PARA HealthCare Analytics Weekly eJournal January 6, 2021

January 6, 2021

PARA

WeeklyeJOURNAL NEWS FOR HEALTHCARE DECISION MAKERS

M edi-Cal Pr ogr am

NO! To "Most Favored Nation" Says Federal Judge

Wh at 's Available For Sen ior s In Calif or n ia?

Page 18

Page 20 - 2021 E&M Versus Time - Om n ibu s Bill St r ips G2211 Paym en t - New COVID-19 Treatment Add-On - 2021 OPPS In pat ien t On ly List Updat ed - CY2021 Medicare

FAST LINKS

Premiums And Deductible Updates - SPECIAL: Billin g An d Codin g For Covid-19 Vaccin es - Many 2020 NCCI Edits Reversed Retroactively - An t ibody Tr eat m en t

- Administration: Pages 1-54 - HIM /Coding Staff: Pages 1-54 - Providers: Pages 2,10,13,16,18,34,42 - Pulmonology: Page 2 - Price Transparency: Pages 3,36 1 13 - Long Term Care: Page

Pr ice Tr an spar en cy.

Th er e's St ill Tim e Page 3

- Outpatient Svcs: Page 10,17,46,40 - Surgical Svcs: Pages 16,46 - California Providers: Page 18 - Pharmacy: Pages 20,26 - Therapy Svcs: Page 30,42,47 - Infusion Therapy: Page 41

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

PARA Weekly eJournal: January 6, 2021

2021 E&M VERSUS TIME

I just want to clarify, when coding E/M and the provider documents time, do we have to code by time or can we code by MDM instead?

Answer: When determining the appropriate E&M level of service to bill, providers may use either time-based coding or Medical Decision-Making (MDM) in 2021. This determination can be made encounter-by-encounter, providers are not required to use the same method across the board. The method that is most beneficial and represents the work of the provider should be used when determining the E&M level to bill.

Since the new 2021 regulations regarding billing based on time will now include non-face to face time, we suspect providers will document time on each patient to cover their bases. However should the MDM score a higher level than time, the MDM should be used to determine the E&M level.

An example: Patient returns for upper respiratory issues. Patient was seen 10 days prior and prescribed a Z pack. Symptoms continue to worsen. Provider examines the patient, orders chest Xray and two labs.

The patient is prescribed a new medication.

The MDM would score as follows.

Number & Complexity of Problem(s) Addressed = Low(since the upper respiratory symptoms continued after a previous prescribed course of treatment, this would be considered Acute, where the first visit would be considered self-limited (based on the new definitions for 2021) Amount/ Complexity of Data = Moderate Risk = Moderate Since two of the 3 elements scores moderate, 99204/99214 would be the correct level of service based on MDM. The provider documented 25 minutes total time which scores a 99203/99213 based on time, so MDM making should be used to determine the level of service for this encounter.

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PARA Weekly eJournal: January 6, 2021

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THE COM PLIANCE GUIDE

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PARA Weekly eJournal: January 6, 2021

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

PARA can help.

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PARA Weekly eJournal: January 6, 2021

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

REQUIREMENT #1

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

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

REQUIREMENT #3 A con su m er -f r ien dly display t h at in clu des t h e st an dar d ch ar ges f or at least 300 "sh oppable" ser vices t h at ar e gr ou ped w it h ch ar ges f or an cillar y ser vices t h at ar cu st om ar ily pr ovided by t h e h5ospit al.

PARA Weekly eJournal: January 6, 2021

SOLUTIONS FOR HOSPITALS THE PARA PTT In speaking with hospital associations, clients, and business vendor groups, we are finding that we are one of the only vendors who can completely satisfy, to the letter of the law, both CMS requirements in a fully customizable manner.

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

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

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

Turnaround time for the Pr ice Tr an spar en cy Tool is 60 days from submission of completed data, however subject to change as we get closer to the January 1, 2021 deadline.

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

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PARA Weekly eJournal: January 6, 2021

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

M EET THE T EAM

Violet Ar ch u let -Ch iu

San dr a LaPlace

Ran di Br an t n er

Senior Account Executive

Account Executive

Vice President of Analytics

varchuleta@para-hcfs.com

splace@para-hcfs.com

rbrantner@hfri.net

800.999.3332 x219

800.999.3332 x 225

719.308.0883

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PARA Weekly eJournal: January 6, 2021

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

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

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

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

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

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PARA Weekly eJournal: January 6, 2021

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

PRESS HERE

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PARA Weekly eJournal: January 6, 2021

OMNIBUS BILL STRIPS G2211 PAYMENT, INCREASES OTHER PRO FEES

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

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

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

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

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PARA Weekly eJournal: January 6, 2021

OMNIBUS BILL STRIPS G2211 PAYMENT, INCREASES OTHER PRO FEES

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

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

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

(continued next page)

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PARA Weekly eJournal: January 6, 2021

OMNIBUS BILL STRIPS G2211 PAYMENT, INCREASES OTHER PRO FEES

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

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

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

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PARA Weekly eJournal: January 6, 2021

NEW COVID-19 TREATMENT ADD-ON PAYMENT (NCTAP)

Medicare recently announced a New COVID-19 Treatment Add-On Payment (NCTAP) program for hospitals paid under its Inpatient Prospective Payment System effective November 2, 2020 through the end of the of the Public Health Emergency (PHE).The NCTAP offers enhanced ?add-on? payments for inpatient care reimbursed under Medicare?s Inpatient Prospective Payment System (IPPS) when certain new products with FDA Administrative approval or emergency use authorization for COVID-19 are provided during an inpatient stay.(The new program is not available to Critical Access Hospitals, which are paid on a cost-reimbursement basis for inpatient care.)

However, add-on payments are triggered only if the cost of the case (as measured by the hospital?s established Medicare cost to charge ratios) exceeds the amount of the DRG payment under IPPS. CMS provides a webpage for NCTAP information at the following link: https://www.cms.gov/medicare/covid-19/covid-19-treatments-add-payment-nctap

The NCTAP add-on payment will be equal to the lesser of: - 65% of the operating outlier claim threshold OR - 65% of the costs that exceed the standard DRG payment (including those cases adjusted to the relative weight under section 3710 of the CARES Act.) For high-cost cases, the NCTAP payments could increase IPPS reimbursement in addition to the 20% bump in the operating portion of IPPS DRG payments for COVID patients previously made available under the CARES Act, announced in September 11, 2020 in MLN Matters SE20015: https://www.cms.gov/files/document/se20015.pdf

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PARA Weekly eJournal: January 6, 2021

NEW COVID-19 TREATMENT ADD-ON PAYMENT (NCTAP)

CMS determines NCTAP eligibility based on claims eligible for the 20% add-on payment under section 3710 of the CARES Act based on the presence of specific ICD-10 codes: - ICD-10-CM Diagnosis Code of U07.1 -COVID-19 AND - An ICD-10-PCS code for Remdesivir (Veklury), COVID-19 convalescent plasma, or Remdesivir administered with Baricitinib (Olumiant)

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PARA Weekly eJournal: January 6, 2021

NEW COVID-19 TREATMENT ADD-ON PAYMENT (NCTAP)

*The Emergency Use Authorization (EUA) requires the administration of Baricitinib with Remdesivir ICD-10-PCS code(s) XW033E5 Introduction of Remdesivir Anti-infective into Peripheral Vein, Percutaneous Approach, New Technology Group 5 or XW043E5 Introduction of Remdesivir Anti-infective into Central Vein, Percutaneous Approach, New Technology Group 5.

While CMS reminds us that, per Chapter 32 of the Claims Processing Manual ? Billing Requirements for Special Services a hospital should not seek additional payment for drugs or biologicals that a governmental entity provided at no cost to to diagnose or treat patients with known or suspected COVID-19, a hospital should report all ICD-10-PCS code(s) associated with the product(s).

Additional billing and reporting information may be obtained from CMS through the following link: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c32.pdf#

Because Medicare is currently providing monoclonal antibody therapy products at no cost to providers, those products are not included in the NCTAP.Medicare does, however, cover the administration/infusion of the monoclonal products.

The ?COVID-19 Frequently Asked Questions (FAQs) on Medicare Fee-For-Service (FFS) Billing? document includes questions on NCTAPs beginning with question number 13 of F. Hospital Inpatient Prospective Payment Systems (IPPS) Payments: https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf

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PARA Weekly eJournal: January 6, 2021

2021 OPPS INPATIENT ONLY LIST UPDATE

There are significant changes to Medicare?s Inpatient-Only list for 2021, and more in store over the next three years. The full list of inpatient-only codes is available on the PARA Data Editor Advisor tab ? enter ?Inpatient Only? into the summary field:

More than 600 HCPCS previously listed on the 2020 OPPS Addendum E (inpatient-only list) were omitted from the CY 2021 list.Here are just a few of the procedures that may now be performed as an outpatient procedure:

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PARA Weekly eJournal: January 6, 2021

2021 OPPS INPATIENT ONLY LIST UPDATE

Medicare explains its philosophy and the reduction in codes in the 2021 OPPS Final Rule Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/cy-2021-medicare-hospital-outpatient-prospective -payment-system-and-ambulatory-surgical-center-0 Elimination of the Inpatient Only List

In this rule, we are finalizing our proposal to eliminate the Inpatient Only (IPO) list over a three-year transitional period, beginning with the removal of approximately 300 primarily musculoskeletal-related services, with the list completely phased out by CY 2024. This will make these procedures eligible to be paid by Medicare in the hospital outpatient setting when outpatient care is appropriate, as well as maintain our ability to pay for these services in the hospital inpatient setting when inpatient care is appropriate, as determined by the physician.

Additionally, procedures removed from the IPO list may become subject to medical review activities related to the 2-midnight rule. In the CY 2020 OPPS/ASC final rule, CMS finalized a two-year exemption from certain medical review activities related to the 2-midnight rule for procedures newly removed from the IPO list. In this rule, we are finalizing a policy in which procedures removed from the IPO list beginning January 1, 2021 will be indefinitely exempted from site-of-service claim denials under Medicare Part A, eligibility for Beneficiary and Family-Centered Care-Quality Improvement Organization (BFCC-QIO) referrals to Recovery Audit Contractors (RACs) for noncompliance with the 2-midnight rule, and RAC reviews for ?patient status? (that is, site-of-service).

This exemption will last until we have Medicare claims data indicating that the procedure is more commonly performed in the outpatient setting than the inpatient setting. This exemption will allow providers more time to become accustomed to the new ability to bill for Medicare payment of claims for services that were previously only paid on an inpatient basis. Providers are still expected to bill in compliance with the 2-Midnight rule. The BFCC-QIOs will still have the opportunity to review such claims in order to provide education for practitioners and providers regarding compliance with the 2-midnight rule, but claims identified as noncompliant will not be denied with respect to the site-of-service under Medicare Part A.

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PARA Weekly eJournal: January 6, 2021

CALIFORNIA MEDI-CAL UPDATED PAYMENT RATES FOR COVID-19 TESTING

Medi-Cal has announced it will cover COVID-19 Detection CPT® Code 87428 effective for dates of service on or after November 10th, 2020. https://files.medi-cal.ca.gov/pubsdoco/newsroom/newsroom_30717_09.aspx?_cldee= bW1jbWlsbGFuQHBhcmEtaGNmcy5jb20%3d&recipientid=contact-9212cfb6eaf 5ea11a815000d3a5bf119-fa09c2e2c2274e6d8b77e43822f7e81c&esid=39193d1f -763e-eb11-a813-000d3a310f17

The full description of the new code is: 87428 -- Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; severe acute respiratory syndrome coronavirus (eg, SARS-CoV, SARS-CoV-2 [COVID-19]) and influenza virus types A and B The frequency limitation for CPT® Code 87428 is once per day for any provider type. There is no established payment rate for this CPT® Code yet; it will be released in future Medi-Cal publications.

Medi-Cal will implement an Erroneous Payment Correction (EPC) plan to reprocess affected claims retroactive to November 10th.

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PARA Weekly eJournal: January 6, 2021

CY2021 MEDICARE PREMIUMS AND DEDUCTIBLE UPDATES

CMS has announced the new updates for the CY2021 premiums and deductibles for Part A and Part B fee for service providers.

Medicare Part B covers physician services, outpatient hospital services, certain home health services, durable medical equipment, and certain other medical and health services not covered under Part A. The standard monthly premium for Medicare Part B enrollees will be $148.50 for CY 2021. This is a slight increase over CY2020, which was $144.60.

The annual deductible for Part B enrollees for CY2021 is $203.00. As with the increase in premiums, this is also a slight increase over CY2020, which was $198.00.

Medicare Part A covers inpatient hospital, skilled nursing facility, and some home health care services.

Currently, CMS records show about 99% (percent) of Medicare beneficiaries do not have a Part A premium since they have at least 40 quarters of Medicare-covered employment.

For CY2021, the Medicare Part A inpatient deductible is $1,484.00. This is an increase of $76.00 from the CY2020 deductible amount of $1,408.00.

CY2021 Co-insurance rates: $371.00 ? 61st ? 90th day $742.00 ? 91st ? 150th day for Lifetime reserve days $ 185.50? 21st ? 100th day for SNF days Medicare Advantage Premiums: In CY2021 Medicare Advantage premiums will decline while plan choices and new benefits increase. On average, Medicare Advantage premiums are estimated to decrease by 23% from CY2020.

Article reference: https://www.cms.gov/newsroom/fact-sheets/2021-medicare-parts-b-premiums-and-deductibles

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PARA Weekly eJournal: January 6, 2021

CMS "MOST FAVORED NATION" STOPPED BY FEDERAL COURT

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

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

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

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

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PARA Weekly eJournal: January 6, 2021

CMS "MOST FAVORED NATION" STOPPED BY FEDERAL COURT

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

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

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

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

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

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

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PARA Weekly eJournal: January 6, 2021

CMS "MOST FAVORED NATION" STOPPED BY FEDERAL COURT

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

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

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

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

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

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

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PARA Weekly eJournal: January 6, 2021

CMS "MOST FAVORED NATION" STOPPED BY FEDERAL COURT

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

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

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

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PARA Weekly eJournal: January 6, 2021

CMS "MOST FAVORED NATION" STOPPED BY FEDERAL COURT

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

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

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

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

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PARA Weekly eJournal: January 6, 2021

CMS "MOST FAVORED NATION" STOPPED BY FEDERAL COURT

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

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

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

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

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

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PARA Weekly eJournal: January 6, 2021

BILLING AND CODING FOR COVID-19 VACCINES

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

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

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

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

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PARA Weekly eJournal: January 6, 2021

BILLING AND CODING FOR COVID-19 VACCINES

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

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

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

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

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PARA Weekly eJournal: January 6, 2021

BILLING AND CODING FOR COVID-19 VACCINES

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

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

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

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PARA Weekly eJournal: January 6, 2021

BILLING AND CODING FOR COVID-19 VACCINES

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

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PARA Weekly eJournal: January 6, 2021

MANY IRKSOME 2020 NCCI EDITS REVERSED RETROACTIVELY

The NCCI Edit contractor for CMS, Capitol Bridge, LLC, informed a PARA client by email that the edit which prevented billing an ED visit with a physical or occupational therapy evaluation (99281-99285 with 97161-97168) will be deleted in the 1/1/2021 CCI edit files, retroactively. The following excerpt from the email was shared with PARA:

PARA recommends resubmitting any claims which were underpaid due to the erroneous NCCI edit to Medicare after the New Year.

This retraction of the NCCI edits applicable to PT/OT evaluations for emergency department services were not the only edits retroactively deleted.The American Physical Therapy Association offers an article on its webpage discussing a number of other retroactive changes: https://www.apta.org/article/2020/12/04/ncci-coding-edit-change

Although APTA argued against most of the NCCI edits which affected physical therapy billing by private practice therapists, the edits particular to ED visits were not among those APTA complained about.Since the ED visit/PT Evaluation NCCI edits primarily affect hospital reimbursement, PARA expressed its opinion to Capitol Bridge on behalf of its clients.Together with the voices of other stakeholders, our efforts were successful in changing the NCCI edits that most affected hospital reimbursement.

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PARA Weekly eJournal: January 6, 2021

MANY IRKSOME 2020 NCCI EDITS REVERSED RETROACTIVELY

PARA?s objection was conveyed by email dated 11/25/2020; the reply from Capitol Bridge was received the next business day.It appears that the decision to ?change? the edits was made prior to our objection.The full text of our objection is provided below.

I represent a revenue cycle consulting firm; I am writing on behalf of several client hospitals regarding the new NCCI edits added effective October 1, 2020 which disallow payment for a physical or occupational therapy evaluation (CPT®s 97161-97169) with an emergency department visit code (CPT®s 99281-99285). Here is an excerpt from the NCCI PTP Edits V263r0 effective 10/1/2020:

We find the edits are ill-informed and unjust for the following reasons: - The abrupt reduction in reimbursement for these PT and OT evaluations is causing unexpected material financial and operational harm to hospitals. Shouldn?t there be some ?due process? notice and comment period prior to imposing an edit that financially damages hospitals rather than an unexplained fiat?

- These new CCI edits reduce Medicare OPPS reimbursement in a manner that is inconsistent with program policy. These edits hold the same financial impact as ?packaging?payment for PT and OT evaluations to an ED visit code, while suppressing reporting revenue which represents a distinct cost from a separate, non-ED cost center. Under OPPS, the APC rate-setting process for APC?s 5021, 5022, 5023, 5024, and 5025 (applicable to CPT® s 99281-99285) could not have included packaging the expense of PT or OT evaluations into the ED visit charge because this CCI edit was not in place at the time rates were calculated. Additionally, PT and OT evaluations are status A, not paid under OPPS but paid under the MPFS.The new edits prohibiting a PT or OT evaluation to be billed with ED visits are limited to only ED visit HCPCS 9928x and not all OPPS status J2 codes, such as G0379, G0380-G0384, and G0463. This belies a well-informed process.

What input was sought or obtained in considering the addition of these new edits?

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PARA Weekly eJournal: January 6, 2021

MANY IRKSOME 2020 NCCI EDITS REVERSED RETROACTIVELY

- PT and OT evaluations provided in the emergency department setting are medically necessary services that represent a specific cost to facilities, as these services are performed by facility-employed PT?s and OT?s, not the ED physician. Hospitals should be permitted to report the services performed by therapists in the Emergency Department setting without contending with an NCCI edit or line item denial, as the cost of rendering those services is valid, measurable, and not included in the Emergency Department revenue center nor in the APC reimbursement for the ED visit codes - CMS should want hospitals to report HCPCS codes for PT and OT evaluations when performed in the ED, as it may prove useful to researchers in determining whether an evaluation has positive outcomes on emergency department patients discharged from outpatient status with various diagnoses - The imposition of these entirely inexplicable edits damages hospital reimbursement at a time when hospitals are stressed financially due to the COVID-19 PHE. We are confident that Medicare did not intend to simply cut emergency department services reimbursement ? all other actions by CMS during the PHE have been on the whole incredibly supportive of community hospitals and healthcare providers in general. Surely the addition of these NCCI edits were poorly timed, to say the least One final piece of information ? here is a link and an excerpt from ?Physical Therapist Practice in the Emergency Department Observation Unit: Descriptive Study?which might illuminate the value of services rendered by therapists in the ED setting: https://academic.oup.com/ptj/article/95/2/249/2684151

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PARA Weekly eJournal: January 6, 2021

MANY IRKSOME 2020 NCCI EDITS REVERSED RETROACTIVELY

?? The first priority of the physical therapist in the EDOU in determining discharge disposition is to determine the patient?s ability to mobilize safely with available social supports and environmental constraints. If the patient is not independent or there is not support at home, recommendations are made regarding appropriate level of rehabilitation care. Physical therapy EDOU management also focuses on care coordination with the medical team to provide symptom management (pain medication, antiemetics) to maximize function and promote self-management of the patients?conditions. Finally, physical therapist services in the EDOU provide for referral to appropriate level and timing of follow-up services such outpatient physical therapy. ? ?

We hope you find this to be a cogent argument for removing the new NCCI edits between the ED visit codes (9928x) and the Physical or Occupational Therapy evaluation codes, 97161-97169.

Please respond at your earliest opportunity, our clients are deeply concerned and frustrated. Thank you in advance for your time in considering these points.

Capitol Bridge replied on 11/30/2020:

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PARA Weekly eJournal: January 6, 2021

MEDICARE BENEFICIARIES AND ACCESS TO COVID-19 ANTIBODY TREATMENT

Th e Cen t er s f or M edicar e & M edicaid Ser vices an n ou n ced t h at st ar t in g Novem ber 10, 2020, M edicar e ben ef iciar ies can r eceive cover age of m on oclon al an t ibodies t o t r eat cor on avir u s disease 2019 (COVID-19) w it h n o cost -sh ar in g du r in g t h e pu blic h ealt h em er gen cy (PHE).

CMS?coverage of monoclonal antibody infusions applies to bamlanivimab, which received an emergency use authorization (EUA) from the U.S. Food and Drug Administration yesterday. ?Today, CMS is announcing a historic, first-of-its kind policy that drastically expands access to COVID-19 monoclonal antibodies to beneficiaries without cost sharing,? said CMS Administrator Seema Verma. ?Our timely approach means beneficiaries can receive these potentially life-saving therapies in a range of settings ? such as in a doctor?s office, nursing home, infusion centers, as long as safety precautions can be met. This aggressive action and innovative approach will undoubtedly save lives.?

CMS anticipates that this monoclonal antibody product will initially be given to health care providers at no charge. Medicare will not pay for the monoclonal antibody products that providers receive for free but today?s action provides for reimbursement for the infusion of the product. When health care providers begin to purchase monoclonal antibody products, Medicare anticipates setting the payment rate in the same way it set the payment rates for COVID-19 vaccines, such as based on 95% of the average wholesale price for COVID-19 vaccines in many provider settings. CMS will issue billing and coding instructions for health care providers in the coming days.

CMS anticipates the announcement today will allow for a broad range of providers and suppliers, including freestanding and hospital-based infusion centers, home health agencies, nursing homes, and entities with whom nursing homes contract, to administer this treatment in accordance with the EUA, and bill Medicare to administer these infusions.

Under section 6008 of the Families First Coronavirus Response Act (FFCRA), state and territorial Medicaid programs may receive a temporary 6.2 percentage point increase in the Federal Medical Assistance Percentage (FMAP), through the end of the quarter in which the COVID-19 PHE ends.

A condition for receipt of this enhanced federal match is that a state or territory must cover COVID-19 testing services and treatments, including vaccines and their administration, specialized equipment, and therapies for Medicaid enrollees without cost sharing.

This means that this monoclonal antibody infusion is expected to be covered when furnished to Medicaid beneficiaries, in accordance with the EUA, during this period, with limited exceptions.To view the Monoclonal Antibody COVID-19 Infusion Program Instruction, visit: https://www.cms.gov/files/document/covid-medicare-monoclonal-antibody -infusion-program-instruction.pdf

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PARA Weekly eJournal: January 6, 2021

NEW CONDITION CODES 90 AND 91 EFFECTIVE FEBRUARY 1, 2021

On October 29, 2020, the National Uniform Billing Committee (NUBC) created condition codes 90 and 91 for services and treatment provided under Expanded Access Approved Services (EA) or Emergency Use Authorization (EUA.) https://www.nubc.org/nubc-announces-new-condition-codes-effective-february-1-2021

For claims received (not based on date of service, admission date, or discharge date) on or after February 1, 2021 Medicare instructs providers to append Condition Code 90 to claims with Expanded Access Approved (EA) services. The EA program, sometimes referred to as ?compassionate use,? authorizes investigational drugs, biologicals, or medical devices for treatments outside of clinical trials when no other therapy or treatment is available for patients with diseases or conditions that are serious or life-threatening. The treatment offered under an EA have not been approved by the FDA and may or may not be effective in treatment.

For claims received (not based on date of service, admission date, or discharge date) on or after February 1, 2021 Medicare instructs providers to append Condition Code 91 to claims with treatment provided as part of an Emergency Use Authorization (EUA). EUA therapy or treatments are approved by the FDA during the Public Health Emergency when no alternative treatments are available. These treatments haven?t been granted full FDA approval. Examples of recent therapies approved by the FDA under EUA are monoclonal antibody drugs Regeneron, combo Casirivimab and Imdevimab, Bamlanivimab, Remdesivir and convalescent plasma.

On November 20, 2020. CMS released MLN Matters MM12049: https://www.cms.gov/files/document/mm12049.pdf

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PARA Weekly eJournal: January 6, 2021

PARA'S PRICE TRANSPARENCY TOOL

TENREASONS Why Hospitals Choose The Price Transparency Tool From PARA HealthCare Analytics and HFRI. 1.

Ensure compliance with the January 1, 2019 and January 1, 2021 CMS mandates for Price Transparency: a. Post a listing of all services and prices available at the facility in a machine-readable format b. Include payer specific reimbursement information for all services available at the facility

2.

Provide customized and meaningful information for patients. Take the guess work out of obtaining an estimate.

3.

Improve collections. Patients will know their liability before the service is provided.

They can even prepay!

4.

Web based solution. Simple implementation. No software to install.

5.

Comprehensive tool that pulls a. Top services at a facility b. User?s insurance information via eligibility checking c. Registration information to return usage statistics readily available to the facility 36

PARA Weekly eJournal: January 6, 2021

PARA'S PRICE TRANSPARENCY TOOL

TENREASONS, cont.

6.

Highly customizable a. The style and functionality of the tool to be directly embedded on the facility website b. The services available on the Decision Tree and how they are presented (i.e. descriptions, categories) c. The Prices that are presented (e.g., Average Line Charge, Average Package Charge, Average CDM Charge, etc.) d. The programming to meet all expectations and functionality

7.

8.

9.

Always up to date with the latest information for all users. With no additional work on behalf of the hospital once implemented. Fully serviced and managed on PARA?s servers with all data and functionality accessible by the facility through the PARA Data Editor.

Ongoing feature upgrades and improvements that reflect changes in practice, technology, and services.

Reporting capabilities to review all activity on hospital website and what services are being shopped. cost-effective solution in the industry. PARA?s 10. Most cost to deploy its solution is market competitive and

in line with what CMS is saying healthcare organizations should pay for to implement a patient price estimator.

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PARA Weekly eJournal: January 6, 2021

COVID-19 UPDATED 12/20/2020

er b m e De c 2 0 2 0 20,

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

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

ICD-10-CM Of f icial Codin g an d Repor t in g Gu idelin es f or Cor on avir u s, ef f ect ive Apr il 1, 2020 t h r ou gh Sept em ber 30, 2020, m ay be dow n loaded f r om t h e lin k below : https://apps.para-hcfs.com/para/Documents /COVID-19%20(Updated%2012-07-2020).pdf

Download the full 24-page update dated December 20, 2020, by clicking the link above or the document to the right.

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PARA Weekly eJournal: January 6, 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!

M on day, Decem ber 28, 2020 Medicare FFS Claims: 2% Payment Adjustment (Sequestration) Suspended Through March The Coronavirus Aid, Relief, and Economic Security (CARES) Act suspended the payment adjustment percentage of 2% applied to all Medicare Fee-For-Service (FFS) claims from May 1 through December 31.

The Consolidated Appropriations Act, 2021, signed into law on December 27, extends the suspension period to March 31, 2021.

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PARA Weekly eJournal: January 6, 2021

There were TWO new or revised MedLearns released this week.

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

2

FIND ALL THESE MEDLEARNS IN THE ADVISOR TAB OF THE PDE

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PARA Weekly eJournal: January 6, 2021

The link to this MedLearn MM11880

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PARA Weekly eJournal: January 6, 2021

The link to this MedLearn MM12126

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PARA Weekly eJournal: January 6, 2021

There were TEN new or revised Transmittals released this week.

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

10

FIND ALL THESE TRANSMITTALS IN THE ADVISOR TAB OF THE PDE

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PARA Weekly eJournal: January 6, 2021

The link to this Transmittal R10547CP

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PARA Weekly eJournal: January 6, 2021

The link to this Transmittal R10547BP

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PARA Weekly eJournal: January 6, 2021

The link to this Transmittal R10546CP

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PARA Weekly eJournal: January 6, 2021

The link to this Transmittal R10542CP

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PARA Weekly eJournal: January 6, 2021

The link to this Transmittal R10540CP

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PARA Weekly eJournal: January 6, 2021

The link to this Transmittal R10541BP

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PARA Weekly eJournal: January 6, 2021

The link to this Transmittal R10541CP

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PARA Weekly eJournal: January 6, 2021

The link to this Transmittal R10537DEMO

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PARA Weekly eJournal: January 6, 2021

The link to this Transmittal R10538PI

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PARA Weekly eJournal: January 6, 2021

The link to this Transmittal R10535CP

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