PARA HealthCare Analytics Weekly eJournal December 15, 2021 by CorroHealth

ej o u r n a l december 15, 2021

Stereotactic Radiosurgery Treatment Of Cerebral Lesions

Balance Billing Emergency Services And The No Surprises Act

Evusheld FDA Authorizes Monoclonal EUA

PARA Weekly eJournal: December 15, 2021

LIABILITY CLAIMS

After reading the CMS guidelines, we a clearer understanding of what we are required to

with liability claims. Are we required to file Medicare claims when it is a liability claim and an attorney is involved? It sounds like they just want us to file the claim so they would only be responsible for the Medicare rate. Can you clarify?

. Attached is a helpful MLN Article which speaks to your question ? it was published in 2017

at the following link: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/ MLNMattersArticles/Downloads/SE17018.pdf

There are a number of FAQs that address more of your question.

PARA Weekly eJournal: December 15, 2021

HCPCS FOR IMPLANTABLE LOOP RECORDERS

We are trying to find the appropriate HCPCS code for a loop recorder. This is the actual

device (implant), and not the monitoring. Can you assist in helping us use the correct code?

Yes. The HCPCS for an implantable cardiac loop recorder is C1764.

HCPCS C1764 is built in the facility?s CDM with a description that leads to a Medtronic device.

PARA Weekly eJournal: December 15, 2021

HCPCS FOR IMPLANTABLE LOOP RECORDERS

Medtronic has a reimbursement guide that gives guidance on billing and coding for the loop recorder that the facility may find useful if the Medtronic device is still being used. If not, most manufacturers have a similar reimbursement guide. Reimbursement Guide: LINQ Family of ICMS (medtronic.com)

PARA Weekly eJournal: December 15, 2021

HCPCS FOR IMPLANTABLE LOOP RECORDERS

In reference to your question about submitting questions to PARA. We encourage the use of the ?Post A Question? feature in the PDE so questions can be routed to the appropriate PARA specialist to be tracked and responded to in a timely manner. The ?Post a Question? radio button is located on the PDE ?Select? tab.

Exam ple

PARA Weekly eJournal: December 15, 2021

SRS 77372

Does a neurosurgeon have to be involved in order to bill

the code 77372? ASTRO's coverage policy for SRS states documentation requirements state, "A radiation oncologist and a neurosurgeon must evaluate the clinical aspects of the treatment, and document and sign this evaluation, as well as the resulting management decisions." Please provide some guidance as our radiation oncologists says a neurosurgeon does not have to be involved.

. It is possible that ASTRO is simply setting out best practice for the team of physicians involved in this highly technical procedure. According to the 2021 CPT® manual: ?Cranial stereotactic radiosurgery is a distinct procedure that utilizes externally generated ionizing radiation to inactivate or eradicate defined target)(s) in the head without the need to make an incision. The target is defined by and the treatment is delivered using high-resolution stereotactic imaging. Stereotactic radiosurgery codes and headframe application procedures are reported by the neurosurgeon.The radiation oncologist reports the appropriate code(s) for clinical treatment planning, physics and dosimetry, treatment delivery, and management from the Radiation Oncology section (77261-77790). Any necessary planning, dosimetry, targeting, positioning, or blocking by the neurosurgeon is included in the stereotactic radiation surgery services. The same individual should not report stereotactic radiosurgery services with radiation treatment management codes (77427-77435). ? ? While both physicians should work in concert for the optimal outcome of the procedure, we find no restrictions in the CPT® code book or in the AMA publication ?CPT® Assistant? which requires evidence of a second physician?s review as a precondition to billing and reimbursement. 6

PARA Weekly eJournal: December 15, 2021

SRS 77372

CPT® Assistant offers information in its October, 2007 edition ? but you may want to read the highlighted paragraph more than once:

St er eot act ic Radiosu r ger y Codes 77371 and 77372 report stereotactic radiosurgery (SRS) delivery for the treatment of cerebral lesions. SRS is a technique for delivering a dose of radiation to a specific target while delivering a minimal dose to surrounding tissues. Stereotactic treatment depends on the accurate and reproducible spatial correlation of the target and the radiation source using three-dimensional (3D) computed tomography (CT) and/or magnetic resonance (MR) simulation. Initially, stereotactic radiation therapy was used only to treat intracranial lesions and is referred to as SRS for this application. However, more recent technological advances have allowed this technique to be applied to the spine and other anatomical sites; in such cases, it is referred to as stereotactic body radiation therapy (SBRT). SRS is given in a single fraction, in which case it can deliver a very high single dose of radiation to a small volume with a minimal dose to surrounding tissue. Stereotactic techniques, however, can also be used with hypofractionation (two to five fractions), also called SBRT, and conventional fractionation. It is important to note that stereotactic treatment to intracranial lesions using two to five fractions is considered SBRT. Any treatment using greater than five fractions is not considered SBRT. For cranial lesions, a team consisting of the radiation oncologist, neurosurgeon, and medical physicist is responsible for supervising the patient positioning and proper alignment of treatment beams involved in SRS. The radiation oncologist is responsible for all radiation clinical planning and physics planning aspects of the treatment process, positioning the patient for the procedure, and properly aligning the treatment beams. This treatment is delivered by either a linear accelerator or a multi-source Cobalt-60 unit. In all cases of SRS, extreme precision of patient and beam positioning is essential for accurate treatment delivery. This is achieved through rigid immobilization, such as with a headframe or frameless image-based immobilization and localization. Alignment of the patient and correlation with a computer-generated treatment plan are analyzed to ensure proper delivery of the radiation beams. The lesion is targeted prior to the procedure through an identification and marking process involving both the radiation oncologist and neurosurgeon. 7

PARA Weekly eJournal: December 15, 2021

SRS 77372 Here is an excerpt from ASTRO?s website: https://www.astro.org/Daily-Practice/Reimbursement/PracticeManagement-Resources/Basics-of-Coding

PARA Weekly eJournal: December 15, 2021

TUESDAY WEBINARS: COMPLYING WITH THE NO SURPRISES ACT

t ime is r unning out .

PARA exper t s ar e pr ovidin g a f r ee w ebin ar each Tu esday design ed t o h elp h ospit als u n der st an d an d com ply w it h t h e r equ ir em en t s u n der t h e No Su r pr ises Act .

Ever y Tu esday 11:30 am PST

To Sign Up Con t act You r Accou n t Execu t ive Or Bar bar a Joh n son at bar bjoh n son @par a-h cf s.com

PARA Weekly eJournal: December 15, 2021

2022 CODING UPDATE: NEW MODIFIERS FOR PROFESSIONAL FEES

Ef f ect iv eJanuar y 1, 2022, Medicar ehas r ef ined cer t ain pr of essional f eecov er ageand bil l ing r ul es, incl uding new modif ier s. Th e n ew m odif ier s ar e:

Transmittal 11146 summarizes the policies of the 2022 Medicare Physician Fee Schedule; Medicare provides the following information regarding the policy changes which pertain to the new modifiers: https://www.cms.gov/files/document/r11146cp.pdf Split (or sh ar ed) Evalu at ion an d M an agem en t (E/ M ) visit s ?For CY 2022, we are refining our longstanding policies for split (or shared) E/M visits by establishing the following: - Definition of split (or shared) E/M visits as evaluation and management (E/M) visits provided in the facility setting by a physician and an NPP in the same group - By 2023, the practitioner who provides the substantive portion of the visit (more than half of the total time spent) will bill for the visit. For 2022, the substantive portion can be history, physical exam, medical decision-making, or more than half of the total time (except for critical care, which must be more than half of the total time) - Split (or shared) visits can be reported for new as well as established patients, and initial and subsequent visits, as well as prolonged services. - Requiring reporting of a new modifier on the claim to identify these services, to inform policy and help ensure program integrity - Documentation in the medical record must identify the two individuals who performed the visit. The individual providing the substantive portion must sign and date the medical record. Codifying these revised policies in new regulations at 42 CFR 415.140 10

PARA Weekly eJournal: December 15, 2021

2022 CODING UPDATE: NEW MODIFIERS FOR PROFESSIONAL FEES

Cr it ical Car e Ser vices For CY 2022, we are refining and clarifying our longstanding policies by establishing the following: - Critical care services are defined in the Current Procedural Terminology (CPT®) Codebook prefatory language for the code set - The CPT® listing of bundled services are not separately payable - When medically necessary, critical care services can be furnished concurrently to the same patient on the same day by more than one practitioner representing more than one specialty, and critical care services can be furnished as split (or shared) visits - Critical care may be paid on the same day as other E/M visits by the same practitioner or another practitioner in the same group of the same specialty, if the practitioner documents that the E/M visit was provided prior to the critical care service at a time when the patient did not require critical care, the visit was medically necessary, and the services are separate and distinct, with no duplicative elements from the critical care service provided later in the day. Practitioners must report modifier - 25 on the claim when reporting these critical care services - Critical care services may be separately paid in addition to a procedure with a global surgical period if the critical care is unrelated to the surgical procedure. Preoperative and/or postoperative critical care may be paid in addition to the procedure if the patient is critically ill (meets the definition of critical care) and requires the full attention of the physician, and the critical care is unrelated to the specific anatomic injury or general surgical procedure performed (e.g., trauma, burn cases). We are creating a new modifier that we will require on such claims to identify that the critical care is unrelated to the procedure. If care is fully transferred from the surgeon to an intensivist (and the critical care is unrelated), the appropriate modifiers must also be reported to indicate the transfer of care. Medical record documentation must support the claims. 11

PARA Weekly eJournal: December 15, 2021

COVID-19 VACCINE PRODUCT & ADMINISTRATION CODES In Special Edition 2021 CPT® Assistant Guides in September and October, the AMA CPT® Editorial Panel announced additional COVID-19 vaccine product and administration codes, including codes for the pediatric dose of Pfizer.Some codes assigned will become effective upon receiving FDA approval. The COVID-19 coding updates are provided on the following pages. (New codes are in red font).

Ref or m u lat ed Pf izer Vaccin e For Pediat r ic Use*

*For patients ages 5 through 11- requires reconstitution using a diluent to administer the appropriate dosage.The second dose should be administered at least 21 days following the first dose.

PARA Weekly eJournal: December 15, 2021

COVID-19 VACCINE PRODUCT & ADMINISTRATION CODES

Pf izer COVID-19 Vaccin e (or igin al ph osph at e bu f f er ) An d Adm in ist r at ion Codes

PARA Weekly eJournal: December 15, 2021

COVID-19 VACCINE PRODUCT & ADMINISTRATION CODES

Pf izer COVID-19 Tr is-su cr ose Bu f f er (Ready-To-Use) Vaccin e An d Adm in ist r at ion Codes

PARA Weekly eJournal: December 15, 2021

COVID-19 VACCINE PRODUCT & ADMINISTRATION CODES

M oder n a Vaccin es

PARA Weekly eJournal: December 15, 2021

COVID-19 VACCINE PRODUCT & ADMINISTRATION CODES

Joh n son & Joh n son (Jan ssen ) Vaccin es

The AMA website publishing these codes is available at: https://www.ama-assn.org/practice-management/cpt/covid-19-cpt-vaccine-and-immunization-codes

PARA Weekly eJournal: December 15, 2021

OIG WORKPLAN: METHOD II CAH PRO FEE DOUBLE-BILLING

The HHS Office of the Inspector General will issue a report in 2022 examining whether professional fees

billed on a facility claim by a Method II Critical Access Hospital may have also been separately submitted for reimbursement on a CMS 1500/837i claim, resulting in double-payment. A link and a summary of the audit is provided below: https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000574.asp

?Under Section 1834(g)(1) of the Social Security Act and Federal regulations (42 CFR §§ 410.152(k) and 413.70(b)), Critical Access Hospitals (CAHs) are paid under the Standard Payment Method unless they elect to be paid under the Optional (Elective) Payment Method. Under Section 1834(g)(2) of the Social Security Act and Federal regulation (42 CFR § 413.70(b)(3)(i)), a CAH may elect the Optional (Elective) Payment Method, under which it bills the Part B Medicare Administrative Contractor (MAC) for both Medicare Part B facility services and Medicare Part B professional services for its outpatients. If a physician or other practitioner reassigns his or her Medicare Part B billing rights pursuant to 42 CFR part 424, subpart F, and agrees to be included under a CAH's Optional (Elective) Payment Method, he or she must not bill the MAC for any outpatient professional services furnished at the CAH once the reassignment becomes effective. The CAH must forward a copy of the completed assignment form (Form CMS 855R) to the MAC and keep the original form on file. Each practitioner must sign an attestation that clearly states that he or she will not bill Medicare Part B for any services furnished in the CAH outpatient department once the reassignment has been given to the CAH (Medicare Claims Processing Manual, Chapter 4, Section 250.2). We will determine whether CAHs forwarded a completed Form CMS 855R to the MAC. We will determine whether both the CAH and physician billed and were paid by the MAC for the same outpatient professional services. We will determine whether the beneficiary paid coinsurance amounts to both the CAH and physician or other practitioner. We will also determine whether CMS has an edit in place to ensure that duplicate payments for beneficiary outpatient professional services are not made.?

PARA Weekly eJournal: December 15, 2021

CY2022 MEDICARE PREMIUMS AND DEDUCTIBLE UPDATES

CMS has announced t henew updat es f or t he CY2022 pr emiums and deduct ibl es f or Par t Aand Par t Bf ee f or ser v icepr ov ider s. M edicar e Par t B covers physician services, outpatient hospital services, certain home health services, durable medical equipment, and certain other medical and health services not covered under Part A. The standard monthly pr em iu m for Medicare Part B enrollees will be $170.10 for CY 2022. This is a slight increase over CY2021, which was $148.50. The annual dedu ct ible for Part B enrollees for CY2022 is $233.00. As with the increase in premiums, this is also a slight increase over CY2021, which was $203.00. M edicar e Par t A covers inpatient hospital, skilled nursing facility, and some home health care services. Currently, CMS records show about 99% (percent) of Medicare beneficiaries do not have a Part A premium since they have at least 40 quarters of Medicare-covered employment. For CY2022, the Medicare Part A inpatient dedu ct ible is $1,556.00. This is an increase of $72.00 from the CY2021 deductible amount of $1,484.00. CY2022 Co-in su r an ce r at es: - $389.00 ? 61st? 90thday - $778.00 ? 91st? 150thday for Lifetime reserve days - $194.50 ? 21st? 100thday for SNF days Medicare Advantage Premiums: In CY2022 Medicare Advantage premiums will be lower at $19.00 per month, compared to $21.22 in CY2021. Article reference: https://www.cms.gov/newsroom/fact-sheets/2022-medicare-parts-b-premiums-anddeductibles2022-medicare-part-d-income-related-monthly-adjustment

PARA Weekly eJournal: December 15, 2021

2022 REQUIREMENTS FOR NO SURPRISES ACT

The No Sur pr ises Act (NSA) is a f eder al l aw which goes int o ef f ect on Januar y 1, 2022. The law bans surprise medical bills for emergency services and elective care when the patient does not have a choice of ancillary service providers. The Department of Health and Human Services (HHS) has realized that not all aspects of the NSA will be able to be implemented by providers and facilities by January 1, 2022, so they have elected to exercise ?enforcement discretion? on portions of the act in 2022. To be in compliance in 2022, health care providers and health care facilities must be prepared to: - Publicize and disseminate a ?Disclosure Notice? which informs patients of their rights under the No Surprises Act; and - Publicize and disseminate a ?Right to Receive a Good Faith Estimate? to uninsured or self-pay patients; and - Provide, upon request, uninsured or self-pay patients with a good faith estimate (within a $400 threshold) of services that will be billed by the ?convening? provider or facility Disclosu r e Not ice By January 1, 2022, the disclosure notice must be prominently displayed on websites, in public areas of an office or facility, and on a one-page (double-sided) notice provided in-person or through mail or e-mail, as chosen by the patient. The disclosure notice must be provided to all commercially insured patients after January 1, 2022, or before that date if the elective service will be provided after January 1, 2022. The notice must be provided before requesting a payment from the insured or before a claim is submitted on behalf of the insured.

PARA Weekly eJournal: December 15, 2021

2022 REQUIREMENTS FOR NO SURPRISES ACT

eCFR :: 45 CFR Part 149 -- Surprise Billing and Transparency Requirements

PARA Weekly eJournal: December 15, 2021

2022 REQUIREMENTS FOR NO SURPRISES ACT

In states where there are state laws that protect patients against surprise billing, providers and facilities can use a state disclosure notice if it meets or exceeds the federal guidelines. If a provider or facility drafts their own disclosure notice it must include these three points: -

Restrictions on providers and facilities regarding balance billing in certain circumstances

Any applicable state laws protecting against balance billing

Contact information for appropriate state and federal agencies if the individual believes their rights have been violated

Righ t t o Receive a Good Fait h Est im at e Not ice All uninsured or self-pay individuals must be made aware, both orally and in writing, of their right to receive a good faith estimate for any services that will be rendered beginning January 1, 2022. The form must be prominently displayed on websites, in offices, and where scheduling or questions about the cost of health care may occur.

PARA Weekly eJournal: December 15, 2021

2022 REQUIREMENTS FOR NO SURPRISES ACT

Good Fait h Est im at es t o Un in su r ed/ Self Pay When discussing the good faith estimate it is important to know a few terms. - A h ealt h car e pr ovider (pr ovider ) is defined as a physician or other health care provider who is acting within the scope of practice of that provider ?s license or certification under applicable State law - A h ealt h car e f acilit y (f acilit y) is defined as a hospital or hospital outpatient department, critical access hospital, ambulatory surgical center, rural health center, federally qualified health center, laboratory, or imaging center that is licensed as an institution pursuant to State laws or is approved by the agency of such State or locality responsible for licensing such institution as meeting the standards established for such licensing - The con ven in g pr ovider or f acilit y is the one who receives the initial request for a good faith estimate from an uninsured or self-pay individual and who is or, in the case of a request, would be responsible for scheduling the primary item or service - A co-pr ovider or co-f acilit y furnishes items or services that are customarily provided in conjunction with the convening provider An uninsured patient is an individual who does not have benefits for an item or service under a group health plan; whereas a self-pay patient is an individual who has benefits under a group health plan but chooses not to have a claim submitted to their plan. The good faith estimate presented to an uninsured or self-pay patient must include services reasonably expected to be provided by the convening provider or facility. At t h is t im e, est im at es f or ser vices pr ovided by co-pr ovider s an d co-f acilit ies do n ot h ave t o be pr ovided by t h e con ven in g pr ovider or f acilit y. The following list is provided in the interim final rule published in the Code of Federal Regulations. CMS followed up with a Fact Sheet that clarifies HHS will not be enforcing the requirement of including services provided by co-providers or co-facilities. A good faith estimate must include: - Patient name and date of birth - Description of the primary item or service - Itemized list of items or services reasonably expected to be furnished - Items or services reasonably expected to be furnished by the convening provider or convening facility for the period of care; and - Items or services reasonably expected to be furnished by co-providers or co-facilities 22

PARA Weekly eJournal: December 15, 2021

2022 REQUIREMENTS FOR NO SURPRISES ACT

- Applicable diagnosis codes, expected service codes, and expected charges associated with each listed item or service - Name, National Provider Identifier, and Tax Identification Number of each provider or facility represented in the good faith estimate, and the State(s) and office or facility location(s) where the items or services are expected to be furnished by such provider or facility - List of items or services that the convening provider or convening facility anticipates will require separate scheduling eCFR :: 45 CFR Part 149 -- Surprise Billing and Transparency Requirements

Requirements Related to Surprise Billing; Part II Interim Final Rule with Comment Period | CMS

PARA can assist with good faith estimates and composing notices. Contact us at 800-999-3332 and ask to speak with an Account Executive for more information. 23

PARA Weekly eJournal: December 15, 2021

NO SURPRISES ACT AND BALANCE BILLING EMERGENCY SERVICES

TheNo Sur pr ises Act (NSA) was written with the intent to protect patients from receiving surprise bills when they seek emergency care, unknowingly receive care from out-of-network providers within an in-network facility, and are emergently transported by an out-of-network air ambulance service. In an emergency, an individual usually gets care at the nearest emergency department and the closest air ambulance service. The first thing to remember is that the Emergency Medical Treatment and Labor Act (EMTALA) takes precedence over the NSA. This paper describes when emergency care ends, and the NSA requirements begin. While providers and medical associations are voicing their disappointment in the NSA arbitration process, they are generally supportive of the NSA in that it protects patients from large balance bills when they don?t have the option to choose an in-network facility or provider. The out-of-network provider and facility may not balance bill an emergency patient until they are stabilized. After stabilization, they must present the patient with a Notice and Consent form which includes a Good Faith Estimate for anticipated services and items. The provider or facility can balance bill for all charges occurring after the patient signs the Notice and Consent form. eCFR :: 45 CFR 149.410 -- Balance billing in cases of emergency services. § 149.410 Balan ce billin g in cases of em er gen cy ser vices. (a)In general.In the case of a participant, beneficiary, or enrollee with benefits under a group health plan or group or individual health insurance coverage offered by a health insurance issuer and who is furnished emergency services (for which benefits are provided under the plan or coverage) with respect to an emergency medical condition with respect to a visit at an emergency department of a hospital or an independent freestanding emergency department (1) A nonparticipating emergency facility must not bill, and must not hold liable, the participant, beneficiary, or enrollee for a payment amount for such emergency services (as defined in 26 CFR 54.9816-4T(c)(2), 29 CFR 2590.716-4(c)(2), and § 149.110(c)(2), as applicable) that exceeds the cost-sharing requirement for such services (as determined in accordance with 26 CFR 54.9816-4T(b)(3)(ii) and (iii),29 CFR 2590.716-4(b)(3)(ii) and (iii), and § 149.110(b)(3)(ii) and (iii), as applicable). (2) A nonparticipating provider must not bill, and must not hold liable, the participant, beneficiary, or enrollee for a payment amount for an emergency service (as defined in26 CFR 54.9816-4T(c)(2),29 CFR 2590.716-4(c)(2), and § 149.110(c)(2), as applicable) furnished to such individual by such provider with respect to such emergency medical condition and visit for which the individual receives emergency services at the hospital or independent freestanding emergency department that exceeds the cost-sharing requirement for such service (as determined in accordance with 26 CFR 54.9816-4T(b)(3)(ii) and (iii), 29 CFR 2590.716-4(b)(3)(ii) and (iii), and § 149.110(b)(3)(ii) and (iii), as applicable). 24

PARA Weekly eJournal: December 15, 2021

NO SURPRISES ACT AND BALANCE BILLING EMERGENCY SERVICES

The Notice and Consent requirement of the NSA does not go into effect until the patient is stabilized to the point they can safely transport in a private vehicle to receive continued care at an in-network facility. Stabilization can continue at an out-of-network facility through an observation or admission period. It is not appropriate to present a Notice and Consent until the patient is stable. Stabilization is determined, and clearly documented, by the emergency or treating physician who must take into consideration the distance a patient would have to travel and the patient?s condition. The patient cannot be balance billed for observation and inpatient services until they consent to receiving out-of-network care after being stabilized. eCFR :: 29 CFR 2590.716-4 -- Preventing surprise medical bills for emergency services. (ii)Inclusion of additional services. (A) Subject to paragraph (c)(2)(ii)(B) of this section, items and services (1) For which benefits are provided or covered under the plan or coverage; and (2) That are furnished by a nonparticipating provider or nonparticipating emergency facility (regardless of the department of the hospital in which such items or services are furnished) after the participant or beneficiary is stabilized and as part of outpatient observation or an inpatient or outpatient stay with respect to the visit in which the services described in paragraph (c)(2)(i) of this section are furnished. (B) Items and services described in paragraph (c)(2)(ii)(A) of this section are not included as emergency services if all of the conditions in 45 CFR 149.410(b) are met. When presenting the Notice and Consent after stabilization: - In-network facility with out-of-network provider: the notice must include any in-network providers available to provide the same service and the patient?s option to request a referral to that in-network provider - Out-of-network facility: the notice must include a good faith estimate with services that are reasonably expected to be furnished by the facility and co-providers - The patient must be in a condition to receive the information and give informed consent as determined by the attending emergency physician or treating provider using appropriate medical judgment. A delegate (as established by state law) may give consent - The written Notice and Consent must be retained for a minimum of 7 years - A payer must be notified when a patient signs a Notice and Consent and provided with a copy of the signed Notice and Consent document. This can be sent with the claim - The provider or facility must satisfy any additional requirements or prohibitions as may be imposed under State law. The Notice and Consent for insured individuals is not being enforced until July 1, 2022

PARA Weekly eJournal: December 15, 2021

NO SURPRISES ACT AND BALANCE BILLING EMERGENCY SERVICES

eCFR :: 45 CFR 149.410 -- Balance billing in cases of emergency services. (1) The attending emergency physician or treating provider determines that the participant, beneficiary, or enrollee is able to travel using non-medical transportation or non-emergency medical transportation to an available participating provider or facility located within a reasonable travel distance, taking into account the individual's medical condition. The attending emergency physician's or treating provider 's determination is binding on the facility for purposes of this requirement. (2) The provider or facility furnishing such additional items and services satisfies the notice and consent criteria of § 149.420(c) through (g) with respect to such items and services, provided that the written notice additionally satisfies paragraphs (b)(2)(i) and (ii) of this section, as applicable. In applying this paragraph (b)(2), a reference in § 149.420 to a nonparticipating provider is deemed to include a nonparticipating emergency facility. (i) In the case of a participating emergency facility and a nonparticipating provider, the written notice must also include a list of any participating providers at the facility who are able to furnish such items and services involved and notification that the participant, beneficiary, or enrollee may be referred, at their option, to such a participating provider. (ii) In the case of a nonparticipating emergency facility, the written notice must include the good faith estimated amount that the participant, beneficiary, or enrollee may be charged for items or services furnished by the nonparticipating emergency facility or by nonparticipating providers with respect to the visit at such facility (including any item or service that is reasonably expected to be furnished by the nonparticipating emergency facility or nonparticipating providers in conjunction with such items or services). (3) The participant, beneficiary, or enrollee (or an authorized representative of such individual) is in a condition to receive the information described in § 149.420, as determined by the attending emergency physician or treating provider using appropriate medical judgment, and to provide informed consent under such section, in accordance with applicable State law. For purposes of this section and § 149.420, an authorized representative is an individual authorized under State law to provide consent on behalf of the participant, beneficiary, or enrollee, provided that the individual is not a provider affiliated with the facility or an employee of the facility, unless such provider or employee is a family member of the participant, beneficiary, or enrollee.

PARA Weekly eJournal: December 15, 2021

NO SURPRISES ACT AND BALANCE BILLING EMERGENCY SERVICES

(4) The provider or facility satisfies any additional requirements or prohibitions as may be imposed under State law. An emergency, which prohibits balance billing, can occur at any time during care. If a patient experiences another emergent crisis during the time frame of the Notice and Consent, charges related to the emergency, and up to stabilization, cannot be balance billed. eCFR :: 45 CFR 149.410 -- Balance billing in cases of emergency services. Inapplicability of notice and consent exception to certain items and services.A non-participating provider or non-participating facility specified in paragraph (a) of this section will always be subject to the prohibitions in paragraph (a) of this section, with respect to items or services furnished as a result of unforeseen, urgent medical needs that arise at the time an item or service is furnished, regardless of whether the nonparticipating provider or nonparticipating emergency facility satisfied the notice and consent criteria in § 149.420(c) through (g). If the above Notice and Consent is not presented, the providers must negotiate with the insurer for payment, but in no event are providers permitted to balance bill the patient for any amounts the insurer did not adjudicate to patient liability.

PARA Weekly eJournal: December 15, 2021

FDA AUTHORIZES MONOCLONAL EUA FOR EVUSHELD

On Wednesday, December 8, 2021, t heFDAissued an Emer gency UseAut hor izat ion (EUA) f or t he administ r at ion of Ast r aZenaca?s t wo- dr ug Ev ushel d monocl onal ant ibody t her apy f or pr ev ent ion of COVID- 19 in cer t ain adul t s. The combination monoclonal antibiotic therapy consisting of tixagevimab with cilgavimab is authorized as a pre-exposure option for patients over the age of 12 who weigh at least 88 pounds and have either of the following: - The patient has moderate to severe immunocompromised systems due to medical conditions or treatments that may prevent an effective COVID-19 vaccination or ; - The patient exhibited an adverse reaction to previous COVID-19 vaccinations, indicating that additional vaccines following vaccine schedules are not recommended. The EUA indicates Evusheld may be administered at least two weeks following a vaccination. Additionally, the patient must not currently have COVID-19 and should not have known recent exposure to COVID-19. A provider may administer an Evusheld dose, consisting of two sequential intramuscular injections (one for each drug), as an option for patients who should not, for conditions outlined in the EUA, take currently available COVID-19 vaccines.

PARA Weekly eJournal: December 15, 2021

FDA AUTHORIZES MONOCLONAL EUA FOR EVUSHELD

The FDA published a Frequently Asked Question (FAQ) document on Evusheld. It is available through the following link: https://www.fda.gov/media/154703/download?utm_medium=email&utm_source=govdelivery

The AMA has not yet announced codes for reporting the drug or the administration of Evusheld. Once available, PARA will update our papers to include those codes. The FDA provides a provider Fact Sheet for the EAU through their website: https://www.fda.gov/media/154701/download?utm_medium=email&utm_source=govdelivery

PARA Weekly eJournal: December 15, 2021

RADIATION ONCOLOGY MODEL 2022 UPDATE

CMS f inal ized it ?s Radiat ion Oncol ogy Model (ROModel ) in t heir 2022 Hospit al Out pat ient Pr ospect iv e Pay ment Syst em(OPPS) and Ambul at or y Sur gical Cent er (ASC) Pay ment Syst em f inal r ul e r el eased on Nov ember 2, 2021. The Radiation Oncology Section begins on page 63912. https://www.federalregister.gov/documents/2021/11/16/2021-24011/medicare-programhospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment

Among the modifications of the RO Model, CMS will adopt an Ext r em e an d Un con t r ollable Cir cu m st an ces (EUC) Policy to adjust model performance periods, reporting requirements, and/or payment methodology when necessary, such as in the case of the COVID-19 Public Health Emergency (PHE). The limited exceptions under consideration during the first performance year, 2022, include: - CMS will allow optional reporting of the quality measure and clinical data elements in performance year (PY) 1 - 2022.CMS states the 2 percent Quality Withhold will not be applied to payments in 2022 - Also optional is active engagement with an AHRQ-listed patient safety organization (PSO) for PY1 2022 - RO participants may also optionally conduct Peer Review on treatment plan in PY1 2022

PARA Weekly eJournal: December 15, 2021

RADIATION ONCOLOGY MODEL 2022 UPDATE

The RO Model performance period begins January 1, 2022 through December 31, 2026. In addition to controlling costs, and improving coding for radiation services, the program is intended to align payments with quality and value. Participation in the RO Model is mandatory for all Radiation Therapy (RT) providers and suppliers that furnish RT services within a list of zip codes that represent approximately 30% of all RT providers nationwide. Cr it ical Access Hospit als ar e exem pt f r om t h e m odel. Selection of the zip codes was randomized among geographic Core-Based Statistical Areas (?CBSAs?). Participation is mandatory for providers of radiation oncology and radiation therapy services operating in over 9,000 zip codes listed by Medicare: https://innovation.cms.gov/media/document/ro-particp-zip-codes-list PARA published ?CMS Innovation:Radiation Oncology (RO) Model? which details the program and the participation requirements.

The CMS Radiation Oncology Model is available through the following link: https://innovation.cms.gov/innovation-models/radiation-oncology-model

PARA Weekly eJournal: December 15, 2021

PAMA REPORTING CLARIFIED FOR ACQUIRED LABORATORIES

During a Medicare Clinical Laboratory Fee Schedule (CLFS) Private Payer Data Collection and Reporting Policies webinar conducted on Wednesday, November 10, 2021, CMS addressed the responsibility for reporting?applicable information? for ?applicable laboratories? which changed ownership during or since the reporting period, January 1, 2019 through June 30, 2019. A screenshot from the slide deck follows:

We expect CMS to post a recording, transcript, and copy of the slide deck provided during the November 10, 2021 call, but that information has not been published as of this writing. Interested readers may also refer to the Additional Frequently Asked Questions document updated on April 20, 2021. https://www.cms.gov/files/document/frequently-asked-questions-cy-2021-clfs.pdf

PARA Weekly eJournal: December 15, 2021

REGULATORY ADVISORY

PARA Weekly eJournal: December 15, 2021

REGULATORY ADVISORY

PARA Weekly eJournal: December 15, 2021

REGULATORY ADVISORY

PARA Weekly eJournal: December 15, 2021

MLN CONNECTS

PARA in vit es you t o ch eck ou t t h e m ln con n ect s page available f r om t h e Cen t er s For M edicar e an d M edicaid (CM S). It 's ch ock f u ll of n ew s an d in f or m at ion , t r ain in g oppor t u n it ies, even t s an d m or e! Each w eek PARA w ill br in g you t h e lat est n ew s an d lin k s t o available r esou r ces. Click each lin k f or t h e PDF!

Th u r sday, Decem ber 9, 2021

New s -

PECOS: Multi-Factor Authentication Requirement Delayed HHS Seeks Public Comments to Advance Equity & Reduce Disparities in Organ Transplantation, Improve Life-Saving Donations, and Dialysis Facility Quality of Care Orthoses Referring Providers: Comparative Billing Report in December

Com plian ce -

Implanted Spinal Neurostimulators: Document Medical Records

M LN M at t er s® Ar t icles -

Reduced Payment for Physical Therapy and Occupational Therapy Services Furnished in Whole or in Part by a Physical Therapist Assistant or an Occupational Therapy Assistant Update to Medicare Deductible, Coinsurance and Premium Rates for Calendar Year (CY) 2022

Pu blicat ion s - Independent Diagnostic Testing Facility (IDTF) ? Revised

PARA Weekly eJournal: December 15, 2021

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Ther e w er e ELEVEN new or r evised Tr ansmittal s r el eased this w eek . To go to the ful l Tr ansmittal document simpl y cl ick on the scr een shot or the l ink .

PARA Weekly eJournal: December 15, 2021

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Ther e w er e THREE new or r evised MedLear ns r el eased this w eek . To go to the ful l Tr ansmittal document simpl y cl ick on the scr een shot or the l ink .

PARA Weekly eJournal: December 15, 2021

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PARA Weekly eJournal: December 15, 2021

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