Knowledge Base Category -

Q:

What HCPCS code do we report for the drug Khapzory?

A:

For dates of service on or after October 1, 2019, use HCPCS code J0642 for levoleucovorin injection products marketed under the brand name of Khapzory.

According to the KHAPZORYTM website, it is a folate analog indicated for:

• Rescue after high-dose methotrexate therapy in patients with osteosarcoma.
• Diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination.
• Treatment of patients with metastatic colorectal cancer in combination with fluorouracil.

Khapzory is the first levoleucovorin product approved by the FDA that contains sodium in its formulation.

Levoleucovorin is also available as the brand name Fusilev (levoleucovorin, calcium) and its generic equivalent (levoleucovorin). These drugs are reported with HCPCS code J0641 effective October 1, 2019. This replaces HCPCS code C9043 as noted in the October OPPS Update. On Monday, September 30, 2019, CMS released a Special Edition of MLN Connects instructing the use of J0642 for the brand Khapzory.

Khapzory and Fusilev are not approved for the treatment of pernicious anemia or megaloblastic anemias.

Providers may want to check payers’ policies concerning the use of these drugs as some payers limit the use of levoleucovorin to when there are shortages of leucovorin, which there currently is. You can check for drug shortages on the FDA website. Also, some payers require providers to use the least costly levoleucovorin product.

Q:

Are there any Medicare guidelines for when it is appropriate to bill hydration therapy?

A:

Yes, there are some. Novitas, the Medicare Administrative Contractor (MAC) for Jurisdictions H and L (JH and JL); Palmetto (JJ and JM MAC), and Noridian (JE and JF MAC) all have coverage articles that address hydration therapy. In addition, Novitas (JH/JL) has a Local Coverage Determination (LCD) for Hydration Therapy, which contains the most exhaustive listing of indications and limitations for hydration.

In May, HMS, the Recovery Auditor for Region 4, posted approved RAC issue 0137, Intravenous Hydration Administration: Medical Necessity and Documentation Requirements. The details of this issue state:

• “Necessity for administration of hydration should be supported within medical documentation. Routine administration of IV fluids, pre/post operatively while the patient is NPO for example, without documentation supporting signs and/or symptoms including those of dehydration or fluid loss is not supported as medically necessary. It is important to distinguish the medical necessity of hydration from the use of fluid administration intended only to initiate flow or to keep the vein open. When the sole purpose of the IV fluid administration is to establish and/or maintain vascular access or patency of the IV line, the service is neither diagnostic nor therapeutic and must not be separately reported.”

The Noridian article includes this statement:

• “Medical necessity is supported in the evaluation performed by the provider (usually on the same day) and involves the clinical assessment of the patient. Documentation of the assessment should describe symptoms warranting HYDRATION, such as those associated with dehydration, the inability to ingest fluids, abnormal fluid losses, abnormal vital signs, and/or abnormal laboratory studies, such as an elevated BUN, creatinine, glucose or lactic acid. Nausea itself does not necessarily indicate fluid volume depletion nor support necessity of fluid repletion.”

Even if you are a provider in another jurisdiction, hydration therapy must be medically necessary as this is required of all Medicare services. You can use the information from the MAC and RAC sources mentioned above for guidance and direct any specific questions concerning coverage of hydration therapy to your regional MAC.

Q:

Our hospital laboratory sometimes sends an employee to a patient’s home or to a nursing home to collect a specimen. What are the Medicare billing requirements for this service?

A:

WPS, the Medicare Administrative Contractor (MAC) for Jurisdictions 5 and 8, recently published an article about Travel Allowance for Phlebotomy and Specimen Collection. Medicare will pay a travel allowance at a per mile rate for distances that are greater than 20 miles (HCPCS code P9603) or at a flat rate for distances of 20 miles or less (HCPCS code P9604). The lab employee must actually collect a specimen by venipuncture or catheterization; Medicare does not reimburse for travel to pick up a pre-collected specimen. For the travel to be covered, the associated laboratory test must be reimbursed. To ensure coverage of the lab test, be sure to have a signed and dated physician’s order or progress note that specifies the test(s) requested, the lab results, a medical diagnosis and relevant signs and symptoms, documentation supporting medical necessity, and documentation that the physician used the lab results in treating the patient.

One of the more stringent requirements for coverage of the travel allowance is that “the patient must be in a nursing facility where there was no qualified staff to collect the specimen or homebound” according to the WPS article. Should a claim for travel allowance be reviewed by a Medicare contractor, there must be documentation supporting one of these requirements. The article provides further details on what makes a patient considered “homebound.”

Another thing to keep in mind is that services must be pro-rated depending on the number of patients for each trip, including both Medicare and non-Medicare patients. For example, if a technician goes to a nursing home and collects from 5 patients, of which 4 are Medicare patients, then the total round-trip miles and/or travel charge would be divided by 5 to determine the mileage or amount that could be billed to each of the four Medicare patients. The WPS article includes specific examples to help providers understand this requirement.

If you have additional questions about the travel allowance, contact your regional MAC.

Q:

Does Medicare cover HBO for arterial insufficiency?

A:

Yes and no – Medicare does not cover chronic arterial insufficiency, but does cover acute peripheral arterial insufficiency.  According to the HBO Local Coverage Determination (LCD) from First Coast (FC), the Medicare Administrative Contractor (MAC) for Jurisdiction N, “acute peripheral arterial insufficiency (APAI) is acute onset of ischemia of an extremity secondary to arterial embolus or thrombus.” HBO for APAI is to be used following a definitive surgical procedure for the condition, such as re-implantation, embolectomy, thrombectomy, decompression of a compartment syndrome or removal of the flow limiting condition of the limb. Immediate surgical intervention is necessary if the extremity is to be saved following APAI.

The FC LCD also states that, “HBO is indicated within the first 4-6 hours of the acute event, and only after documented restoration of the blood circulation.” A recent Palmetto HBO Training Module indicates that treatments for APAI may occur up to three times per day immediately after surgery before dropping to once daily within 24-48 hours.  The HBO reduces edema and enhances oxygen at the tissue level to counter reactive edema that often presents after surgical restoration of blood flow. This helps prevent or lessen the likelihood of secondary complications such as infection, non-healing wounds, fracture non-union, and necrosis with subsequent amputation.

Medicare medical review of HBO services is widespread:

• It is part of the OIG Work Plan.
• It is on the list of Targeted Probe and Educate (TPE) reviews for First Coast JN, Novitas JH and JL, Palmetto JM, and WPS J5 and J8.
• It is an approved and posted issue for complex review for all 4 Recovery Auditor regions. Details from the Cotiviti issue are “Medical records will be reviewed to determine if Hyperbaric Oxygen Therapy (HBOT) is medically necessary according to Medicare coverage indications.”
• It was one of the first issues reviewed by Strategic Health Solutions, the first CMS Supplemental Medical Review Contractor (SMRC) with an error rate of 58%.

In addition to First Coast’s LCD, there is a National Coverage Determination (NCD 20.29) and Novitas has a coding and billing article.

The Palmetto education module mentioned above includes the expected documentation for HBO for APAI

• Origin of the condition such as reconstruction/graft thrombosis, iatrogenic trauma, native thrombosis, embolism, or peripheral aneurysm with embolism or thrombosis;
• Diagnostic testing such as arteriogram, CT angiogram, and/or MRI angiogram; and
• Previous treatments such as anticoagulation and percutaneous aspiration or mechanical thromboembolectomy.

Also, there must be a detailed physician’s order for the HBO and a treatment plan with expected goals for HBO therapy.

Remember HBO treatment for chronic arterial insufficiency is not considered medically reasonable and necessary for coverage.

Q:

Is it still true that when a patient with a previous history of sick sinus syndrome (SSS), which is currently being controlled by a pacemaker, is admitted for an unrelated condition, only the presence of the pacemaker is assigned?  My understanding is that since the condition is controlled by the device, SSS would not be considered an active condition.

A:

No.  This is an old rule which was addressed in previous Coding Clinics 3rd Qtr. 2010 page 9-10 and 5th Issue 1993 page 12.   Coders are now instructed that it is appropriate to report a code for both the sick sinus syndrome and presence of a pacemaker.  This is according to updated guidelines found in Coding Clinic 1st Qtr. 2019 page 33 (effective with discharges from March 20, 2019 forward).  The SSS is still present and is a reportable chronic condition.  A pacemaker only controls the heart rate.  It does not cure the condition itself.

Q:

Are there any guidelines for what is expected for an electronic signature for Medicare?

A:

National Government Services (NGS), the Medicare Administrative Contractor (MAC) for Jurisdictions 6 and K, recently published an article concerning electronic signatures. The article references section 3.3.2.4 of the Medicare Program Integrity Manual, that states, “For medical review purposes, Medicare requires that services provided/ordered/certified be authenticated by the persons responsible for the care of the beneficiary in accordance with Medicare’s policies.”

The article provides a list of examples of electronic signatures that would be acceptable. There are various ways to say the documentation is “approved,” “accepted,” or “verified” but the constant is that all electronic signatures must contain the provider’s name.

The article further states the following about sending your policy for electronic signatures.

“When you submit medical records to a Medicare contactor with an electronic signature, you must also include a copy of the electronic signature protocol/procedure. The protocol/procedure should describe the requirements that the physician uses his own ID and password to enter the system to sign the medical records. The Medicare contractor will keep a copy of the protocol/procedure on file for each provider for future documentation request, so only one copy will need to be submitted.”

The Program Integrity Manual does not contain this requirement so it may be specific to NGS. Check with your local MAC to determine if they require this also.

Also remember that Medicare reviewers will accept a signature log for initials or illegible signatures. For some types of documentation, they will accept an attestation of authorship if a signature is missing. However, this does not apply to orders – “If the signature is missing from an order, MACs, SMRC, and CERT shall disregard the order during the review of the claim (e.g., the reviewer will proceed as if the order was not received).”

Q:

In ICD-9-CM, hemorrhagic was listed as one of the modifiers for pneumonia so it couldn’t be coded separately; however, it has been removed as a modifier for ICD-10-CM.  Can we now code hemoptysis in addition to a diagnosis of pneumonia?

A:

Yes.  Since hemorrhagic is no longer a non-essential modifier for pneumonia, coders can assign an additional code for it.  Even though hemoptysis is a sign and/or symptom, it may be reported in addition to a code for pneumonia, because it is not routinely associated with the diagnosis.

References:

Coding Clinic, Fourth Quarter 2013: Page 118

Q:

What is the code assignment for a patient with a history of emphysema presenting to the hospital with COPD exacerbation? 

A:

Emphysema, unspecified (J43.9) should be assigned for a patient that has COPD exacerbation with emphysema, as long as the patient does not have chronic bronchitis.  There is an Excludes1 note, found in the alphabetic index under category J44, that excludes coding J44.1 with code J43.9.

J44  Other chronic obstructive pulmonary disease

        Excludes1:  emphysema without chronic bronchitis (J43.-)

There was some confusion of how to capture the acuity for COPD after Coding Clinic, Fourth Quarter, 2017 published the above information; however, advice in Coding Clinic, First Quarter 2019, further clarifies coding emphysema (J43.9) only when a present also has acute exacerbation of COPD.

The Centers for Disease Control and Prevention (CDC)/7National Center for Health Statistics (NCHS), the organization responsible for revisions to ICD-10-CM, is aware of this issue and has agreed to consider a Coordination and Maintenance proposal for possible revisions to the instructional note..

Resources:

ICD-10-CM Official Guidelines for Coding and Reporting

Coding Clinic, Fourth Quarter, 2017

Coding Clinic, First Quarter 2019

Q:

Our facility plans to start giving the new drug, Evenity (romosozumab-aqqg), but we are unable to find a HCPCS code for this newly FDA-approved drug. How should we bill Medicare for it and what can we expect to be paid?

A:

For Medicare, it would be appropriate to report HCPCS code C9399 (unclassified drug or biological). Medicare says this code can be reported for new drugs & biologicals that are approved by the FDA for which there is no HCPCS code that describes the drug.

From the FDA announcement on April 9, 2019, “The U.S. Food and Drug Administration today approved Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women at high risk of breaking a bone (fracture). These are women with a history of osteoporotic fracture or multiple risk factors for fracture, or those who have failed or are intolerant to other osteoporosis therapies.”

Instructions for billing and payment of newly approved drugs that have not yet been assigned a HCPCS code can be found in Chapter 17 of the Medicare Claims Processing Manual, Section 90.3. Beginning January 1, 2004, hospitals can bill for new drugs and biologicals that are approved by the FDA for which a product-specific HCPCS code has not been assigned with HCPCS code C9399 (Unclassified drug or biological).

In addition to reporting C9399, the hospital should enter the National Drug Code (NDC), the quantity of the drug administered, and the date furnished in the Remarks section of the claim. The Medicare Administrative Contractor (MAC) will manually price the drug or biological at 95 percent of Average Wholesale Price (AWP). Medicare pays 80% of this amount and the Medicare beneficiary is liable for the remaining 20%, after their deductible is met.

Q:

Our facility has recently started performing digital mammography, but Medicare is denying all of the charges for HCPCS codes 77063 (screening digital tomosynthesis for mammography) and G0279 (diagnostic digital breast tomosynthesis, unilateral or bilateral). Do you know what could be causing these denials?

A:

There are a couple of reasons why you could be receiving these denials. You should be able to determine the reason from the Claim Adjustment Reason Code (CARC) on your remittance.

Lack of Primary Code

One possibility is that you are reporting these add-on codes without the primary code.

• CPT code 77063 must be reported with CPT 77067 (screening mammography).
• HCPCS code G0279 is to be listed separately in addition to CPT codes 77065 (diagnostic mammogram, unilateral) or 77066 (diagnostic mammogram, bilateral).

The manual wording from the Medicare Claims Processing Manual, chapter 18 , section 20.2.1 indicates CPT code 77063 will be returned to the provider for institutional claims if billed without 77067, but HCPCS code G0279 will be denied if not reported with the appropriate code.

 “Effective for claims with dates of service January 1, 2018 and later A/B MACs (A) and (B) must assure that claims containing code G0279 also contain HCPCS code 77065 or 77066. A/B MACs (A) or (B) deny claims containing code G0279 that do not also contain HCPCS code 77065 or 77066 with an explanation that payment for code G0279 cannot be made when billed alone.”

Lack of Appropriate FDA Certification Status

We have seen denials of the two codes (77063 and G0279) on claims with a CARC of 171- “Payment is denied when performed/billed by this type of provider in this type of facility.” We believe this is related to lack of appropriate FDA certification. See CMS Transmittal R1387CP or section 20.1 of the Medicare Claims Processing Manual, chapter 18.

All facilities providing screening and diagnostic mammography services (except VA facilities) must be certified by the Food and Drug Administration (FDA). The FDA maintains this data in the Mammography Quality Standard Act (MQSA) file and shares the file with CMS and their contractors weekly. The MQSA indicates whether a facility if certified to perform film or digital mammography.

CMS contractors rely on the FDA certification data contained in the MQSA file to know whether the mammography facility is certified to perform digital mammography. Contractors will deny a claim for a mammography service if the nature of the billed HCPCS code (i.e., film or digital) does not correspond to the FDA certification status listed on the MQSA file for the billing mammography facility.  This means if the FDA MQSA file does not indicate a facility is certified to perform digital mammography, the Medicare contractor will deny the HCPCS codes for these digital mammography services, i.e. HCPCS codes 77063 and G0279.