Knowledge Base Category -
MEDICARE TRANSMITTALS
Adjustments to Qualified Medicare Beneficiary (QMB) Claims Processed Under CR 9911
Directs MACs to mass adjust QMB claims impacted by CR9911.
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10494.pdf
April 2018 Integrated Outpatient Code Editor (I/OCE) Specifications Version 19.1 – REVISED
Revised to correct the status indicator for the drug code J0606 from SI=G to SI=K.
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10514.pdf
April 2018 Update of the Hospital Outpatient Prospective Payment System (OPPS) - REVISED
Updated the number of drugs and biologicals with OPPS pass-through status effective April 1, 2018, from twelve to eleven and removed HCPCS code J0606, Injection, etelcalcetide, 0.1 mg, from Table 5, Attachment A in the CR since its status indicator remains "K" for the April update.
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10515.pdf
Claims Processing Actions to Implement Certain Provisions of the Bipartisan Budget Act of 2018
Provides direction to MACs to reprocess claims related to several provisions of the Bipartisan Budget Act of 2018, specifically the Ambulance add-on payment provisions, the Work Geographic Practice Cost Index (GPCI) Floor, the 3% Home Health (HH) Rural Add-on Payment, and the repeal of outpatient therapy caps with requirement to submit the KX modifier for services in excess of the prior cap amounts.
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10531.pdf
Institutional Billing for No Cost Items
Provides clarification of the billing instructions specific to drugs provided at no cost when claims processing edits prevent drug administration charges from being billed when the claim does not contain a covered/billable drug charge.
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10521.pdf
New Waived Tests
New Clinical Laboratory Improvement Amendments of 1988 (CLIA) waived tests approved by the Food and Drug Administration (FDA).
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM10586.pdf
Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD) – REVISED
Clarifies that the SET program must be provided in a physician’s office (Place of Service code 11).
NOTE: MMP contacted CMS and was informed another revision of this CR would be forthcoming.
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM10295.pdf
Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 24.2 Effective July 1, 2018
Change in Type of Service (TOS) for Current Procedural Terminology (CPT) Code 77067
Corrects the TOS indicator assigned to CPT code 77067 – Screening Mammography to “1” instead of “4” to allow screening mammography claims to be billed without referring physician information on the claim, consistent with Medicare’s coverage policy for screening mammograms.
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10607.pdf
Notice of New Interest Rate for Medicare Overpayments and Underpayments - 3rd Qtr Notification for FY 2018
Medicare contractors shall implement an interest rate of 10.25 percent effective April 17, 2018 for Medicare overpayments and underpayments.
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R303FM.pdf
Internet Only Manual Update to Pub 100-04, Chapter 16, Section 40.8 - Date of Service Policy
Updates the Date of Service (DOS) Policy for Clinical Laboratory and Pathology Specimens
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R4000CP.pdf
Quarterly Healthcare Common Procedure Coding System (HCPCS) Drug/Biological Code Changes – July 2018 Update
Quarterly update of drug/biological HCPCS codes.
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNmattersArticles/downloads/MM10624.pdf
MEDICARE SPECIAL EDITION ARTICLES
Prohibition Billing Dually Eligible Individuals Enrolled in the Qualified Medicare Beneficiary (QMB) Program - REVISED
Updates information about the Remittance Advice (RA) and Medicare Summary Notice (MSN) for all Medicare Fee-For-Service (FFS) QMB claims and includes new statistics on the number of beneficiaries enrolled in QMB.
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE1128.pdf
Proper Coding for Specimen Validity Testing Billed in Combination with Drug Testing
Reminds laboratories and other providers performing validity testing on urine specimens utilized for drug testing not to separately bill the validity testing.
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE18001.pdf
MEDICARE COVERAGE UPDATES
Decision Memo for Magnetic Resonance Imaging (MRI) (CAG-00399R4)
Evidence is sufficient to conclude that magnetic resonance imaging (MRI) for Medicare beneficiaries with an implanted pacemaker (PM), implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy pacemaker (CRT-P), or cardiac resynchronization therapy defibrillator (CRT-D) is reasonable and necessary. Will modify current NCD to eliminate the collection of additional information under the Coverage with Evidence Development paradigm.
https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=289&TimeFrame=7&DocType=All&bc=AgAAYAAAQAAA&
OTHER MEDICARE UPDATES
New Proposed RAC Review Topics – April 2018
April 2018 proposed topics include:
- Exact Duplicate Claims
- Implantable Automatic Defibrillators
- Group 3 Support Surfaces
- Percutaneous Implantation of Neurostimulator Electrode Array
March Patients Over Paperwork Newsletter
New OIG Compliance Resource Portal
OIG launches new compliance resource portal that provides links to handy resources for the public that can help ensure that you are in compliance with Federal health care laws.
https://oig.hhs.gov/compliance/compliance-resource-portal/
The Outpatient Prospective Payment System (OPPS) final rule is released each year around the first of November, and that only gives hospitals two months (during an already busy and short-staffed holiday season I might add) to implement the new requirements for the coming year. Sometimes this means beginning to make changes before final guidance and addenda are available – a good way to get a jump on necessary revisions. The caution for this approach is to be sure to check any additional guidance and revised addenda prior to implementation and make the necessary adjustments.
For example, the 2018 OPPS final rule required the reporting of modifiers for drugs purchased through the 340B drug discount program. Modifier JG is reported with separately payable drugs with a status indicator of “K” by most hospitals purchasing drugs through the 340B program. The JG modifier causes Medicare payment to be made at average sale price (ASP) minus 22.5%, instead of the ASP +6% that is paid for separately payable drugs not purchased through the 340B program and a few other exceptions. Modifier TB is reported on the applicable drugs by certain excepted types of providers (rural sole-community hospitals, children’s hospitals and cancer hospitals) and for pass-through drugs which have a status indicator of “G.” If your hospital proactively added the applicable modifiers to your chargemaster, did you remember to verify that the status indicator for each drug did not change for 2018?
In claim review, MMP has observed some drugs, whose status indicator changed from “G” in 2017 to “K” in 2018, being reported with the incorrect modifier. Status indicator “G” pass-through drugs purchased through the 340B program are reported with a TB modifier, but once their SI changes to “K” they are to be reported with a JG modifier resulting in a reduced drug payment. Below is a table of those drugs that had a status indicator of “G” for 2017 that changed to “K” for 2018.
Hospitals may want to verify again that the modifiers they are reporting for drugs purchased through the 340B program are correct and appropriate based on the drug’s OPPS status indicator. When billing Medicare, it is a good idea to check and double-check as things can change in an instant.
Debbie Rubio
When we think of copycat products, we often picture the nefarious character flipping open his overcoat to reveal a row of “Rolex” watches available at bargain basement prices - in other words, counterfeit products of a lesser quality and illegally bearing a trademark name. But in the world of biological drugs, legitimate but costly copycat products offer physicians and patients other options for treatment. With appropriate payment policies, the United States biosimilar product marketplace can continue to grow resulting in cost savings and those additional treatment options. In the 2018 Medicare Physician Fee Schedule Final Rule (MPFS), CMS changed the payment policy for biosimilars to separately code and determine payment for each biological biosimilar product under Medicare Part B.
The original policy addressing biosimilars was from the 2016 MPFS rule. At that time CMS decided to base the payment amount for a biosimilar biological product on the average sales price (ASP) of all biosimilars for one reference product and to assign one payment code (HCPCS code) to all biosimilars for the same reference product. “In general, this means that products that rely on a common reference product’s biologics license application (that is, FDA’s previous finding of safety, purity, and potency for the common reference product) are grouped into the same payment calculation for determining a single ASP payment limit and that a single HCPCS code is used for such biosimilar products. The regulation went into effect on January 1, 2016.” Biosimilars sharing the same HCPCS code, but produced by different manufacturers, were distinguished by HCPCS modifiers.
There were varying opinions about Medicare’s payment policy for biosimilars from the beginning – some stakeholders supporting the use of one HCPCS code and others opposing it. In the 2018 MPFS FR, CMS notes, “The biosimilar product marketplace has continued to grow, and four biosimilar biological products that are paid under Part B have been licensed, including one product approved in 2017 that is sharing a HCPCS code with another previously licensed biosimilar biological product. Based on the number of biosimilar biological products that are reported to be nearing approval and the approvals made over the past 2 years, CMS anticipates that several more biosimilar biological products will be licensed for use in the United States during the next year and that during the following years, the marketplace will continue to grow steadily, provided that the approved products are marketed without delay. …CMS is aware of concerns that current Medicare policy may discourage development of new biosimilars and other innovation in this area potentially resulting in higher costs over time due to a lack of competition in the market place.”
As usual for CMS rules, the topic was discussed in great detail in the 2018 MPFS Final Rule (starting on page 53182). Some of the more interesting points of the discussion include,
Facts about Biosimilars:
- Biosimilars are similar, but not identical, to their reference products, and due to these subtle differences, they may have different therapeutic and adverse effects on patients, requiring clinical distinctions between the products.
- None of the currently available biosimilars are approved as interchangeable. The current biosimilar approval process does not compare biosimilar biological products to each other, rather, only similarity to a reference product is established and the licensing of a biological product under the biosimilar pathway does not mean that the products are interchangeable.
- Biosimilar biological products may be approved for fewer indications than the reference product and the approved indications within a group of biosimilar biological products with the same reference product may vary.
- These products are likely to be expensive and may have different acquisition costs. The development costs for these products and their manufacturing facilities are estimated to be in the hundreds of millions of dollars.
Stakeholders’ Comments
- Grouping (biosimilars) for payment could lead to prescribing choices based on cost rather than clinical considerations.
- The current policy may impair access to biosimilars, could potentially limit the introduction of biosimilars to the US market, and would fail to maximize competition and savings.
- Grouping products for payment that do not have all the same indications could cause clinicians and patients to think the products are interchangeable or could lead to off-label use.
- Blended payment could be a significant financial risk to the provider because the products that would be the best choice for a patient may not be paid above acquisition cost.
- ‘‘Race to the bottom’’ pricing competition would result from shared codes and lead to prices that could not sustain educational efforts and other activities associated with marketing new and complex biological products, ultimately resulting in manufacturers leaving the United States marketplace.
- Determining a payment for each biosimilar product by using individual HCPCS codes would drive and reward innovators, producing the potential cost savings of at least 10–15 percent compared to the reference biologic ASP necessary for biosimilar products to compete with the reference biological.
Because of the above facts and concerns, CMS has “become increasingly concerned about the relationship between cost, prices and competition; specifically, many commenters’ continued unease regarding the effects of our payment policy on patient and provider choices, as well as the biosimilar marketplace. We have also considered how the payment policy could affect market entry of new biosimilar manufacturers. If payment amounts limit manufacturers’ willingness to invest in the development of new biosimilars, it could in the long term, decrease the number of biosimilar biological products that are available to prescribe and thus impair price competition. Given that the United States’ biosimilar biological product marketplace is still relatively new, we believe that it is important to maintain a payment policy innovation as well as reasonable pricing for consumers. We agree that it is important to consider and effect policy changes early, as this portion of the drug marketplace develops, in order to support a robust marketplace that provides choices for providers and patients while maximizing savings.”
Effective January 1, 2018, newly approved biosimilar biological products with a common reference product will no longer be grouped into the same HCPCS code. Each biosimilar will be assigned a unique HCPCS code and payment will be based on the ASP for that individual biosimilar. Biosimilar HCPCS codes in use prior to January 1, 2018 are being changed and replaced to be in compliance with the new payment policy. This is described on the Medicare Biosimilar webpage and addressed in the April 2018 OPPS Update MLN Matters Article. Effective April 1, 2018, the descriptor for HCPCS code Q5101 (filgrastim biosimilar) is being changed to “Injection, zarxio.” HCPCS code Q5102 (infliximab biosimilar) is being replaced effective April 1, 2018 with HCPCS codes Q5103 (Injection, inflectra) and Q5104 (Injection, renflexis). The new biosimilar payment policy also makes the use of modifiers that describe the manufacturer of a biosimilar product unnecessary. Therefore, modifiers ZA, ZB, and ZC will be discontinued for dates of service on or after April 1, 2018. However, please note that HCPCS code Q5102 and the requirement to use applicable biosimilar modifiers remain in effect for dates of service prior to April 1, 2018.
Debbie Rubio
In recent news, a pedestrian bridge under construction on the Florida International University campus collapsed killing 6 people and injuring many others - a terrible tragedy and an engineering failure. Humans are fallible, and objects built by man, big or small, are subject to failure. Sadly, medical devices that save millions of lives are not exempt from the propensity to fail. In February, Medtronic issued a recall for Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs). The Federal Drug Administration (FDA) identified this as a Class I recall, with the potential to cause serious injuries or death. According to the FDA Recall information “a defect in the manufacturing process … may prevent the device from delivering the electrical shock needed to pace a patient’s heartbeat or revive a patient in cardiac arrest. The delay or inability to deliver a shock to a patient in cardiac arrest or pace a patient’s heart whose heartbeat is too slow could result in serious injury and/or death.” This is a scary life-threatening prospect for patients with one of these devices and replacements will be occurring fast and furious.
Though not nearly as concerning as a fatal heart attack, providers must be concerned with the correct reporting to Medicare of the replacement of these devices for their Medicare patients. Reporting of device credits is an area historically fraught with errors. Almost every Office of Inspector General (OIG) Hospital Compliance Review includes a few inpatient and/or outpatient errors associated with device credit reporting. This trend continued when a September 2017 OIG report identified that Medicare paid for many device replacement procedures incorrectly. And more recently, a March 2018 OIG Report found that “All 296 payments reviewed for recalled cardiac medical devices did not comply with Medicare requirements for reporting manufacturer credits. Medicare contractors incorrectly paid hospitals $7.7 million for cardiac device replacement claims rather than the $3.3 million they should have been paid, resulting in potential overpayments of $4.4 million.”
Why so many errors? The process of identifying patients receiving applicable no-cost or reduced-cost devices, knowing when credits are received or should be received, the amount of such credits, and coordination between various departments to get this information onto the Medicare claim can be daunting. The OIG states that along with lack of hospital policies, procedures and controls, the need to involve various hospital departments and personnel contributes to the lack of identification, tracking, and reporting of these credits on Medicare claims. The March 2018 OIG report identifies the hospital challenges and discusses them in detail. Here are some of the OIG comments, but I encourage providers to read the entire report as the OIG offers specific suggestions, such as holding claims or submitting adjustment claims when it is not known if a credit will be received for a replacement device.
“Different hospital personnel are responsible for contacting the manufacturer, tracking the availability of the credit, and determining whether an adjustment claim needs to be submitted to pass along the credit to Medicare. …Furthermore, hospital staff submitting Medicare claims must
be aware of credits that are at least 50 percent of the price the facility paid for the replacement device, and staff must report the credit as a deduction on a submitted claim. However, hospitals may not know whether they will receive a credit or how much that credit will be at the time of billing for the device replacement procedure. … Specifically, hospitals attributed their incorrect billings to inadequate policies and procedures for reporting manufacturer credits, lack of awareness of warranties and credit availability, and hospital misapplication of the credit amounts.”
Medicare’s device credit policy only applies to implantable, high-cost devices when the OPPS device off-set amount exceeds 40% of procedure payment and for inpatients, select DRGs. This includes, but is not limited to, devices such as cardiac pacemakers and defibrillators, neurostimulators, prostheses, and intraocular lens. For such devices, credit reporting is required when:
- a hospital furnishes without cost an initial placement of a medical device as part of a clinical trial or a free sample medical device or
- when a hospital furnishes a new replacement device due to warranty, recall, or field action
- without cost or
- with a credit of 50% or more of the cost of a new replacement from a manufacturer.
Hospitals must report on the Medicare claim
- Value code “FD” (Credit Received from the Manufacturer for a Medical Device)
- The amount of the device credit in the amount portion for value code FD, and
- One of the following condition codes
- 49 - Product Replacement within Product Lifecycle—Replacement of a product earlier than the anticipated lifecycle.
- 50 - Product Replacement for Known Recall of a Product—Manufacturer or FDA has identified the product for recall and therefore replacement.
- 53 - Initial placement of a medical device provided as part of a clinical trial or free sample—Code is for outpatient claims that have received a device credit upon initial medical device placement in a clinical trial or a free sample.
As complicated as it already is, it may get worse. CMS is concerned about the overall cost and health impact of recalled or prematurely failed medical devices. In the OIG September 2017 report, the OIG determined that Medicare costs related to the replacement of recalled or prematurely failed medical devices could not be identified and tracked using only claim data. They recommended a Device Identifier
(DI) be included on the next version of claim forms which is under consideration as a policy by CMS. The OIG maintains “that by including the DI on claim forms and expanding the use of condition codes, CMS could more effectively identify and track Medicare’s aggregate costs related to recalled or prematurely failed devices, reduce Medicare costs by identifying poorly performing devices more quickly, facilitate device recipients’ chances of receiving timely follow-up care, and protect beneficiaries from unnecessary costs.” It would be hard to argue this is not a good idea, but the additional paperwork burden would fall on hospitals submitting the claims. Hospitals who already are not getting the required reporting right.
It is also worth noting the different approach the OIG took for the March 2018 report referenced above. For this audit, the OIG obtained a list of warranty credits that two device manufacturers issued to hospitals for five cardiac medical devices that had been recalled or had high failure rates. Auditing the at-risk claims identified based on the list, resulted in the OIG finding errors for all claims reviewed as noted above. Providers may want to follow the OIG’s lead and work with their vendors to obtain lists of credits issued. This could help in initial correct claim reporting and identifying prior reporting errors so a corrected adjustment claim could be submitted.
The best practice first step and necessary action is to bring key stakeholders together to consider all the different factors and develop a process together that includes policies, procedures, and controls. First you have to identify the involved departments and personnel – clinical departments of cardiology and surgery, materials management, accounts payable, billing, physicians who may implant such devices, compliance, and maybe others.
If your facility hasn’t already addressed this issue, it is good to do so now. As long as the OIG can identify over $4 million in overpayments, it is not going away.
Debbie Rubio
MEDICARE TRANSMITTALS
ICD-10 and Other Coding Revisions to National Coverage Determinations (NCDs) – (Revised 3/1/18)
A maintenance update of the ICD-10 conversions and other coding updates specific to National Coverage Determinations (NCDs).
Appropriate Use Criteria for Advanced Diagnostic Imaging – Voluntary Participation and Reporting Period - Claims Processing Requirements – HCPCS Modifier QQ
New HCPCS modifier (QQ) that may be reported with CPT code for an advanced diagnostic imaging service when the ordering physician consults appropriate use criteria.
April 2018 Integrated Outpatient Code Editor (I/OCE) Specifications Version 19.1
The modifications of the I/OCE for the April 2018 V19.1 update.
April 2018 Update of the Hospital Outpatient Prospective Payment System (OPPS)
Changes to the OPPS to be implemented in the April 2018 update.
Quarterly Healthcare Common Procedure Coding System (HCPCS) Drug/Biological Code Changes - April 2018 Update
The HCPCS code set is updated on a quarterly basis. Change Request (CR) 10454 informs MACs of the April 2018 updates of specific biosimilar biological product HCPCS code, modifiers used with these biosimilar biologic products and an autologous cellular immunotherapy treatment.
Clarification of Instructions Regarding the Intensive Level of Rehabilitation Therapy Services Requirements
Instructions for conducting medical review of Inpatient Rehabilitation Facility (IRF) claims when reviewing the requirements for the intensive level of rehabilitation therapy services.
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R771PI.pdf
Correction to Pub. 100-04, Chapter 5
Updates the list of Types of Bill subject to application of the therapy caps and related policies to Critical Access Hospital (CAH) claims in accordance with CR 8426.
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R3995CP.pdf
Quarterly Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment – (Revised 3/15/18)
Changes in the April 2018 quarterly update to the Clinical Laboratory Fee Schedule (CLFS).
Internet Only Manual Update to Pub 100-04, Chapter 16, Section 40.8 -Date of Service Policy
Manualizes the additional exception to the current laboratory DOS regulations from the CY 2018 OPPS/ASC final rule published December 14, 2017, so that the DOS for Advanced Diagnostic Laboratory Tests and molecular pathology tests excluded from OPPS packaging policy is the date the test was performed if certain conditions are met. This new exception to the laboratory DOS policy is effective beginning on January 1, 2018.
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R4000CP.pdf
MEDICARE SPECIAL EDITION ARTICLES
Billing Requirements for OPPS Providers with Multiple Service Locations
Enforcement editing requirements for hospitals operating off-campus, outpatient, provider-based departments of a hospital’s facilities (facility address and appropriate modifiers).
MEDICARE COVERAGE UPDATES
MEDICARE PRESS RELEASES
CMS finalizes coverage of Next Generation Sequencing tests, ensuring enhanced access for cancer patients
CMS finalized a National Coverage Determination that covers diagnostic laboratory tests using Next Generation Sequencing (NGS) for patients with advanced cancer (i.e., recurrent, metastatic, relapsed, refractory, or stages III or IV cancer).
Trump Administration Announces MyHealthEData Initiative to Put Patients at the Center of the US Healthcare System
The MyHealthEData initiative will work to make clear that patients deserve to not only electronically receive a copy of their entire health record, but also be able to share their data with whomever they want, making the patient the center of the healthcare system.
MEDICARE EDUCATIONAL RESOURCES
OTHER MEDICARE UPDATES
Enforcement Instruction on Supervision Requirements for Outpatient Therapeutic Services in Critical Access Hospitals and Small Rural Hospitals
February Patients Over Paperwork Newsletter
Update on CMS’s initiative to evaluate and streamline regulations with a goal to reduce unnecessary burden, to increase efficiencies, and to improve the beneficiary experience.
Website for Providers about New Medicare Cards
New Medicare cards start going out in April and providers must be able to accept them. This website has information and other resources on the new cards.
https://www.cms.gov/Medicare/New-Medicare-Card/Providers/Providers.html
January 1, 2020 – that is the date currently planned for full implementation of the required consultation of Appropriate Use Criteria (AUC) for ordering advanced diagnostic imaging services and the required claim reporting of such. Though that seems a long time away, Medicare is making first steps towards this implementation. And once here, the process will require coordination of several providers, so planning ahead is a good idea for all involved. 2020 will be here before you know it.
This new program was established by the Protecting Access to Medicare Act (PAMA) of 2014, to ensure advanced diagnostic imaging services are being ordered appropriately. The program will require ordering physicians/practitioners to consult appropriate use criteria (AUC) through a qualified electronic portal (known as a Clinical Decision Support Mechanism (CDSM)) prior to ordering advanced imaging services. The CDSM lets the ordering professional know whether the order adheres, or does not adhere, to AUC, or if there is no AUC applicable. The final part of the requirement is that the furnishing professional (e.g. the radiologist) and the performing facility must report consultation information on their respective claims. Per CMS, “Ultimately, this program will result in identified outlier ordering professionals being subject to prior authorization.”
The program applies to advanced imaging services –
- Specifically, computerized tomography (CT), positron emission tomography (PET), nuclear medicine (NM), and magnetic resonance imaging (MRI);
- Furnished in physician offices, hospital outpatient departments (including emergency departments), ambulatory surgical centers, and any other outpatient setting determined appropriate in the future; and
- Paid under the physician fee schedule (PFS), the hospital outpatient prospective payment system(OPPS), or the ambulatory surgical center payment system.
There are exceptions to the requirements for ordering professionals with significant hardships, patients with emergency medical conditions, and inpatients paid under Part A.
MLN Matters MM10481 announces a new modifier for voluntary reporting. “Effective July 1, 2018, HCPCS modifier QQ (Ordering Professional Consulted A Qualified Clinical Decision Support Mechanism For This Service And The Related Data Was Provided To The Furnishing Professional) is available for this reporting. The modifier may be:
- Used when the furnishing professional is aware of the result of the ordering professional’s consultation with a CDSM for that patient,
- Reported on the same claim line as the CPT code for an advanced diagnostic imaging service furnished in an applicable setting and paid for under an applicable payment system, and,
- Reported on both the facility and professional claim.”
CMS has not yet provided detailed claim-reporting instructions for the future beyond the voluntary reporting of the QQ modifier. CMS indicates the ordering practitioner’s National Provider Identifier (NPI) and the specific CDSM consulted will have to be reported once the program is fully implemented. CMS will publish claim instructions prior to any additional reporting requirements. The MLN article includes a list of applicable CPT codes, though for now the modifier may be used on codes outside the specified ranges. The new modifier is voluntary and Medicare will continue to pay for advanced imaging services with or without the modifier.
CMS has a website about the Appropriate Use Criteria program with more information. The website includes a definition of AUC as “criteria that are evidence-based (to the extent feasible) and assist professionals who order and furnish applicable imaging services to make the most appropriate treatment decisions for a specific clinical condition.” The website also includes a list of qualified CDSMs and priority clinical areas.
Appropriate consultation and claim reporting will require coordination between the ordering professional, the furnishing physician (radiologist) and the facility providing the service. For example, how will the ordering physician convey to the performing facility and furnishing physician that he/she has consulted a CDSM, which CDSM was consulted, and what the results were? How will the facility and furnishing physician get modifiers and other required information on the claim? A lot to consider and plan – 2020 will be here before you know it.
Debbie Rubio
MEDICARE TRANSMITTALS
Quarterly Healthcare Common Procedure Coding System (HCPCS) Drug/Biological Code Changes - April 2018 Update
The April 2018 updates of specific biosimilar biological product HCPCS code, modifiers used with these biosimilar biologic products and an autologous cellular immunotherapy treatment.
E/M Service Documentation Provided By Students (Manual Update)
Allows the teaching physician to verify in the medical record any student documentation of components of E/M services, rather than re-documenting the work.
Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 24.1, Effective April 1, 2018
Medicare Fee-for-Service Recovery Audit Program Additional Documentation Limits for Medicare Institutional Providers (i.e. Facilities)
New ADR limits for the Recovery Audit Program.
Diagnosis Code Update for Add-on Payments for Blood Clotting Factor Administered to Hemophilia Inpatients
Updates to diagnosis codes required in order to allow add-on payments under the Inpatient Prospective Payment System (IPPS) for blood clotting factor administered to hemophilia inpatients.
Quarterly Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment
Changes in the April 2018 quarterly update to the Clinical Laboratory Fee Schedule (CLFS).
Replacement of Mammography HCPCS Codes, Waiver of Coinsurance and Deductible for Preventive and Other Services, and Addition of Anesthesia and Prolonged Preventive Services – REVISED
Healthcare Common Procedure Coding System (HCPCS) Codes Subject to and Excluded from Clinical Laboratory Improvement Amendments (CLIA) Edits – REVISED
Revised to add HCPCS code G0475 as a code that is subject to CLIA edits effective, April 13, 2015.
Modifications to the Implementation of the Paperwork (PWK) Segment of the Electronic Submission of Medical Documentation (esMD) System
Enables MACs to receive unsolicited documentation (also known as paperwork (PWK)) via the Electronic Submission of Medical Documentation (esMD) system.
Update to the Medicare Physician Fee Schedule Database (MPFSDB) - April 2018 Update
Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code (CARC), Medicare Remit Easy Print (MREP) and PC Print Update
Updates the Remittance Advice Remark Codes (RARC) and Claims Adjustment Reason Code (CARC) lists and instructs Medicare Shared System Maintainers (SSMs) to update Medicare Remit Easy Print (MREP) and PC Print.
ICD-10 and Other Coding Revisions to National Coverage Determinations (NCDs)
A maintenance update of the International Classification of Diseases, Tenth Revision (ICD-10) conversions and other coding updates specific to National Coverage Determinations (NCDs). These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.
MEDICARE COVERAGE UPDATES
Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD)
Effective May 25, 2017, new NCD to cover Supervised Exercise Therapy (SET) for beneficiaries with Intermittent Claudication (IC) for the treatment of symptomatic Peripheral Artery Disease (PAD).
Decision Memo for Implantable Cardioverter Defibrillators (CAG-00157R4)
Changes to the ICD NCD from the 2005 reconsideration.
OTHER MEDICARE UPDATES
Medicare Fee-for-Service Recovery Audit Program Additional Documentation Limits for Medicare Institutional Providers (i.e. Facilities)
Correction: Hospital Outpatient Prospective Payment (OPPS) and Ambulatory Surgical Center (ASC) Payment Systems and Quality Reporting Programs
https://www.gpo.gov/fdsys/pkg/FR-2018-01-31/pdf/C1-2017-27949.pdf
Targeted Probe and Educate (TPE) Website Update
New resources available on the TPE website.
MEDICARE EDUCATIONAL RESOURCES
Transition to New Medicare Numbers and Cards FACTSHEET
DECISION
CMS posted a Final Decision Memo on February 15, 2018 for the National Coverage Determination (NCD) for Implantable Automatic Defibrillators (20.4). CMS finalized what they describe as “minimal changes” to the ICD NCD from the 2005 reconsideration. After you have finished reading this article I will leave it to you to decide if you agree with their definition of “minimal changes.”
DECISION SUMMARY OF THE CHANGES
Patient Criteria
- Add cardiac magnetic resonance imaging (MRI) to the list of diagnostic imaging studies that can evaluate left ventricular ejection fraction (LVEF).
- Note: Prior approved diagnostic imaging studies included echocardiography, radionuclide (nuclear medicine) imaging, and catheter angiography.
- Require patients who have severe non-ischemic dilated cardiomyopathy but no personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation to have been on optimal medical therapy (OMT) for at least 3 months.
- Require a patient shared decision making (SDM) interaction prior to ICD implementation for certain patients.
- Note: This includes all patient’s receiving an ICD for primary prevention.
Additional Patient Criteria
- Remove the Class IV heart failure requirement for cardiac resynchronization therapy (CRT)
Exceptions to Waiting Periods
- Add an exception for patients meeting CMS coverage requirements for cardiac pacemakers, and who meet the criteria for an ICD;
- Add an exception for patients with an existing ICD and qualifying replacement
- End the data collection requirement
Evidence
When developing a National Coverage Determination (NCD), CMS in general “evaluates relevant clinical evidence to determine whether or not the evidence is of sufficient quality to support a findings that an item or service falling within a benefit category is reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.”
The evidence review primarily focused “on randomized controlled trials that assess the clinical utility of defibrillators compared to optimal medical therapy, and relevant formal Technology Assessments and professional society guidelines. While reading through this part of the Decision Memo, some of the conclusions were reminiscent of statements made when Jack Handy shared “Deep Thoughts” on Saturday Night Live in the 1990’s. The following table highlights four of the studies.
PUBLIC COMMENTS
A significant portion of this Decision Memo was dedicated to detailing public comments received and CMS responses. The following table highlights comments and responses related to the “minimal changes” being made.
ANALYSIS
Patient Shared Decision Making
In addition to the example SDM tool for ICDs, CMS notes that a website was also developed “which leads patients step-by[step through some information on ICDs designed to increase patients’ knowledge of their medical condition, the risks and benefits of available treatments and to empower patients to become more involved in the decision-making process. https://patientdecisionaid.org/icd/.
CONSIDERATIONS MOVING FORWARD
Shared Decision Making
There are now 6 covered indications listed in the NCD. All patients receiving an ICD for primary prevention must be provided SDM. “For these patients…a formal shared decision making encounter must occur between the patient and a physician (as defined in Section 1861(r)(1)) or qualified non-physician practitioner (meaning a physician assistant, nurse practitioner, or clinical nurse specialist as defined in §1861(aa)(5)) using an evidence-based decision tool on ICDs prior to initial ICD implantation. The shared decision making encounter may occur at a separate visit.”
Questions to Consider:
- Who will be the healthcare provider to provide the SDM encounter?
- What tool will you utilize?
- When will this SDM be done? For example, the patient meeting Pacemaker and ICD indications that has been admitted for an AMI, Stent or CABG and placement is advised prior to the patient’s discharge.
- Since the SDM encounter can occur at a separate visit, what will be your process to make sure this information makes it into the medical record when the patient receives an ICD?
Optimal Medical Therapy
Patients who have severe non-ischemic dilated cardiomyopathy but no personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation must have been on optimal medical therapy (OMT) for at least 3 months prior to ICD placement.
Questions to Consider:
- Who is the healthcare provider providing optimal medical therapy? Is it a patient’s Internal Medicine Doctor, Cardiologist, Electrophysiologist?
- Similar to SDM, what will be your process to make sure this information makes it into the medical record when the patient receives an ICD?
MMP strongly encourages key stakeholders take the time to read the entire Decision Memo.
Beth Cobb
It is that time of year when the winter season tries its best to hang on while spring makes faltering attempts to assert itself. The intermittent but increasing days of warmer weather are accompanied by spring rains, spring fever, spring breaks, and oh don’t forget taxes. If you have family or friends in the accounting business, you experience first hand that it is also the “busy season” for tax accountants. Income taxes are one of the prime examples of the government taking away. In the recent Bipartisan Budget Act (BBA) of 2018, an example of our government giving and taking relates to rehabilitative therapy services and the infamous therapy cap.
Since the Balanced Budget Act of 1997, there has been an annual limitation on the amount Medicare will pay for rehabilitative therapy services for a beneficiary. This is known as the therapy caps. There has been one therapy cap for outpatient occupational therapy (OT) services and another separate therapy cap for physical therapy (PT) and speech-language pathology (SLP) services combined. Finally, however, the therapy cap is gone. The BBA signed into law on February 9, 2018 repealed the therapy cap effective for claims on and after January 1, 2018.
There are a few catches to the repeal. Providers must continue to report the KX modifier for therapy services that exceed the dollar amount previously known as the therapy cap. That amount remains $2,010 for 2018 – one $2,010 limit for physical therapy and speech-language services combined and another $2,010 limit for occupational therapy. The KX modifier is attestation the services above this dollar amount are reasonable and necessary and that there is documentation of medical necessity for the services in the patient’s medical record. Since there is not technically a therapy cap, it is not yet known if therapy services exceeding the dollar amount reported without a KX modifier will be denied. Such details should be forthcoming from CMS in sub-regulatory guidance. All types of therapy providers, including those in a hospital outpatient setting, are affected by the new rules.
There will also continue to be targeted medical reviews of therapy services that exceed a threshold amount. The BBA lowered that threshold amount for 2018 through 2028 from $3,700 to $3,000 – again, one threshold for PT/Speech combined and a separate threshold for OT. Not all therapy services exceeding the new, lower threshold will be reviewed. Targeted reviews for therapy exceeding the threshold will be selected based on such factors as therapy providers with a high claims denial rate for therapy services or with aberrant billing practices compared to their peers. The Supplemental Medical Review Contractor (SMRC) currently performs these types of reviews for CMS.
The bad news (i.e. the taking away) for therapy providers from the Bipartisan Budget Act relates to payment rates for services provided by therapy assistants. The BBA mandates that for PT and OT services furnished on and after January 1, 2022, the payment rate will be 85% of the usual payment when the services are provided in whole or in part by a therapy assistant. A modifier will be created to be reported when therapy services are provided by a therapy assistant to trigger the reduced payment rate.
This requirement for reduced payment for therapy assistant services offsets the excitement of the therapy cap repeal. At least there are a few years prior to any reduction in payment for assistant services. A lot can happen between now and then – maybe even another incident of the “government giveth.” We can always hope.
Debbie Rubio
“If you have an apple and I have an apple and we exchange these apples then you and I will still each have one apple. But if you have an idea and I have an idea and we exchange these ideas, then each of us will have two ideas.”
-George Bernard Shaw
Probe & Educate Target: Emergency Room Services
This past November, the Medicare Administrative Contractor (MAC) WPS announced that they would begin reviewing facilities billing emergency room services (CPT codes 99281-99285) as part of the Targeted Probe and Educate (TPE) review process.
The TPE process includes MACs utilizing data analysis to identify:
- Providers and suppliers who have high claim error rates or unusual billing practices, and
- Items or services that have high national error rates and are a financial risk to Medicare.
WPS provides the following guidance in the announcement for a successful review of emergency department visits for facility services (Type A Emergency Rooms):
- The number and type of interventions under the facility charge,
- The visit record showing the signs/symptoms that support medical necessity for the interventions, and
- The internal guidelines used to determine the HCPCS equivalent CPT code (99281-99285) for the hospital resources being billed.
WPS is currently the MAC for Jurisdiction 5 (IA, KS, MO, and NE Providers) and Jurisdiction 8 (IN, MI Providers). For those of you in a different MAC Jurisdiction, take note now as in general when one MAC targets a specific service it is not long before other MACs follow suit.
Are you an Outlier?
The question is, how do your E.R. levels codes compare to other facilities? Now, the Program for Evaluating Payment Patterns Electronic Report for short-term acute care hospitals (ST PEPPER) can assist you in analyzing your volume of emergency room services claims and comparing your data to your state, MAC jurisdiction and at the national level.
As of the 4th Quarter of the 2017 CMS IPPS Fiscal Year (July – September 2017), Emergency Department Evaluation and Management Visits (ED E&M) is a new PEPPER Target Area.
Target areas are approved by CMS because they have been identified as prone to improper payments. The Twenty-fourth Edition of the ST PEPPER User’s Guide notes that “concerns with overuse/misuse of higher level E&M codes have been prevalent for several years. The Office of Inspector General identified increasing trends of E&M coding for higher-level services (https://oig.hhs.gov/oei/reports/oei-04-10-00180.pdf ) as well as improper payments associated with E&M coding errors (https://oig.hhs.gov/oei/reports/oei-04-10-00181.pdf).”
PEPPER Recommendations for Outliers?
High Outliers could represent coding and billing errors related to over-coding of CPT code 99285. Appendix 5 of the User’s Guide notes attributes CPT 99285 as when “usually, the presenting problem(s) are of high severity and pose an immediate significant threat to life or physiologic function.” The ST PEPPER recommends reviewing a sample of claims coded to 99285 to validate the code is supported by documentation in the medical record.
Low Outliers could represent coding errors related to under-coding 99285. The ST PEPPER recommends reviewing a sample of claims coded to 99281, 99282, 99283 or 99284 should be reviewed to validate the code level is supported by documentation in the medical record.
Related article about the ST PEPPER: http://www.mmplusinc.com/news-articles/item/pepper-resources-guide-updates.
To learn more about the TPE Review Process visit the CMS TPE webpage at: https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Medical-Review/Targeted-Probe-and-EducateTPE.html
Beth Cobb
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