PARA HealthCare Analytics Weekly eJournal October 16, 2019 by CorroHealth

PARA

O ctober 16, 2019 an HFRI Company

HealthCare Analytics

Weekly

eJOURNAL

NEWS FOR HEALTHCARE DECISION MAKERS

IN THIS ISSUE

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QUESTIONS & ANSWERS - ALS2 Procedure - 93668 PAD Rehabilitation - Platelet Charge - Global Billing - Coding And Reimbursement For Hormonal Replacement - Billing For Inpatient Vaccines MODIFIER REQUIREMENTS FOR SERVICES FROM THERAPY ASSISTANTS

California Department Of Health Lab Payment Reporting Requirements

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

PAMA PRIVATE PAYER LAB PAYMENT RATE REPORTING

The number of new or revised Transmittals released this week.

2020 Coding Update Documents Available

ACCURATE CODING FOR VACCINES REQUIRES PRECISION USE OF KX MODIFIER FOR PART B IMMUNOSUPPRESSIVE DRUG CLAIMS

PARA COMPANY NEWS

SERVICES

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ge a P 1 2

Administration: Pages 1-48 HIM /Coding Staff: Pages 1-48 Providers: Pages 2,6,8,12,21,33 Respiratory Therapy: Pages 5,19 Hematology: Page 6 Women's Health: Page 8 Pharmacy: Pages 12,30,34,38,41

- California Providers: Page 13 - Laboratory Services: Pages 13,22 - Finance: Pages 21,32,35,42 - Skilled Nursing Facilities: Page 36 - Home Health: Pages 39,45

PARA Weekly eJournal: October 16, 2019

ALS2 PROCEDURE

A question has come to light about an ambulance patient whose airway was protected using a King Airway -- and as to whether or not this constitutes a level 2 ALS call. A King Airway is a blind airway insertion device which we use now in place of a Combi-Tube.

Answer: Medicare does not describe which brand of airway constitutes an ALS procedure, but Medicare specifically identifies endotracheal intubation as an ALS2 procedure. According to our research, the King airway is not inserted into the trachea, therefore it?s use is not considered endotracheal intubation. Consequently, it is not an ALS2 procedure. The King Airway manufacturer?s website describes an airway which seals the esophagus and oropharynx; it does not enter the trachea: https://www.narescue.com/media/custom/upload/File-1443546141.pdf

PARA Weekly eJournal: October 16, 2019

ALS2 PROCEDURE

According to the Merck Manual, endotracheal intubation means that a tube is inserted directly into the trachea: https://www.merckmanuals.com/professional/critical-care-medicine/respiratory-arrest/ airway-and-respiratory-devices An endotracheal tube is inserted directly into the trachea via the mouth or, less commonly, the nose. Another class of rescue ventilation devices is laryngeal tube or twin-lumen airways (eg, CombitubeÂŽ, King LTÂŽ). These devices use 2 balloons to create a seal above and below the larynx and have ventilation ports overlying the laryngeal inlet (which is between the balloons). The Medicare Benefits Policy Manual defines the list of ALS2 procedures, which includes endotracheal intubation: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c10.pdf

Advanced Life Suppor t , Level 1 (ALS1) Definition: Advanced life support, level 1 (ALS1) is the transportation by ground ambulance vehicle (as defined in section 10.1, above) and the provision of medically necessary supplies and services (as defined in section 10.2, above) including the provision of an ALS assessment by ALS personnel or at least one ALS intervention. Advanced Life Suppor t Assessment Definition: An ALS assessment is an assessment performed by an ALS crew as part of an emergency response (as defined below) that was necessary because the patient's reported condition at the time of dispatch was such that only an ALS crew was qualified to perform the assessment. An ALS assessment does not necessarily result in a determination that the patient requires an ALS level of service. In the case of an appropriately dispatched ALS Emergency service, as defined below, if the 3

PARA Weekly eJournal: October 16, 2019

ALS2 PROCEDURE

ALS crew completes an ALS Assessment, the services provided by the ambulance transportation service provider or supplier shall be covered at the ALS emergency level, regardless of whether the patient required ALS intervention services during the transport, provided that ambulance transportation itself was medically reasonable and necessary, as defined in section 10.2, above and all other coverage requirements are met. Advanced Life Suppor t Inter vention Definition: An ALS intervention is a procedure that is in accordance with state and local laws, required to be done by an emergency medical technician-intermediate (EMT-Intermediate) or EMT-Paramedic. Application: An ALS intervention must be medically necessary to qualify as an intervention for payment for an ALS level of service. An ALS intervention applies only to ground transports. Advanced Life Suppor t , Level 1 (ALS1) - Emer gency Definition: When medically necessary, the provision of ALS1 services, as specified above, in the context of an emergency response, as defined below. Advanced Life Suppor t , Level 2 (ALS2) Definition: Advanced life support, level 2 (ALS2) is the transportation by ground ambulance vehicle and the provision of medically necessary supplies and services including (1) at least three separ ate administr ations of one or more medications by intravenous (IV) push/ bolus or by continuous infusion (excluding crystalloid fluids) or (2) ground ambulance transport, medically necessary supplies and services, and the provision of at least one of the ALS2 procedures listed below: a. Manual defibrillation/ cardioversion; b. Endotracheal intubation; c. Central venous line; d. Cardiac pacing; e. Chest decompression; f. Surgical airway; or g. Intraosseous line. ? Endotracheal (ET) intubation (which includes intubating and/ or monitoring/ maintaining an ET tube inserted prior to transport) is a service that qualifies for the ALS2 level of payment. Therefore, it is not necessary to consider medications administered by ET tube to determine whether the ALS2 rate is payable.

PARA Weekly eJournal: October 16, 2019

93668 PAD REHABILITATION

Do you have any information you can share on the appropriate use and coverage for CPTÂŽ 93668 PAD rehab? Answer: NCD 20.35 explains the coverage requirements for Supervised Exercise Therapy, which is reported with 93668 - PERIPHERAL ARTERIAL DISEASE (PAD) REHABILITATION, PER SESSION: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx? NCDId=371&ncdver=1&CoverageSelection=Both&ArticleType=All&PolicyType =Final&s=Indiana&KeyWord=Peripheral&KeyWordLookUp=Title& KeyWordSearchType=And&bc=gAAAACAAAAAA&

Benefit Category - Incident to a Physician's Professional Service - Outpatient Hospital Services Incident to a Physician's Service - Physicians' Services - Please Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service. - Item/Service Description A. General Research has shown supervised exercise therapy (SET) to be an effective, minimally invasive method to alleviate the most common symptom associated with peripheral artery disease (PAD) ? intermittent claudication (IC). SET has been shown to be significantly more effective than unsupervised exercise, and could prevent the progression of PAD and lower the risk of cardiovascular events that are prevalent in these patients. SET has also been shown to perform at least as well as more invasive revascularization treatments that are covered by Medicare. Indications and Limitations of Coverage B. Nationally Covered Indications Effective for services performed on or after May 25, 2017, the Centers for Medicare & Medicaid Services has determined that the evidence is sufficient to cover SET for beneficiaries with IC for the treatment of symptomatic PAD. Up to 36 sessions over a 12-week period are covered if all of the following components of a SET program are met. The SET program must: - consist of sessions lasting 30-60 minutes comprising a therapeutic exercise-training program for PAD in patients with claudication; - be conducted in a hospital outpatient setting, or a physician?s office; - be delivered by qualified auxiliary personnel necessary to ensure benefits exceed harms, and who are trained in exercise therapy for PAD; and - be under the direct supervision of a physician (as defined in 1861(r)(1)), physician assistant, or nurse practitioner/clinical nurse specialist (as identified in 1861(aa)(5)) who must be trained in both basic and advanced life support techniques. Beneficiaries must have a face-to-face visit with the physician responsible for PAD treatment to obtain the referral for SET. At this visit, the beneficiary must receive information regarding cardiovascular 5

PARA Weekly eJournal: October 16, 2019

93668 PAD REHABILITATION

disease and PAD risk factor reduction, which could include education, counseling, behavioral interventions, and outcome assessments. C. Nationally Non-Covered Indications SET is non-covered for beneficiaries with absolute contraindications to exercise as determined by their primary physician. D. Other Medicare Administrative Contractors (MACs) have the discretion to cover SET beyond the nationally covered 36 sessions over a 12-week period. MACs may cover an additional 36 sessions over an extended period of time. A second referral is required for these additional sessions (This NCD last reviewed May 2017.)

PLATELET CHARGE A physician ordered pheresis platelet unit on newborn & the bag contained 226 ml but the physician only gave 31 ml out of the bag & the rest was disposed. There is no pediatric bag for this type of product. So, do we charge for the entire bag or just the portion that was used?

Answer: The hospital may charge for the entire bag. Since the HCPCS for platelets is ?per unit?, the hospital is unable to separately report wastage on a separate line. Also, the JW modifier is required on only Status K and G medications. Platelets are assigned OPPS Status Indicator R.

PARA Weekly eJournal: October 16, 2019

GLOBAL BILLING

I am a nurse practitioner working in a critical access hospital outpatient wound clinic. I am often providing wound care follow up for a local general surgeon's patients (who works for a different, larger organization) with wounds that are not healing as expected, or, sometimes I join him in the operating room and place a wound vac. I am wondering if my follow up visits would technically fit into the 90 day global assignment, or, since I am at a critical access facility that this doesn't apply. These visits normally include wound vac- or- debridement. Answer: The facility fees for services rendered in the global period are not included in the physician?s reimbursement for the global surgical package, therefore the hospital may bill for follow-up care within the global period. The professional fees might be a different matter. It depends on the extent of services required, and whether the surgeon transferred all postoperative care to the nurse practitioner for that surgery. In some instances, a surgeon will bill for the surgical procedure alone by appending modifier 54 to the CPTÂŽ for that procedure; the surgeon then transfers (in writing) all post-op care to another provider. The post-operative care provider appends modifier 55 to the same surgical procedure code, and the payer will split the ?global? reimbursement accordingly.

There are some exceptions to the Use of Modifiers ?-54? and ?-55?, which might apply ? these are explained in a Medicare publication that may be helpful: https://www.cms.gov/Outreach-and-Education/Medicare-LearningNetwork-MLN/MLNProducts/downloads/GloballSurgery-ICN907166.pdf ?Where a transfer of care does not occur, occasional post-discharge services of a physician other than the surgeon are reported by the appropriate E/M code. No modifiers are necessary on the claim. Physicians who provide follow-up services for minor procedures performed in emergency departments bill the appropriate level of E/M code, without a modifier. ?If the services of a physician, other than the surgeon, are required during a post-operative period for an underlying condition or medical complication, the other physician reports the appropriate E/M code. No modifiers are necessary on the claim. An example is a cardiologist who manages underlying cardiovascular conditions of a patient. For more information, refer to the Medicare Claims Processing Manual, Chapter 12, Sections 40.2 and 40.4.? While the information quoted from the publication above offers some reassurance, it?s a fuzzy area in the regulations. Technically, the surgeon is responsible for post-operative care related to the surgery within the global period. That includes wound care. There is a possibility that, if audited, your claims and the claims of the surgeon would be considered duplicative because the surgeon has received payment for all post-op care, including complications. I would be concerned if the treatment plan for the surgical wound requires repeated services, such as weekly visits, debridement(s), NPWT, etc.; extensive services within the global period that are directly related to the surgery should be the financial responsibility of the surgeon. It might be possible to bill the surgeon if s/he still wants you to provide the post-op care, but that would a decision the surgeon should make. 7

PARA Weekly eJournal: October 16, 2019

CODING AND REIMBURSEMENT FOR HORMONAL REPLACEMENT

We would like to offer hormone pellet replacement therapy in our Rural Health Clinic (RHC). What are the criteria for the visit? What is the appropriate diagnosis? What are indications for follow-up care and treatment?

Response: Hormone Pellet Replacement Therapy describes subcutaneously implanted hormone pellets. The individual pellets are smaller than a grain of rice and are implanted into the subcutaneous tissue, where they continuously release the hormone into the bloodstream. The pellets are implanted in the lower abdomen or buttocks. The actual procedure is done in a physician?s office with the use of a local anesthetic and small incision for insertion. The release of the drug is over a time period of 3-6 months. Subcutaneous implantable pellets are made up of estradiol, estrogen, or testosterone in combination with estrogen or estradiol that has been custom compounded by pharmacists in accordance with the physician specifications. It should be noted however, none of these are FDA approved in the U.S. for distribution and their safety and efficacy has not been adequately demonstrated in well-designed clinical trials. Subcutaneous hormone pellets containing estrogen alone or estrogen combinations (including Estradiol and bioidentical hormone formulations) are considered INVESTIGATIVE for all indications including symptoms associated with female menopause. There is a long list of potential adverse effects that could occur with testosterone replacement, examples as follows: - Prostate-related events, including development or worsening of prostate cancer, prostatic hypertrophy, increased in PSA levels, and symptoms of prostatism - Cardiovascular events - Adverse changes in lipid profile - Erythrocytosis and increases in hematocrit - Precipitation or worsening of sleep apnea - Liver toxicity - Suppression of spermatogenesis - Acne - Worsening of male pattern baldness - Gynecomastia Globally, European and American specialty societies recommend replacement testosterone therapy be considered at serum total testosterone levels resulting less than 300-350ng/dL. However, the testing methods for testosterone levels vary making the level of deficiency not standard among providers. 8

PARA Weekly eJournal: October 16, 2019

CODING AND REIMBURSEMENT FOR HORMONAL REPLACEMENT

Medicare will consider testosterone pellets (Testopel) medically reasonable and necessary for the following indications: - Second line testosterone replacement therapy in males with congenital or acquired endogenous androgen absence or deficiency associated with primary or secondary hypogonadism when other standard replacement (intramuscular (IM), buccal, transdermal) is not clinically effective or; - For treatment of delayed male puberty Testosterone pellets (Testopel) method of administration is subcutaneously by a health care professional. Procedure codes: 11980, J3490* (*Testopel) and S0189* (*code not recognized by Medicare):

Diagnosis codes*: E8941, N950, N951, N952, N958, Z79890 (*codes are subject to medical necessity review)

PARA Weekly eJournal: October 16, 2019

CODING AND REIMBURSEMENT FOR HORMONAL REPLACEMENT

Limitations for Testosterone Replacement Therapy: - Androgens are contraindicated in men with carcinomas of the breast or with known or suspected carcinomas of the prostate - For patients that meet the indication for testosterone replacement, the reason(s) for a transition to pellets from other effective replacement (IM, buccal, transdermal) must be specifically addressed in the medical record(s) - Clinical diagnosis of androgen deficiency (non-specific symptoms, low normal testosterone levels, and normal free testosterone) is not a covered indication. Physician Office Practices with high utilization of testosterone pellet implantations can be subject to pre-or-post-payment reviews - Implantable testosterone pellets for the treatment of symptoms associated with menopause is considered not reasonable and necessary as there is insufficient clinical evidence to support this use and is therefore non-covered Hormone Replacement Therapy for Women: Hormone therapy for menopause may also treat long-term changes such as bone-loss that result from declining levels of estrogen and progesterone. In accordance with the Food and Drug Administration (FDA), hormone therapy for women come in the form of a pill, patch, gel, vaginal cream, vaginal insert, skin spray, skin cream or injection. Hormone therapy drugs include: (drugs identified below are not all-inclusive) - Estrogen alone (brand name: Premarin, Estraderm, Divigel, Cenestin, Climara) - Progestin alone (brand name: Prometrium and Provera) Estrogen plus progestin (brand name: Prempro, Femhrt, Climara Pro, Activella) Does Medicare cover hormone therapy for menopause? Original Medicare Part A and Part B only covers limited prescription drugs. Medicare Part A may cover prescription drugs you receive as an inpatient during a hospital stay or other inpatient facility. Medicare Part B may cover certain prescription drugs you receive as an outpatient, such as infusions or injections. However, most hormone therapy drugs are classified as take-home drugs, Medicare Part A and Part B will not cover hormone therapy for menopause. For Medicare coverage, beneficiaries that have enrollment in Medicare Part D.

PARA Weekly eJournal: October 16, 2019

CODING AND REIMBURSEMENT FOR HORMONAL REPLACEMENT

References for this article: https://www.testopel.com/billing-and-coding.php

https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=36538&ContrId =364&ver=10&ContrVer=1&CntrctrSelected=364*1&Cntrctr=364&s=66&DocType=2&bc=AAgAAAQAAAAA&

https://med.noridianmedicare.com/documents/10546/12461373/Testopel+Coverage+Article

PARA Weekly eJournal: October 16, 2019

BILLING FOR INPATIENT VACCINES

We provide our vaccines to inpatients and SNF patients on date of discharge per CMS guidelines: ?10.2.2 - Bills Submitted to FIs/AB MACs. ?When vaccines are provided to inpatients of a hospital or SNF, they are covered under the vaccine benefit. However, the hospital bills the FI on bill type 12X using the discharge date of the hospital stay or the date benefits are exhausted. A SNF submits type of bill 22X for its Part A inpatients.? We have an Inpatient Rehab Center here also. How should we report vaccine administration for IRC patients? Should it also be on date of discharge? Would the reimbursement be any different since IRC is reimbursed based on CMG? Answer: It is not necessary to delay administration of the vaccine to the date of discharge for inpatients during covered inpatient acute care or inpatient rehab stays. The vaccine may be administered on any day during the covered stay. Medicare simply requires, for claim processing purposes, that the date of discharge is reported on the separate claim for the vaccine and its administration. This enables the Medicare claims processing system to process separate payment, as appropriate, for this separately covered benefit. Hospitals should report the vaccine administration on the date of discharge, regardless of the date on which the vaccine was administered during the inpatient rehab visit. Reimbursement for the vaccine and its administration will be the same, regardless if it was administered during an outpatient encounter or during an inpatient stay (rehab or acute care.)

PARA Weekly eJournal: October 16, 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

PARA Weekly eJournal: October 16, 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 14

PARA Weekly eJournal: October 16, 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.

PARA Weekly eJournal: October 16, 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.

PARA Weekly eJournal: October 16, 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.

PARA Weekly eJournal: October 16, 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.

PARA Weekly eJournal: October 16, 2019

MODIFIER REQUIREMENT FOR SERVICES FROM THERAPY ASSISTANTS CMS will require providers to identify therapy services furnished by a Physical Therapy Assistant (PTA) or Occupational Therapy Assistant (OTA) by use of the CQ and CO modifiers effective 1/ 1/ 2020 .

Section 1834 (v)(2)(B) of the Bipartisan Budget Act of 2018 requires that claims submitted on or after January 1, 2020 for outpatient physical therapy or occupational therapy must include the modifiers established by CMS to identify that services were rendered in whole or in part by a PTA or an OTA. These modifiers will be for reporting and data collection only; payment will not be affected in 2020. Beginning January 1, 2022 providers will receive payment at 85% of the of the otherwise applicable Medicare Part B payment for services provided by a PTA or OTA. Beginning January 1, 2020 providers will be required to report Modifiers CO and CQ to identify services furnished by a PTA or an OTA respectively. The use of the CO and CQ modifiers and the subsequent 2022 payment reduction apply to all hospital outpatient departments, SNFs, CORFs, Home Health and Rehabilitation Agencies. Critical Access Hospitals are exempt from these requirements because they are not paid under PFS rates for therapy services.

When therapy services are rendered by a PTA or an OTA, the CO and CQ modifiers will be used instead of the existing GP and GO modifiers that are currently used to identify physical and occupational therapy services. The GP and GO modifiers will continue to be used to identify services provided by a physical or occupational therapist.

The 2020 MPFS proposed rule sets a 10 percent minimum standard for when the CO and CQ modifiers will apply. If a PTA or OTA provides more than 10 percent of the care in a treatment session, then the provider would report the services rendered with the CO and CQ modifiers. 19

PARA Weekly eJournal: October 16, 2019

MODIFIER REQUIREMENT FOR SERVICES FROM THERAPY ASSISTANTS

A link to the fact sheet on the 2020 MPFS Proposed Rule, which includes this requirement: https://www.cms.gov/newsroom/fact-sheets/proposed -policy-payment-and-quality-provisions-changesmedicare-physician-fee-schedule-calendar-year-2 The proposed rule provides clarification on how to calculate the 10 percent limit. There are two possible methods that can be used for calculation: Method 1: Divide the number of minutes of care provided by the PTA/OTA by the total minutes of care provided then multiply by 100. That will give providers the percentage of time of care provided by the PTA/OTA. Providers should round the number to the nearest whole number. Anything equal to or greater than 11 percent requires application of the modifier. Method 2: Divide the total time of care provided to the patient by 10 (round to the nearest whole number) and add 1 minute to set the minimum time requirement. If the treatment total time was 60 minutes, then 10% is 6 minutes plus 1 minute is 7 minutes. If the PTA/OTA care was 7 minutes or more then the CO/CQ modifier would be added to those line items. The following chart is provided in the proposed rule for the Method 2 calculation:

Also, it is important to note that there is a proposed documentation requirement included in the MPFS proposed rule. This proposed requirement provides a short description of the application or non-application of the CO/CQ modifiers. Since modifiers are applied on a per code basis, documentation would need to state the code, modifier applied or not applied, and the amount of time services were provided by the PTA/OTA to justify appending or omitting the CO/CQ modifiers.

PARA Weekly eJournal: October 16, 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.

PARA Weekly eJournal: October 16, 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.) 22

PARA Weekly eJournal: October 16, 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

PARA Weekly eJournal: October 16, 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). 24

PARA Weekly eJournal: October 16, 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 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 25

PARA Weekly eJournal: October 16, 2019

PAMA PRIVATE PAYER LAB PAYMENT RATE REPORTING

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. 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. 26

PARA Weekly eJournal: October 16, 2019

PAMA PRIVATE PAYER LAB PAYMENT RATE REPORTING

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 requirements that the reporting entity is obligated to follow, as addressed in the other paragraphs in ยง 414.504.

PARA Weekly eJournal: October 16, 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. 28

PARA Weekly eJournal: October 16, 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 29 reporting entity.

PARA Weekly eJournal: October 16, 2019

ACCURATE CODING FOR VACCINES REQUIRES PRECISION

From flu to tetanus, vaccines are among the most common outpatient procedures providers administer on a day-to-day basis. But they can also be complex to code and bill, and undetected mistakes can result in continual underpayment for services rendered.

What makes vaccines so tricky? In most instances, coders must consider a range of factors to ensure the procedure is properly coded, and it can be easy to overlook specific details or nuances. This is especially true if multiple injections are given to a single patient during one encounter. Some of the key variables associated with vaccine coding include: - Patient age - Insurance - Route of administration - Total number of vaccines given in the same encounter - Physician counseling - State vaccines programs Q-Codes Vaccine codes are published on a semi-annual basis, typically July 1 and January 1, by the American Medical Association (AMA). CPT速 vaccine codes range from 90476 through 90749. In recent years, Medicare has created additional Q-codes for vaccines. Q-codes are reimbursed at reasonable cost to providers, and Medicare deductible and co-insurance amounts do not apply when the Q-codes are reported to Medicare. Age-restricted vaccines While many vaccines don?t have specific age requirements, others can be designated pediatric, adolescent or adult. As a result, it?s important for coders to confirm that the vaccine administered is appropriate for the patient?s age. Code set administration In most vaccine billing scenarios, practices will bill separately for the vaccine and the vaccine administration. Administration codes encompass three general categories: - CPT速 range 90471 ? 90474 identifies vaccines without Counseling (over 18 years of age) - CPT速 range 90460 ? 90461 identifies vaccines with Counseling (thru age 18) - HCPCS Codes G0008, G0009 and G0010 are specific to Medicare beneficiaries State programs Some physician practices participate in state-sponsored Vaccines for Children (VFC) programs. Because the state generally provides the practice with the vaccines, physicians may not charge beneficiaries for the vaccines and physicians are not separately reimbursed by Medicaid or commercial carriers. However, providers may charge patients for the administration fee associated with providing the vaccine. For vaccines provided as part of the VFC program, the CPT速 code range is 90476 ? 90749, with modifier SL appended in the first reporting modifier field. 30

PARA Weekly eJournal: October 16, 2019

ACCURATE CODING FOR VACCINES REQUIRES PRECISION

Route of administration Ensuring the correct route of administration allows the coder to select the appropriate administration code. Most vaccines are given as injections and are reported using administration codes 90471 and 90472. But there are a few oral and intra-nasal vaccines that are reported using administration codes 90473 and 90474. Initial vaccines If one or more vaccines are administered during an encounter, it is necessary to specify an initial administration code first. Initial administration codes include: - 90471: Immunization administration for percutaneous, intra-dermal, subcutaneous or intramuscular injections, initial - 90473: Immunization administration for intra-nasal or oral route, initial Only one initial administration code is reported per encounter. If both injectable and oral/intra-nasal vaccines are performed during the same visit, providers should report 90471 as the initial administration code. Codes 90471 ? 90472 have a slightly higher reimbursement than oral/intra-nasal administration. Subsequent vaccines If more than one vaccine is administered on the same day, a second or third administration code is required to document the additional vaccines. All subsequent vaccine codes (90472 and 90474) are classified as add-on codes and must be reported with an initial administration code. The definitions for subsequent administration codes are: - 90472: Immunization administration for percutaneous, intra-dermal, subcutaneous or intramuscular injections, each additional vaccine - 90474: Immunization administration for intra-nasal or oral route, each additional vaccine When three or more vaccines are performed during an encounter, units should be applied to the administration code for each additional vaccine of the same type (injectable or oral). Here are some examples: - Five injectable vaccines: report 90471 X1 unit (initial) and 90472 X4 units (subsequent) - One intra-nasal and two oral vaccines: 90473 X1 unit (initial) and 90474 X2 units (subsequent) - Four injectable vaccines and one oral vaccine: 90471 X1 unit (initial) and 90472 X3 units (subsequent) and 90474 X1 unit (subsequent)

Keepin g it all st r aigh t Staying abreast of the latest coding directives can be a challenge, and it can be doubly so when it comes to vaccines, given all the factors that need to be accounted for to code and bill correctly. That?s why Healthcare Financial Resources Inc. (HFRI) and PARA HealthCare Analytics have partnered to deliver comprehensive revenue cycle services to support accurate coding, clean claims and timely and appropriate reimbursement. Contact us today to learn more about the many ways we can help your organization. 31

PARA Weekly eJournal: October 16, 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.

PARA Weekly eJournal: October 16, 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

PARA Weekly eJournal: October 16, 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

PARA Weekly eJournal: October 16, 2019

IT'S HERE! GET YOURS TODAY

It's here. Thi s i s the defi ni ti ve gui de coveri ng the new and proposed rules and payment rates and schedules from CM S. In thi s speci al edi ti on of the PARA week ly eJournal, we bri ng together i nformati on every revenue cycle professi onal, healthcare provi der and fi nance executi ve needs to k now, all i n one place.

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PARA Weekly eJournal: October 16, 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 10, 2019 New s

· New Medicare Card: 80% of Claims Submitted with MBI · Nursing Homes: Enhancing Transparency about Abuse and Neglect · Quality Payment Program: MIPS Dates and Deadlines · October is National Breast Cancer Awareness Month Com plian ce

· Proper Use of the KX Modifier for Part B Immunosuppressive Drug Claims Claim s, Pr icer s & Codes

· FY 2020 IPPS and LTCH PPS Claims Hold Even t s

· Submitting Your Medicare Part A Cost Report Electronically Webcast ? November 5 M LN M at t er s® Ar t icles

· Ambulance Inflation Factor for Calendar Year (CY) 2020 and Productivity Adjustment

· Provider Enrollment Rebuttal Process · Implementation of the Skilled Nursing Facility (SNF) Patient Driven Payment Model (PDPM) ? Revised

· International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determination (NCDs) ? January 2020 Update ? Revised

· Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) Updates for Fiscal Year (FY) 2020 ? Revised

PARA Weekly eJournal: October 16, 2019

There were TWO 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

PARA Weekly eJournal: October 16, 2019

The link to this Med Learn MM11335

PARA Weekly eJournal: October 16, 2019

The link to this Med Learn MM11330

PARA Weekly eJournal: October 16, 2019

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

FIND ALL THESE TRANSMITTALS IN THE ADVISOR TAB OF THE PDE

PARA Weekly eJournal: October 16, 2019

The link to this Transmittal R2372OTN

PARA Weekly eJournal: October 16, 2019

The link to this Transmittal R4412CP

PARA Weekly eJournal: October 16, 2019

The link to this Transmittal R4415CP

PARA Weekly eJournal: October 16, 2019

The link to this Transmittal R327FM

PARA Weekly eJournal: October 16, 2019

The link to this Transmittal R2373OTN

PARA Weekly eJournal: October 16, 2019

The link to this Transmittal R2371OTN

PARA Weekly eJournal: October 16, 2019

The link to this Transmittal R2370OTN

PARA Weekly eJournal: October 16, 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