Knowledge Base Category -
There has been a lot of talk lately about surprise medical bills. These are usually that seemingly never-ending stream of bills people get after having a procedure or surgery from “other” physicians such as anesthesiologists, radiologists, pathologists, etc. But what if you were a Medicare Advantage (MA) insurer and that surprise bill was for $375,000 or more for an innovative therapy newly approved by Medicare? Luckily for the MA plans, Medicare fee-for-service (FFS) will be paying for CAR T-cell therapy for MA beneficiaries for two years – 2019 and 2020. CMS has instructed the MA plans to account for CAR T-cell therapy for cancer items and services in their contract year 2021 bids.
Chimeric Antigen Receptor (CAR) T-cell therapy is an immunotherapy where a patient’s lymphocyte T-cells are genetically altered to improve their ability to fight cancer. In a new National Coverage Determination, CMS approved coverage for CAR T-cell therapy:
Effective for services performed on or after August 7, 2019, the Centers for Medicare & Medicaid Services (CMS) covers autologous treatment for cancer with T-cells expressing at least one Chimeric Antigen Receptor (CAR) when administered at healthcare facilities enrolled in the Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategies (REMS) and used for a medically accepted indication as defined at Social Security Act Section 1861(t)(2) ‐i.e., is used for either an FDA-approved indication (according to the FDA-approved label for that product), or for other uses when the product has been FDA-approved and the use is supported in one or more CMS-approved compendia.
On October 24, 2019, CMS released MLN Matters Article SE19024 concerning billing instructions for beneficiaries enrolled in MA plans for CAR T-cell therapy. As a result of the significant cost of this therapy, effective August 7, 2019, original fee-for-service Medicare will pay for CAR T-cell therapy for cancer obtained by beneficiaries enrolled in Medicare Advantage (MA) plans when the coverage criteria outlined in the decision memorandum is met. This applies for Calendar Years (CYs) 2019 and 2020 only.
The MLN article goes on to provide billing instructions for MA beneficiaries. The main issue with billing for CAR T-cell therapy is that providers can choose different methods of reporting charges for the various steps required to collect and prepare CAR T-cells. These costs can be included in the charge for the biological or they may be reported separately for tracking purposes. Medicare payment for the preparation services is included in the payment for the biological. HCPCS and revenue codes reported separately for the preparation services are not paid separately and will be rejected by Medicare. As stated above, this option is only for tracking purposes.
Do not report the same charge(s) twice. Providers should choose one option described below. You must not include charges for pre-infusion steps in both the drug revenue code (0891) and separately listed for the pre-infusion revenue codes (0871, 0872, and 0873).
When all services are provided on an outpatient basis:
- Report CPT code 0540T with Revenue Code 0874 for the administration of CAR T-cells
- Report HCPCS Q-code Q2041 or Q2042 for the drug/biological with Revenue Code 0891
- Option 1 for charges to collect and prepare CAR T-cells - report
- HCPCS 0537T with revenue code 0871
- HCPCS 0538T with revenue code 0872
- HCPCS 0539T with revenue code 0873
- Option 2 for charges to collect and prepare CAR T-cells - include the charges for these various steps in the charge submitted for the biological
When CAR-T dosing and preparation services are done in an outpatient setting, but the T-cells are administered in the hospital inpatient setting:
- Report the administration of the T-cells on the inpatient claim with revenue code 0874
- Report the drug/biological on the inpatient claim with revenue code 0891
- Option 1 for charges to collect and prepare CAR T-cells - report on inpatient claim under revenue codes 0871, 0872, and 0873 OR
- Option 2 for charges to collect and prepare CAR T-cells - include the charges for these various steps in the charge reported for the biological using revenue code 0891
If CAR-T dosing and preparation Services are performed in the hospital outpatient setting, but the viable T-cells are never administered back to the patient, report CPT codes 0537T, 0538T, and 0539T (as appropriate) and the charges associated with each code under the appropriate revenue code on the outpatient claim. Medicare will not pay for these services when the T-cells are not administered. They will reject these codes but reporting allows tracking of the services and inclusion of the associated costs in your charges.
For more details on billing CAR-T, refer to the MLN Matters Article referenced above or MLN Matters Article SE19009.
Debbie Rubio
MEDICARE TRANSMITTALS – RECURRING UPDATES
Changes to the Laboratory National Coverage Determination (NCD) Edit Software for January 2020
Announces changes to be included in the January 2020 quarterly release of the edit module for clinical diagnostic laboratory services.
January 2020 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files
Informs MACs about new and revised Average Sales Price (ASP) and ASP Not Otherwise Classified (NOC) drug pricing files for Medicare Part B drugs.
Updating Calendar Year (CY) 2020 Medicare Diabetes Prevention Program (MDPP) Payment Rates
CMS intends to calculate the payment rates for each calendar year, based on the Consumer Price Index for All Urban Consumers (CPI-U); and instruct the MACs and the Railroad Specialty MAC to update the MDPP payment rates each year.
Notice of New Interest Rate for Medicare Overpayments and Underpayments - 1st Qtr Notification for FY 2020
The interest rate for the first quarter of FY 2020 is 10.125%.
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2019Downloads/R327FM.pdf
OTHER MEDICARE TRANSMITTALS
Provider Enrollment Rebuttal Process
Puts into operation the provision which permits providers/suppliers whose Medicare billing privileges are deactivated to file a rebuttal.
Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) Updates for Fiscal Year (FY) 2020
Identifies changes as part of the annual IPF PPS update established in the IPF PPS FY 2020 Final Rule. These changes are applicable to discharges occurring from October 1, 2019, through September 30, 2020 (FY 2020).
Fiscal Year (FY) 2020 Inpatient Prospective Payment System (IPPS) and Long Term Care Hospital (LTCH) PPS Changes
The Fiscal Year (FY) 2020 update to the Inpatient Prospective Payment System (IPPS) and LTCH Prospective Payment System (PPS).
Add Dates of Service (DOS) for Pneumococcal Pneumonia Vaccination (PPV) Health Care Procedure Code System (HCPCS) Codes (90670, 90732), and Remove Next Eligible Dates for PPV HCPCS
Instructs Medicare's Common Working File (CWF) to send the Date of Service (DOS) for both PPV HCPCS codes (90670 and 90732) to the Medicare Beneficiary Database (MBD).This will allow other systems to know whether the DOS was for the initial vaccine or the second vaccine. Once the CR is implemented, providers will receive more detail in reply to eligibility transactions on whether their beneficiaries have received one or both PPV vaccines.
REVISED MEDICARE TRANSMITTALS
International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determination (NCDs) – January 2020 Update – REVISED
Revised on October 1, 2019, to clarify that the effective date is January 1, 2020, unless noted otherwise.
October 2019 Update of the Hospital Outpatient Prospective Payment System (OPPS) – REVISED
Revised to correct Table 7 to reinstate C9043 rather than delete it effective October 1, 2019. Also adds a new HCPCS code J0642, which is effective October 1, 2019, and revises the descriptor for J0641.
MEDICARE SPECIAL EDITION ARTICLES
Billing Instructions for Beneficiaries Enrolled in Medicare Advantage (MA) Plans for Services Covered by Decision Memo CAG-00451N
CMS is providing this information for hospitals providing CAR T-cell therapy to beneficiaries enrolled in Medicare Advantage (MA) plans.
MEDICARE EDUCATIONAL RESOURCES
Medicare Fast Facts
Medicare Fast Facts resources this month include:
- Cardiac Device Credits: Medicare Billing
- Proper Use of the KX Modifier for Part B Immunosuppressive Drug Claims
- Payment for Outpatient Services Provided to Beneficiaries Who Are Inpatients of Other Facilities
OTHER MEDICARE UPDATES
Final Rule: Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals (CAH), and Home Health Agencies (HHA), and Hospital and CAH Changes to Promote Innovation, Flexibility, and Improvement in Patient Care
The rule finalizes requirements for hospitals, CAHs, and HHAs to implement discharge planning processes that will provide more information (such as a PAC provider or supplier’s performance in quality measures and resource measures) to patients and their families to help them make more informed decisions about PACs in order to better address their goals for care and treatment preferences.
Final Rule: Omnibus Burden Reduction (Conditions of Participation)
Finalizes provisions of three separate proposed rules: the Omnibus Burden Reduction proposed rule (dated September 20, 2018); Hospital and Critical Access Hospital Changes to Promote Innovation, Flexibility, and Improvement in Patient Care proposed rule (dated June 6, 2016); and the Fire Safety Requirements for Certain Dialysis Facilities proposed rule (dated November 4, 2016).
Modernizing and Clarifying the Physician Self-Referral Regulations Proposed Rule
A proposed rule to modernize and clarify the regulations that interpret the Medicare physician self-referral law (often called the “Stark Law”), which has not been significantly updated since it was enacted in 1989.
Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2020
The annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review. The 2020 AIC threshold is $170 for ALJ hearings and $1,670 for judicial review.
https://www.govinfo.gov/content/pkg/FR-2019-10-07/pdf/2019-21751.pdf
Medicare Quarterly Provider Compliance Newsletter October 2019
This quarter’s newsletter addresses Ambulance Services Subject to SNF Consolidated Billing Requirements and Outpatient Physical Therapy Services.
MAC UPDATES
Palmetto GBA 2020 Medical Review TPE Teleconference Schedule
https://www.palmettogba.com/palmetto/providers.nsf/ls/JJ%20Part%20A"BGQT2X1030?opendocument
The holiday season is almost upon us. Since it is the time of year for spending time with family and revisiting old friends, I thought it would be a good time for this newsletter to revisit an old “friend,” the three-day payment window. This issue especially deserves a revisit since it is also being revisited by some of our favorite Medicare review entities. In August 2019, the Office of Inspector General (OIG) published a new Work Plan item, “Review of the Medicare DRG Window Policy”, and the Recovery Auditors have long had an automated issue for “Outpatient Service Overlapping or During an Inpatient Stay.”
The description from the OIG Work Plan item provides a good summary of the 3-day payment window – “Outpatient services directly related to an inpatient admission are considered part of the inpatient payment and are not separately payable by Medicare. The diagnosis-related group (DRG) window policy defines when CMS considers outpatient services to be an extension of inpatient admissions, and generally includes services that are (1) provided within the 3 days immediately preceding an inpatient admission to an acute-care hospital, (2) diagnostic services or admission-related nondiagnostic services, and (3) provided by the admitting hospital or by an entity wholly owned or operated by the admitting hospital.”
The DRG window policy can be found in Section 40.3 of the Medicare Claims Processing Manual (CPM), Chapter 3. However, reading through this section can be somewhat confusing to me, especially with all the directions of “before this date” and “after this date.” Let’s simplify as to where the rules stand now.
Entities to Which the Payment Window Applies
The payment window policy applies to both IPPS hospitals, and hospitals and units excluded from IPPS which are psychiatric hospitals and units, inpatient rehabilitation facilities (IRF) and units, long-term care hospitals (LTCH), children’s hospitals, and cancer hospitals. For these hospitals and units excluded from IPPS, this provision applies only to services furnished within one day prior to and including the date of the beneficiary's admission.
The window policy applies to services provided by the admitting hospital or by an entity wholly owned or operated by the admitting hospital. According to the CPM referenced above, “An entity is considered to be "wholly owned or operated" by the hospital if the hospital is the sole owner or operator. A hospital need not exercise administrative control over a facility in order to operate it. A hospital is considered the sole operator of the facility if the hospital has exclusive responsibility for implementing facility policies (i.e., conducting or overseeing the facility's routine operations), regardless of whether it also has the authority to make the policies.”
The provision applies to the technical portion of services rendered at a hospital-owned or hospital-operated physician clinic or practice. The provision does not apply when the admitting hospital is a critical access hospitals (CAH) but services rendered to a beneficiary at a CAH that is wholly owned or operated by a non-CAH hospital, during the payment window, are subject to the 3-day (or 1-day) payment window policy. The 3-day (or 1-day) payment window policy does not apply to outpatient services that are included in the rural health clinic (RHC) or Federally qualified health center (FQHC) all-inclusive rate.
Services Affected by the Payment Window for IPPS Hospitals
I like to break this down into three different categories – services on the day of admission, diagnostic services, and related, nondiagnostic services:
- All outpatient services (both diagnostic and nondiagnostic services) provided on the day of an inpatient admission must be billed with the inpatient stay.
- Diagnostic services (including clinical diagnostic laboratory tests) provided within 3 days prior to admission are deemed to be inpatient services and included in the inpatient payment, unless there is no Part A coverage.
- Diagnostic services are defined by the presence on the bill of specific revenue and/or CPT codes as listed in this section of the CPM.
- Nondiagnostic outpatient services that are related to a beneficiary’s hospital admission and that are provided to the patient during the 3 days immediately preceding are deemed to be inpatient services and are included in the inpatient payment.
- Nondiagnostic services are considered related unless they are clinically distinct or independent from the reason for the beneficiary’s admission.
- Hospitals must attest that nondiagnostic services are unrelated by adding a condition code 51 (definition “51 - Attestation of Unrelated Outpatient Non-diagnostic Services”) to the separately billed outpatient non-diagnostic services claim.
The 3-day timeframe along with the day of admission bundling requirement means that if a patient is admitted on a Wednesday, outpatient services meeting the above criteria provided by the hospital on Sunday, Monday, Tuesday, or Wednesday are included in the inpatient Part A payment.
Hospitals must include on the inpatient Medicare claim the diagnoses, procedures, and charges for all preadmission outpatient diagnostic services and all preadmission outpatient nondiagnostic services that meet the above requirements. The hospital must convert CPT codes to ICD procedure codes and must only include outpatient diagnostic and admission-related nondiagnostic services that span the period of the payment window. POA (present on admission) indicators are assigned based on conditions the patient has at the time of the inpatient admission order, irrespective of whether or not the patient had the condition at the time of being registered as a hospital outpatient.
The Payment Window provision does not apply to ambulance and maintenance renal dialysis services or to Part A services furnished by skilled nursing facilities, home health agencies, and hospices.
Separately Billable Services
Unrelated nondiagnostic services and services outside the payment window are separately billable to Medicare on an outpatient claim.
- This means outpatient nondiagnostic services provided during the payment window that are unrelated to the admission and are covered by Part B may be separately billed to Part B. Hospitals should use condition code 51 as described above and must maintain documentation in the patient’s medical record to support that the services are unrelated to the inpatient admission.
- Outpatient services furnished to a patient more than 3 days (or 1 day for non-IPPS hospitals/units) preceding the date of admission, are not part of the payment window and must not be bundled on the inpatient bill with other outpatient services that were furnished during the span of the 3-day (or 1-day) payment window, even when all of the outpatient services were furnished during a single, continuous outpatient encounter. Instead, the outpatient services that were furnished prior to the span of the payment window may be separately billed to Part B.
Understanding and correctly applying the Medicare DRG payment window will help hospitals avoid recoupments by Medicare reviewers such as the RACs and the OIG. Hospitals also need to understand when it is acceptable to separately bill for Part B services to prevent inappropriate bundling and loss of separate payments.
One other concern for hospitals is that the OIG continues to encourage expansion of the 3-day time frame in order to capture more admission-related outpatient services into the inpatient admission payment. As noted in their Work Plan, they want to “determine the amounts that Medicare and beneficiaries would have saved in 2018 if the DRG window policy had been updated to include more days and other hospital ownership structures.” Looks like our “old friend” could be becoming less friendly.
Debbie Rubio
One of the most complicated phrases in Southern lexicon is “bless your heart.” It can convey concern, empathy, pity, spitefulness, rudeness, or plain meanness. Whatever the intended meaning, if you are on the receiving end of this catchphrase, something is not going well for you.
This is my third article in the Wednesday@One newsletter about Appropriate Use Criteria (AUC) in the last six weeks. When a topic appears that many times in such a short timeframe, it means it is difficult; likely to have serious impact, either financially or in work processes; and hospitals need to pay attention. I focus on hospitals because they are MMP’s target client, but the AUC requirements affect more than just hospitals. This adds an additional layer of difficulty by requiring communication and coordination between the various providers.
You can refer back to my previous articles for more details about the requirements – Appropriate Use Criteria Is Coming Soon and Clarification of AUC Requirements for Emergency Conditions. In this week’s article, I want to offer some suggestions on how you might approach the process. AUC requires the ordering practitioner to consult an interactive, electronic tool known as a Clinical Decision Support Mechanism (CDSM) prior to ordering advanced imaging studies (CTs, MRs, NM studies and PET scans) to determine if the study is appropriate for the patient’s condition or signs and symptoms. That information, including which CDSM was consulted, or why a CDSM was not consulted if applicable, must be communicated to the facility performing the technical portion of the test and to the interpreting radiologist. Finally, the facility and the interpreting professional must append modifiers and sometimes HCPCS codes to their claims conveying the AUC information to Medicare. 2020 is a testing year but once the program is fully implemented, claims without the appropriate information will not be paid. The goal of the program is to ultimately be able to identify practitioners who overutilize or inappropriately utilize advanced imaging studies and require those practitioners to get a prior approval (PA) for advance imaging studies. The desired outcome is reduced costs and radiation exposure by eliminating unnecessary advanced imaging studies.
If I still worked in Compliance in a hospital, how would I approach this? Who needs to be involved? What questions need to be considered? How can we make the process work?
As with most issues, after you are familiar with the requirements, you will need to start with a meeting of the key players. The necessary team members may vary among facilities and you may not think of everyone for the first meeting. Here are some departments you will likely want to include – compliance, information technology, business office/billing, registration, scheduling, radiology, and the emergency department. At your first meeting, you will want to make sure everyone understands what the requirements are and what role they will likely play in the process. An excellent resource to share with team members is the Appropriate Use Criteria MLN Fact Sheet.
Also, I recommend developing a list of questions that must be answered, such as:
- Where and how does our facility receive orders for advanced imaging tests? Who are these orders communicated from and to?
- Are the practitioners who order advanced imaging exams aware of the new requirements and where are they on preparedness? What can we do to educate the ordering physicians/NPPs?
- Are there hospital clinics or hospital-employed practitioners that must use a CDSM? If so, have we/they selected a CDSM to be purchased and installed? Who and when will users be trained on the CDSM?
- Can IT develop queries in the electronic scheduling and ordering system to gather the needed information? Can these queries select the appropriate CPT/HCPCS code(s) and modifiers and push them to the claim?
- How will the facility share this information with the interpreting professional?
- Are there other facility departments that need to be involved?
- How do we determine if a patient in the emergency room meets the emergency condition exception or not? If not, who in the ED is responsible for checking the CDSM and entering the information?
I found over the years that as much as I wracked my brain prior to such a meeting, once the meeting occurred, many other questions and issues arose from the meeting members. That is definitely what you want and how you start! As you answer the questions, you will begin to develop ideas on how the process will work and how information will be communicated between parties and eventually to the claim.
The key to success is working with smart people who work well as a team and are dedicated to making the process a success. If you do not have such people working with you, good luck and “bless your heart.”
Debbie Rubio
MEDICARE TRANSMITTALS – RECURRING UPDATES
2020 Annual Update of Healthcare Common Procedure Coding System (HCPCS) Codes for Skilled Nursing Facility (SNF) Consolidated Billing (CB) Update
Annual Clotting Factor Furnishing Fee Update 2020
The clotting factor furnishing fee for 2020 is $0.226 per unit.
Influenza Vaccine Payment Allowances - Annual Update for 2019-2020 Season
October 2019 Integrated Outpatient Code Editor (I/OCE) Specifications Version 20.3
October 2019 Update of the Hospital Outpatient Prospective Payment System (OPPS)
Includes numerous new and revised codes.
October Quarterly Update for 2019 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule
October 2019 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files
Quarterly Healthcare Common Procedure Coding System (HCPCS) Drug/Biological Code Changes - October 2019 Update
OTHER MEDICARE TRANSMITTALS
Implementation to Exchange the List of Electronic Medical Documentation Requests (eMDR) for Registered Providers via the Electronic Submission of Medical Documentation (esMD) System – REVISED
Article revised on August 26, 2019, to reflect changes made to the eMDR registration screens within NPPES. The article includes illustrations of the new screens that providers will have to complete in order to register to receive the eMDRs.
Implementation of the Award for the Jurisdiction H Part A and Part B Medicare Administrative Contractor (JH A/B MAC)
Announces the Jurisdiction JH A/B MAC re-competition procurement that was recently awarded to Novitas Solutions, Inc., the incumbent contractor for this workload.
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2019Downloads/R2358OTN.pdf
Billing for Hospital Part B Inpatient Services
Reminder of the policy regarding billing instructions for hospital Part B inpatient service claims, including the allowance of Revenue Code 0240 on 012x Type of Bills (TOB).
MEDICARE SPECIAL EDITION ARTICLES
Medicare Part B Clinical Laboratory Fee Schedule: Revised Information for Laboratories on Collecting and Reporting Data for the Private Payor Rate-Based Payment System – REVISED
Revised on September 5, 2019, to delete incorrect information in the section titled Only Applicable Information Attributed to non-Hospital Patients is Reported.
Activation of Systematic Validation Edits for OPPSProviders with Multiple Service Locations – Update – REVISED
Revised on September 5, 2019, to announce a delay of full implementation until April 2020.
MEDICARE EDUCATIONAL RESOURCES
Medicare Fast Facts
Medicare Fast Facts resources this month include:
OTHER MEDICARE UPDATES
Case Review Connections, Fall 2019
KEPRO Quarterly Acute Care Newsletter
In the August 20, 2019 Wednesday@One, we published an article about Appropriate Use Criteria (AUC) which will enter the Educational and Operations Testing Period beginning January 1, 2020. During this phase, providers are encouraged to participate, but claims will not be denied for lack of AUC claim elements. In that article, I stated, “It is confusing to me why applicable settings include hospital emergency departments when patients with an emergency medical condition are exempt.” I reached out to CMS for further clarification and they directed me to the CY 2019 Physician Fee Schedule final rule on page 59699 (https://www.govinfo.gov/content/pkg/FR-2018-11-23/pdf/2018-24170.pdf) for more information about this exception. I appreciated their prompt response and I think it actually did answer my question.
After reading the above reference and the section of the Social Security Act which it references, I determined that the difference in the exception versus all services provided in a hospital emergency department depends on differing definitions of the term “emergency.”
The exception for following the AUC guidelines does not apply to section 1867(a) of the Act which is where the requirement for an appropriate medical screening examination is set forth. This section states,
- “In the case of a hospital that has a hospital emergency department, if any individual (whether or not eligible for benefits under this title) comes to the emergency department and a request is made on the individual’s behalf for examination or treatment for a medical condition, the hospital must provide for an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition (within the meaning of subsection (e)(1)) exists.”
We all know that many patients present to the emergency department for conditions that are not really “emergencies” as defined further in the Act. Advanced imaging services provided for these types of conditions will be required to follow the AUC guidelines.
It is only those “serious jeopardy” emergency conditions as defined in section 1867(e)(1) of the SSA that are exempt from the AUC requirements. This section of the Act defines “emergency medical condition” to mean
- a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that the absence of immediate medical attention could reasonably be expected to result in—
- placing the health of the individual (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy,
- serious impairment to bodily functions, or
- serious dysfunction of any bodily organ or part; or
- with respect to a pregnant woman who is having contractions—
- that there is inadequate time to effect a safe transfer to another hospital before delivery, or
- that transfer may pose a threat to the health or safety of the woman or the unborn child.
The discussion in the 2019 MPFS Final Rule does clarify that the exception to using AUC includes “instances where an emergency medical condition is suspected, but not yet confirmed. This may include, for example, instances of severe pain or severe allergic reactions. In these instances, the exception is applicable even if it is determined later that the patient did not in fact have an emergency medical condition.”
Even though I think I understand the distinction between less severe conditions of ED patients and those with conditions placing the patient’s health in serious jeopardy, impairment or dysfunction, I am curious to see how CMS will make this determination for payment purposes once consultation and reporting of use of AUC is required. For example, an ED claim with a diagnosis of GERD could have been a patient presenting with chest pain, a condition that could potentially place the patient’s health in serious jeopardy. Is CMS going to perform a complex review to determine if AUC is required or not? If so, what documentation would they expect to see in the ED record to support that an emergency medical condition was suspected? I guess we will just have to wait and see how it all plays out.
Debbie Rubio
Medicare has National Coverage Determinations (NCDs) that describe the requirements that must be performed and documented for the cardiac services of Transcatheter Aortic Valve Replacement (TAVR), Left Atrial Appendage Closure (LAAC), and Transcatheter Mitral Valve Repair (TMVR). Be sure to read the other article in this week’s Wednesday@One that discusses these requirements. Hopefully your cardiology department is familiar with the NCDs and has implemented processes to ensure the documentation in your records supports Medicare’s requirements. But isn’t it frustrating if all the requirements are met and appropriately documented, to have your Medicare claim denied, rejected, or returned due to missing claim elements? And in addition to the frustration, your facility is delaying or missing out on your Medicare DRG payments.
Claims for these services obviously must include the appropriate procedure codes and diagnosis codes. In addition, since all of these cardiac services are covered under Coverage with Evidence Development (CED), the claims must include a secondary diagnosis code, condition code, and value code related to the clinical trial/registry. All three of these procedures are inpatient-only procedures and would be billed on an inpatient claim, type of bill, 11x and paid under a Medicare DRG payment.
Specifically, for each procedure the following is required on the institutional inpatient claim:
Left Atrial Appendage Closure (LAAC) (Watchman procedure):
- Procedure Code - 02L73DK (Occlusion of Left Atrial Appendage with Intraluminal Device, Percutaneous Approach)
- One of the following diagnosis codes –
- I48.0 - Paroxysmal Atrial Fibrillation
- I48.1 - Persistent Atrial Fibrillation
- I48.2 - Chronic Atrial Fibrillation
- I48.91 - Unspecified Atrial Fibrillation
- Secondary diagnosis code – Z00.6 - Encounter for examination for normal comparison and control in clinical research program
- Condition Code 30 - Qualified Clinical Trial
- Value Code D4 and corresponding 8-digit clinical trial number (Clinical trail and/or registry numbers can be found on Medicare’s CED website.)
Transcatheter Aortic Valve Replacement (TAVR):
- Procedure Code – One of the following procedure codes –
- 02RF37Z (Replacement of Aortic Valve with Autologous Tissue Substitute, Percutaneous Approach),
- 02RF38Z (Replacement of Aortic Valve with Zooplastic Tissue, Percutaneous Approach),
- 02RF3JZ (Replacement of Aortic Valve with Synthetic Substitute, Percutaneous Approach),
- 02RF3KZ (Replacement of Aortic Valve with Nonautologous Tissue Substitute, Percutaneous Approach),
- 02RF37H (Replacement of Aortic Vavle with Autologous Tissue Substitute, Transapical, Percutaneous Approach),
- 02RF38H (Replacement of Aortic Valve with Zooplastic Tissue, Transapical, Percutaneous Approach),
- 02RF3JH (Replacement of Aortic Valve with Synthetic Substitute, Transapical, Percutaneous Approach), or
- 02RF3KH (Replacement of Aortic Valve with Nonautologous Tissue Substitute, Transapical, Percutaneous Approach)
- Procedure Code - X2A5312 (Cerebral Embolic Filtration, dual filter in innominate artery and left common carotid artery, percutaneous approach) when used
- One of the following diagnosis codes –
- I35.0 - Nonrheumatic aortic (valve) stenosis
- T82.222A - Displacement of biological heart valve graft, initial encounter (Code for when a previously placed valve was malpositioned or became displaced)
- T82.857A - Stenosis of cardiac prosthetic devices, implants and grafts, initial encounter (Code for when the previously placed valve developed stenosis prematurely)
- T82.223A - Leakage of biological heart valve graft, initial encounter (Code for when the previously placed valve developed regurgitation prematurely)
- Z45.09 - Encounter for adjustment and management of other cardiac device (Code for when the previously placed valve developed stenosis or regurgitation as an expected occurrence as it degenerates towards end-of-life)
- Secondary diagnosis code – Z00.6 - Encounter for examination for normal comparison and control in clinical research program
- Condition Code 30 - Qualified Clinical Trial
- Value Code D4 and corresponding 8-digit clinical trial number
Transcatheter Mitral Valve Repair (TMVR) (MitraClip procedure):
- One of the following Procedure Codes
- 02UG3JZ - Supplemental Mitral Valve with Synthetic Substitute, Percutaneous approach
- 02QG3ZE - Repair Mitral Valve created from Left Atrioventricular Valve, Percutaneous Approach
- 02QG4ZE - Repair Mitral Valve created from Left Atrioventricular Valve, Percutaneous Endoscopic Approach
- 02UG37E - Supplement Mitral Valve created from Left Atrioventricular Valve with Autologous Tissue Substitute, Percutaneous Approach
- 02UG38E - Supplement Mitral Valve created from Left Atrioventricular Valve with Zooplastic Tissue, Percutaneous Approach
- 02UG3JE - Supplement Mitral Valve created from Left Atrioventricular Valve with Synthetic Substitute, Percutaneous Approach
- 02UG3KE - Supplement Mitral Valve created from Left Atrioventricular Valve with Nonautologous Tissue Substitute, Percutaneous Approach
- 02UG3KZ - Supplement Mitral Valve with Nonautologous Tissue Substitute, Percutaneous Approach
- 02UG47E - Supplement Mitral Valve created from Left Atrioventricular Valve with Autologous Tissue Substitute, Percutaneous Endoscopic Approach
- 02UG48E - Supplement Mitral Valve created from Left Atrioventricular Valve with Zooplastic Tissue, Percutaneous Endoscopic Approach
- 02UG4JE - Supplement Mitral Valve created from Left Atrioventricular Valve with Synthetic Substitute, Percutaneous Endoscopic Approach
- 02UG4KE - Supplement Mitral Valve created from Left Atrioventricular Valve with Nonautologous Tissue Substitute, Percutaneous Endoscopic Approach
- 02WG37Z - Revision of Autologous Tissue Substitute in Mitral Valve, Percutaneous Approach
- 02WG38Z - Revision of Zooplastic Tissue in Mitral Valve, Percutaneous Approach
- 02WG3JZ - Revision of Synthetic Substitute in Mitral Valve, Percutaneous Approach
- 02WG3KZ - Revision of Nonautologous Tissue Substitute in Mitral Valve, Percutaneous Approach
- One of the following diagnosis codes –
- I34.0 - Nonrheumatic mitral (valve) insufficiency
- I34.1 - Nonrheumatic mitral valve prolapse
- Secondary diagnosis code – Z00.6 - Encounter for examination for normal comparison and control in clinical research program
- Condition Code 30 - Qualified Clinical Trial
- Value Code D4 and corresponding 8-digit clinical trial number
MACs will fully reject inpatient claims for these cardiac procedures when billed without the appropriate procedure, diagnosis, or clinical trial codes. Hospitals that perform these procedures need to put processes in place for communication between the clinical department, coding, and the billing office so that the appropriate claim elements are added. Internal claim processing edits to halt claims with one of the applicable procedure codes may be an option to verify appropriate diagnosis codes and allow the addition of the clinical trial codes.
Refer to the NCDs and corresponding claims processing instructions for complete Medicare requirements.
Debbie Rubio
Back in 2017, I wrote the section below about changes to the laboratory date-of-service policy changes from the 2018 OPPS Final Rule. The importance of laboratory date of service (DOS) requirements is that they are used to determine whether a hospital bills Medicare directly for a clinical diagnostic laboratory test (CDLT) or whether the laboratory performing the test bills Medicare. Remember, most CDLTs are conditionally packaged under OPPS, and are only paid separately to the hospital when they are: (1) the only service provided to a beneficiary on a claim; (2) considered a preventive service; (3) a molecular pathology test; or (4) an advanced diagnostic laboratory test (ADLT) that meets certain criteria. Preventive services, molecular pathology tests, and ADLTs are assigned an OPPS status indicator (SI) of “A” and paid under the Clinical Lab Fee Schedule (CLFS). CDLTs with an SI of “Q4” are paid separately under the CLFS when they are the only types of services on the claim, but payment is bundled when they appear with other outpatient services.
Excerpt from Prior Wednesday@One Article on Laboratory Date of Service Rule
“Laboratory date of service (DOS) rules start simple:
- The DOS for clinical diagnostic laboratory services generally is the date the specimen is collected.
- For archived lab specimens that are stored for more than 30 days before testing, the DOS is the date the specimen was obtained from storage.
Now this is where it starts getting complicated with what is known as the 14-day rule.
- The DOS is the date the test was performed (instead of the date of collection) if the following conditions are met:
- The test is ordered by the patient’s physician at least 14 days following the date of the patient’s discharge from the hospital;
- The specimen was collected while the patient was undergoing a hospital surgical procedure;
- It would be medically inappropriate to have collected the sample other than during the hospital procedure for which the patient was admitted;
- The results of the test do not guide treatment provided during the hospital stay; and
- The test was reasonable and medically necessary for the treatment of an illness.
- Another 14-day rule applies to chemotherapy sensitive tests performed on live tissue under the same conditions as described above with only slight variation to the first condition:
- The decision regarding the specific chemotherapeutic agents to test is made at least 14 days after discharge;
Both of these 14-day rules apply to hospital inpatients and outpatients and the key point is that the test is ordered at least 14 days after discharge. These DOS requirements determine whether the hospital bills Medicare for a clinical diagnostic laboratory test (CDLT) or whether the laboratory performing the test bills Medicare directly. When the 14-day rule applies, laboratory tests are not bundled into the hospital stay, but are instead paid separately under Medicare Part B to the testing laboratory.
Stakeholders expressed concerns about the current (2017) DOS policy because it requires hospitals to bill for tests they did not perform and that may have no relationship to or bearing on treatment received by the patient while in the hospital and it creates billing difficulties for the hospital. CMS agreed with these concerns and modified the date of service rule for hospital outpatients for molecular pathology tests and advanced diagnostic laboratory tests (ADLTs) that are not packaged under OPPS. These types of lab test have a Status Indicator of “A” on Addendum B.
The new rule (from the 2018 OPPS Final Rule) states that in the case of a molecular pathology test or an ADLT, the DOS of the test must be the date the test was performed only if—
- The test was performed following a hospital outpatient’s discharge from the hospital outpatient department;
- The specimen was collected from a hospital outpatient during an encounter (as both are defined in 42 CFR 410.2);
- It was medically appropriate to have collected the sample from the hospital outpatient during the hospital outpatient encounter;
- The results of the test do not guide treatment provided during the hospital outpatient encounter; and
- The test was reasonable and medically necessary for the treatment of an illness.
This new exception to the laboratory DOS policy does not apply to ADLT or molecular pathology tests when performed on a specimen collected from a hospital inpatient.
This new laboratory DOS policy will enable laboratories performing ADLTs and molecular pathology tests excluded from the OPPS packaging policy to bill Medicare directly for those tests, instead of requiring them to seek payment from the hospital outpatient department. In fact, for molecular pathology tests and ADLTs meeting the above requirements, the DOS must be the date the test was performed and the test must be billed by the performing laboratory. Hospital laboratories cannot bill for these tests unless they perform them.”
Although the “new” lab DOS rule from the 2018 OPPS Final Rule described above was originally set to be implemented July 2, 2018, many hospitals and laboratories reported to CMS they were having administrative difficulties implementing the DOS exception. For that reason, CMS has repeatedly exercised enforcement discretion regarding the new rule, with the latest enforcement discretion in effect until January 2, 2020.
Because of continued concerns about the readiness of labs and hospitals to implement the new rule and additional concerns that some entities performing molecular pathology testing subject to the laboratory DOS exception, such as blood banks and blood centers, may not be enrolled in the Medicare program and may not have established a mechanism to bill Medicare directly, CMS is rethinking this DOS rule. In the 2020 OPPS Proposed Rule, they are seeking comments on three options for potential changes to the laboratory DOS exception.
- Changing the Test Results Requirements – Under this option, the test would be considered a hospital service unless the ordering physician determines that the test does not guide treatment during a hospital outpatient encounter.
- Limiting the Laboratory DOS Exception to ADLTs
- Excluding Blood Banks and Blood Centers from the Laboratory DOS Exception
These options would only affect the new lab DOS exception put forth in the 2018 OPPS Final Rule that applies to molecular pathology tests and ADLTs. The basic lab DOS rules and the 14-day rule DOS exception and the chemotherapy sensitivity test DOS exception would not be affected.
I encourage hospitals and laboratories affected by these date of service rules to read the discussion in the Proposed Rule and to submit comments to CMS. (Lab DOS Policy section begins on page 201 of 247 pages of the pdf printed version.)
Debbie Rubio
MEDICARE TRANSMITTALS – RECURRING UPDATES
Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment
Quarterly update.
October Quarterly Update to 2019 Annual Update of HCPCS Codes Used for Skilled Nursing Facility (SNF) Consolidated Billing (CB) Enforcement
Updates the lists of HCPCS codes that are subject to the consolidated billing provision of the SNF Prospective Payment System (PPS).
Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) Updates for Fiscal Year (FY) 2020
Changes from IPF Final Rule applicable to discharges occurring from October 1, 2019, through September 30, 2020 (FY 2020).
International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determination (NCDs) – January 2020 Update
Relevant NCD coding changes for:
- NCD20.7 Percutaneous Transluminal Angioplasty
- NCD110.18 Aprepitant
- NCD110.23 Stem Cell Transplantation
- NCD150.3 Bone Mineral Density Studies
- NCD220.4 Mammography
- NCD220.13 Percutaneous Image-Guided Breast Biopsy
- NCD270.3 Blood Derived-Products for Chronic, Non-Healing Wounds
Quarterly Healthcare Common Procedure Coding System (HCPCS) Drug/Biological Code Changes - October 2019 Update
Claim Status Category and Claim Status Codes Update
Healthcare Provider Taxonomy Codes (HPTCs) October 2019 Code set Update
OTHER MEDICARE TRANSMITTALS
Documentation of Medical Necessity of the Home Visit; and Physician Management Associated with Superficial Radiation Treatment - REVISED
Removes the requirement that the medical record show a home visit was medically necessary instead of an office or outpatient visit and allows billing E/M codes (99211, 99212, and 99213) for levels I through III with modifier 25 when performed for the purpose of reporting physician work associated with radiation therapy planning, radiation treatment device construction, and radiation treatment management when performed on the same date of service as superficial radiation treatment delivery.
Oxygen Policy Update
Implements a new policy and coding for oxygen content.
Instructions for Use of Informational Remittance Advice Remark Code Alert on Laboratory Service Remittance Advices
To assist in reminding laboratories of their reporting obligations, the following new alert RARC code will appear on remittances:
- N817: ALERT-Applicable laboratories are required to collect and report private payor data and report that data to CMS between January 1, 2020 - March 31, 2020
Bypassing Payment Window Edits for Donor Post-Kidney Transplant Complication Services
Manual Update to Sections 1.2 and 10.2.1 in Chapter 18 of the Medicare Claims Processing Manual
Adds a link to the current influenza codes and payment rates.
MEDICARE SPECIAL EDITION ARTICLES
Medicare Coverable Services for Integrative and Non-pharmacological Chronic Pain Management
Given the issues associated with using opioids for acute and chronic pain, this article summarizes some other treatment options to consider when you treat Medicare patients for chronic pain.
New Medicare Beneficiary Identifier (MBI) Get It, Use It – REISSUED
Use MBIs now for all Medicare transactions.
New Documentation Requirements for Filing Medicare Cost Reports
The FY 2019 Medicare IPPS final rule changed the required supporting documentation that providers must submit with the Medicare cost report.
MEDICARE COVERAGE UPDATES
Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)
Posted final decision memo.
https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=291
Medicare Press Releases
MEDICARE EDUCATIONAL RESOURCES
Medicare Fast Facts
Medicare Fast Facts resources this month include:
- Ambulance Fee Schedule and Medicare Transports
- Skilled Nursing Facility 3-Day Rule Billing
Skilled Nursing Facility 3-Day Rule Billing
MLN Fact Sheet
Ambulance Fee Schedule and Medicare Transports Booklet
MLN Booklet
OTHER MEDICARE UPDATES
FY 2020 Coding Updates
ICD-10-CM Coding Guidelines - https://www.cdc.gov/nchs/icd/icd10cm.htm
ICD-10-CM (Diagnosis Codes) - https://www.cms.gov/Medicare/Coding/ICD10/2020-ICD-10-CM.html
ICD-10-PCS (Procedure Codes) - https://www.cms.gov/Medicare/Coding/ICD10/2020-ICD-10-PCS.html
2020 Advance Beneficiary Notice (ABN) Forms
https://www.cms.gov/Medicare/Medicare-General-Information/BNI/ABN.html
A recent story by National Public Radio (NPR) discussed the delay in the implementation of the law requiring physicians to consult clinical guidelines before ordering certain imaging tests. The story notes that critics believe the delay has resulted in unnecessary costs and radiation exposure. I am not agreeing or disagreeing with any of the concerns raised by the story, but I want to point out a few things I know based on my understanding of the new requirements and my experience in healthcare. First, not all physicians order unnecessary tests. The article quotes studies that have found widespread overuse, including one study that reported 26% of the CTs and MRIs they reviewed were inappropriate. However, this was at a large academic medical center, so hopefully most physicians use their training to appropriately order advanced imaging exams.
A fallacy in the story in my opinion is how easy the new process will be – “4 clicks on the computer – or less than a minute.” I am skeptical that the ordering physician’s process will be that easy and there are numerous requirements on the back end, i.e. the performing entity and the interpreting professional claim requirements. Beginning July 1, 2018 through December 31, 2019, providers could voluntarily participate in the program. January 1, 2020 through December 31, 2020 is the Educational and Operations Testing Period in which providers are encouraged to participate, but claims will not be denied. These voluntary and testing periods are beneficial to providers to work out the kinks in what is an anything-but-simple process.
On July 26, 2019, CMS released a transmittal that details the requirements for the Testing Period in 2020. The basic premise of the program - Appropriate Use Criteria (AUC) for Advanced Diagnostic Imaging is:
Step One – When an advanced imaging service is ordered for a Medicare beneficiary, the ordering professional must consult a qualified Clinical Decision Support Mechanism (CDSM), an interactive, electronic tool that assists practitioners in making the most appropriate treatment decision for a patient’s specific clinical condition. The CDSM will provide the ordering professional with a determination of whether the order adheres to AUC, does not adhere to AUC, or if there is no AUC applicable (for example, no AUC is available to address the patient’s clinical condition).
Step Two – The ordering physician must communicate the status and outcome of use of the CDSM to the furnishing entity and physician.
Step Three – The furnishing providers and practitioners must report on their Medicare claim, modifiers describing the CDSM status and decision, if applicable, and when appropriate, a HCPCS indicating which CDSM was used.
The AUC program applies to:
- Advance imaging services such as computed tomography (CT), Positron emission tomography (PET), Nuclear medicine (NM), and Magnetic resonance imaging (MRI). The specific CPT/HCPCS codes affected are listed in the transmittal.
- The following settings:
- Physician offices
- Hospital outpatient departments (including emergency departments)
- Ambulatory Surgical Centers (ASCs)
- Independent diagnostic testing facilities
- Services paid under the Medicare Physician Fee Schedule (MPFS), the Hospital Outpatient Prospective Payment System (OPPS), or the Ambulatory Surgical Center (ASC) fee schedule
CMS does allow exceptions to participation in the program for ordering professionals with a significant hardship (such as limited access to the internet, etc.), patients with an emergency medical condition, and inpatients paid under Medicare Part A. It is confusing to me why applicable settings include hospital emergency departments when patients with an emergency medical condition are exempt. I have submitted a question to CMS for clarification regarding this and will share through the Wednesday@One newsletter any information I receive.
The modifiers to be reported (MA-MH and QQ) describe whether a CDSM was consulted or not and if not, the reason, or if so, the outcome/decision. The modifier is to be appended to the advanced imaging line item code on the claim. If a modifier is reported that indicates a CDSM was consulted (ME, MF or MG), then the claim should additionally contain a G-code (on a separate claim line) to report which qualified CDSM was consulted. These are informational-only G-codes that will not result in any payment, similar to the codes previously required for Functional Limitation Reporting for therapy services. Providers will have to deal with the same issues of submitting a $0 or minimal charge for these codes. The transmittal includes descriptions of all the modifiers and G-codes.
The plan at this time is to fully implement the requirements of AUC effective January 1, 2021. Upon full implementation, claims for the affected imaging services will be denied if they do not contain information regarding the ordering professional’s consultation with CDSM, or exception to such consultation. The ultimate goal of the program is to identify professionals with outlier-ordering patterns and require those practitioners to obtain prior authorizations for these tests. That requirement will likely be several more years down the road.
Just thinking of the processes hospitals and radiologists will have to put into place to make this happen makes my head spin. And that is all after the process the ordering practitioner goes through – (no need to worry about that though as it is only 4 clicks on the computer). Now is the time, during this Testing phase, for hospitals to develop and implement the necessary processes for this program – how will you receive, document, and internally communicate the information from the ordering practitioner; how will the correct modifier get on the claim line item; and how will the appropriate G-code get added to the claim. And still to be worked out is how institutional providers will report line level ordering physician information on the institutional claim since that capability is not currently available.
Sometimes there are good reasons for delaying a well-intentioned idea.
Debbie Rubio
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