PARA HealthCare Analytics eJournal November 6, 2019 Grayscale

PARA

November 6, 2019 an HFRI Company

HealthCare Analytics

Weekly

eJOURNAL

NEWS FOR HEALTHCARE DECISION MAKERS Page 16

IN THIS ISSUE QUESTIONS & ANSWERS - Coding Changes For 2020 - Midline Catheter - Lab Reimbursement Information - Appropriate HCPCS For Mitomycin

Coding For Vaping Treatment Encounters

ALL EYES ON PRICING TRANSPARENCY REPLACEMENT MEDICATIONS FOR THOSE IMPACTED BY CALIFORNIA WILDFIRES CARDIAC REPLACMENT DEVICE CREDITS CALIFORNIA DOH LAB PAYMENT REPORTING REQUIREMENTS

3

The number of new or revised Med Learn articles released this week.

9

The number of new or revised Transmittals released this week.

Page 18

2020 CODING UPDATE DOCS AVAILABLE WEEKLY I.T. UPDATE PAMA PRIVATE PAYER LAB PAYMENT RATE REPORTING

EHRs Underperforming On Revenue Cycle Management: How To Achieve Performance

PARA COMPANY NEWS

SERVICES

ABOUT PARA

CONTACT US

FAST LINKS

- Administration: Pages 1-53 - HIM /Coding Staff: Pages 1-53 - Providers: Pages 2,5,10,14,16,20,28 - Cardiology: Pages 5,14 - Laboratory: Pages ,20,28,38,52 - Ophthamology: Page 9

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Compliance: Pages 10,28 Pharmacy: Pages 10,13,36,49 Finance: Pages 10,18,35 California Providers: Pages 13,20 - Pulmonology: Page 16 - Public Affairs: Page 16

© 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: November 6, 2019

CODING CHANGES FOR 2020

Is there a way to obtain a complete list of the coding changes coming in 2020?

Unfortunately, the AMA prevents us from having both deleted and new codes reported together in just one click. Consequently, there?s two-step process; new code descriptions are available in the 2020 Code Map or by individual query on the PDE Calculator tab, and deleted or changed codes are available on the ?Changes? report on the CPT速 line of the Calculator tab.

A detailed list of the deleted or changed CPT速 codes, and the CPT速 number (without description) of the new 2020 CPT速 codes, is available on the PARA Data Editor Calculator tab ? click on the ?Changes? hyperlink and select 2020 from the drop down:

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PARA Weekly eJournal: November 6, 2019

CODING CHANGES FOR 2020

The Appendix B report indicates deleted codes and the number assigned to a new code added for 2020, but the AMA did not provide the description of the new code in that document. Note in the snip below that next to new codes with a red dot, it only gives the CPTÂŽ and ?Code added? ? no descriptor: New CPTÂŽ codes for 2020 can be queried in the Calculator one at a time, or multiples if you separate each code by a comma (no space.)

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PARA Weekly eJournal: November 6, 2019

CODING CHANGES FOR 2020

Alternately, you can look at the list of all new CPT® codes on their own tab in the 2020 Code Map.

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PARA Weekly eJournal: November 6, 2019

MIDLINE CATHETER

How do you bill for a midline placement as opposed to a PICC line insertion in 2019?

Answer: Report CPT速 code(s) 36400, 36405,36406, or 36410 effective January 1, 2019. The 2019 CPT速 code book has provided updated guidelines for reporting midline catheter placements.

A midline catheter by definition terminates in the peripheral venous system. Contrary to previous CPT速 Assistant advice, midline catheters are not considered central venous access devices and therefore should not be reported as a PICC service.

Please refer to the CPT速 Code book guidelines on page 268 which support this recommendation.

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PARA Weekly eJournal: November 6, 2019

LAB REIMBURSEMENT INFORMATION

How can I look up the cost of running lab tests in PARA Data Editor? HCPCS code 85396? It's called the FibTEM A5 and ExTEM tests (ROTEM). I was able to find the reimbursement from Medi-Cal and competitor charge values.

Answer: We assume you meant to ask for payment rates. The PARA Data Editor does not offer cost data.

The PARA Data Editor Calculator HCPCS search is a multi-purpose report which returns Medicare reimbursement either by fee schedule (such as Clinical Lab, DME, or Physician?s fee schedule) and it will return reimbursement under OPPS APC rates for hospital services as well. To check Medicare or Medicaid reimbursement for a CPTÂŽ/HCPCS code, navigate to the Calculator tab, enter the code(s) in the field on the lower left, and select the HCPCS report and the Medicaid report, as illustrated below ? if looking up more than one HCPCS, separate the codes by only a comma, no space:

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PARA Weekly eJournal: November 6, 2019

LAB REIMBURSEMENT INFORMATION

The reports will open separate new subtabs on the calculator with results as illustrated ? please note that 85396 is paid under the Physician fee schedule ? there is no separate reimbursement under either the ClinLab fee schedule or OPPS for facilities. Under OPPS, status ?N? means that it may be reported by a hospital, but under OPPS it will not generate additional reimbursement. Since your facility is a Critical Access Hospital, it is not subject to OPPS reimbursement methodology; it will be reimbursed for 85396 on a percentage-of-charge basis calculated specifically for the individual hospital. Only the physician professional fee has a reimbursement rate established for 85396:

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PARA Weekly eJournal: November 6, 2019

LAB REIMBURSEMENT INFORMATION

There is also a ?Clinical Lab? report which will also return the same clinical lab fee schedule information as appears on the HCPCS report, but notice that 85396 does not return any information because it is not reimbursed under the ClinLab fee schedule:

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PARA Weekly eJournal: November 6, 2019

APPROPRIATE HCPCS FOR MITOMYCIN

Our facility currently uses Mitomycin in the Oncology Clinic and also in our surgical area (bladder instillations. which would fall under topical use). Previously we had been advised to use J9280 when it is used in Oncology and J7999 when it is used topically.

Are both of these codes still current and correct?

Answer: Report J3490. Medicare published guidance on billing topical mitomycin during ophthalmic surgery in 2014:

https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R2903CP.pdf h. Billing Guidance for the Topical Application of Mitomycin During or Following Ophthalmic Surgery Hospital outpatient departments should only bill HCPCS code J7315 (Mitomycin, ophthalmic, 0.2 mg) or HCPCS code J3490 (unclassified drugs) for the topical application of mitomycin during or following ophthalmic surgery. J7315 may be reported only if the hospital uses mitomycin with the trade name MitosolÂŽ. Any other topical mitomycin should be reported with J3490. Hospital outpatient departments are not permitted to bill HCPCS code J9280 (Injection, mitomycin, 5 mg) for the topical application of mitomycin. Here are the codes for reference; note that the mitomycin HCPCS codes are specific to the application ? J7315 is exclusive to ophthalmic application, and J9280 is specific to injections.

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PARA Weekly eJournal: November 6, 2019

SPECIAL

All Eyes On Pricing Transparency Like it or not, pricing transparency has moved to the forefront of healthcare reform efforts. That means hospitals must be ready to make detailed price information available for consumers interested in shopping procedures and services.

Yet it?s no secret transparency is a double-edged sword. Publicizing pricing information before an organization has made sure its prices are rational, competitive and defensible can damage a hospital?s brand and undermine the bottom line.

The good news is that capabilities now exist to help hospitals develop comprehensive, market-based pricing strategies that allow them to optimize margins while remaining competitive with local and regional peer organizations. This pricing data can then be shared publicly in easy-to-use formats and harnessed to accurately convey patient payment responsibilities.

Government pressure Price transparency has been one of the most talked-about healthcare reform objectives for a decade or more. Much of this emphasis has been fueled by the continued growth of high deductible insurance plans. Proponents say consumers need, and expect, detailed price information to be sure they?re getting the most for their hard-earned healthcare dollars. Policymakers also believe transparency will spur provider competition and help drive down costs.

But with much of the industry?s attention focused elsewhere in recent years ? notably on the implementation of value-based reimbursement models ? transparency has taken a back seat. In fact, the percentage of hospitals unable to provide price information increased between 2012 and 2016, from 14 percent to 44 percent.[1] That?s likely to change, however, now that the government has signaled it?s serious about making hospital pricing information more accessible to all. In January 2019, the Centers for Medicare and Medicaid Services (CMS) announced a rule mandating that hospitals post their standard charges, or chargemaster, online. CMS then upped the ante in July of this year with a proposed rule that would require hospitals to post not just the often-inflated numbers of the chargemaster but also typically confidential information showing actual negotiated rates by payer and plan for specific procedures and services.

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PARA Weekly eJournal: November 6, 2019

SPECIAL

Failure to comply with the rule, which is scheduled to take effect on Jan. 1, 2020, could result in civil monetary penalties of up to $300 per day. Hospitals could also be subject to audits and corrective action plans if they fail to disclose negotiated rates.[2] Both hospital and insurance groups are vehemently opposed to the requirement that negotiated rates be made public. They argue that publicizing the information could inhibit competition, increase the administrative burden for hospitals, increase costs and reduce access to care.[3] As a result, the rule is expected to trigger a number of legal challenges, and whether it will take effect in January remains to be seen. But if the past is any prologue, government healthcare reform efforts ? regardless of their popularity ? eventually find their way into the market, in one fashion or another.

Peer analysis That?s why forward-thinking hospitals would do well to begin developing their own transparency strategies. Before this can happen, though, it?s essential that organizations are fully confident the numbers they?re prepared to share publicly make economic sense and are justifiable when it comes to peer pricing.

Healthcare Financial Resources (HFRI) has developed a comprehensive process to help hospitals create rational pricing models built around cost, reimbursement and peer pricing data. The effort begins with a review of existing pricing information across all hospital revenue streams, including room rates, emergency visits, diagnostic and therapeutic procedures, operating room, anesthesia, PACU, pharmacy and medical supplies.

Once this baseline information is established, HFRI will compare service line and procedure prices against equivalent pricing from a designated group of peer institutions.

The latter information is acquired through review of the most recent quarterly Inpatient and Outpatient Standard Analytic File (SAF) data generated by the Centers for Medicare and Medicaid Services (CMS). Using these comparisons, hospitals can see exactly how their pricing stacks up against specific facilities and also against averages for the entire group.

Quantifying in percentage terms the extent to which the price for a particular service or product deviates from the group average enables hospitals to quickly spot opportunities for increasing prices while still remaining competitive.

Conversely, HFRI can also flag any instances in which an organization?s high prices represent over-market outliers.

All Eyes On Pricing Transparency

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PARA Weekly eJournal: November 6, 2019

SPECIAL

The right prices Armed with this data, HFRI pricing experts work alongside the hospital?s financial management team to establish specific pricing targets and timelines based on the opportunities presented. These calculations will also take into account contractual reimbursement rates to ensure the new prices are consistent with payer policies.

Likewise, HFRI can help develop effective strategies for areas or services that require pricing sensitivity.

For example, an organization may want to keep prices at, near or even below cost for some services to remain competitive with independent, free-standing facilities.

Importantly, the pricing developed through HFRI?s rational pricing model is competitive with peer pricing and therefore both defensible and supportive of an effective consumer-facing transparency strategy.

A comprehensive solution Meeting the challenges of pricing transparency demands a systematic approach grounded in empirical evidence and a capable staff implementing proven solutions. HFRI can help you refine your pricing to improve revenue capture and strengthen margins while remaining competitive in your market.

Contact us today to learn more about how we can help your organization prepare for the transparency transformation ahead.

[1] Tony Abraham, ?No way to enforce hospital price transparency rule, CMS says,? Healthcare Dive, Jan. 11, 2019.

[2] Jacqueline LaPointe, ?Proposed Hospital Price Transparency Rule Faces Industry Criticism,? RevCycle Intelligence, Aug. 5, 2019.

[3] Ibid.

Catch up on other HFRI Blog entries by clicking here

All Eyes On Pricing Transparency 12

PARA Weekly eJournal: November 6, 2019

REPLACEMENT MEDICATION FOR THOSE IMPACTED BY WILDFIRES

California Update The Department of Health Care Services (DHCS) has prepared a response to the recent declaration of a state of emergency declared by the Governor for the State of California.

The following applies to Medi-Cal fee-for-service recipients displaced or impacted by the fires, pharmacies are to: - Submit a Treatment Authorization Request (TAR) using the special handling of ?Six Prescription Limit? and add the following statement to the Miscellaneous Information field of the TAR: ?Patient impacted by (identify the specific county) county fire?

- If a pharmacy receives a real-time claim denial for frequency limitation, the pharmacy is being advised by DHCS to submit a TAR using the special handling of ?Exceeded Billing Frequency Limit? and add the following statement to the Miscellaneous Information field of the TAR: ?Patient impacted by (identify the specific county) county fire?

Further, DHCS is encouraging Pharmacy providers to dispense the requested medication immediately if the need to dispense is related to the recipient?s displacement, and not have the recipient return after receiving the TAR approval. http://files.medi-cal.ca.gov/pubsdoco/newsroom/newsroom_30049.asp

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PARA Weekly eJournal: November 6, 2019

CARDIAC REPLACEMENT DEVICE CREDITS

2018 Office of Inspector General (OIG) report identified payments reviewed for cardiac medical devices that had been recalled, and did not comply with billing requirements for reporting manufacturer credits. The report identified that Medicare incorrectly paid hospitals overpayments of approximately $4.4 million.

Overpayments were incurred because manufacturers issued reportable credits to hospitals for cardiac medical devices that had been recalled, but hospitals did not adjust their claims with proper condition codes, value codes and modifiers as required to reduce payment.

Federal regulations direct hospitals to report the replacement of implanted cardiac devices. If a hospital receives full or partial credit from a manufacturer for covered devices that are under warranty, or a device is replaced because of a recall or defect, these must be identified, and the claims billed for replacement devices should be tracked.

Medicare reduces payments for cardiac replacement devices when they are provided at no cost, a reduced cost or with a credit that is 50 percent or greater than the cost of the device. CMS requires the use of modifiers FB and FC to report implanted cardiac devices.

These modifiers are also required when reporting devices that are part of a recall. Modifier FB should be appended when a facility incurs no cost or receives full credit for the cost of a device and modifier FC should be appended when a facility receives manufacturer credit of 50% or more of the total cost of the device.

If a facility is not aware at the time of the device replacement procedure whether the device was provided at no cost, a reduced cost or with a 50 percent or greater credit, hospitals have the option of submitting a claim without the appropriate modifier and subsequently submitting a claim adjustment with the modifier once the determination of how the replacement device was obtained has been made or, they can hold the claim until the determination has been made.

THE

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PARA Weekly eJournal: November 6, 2019

CARDIAC REPLACEMENT DEVICE CREDITS

In addition to the modifier requirements for the replacement of implanted cardiac devices, CMS has issued a billing fact sheet to assist hospitals in properly reporting manufacturer credits to avoid overpayment recoveries with the appropriate condition codes and value codes.

https://www.cms.gov/Outreach-and-Education/ Medicare-Learning-Network-MLN/MLNProducts /Downloads/cardiacdevicecredits-ICN909368.pdf

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PARA Weekly eJournal: November 6, 2019

ICD-10 CODING FOR VAPING AND E-CIGARETTES

More t han 1,299 cases of lung illness associat ed wit h t he use of e-cigaret t e and vaping product s have been report ed in 49 st at es and t he U.S. Virgin Islands, according t o a recent Cent ers for Disease Cont rol and Prevent ion (CDC) release.

There are key sympt oms t o look for and coding guidance for healt hcare encount ers and deat hs relat ed t o e-cigaret t e, and vaping product use associat ed wit h lung injury.

Question: What are the symptoms associated with lung conditions related to e-cigarettes and vaping products?

Answer: Based on a CDC investigation, patients with vaping and e-cigarette associated lung conditions, have reported symptoms such as: - Cough, shortness of breath, or chest pain - Nausea, vomiting, or diarrhea - Fatigue, fever, or weight loss Question: How should a lung-related complication or injury resulting from electronic cigarette or vaping products use be coded?

Answer: In ICD-10 CM, some lung conditions have code detail that states ?due to chemicals, gases, fumes and vapors? such as Bronchitis and pneumonitis. Documentation must support the relationship between the lung condition/injury and the vaping product.

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PARA Weekly eJournal: November 6, 2019

ICD-10 CODING FOR VAPING AND E-CIGARETTES

Refer to the PARA Data Editor code description provided below.

For patients with acute lung injury but without further documentation identifying a specific condition, such as pneumonitis or bronchitis, assign ICD-10 CM code J68.9, Unspecified respiratory condition due to chemicals, gases, fumes, and vapors. Refer to the PARA Data Editor code description provided below.

When a poisoning or toxicity occurs in a patient by swallowing, breathing, or absorbing e-cigarette liquid through their skin or eyes, assign an ICD-10 CM code from series T65.291-, Toxic effect of other nicotine and tobacco, accidental (unintentional). Code series T65.291- includes Toxic effect of other tobacco and nicotine NOS. The 7th character will indicate the episode of care, such as initial, subsequent or sequela.

Refer to the PARA Data Editor code description provided below.

For a patient with acute tetrahydrocannabinol (THC) toxicity, assign ICD-10 CM code T40.7X1- Poisoning by cannabis (derivatives), accidental (unintentional). The 7th character will indicate the episode of care, such as initial, subsequent or sequela.

Refer to the PARA Data Editor code description provided below.

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PARA Weekly eJournal: November 6, 2019

EHRS UNDERPERFORM IN THE REVENUE CYCLE: ACHIEVING RESULTS

With the majority of hospitals and health systems struggling to achieve the full potential of their electronic health systems (EHR), many organizations are turning to outsource companies and other vendors to improve revenue cycle performance, a new survey shows.

More than 60% of healthcare executives believe the challenges associated with EHR revenue cycle management (RCM) outweighed the benefits,[1] according to analysis conducted by Navigant based on a survey done by the Healthcare Financial Management Association (HFMA). A total of 108 hospital and health system chief financial officers and revenue cycle executives responded to the survey.[2] Unmet expectations The survey underscores providers?ongoing disappointment with EHR performance and the actions they?re taking to overcome those shortcomings. Historically, EHR solutions have frequently failed to deliver key RCM capabilities.

For example, most systems typically do not integrate with practice management systems to facilitate effective charge capture.[3] Ineffective charge capture can result in a significant amount of money being left on the table due to under-coding, or an increased compliance risk because of over-coding. ?It was anticipated that EHRs would be the main driver of broad performance improvement, but that has not occurred in many cases,? said Timothy Kinney, managing director of Navigant.[4] ?Instead, providers are now taking other steps, including looking outside their organizations to collaborate with external entities and leveraging advanced technology solutions, and they?re seeing successes.?

According to the survey, 46% of respondents said they were collaborating with external organizations, including outsourcing and vendor partnerships, to decrease revenue cycle costs and increase economies of scale.[5] At the same time, the survey also found that spending for staff training, business intelligence/analytics and coding all declined in 2019.

So, w hat does this mean for providers?

With less money being spent for training and analytics, providers must look to establish new alliances with partners that can deliver the cost-effective expertise needed to supplement a health system?s revenue cycle management resources.

Areas where outside partners can provide additional value include: - Creation of a market-based pricing strategy For hospitals and health systems, a solid financial footing begins with the development of a comprehensive, market-based pricing strategy built around cost, reimbursement and peer pricing data. Most hospitals don?t have the resources to conduct in-depth competitive pricing analysis.

Healthcare Financial Resources (HFRI) has the expertise to create a detailed and empirically based pricing model to ensure you?re aligned with peer group averages and simultaneously positioned to capitalize on opportunities for maximizing returns on below-market-priced items and services.

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PARA Weekly eJournal: November 6, 2019

EHRS UNDERPERFORM IN THE REVENUE CYCLE: ACHIEVING RESULTS

- Implementation of a revenue integrity program It?s vital that hospitals and healthcare systems ensure critical elements of the revenue cycle ? coding, charge capture and claims management ? are executed correctly and consistently. Charge master reviews can uncover where you may be either losing reimbursement or be at risk for compliance issues. On-site audits by an external partner can help spot opportunities for increased reimbursement, improved charge accuracy, more effective compliance and denial reductions. A retrospective claims analysis will compare the claim against the supporting documentation and target inconsistencies that can lead to reduced reimbursement.

- Accounts Receivable (AR) recovery and resolution Hospitals often don?t have the resources to work aged and/or small balance claims to recover everything they are owed from insurance claims that otherwise would have been written off.

While the administrative costs of reworking denials approach $9 billion annually,[6] only about 35% of payer rejections are ever reworked and resubmitted.[7] Partnering with a qualified third-party vendor that possesses the technology and expertise required to help hospitals isolate, identify and remediate issues that result in unresolved claims can drastically improve margins and increase cash.

- Robotic Process automation (RPA) Significantly, the HFMA survey found that 15% of health system executives said their organizations are now targeting RPA to improve revenue cycle management. That?s up from zero in 2018.[8] ?New technologies leveraging RPA, artificial intelligence, and machine learning have unlocked significant opportunities to reach previously unattainable levels of revenue cycle performance,? said Kent Ritter, director with Navigant.[9] Vendors that have already implemented RPA as well as intelligent automation can provide a more robust and powerful process for quickly and more effectively handing outstanding AR. HFRI can help Armed with this data, HFRI pricing experts work alongside the hospital?s financial management team to establish specific pricing targets and timelines based on the opportunities presented. These calculations will also take into account contractual reimbursement rates to ensure the new prices are consistent with payer policies.

Likewise, HFRI can help develop effective strategies for areas or services that require pricing sensitivity.

For example, an organization may want to keep prices at, near or even below cost for some services to remain competitive with independent, free-standing facilities. Importantly, the pricing developed through HFRI?s rational pricing model is competitive with peer pricing and therefore both defensible and supportive of an effective consumer-facing transparency strategy.

[1] ?EHRs, Consumer Self-Pay Remain Providers?Top Revenue Cycle Challenges,? 2019 Navigant/HFMA Revenue Cycle Trends Survey, Sept. 25, 2019.

[2] Ibid [3] Jacqueline LaPointe, ?Hospitals Looking Beyond EHR to Improve Revenue Cycle Performance,? RevCycle Intelligence, Sept. 25, 2019.

[4] ?Revenue Cycle Technology Trends,? Navigant/HFMA, September 2019.

[5] Ibid.

[6] Philip Betbeze, ?Claims Appeals Cost Hospitals Up to $8.6B Annually,? HealthLeaders, June 26, 2017.

[7] Chris Wyatt, ?Optimizing the Revenue Cycle Requires a Financially Integrated Network,? HFMA, July 7, 2015.

[8] ?EHRs, Consumer Self-Pay Remain Providers?Top Revenue Cycle Challenges,? 019 Navigant/HFMA Revenue Cycle Trends Survey, Sept. 25, 2019.

[9] ?Revenue Cycle Technology Trends,? Navigant/HFMA, September 2019

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PARA Weekly eJournal: November 6, 2019

CALIFORNIA DOH LAB PAYMENT REPORTING REQUIREMENTS

Hundreds of California hospitals are struggling with a requirement to report payment data on laboratory services for all of 2018 to the California State Department of Health Care Services (DHCS). DHCS mailed letters in February reminding hospitals of their obligation to report 2018 payment data on lab services by June 30, 2019 (see a copy on the last page of this document).

Failure to report the data can result in suspension from participation in the Medi-Cal program. This obligation poses a very tough problem for hospitals which do not ?line item post? remittances for lab services.

PARA can help. Please contact your Account Executive for a proposal to mine data from the hospital?s electronic claim file, remittance files, or transaction files which may substantially advance the hospital?s compliance with the data submission requirement.

DHCS has posted a list of the NPIs of organizations that are required to report payment data by CPTÂŽ for all bill types. There is also a list of the laboratory CPTÂŽs which must be reported. https://www.dhcs.ca.gov/provgovpart/Pages/CLLS.aspx

Links and excerpts from the State regulations which impose this requirement are provided below: http://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=201120120AB1494

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PARA Weekly eJournal: November 6, 2019

CALIFORNIA DOH LAB PAYMENT REPORTING REQUIREMENTS

Assembly Bill No. 1494 CHAPTER 28 SEC. 9.

Section 14105.22 of the Welfare and Institutions Code, as added by Section 64 of Chapter 230 of the Statutes of 2003, is amended to read: 14105.22. (a) (1) Reimbursement for clinical laboratory or laboratory services, as defined in Section 51137.2 of Title 22 of the California Code of Regulations, may not exceed 80 percent of the lowest maximum allowance established by the federal Medicare Program for the same or similar services.

(2) This subdivision shall be implemented only until the new rate methodology under subdivision (b) is approved by the federal Centers for Medicare and Medicaid Services (CMS). (b) (1) It is the intent of the Legislature that the department develop reimbursement rates for clinical laboratory or laboratory services that are comparable to the payment amounts received from other payers for clinical laboratory or laboratory services. Development of these rates will enable the department to reimburse clinical laboratory or laboratory service providers in compliance with state and federal law.

(2) (A) The provisions of Section 51501(a) of Title 22 of the California Code of Regulations shall not apply to laboratory providers reimbursed under the new rate methodology developed for clinical laboratories or laboratory services pursuant to this subdivision.

(B) In addition to subparagraph (A), laboratory providers reimbursed under any payment reductions implemented pursuant to this section shall not be subject to the provisions of Section 51501(a) of Title 22 of the California Code of Regulations for 12 months following the date of implementation of this reduction.

(3) Reimbursement to providers for clinical laboratory or laboratory services shall not exceed the lowest of the following: (A) The amount billed.

(B) The charge to the general public.

(C) Eighty percent of the lowest maximum allowance established by the federal Medicare Program for the same or similar services.

(D) A reimbursement rate based on an average of the lowest amount that other payers and other state Medicaid programs are paying for similar clinical laboratory or laboratory services. http://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=201320140AB1124 Assembly Bill No. 1124, CHAPTER 8 (3) Reimbursement to providers for clinical laboratory or laboratory services shall not exceed the lowest of the following: (A) The amount billed (B) The charge to the general public (C) Eighty percent of the lowest maximum allowance established by the federal Medicare Program for the same or similar services (D) A reimbursement rate based on an average of the lowest amount that other payers and other state Medicaid programs are paying for similar clinical laboratory or laboratory services 21

PARA Weekly eJournal: November 6, 2019

CALIFORNIA DOH LAB PAYMENT REPORTING REQUIREMENTS

A(4) (A) In addition to the payment reductions implemented pursuant to Section 14105.192, payments shall be reduced by up to 10 percent for clinical laboratory or laboratory services, as defined in Section 51137.2 of Title 22 of the California Code of Regulations, for dates of service on and after July 1, 2012. The payment reductions pursuant to this paragraph shall continue until the new rate methodology under this subdivision has been approved by CMS. (B) Notwithstanding subparagraph (A), the Family Planning, Access, Care, and Treatment (Family PACT) Program pursuant to subdivision (aa) of Section 14132 shall be exempt from the payment reduction specified in this section.

(5) (A) For purposes of establishing reimbursement rates for clinical laboratory or laboratory services based on the lowest amounts other payers are paying providers for similar clinical laboratory or laboratory services, laboratory service providers shall submit data reports within 11 months of the date the act that added this paragraph becomes effective and annually thereafter.

The data initially provided shall be for the 2011 calendar year, and for each subsequent year, shall be based on the previous calendar year and shall specify the provider?s lowest amounts other payers are paying, including other state Medicaid programs and private insurance, minus discounts and rebates. The specific data required for submission under this subparagraph and the format for the data submission shall be determined and specified by the department after receiving stakeholder input pursuant to paragraph (7). (B) The data submitted pursuant to subparagraph (A) may be used to determine reimbursement rates by procedure code based on an average of the lowest amount other payers are paying providers for similar clinical laboratory or laboratory services, excluding significant deviations of cost or volume factors and with consideration to geographical areas. The department shall have the discretion to determine the specific methodology and factors used in the development of the lowest average amount under this subparagraph to ensure compliance with federal Medicaid law and regulations as specified in paragraph (10).

(C) For purposes of subparagraph (B), the department may contract with a vendor for the purposes of collecting payment data reports from clinical laboratories, analyzing payment information, and calculating a proposed rate.

(D) The proposed rates calculated by the vendor described in subparagraph (C) may be used in determining the lowest reimbursement rate for clinical laboratories or laboratory services in accordance with paragraph (3).

(E) Data reports submitted to the department shall be certified by the provider?s certified financial officer or an authorized individual.

(F) Clinical laboratory providers that fail to submit data reports within 30 working days from the time requested by the department shall be subject to the suspension provisions of subdivisions (a) and (c) of Section 14123.

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PARA Weekly eJournal: November 6, 2019

CALIFORNIA DOH LAB PAYMENT REPORTING REQUIREMENTS

http://leginfo.legislature.ca.gov/faces/codes_displayText.xhtml?lawCode=WIC&division=9.&title =&part=3.&chapter=7.&article=3 Welfare and Institutions Code WIC DIVISION 9. PUBLIC SOCIAL SERVICES [10000 - 18999.8] ( Division 9 added by Stats. 1965, Ch. 1784. ) PART 3. AID AND MEDICAL ASSISTANCE [11000 - 15771] ( Part 3 added by Stats. 1965, Ch. 1784. ) CHAPTER 7. Basic Health Care [14000 - 14199.56] ( Chapter 7 added by Stats. 1965, 2nd Ex. Sess., Ch. 4. ) ARTICLE 3. Administration [14100 - 14124.14] ( Article 3 added by Stats. 1965, 2nd Ex. Sess., Ch. 4. ) 14123.

Participation in the Medi-Cal program by a provider of service is subject to suspension in order to protect the health of the recipients and the funds appropriated to carry out this chapter. (a) (1) The director may suspend a provider of service from further participation under the Medi-Cal program for violation of any provision of this chapter or Chapter 8 (commencing with Section 14200) or any rule or regulation promulgated by the director pursuant to those chapters.

The suspension may be for an indefinite or specified period of time and with or without conditions, or may be imposed with the operation of the suspension stayed or probation granted. The director shall suspend a provider of service for conviction of any felony or any misdemeanor involving fraud, abuse of the Medi-Cal program or any patient, or otherwise substantially related to the qualifications, functions, or duties of a provider of service.

(2) If the provider of service is a clinic, group, corporation, or other association, conviction of any officer, director, or shareholder with a 10 percent or greater interest in that organization, of a crime described in paragraph (1) shall result in the suspension of that organization and the individual convicted if the director believes that suspension would be in the best interest of the Medi-Cal program. If the provider of service is a political subdivision of the state or other government agency, the conviction of the person in charge of the facility of a crime described in paragraph (1) may result in the suspension of that facility. The record of conviction or a certified copy thereof, certified by the clerk of the court or by the judge in whose court the conviction is had, shall be conclusive evidence of the fact that the conviction occurred. A plea or verdict of guilty, or a conviction following a plea of nolo contendere is deemed to be a conviction within the meaning of this section.

(3) After conviction, but before the time for appeal has elapsed or the judgment of conviction has been affirmed on appeal, the director, if he or she believes that suspension would be in the best interests of the Medi-Cal program, may order the suspension of a provider of service. When the time for appeal has elapsed, or the judgment of conviction has been affirmed on appeal or when an order granting probation is made suspending the imposition of sentence irrespective of any subsequent order under Section 1203.4 of the Penal Code allowing a person to withdraw his or her plea of guilty and to enter a plea of not guilty, or setting aside the verdict of guilty, or dismissing the accusation, information, or indictment, the director shall order the suspension of a provider of service.

The suspension shall not take effect earlier than the date of the director?s order. Suspension following a conviction is not subject to the proceedings required in subdivision (c). However, the director may grant an informal hearing at the request of the provider of service to determine in the director?s sole discretion if the circumstances surrounding the conviction justify rescinding or otherwise modifying the suspension provided for in this subdivision.

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PARA Weekly eJournal: November 6, 2019

CALIFORNIA DOH LAB PAYMENT REPORTING REQUIREMENTS

(4) If the provider of service appeals the conviction and the conviction is reversed, the provider may apply for reinstatement to the Medi-Cal program after the conviction is reversed.

Notwithstanding Section 14124.6, the application for reinstatement shall not be subject to the one-year waiting period for the filing of a reinstatement petition pursuant to Section 11522 of the Government Code. (b) Whenever the director receives written notification from the Secretary of the United States Department of Health and Human Services that a physician or other individual practitioner has been suspended from participation in the Medicare or Medicaid programs, the director shall promptly suspend the practitioner from participation in the Medi-Cal program and notify the Administrative Director of the Division of Workers?Compensation of the suspension, in accordance with paragraph (2) of subdivision (e). This automatic suspension is not subject to the proceedings required in subdivision (c). No payment from state or federal funds may be made for any item or service rendered by the practitioner during the period of suspension. (c) The proceedings for suspension shall be conducted pursuant to Section 100171 of the Health and Safety Code. The director may temporarily suspend any provider of service prior to any hearing when in his or her opinion that action is necessary to protect the public welfare or the interests of the Medi-Cal program. The director shall notify the provider of service of the temporary suspension and the effective date thereof and at the same time serve the provider with an accusation. The accusation and all proceedings thereafter shall be in accordance with Section 100171 of the Health and Safety Code. Upon receipt of a notice of defense by the provider, the director shall set the matter for hearing within 30 days after receipt of the notice. The temporary suspension shall remain in effect until such time as the hearing is completed and the director has made a final determination on the merits. The temporary suspension shall, however, be deemed vacated if the director fails to make a final determination on the merits within 60 days after the original hearing has been completed. This subdivision does not apply where the suspension of a provider is based upon the conviction of any crime involving fraud, abuse of the Medi-Cal program, or suspension from the federal Medicare program. In those instances, suspension shall be automatic. (d) (1) The suspension by the director of any provider of service shall preclude the provider from submitting claims for payment, either personally or through claims submitted by any clinic, group, corporation, or other association to the Medi-Cal program for any services or supplies the provider has provided under the program, except for services or supplies provided prior to the suspension.

No clinic, group, corporation, or other association which is a provider of service shall submit claims for payment to the Medi-Cal program for any services or supplies provided by a person within the organization who has been suspended or revoked by the director, except for services or supplies provided prior to the suspension.

(2) If the provisions of this chapter, Chapter 8 (commencing with Section 14200), or the regulations promulgated by the director are violated by a provider of service that is a clinic, group, corporation, or other association, the director may suspend the organization and any individual person within the organization who is responsible for the violation.

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PARA Weekly eJournal: November 6, 2019

CALIFORNIA DOH LAB PAYMENT REPORTING REQUIREMENTS

(e) (1) Notice of the suspension shall be sent by the director to the provider?s state licensing, certifying, or registering authority, along with the evidence upon which the suspension was based.

(2) At the same time notice is provided pursuant to paragraph (1), the director shall provide written notification of the suspension to the Administrative Director of the Division of Workers?

Compensation, for purposes of Section 139.21 of the Labor Code. (f) In addition to the bases for suspension contained in subdivisions (a) and (b), the director may suspend a provider of service from further participation under the Medi-Cal dental program for the provision of services that are below or less than the standard of acceptable quality, as established by the California Dental Association Guidelines for the Assessment of Clinical Quality and Professional Performance, Copyright 1995, Third Edition, as periodically amended. The suspension shall be subject to the requirements contained in subdivisions (a) to (e), inclusive.

(Amended by Stats. 2016, Ch. 852, Sec. 3. (AB 1244) Effective January 1, 2017.)

A copy of a DHCS letter received by one hospital is provided here.

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PARA Weekly eJournal: November 6, 2019

2020 CODING UPDATE DOCUMENTS AVAILABLE

In preparation for the year-end CPT®/HCPCS update, PARA has prepared eleven brief ?2020 Coding Update? documents listing deleted codes and added codes within a particular clinical area or procedure group. The documents are available on the PARA Data Editor ?Advisor? tab.

The coding topics addressed do not encompass all CPT® updates, only those which are most likely to be ?hard-coded? to a line item in a facility chargemaster. Topics are divided into immediately related areas, and more than one paper may contain information useful to a service line manager.

Due to CPT® licensing restrictions, these documents cannot be published within the PARA Weekly Update. PARA Data Editor users may access the information on the Advisor tab; search ?Coding Update? in the type field, and/or 2020 in the subject field, as illustrated below:

Medicare coverage information is not available on all of the new codes at this time. Following the release of the OPPS Final Rule in November, coding update papers will be revised to indicate whether Medicare will accept/cover the new codes that are not clear.

PARA Data Editor users can identify updated papers by the word ?Revised? in the title and the date issued will be updated.

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PARA Weekly eJournal: November 6, 2019

WEEKLY IT UPDATE

PARA HealthCare Analytics has provided a list of enhancements and updates that our Information Technology (IT) team has made to the PARA Data Editor this past week.

The following tables includes which version of the PDE was updated, the location within the PDE, and a description of the enhancement.

Week ly IT Updat e

T his Week 's Updates

Prev ious Updates

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PARA Weekly eJournal: November 6, 2019

PAMA PRIVATE PAYER LAB PAYMENT RATE REPORTING

In the 2019 OPPS Final Rule Medicare added a new reporting requirement to hospital ?outreach? laboratories which submit claims for non-patient services, i.e. blood sample processing without patient contact, on the ?non-patient services? 14X type of bill (TOB.) In early 2020, hospitals will be required to report private payor payment rates for the same tests that Medicare reimburses on the clinical laboratory fee schedule if they received greater than $12,500 in Medicare revenues/reimbursement for claims billed on the 141 TOB for dates of service between January 1, 2019 and June 30, 2019.

CMS will collect private-payer data from hospitals for January through June of 2019, and use it to develop the overall weighted median payment rate for each test under the Clinical Laboratory Fee Schedule (CLFS). The weighted median will then serve as the basis of reimbursement for three years beginning in 2021.

Medicare clarified reporting requirements in an MLN article published in late February, 2019: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/ MLNMattersArticles/Downloads/SE19006.pdf

Hospitals conducting ?outreach? laboratory service should verify whether the 141 bill type was used to report ?non-patient services? for lab testing. Regardless if the outreach lab services are reported under the same NPI as the hospital, the hospital must evaluate whether it meets two other tests, and report private payer data if it meets the tests for an ?applicable laboratory.?

Hospitals with labs billing on the 141 TOB are required to report payment data if: - the hospital receives more than $12,500 in Medicare revenue/reimbursement for non-patient clinical lab services reported on bill type 141 in the period January 1 through June 30 2019, and - the majority of revenue/reimbursements received from Medicare for services billed on the 141 bill type were paid under the Clinical Lab Fee Schedule (this is highly likely for TOB 141 claims.)

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PARA Weekly eJournal: November 6, 2019

PAMA PRIVATE PAYER LAB PAYMENT RATE REPORTING

If a hospital is required to report, private payer data must be collected for the period 1/1/19 through 6/30/19, analyzed, validated, and reported to Medicare in the next reporting period, 1/1/20 through 3/31/20. The window for reporting this data to Medicare is after January 1, 2020, but no later than March 31, 2020. Significant penalties (of $10,017 per violation per day) may apply if reporting is not complete, accurate, and timely. There is no exception for Critical Access Hospitals.

Since the vast majority of services billable on the 141 type of bill are paid under the Clinical Lab Fee Schedule, the central question is whether the hospital received $12,500 in reimbursement from Medicare (not including managed Medicare) during the data collection period January through June 2019 for non-patient lab testing.

PARA clients can reasonably assess whether the $12,500 threshold was met by contacting their PARA Account Executive. PARA purchases Medicare outpatient claims data for prior periods, and this data includes payments made on the 14X type of bill by Medicare. We have 2018 and Q1 2019, Q2 will be available soon.

If the sum of payments on 141 TOB indicate that the hospital has met or exceeded the $12,500 threshold in the period January through June, 2019, then the hospital should prepare to report data for the January-June 2019 data collection period.

PARA offers assistance with generating the data required for reporting private payer rates. The PARA Data Editor offers the ability to analyze electronic remittance files to quickly generate a spreadsheet of the allowable rate paid by CPTÂŽ codes on 141 bill types. This data will be configured into the required format for Medicare reporting.

Clients will likely have some payments that will require manual research if not paid on a submitted 835 file, since PARA cannot research payments submitted on paper remittances.

To learn more about PARA?s Lab Payment Reporting Analytical Services, please contact your PARA account executive (Sandra LaPlace at slaplace@para-hcfs.com, or Violet Archuleta-Chiu at varchuleta@para-hcfs.com.)

A link and an excerpt from the Medicare MLN Matters publication on this topic is provided below: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/ Downloads/SE19006.pdf

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PARA Weekly eJournal: November 6, 2019

PAMA PRIVATE PAYER LAB PAYMENT RATE REPORTING

Additionally, Medicare updated an FAQ document on September 9, 2019 at the following link: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/ Downloads/CY2019-CLFS-FAQs.pdf

Finally, excerpts from the 2019 Clinical Lab Fee Schedule Final Rule regarding penalties and certification are provided below: https://www.govinfo.gov/content/pkg/FR-2016-06-23/pdf/2016-14531.pdf Federal Register / Vol. 81, No. 121 / Thursday, June 23, 2016 / Rules and Regulations; page 41038 ?? We proposed to apply a civil monetary penalty (CMP) to an applicable laboratory that fails to report or that makes a misrepresentation or omission in reporting applicable information. We proposed to require all data to be certified by the President, Chief Executive Officer (CEO), or Chief Financial Officer (CFO) of an applicable laboratory before it is submitted to CMS. As required by section 1834A(a)(10) of the Act, certain information disclosed by a laboratory under section 1834A(a) of the Act is confidential and may not be disclosed by the Secretary or a Medicare contractor in a form that reveals the identity of a specific payor or laboratory, or prices, charges or payments made to any such laboratory, with several exceptions. We are revising the certification and CMP 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 delegated to sign for, and who reports directly to such an officer. Similarly, the reporting entity will be subject to CMPs for the failure to report or the misrepresentation or omission in reporting applicable information. Additionally, we are updating the CMP amount to reflect changes required by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Sec. 701 of the Bipartisan Budget Act of 2015, Pub. L. 114?74, November 2, 2015).

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PARA Weekly eJournal: November 6, 2019

PAMA PRIVATE PAYER LAB PAYMENT RATE REPORTING

Comment: Several commenters commented on the proposed CMPs of up to $10,000 per day per violation and said the amount should be reconsidered, particularly for community laboratories that cannot afford such penalties. The commenters also suggested that CMS only apply penalties in cases where there is evidence that a laboratory intentionally provided inaccurate or mistaken information.

Response: The statute authorizes CMPs of up to $10,000 per day per violation. However, in situations where our review reveals that the data submitted is incomplete or incorrect, we will work with the OIG to assess whether a CMP should be applied, and if so, the appropriate amount based on the specific circumstances. Although the statute authorizes CMPs of up to $10,000 per day per violation, we recognize that this is the maximum statutory amount, and not a minimum. The actual penalty imposed will be determined based on the facts and circumstances of each violation.

We note that this amount was recently amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Sec. 701 of the Bipartisan Budget Act of 2015, Public Law 114?74, November 2, 2015) (the 2015 Act), which amends the Federal Civil Penalties Inflation Adjustment Act of 1990 (the Inflation Adjustment Act) (Pub. L. 101?410, 104 Stat. 890 (1990) (codified as amended at 28 U.S.C. 2461 note 2(a)). The Inflation Adjustment Act required all agencies, including HHS, to adjust any CMPs within their jurisdiction by increasing the maximum CMP or the range of minimum and maximum CMPs, as applicable, for each CMP by the cost-of-living adjustment.

The 2015 Act was enacted to improve the effectiveness of civil monetary penalties and to maintain their deterrent effect. Among other things, it revises the method of calculating inflation adjustments so that, instead of the significant rounding methodology applied under the Inflation Adjustment Act, penalty amounts are now simply rounded to the nearest $1.

Accordingly, in applying the requirements of the Inflation Adjustment Act, as amended, to the penalty amounts specified in section 1834A(a)(9) of the Act, the Secretary may assess CMPs of up to $10,017 per day per violation beginning on the effective date of this rule. We have revised ยง 414.504(e) to reflect this statutory adjustment.

The 2015 Act also requires agencies to publish annual adjustments not later than January 15 of every year after publication of the initial adjustment. Therefore, subsequent to this initial adjustment, CMP adjustments applicable to section 1834A of the Act will be updated annually through regulations published by the Secretary no later than January 15 of every year.

Comment: Several commenters requested clarification as to what constitutes an error that warrants a penalty, and stated that CMS should not apply any penalties or sanctions for reporting errors until an appeals process is outlined. Some commenters stated that CMS indicated in the proposed rule that full implementation of the new CLFS regulations will take between 5 and 6 years, and suggested that no penalties be assessed during this time.

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PARA Weekly eJournal: November 6, 2019

PAMA PRIVATE PAYER LAB PAYMENT RATE REPORTING

Response: As previously mentioned, following the publication of this final rule, we will issue additional guidance on the assessment of CMPs, including what would constitute a failure to report or a misrepresentation or omission in reporting.

We also note that we do not intend to assess CMPs for minor errors.

The actual penalty imposed will be determined based on the facts and circumstances of each violation.

While full implementation of the new CLFS regulations will take several years, it is critical that reporting entities provide accurate and complete information at the outset so that accurate prices can be set, and while we do not expect that CMPs will be assessed frequently, we believe the ability to assess CMPs on reporting entities when appropriate is consistent with our statutory authority.

Section 1834A(a)(9)(B) of the Act further provides that the provisions of section 1128A of the Act (other than sections (a) and (b)) shall apply to a CMP under this paragraph in the same manner as they apply to a CMP or proceeding under section 1128A(a) of the Act. Comment: A commenter stated that the economics and other characteristics of the laboratory industry differ greatly from the pharmaceutical industry making the comparison to Part B drugs inapplicable.

Response: We agree there are important differences between the pharmaceutical industry and the laboratory industry, but believe the general approach taken for the application of CMPs for violations in reporting drug prices is an appropriate model to consider when we develop guidance on the application of CMPs for violations in reporting of applicable information.

Comment: A commenter stated that CMPs can be an effective tool for encouraging data reporting and ensuring compliance with the PAMA reporting obligations but that there will be significant confusion within the laboratory community initially.

The commenter requested that CMS not impose CMPs during the initial cycle on any laboratory that has shown a good faith effort to comply with the reporting requirements, and that CMS should notify applicable laboratories of their reporting obligations to ensure compliant reporting and to reduce the likelihood of penalties.

Response: We appreciate the commenter?s understanding of the important role of CMPs in ensuring accurate and complete data reporting and acknowledge the commenter?s concerns regarding the provision of data during the initial reporting period. We are uncertain as to what the commenter means by ??any laboratory that has shown a good faith effort to comply with the reporting requirements??As we have noted previously, we do not intend to assess CMPs for minor errors, and will provide additional information in subregulatory guidance to facilitate compliant reporting and to reduce the likelihood of penalties.

Additionally, we are clarifying in ยง 414.504(e) that the CMPs will be assessed at the reporting entity level, not at the applicable laboratory level, to ensure consistency with the data reporting and certification 32

PARA Weekly eJournal: November 6, 2019

PAMA PRIVATE PAYER LAB PAYMENT RATE REPORTING

Comment: Some commenters stated that smaller laboratories without sufficient administrative staff face challenges in reporting as compared to larger, well-resourced laboratories. These commenters suggested that the size of the penalty should correspond to the size of the laboratory, so that laboratories with limited resources would not be forced to close as a result of such penalties.

Response: We will consider all relevant information when determining the amount of a CMP, and we will work with the OIG to ensure that any penalties assessed are fairly applied. The purpose of PAMA is to collect complete and accurate data in order to set payment rates, not to force a laboratory to close as a result of a CMP assessment.

Comment: Some commenters were concerned that the period to understand and comply with the data requirements is too short and could compromise the integrity of the data submitted.

Response: In section II.D of this final rule, we discuss our final data collection and reporting process, which is changed from our proposal in the proposed rule.

Under the process we are adopting in this final rule, applicable laboratories will have a 6-month data collection period, followed by a 6-month period between the end of the data collection period and the beginning of the data reporting period to allow applicable laboratories time to ensure the accuracy of their data, followed by a 3-month data reporting period during which reporting entities will report applicable information to us.

We believe this process will provide applicable laboratories adequate time to understand and prepare for the submission of the required data.

Comment: Some commenters noted that accidental errors are inevitable with a new, first-of-its-kind, untested laboratory price reporting system, and the associated fines are significant. These commenters also opined that the new reporting requirements will require significant changes for the clinical laboratory community to undertake with no funding provided to make those changes, and that implementation of this law is being fast-tracked, which will lead to mistakes and unexpected problems.

Response: As discussed in section II.D.3 of this final rule, we are moving the implementation date of section 1834A of the Act to January 1, 2018. We expect applicable laboratories will have sufficient time to review their data for accuracy and completeness during the 6-month time period we are affording between the end of the data collection period and the beginning of the data reporting period. We recognize that there is a cost associated with the development and submission of data under section 1834A of the Act, but we believe this data submission process is an essential mechanism to establish fair and accurate Medicare payment rates for CDLTs. We are proceeding with implementation of the new reporting requirements in accordance with the statutory requirements, notwithstanding the new implementation date of January 1, 2018.

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PARA Weekly eJournal: November 6, 2019

PAMA PRIVATE PAYER LAB PAYMENT RATE REPORTING

2. Data Certification Section 1834A(a)(7) of the Act requires that an officer of each laboratory must certify the accuracy and completeness of the reported information required by section 1834A(a) of the Act. We proposed to implement this provision by requiring in ยง 414.504(d) that the President, CEO, or CFO of an applicable laboratory or an individual who has been delegated authority to sign for, and who reports directly to, the laboratory?s President, CEO, or CFO, must sign a certification statement and be responsible for assuring that the applicable information provided is accurate, complete, and truthful, and meets all the reporting parameters. We stated that we would specify the processes for certification in subregulatory guidance prior to January 1, 2016.

A discussion of the comments we received on this topic, and our responses to those comments, appears below.

Comment: A few commenters objected to our plan to specify the processes for certification in subregulatory guidance prior to January 1, 2016, stating that some of these process issues need to be resolved in the final rule before subregulatory guidance is issued. Others have asked that the subregulatory guidance be issued as soon as possible.

Response: We will issue subregulatory guidance specifying the certification process for the submission of applicable information following publication of this final rule.

As discussed in section II.D.3 of this final rule, we are moving the implementation date of the revised CLFS to January 1, 2018, so we now expect to issue the subregulatory guidance prior to January 1, 2018.

Comment: Some commenters requested that CMS create a certification form for applicable laboratories that states that the information and statements submitted are accurate and complete to the best of the laboratory?s knowledge and the submission is made in good faith.

Response: We appreciate the commenters?suggestion and will take it into consideration as we develop subregulatory guidance for the certification process following the publication of this final rule.

Comment: Some commenters stated that most laboratory Presidents, CEOs, and CFOs are not personally familiar with the volume and private payor rates for each laboratory test their labs offer, and they should not be required to certify the accuracy of the data submitted. The commenter suggested that a laboratory officer should be responsible for certifying that the data submitted is accurate to the best of his or her knowledge.

Response: We agree with the commenter and in accordance with the changes to the data reporting requirements in this final rule, we have revised ยง 414.504(d) to require the President, CEO, or CFO of the reporting entity or an individual who has been delegated authority to sign for, and who reports directly to, such an officer to certify the accuracy of the data submitted for the 34 reporting entity.

PARA Weekly eJournal: November 6, 2019

PARA YEAR-END HCPCS UPDATE PROCESS -- NEW UPDATES

As usual, PARA clients will be fully supported with information and assistance on the annual CPT速 HCPCS coding updates.

The PARA Data Editor (PDE) contains a copy of each client chargemaster; we use the powerful features of the PDE to identify any line item in the chargemaster which has a HCPCS code assigned that will be deleted as of January 1, 2020. For this reason, it is important that clients check to ensure that a recent copy of the chargemaster has been supplied to PARA for use in the year-end update.

PARA will produce excel spreadsheets of each CDM line item, as well as our recommendation for alternate codes, in three waves as information is released from the following sources: 1. The American Medical Association?s publication of new, changed, and deleted CPT速 codes; this information is released in September of each year. PARA will produce the first spreadsheet of CPT速 updates for client review in October, 2019.

2. Medicare?s 2019 OPPS Final Rule, typically published the first week of November; PARA will perform analysis and produce the second spreadsheet to include both the CPT速 information previously supplied, as well as alpha-numeric HCPCS updates (J-codes, G-codes, C-codes, etc.) from the Final Rule. Clients may expect this spreadsheet to be available in November, 2019.

3. Medicare?s 2018 Clinical Lab Fee Schedule (CLFS) ? typically published in late November, the CLFS will reveal whether Medicare will accept new CPTs generated by the AMA, or whether Medicare will require another reporting method. The final spreadsheet will be available in December, 2019.

Clients will be notified by email as spreadsheets are produced and recorded on the PARA Data Editor ?Admin? tab, under the ?Docs? subtab. The spreadsheet will appear.

In addition, PARA consultants will publish concise papers on coding update topics in order to ensure that topical information is available in a manner that is organized and easy to understand. PARA clients may rest assured that they will have full support for year-end HCPCS coding updates to the chargemaster.

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PARA Weekly eJournal: November 6, 2019

USE OF KX MODIFIER FOR PART B IMMUNOSUPPRESIVE DRUG CLAIMS

Medicare covers Part B beneficiaries for immunosuppressive drugs when the patient has received an organ transplant paid through Medicare Part A. If the Medicare Common Working File (CWF) cannot locate the claim that paid for the transplant in the patient?s Master Beneficiary Record (MBR), the claim line for the drug will deny.

This could happen in cases where the patient was enrolled in a Medicare Advantage (MA) program. The CWF does not have a record of the transplant unless Medicare paid for the procedure. To ensure payment for claims when a beneficiary is covered, a KX modifier may be used to indicate the beneficiary meets the coverage requirements.

Additional information can be found through CMS through the link below: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/ Fast-Facts/Proper-Use-KX-Modifier-for-Part-B-Immunosuppressive-Drug-Claims.html

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PARA Weekly eJournal: November 6, 2019

USE OF KX MODIFIER FOR PART B IMMUNOSUPPRESIVE DRUG CLAIMS

Use of the KX modifier indicates that the supplier of the drug (e.g., pharmacies) attests the patient was eligible for Medicare Part A on the date of the transplant, the immunosuppressive drugs are medically necessary, and the transplant date and eligibility are documented in the patient?s record. Additionally, the date of the transplant must precede the date of service of administration of first immunosuppressive drug.

If the supplier is not able to meet the requirements for using the KX modifier, they cannot bill Medicare for the immunosuppressive drug. The supplier also may not issue the beneficiary an ABN or collect or bill for the drug.

CMS provided additional information after an OIG audit reported that of 75 claims reviewed, 10 did not support the use of the KX modifier. https://oig.hhs.gov/oas/reports/region6/61500018.pdf

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PARA Weekly eJournal: November 6, 2019

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!

Thursday, October 31, 2019 New s

· Protect Your Patients?Identities: Use the MBI Now · Hospital Value-Based Purchasing Program Results for FY 2020 · IRF/LTCH/SNF Quality Reporting Program Submission Deadline: November 15 · Nursing Home Compare Refresh · Influenza Vaccination: Protect Your Patients this Season Com plian ce

· DMEPOS: Bill Correctly for Items Provided During Inpatient Stays Claim s, Pr icer s & Codes

· Liver Transplant Claims: Possible Overpayment Even t s

· Submitting Your Medicare Part A Cost Report Electronically Webcast ? November 5

· Clinical Diagnostic Laboratory Test Payment System: Data Reporting Call ? November 14

· Success with the Hospice Quality Reporting Program Webinar ? November 14 M LN M at t er s® Ar t icles

· Billing Instructions for Beneficiaries Enrolled in Medicare Advantage (MA) Plans for Services Covered by Decision Memo CAG-00451N

· Overview of the Repetitive, Scheduled Non-emergent

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PARA Weekly eJournal: November 6, 2019

There were THREE new or revised Med Learn (MLN Matters) article released this week.

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

FIND ALL THESE MED LEARNS IN THE ADVISOR TAB OF THE PDE

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PARA Weekly eJournal: November 6, 2019

The link to this Transmittal MM11327

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The link to this Transmittal MM11508

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The link to this Transmittal MM11485

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PARA Weekly eJournal: November 6, 2019

There were NINE new or revised Transmittals released this week.

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

9

FIND ALL THESE TRANSMITTALS IN THE ADVISOR TAB OF THE PDE

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PARA Weekly eJournal: November 6, 2019

The link to this Transmittal R128GI

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The link to this Transmittal R4443CP

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The link to this Transmittal R233DEMO

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The link to this Transmittal R4431CP

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The link to this Transmittal R2377OTN

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The link to this Transmittal R2378OTN

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The link to this Transmittal R2379OTN

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The link to this Transmittal R2382OTN

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The link to this Transmittal R4424CP

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PARA Weekly eJournal: November 6, 2019

Con t act Ou r Team

Peter Ripper

M onica Lelevich

Randi Brantner

President

Director Audit Services

Director Financial Analytics

m lelevich@para-hcfs.com

rbrantner@para-hcfs.com

pripper@para-hcfs.com

Violet Archuleta-Chiu Senior Account Executive

Sandra LaPlace

Steve M aldonado

Account Executive

Director Marketing

slaplace@para-hcfs.com

smaldonado@para-hcfs.com

varchuleta@para-hcfs.com

In t r odu cin g, ou r n ew par t n er .

Nikki Graves

Sonya Sestili

Deann M ay

Senior Revenue Cycle Consultant

Chargemaster Client Manager

h f r Review i.n et Claim Specialist

ngraves@para-hcfs.com

ssestili@para-hcfs.com

dmay@para-hcfs.com

M ary M cDonnell

Patti Lew is

Director, PDE Training & Development

Director Business Operations

mmcdonnell@para-hcfs.com

plewis@para-hcfs.com

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