ParaRev Weekly eJournal, March 29, 2023

Quest ion: We recent ly learned t hat for t he past t hree m ont hs one of our providers has been offering ordered a ket am ine infusion t o t reat severe depression. Should w e bill for t his as a covered service? I am concerned because several claim s for t his t reat m ent have been paid by t he insurer and/ or Medicare

Answ er: You are correct to be concerned about billing Medicare for ketamine infusions for the purpose of treating depression The use of ketamine infusions to treat depression is considered ?off-label?. Here?s what the FDA says about it:

https://www fda gov/drugs/human-drug-compounding/fda-alerts-health-careprofessionals-potential-risks-associated-compounded-ketamine-nasal-spray

? Ketamine is not FDA-approved for the treatment of any psychiatric disorder However, the ?S?form of ketamine, which is derived from ketamine and known as Spravato (esketamine), is a Schedule III controlled substance that was approved by FDA in 2019 as a nasal spray for treatment-resistant depression in adults and depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior, in conjunction with an oral antidepressant.

The Medicare Benefits Policy Manual says that the decision to cover an off-label use of a drug must come from the MAC? in your region, would be Noridian:

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf#

50 4 2 - Unlabeled Use of Drug (Rev. 1, 10-01-03)

B3-2049.3

An unlabeled use of a drug is a use that is not included as an indication on the drug?s label as approved by the FDA FDA approved drugs used for indications other than what is indicated on the official label may be covered under Medicare if the A/B MAC(B) determines the use to be medically accepted, taking into consideration the major drug compendia, authoritative medical literature and/or accepted standards of medical practice

In the case of drugs used in an anti-cancer chemotherapeutic regimen, unlabeled uses are covered for a medically accepted indication as defined in §50.5.

Thesedecisionsare madebythe MACon a case-by-casebasis.

Some MACs provide guidance in the form of an Local Coverage Determination (LCD) for ?off-label?use of a drug, but we found no LCD on that topic from the MACin Jurisdiction F, Noridian. Another MAC, First Coast Options (Florida) established an LCD with the following instruction to providers, which seems to dovetail with the requirements of the Benefits Manual quoted above:

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=33915&ver=17 ?

In the absence of a NCD, LCD or coverage article from the contractor, coverage for an off-label indication must be requested in writing and must include data or documentation to support the request of coverage. Supporting documentation should include, but is not limited to the following (also refer to the documentation requirements section of this LCD):

- Published recommendations from specialty societies or other authoritative evidence-based guidelines

- At least one of the Centers for Medicare & Medicaid Services (CMS) approved compendium

- Phase ll or phase llI trials that have been published in national or international peer reviewed journals The trials should be from different centers, and should not include publications from the pharmaceutical manufacturing companies

BILLINGFOROFF-LABEL DRUGTHERAPY

If the contractor determines that the evidence, as supported by the criteria listed above, is supported, then off-label coverage will be outlined in an LCD or article ?

Consequently, we agree that claims for this treatment were billed incorrectly, and the payment from Medicare should be returned. Since Noridian (nor any other MACin the US) has not approved the off-label use of Ketamine to treat any mental health condition, it is non-covered

We are not surprised that the claims for this treatment were paid by Medicare. There is no HCPCSfor ketamine Consequently, the hospital?s claim may have reported an IVadministration code, such as 96365, and an unidentified drug listed under revenue code 0250 and/or some IV fluids like normal saline. There would be no way for Medicare to determine that the infusion therapy provided used ketamine for an off-label indication.

If the problem claims were submitted only within the last few months, perhaps the claims are available in DDEfor adjustment. The billers might be able to adjust the claim online by moving all the charges to the non-covered column (both for the drug and the administration of the drug) and appending modifier GZ to the HCPCS(non-covered, no ABN = Provider write off ) Another MAC, NGS, offers a slide deck that explains how to adjust or cancel a claim at the following link:

https://www.ngsmedicare.com/documents/20124/121705/2364 0921 using fiss dde to adjust or cancel medicare 508 pdf/8745c2bb-2cd5-c482-5476-39c296f3c883?t= 1632163309367

In addition, we found an article published by the Journal of the American Academy of Psychiatry and the Law which recommends that the patient is offered a disclosure document explaining that the treatment they will receive is off label That article is available here:

https://jaapl.org/content/early/2020/11/24/JAAPL.200049-20

Summing this information up, here are our recommendations:

- Adjust or cancel the claims submitted to Medicare or any other payor for infusions of Ketamine that were off-label use of that drug

- Consider submitting a request to the organization?s risk manager and/or medical staff to review the practice of offering ketamine infusions for off-label use

- If the organization decides to continue offering off-label ketamine infusions, provide the patient with an Advance Beneficiary Notice explaining that the cost will become the patient?s financial liability, and provide any patient receiving an off-label drug with an ?informed consent?notice prior to treatment.

Theprecedingmaterialsare for instructional purposesonly Theinformation ispresented "as-is"and to thebest of CorroHealth'sknowledgeisaccurateat the timeof distribution. However, dueto the ever-changinglegal/regulatory landscape, thisinformation issubject to modification asstatutes, laws, regulations, and/or other updatesbecome available. Nothingherein constitutes, isintended to constitute, or should berelied on aslegal advice. CorroHealth expressly disclaimsanyresponsibilityfor anydirect or consequential damagesrelated in anywayto anythingcontained in the materials, which are provided on an "as-is"basisand should beindependentlyverified beforebeingapplied. You expressly accept and agreeto thisabsoluteand unqualified disclaimer of liability Theinformation in thisdocument isconfidential and proprietaryto CorroHealth and isintended onlyfor thenamed recipient. No part of thisdocument maybereproduced or distributed without expresspermission. Permission to reproduceor transmit in anyform or byanymeanselectronicor mechanical, includingpresenting, photocopying, recordingand broadcasting, or byanyinformation storageand retrieval system must beobtained in writingfrom CorroHealth. Request for permission should bedirected to Info@Corrohealth.com

CPT® isa registered trademarkof theAmerican Medical Association

MEDICARECODINGFORESKETAMINETREATMENT

In 2020, Medicare began covering the use of esketamine, a nasal spray, for treatment-resistant depression (TRD.) Although patient self-administers the nasal spray, the patient must be supervised for several hours post-administration in a monitored healthcare setting, as some patients experience significant adverse reactions. Medicare created two HCPCScodes, G2082 or G2083, to enable physicians and hospital outpatient clinics to report the cost of the drug and the subsequent monitoring of the patient:

G2082 - OFFICEOROTHEROUTPATIENT VISITFORTHEEVALUATION AND MANAGEMENTOF AN ESTABLISHED PATIENT THAT REQUIRESTHESUPERVISION OFA PHYSICIAN OROTHER QUALIFIED HEALTH CAREPROFESSIONAL AND PROVISION OFUPTO 56 MG OFESKETAMINE NASAL SELF-ADMINISTRATION, INCLUDES2 HOURSPOST-ADMINISTRATION OBSERVATION G2083 ? OFFICEOROTHEROUTPATIENT VISIT FORTHEEVALUATION AND MANAGEMENT OF AN ESTABLISHED PATIENT THAT REQUIRESTHESUPERVISION OFA PHYSICIAN OROTHER QUALIFIED HEALTH CAREPROFESSIONAL AND PROVISION OFGREATERTHAN 56 MG ESKETAMINENASAL SELF-ADMINISTRATION, INCLUDES2 HOURSPOST-ADMINISTRATION OBSERVATION Medicare reimbursement rates for 2023 are available in the PARA Dat a Edit or Calculat or t ab:

The cost of the esketamine nasal spray is the main consideration in Medicare payment levels. When the service is provided to a Medicare beneficiary in the outpatient facility setting, both the physician or qualified non-physician practitioner should report either G0282 or G0283 Pricing the service should take into consideration the cost of the drug, which is not separately reported because the G-codes includes the drug, with two dosage options available

MEDICARECODINGFORESKETAMINETREATMENT

Janssen Neuroscience, the manufacturer of Spravato, offers a coding guide at https://www.spravatohcp.com/sites/www.spravatohcp-v1.com/files/cp133468v3 spravato coding overview brochure digital version pdf?v=14875

The 2020 Medicare Physician Fee Schedule Final Rule discusses the added Medicare coverage for the treatment and the new codes; an excerpt is provided on the following pages.

https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-24086.pdf

V Int erim Final Rule w it h Com m ent Period [CMS-1715-IFC]

A. Coding and Paym ent for Evaluat ion and Managem ent , Observat ion and Provision of Self-Adm inist ered Esket am ine (HCPCS codes G2082 and G2083)

On March 5, 2009, the U.S. Food and Drug Administration (FDA) approved Spravato? (esketamine) nasal spray, used in conjunction with an oral antidepressant, for treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression (TRD)) Because of the risk of serious adverse outcomes resulting from sedation and dissociation caused by Spravato administration, and the potential for abuse and misuse of the product, it is only available through a restricted distribution system under a Risk Evaluation and Mitigation Strategy (REMS) A REMSis a drug safety program that the FDA can require for certain medications with serious safety concerns to help ensure the benefit of the medication outweigh its risks

Patients with major depression disorder who, despite trying at least two antidepressant treatments given at adequate doses for an adequate duration in the current episode, have not responded to treatment are considered to have TRD. TRD is especially relevant for Medicare beneficiaries.

MEDICARECODINGFORESKETAMINETREATMENT

Depression in the elderly is associated with suicide more than at any other age; adults 65 or older constitute 16 percent of all suicide deaths. The decrease in average life expectancy for those with depressive illness, including Medicare beneficiaries, is 7 to 11 years. Depression is a major predictor of the onset of stroke, diabetes, and heart disease; it raises patients?risk of developing coronary heart disease and the risk of dying from a heart attack nearly threefold

There has also been a longstanding need for additional effective treatment for TRD, a serious and life-threatening condition A treatment session of esketamine consists of instructed nasal self-administration by the patient, followed by a period of post-administration observation of the patient under direct supervision of a health care professional

Esketamine is a non-competitive N-methyl Daspartate (NMDA) receptor antagonist It is a nasal spray supplied as an aqueous solution of esketamine hydrochloride in a vial with a nasal spray device. This is the first FDA approval of esketamine for any use. Each device delivers two sprays containing a total of 28 mg of esketamine.

Patients would require either two (2) devices (for a 56mg dose) or three (3) devices (for an 84 mg dose) per treatment. After reviewing the Spravato Prescribing Information, Medication Guide, and REMSrequirements, we have concluded that effective and appropriate treatment of TRD with esketamine requires discrete services of a medical professional, meaning those that may furnish and report E/M services under the PFS, both during an overall course of treatment and at the time the drug is administered

Because of the risk of serious adverse outcomes resulting from sedation and dissociation caused by Spravato administration, and the potential for abuse and misuse of the product: the product is only available through a restricted distribution system under a REMS; patients must be monitored by a health care provider for at least 2 hours after receiving their Spravato dose; the prescriber and patient must both sign a Patient Enrollment Form; and the product will only be administered in a certified medical office where the health care provider can monitor the patient

Further information regarding certification of medical offices is available at www SPRAVATOrems com or 1-855-382-6022

Because this newly available treatment regimen addresses a particular and urgent need for people with TRD, including Medicare beneficiaries, we recognize that it is in the public interest to ensure appropriate patients have access to this potentially life-saving treatment. We recognize, however, that the services and resources involved in furnishing this treatment are not adequately reflected in existing coding and payment under the PFS, or otherwise under Medicare Part B

Given the FDA approval conditions/requirements including that the drug is only available as an integral component of a physicians?service, the absence of existing HCPCScoding that would adequately describe the service with the provision of the product, and our understanding based on review of the Spravato Prescribing Information, Medication Guide, and REMSrequirements, we do not believe the Medicare beneficiaries in the greatest medical need of this treatment would be likely to have access to it until such time that Medicare coding and payment are updated

Medicare coding and payment policies are generally adopted through annual updates to the PFS Unless we adopt coding and payment changes for this treatment beginning January 1, 2020, we believe that the next practicable alternative would be either standalone rulemaking or PFS rulemaking for 2021. Both of these alternatives would risk the lives of Medicare beneficiaries with TRD for several months to over a year.

Therefore, to facilitate prompt beneficiary access to the new, potentially life-saving treatment for TRD using esketamine, we are creating two new HCPCSG codes, G2082 and G2083, effective January 1, 2020 on an interim final basis For CY2020, we are establishing RVUs for these services that reflect the relative resource costs associated with the evaluation and management (E/M), observation and provision of the self-administered esketamine product using HCPCSG codes.

We note that we have historically established coding and payment on an interim final basis for truly new services when it is in the public interest to do so. Like most other truly new services, we expect diffusion of this kind of treatment into the market will take place over several years, even though we expect some people to benefit immediately

Consequently, the expected impact on other PFSservices is negligible for 2020, and we will consider the public comments we receive on this interim final policy as we consider finalizing coding or payment rules for this treatment beginning in 2021 The HCPCSG-codes are described as follows:

MEDICARECODINGFORESKETAMINETREATMENT

- HCPCScode G2082: Office or other outpatient visit for the evaluation and management of an established patient that requires the supervision of a physician or other qualified health care professional and provision of up to 56 mg of esketamine nasal self-administration, includes 2 hours post-administration observation

- HCPCScode G2083: Office or other outpatient visit for the evaluation and management of an established patient that requires the supervision of a physician or other qualified health care professional and provision of greater than 56 mg esketamine nasal self-administration, includes 2 hours post-administration observation.

In developing the interim final values for these codes, we used a building block methodology that sums the values associated with several codes. For the overall E/M and observation elements of the services, we are incorporating the work RVUs, work time and direct PEinputs associated with a level two office/outpatient visit for an established patient, CPT® code 99212 (Office or other outpatient visit for the evaluation and management of an established patient, which requires at least 2 of these 3 key components: A problem focused history; A problem focused examination; Straightforward medical decision making

Counseling and/or coordination of care with other physicians, other qualified healthcare professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs Usually, the presenting problem(s) are self limited or minor

Typically, 10 minutes are spent face-to-face with the patient and/or family), which has a work RVU of 0 48 and a total work time of 16 minutes, which is based on a pre-service evaluation time of 2 minutes, an intraservice time of 10 minutes, and a post service time of 4 minutes

We are also incorporating CPT® codes 99415 (Prolonged clinical staff service (the service beyond the typical service time) during an evaluation and management service in the office or outpatient setting, direct patient contact with physician supervision; first hour (List separately in addition to code for outpatient Evaluation and Management service)) and 99416 (Prolonged clinical staff service (the service beyond the typical service time) during an evaluation and management service in the office or outpatient setting, direct patient contact with physician supervision; each additional 30 minutes (List separately in addition to code for prolonged service)) in which neither code has a work RVU, but includes direct PEinputs reflecting the prolonged time for clinical staff under the direct supervision of the billing practitioner.

Additionally, to account for the cost of the provision of the self-administered esketamine as a direct PEinput, we are incorporating the wholesale acquisition cost (WAC) data from the most recent available quarter. For HCPCScode G2082, we are using a price of $590.02 for the supply input that describes 56 mg (supply code SH109) and for HCPCScode G2083, we are using a price of $885 02 for the supply input describing 84 mg of esketamine (supply code SH110)

MEDICARECODINGFORESKETAMINETREATMENT

We note that we are valuing these two HCPCScodes, in part, on the basis of a level 2 established patient office/outpatient E/M visit; consequently, for purposes of relevant Medicare conditions of payment, reporting these codes is similar to reporting a level 2 office/outpatient E/M visit code.

In addition to seeking comment on the interim final values we are establishing for HCPCScodes G2082 and G2083, we also seek comment on the assigned work RVUs, work times, and direct PE inputs. Under circumstances where the health care professional supervising the self administration and observation does not also provide the esketamine product, the provider cannot report HCPCScodes G2082 or G2083 Rather, the visit and the extended observation (by either the billing professional or clinical staff) could be reported using the existing E/M codes that describe the visit and the prolonged service of the professional or the clinical staff. CMSwill monitor claims data to safeguard against duplicative billing for these services and items.

Historically, supply input prices are updated on a code by code basis and periodically through annual notice and comment rulemaking. The prices, including for a variety of pharmaceutical products, are not routinely updated like Part B drugs paid under the ASP methodologies.

For the supply inputs for the esketamine product, used in developing rates for HCPCScodes G2082 and G2083, we are using the most recent available quarter of WACdata for 2020 pricing, but we anticipate using either data that is reported for determining payments under section 1847A of the Act (such as ASP) or compendia pricing information (such as WAC) in future years and expect to address this issue in further rulemaking.

We seek comments on how to best establish input prices for the esketamine product, as well as other potential selfadministered drugs that necessitate concurrent medical services, under PFS ratesetting in future years.

On March 9, 2023, the U S Food and Drug Administration issued revised regulations for mammography. Effective September 10, 2024, mammography centers must inform patients about their breast density. The FDA has also enhanced its supervision and enforcement of these facilities and is assisting radiologists in accurately evaluating and categorizing mammograms. https://public-inspection.federalregister.gov/2023-04550.pdf

These regulations were issued under the Mammography Quality Standards Act (MQSA) of 1992 The MQSA oversees accreditation, certification, annual inspections, and enforcement of standards for mammography facilities

Dense breast tissue lowers the sensitivity of mammography studies Notifying patients of their breast density will offer additional information regarding the potential limitations of their mammogram results It will also allow patients and their healthcare providers to make informed decisions about ordering additional tests and discuss their individual risk for breast cancer.

The MQSA Final Rule outlines the specific requirements for reporting breast density and the standardized language which should be used The above amendments to MQSA must be implemented within 18 months (by September 10, 2024). According to the FDA, these new regulations will improve the examination of mammography practices and the exchange of information with patients and providers

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 23, 2023

New s

- Additional Residency Positions: Apply by March 31

- Laboratory Testing Urinalysis: Comparative Billing Report in March

- Long-Term Care Hospital Provider Preview Reports: Review by April 14

- Inpatient Rehabilitation Facility Provider Preview Reports: Review by April

14

- Promote Kidney Health During National Kidney Month

Com pliance

- Critical Access Hospitals: Bill Correctly

Claim s, Pricers, & Codes

- Integrated Outpatient Code Editor: Version 24.1

Event s

- Medicare Home Health Prospective Payment System CY2023 Webinar ?

March 29

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 R11928OTN

TRANSMITTAL R11929NCD

TRANSMITTAL R119240I

TRANSMITTAL R4P247I

TRANSMITTAL R11927CP

TRANSMITTAL R11920CP

TRANSMITTAL R11919CP

1 m edl ear ns

Therew asONEnew or revised MedLearnsreleased thisw eek.

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

Theprecedingmaterialsare for instructional purposesonly. Theinformation ispresented "as-is"and to the best of ParaRev?s knowledgeisaccurate at thetime of distribution. However, dueto theever changing legal/regulatorylandscapethisinformation issubject to modification, asstatutes/laws/regulationsor other updatesbecomeavailable.

Nothingherein constitutes, isintended to constitute, or should berelied on as, legal advice ParaRev expressly disclaimsanyresponsibilityfor anydirect or consequential damagesrelated in anywayto anythingcontained in thematerials, which areprovided on an ?as-is?basisand should beindependentlyverified beforebeing applied.

You expresslyaccept and agree to thisabsoluteand unqualified disclaimer of liability.Theinformation in this document isconfidential and proprietaryto ParaRev and isintended onlyfor thenamed recipient. No part of thisdocument maybereproduced or distributed without expresspermission. Permission to reproduce or transmit in anyform or byanymeanselectronicor mechanical, includingpresenting, photocopying, recording and broadcasting, or byanyinformation storageand retrieval system must be obtained in writingfrom ParaRev. Request for permission should be directed to sales@pararevenue.com.

ParaRev is excited to announce we have joined industry leader CorroHealt h to enhance the reach of our offerings! ParaRev services lines are additive in nature strengthening CorroHealt h?s impact to clients?revenue cycle. In addition, you now have access to a robust set of mid-cycle tools and solutions from CorroHealt h that complement ParaRev offerings

In terms of the impact you?ll see, there will be no change to the management or services we provide The shared passion, philosophy and cultures of our organizations makes this exciting news for our team and you, our clients

While you can review the CorroHealt h site HERE, we can coordinate a deeper dive into any of these solutions Simply let us know and we?ll set up a meeting to connect.

As always, we are available to answer any questions you may have regarding this news We thank you for your continued partnership