PARA HealthCare Analytics Weekly eJournal July 21, 2021

July 21, 2021

PARA

WeeklyeJOURNAL NEWS FOR HEALTHCARE DECISION MAKERS Th e St ak es Ju st Got High er Wit h Pr ice Tr an spar en cy.

Don't Roll Th e Dice.

PARA Can Help.

Page 12

Un billable Ser vices Page 2 - Su r gical Su pplies For Equ ipm en t - Reporting Incorrect Second Dose For COVID-19 Vaccine - Calif or n ia M edi-Cal Updat es - Lab PAMA Reporting

FAST LINKS

- Ju ly 2021 CCI Edit Ch an ges For Radiat ion Th er apy - July 2021 OPPS Updates - UPDATED COVID Billin g Gu ide - Expanded PDE Training

- Administration: Pages 1-67 - HIM /Coding Staff: Pages 1-67 - Providers: Pages 2,4,5,6,14,24,27,29,55,59,64 - Price Transparency: Page 12 - Laboratory: Pages 18,29,54 1 - Oncology: Pages 24,27,59

Colon Can cer Scr een in g Page 25 -

California Providers: Page 6 Radiation Therapy: Page 27 PAM A Compliance: Page 44 COVID Treatment: Page 29 COVID Billing Guide: Page 42 PDE Users: Page 43 Pharmacy: Pages 55,63

© PARA Healt h Car e An alyt ics an HFRI Company CPT® is a r egist er ed t r adem ar k of t h e Am er ican M edical Associat ion

PARA Weekly eJournal: July 21, 2021

UNBILLABLE SERVICES

We are experiencing more and more insurance companies recently who will not pay for specific line items. Some examples are: Medicaid will not pay for trauma activation.

CIGNA will not pay for hydration, infusion, etc., in the ER. They will only pay the facility E & M. CIGNA will not pay the contrast material separately from the procedure. Anthem will not pay the ER Physician EKG professional fee separately. They will only pay the ER Physician E&M. Several insurance companies will no longer pay for the venipuncture, we still have to report all of the line items and bill them appropriately. Medicare is our largest payer and pays for them. We've been writing them off as "unbillable." Is there another way we should handle these as a critical access hospital?

Answer: We agree that legitimate charges which are billable in keeping with the UB committee specifications should be reported on your claims regardless if the payer policy will prevent any reimbursement for them, particularly if there are HCPCS associated with the services (such as 36415 for venipuncture). Even if the payer will not reimburse such charges, all patients should be charged the same, regardless of the source of payment (insured, Medicare, or self-pay.)

In fact, Anthem BCBS Colorado?s provider billing manual says: https://www.anthem.com/docs/public/inline/PM_CO_00009.pdf ?Provider and Facility will follow industry standards related to billing. ? ?

Turning to the question of whether the non-payable charges should be written off as ?non-billable? -whether the non-allowed charges are written-off as ?unbillable? or ?contractual discount? is purely an internal accounting decision.

The purpose of characterizing the nature of the write-off is to enable the hospital revenue accountants to anticipate, in aggregate, the net reimbursement forecast by establishing a ?reserve? amount by which gross revenue is reduced in aggregate. The reserve calculates the net value of open accounts receivable for a given payer based on past experience under that payor?s reimbursement scheme. The question is whether the accounting department will find utility in characterizing the write off as ?non-billable? or thrown together into the bucket of usual contractual write-offs is not a compliance issue.

The impact of payer reimbursement policies which reduce reimbursement above and beyond the negotiated contractual discount may be of interest to the managed care contract negotiating team. The information you record related to payer policy discounts, as opposed to negotiated discounts, enables the negotiators to better understand the total reimbursement landscape.

Theoretically, the organization may consider terminating a contract if the actual reimbursement yield was significantly reduced by the impact of unforeseen payer policies which are part of the participating contract with a payer.

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PARA Weekly eJournal: July 21, 2021

UNBILLABLE SERVICES

These are the most common no-pay policies (basically what you?ve already identified): - Trauma activation (G0390) ? non-covered by Colorado Medicaid - IV Therapy (hydration, infusions, injections) in the ER ? CIGNA, Anthem - Facility personnel charges ? PICC line placement, PT, OT, Speech, respiratory therapists (Anthem) - Contrast Material ? CIGNA - Emergency Dept. physician EKG interpretations ? Anthem - Blood product storage/handling, thawing, and administration charges - Anthem While we support the idea of reallocating certain supply charges into the procedure charge, PARA recommends that hospitals continue to report HCPCS-coded charges whether or not the insurer will reimburse those charges separately, or ?package? them into another charge on the same claim.

Bottom line, if there?s an appropriate CPT®/HCPCS code to describe the service provided, and that code passes CCI edits, it should be reported on the outpatient claim.

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PARA Weekly eJournal: July 21, 2021

SURGICAL SUPPLIES FOR EQUIPMENT

We will start performing surgical services using a Robotic Arm. This machine requires a drape to cover the robotic arm during surgery. In review, we have found that there is not a CPT® code to identify the use of robotic assisted surgery for 27447, but we can apply an ICD-10 procedure code.

Our question is this: Should we charge for the "drape" used to cover the robotic equipment? We are leaning towards "no", we should not, due ot it's part of the use of the equipment. Do you agree?

Answer: No, we don?t recommend charging separately for drapes used during procedures. As Peter mentioned in his initial comment to your question, there may be enough of a cost difference in robotic surgeries vs. non-robotic to create a separate timeand acuity-based Operating Room level charge.I have attached our paper on Billing for Supplies.

PARA uses the four-question test to determine whether an item may be billed as a separate supply expense. As you can see, drapes are specifically identified as non-billable in question #4:

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PARA Weekly eJournal: July 21, 2021

REPORTING INCORRECT SECOND DOSE FOR COVID-19 VACCINATION

If a provider gave a patient the incorrect second-dose COVID-19 vaccine product, what is the correct way to report it on a claim?

Answer: The CDC states the COVID-19 vaccine product for the first dose must be the same as the vaccine product for the second dose.

When the two doses mistakenly do not match, per the June AMA CPT® Assistant, the provider should report the code for the vaccine given (even though it does not match the first vaccine product) along with the given vaccine?s associated administration code.

The CDC offers additional guidance in its COVID-19 Vaccine Frequently Asked Questions for Healthcare Professionals page

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PARA Weekly eJournal: July 21, 2021

CALIFORNIA MEDI-CAL MONTHLY UPDATES

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

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

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PARA Weekly eJournal: July 21, 2021

CALIFORNIA MEDI-CAL MONTHLY UPDATES

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

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

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

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PARA Weekly eJournal: July 21, 2021

CALIFORNIA MEDI-CAL MONTHLY UPDATES

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

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

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

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PARA Weekly eJournal: July 21, 2021

CALIFORNIA MEDI-CAL MONTHLY UPDATES

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

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

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

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

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PARA Weekly eJournal: July 21, 2021

CALIFORNIA MEDI-CAL MONTHLY UPDATES

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

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

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PARA Weekly eJournal: July 21, 2021

CALIFORNIA MEDI-CAL MONTHLY UPDATES

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

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

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

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PARA Weekly eJournal: July 21, 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

50

$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.

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PARA Weekly eJournal: July 21, 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.

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PARA Weekly eJournal: July 21, 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 14

PARA Weekly eJournal: July 21, 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:

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PARA Weekly eJournal: July 21, 2021

CMS PRICE TRANSPARENCY COMPLIANCE UPDATE

And CMS Means Business!

See how in the letter below:

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PARA Weekly eJournal: July 21, 2021

CMS PRICE TRANSPARENCY COMPLIANCE UPDATE

Page 2 of CMS Letter

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PARA Weekly eJournal: July 21, 2021

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

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

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

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

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

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

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

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PARA Weekly eJournal: July 21, 2021

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

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

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

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

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

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

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

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PARA Weekly eJournal: July 21, 2021

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

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

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PARA Weekly eJournal: July 21, 2021

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

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

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

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

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

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PARA Weekly eJournal: July 21, 2021

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

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

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

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

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PARA Weekly eJournal: July 21, 2021

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

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

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

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

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PARA Weekly eJournal: July 21, 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.

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PARA Weekly eJournal: July 21, 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

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PARA Weekly eJournal: July 21, 2021

NEW COLON CANCER SCREENING BLOOD TEST, NON-COVERED

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PARA Weekly eJournal: July 21, 2021

JULY 2021 CCI EDIT CHANGES FOR RADIATION TX PLANNING

Medicare?s quarterly update of OPPS CCI edits for July 2021 included several changes related to HCPCS 77295 (3D radiotherapy plan? ) when billed on the same claim with certain radiation therapy isodose plan codes. As of July 1, 2021, a modifier (such as XU, ?Unusual Non-Overlapping Service?) will resolve a CCI edit between HCPCS 77295 and: - Teletherapy isodose plan codes 77306-77307; or - Brachytherapy isodose plan codes 77316-77318, or CT guidance for placement of radiotherapy fields, 77014

Last quarter, the NCCI edits did not permit reporting those codes together, even with a modifier:

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PARA Weekly eJournal: July 21, 2021

JULY 1, 2021 OPPS UPDATE

On Ju n e 11, 2021, CM S issu ed Tr an sm it t al R10825CP w it h M LN, ?Ju ly 2021 Updat e of Hospit al Ou t pat ien t Paym en t Syst em (OPPS).?

https://www.cms.gov/files/document/mm12316.pdf

PARA will advise chargemaster clients by email of any line items in the hospital CDM that require an update because of a deleted HCPCS code; we will also provide a replacement HCPCS where available.

Clients are encouraged to upload a current CDM at least quarterly to take full advantage of PARA support.

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PARA Weekly eJournal: July 21, 2021

JULY 1, 2021 OPPS UPDATE

The following summarizes the OPPS updates effective July 1, 2021.

- COVID-19 Vaccine Novavax codes will become effective once the FDA approves under an Emergency Use Authorization (EUA):

- Monoclonal Antibody Therapy - Bamlanivimab - The FDA revoked the EUA for the monoclonal antibody therapy bamlanivimab on April 16, 2021, when administered alone. CMS deleted HCPCS codes M0239 and Q0239 from the July 2021 Integrated Outpatient Code Editor (I/OCE).

- APC Change - Effective May 6, 2021, monoclonal antibody codes M0243 and M0245 moved from APC 5694 (Level 4 Drug Administration) with a payment rate of $310.75 to APC 1506 (New Technology - Level 6) with a payment rate of $450.

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PARA Weekly eJournal: July 21, 2021

JULY 1, 2021 OPPS UPDATE

- COVID-19 MAB in Home ? M0244 and M0246, effective May 6, 2021, assigned for monoclonal antibody therapy services provided in the home or residence.These are assigned APC 1509 ((New Technology - Level 9) with a payment rate of $750.

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PARA Weekly eJournal: July 21, 2021

JULY 1, 2021 OPPS UPDATE

- Proprietary Laboratory Analysis (PLA) Changes ? Effective July 1, 2021, CMS provided 7 new PLA codes.

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

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PARA Weekly eJournal: July 21, 2021

JULY 1, 2021 OPPS UPDATE

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

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PARA Weekly eJournal: July 21, 2021

JULY 1, 2021 OPPS UPDATE

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

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PARA Weekly eJournal: July 21, 2021

JULY 1, 2021 OPPS UPDATE

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

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PARA Weekly eJournal: July 21, 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)

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PARA Weekly eJournal: July 21, 2021

JULY 1, 2021 OPPS UPDATE

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

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PARA Weekly eJournal: July 21, 2021

JULY 1, 2021 OPPS UPDATE

- Six HCPCS Pass-Through status ending June 30, 2021 ? Status indicator changing from G (pass-through) to K (paid under OPPS; separate APC payment):

- Five New HCPCS Effective July 1, 2021 ? Because of a late correction to HCPCS A9593 (Gallium ga-68 psma-11, diagnostic, (ucsf), 1 millicurie) and A9594 (Gallium ga-68 psma-11, diagnostic, (ucla), 1 millicurie), these codes are in the I/OCE with a status indicator of G (pass-through) but with a zero-dollar payment for July 1, 2021 ? September 30, 2021.CMS will make a retroactive correction to a status indicator N when they publish the October 2021 Quarterly OPPS Update. Below are the 5 new drugs, biologicals, and radiopharmaceutical HCPCS codes:

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PARA Weekly eJournal: July 21, 2021

JULY 1, 2021 OPPS UPDATE

- Manual Adjudication Status Change Effective July 1, 2021?

- Updates on Drugs and Biologicals with payments based on Average Sales Price (ASP): - Most non pass-through, non 340B Program = ASP +6% of reference product for biosimilars - Non pass-through, acquired through 340B Program = ASP ? 22.5 percent of 340B acquired biosimilar - Single payment of ASP + 6 percent for pass-through to provide payment for the acquisition cost and pharmacy overhead costs - Based on OPPS/ASC final rule comments, values for many drugs and biologicals changed based on sales price from third quarter CY 2020.The full updated list will be available at the July 2021 update of OPPS Addendum A and B: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ HospitalOutpatientPPS/Addendum-A-and-Addendum-B-Updates

-

Restated ASP Methodology Payment Rates -Quarterly retroactive correction to some drugs and biological payment rates will be available on the first date of the quarter at the following CMS website:

https://www.cms.gov/medicaremedicare-fee-service-paymenthospitaloutpatientppsopps -restated-payment-rates/july-2021-update-hospital-outpatient-prospectivepayment-system-opps

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PARA Weekly eJournal: July 21, 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

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PARA Weekly eJournal: July 21, 2021

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

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

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

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

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PARA Weekly eJournal: July 21, 2021

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

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

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

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PARA Weekly eJournal: July 21, 2021

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

Download the updated Guidebook by clicking here.

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PARA Weekly eJournal: July 21, 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 43

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 21, 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 44

PARA Weekly eJournal: July 21, 2021

Introduction 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.

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

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

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PARA Weekly eJournal: July 21, 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.

"

THE DETAILS

"

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 46

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

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

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

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PARA Weekly eJournal: July 21, 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

FREQUENTLY ASKED QUESTIONS

Hospitals which received more than $12,500 in Medicare revenues for non-patient lab services paid between 1/1/209 and 6/20/2019, will likely meet the definition of an ?applicable laboratory?, which triggers the requirement to report private payer rates early next year.

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

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

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

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PARA Weekly eJournal: July 21, 2021

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

CURRENT CM P $10,017 Per Day

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PARA Weekly eJournal: July 21, 2021

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

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

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

Ran di Br an t n er

San dr a LaPlace

Violet Ar ch u let -Ch iu

Vice President of Analytics

Account Executive

Senior Account Executive

rbrantner@hfri.net

splace@para-hcfs.com

varchuleta@para-hcfs.com

719.308.0883

800.999.3332 x 225

800.999.3332 x219

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PARA Weekly eJournal: July 21, 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 15, 2021

New s -

Cognitive Assessment: Resources for Providers CMS Opens National Coverage Determination Analysis on Treatment for Alzheimer ?s Disease PEPPERs for HHAs and PHPs

Com plian ce -

IRF Services: Follow Medicare Billing Requirements

Claim s, Pr icer s, & Codes -

ICD-10-CM Codes: FY 2022

M u lt im edia -

Medicare Billing: Form CMS-1500 and 837 Professional Web-Based Training ?

Revised Medicare Billing: Form CMS-1450 and 837 Institutional Web-Based Training ?

Revised

View this edition as PDF (PDF)

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PARA Weekly eJournal: July 21, 2021

There were 3 new or revised MedLearns released this week.

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

3

FIND ALL THESE MEDLEARNS IN THE ADVISOR TAB OF THE PDE

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PARA Weekly eJournal: July 21, 2021

The link to this MedLearn MM12254

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PARA Weekly eJournal: July 21, 2021

The link to this MedLearn MM12384

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PARA Weekly eJournal: July 21, 2021

The link to this MedLearn MM12342

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PARA Weekly eJournal: July 21, 2021

There were TEN new or revised Transmittals released this week.

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

10

FIND ALL THESE TRANSMITTALS IN THE ADVISOR TAB OF THE PDE

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PARA Weekly eJournal: July 21, 2021

The link to this Transmittal R10891NCD

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PARA Weekly eJournal: July 21, 2021

The link to this Transmittal R10890OTN

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PARA Weekly eJournal: July 21, 2021

The link to this Transmittal R10891CP

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PARA Weekly eJournal: July 21, 2021

The link to this Transmittal R10888NCD

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PARA Weekly eJournal: July 21, 2021

The link to this Transmittal R10875CP

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PARA Weekly eJournal: July 21, 2021

The link to this Transmittal R10878CP

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PARA Weekly eJournal: July 21, 2021

The link to this Transmittal R10870CP

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PARA Weekly eJournal: July 21, 2021

The link to this Transmittal R10869CP

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PARA Weekly eJournal: July 21, 2021

The link to this Transmittal R10868PI

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PARA Weekly eJournal: July 21, 2021

The link to this Transmittal R10862CP

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PARA Weekly eJournal: July 21, 2021

719.308.0883

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