PARA HealthCare Analytics Weekly eJournal July 28, 2021 by CorroHealth

July 28, 2021

PARA

WeeklyeJOURNAL NEWS FOR HEALTHCARE DECISION MAKERS

No Su r pr ises Act " Par t 1" Regu lat ion Issu ed Page 28

HFRI Acqu ir es Leadin g Zer o Balan ce Recover y Fir m Page 4

Navigat in g M edi-Cal Page 5

- SRS 7732 - Medi-Cal Expiring Waiver - CM S Rever sin g IOP List An d ASC CPL In 2022 Pr oposed Ru le - Lab PAMA Reporting - M edicar e KX M odif ier

FAST LINKS

- Colon Cancer Screening - Ju ly OPPS Updat e - HCPCS Update List - COVID-19 Updat ed Billin g Gu ide - PDE Training

Raisin g Th e St ak es On Pr ice Tr an spar en cy Page 8

Administration: Pages 1-61 HIM /Coding Staff: Pages 1-61 Providers: Pages 2,5,14,25,32 Neurosurgery: Page 2 California Providers: Page 5 Price Transparency: Page 8 1 14 Surgical Services: Page

Laboratory: Pages 16,25,50,56 PAM A Compliance: Pages 16,49 Oncology: Page 25 COVID Billing Guide: Page 47 PDE Users: Page 48 Pharmacy: Page 32 Wound Care: Page 56

PARA Weekly eJournal: July 28, 2021

SRS 77372

Does a neurosurgeon have to be involved in order to bill the code 77372? ASTRO's coverage policy for SRS documentation requirements state, "a radiation oncologist and a neurosurgeon must evaluate the clinical aspects of the treatment, and the document and sign this evaluation, as well as the resulting management decisions." Can you please provide some guidance as our radiation oncologist says a neurosurgeon does not have to be involved. Answer: It would be helpful if you provided the ASTRO policy you have referenced so that we can examine the remark in context. 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. CPT® Assistant offers information in its October, 2007 edition ? but you may want to read the highlighted paragraph more than once: Stereotactic Radiosurgery 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).

PARA Weekly eJournal: July 28, 2021

SRS 77372

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

PARA Weekly eJournal: July 28, 2021

BREAKING NEWS

HFRI Acqu ir es Leadin g Zer o Balan ce Recover y Fir m Ju ly 22, 2021 09:15 AM East er n Dayligh t Tim e

CHICAGO--(BUSINESS WIRE)-- Healthcare Financial Resources (HFRI), a leader in healthcare accounts receivable (AR) recovery and resolution management, today announced the acquisition of Emeryville, CA-based STATRevenue, a leading provider of zero balance (closed) claims review and recovery services for hospitals and health systems.

For Th e Fu ll Text , Click Her e

PARA Weekly eJournal: July 28, 2021

NAVIGATING MEDI-CAL Working with Medi-Cal ? California Medicaid ? can be quite a challenge at times. Navigating their phone system, waiting on hold, utilizing their website and even manually filling out their specialized forms just to get status on a claim can be a daunting task for representatives.

You are not alone! There are some challenges when it comes to Medi-Cal, however, knowing some tips and tricks may help ease your mind when you are faced with this payer. Medi-Cal Manual Forms can be Challenging Filling out Medi-Cal manual forms can be difficult to adapt to. There are not one, but two different forms that need to be completed at any given time, depending on the scenario and at what time the request is being submitted. - Claims Inquiry Form or CIF: Used to request an adjustment for either an underpaid or overpaid claim, request the Share of Cost (SOC) reimbursement or request a reconsideration of a denied claim - Appeal Form or 90-1: Used when all other avenues have been exhausted and an attempt to overturn a denial is being filed How do I obtain the CIF and 90-1 forms? To obtain the CIF and 90-1 forms contact Medi-Cal directly with the provider NPI number and the shipping address of where the forms should be sent. These forms come in boxes of 1,200 each and will also need envelopes to go with them. Once the order is placed, allow 10 days to ship. Make sure you order in plenty of time so as you do not run out!

PARA Weekly eJournal: July 28, 2021

NAVIGATING MEDI-CAL

Completing the Claims Inquiry Form There are 17 areas on the form that needs to be completed. The form allows entering up to four patients on one form at a time. Information needed will be: - Patient name - Medi-Cal ID number - Claim number - Date of service - Denied code - Amount billed Box 16 allows the break down what is needed, such as: ?Line 1, Line 2, etc.? Completing the 90-1 Appeal Form There are 15 areas on the 90-1 form that requires completion prior to submission. This form can only be completed for one patient at a time, but for up to 14-line items that have denied or have different dates of services. Information needed will be: - Patient name - Medi-Cal ID number - Claim number - Date of service - Remittance Advice Details (RAD) or Explanation of Benefits (EOB)/Remittance Advice (RA) Code - Remittance Advice (RA) and Remittance Advice Details (RAD) Another Complication Another complication in completing CIF and 90-1 forms is they must be hand-written. This can not only be tiring for the person completing the forms, but the process takes longer and can be difficult to read depending upon the persons handwriting. But is there a better alternative? HFRI can Help with Completing Medi-Cal Forms Healthcare Financial Resources (HFRI) has developed a process to eliminate the necessity of hand-writing CIF and 90-1 forms. Utilizing a mail merge process allows each individual staff member to complete an Excel sheet with the requested/required information. This Excel document is transmitted to the dedicated HFRI mailing team who takes the provided data and transfers it onto the form. The benefit to this process is that the forms are legible, cannot be smudged, have a reduced chance for spelling errors and no one?s hand gets cramped! Healt h car e Fin an cial Resou r ces (HFRI) specializes in accou n t s r eceivable r ecover y an d r esolu t ion an d ser ves as a vir t u al ext en sion of you r h ospit al cen t r al billin g of f ice t o h elp you qu ick ly r esolve an d collect m or e of you r in su r an ce accou n t s r eceivable. We u t ilize pr opr iet ar y in t elligen t au t om at ion an d st af f specializat ion t o ef f icien t ly pr ocess all claim s r egar dless of size or age. In addit ion t o ou r r esolu t ion capabilit ies, HFRI also can pr ovide den ial m an agem en t assist an ce by con du ct in g r oot cau se an alysis an d r ecom m en d pr ocess im pr ovem en t s t o h elp decr ease aged an d den ied claim s goin g f or w ar d. Con t act HFRI t oday t o lear n m or e abou t h ow w e can h elp you w it h you r h ospit al?s accou n t s r eceivable m an agem en t .

PARA Weekly eJournal: July 28, 2021

MEDI-CAL EXPIRING WAIVER

Completing the Claims Inquiry Form California Governor Gavin Newsome lifted, modified and reset expiration dates on many of the executive orders he put in place during the COVID-19 pandemic.Beginning July 1, 2021, an in-person signature is required by the beneficiary (or their representative) for delivered medication.The executive order (EO N-55-20) that included a temporary suspension of signatures expired on June 30, 2021. https://files.medi-cal.ca.gov/pubsdoco/newsroom/newsroom_31132_08.aspx

PARA Weekly eJournal: July 28, 2021

PRICE TRANSPARENCY COMPLIANCE: THE STAKES JUST GOT HIGHER

CM S ju st r aised t h e st akes on Pr ice Tr an spar en cy com plian ce. Don't r oll t h e dice on t h e n ew civil m on et ar y pen alt ies. On May 3, 2021, the American Hospital Association (AHA) released a M ember Advisory regarding noncompliance with the Centers for Medicare & Medicaid Services?(CMS) Hospital Price Transparency requirements.In it, they note that CMS has launched proactive audits of hospital websites and have evaluated complaints presented to CMS by consumers. 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.

Nu m ber Of Hospit al Beds

M axim u m An n u al Civil M on et ar y Pen alt y

<30

$109,500

$182,500

100

$365,000

200

$730,000

300

$1,095,000

400

$1,460,000

500

$1,825,000

550+

$2,007,500

The PARA Price Transparency Solution is so effective, that clients are indemnified from any civil monetary penalty. There's no risk with PARA.

PARA Weekly eJournal: July 28, 2021

PRICE TRANSPARENCY COMPLIANCE: THE STAKES JUST GOT HIGHER

The July 19, 2021 mlnconnects Special Edition states that CMS is updating the civil monetary penalty amount.The current minimum civil monetary penalty of $300/day would apply to smaller hospitals with less than 30 patient beds.However, for hospitals with more than 30 beds, the penalty will be $10/bed/day, not to exceed a maximum daily dollar amount of $5,500. ?Under this proposed approach, for a full calendar year of noncompliance, the minimum total penalty amount would be $109,500 per hospital, and the maximum total penalty amount would be $2,007,500 per hospital.? [mln connects Special Edition] 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. 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 HFM A Article on the topic, this detailed approach could cost a hospital several hundred thousand dollars to contract with a consulting firm.

PARA Weekly eJournal: July 28, 2021

PRICE TRANSPARENCY COMPLIANCE: THE STAKES JUST GOT HIGHER 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, an HFRI Company, 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 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.

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 10

PARA Weekly eJournal: July 28, 2021

BIDEN SAYS HE'LL ENFORCE TRUMP-ERA RULES ON PRICE TRANSPARENCY

Th e Healt h 202: Biden says h e'll en f or ce Tr u m p-er a r u les r equ ir in g h ospit als t o post t h eir pr ices.

By Alexandra Ellerbeck Researcher July 12, 2021|with Paige Winfield Cunningham President Biden is putting his foot down on a price transparency rule that many hospitals have skirted over the past seven months. On Friday, Biden released an executive order instructing the Secretary of Health and Human Services to ?support? price transparency regulations issued by the Trump administration. Starting on Jan. 1, hospitals were required to post the prices they charge cash-paying customers and the rates they negotiate with insurers ? figures that were largely obscured from public scrutiny. Proponents of greater hospital transparency championed the change, saying it would help patients shop for better deals and drive down health care prices. Until now, it was unclear exactly how the Biden administration would approach the Trump-era rules, even as advocates and some lawmakers urged stronger enforcement amid signs of widespread noncompliance. Friday?s executive order still didn?t provide many details,but it signaled that the new administration views the transparency rules as valuable, even if they ultimately don?t pack as much of a punch as former president Donald Trump had claimed. Recent studies have found that many hospitals aren?t complying with the rule. - A study published in the American Journal of Managed Care last month looked at 20 prominent U.S. hospitals and found that only 60 percent listed their cash prices on their websites, as of February. Only 5 percent displayed the minimum charges that they negotiated with insurers. - Another study published in the journal JAMA Internal Medicine found that some 83 percent of hospitals are not fully complying with the price transparency rules. Many hospitals provided a price estimator tool for patients, the JAMA study found, but far fewer provided an easy-to-use file with the prices the hospital negotiated with different insurers.

Read the entire Washington Post article by clicking here:

PARA Weekly eJournal: July 28, 2021

CMS PRICE TRANSPARENCY COMPLIANCE UPDATE

And CMS Means Business! See how in the letter below:

PARA Weekly eJournal: July 28, 2021

CMS PRICE TRANSPARENCY COMPLIANCE UPDATE

Page 2 of CMS Letter

PARA Weekly eJournal: July 28, 2021

CMS REVERSING IOP LIST AND ASC CPL IN 2022 OPPS PROPOSED RULE

In the 2022 OPPS proposed rule, CMS proposes to reverse two of the 2021 policies that some hospital stakeholders had opposed; the phase-out of the inpatient-only (IOP) list and relaxing criteria for adding services to the ambulatory surgical center covered-procedures list (ASC CPL.) A copy of the proposed rule is available on the Advisor tab of the PARA Data Editor; search ?2022?:

Inpatient only-- The 298 inpatient-only procedures that were being phased out under the 2021 OPPS rule would be added back to the IPO list under the 2022 OPPS proposed rule. CMS will be soliciting further comments on whether they should maintain the longer-term objective of eliminating the IPO list or maintain the IPO list but continue to systematically scale the list back. CMS also proposes to shorten the exemption from medical review activities for services removed from the IPO list to two years. CY 2022 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Proposed Rule (CMS-1753-P) | CMS

PARA Weekly eJournal: July 28, 2021

CMS REVERSING IOP LIST AND ASC CPL IN 2022 OPPS PROPOSED RULE

Ambulatory surgical center covered-procedures-- CMS is proposing to reinstate the ASC CPL criteria that was in effect in CY 2020 and remove 258 of the 267 procedures that were added to the ASC CPL in CY 2021. CMS is requesting comments on whether any of the 258 procedures meet the CY 2020 criteria they are proposing to reinstate. They are also proposing to change the notification process adopted in CY 2021 to a nomination process, under which stakeholders could nominate procedures they believe meet the requirements to be added to the ASC CPL. The formal nomination process would begin in CY 2023.

In addition to the IOP list and ASC CPL changes, the proposed rule addresses the health equity gap and fighting the Covid-19 PHE. The rule will also be promoting safe, effective, and patient-centered healthcare through proposals that affect the newly established Rural Emergency Hospital provider type, partial hospitalization programs, and the Radiation Oncology Model. The new rule also includes proposals to encourage transparency in health systems. PARA HealthCare Analytics, a leader in supporting hospitals in achieving readiness for CMS Price Transparency regulations, will be following these proposals closely.

PARA Weekly eJournal: July 28, 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:

PARA Weekly eJournal: July 28, 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.

PARA Weekly eJournal: July 28, 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.?

PARA Weekly eJournal: July 28, 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

PARA Weekly eJournal: July 28, 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. 20

PARA Weekly eJournal: July 28, 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.

PARA Weekly eJournal: July 28, 2021

2021 UPDATE FOR MEDICARE KX MODIFIER THERAPY THRESHOLDS

The Bipartisan Act of 2018 repealed the Medicare outpatient therapy caps but retained the former cap amount as a threshold of incurred expenses.Claims with expenses above those thresholds must include modifier KX as an attestation that services are medically necessary and appropriately documented in the medical record.It no longer represents an exception request but serves as a confirmation that services are medically necessary after the beneficiary has exceeded the KX modifier threshold of incurred expenses. The benefit caps do not apply to Skilled Nursing facility residents in a covered Part A stay, including Swing Beds. The following types of Medicare-enrolled therapy providers are subject to the caps in the outpatient setting: - Physical, speech, and occupational therapists in private practice - Physician offices ? Private practices - Home Health therapy providers, where therapy is offered outside the home health benefit (TOB 34X) - Hospital outpatient therapy departments - Critical Access Hospitals (CAH) - SNF providers (Part B billing where the patient has no Part A benefit)·Comprehensive outpatient rehabilitation facilities (CORF)

PARA Weekly eJournal: July 28, 2021

2021 UPDATE FOR MEDICARE KX MODIFIER THERAPY THRESHOLDS

For Cardiac Rehabilitation (CR) and Pulmonary Rehabilitation (PR), the inclusion of the KX modifier on the claim lines is an attestation by the provider of the service that documentation is on file verifying that further treatment beyond the 36 sessions is medically necessary up to a total of 72 sessions. Cardiac Rehab does not have a lifetime limit of 72 sessions, but rather a limit of 72 after each qualifying cardiac episode. Pulmonary rehab is limited to a maximum of 72 sessions in a lifetime. Unlike the time limit of 36 sessions within 36 weeks for cardiac rehab, there is no stated time limit for providing the 36-72 sessions of pulmonary rehab. For Physical Therapy (PT), Occupational Therapy (OT), and Speech Therapy (ST), claims exceeding the threshold amounts must include the KX modifier as an attestation that services are medically necessary and justified by appropriate documentation in the medical record. There are no set dollar limits for PT, OT, and ST other than the requirements for medical necessity and patient benefit. When therapy treatment for a condition reaches a plateau where further therapy adds no benefit for the patient, or simply becomes routine maintenance therapy that does not require the skills of a therapist, it no longer meets the Medicare therapy benefit definition. Also note that PT and ST services combined, and OT services alone, are subject to a targeted medical review at a threshold amount of $3,000. Only selected claims exceeding the threshold amount are subject to review.To avoid review, use the KX modifier only in cases where the patient?s condition is such that services are medically necessary and clearly documented in an episode that exceeds the therapy cap. Routine use of the KX modifier for all therapy patients will likely trigger a targeted medical review. When the cap is exceeded by at least one line on the claim, use the KX modifier on all the lines on that claim that refer to the same therapy cap (PT/SLP or OT), regardless of whether the other services exceed the cap. For example, if one PT service line exceeds the cap, use the KX modifier on all the PT and ST service lines (also identified with the GP or GN modifier) for that claim. When the PT/ST cap is exceeded by PT services, the ST lines on the claim may meet the requirements for an exception due to the complexity of two episodes of service. Use the KX modifier on either all or none of the ST lines on the claim, as appropriate. In contrast, if all the OT lines on the claim are below the cap, do not use the KX modifier on any of the OT lines, even when the KX modifier is appropriately used on all the PT lines. Refer to Pub.100-04, Medicare Claims Processing Manual, chapter 25, for more detail. The KX modifier threshold amounts were updated January 1, 2021, and published in MM12014.

PARA Weekly eJournal: July 28, 2021

2021 UPDATE FOR MEDICARE KX MODIFIER THERAPY THRESHOLDS

The rehabilitative services requiring the KX modifier are outlined in the table below as defined in the Medical Claims Processing Manual. Medicare Claims Processing Manual (cms.gov)

We recommend monitoring your claim denials; specifically looking for denials stating, ?the benefit maximum for this time period or occurrence has been reached.? While appealing the claims may not be worth the time and effort, reviewing these denials will let you know if you need to review your upfront processes to determine if they are working.

PARA Weekly eJournal: July 28, 2021

NEW COLON CANCER SCREENING BLOOD TEST, NON-COVERED Epi proColon® is a new FDA-approved colorectal cancer (CRC) screening test which is not covered by Medicare. The manufacturers of this test applied to Medicare in seeking coverage of this test as a preventive colorectal screening technique that would serve as an alternative to a screening colonoscopy, Cologuard®, or other fecal occult tests.Medicare considered the request carefully and responded by updating its National Coverage Determination 210.3 for Colorectal Cancer Screening. The updated NCD includes the previous approved screening methods and adds coverage for blood-based biomarker Tests effective January 19, 2021. In addition, CMS created a new HCPCS for covered blood-based biomarker tests which meet certain standards for technical quality and recognition. https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=281&ncdver= 6&DocID=210.3&bc=gAAAAAgAAQAAAAAA&

However, Epi proColon® failed to meet the standards Medicare established for coverage. The requirements for coverage are: - FDA approval, and - Sensitivity greater than or equal to 74% (sensitivity is defined as the ability of the test to give a positive finding when the individual screened has CRC), and - Specificity greater than or equal to 90% in the detection of CRC (specificity is defined as the ability of the test to give a negative finding when the individual screened does not have CRC), and - Recommended CRC in at least one professional society guideline or consensus statement or United Sates Preventative Services Task Force (USPSTF) recommendation. Although Medicare created a new HCPCS, G0327 (Colorectal cancer screening; blood-based biomarker) effective July 1, 2021, it appears that Medicare evaluated only Epi proColon®, and found it does not qualify for coverage. No other blood tests have yet been evaluated.

PARA Weekly eJournal: July 28, 2021

NEW COLON CANCER SCREENING BLOOD TEST, NON-COVERED

While Epi proColon® is currently the only FDA-approved blood-based biomarker test for CRC screening, there are other blood-based tests in development using different biomarkers. The NCD provides Medicare coverage of a blood-based biomarker test as an appropriate CRC screening test once every three years. The test must be ordered by the treating physician and performed in a Clinical Laboratory Improvement Act (CLIA)-certified lab. Tests recommended in the USPSTF 2008 CRC screening guidelines, such as colonoscopy and fecal occult blood test, should be declined by the patient before offering a blood-based biomarker test. All three of the following qualifications of the patient must be met for the test to be covered: - Patient must be 50 years or older, and - Asymptomatic of CRC, and - Average risk for CRC Decision Memo for Screening for Colorectal Cancer - Blood-Based Biomarker Tests (CAG-00454N) (cms.gov)

continued next page

PARA Weekly eJournal: July 28, 2021

NEW COLON CANCER SCREENING BLOOD TEST, NON-COVERED

PARA Weekly eJournal: July 28, 2021

NO SURPRISES ACT "PART 1" REGULATION ISSUED

Background: In 2020, Congress held meetings to determine whether laws should be enacted to prevent the devastating financial obligations imposed on a patient with healthcare insurance who is treated by an out-of-network provider, particularly when the patient did not know or expect that insurance coverage would be limited for that care. During Congressional hearings, citizens recounted unexpected, and devastating, financial obligations incurred by patients who were transported by out-of-network air ambulance services. According to the Nebraska Department of Insurance, the average air ambulance trip is 52 miles and costs between $12,000 to $25,000 per flight. Since most air ambulance services do not participate as ?network? providers with insurers, that portion of the bill that the insurer will not cover becomes patient liability.The plight of these patients and others convinced Congress that federal law should prevent a ?surprise? bill resulting from an uninformed patient owing large sums of money to an out-of-network provider. The resulting legislation, the ?No Surprises Act?,was incorporated into the Consolidated Appropriations Act of 2021, which was signed into law by then-President Trump in late December, 2020. The new federal law limits the ability of both insurers and out-of-network providers to shift a significant financial obligation to the patient/beneficiary, unless that patient is provided with advance written notice of the anticipated amount that the patient will owe, along with information about the patient?s alternatives to out-of-network care. If there is a state law that addresses the same concern, state law takes precedence. The new law becomes effective on January 1, 2022, and the Office of Personnel Management, along with the Department of Health and Human Services, Labor, and Treasury developed implementing regulations.The first regulations, dubbed ?Part 1?, were released on July 1, 2021 in an ?Interim Final Rule with Comment Period? (CMS-9909-IFC.)

PARA Weekly eJournal: July 28, 2021

NO SURPRISES ACT "PART 1" REGULATION ISSUED

Stakeholders should pay particular attention to provider obligations arising from the law, including: - Distributing standard information about patient rights under the No Surprises Act; information must be posted on the provider website, in signage in public areas of the facility, and in a written one-page, double-sided document distributed to insured patients prior to collecting payment from the patient or submitting a claim to the patient?s group health insurer. (A model notice is under development). - The ?Notice and Consent? requirements -- out-of-network providers and facilities must obtain the patient?s informed consent to collect out-of-network costs from the patient.The notice requirements include an estimate of the costs the patient will be liable to pay and information about in-network service alternatives.Notices must be available in the 15 most common languages spoken in the provider?s region. (It is not clear whether a provider may simply opt-out of the notice requirement and accept whatever the insurer?s discounted payment rate may be). - The method insurer must use to calculate the ?Qualifying Payment Amount? for out-of-network services -- the payment the insurer is obligated to use in calculating provider reimbursement and patient liability for services at an out-of-network provider.(Depending on specific circumstances, that rate could be based on that insurer?s median in-network contracted rates with other like providers within the same region). The second set of implementing regulations, ?Part 2?,are expected to be published in coming months relating to dispute resolution and other provisions of the new law. Interested readers seeking tolearn more about the No Surprises Act and the regulations implementing the new law are encouraged to visit the following websites (see pages 2 and 3.) - The full text of the Interim Final Rule, CMS-9909-IFC, was published on7-13-21 in the Federal Register: https://www.federalregister.gov/documents/2021/07/13/2021-14379/requirements-relatedto-surprise-billing-part-i

PARA Weekly eJournal: July 28, 2021

NO SURPRISES ACT "PART 1" REGULATION ISSUED

Subpart E ? Health Care Provider, Health Care Facility, and Air Ambulance Service Provider Requirements - 149.410 Balance billing in cases of emergency services - 149.420 Balance billing in cases of non-emergency services performed by nonparticipating providers at certain participating health care facilities - 149.430 Provider and facility disclosure requirements regarding patient protections against balance billing - 149.440 Balance billing in cases of air ambulance services - 149.450 Complaints process for balance billing regarding providers and facilities - CMS offers a concise ?Fact Sheet?on the interim final rule: https://www.cms.gov/newsroom/fact-sheets/requirements-related-surprise-billing-part-i-interimfinal-rule-comment-period

- The American Hospital Association offers a concise summary and analysis: https://www.aha.org/system/files/media/file/2021/07/agencies-issue-part-one-of-regulationsbanning-surprise-medical-bills-bulletin-7-2-21.pdf

PARA Weekly eJournal: July 28, 2021

NO SURPRISES ACT "PART 1" REGULATION ISSUED

- The American Medical Association offers a high-level summary: https://www.ama-assn.org/system/files/2020-12/no-surprises-act-summary.pdf

- United Healthcareoffers a convenient FAQ-style resource on its website: https://www.uhc.com/united-for-reform/health-reform-provisions/no-surprises-act

- The website for the No Surprises Campaign (People against Unfair Medical Bills) offers consumer stories and letters from diverse interests participating in the development of the No Surprises Act: https://nosurprisescampaign.org/consumer-stories/

PARA Weekly eJournal: July 28, 2021

EUA FOR NEW DOSING REGIMEN OF REGENERON MONOCLONAL AB

On June 3, the FDA updated its Emergency Use Authorization for casirivimab and imdevimab (Regeneron cocktail.) The FDA revoked the previously authorized dosage of 1200 mg of casirivimab and 1200 mg of imdevimab on 06/03/2021. The new version includes a dosing regimen of 600 mg of casirivimab and 600 mg of imdevimab by subcutaneous administration. The link for the original FDA announcement (Casirivimab and Imdevimab EUA Fact Sheet for Healthcare) is no longer active. However, the FDA published a Frequently Asked Questions paper on the Authorization of the Regeneron cocktail. https://www.fda.gov/media/143894/download

PARA Weekly eJournal: July 28, 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. 33

PARA Weekly eJournal: July 28, 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.

PARA Weekly eJournal: July 28, 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.

PARA Weekly eJournal: July 28, 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.

PARA Weekly eJournal: July 28, 2021

JULY 1, 2021 OPPS UPDATE

- 31 New CPT® Category III Codes ? Effective July 1, 2021, CMS adds codes 0640T through 0670T.

PARA Weekly eJournal: July 28, 2021

JULY 1, 2021 OPPS UPDATE

- 31 New CPT® Category III Codes ? Effective July 1, 2021, CMS adds codes 0640T through 0670T.

PARA Weekly eJournal: July 28, 2021

JULY 1, 2021 OPPS UPDATE

- 31 New CPT® Category III Codes ? Effective July 1, 2021, CMS adds codes 0640T through 0670T.

PARA Weekly eJournal: July 28, 2021

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)

PARA Weekly eJournal: July 28, 2021

JULY 1, 2021 OPPS UPDATE

- Drug, Biologicals and Radiopharmaceuticals - Nine New HCPCS codes assigned for pass-through status:

PARA Weekly eJournal: July 28, 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:

PARA Weekly eJournal: July 28, 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

PARA Weekly eJournal: July 28, 2021

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

PARA Weekly eJournal: July 28, 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.

PARA Weekly eJournal: July 28, 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.

PARA Weekly eJournal: July 28, 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. 47

PARA Weekly eJournal: July 28, 2021

Expanded PDE Training Sessions Available PARA offers nationwide overview training on the PARA Data Editor each week. And, due to increased demand, we are expanding the training schedule to include sessions that focus on the two most frequently used modules with the PDE. Sessions on Charge Quote and the Calculator will now be offered on Tuesdays (Charge Quote) and Thursdays (Calculator) at the following times: Tuesdays: 11:00 am Pacific Daylight Time Thursdays: 8:00 am Pacific Daylight Time Regular PDE Training Sessions: Wednesdays at 11:00 am PDT and Fridays at 8:00 am PDT

I nterested? Please contact one of the following experts for a session key.

Mary McDonnell: 800.999.3332, ext 216 mmcdonnell@para-hcs.com Violet Archuleta-Chiu: 800.999.3332, ext 219 varchuleta@para-hcfs.com Sandra LaPlace: 800.999.3332, ext 225 slaplace@para-hcfs.com Gail Langord: 800.999.3332, ext 426 glangford@para-hcs.com Randi Brantner: 800.999.3332, ext 215 rbrantner@para-hcfs.com 48

If you can't make any of these sessions, but would still like to attend, please contact Mary McDonnell for options.

PARA Weekly eJournal: July 28, 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 49

PARA Weekly eJournal: July 28, 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. .

PARA Weekly eJournal: July 28, 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 51

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 28, 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. 52

PARA Weekly eJournal: July 28, 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.

THE COST OF NON-COM PLIANCE

PARA Weekly eJournal: July 28, 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

PARA Weekly eJournal: July 28, 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

PARA Weekly eJournal: July 28, 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 22, 2021

New s -

COVID-19: EUA for Tocilizumab Monoclonal Antibody Product Medicare Ground Ambulance Data Collection System FAQs Wound Debridement: Comparative Billing Report in July 3 Ways to Protect Your Medicare Enrollment Information Americans with Disabilities Act: 31st Anniversary Viral Hepatitis: Medicare Covers Preventive Services

Com plian ce -

Polysomnography Services: Bill Correctly

Claim s, Pr icer s, & Codes -

ICD-10-CM Diagnosis Code Files for FY 2022

M LN M at t er s® Ar t icles -

Changes to the Laboratory National Coverage Determination (NCD) Edit Software for October 2021 Implement Operating Rules - Phase III Electronic Remittance Advice (ERA) Electronic Funds Transfer (EFT): Committee on Operating Rules for Information Exchange (CORE) 360 Uniform Use of Claim Adjustment Reason Codes (CARC), Remittance Advice Remark Codes (RARC) and Claim Adjustment Group Code (CAGC) Rule - Update from Council for Affordable Quality Healthcare (CAQH) CORE October 2021 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 27.3, Effective October 1, 2021 Section 50 in Chapter 30 of Publication (Pub.) 100-04 Manual Updates National Coverage Determination (NCD 110.24): Chimeric Antigen Receptor (CAR) T-cell Therapy ? Revised

Pu blicat ion s -

Critical Access Hospital ? Revised Medicare Advance Written Notices of Noncoverage ? Revised Rural Health Clinic ? Revised

PARA Weekly eJournal: July 28, 2021

There were 1 new or revised MedLearns released this week. To go to the full Transmittal document simply click on the screen shot or the link.

FIND ALL THESE MEDLEARNS IN THE ADVISOR TAB OF THE PDE

PARA Weekly eJournal: July 28, 2021

The link to this MedLearn MM12177

PARA Weekly eJournal: July 28, 2021

There was ONE new or revised Transmittals released this week. To go to the full Transmittal document simply click on the screen shot or the link.

FIND ALL THESE TRANSMITTALS IN THE ADVISOR TAB OF THE PDE

PARA Weekly eJournal: July 28, 2021

The link to this Transmittal R10896OTN

PARA Weekly eJournal: July 28, 2021

719.308.0883