ParaRev Weekly eJournal, March 15, 2023

OPPSPAYMENTPACKAGING--PACEMAKERPROCEDURES

Quest ion: We recent ly perform ed bot h a t em porary pacem aker and a perm anent pacem aker procedure during t he sam e out pat ient encount er (w it h a span of 2 days.) Medicare didn? t pay for t he t em porary pacem aker procedure. Can you offer guidance t o help us get paid for bot h procedures?An exam ple w ould be 33210, follow ed by 33208 on a subsequent day

Answ er: Actually, under Medicare?s Outpatient Prospective Payment System (OPPS), the hospital was paid for both procedures, although only CPT33208 carries the total reimbursement amount

Medicare?s OPPSpayment system calculates reimbursement for a claim according to the ?Status Indicator?of the HCPCScodes reported on the same outpatient claim, regardless of the date of service.Both HCPCS(33210 and 33208) are OPPSstatus J1 ? ?Hospital Part B Services Paid Through a Comprehensive APC?:

Under OPPS, only one Status J1 code will be paid, payment for all other lines will be ?packaged?to the primary (highest paying) J1 code on the same claim.When CMSsets the rate of reimbursement for a ?comprehensive APC?, the rate-setting process takes into consideration costs reported from the entire body of claims submitted by facilities nationwide for the same procedure.

OPPSPAYMENTPACKAGING--PACEMAKERPROCEDURES

Under OPPS, only one Status J1 code will be paid, payment for all other lines will be ?packaged? to the primary (highest paying) J1 code on the same claim When CMSsets the rate of reimbursement for a ?comprehensive APC?, the rate-setting process takes into consideration costs reported from the entire body of claims submitted by facilities nationwide for the same procedure

Therefore, it?s not quite true that the hospital isn? t paid for the temporary pacemaker procedure, it?s just that its reimbursement is ?packaged?into the rate paid on the primary code, which payment has already taken into account the typical costs for accompanying procedures ? including a temporary pacemaker procedure. We found a claim that illustrates Medicare?s OPPS payment for the services described within the Medicare claims database, using the PARA Dat a Edit or CMS tab:

Here?s an excerpt from the Medicare document that explains status indicator J1 (Addendum D1 of the OPPSFinal Rule) ? it explains that ?all covered Part B services on the claim are packaged with the primary ?J1?service for the claim? ?:

Here?s an excerpt from Medicare?s Integrated OCE(IOCE) CMSSpecifications V24 0, effective 1/1/2023, which explains how Comprehensive APCpayment is processed:

5 5 Com prehensive APC Processing

Effective 1/1/2015 (v16.0), certain high cost procedure codes which have an SI=J1 are paid an all-inclusive rate to include all services submitted on the claim, except, for services excluded by statute All allowed, adjunctive services submitted on the claim are packaged into the ?comprehensive?APCpayment rate (i e , the status indicator is changed to N) Multiple comprehensive procedures, if present on the claim in specified combinations, may be assigned to a higher-paying comprehensive APCrepresenting a complexity adjustment. Services that are excluded from the all-inclusive payment retain their standard APCand SI for standard processing

5 5 1 General Com prehensive APC Assignm ent Rules and Crit eria: V16 0- Current

? C. If there are multiple comprehensive APCprocedures existing on the same claim from the different categories listed above, the comprehensive APCprocedures are packaged (SI = N) according to the hierarchy of services present; the procedure or service highest in the hierarchy is assigned the comprehensive APCfor the claim Additional processing conditions for each of the different categories is listed separately below.

Outside of the ordinary APCreimbursement rate, there are only two ways that both procedures 33210 and 33208 reported on the same claim wilI qualify for additional reimbursement under OPPS? and that additional reimbursement would be paid on only the primary J1 code on the claim:

1 Certain combinations of two or more HCPCSwith status J1 on the same claim will trigger a higher payment due to a ?complexity adjustment?? but that higher payment will be included in the amount paid on the primary code.

2.If a claim has an extraordinarily high amount of charges, the claim may become eligible for additional ?outlier?reimbursement ? but this claim did not meet outlier criteria.This case did not qualify for a complexity adjustment, nor were the total charges high enough to generate additional reimbursement under OPPSOutlier methodology Com plexit y Adjust m ent :

For certain combinations of J1 procedure reported on the same claim, OPPSprovides for additional payment on the primary code called a ?complexity adjustment.?CMSpublishes the list of code combinations that result in a complexity adjustment in Addendum Jof the OPPSFinal Rule In the 2023 Addendum J, the combination of 33208 with 33210 does not qualify for a complexity adjustment

Here?s an excerpt from Addendum Jindicating that the code pair 33208 with 33210 did not qualify for a complexity adjustment in 2023 (note there are several tabs in the workbook):

Out lier Adjust m ent ?Under OPPS, a claim paid by APCmay become eligible for additional reimbursement in the form of an outlier adjustment if two criteria are met:

1 In 2023, the cost of the procedure, as measured by total covered charges x the facility?s ?Cost to Charge?ratio, must be more than $8,625 above the regular APCrate of reimbursement, and

2 The facility?s cost must exceed 1 75 x the APCrate

Here's an example of the OPPSoutlier calculation for a claim with very high charges:

Quest ion: Has Medicare provided guidance on how t o report separat ely payable drugs w hen no docum ent at ion of w ast age exist s? How are facilit ies required t o report drugs w here t he rem aining am ount of a vial w as used for a different pat ient ? It w ould be inappropriat e t o report JW, and also inappropriat e t o report JZ if w e w ast ed a port ion of a single-use vial but had no docum ent at ion t o affirm t hat t he w ast ed port ion w as not reallocat ed t o anot her pat ient .

Answ er: At this time, Medicare has not provided guidance that permits wastage without documentation of the portion of a single-use vial that was administered and the portion that was wasted The definition of modifier JW is ?Drug amount discarded/not administered to any patient;?therefore the documentation should support that wastage was truly discarded:

Optimal documentation in support of modifier JW would attest that the wasted portion was not used for any patient That being said, this documentation could be simplified if the facility has adopted a policy that prohibits using a single-use vial to treat more than one patient The recently published FAQ regarding modifiers JZ and JW from CMS, available in the Advisor tab of the PARA Dat a Edit or, does not allow for the possibility that providers would not have documented the wastage; it states that providers must document the amount of discarded drugs:

https://www cms gov/medicare/medicare-fee-for-service-payment/hospitaloutpatientpps/ downloads/jw-modifier-faqs pdf

Here?s the section of the FAQ document which addresses documentation:

To simplify documentation, hospitals should consider adopting a policy which prohibits administering the discarded portion of a single-use vial to any other patient. The Centers for Disease Control and Prevention (CDC) discourages providers from using a single-use vial for multiple patients as an infection control policy; guidance is offered at the following link:

(Next Page)

MODIFIERSJW AND JZ AND SINGLE- AND MULTI-USEVIALS

https://www cdc gov/injectionsafety/providers/provider faqs singlevials html

?Vials that are labeled as single-dose or single-use should be used for only a single patient as part of a single case, procedure, injection There have been multiple outbreaks resulting from healthcare personnel using single-dose or single-use vials for multiple patients [3,6?9].

?Even if a single-dose or single-use vial appears to contain multiple doses or contains more medication than is needed for a single patient, that vial should not be used for more than one patient nor stored for future use on the same patient ? ?

The Joint Commission surveys many facilities for compliance with the Medicare Conditions of Participation. They survey effective processes and procedures for infection control, one of which provides that hospitals should have a policy that single use vials should be used for only one patient:

https://www.jointcommission.org/-/media/tjc/documents/resources/patient-safety-topics/sentinelevent/sea 52 pdf

Effect ive processes and procedures

1. Develop and implement effective evidence-based organization-wide standardized policy and procedures for the prevention of the misuse of vials The policy should apply to all staff who administer injections to patients, and should address the following:

Single-dose/ single-use vials Mult iple-dose vials

- Use a single-dose/single-use vial for a single patient during the course of a single procedure. Discard the vial after this single use; used vials should never be returned to stock on clinical units, drug carts, anesthesia carts, etcThe One & Only Campaign from the CDCand Safe Injection Practices Coalition emphasizes ONEneedle, ONEsyringe, ONLYONE time Medications in single-dose/single-use vials lack antimicrobial preservatives and are therefore at greater risk to become contaminated and serve as a source of infection when used inappropriately. See campaign resources, including video

- If a single-dose/single-use vial must be entered more than once during a single procedure for a single patient to achieve safe and accurate titration of dosage, use a new needle and new syringe for each entry.21 Note: USP797 states that single-dose/single-use vials opened in less than ISO Class 5 air quality be used within one hour, with any remaining contents discarded Single-dose/single-use vials opened in ISO Class 5 air quality can be used up to six hours.22

- Do not combine or pool leftover contents of single-dose/single-use vials Do not store used single-dose/single-use vials for later use, no matter what the size of the vial.3

- Unopened single-dose/single-use vials may be repackaged into multiple single-dose/single-use containers (e g , syringes), which should be properly labeled, including the expiration date and a beyond-use date (which is different from the manufacturer assigned expiration date) This repackaging should be performed only by qualified personnel in ISO Class 5 air conditions in accordance with standards in the United States Pharmacopeia General Chapter 797, Pharmaceutical Compounding ? Sterile Preparations. Also, follow the manufacturer?s recommendations pertaining to safe storage of that medication outside of its original container 3,22

CMSissued the following Memorandum in 2012 outlining guidance for reuse or repackaging of single-use vials, as well as the infection control requirements with which providers and suppliers must comply under Medicare:

https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/ Downloads/Survey-and-Cert-Letter-12-35 pdf

Under certain conditions, it is permissible to repackage single-dose vials or single use vials (collectively referred to in this memorandum as ?SDVs?) into smaller doses, each intended for a single patient: The United States Pharmacopeia (USP) has established standards for compounding which, to the extent such practices are also subject to regulation by the Food and Drug Administration (FDA), may also be recognized and enforced under §§501 and 502 of the Federal Food, Drug and Cosmetics Act (FDCA). These USPcompounding standards include USP General Chapter 797, Pharmaceutical Compounding - Sterile Preparations (?USP?).

Under USP, healthcare facilities may repackage SDVs into smaller doses, each intended for use with one patient Among other things, these standards currently require that:

- The facility doing the repackaging must use qualified, trained personnel to do so, under International Organization for Standardization (ISO) Class 5 air quality conditions within an ISO Class 7 buffer area. All entries into a SDVfor purposes of repackaging under these conditions must be completed within 6 hours of the initial needle puncture

- All repackaged doses prepared under these conditions must be assigned and labeled with a beyond use date (BUD), based on an appropriate determination of contamination risk level in accordance with USP, by the licensed healthcare professional supervising the repackaging process

- Administering drugs from one SDVto multiple patients without adhering to USPstandards is not acceptable under CMSinfection control regulations: Medications in SDVs typically lack antimicrobial preservatives. According to the Centers for Disease Control and Prevention (CDC), ongoing outbreaks provide evidence that medications from SDVs can become contaminated and serve as a source of infection when they are used inappropriately

- Deficiency Citation Policy: Healthcare facilities that do not adhere to USPstandards but reuse SDVs for multiple patients must be cited for deficiencies under the applicable infection control standards for each type of provider/supplier On the other hand, healthcare facilities that utilize appropriately stored medications, derived from repackaged SDVs and prepared in accordance with USPmust not be cited solely on the basis of this practice

Readers may wish to peruse our previous paper regarding appropriate use of JZ/JW modifiers at the link below:

https://apps.para-hcfs.com/pde/documents/New%20Modifier%20JZ%20Required%20When %20Reporting%20Payable%20Drugs%20(November%202022).pdf

According to an MLN Fact Sheet published in December, 2022, Medicare will require all 340(B) entities, including Critical Access Hospitals, which submit claims for separately payable Part B drugs and biologicals to report modifier ?JG?or ?TB?on claim lines for drugs acquired through the 340(B) discount program.

The MLN is available at the following website:

www cms gov/files/document/mln4800856-medicare-part-b-inflation-rebate-guidance-use340b-modifier pdf

ALL FACILITIESREQUIRED TO REPORT340B MODIFIERSIN 2024

This is a substantial change from the original 340B billing requirement Previously, Critical Access Hospitals and Maryland All-Payer or Total Cost of Care Model hospitals were not required to report a modifier on 340(B) drugs. CMSissued a companion ?FAQ?document which reiterates this point:

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/ Downloads/Billing-340B-Modifiers-under-Hospital-OPPS.pdf

ALL FACILITIESREQUIRED TO REPORT340B MODIFIERSIN 2024

The FAQ document provides a table summarizing the requirement for affected provider types:

The modifier requirement does not apply to all drugs purchased under 340(B), although hospitals may opt to report the modifier for all 340B drugs. The obligation to append a modifier applies to only Part B drugs and biologicals assigned OPPSStatus Indicator G or K(?separately payable?under OPPS.)

PARA Dat a Edit or users may identify the line items within the hospital charge master which are separately payable drugs by navigating to the ?Filters?tab, clicking the checkbox next to ?Status Indicator?, and clicking on both status G and status K, as illustrated below:

PARA invit es you t o check out t he m lnconnect s page available from t he Cent ers For Medicare and Medicaid (CMS). It 's chock full of new s and inform at ion, t raining opport unit ies, event s and m ore! Each w eek PARA w ill bring you t he lat est new s and links t o available resources. Click each link for t he PDF!

Thursday, March 9, 2023

New s

- Nutrition-Related Health Conditions: Recommend Medicare Preventive Services

Com pliance

- Advance Care Planning: Bill Correctly for Services

Claim s, Pricers, & Codes

- Medicare Physician Fee Schedule Database: April Update

- Home Health Prospective Payment System Grouper: April Update

Event s

- Ambulance Open Door Forum: Medicare Ground Ambulance Data Collection System ? March 16

MLN Mat t ers®Art icles

- Extension of Changes to the Low-Volume Hospital Payment Adjustment & the Medicare Dependent Hospital Program

- National Coverage Determination: Cochlear Implantation

- Patient Driven Payment Model: Claim Edit Enhancements ? Revised

Publicat ions

- Medicare Part B Inflation Rebate Guidance: Use of the 340B Modifier ? Revised

t r ans mit t al s

Therew ereSEVEN new or revised Transmittalsreleased thisw eek.

To go to thefull Transmittal document simply click on thescreen shot or thelink.

TRANSMITTAL R11900CP

TRANSMITTAL R11894OTN

TRANSMITTAL R11897CP

TRANSMITTAL R11897CP

TRANSMITTAL R11899OTN

TRANSMITTAL R11892NCD

TRANSMITTAL R11891PI

edl ear ns

Therew ereNOnew or revised MedLearnsreleased thisw eek.

To go to thefull Transmittal document simply click on thescreen shot or thelink.

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