PARA HealthCare Analytics Weekly eJournal July 7, 2021

July 7, 2021

PARA

WeeklyeJOURNAL NEWS FOR HEALTHCARE DECISION MAKERS In dian a M edicaid Updat es Page 9

Labs Billed Page 5 On 13x TOB Page 10

Calif or n ia M edi-Cal Updat es Page 3

- ED Pr ocedu r e Ch ar ges - CMS Clarifies Pulmonary, Cardiac Rehab Requirements - M edicar e COVID-19 M on oclon al AB Th er apy In Th e Hom e

FAST LINKS

- UPDATES! July OPPS - REVISIONS! HCPCS List Revised 7/ 6/ 21 - Paus Of Bamlanivimab/ Etesevimab COVID-19 MAB - NEW INSERT: Tim e To Com ply Wit h PAM A

- Administration: Pages 1-64 - HIM /Coding Staff: Pages 1-64 - Providers: Pages 2,3,9,10,16,21,37,52 - Emergency Dept.: Page 2 - Pharmcy: Pages 3,21,25,53 - Oncology: Page 7 1

CM S M ean s Bu sin ess!

Page 60

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California Providers: Page 3 COVID-19: Pages 9,21,37,46 PAM A Compliance: Page 39 Outpatient Svcs: Pages 23,47 DM E: Page 55 HCPCS: Page 34 SNF: Page 56

© 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: July 7, 2021

ED PROCEDURE CHARGES

Currently, our chargemaster for the Emergency Department doesn't have a breakout of procedures by CPT® code. Rather, we have two "general" charges set up (3585006 and 3585007); Surgical Procedure Groups 1 & 2.

Any time there is a procedure done in the ED (for example: 10060 I&D of Abscess; 10021 FNA Biopsy; 27818 Closed Treatment Of Ankle Fracture; 36556 Insertion of Non-Tunneled CV Cath), we charge one of the "general charges" mentioned above; and HIM applies the appropriate CPT® code at time of coding.

Is this a common structure? By doing a quick glance we are charging less than the MCR allowable for certain procedures by using our current methodology. Should we consider changing the charge structure in the chargemaster to have the charges built by the CPT® code so we can price appropriately, instead of using a set fee for a vareity of procedures?

Answer: Charge capture in the ED is not a one-size-fits-all. There is no ?best practice? for charge capture of the facility portion of physician procedures in the ED ? it all depends on how much effort the hospital is willing to expend toward the process of capturing the facility fee charge and the specific code that is supported by the documentation.

Some hospitals have added to the chargemaster each individual HCPCS/CPT® code (priced individually) for the majority of billable procedures that are performed by ED physicians. Usually, nurses are not expected to code the physician procedure, so the nurses don?t select or enter the charge -- usually a coder will review the documentation and select and enter the appropriate facility fee charge. However, some coding departments draw a firm line against engaging in the job of charge entry.

Alternately, some hospitals have very sophisticated EHR systems that trigger a charge on documentation ? either the physician?s documentation or the nurses.

The approach that we find works adequately is having generic charge ?levels? which are assigned to the procedure based in general on the complexity and time it takes to perform. The ED nurses select the ?level? procedure charge, and a coder merely assigns the appropriate HCPCS to the price on the claim.

PARA produced a paper discussing all aspects of the ED charge process which recommends three levels of charges rather than the two you currently use. Adding a third level and repricing them might get the additional reimbursement needed to align with the fee schedules more closely.

PARA_EmergencyDepartmentChargeProcess_November_2011.pdf (para-hcfs.com)

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PARA Weekly eJournal: July 7, 2021

CALIFORNIA MEDI-CAL MONTHLY UPDATES

For t h e m on t h of Ju n e 2021, M edi-Cal is im plem en t in g t h e f ollow in g ch an ges: -

New codes / Modifiers Replacement codes Discontinued codes Updated codes to specific Medi-Cal Programs - Updated restrictions to codes - Updated rates - ICD-10 update https://files.medi-cal.ca.gov/pubsdoco/bulletins/artfull/cah202106.aspx

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PARA Weekly eJournal: July 7, 2021

CALIFORNIA MEDI-CAL MONTHLY UPDATES

Providers ? Clinics and Hospitals, General Medicine, Obstetrics, All Medi-Cal Providers contracted to provide services under Every Women Counts (EWC) Program New: Telehealth Code (G0071) for FQHC/RHC Providers of Every Woman Counts (EWC) Program ? Effective retroactive for dates of service on or after March 04, 2020, HCPCS code G0071 has been added as a new benefit under the EWC Medi-Cal Program.

DCHS will issue an EPC to reprocess denied claims with dates of service on or after the effective dates of this policy change.

Providers: All Medi-Cal Participating Providers New: CY2021 3rdQuarter HCPCS Updates: Providers are encouraged to review the web link below for special billing requirements. https://files.medi-cal.ca.gov/pubsdoco/HCPCS/articles/hcpcs_2021_q3_policy_updates_31137.pdf

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PARA Weekly eJournal: July 7, 2021

CALIFORNIA MEDI-CAL MONTHLY UPDATES

Providers ? Clinics and Hospitals, General Medicine, Obstetrics Updates ? Opioid Use Disorder Emergency Room Treatment (G2213) ? Effective retroactively for dates of service on or after January 01, 2021, the policy has been updated with the following changes: - The frequency limit for code G2213 is updated to once (1) per day, any provider - Modifier UD is no longer allowed to be reported with this code - Modifiers 24 and 25 are allowed when reporting this code at the claim level

Providers ? Clinics and Hospitals, General Medicine, Obstetrics, Rehabilitation Clinics Updates- Drug and Alcohol Use Screening and Counseling (G0442, G0443, H0050, H0049) ?

Effective for dates of service on or after July 01, 2021, HCPCS codes G0442, G0443 and H0050 are updated.

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PARA Weekly eJournal: July 7, 2021

CALIFORNIA MEDI-CAL MONTHLY UPDATES

Effective retroactively for dates of service on orafter June 09, 2020, HCPCS code H0049 is updated as follows:

Codes H0049 and H0050 are reimbursed ?by report only?.

Retroactive policy changes for H0049 ? Providers who have NOT previously billed, but have applicable claims. DHCS is aware there may be claims applicable to this policy update, with dates of service past the timeliness limits that Medi-Cal requires for providers.

To accommodate providers impacted by this policy update, DHCS is allowing retroactive billing for claims with dates of service that exceed the six (6) month billing limit, however, the following criteria MUST be met by providers seeking reimbursement: - Providers must bill using a paper claim form (CMS1500 or UB04); and - Claims reporting H0049 that are past the timeliness rule, must use delay reason code 11; and - List ?retroactive policy change? as the justification Applicable claims must be submitted within 90 days of this publication. The last day claims will be accepted in this manner is September 14, 2021. Claims received after this date, will be denied and returned to provider.

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PARA Weekly eJournal: July 7, 2021

CALIFORNIA MEDI-CAL MONTHLY UPDATES

Providers ? All participating Medi-Cal providers administering Chemotherapy Injections Update: Policy for Specific Chemotherapy and Injection HCPCS Codes (J9023, J9228, J9299 and Q5110) to include the following updates for reimbursement under the Medi-Cal program effective for services on or after June 01, 2021: - No Treatment Authorization Request (TAR) is required - FDA approved indications - FDA approved dosages

Providers ? Clinics and Hospitals, General Medicine, Inpatient Services, Obstetrics Update ? Procedure Type and Benefit Status for CPT® code 48160 ? Effective for dates of services on or after July 01, 2021, the following updates are effective for CPT code 48160: - Obsolete procedure types B, 5 and 6 have been terminated - This code is now a Medi-Cal BENEFIT for surgeons and assistant surgeons - Requires an approved TAR for reimbursement

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PARA Weekly eJournal: July 7, 2021

CALIFORNIA MEDI-CAL MONTHLY UPDATES

Providers: All Participating Medi-Cal Providers New- Payment Error Rate Measurement (PERM) Cycle beginning Reporting Year (RY) 2023: DHCS is notifying all California Medi-Cal providers of the start of the Reporting Year (RY) 2023 Payment Error Rate Measurement (PERM) by CMS. The purpose of PERM is to identify erroneous payments made in Medicaid and the Children?s Health Insurance Program (CHIP) in all 50 states and report improper payment estimates to Congress.

Beginning RY2023 PERM, Medicaid and CHIP Medi-Cal claims will be randomly selected for Medical Reviews for the fiscal year beginning July 01, 2021 and ending June 30, 2022.

Providers are encouraged to review the Medi-Cal Newsletter for further information regarding this program. https://files.medi-cal.ca.gov/pubsdoco/bulletins/artfull/cah202106.aspx

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PARA Weekly eJournal: July 7, 2021

INDIANA MEDICAID EXPIRING COVID-19 POLICIES

On July 01, 2021, Indiana Medicaid Program has announced the following policies that were put in place for the COVID-19 Public Health Emergency (PHE), will no longer be effective as of July 31, 2021: - PA process for acute care hospital inpatient admissions http://provider.indianamedicaid.com/ihcp/Bulletins/BT202030.pdf -

Removal of prior authorization for certain DME or HME supplies and services http://provider.indianamedicaid.com/ihcp/Bulletins/BT202031.pdf

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Home Health prior authorization and telemedicine policies http://provider.indianamedicaid.com/ihcp/Bulletins/BT202040.pdf

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Revised policy for certain behavioral health services http://provider.indianamedicaid.com/ihcp/Bulletins/BT202042.pdf

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Revised policy for LTAC and AIR facility admissions http://provider.indianamedicaid.com/ihcp/Bulletins/BT202046.pdf

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Revised policy for managed care health plan PA policies for SNF admissions http://provider.indianamedicaid.com/ihcp/Bulletins/BT202047.pdf

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Temporary changes allowed for signature requirements http://provider.indianamedicaid.com/ihcp/Bulletins/BT202055.pdf

Claims reporting dates of service on or after August 01, 2021, will require all Medicaid participating providers to follow established Medicaid guidelines in place prior to March 01, 2020.

Reference for this article: http://provider.indianamedicaid.com/ihcp/Bulletins/BT202152.pdf

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PARA Weekly eJournal: July 7, 2021

LAB PAMA REPORTING: DO WE REPORT LABS BILLED ON 13X TOB?

Th e Pr ot ect in g Access To M edicar e Act (PAM A) w as passed in 2014, bu t m an y h ospit als ar e on ly n ow gr applin g w it h t h e pr ovision of t h e law t h at w ill con su m e an ext r aor din ar y am ou n t of ef f or t t h is year .

For the first time, hospitals which qualify as an ?Applicable Laboratory? are required to report commercial insurer payment rates for lab testing paid between January 1 and June 30, 2019 (Lab PAMA reporting.)Reports are due in the first quarter of 2022, and penalties for failure to report can be severe.

Under PAMA, an ?Applicable Laboratory? includes hospitals which were paid $12,500 or more by Medicare for non-patient lab claims (Type of Bill 14X) in the six-month period ending 6/30/2019.

For additional background on private payer rate reporting requirements, see our related paper at: https://apps.para-hcfs.com/para/Documents/CMS%20Expands%20Private%20Payor%20Lab%20 Reimbursement%20Reporting%20-%20Sept%202020.pdf

Applicable Laboratories must examine their claim payment records to report each commercial payer payment rate received for each laboratory CPT® code, and the quantity of times each rate of payment was received between 1/1/2019 and 6/30/2019, for every lab test under Medicare?s Clinical Lab Fee Schedule.

The next page contain's an example of just a few lines reporting varying payment rates for the same CPT® on Medicare?s required reporting template:

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PARA Weekly eJournal: July 7, 2021

LAB PAMA REPORTING: DO WE REPORT LABS BILLED ON 13X TOB?

Since this line-item payment data is not typically stored in the hospital patient accounting system, preparing the report is complex and burdensome work.

As hospitals come to grips with the problem of reporting unrecorded payment details, several have asked PARA whether payments for lab testing billed on the outpatient hospital (13X or 85X) Type of Bill (TOB) should be reported. It seems that some hospitals have reported non-patient lab services (also known as ?outreach laboratory? or specimen-only processing) on the outpatient TOB 13X (or 85X for a CAH), although the UB data specifications instruct hospitals to report such services on the 14X TOB. Some say they use the 13X TOB because commercial payers ?don?t recognize? the 14X TOB. Others say they misunderstood, and thought the requirement to use the 14X TOB was no longer in effect, or that private payers don?t specifically require hospitals to use TOB 14X for non-patient services.

To date, the CMS publications regarding private payer rate reporting specify that payments reported should be for non-patient services only, although CMS has not specified the Type of Bill on which the commercial payer based its payment for non-patient lab testing.

Language in CMS documents clearly instructs hospitals to limit payments reported to ?non-hospital patients.?

However, the discussion of 014X TOB within the CMS PAMA reporting publications is specific only in the context of determining whether the hospital met the ?majority of Medicare revenues? threshold of an Applicable Lab. To obtain clarification from CMS, PARA submitted the question (without identifying any particular facility) for the second time on June 22, 2021 to CLFS_Inquiries@cms.hhs.gov.

The ?Inquiries? email address acknowledged receipt of the inquiry, but has not yet responded.

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PARA Weekly eJournal: July 7, 2021

LAB PAMA REPORTING: DO WE REPORT LABS BILLED ON 13X TOB?

A follow-up email sent on June 22, 2021 with a request for status was answered on June 23, 2021 with the short reply ?Nothing to share yet.?

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PARA Weekly eJournal: July 7, 2021

LAB PAMA REPORTING: DO WE REPORT LABS BILLED ON 13X TOB?

HIPAA ?Standard Transaction Set? Regulations-- The original HIPAA law established national standards for electronic transactions to improve the efficiency and effectiveness of the nation's health care system. These standards apply to all HIPAA-covered entities, including hospitals and health plans.

The National Uniform Billing Committee (NUBC) serves as one of the organizations which set the standard for electronic transactions -- here?s an excerpt from the UB Committee website: https://www.nubc.org/system/files/media/file/2020/06/NUBCProtocolApproved_07_15_09_ updated_10_07_19%2606_17_20.pdf ?The final rule on Standards for Electronic Transactions published on August 17, 2000 calls for the creation of the Designated Standards Maintenance Organizations (DSMO). The charge of the DSMO is to maintain the electronic transaction standards adopted by the Secretary of Health and Human Services.The following six organizations serve as part of the DSMO, they are: - Accredited Standards Committee X12 (ASC X12), - Dental Content Committee (DeCC) of the American Dental Association - Health Level 7 (HL7), - National Council for Prescription Drug Programs (NCPDP) - National Uniform Billing Committee - National Uniform Claim Committee ??

Given the NUBC role in the established HIPAA standard transaction set, compliance with the UB Manual directions is compliance with HIPAA.?Covered entities?, including hospitals and physician clinics which submit electronic claims, are required to comply with HIPAA standards.

Returning to Medicare publications on private payer lab payment rate reporting-- here?s an excerpt from the original MLN Matters article explaining the data requirements for Lab PAMA: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/ Downloads/SE19006.pdf Page 18

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PARA Weekly eJournal: July 7, 2021

LAB PAMA REPORTING: DO WE REPORT LABS BILLED ON 13X TOB?

The following excerpt from the 2021 FAQ document on the CMS PAMA Regulations website repeats the point: https://www.cms.gov/files/document/frequently-asked-questions-cy-2021-clfs.pdf

Even Medicare can?t violate HIPAA -- Experienced Medicare observers may recall a 2014 kerfuffle that caused CMS to promptly reverse its instruction that hospitals use the 14X TOB for certain in-person outpatient lab services, which instruction was inconsistent with the NUBC standards. The NUBC upbraided CMS in a letter sent to Medicare on January 21, 2014 ? excerpts clearly show that the UB committee deems unauthorized deviations from the technical requirements of the UB Data Specifications constitute a violation of HIPAA Standard Transaction Set requirements: ?? writing on behalf of the members of the National Uniform Billing Committee (NUBC) to express our concern about a recent Centers for Medicare & Medicaid (CMS) action that alters the official definition and purpose of an NUBC data element (as indicated in the Official UB-04 Data Specifications Manual (UB-04 Data Set)). ? ?Unless the situation is corrected, the NUBC plans on filing a HIPAA complaint with CMS OESS for failure to adhere to the HIPAA standards. ? ?Even if CMS had done so, the rule making process is not applicable to an external code list that is not within the purview of CMS to arbitrarily change. The NUBC has a change request process that CMS, in this instance, did not follow.?

Given that Medicare was not permitted to deviate from HIPAA requirements in its instruction, it seems unlikely that hospitals are entitled to deviate ? particularly if the deviation results in payment that might not otherwise be available due to commercial payer policies.

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PARA Weekly eJournal: July 7, 2021

LAB PAMA REPORTING: DO WE REPORT LABS BILLED ON 13X TOB?

Commercial insurer guidance-- United Healthcare is a commercial insurer which has issued a notice to providers that it is inappropriate to report non-patient laboratory services on a 13X or 12X Type of Bill: https://www.uhcprovider.com/content/dam/provider/docs/public/policies/comm-reimbursement/ COMM-Non-Patient-Facility-Laboratory-Service-Policy.pdf

PARA is eagerly awaiting a reply from the CMS CLFS team on the question of whether non-patient lab services billed on the 13X TOB should or should not be included in the payment data submitted for the reporting period January 1, 2019 through June 30, 2019.

Stay tuned for any updates on this topic in the PARA weekly eJournal.

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PARA Weekly eJournal: July 7, 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: July 7, 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: July 7, 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: July 7, 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: July 7, 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: July 7, 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 furnish COVID-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: July 7, 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 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.?

There is no cost-sharing (co-payments, 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: July 7, 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: July 7, 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: July 7, 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: July 7, 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: July 7, 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: July 7, 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: July 7, 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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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: July 7, 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: July 7, 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: July 7, 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

-

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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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: July 7, 2021

JULY 2021 HCPCS UPDATE LIST -- REVISED 7-6-2021

On Tuesday, June 22, 2021, CMS belatedly published the updated OPPS Addendum A and Addendum B files to be effective on 7/1/2021. New and updated HCPCS codes related to drugs and biologics are summarized in the table below. New non-pharmacy HCPCS are provided on the next page.

Please note -- CMS did not list new HCPCS J9314 in the Addendum B published in late June; MAC?s are advising providers to continue to report C9065 for non-lyphilized romidepsin.

This paper does not include or address the numerous added proprietary lab CPT® codes that Medicare has acknowledged this quarter. Those codes are not changing, although many are new codes. Providers are typically informed of proprietary codes when they purchase the lab test or equipment.

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PARA Weekly eJournal: July 7, 2021

JULY 2021 HCPCS UPDATE LIST -- REVISED 7-6-2021

July 1, 2021 HCPCS Update -- Drugs & Biologics, continued.

The following new HCPCS do not represent pharmacy items, although M0244 is the administration of a combination monoclonal antibody treatment.

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PARA Weekly eJournal: July 7, 2021

PAUSE OF BAMLANIVIMAB/ETESEVIMAB COVID-19 MAB

On June 25, 2021, the Assistant Secretary for Preparedness and Response (ASPR), a department of the U.S. Department of Health and Human Services (HHS), announced a pause of the COVID-19 monoclonal antibody therapy drugs bamlanivimab and etesevimab when administered either together or alone. https://www.phe.gov/emergency/ events/COVID19/ investigation-MCM/ Bamlanivimab-etesevimab/Pages/ bamlanivimab-etesevimab -distribution-pause.aspx This follows the April 16, 2021, FDA revocation of the Emergency Use Authorization (EUA) for ?solo?

Bamlanivimab, the first EUA issued for monoclonal antibody treatment of a COVID-19 positive patient on an outpatient infusion basis.

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PAUSE OF BAMLANIVIMAB/ETESEVIMAB COVID-19 MAB

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-updatefda-revokes-emergency-use-authorization-monoclonal-antibody-bamlanivimab The FDA recommends alternate monoclonal antibody therapy of REGEN-COV (casirivimab and imdevimab) or sotrovimab in accordance with the terms and conditions of the EUAs. On June 3, 2021 the FDA revised the EUA dosing authorization for REGEN-COV from 2400 mg (1200 mg casirivimab and 1200 mg imdevimab) to 1200 mg (600 mg casirivimab and 600 mg imdevimab).A single vial of casirivimab and imdevimab in a 1:1 ration was also introduced.HHS is coordinating the distribution of REGEN-COV through AmerisourceBergen.

REGEN-COV (casirivimab and imdevimab) fact sheet is available through the following link: https://www.regeneron.com/downloads/treatment-covid19-eua-fact-sheet-for-hcp.pdf

Sotrovimab must be purchased through AmerisourceBergen using one of the following sources: - Customer portal at https://abcorder.amerisourcebergen.com/ - AmerisourceBergen Customer Service - 1-800-746-6273 Monday through Thursday 7:00 AM to 6:30 PM, and Friday 7:00 AM to 6:00 PM CT - Purchase through AB ordering platforms (search product name, material item number 10258949,or NDC GlaxoSmithKline (GSK) published a Sotrovimab Infusion Guide available through the following link: https://www.sotrovimab.com/content/dam/ cf-pharma/hcp-sotrovimab-phase2/ en_US/sotrovimab-infusion-guide.pdf 38

PARA Weekly eJournal: July 7, 2021

JULY 2021 LAB PAMA ISSUES

TI M E

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

LAB PAM A

DETAILED GUIDANCE BOOKLET TIM ELINES AND REQUIREM ENTS

Pr icin g | Codin g | Reim bu r sem en t | Com plian ce 39

PARA Weekly eJournal: July 7, 2021

Introduction

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

"

BACKGROUND

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

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

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PARA Weekly eJournal: July 7, 2021

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

"

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

-

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

-

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

-

- Standard Tests - Drug Abuse Testing - Molecular Diagnostics 41

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

PARA Weekly eJournal: July 7, 2021

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

JUST THE FACTS, PLEASE

PAMA requires CMS to set the rates paid under its Clinical Lab Fee Schedule at the weighted median rate of payment that private payers pay for each specimen-only lab test.

Consequently, CMS must compel certain ?applicable laboratories?, including certain hospitals and physician clinics, to periodically report the payment rates each provider received for non-patient lab services billed to commercial and managed care payers. CMS will use data collected from the first six month of 2019 to set the Clinical Lab Fee Schedule (CLFS) rates for 2023 through 2025.

The current CLFS rates, which many providers complain are too low, were calculated from data submitted by a small number of national and regional labs in 2016. Going forward, more providers of non-patient laboratory services will be required to report payment rates to be used in calculating the CLFS. CMS efforts to communicate the data reporting requirement have been muddled with excruciating detail, causing the requirement to be widely misunderstood. In an effort to clarify the requirement as the deadline for reporting approaches, CMS published a ten-page ?summary? document and a new FAQ on April 20, 2021, at the links on the next page.

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PARA Weekly eJournal: July 7, 2021

https://www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/ClinicalLabFeeSched/Downloads/ CY2019-CLFS-PrivatePayor-RateBased-Summary.pdf https://www.cms.gov/files/document/frequently-asked -questions-cy-2021-clfs.pdf Hospitals which received more than $12,500 in Medicare revenues for non-patient lab services paid between 1/1/209 and 6/20/2019, will likely meet the definition of an ?applicable laboratory?, which triggers the requirement to report private payer rates early next year.

Applicable laboratories must report each CLFS CPT® , each payment rate, and the quantity of times each rate was paid for a non-patient service billed to commercial and Medicare or Medicaid managed care payers; reports must be submitted online through the CMS PAMA reporting website in early 2022.Failure of an applicable laboratory to report carries a risk of substantial penalties.

While data was initially collected from a few national lab providers in 2016, Medicare has expanded the definition of ?Applicable Laboratories? since then to include certain hospitals and physician practices.

Payment reporting requirement is burdensome and confusing, but PARA can help you determine whether your facility qualifies as an ?applicable lab? and in preparing the data for submission.

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THE COST OF NON-COM PLIANCE

PARA Weekly eJournal: July 7, 2021

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

CURRENT CM P $10,017 Per Day

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PARA Weekly eJournal: July 7, 2021

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

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

Th en con t act you r PARA Accou n t Execu t ive f or det ails.

Ran di Br an t n er

San dr a LaPlace

Violet Ar ch u let -Ch iu

Vice President of Analytics

Account Executive

Senior Account Executive

rbrantner@hfri.net

splace@para-hcfs.com

varchuleta@para-hcfs.com

719.308.0883

800.999.3332 x 225

800.999.3332 x219

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PARA Weekly eJournal: July 7, 2021

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

Download the updated Guidebook by clicking here.

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PARA Weekly eJournal: July 7, 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. 47

PARA Weekly eJournal: July 7, 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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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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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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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: July 7, 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: July 7, 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 ly 1, 2021

New s -

Quality Payment Program: 2021 APM Incentive Payments

Com plian ce -

Inhalant Drugs: Bill Correctly

Even t s -

Organ Procurement Organization Conditions for Coverage Webinar ? July 7

M LN M at t er s® Ar t icles -

July 2021 Update of the Ambulatory Surgical Center [ASC] Payment System

Pu blicat ion s -

Medicare Preventive Services ? Revised

M u lt im edia ·LTCH

QRP: Achieving a Full APU ? May 27 Webinar Materials

View this edition as PDF (PDF)

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PARA Weekly eJournal: July 7, 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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The link to this MedLearn MM12345

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The link to this MedLearn MM 12272

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PARA Weekly eJournal: July 7, 2021

There were TWO new or revised Transmittals released this week.

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

2

FIND ALL THESE TRANSMITTALS IN THE ADVISOR TAB OF THE PDE

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The link to this Transmittal R10872CP

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The link to this Transmittal R10856OTN

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PARA Weekly eJournal: July 7, 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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CMS PRICE TRANSPARENCY COMPLIANCE UPDATE

And CMS Means Business!

See how in the letter below:

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CMS PRICE TRANSPARENCY COMPLIANCE UPDATE

Page 2 of CMS Letter

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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: July 7, 2021

719.308.0883

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