PARA HealthCare Analytics Weekly eJournal August 4, 2021

August 4, 2021

PARA

WeeklyeJOURNAL NEWS FOR HEALTHCARE DECISION MAKERS Don't Roll Th e Dice Wh en It Com es To Pr ice Tr an spar en cy Com plian ce Page 8

It 's Tim e To Com ply Page 34

Im por t an t M edi-Cal Updat es Page 2

AUG

- CM S Rever sin g IOP List An d ASC CPL In 2022 Pr oposed Ru le - FDA To Withdraw EUA On COVID PCR Test December 31, 2021 - FDA Au t h or izes Tocilizu m ab Rx

FAST LINKS

- 2021 Update For Medicare KX Modifier Therapy Thresholds - New Colon Can cer Scr een in g Blood Test - EUA Dor New Dosing Regimen Of Regeneron Monoclonal AB

- Administration: Pages 1-51 - HIM /Coding Staff: Pages 1-51 - Providers: Pages 2,4,14,16,19,21,28,31 - California Providers: Page 2 - DM E: Page 2 1 4 - Imaging Services: Page

No Su r pr ises Page 25

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PTT Compliance: Page 8, 11 Laboratory: Pages 16,17,41 PAM A Compliance: Pages 31 Oncology: Page 22 COVID Billing Guide: Page 32 PDE Users: Page 33 Inpatient Svcs: Page 14

© 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: August 4, 2021

CALIFORNIA MEDI-CAL MONTHLY UPDATES

AUG

The following services have been detailed in the associated Bulletins -https://files.medi-cal.ca.gov/ pubsdoco/Bulletins_ menu.aspx

- Allied Health Acupuncture (ACU) Audiology and Hearing Aids (AUD) Chiropractic (CHR) Durable Medical Equipment and Medical Supplies (DME) Medical Transportation (MTR) Orthotics and Prosthetics (OAP) Psychological Services (PSY) Therapies (THP) - Inpatient / Outpatient Inpatient Services (IPS) Community?Based Adult Services (CBAS) AIDS Waiver Program (AID) Clinics and Hospitals (CAH) Chronic Dialysis Clinics (DIA)

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PARA Weekly eJournal: August 4, 2021

CALIFORNIA MEDI-CAL MONTHLY UPDATES

Inpatient / Outpatient, con't.

Heroin Detoxification (HER) Home Health Agencies/Home & Community-Based Services (HOM) Hospice Care Program (HOS) Local Educational Agency (LEA) Multipurpose Senior Services Program (MSSP) Rehabilitation Clinics (REH) - Long Term Care https://files.medi-cal.ca.gov/pubsdoco/bulletins/artfull/ltc202107.aspx - Medical Services General Medicine (GM) Obstetrics (OB) - Pharmacy ? https://files.medi-cal.ca.gov/pubsdoco/bulletins/artfull/ph202107r.aspx - Vision Care ? https://files.medi-cal.ca.gov/pubsdoco/bulletins/artfull/vc202107.aspx - Family PACT ? https://files.medi-cal.ca.gov/pubsdoco/bulletins/artfull/fpact202107.aspx The July 2021 Clinics and Hospitals Medi-Cal Update is located: https://files.medi-cal.ca.gov/ pubsdoco/bulletins/artfull/cah202107.aspx

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PARA Weekly eJournal: August 4, 2021

CALIFORNIA MEDI-CAL MONTHLY UPDATES

All participating Medi-Cal Program providers: COVID-19 expired waiver for in-person signature requirement for delivered medications: Effective on April 28, 2020, a waiver was placed related to providers who dispense controlled drugs, dangerous drugs or dangerous devices to a Medi-Cal beneficiary due to the COVID-19 PHE. Effective July 01 2021, this waiver will no longer be in effect. Providers will be required to obtain beneficiary signatures for medications in person from their home or sign onsite at the provider?s location.

Update: Rates for Hormone Containing Vaginal Rings: Effective for dates of service on or after April 01, 2021, rates have been updated for claims reporting HCPCS code J7303 and modifier U1 or U2 as follows:

Update: Radiology Reimbursement: Effective retroactively for dates of service on or after January 01, 2019 and January 01, 2020, radiology reimbursement rates have been adjusted.

DHCS adjusted radiology reimbursement rates, so they do not exceed 80% of the corresponding Medicare rate.

No action is required from providers for this adjustment, an Erroneous Payment Correction will be implemented to reprocess impacted provider claims.

Clinics and Hospitals, General Medicine, Obstetrics: Update: Minimum Age Limit for Colorectal Screening: Effective for dates of service on or after May 18, 2021, CPT® code 81528 has an updated minimum age limit of 45 years of age.

An Erroneous Payment Correction will be implemented to reprocess denied claims. Providers may elect to use this updated policy to resubmit previously denied claims.

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PARA Weekly eJournal: August 4, 2021

CALIFORNIA MEDI-CAL MONTHLY UPDATES

Clinics and Hospitals, General Medicine, Obstetrics, Rehabilitation Clinics, Chronic Dialysis Clinics, Pharmacy: New Benefit ? Sotrovimab for COVID-19: Effective for dates of service on or after May 26, 2021, the FDA has authorized Sotrovimab for the treatment of COVID-19 under an Emergency Use Authorization (EUA).

Sotrovimab must be purchased by providers who must bill and be reimbursed for the cost of the product.

Providers who bill for the cost of the administration report applicable administration HCPCS - Q0247- injection, sotrovimab, 500 mg - M0247- intravenous infusion, sotrovimab, includes infusion and post administration monitoring - M0248- INTRAVENOUS INFUSION, SOTROVIMAB, INCLUDES INFUSION AND POST administration monitoring in the home or residence; this includes a beneficiary's home that has been made provider-based to the hospital during the covid-19 public health emergency

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PARA Weekly eJournal: August 4, 2021

CALIFORNIA MEDI-CAL MONTHLY UPDATES

Clinics and Hospitals, General Medicine, Obstetrics, Chronic Dialysis Clinics, Pharmacy, Rehabilitation Clinics, Inpatient Services: Update: Allowable Specialized Services?

Effective for dates of service on or after July 01, 2021, the list of specialized services that can be billed on an outpatient claim, even when provided on an inpatient basis, has been updated to reflect the following: Existing policy in place shall remain in place for all other allowable specialized services.

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PARA Weekly eJournal: August 4, 2021

CALIFORNIA MEDI-CAL MONTHLY UPDATES

Clinics and Hospitals, General Medicine, Obstetrics providers that participate in the Medi-Cal Every Woman Counts (EWC) Program: New Benefit ? Telehealth Services? Effective retroactively for dates of service on or after November 01, 2013, HCPCS code Q3014 and T1014 are new benefits to the Medi-Cal EWC Program.

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PARA Weekly eJournal: August 4, 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: August 4, 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: August 4, 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: August 4, 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: August 4, 2021

CMS PRICE TRANSPARENCY COMPLIANCE UPDATE

And CMS Means Business!

See how in the letter below:

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PARA Weekly eJournal: August 4, 2021

CMS PRICE TRANSPARENCY COMPLIANCE UPDATE

Page 2 of CMS Letter

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PARA Weekly eJournal: August 4, 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

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PARA Weekly eJournal: August 4, 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.

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PARA Weekly eJournal: August 4, 2021

FDA TO WITHDRAW EUA ON COVID PCR TEST DECEMBER 31, 2021

On July 21, 2021, the CDC announced it will withdraw its Emergency Use Authorization (EUA) request for the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel after December 31, 2021.

The advanced notice allows laboratories to adopt and prepare to use an alternative FDA approved test.

The 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel detects only COVID-19.The CDC suggests laboratories begin using a multiplex assay that can detect both COVID-19 and influenza, which will be save time and laboratory resources as we enter flu season. https://www.cdc.gov/csels/dls/locs/2021/07-21-2021-lab-alert-Changes_CDC_ RT-PCR_SARS-CoV-2_Testing_1.html

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PARA Weekly eJournal: August 4, 2021

FDA AUTHORIZES TOCILIZUMAB RX FOR INPATIENT COVID-19

On Ju n e 24, 2021, t h e FDA issu ed an Em er gen cy Use Au t h or izat ion (EUA) f or t r eat m en t of COVID-19 in h ospit alized pat ien t s w it h t h e dr u g t ocilizu m ab (Act em r a):

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization#coviddrugs

The ICD-10 codes for reporting tocilizumab on an inpatient claim are XW033H5 and XW043H5:

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PARA Weekly eJournal: August 4, 2021

FDA AUTHORIZES TOCILIZUMAB RX FOR INPATIENT COVID-19

PARA Data Editor users may find the NDC?s and HCPCS assigned to Tocilizumab on the Calculator tab by searching ?tocilizumab? or ?Actemra? using the ?NDC to J-Code Crosswalk? report:

As of July 29, 2021, the ICD10 codes for Tocilizumab are not on the list of codes qualifying an inpatient claim for enhanced DRG reimbursement under Medicare?s ?New COVID-19 Treatments Add-On Payment? program (NCTAP). https://www.cms.gov/medicare/covid-19/new-covid-19-treatments-add-payment-nctap

If and when CMS adds the ICD10 codes for tocilizumab to the NCTAP program, PARA will update this article.

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PARA Weekly eJournal: August 4, 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)

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PARA Weekly eJournal: August 4, 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.

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PARA Weekly eJournal: August 4, 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.

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PARA Weekly eJournal: August 4, 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: August 4, 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: August 4, 2021

NEW COLON CANCER SCREENING BLOOD TEST, NON-COVERED

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PARA Weekly eJournal: August 4, 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.)

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PARA Weekly eJournal: August 4, 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

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PARA Weekly eJournal: August 4, 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

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PARA Weekly eJournal: August 4, 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/

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PARA Weekly eJournal: August 4, 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

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PARA Weekly eJournal: August 4, 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: August 4, 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: August 4, 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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Updated And Revised August 4, 2021

PARA Weekly eJournal: August 4, 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 33

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

PARA Weekly eJournal: August 4, 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 34

PARA Weekly eJournal: August 4, 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: August 4, 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 36

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: August 4, 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: August 4, 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: August 4, 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: August 4, 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: August 4, 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!

Special Edit ion Th u r sday, Ju ly 29, 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

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PARA Weekly eJournal: August 4, 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: August 4, 2021

The link to this MedLearn MM12177

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The link to this MedLearn MM12254

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PARA Weekly eJournal: August 4, 2021

The link to this MedLearn MM12206

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PARA Weekly eJournal: August 4, 2021

There was FIVE new or revised Transmittals released this week.

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

5

FIND ALL THESE TRANSMITTALS IN THE ADVISOR TAB OF THE PDE

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PARA Weekly eJournal: August 4, 2021

The link to this Transmittal R10896OTN

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PARA Weekly eJournal: August 4, 2021

The link to this Transmittal R10928OTN

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PARA Weekly eJournal: August 4, 2021

The link to this Transmittal R10927NCD

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PARA Weekly eJournal: August 4, 2021

The link to this Transmittal R10899OTN

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PARA Weekly eJournal: August 4, 2021

The link to this Transmittal R10891NCD

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