsy (IVL) catheter, which received FDA Breakthrough Device Designation (BDD) in 2019. Effective July 1, 2021, CMS granted approval for a Transitional Pass-Through (TPT) payment for the Shockwave C2 Coronary IVL catheter when performed in the hospital outpatient setting.CMS issued HCPCS C1761 (Catheter, transluminal intravascular lithotripsy, coronary) for use by hospitals to bill for the Shockwave C2 Coronary IVL catheter in addition to the appropriate procedure codes, CPT® 92928 and HCPCS C9600.

The July 2021 update of the hospital OPPS, with more detailed information, can be accessed at this link: r10825cp.pdf (cms.gov).

The Shockwave C2Coronary IVL device will be eligible for TPT payments for three years. When a claim includes Status Indicator H (Pass-Through Device Categories), a payment for the device is made in addition to the payment for the procedure.

Charging for the procedure and the device for the next three years will aid in adjusting the APC rate for the procedure after the device category expires.

Intravascular lithotripsy (IVL) uses acoustic pressure waves to safely and effectively break up calcium which aids in stent delivery and stent expansion in patients with severely calcified coronary lesions.More information can be viewed on the manufacturer?s website: IVL for CAD - Shockwave Medical.

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PARA Weekly eJournal: June 23, 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, Ju n e 17, 2021

New s -

COVID-19: EUA for Sotrovimab Monoclonal Antibody Product COVID-19: EUA for Regeneron Monoclonal Antibody Product Men?s Health: Medicare Covers Preventive Services

Casirivimab & Imdevimab

Com plian ce -

Hospice Care: Safeguards for Medicare Patients

Even t s -

HCPCS Public Meeting ? Begins July 7

M LN M at t er s® Ar t icles -

Addition of the QW Modifier to Healthcare Common Procedure Coding System (HCPCS) Codes 0240U, 0241U, and 87637 Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP) - October 2021 Quarterly Update to Home Health (HH) Grouper July 2021 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files ?

Revised

Pu blicat ion s -

Medicare Mental Health ? Revised Medicare Secondary Payer ? Revised Skilled Nursing Facility 3-Day Rule Billing ? Revised

M u lt im edia -

World of Medicare Web-Based Training ? Revised

View this edition as PDF (PDF)

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PARA Weekly eJournal: June 23, 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: June 23, 2021

The link to this MedLearn MM12289

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PARA Weekly eJournal: June 23, 2021

The link to this MedLearn MM12171

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PARA Weekly eJournal: June 23, 2021

There were THREE new or revised Transmittals released this week.

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

3

FIND ALL THESE TRANSMITTALS IN THE ADVISOR TAB OF THE PDE

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PARA Weekly eJournal: June 23, 2021

The link to this Transmittal R10860CP

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PARA Weekly eJournal: June 23, 2021

The link to this Transmittal R10859DEMO

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PARA Weekly eJournal: June 23, 2021

The link to this Transmittal R10854CP

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PARA Weekly eJournal: June 23, 2021

719.308.0883

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