Monday, May 11, 2015

J3590/C9399 Vimizim™ (elosulfase alfa) and Diagnostic Tests- CMS Requirements


J3590/C9399 Vimizim™ (elosulfase alfa)

Vimizim™ (elosulfase alfa) injection, for intravenous use is a hydrolytic lysosomal glycosaminoglycan (GAG) specific enzyme indicated for patients with Mucopolysaccharidosis type IVA (MPS IVA: Morquio A syndrome). Vimizim™ was approved by the Food and Drug Administration (FDA) on February 14, 2014.
Vimizim™ is supplied as a concentrated solution for infusion in a 5mg/5ml (1mg / mL) single-use vial requiring dilution. As approved by the FDA the recommended dose is 2mg per kg administered intravenously over a minimum range of 3.5 to 4.5 hours, based on infusion volume, once every week. Pre-treatment with antihistamines with or without antipyretics is recommended 30-60 minutes prior to the start of the infusion.

In the absence of a national coverage determination (NCD) or local coverage determination (LCD), Medicare can consider coverage of a drug that is usually not self-administered per the FDA indication when administered incident to a physician service or in the hospital setting. The patient’s medical record must also support the diagnosis of Mucopolysaccharidosis, type IVA (MPS IVA; Morquio A syndrome using the appropriate ICD-9-CM code(s) of 277.5 (Mucopolysaccharidosis) and FDA guidance for use as well as the administration.

Diagnostic Tests- CMS Requirements
The Centers for Medicare & Medicaid Services (CMS), is continuing to focus on lowering the Comprehensive Error Rate Testing (CERT) claims paid error rate. Currently, one area of concern identified in the CERT data is denial of diagnostic tests due to missing physician/non-physician practitioner order or intent within the medical record.  This has led to the recoupment of overpayments by Novitas Solutions, Inc totaling over $355.64. More importantly, when CMS and CERT extrapolate these errors to the universe, they will account for approximately $22.1 million in claims payment errors for the November 2012 report.
Medicare defines a Diagnostic Test as including:
"All diagnostic x-ray tests, all diagnostic laboratory tests, and other diagnostic tests furnished to a beneficiary."

And further defines Clinical Laboratory Services as:

"The biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition."
CMS also gives direction that Clinical Laboratory Services "must be ordered and used promptly by the physician who is treating the beneficiary."

CMS defines an order as:
" A communication from the treating physician/practitioner requesting that a diagnostic test be performed for a beneficiary. The order may conditionally request an additional diagnostic test for a particular beneficiary if the result of the initial diagnostic test ordered yields to a certain value determined by the treating physician/practitioner (e.g., if test X is negative, then perform test Y)."
An order can be written in the beneficiary's record or can be a telephone order from the physician's office to the testing facility.  If a telephone order, both the treating physician and the testing facility must have documented in the beneficiary's record the telephone call and the extent of the diagnostic tests being ordered.

Although CMS does not require the order to be signed by the physician, the physician must have clearly documented in the beneficiary's record the intent to order the diagnostic test.

Documentation requested by the CERT contractor or Novitas Solutions, Inc to support the order for the diagnostic test (or the physician's intent to order), will be sent to the testing facility, as it is the facility that is billing for the test.   Often the testing facility is unable to provide the physician's order or intent because this information is in the beneficiary's record in the physician's office.   The testing facility has to request this information from the physician in order to be paid for the service.  Without the order for the test, or the intent to order, both the CERT contractor and Novitas Solutions, Inc will deny payment for the diagnostic test or service.

To avoid such denials, testing facilities and physician's offices need to work together.  Testing facilities should attempt at the time the beneficiary is presenting to the facility, to have a diagnostic test performed, to obtain a physician's order.  This can be accomplished by directing the beneficiary to bring a prescription that includes the condition or diagnosis code for which the diagnostic test is ordered as well as the order for the diagnostic test. If the beneficiary presents without a valid order, the testing facility could call the physician's office to obtain a telephone order for the diagnostic test.

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