Immunosuppressive Drugs - Policy Article

**NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES**  
  
For any item to be covered by Medicare, it must 1) be eligible for a defined
Medicare benefit category, 2) be reasonable and necessary for the diagnosis or
treatment of illness or injury or to improve the functioning of a malformed
body member, and 3) meet all other applicable Medicare statutory and
regulatory requirements. Information provided in this policy article relates
to determinations other than those based on Social Security Act 1862(a)(1)(A)
provisions (i.e. "reasonable and necessary").

Immunosuppressive drugs are covered under the immunosuppressive therapy
benefit [Social Security Act 1861(s)(2)(J)]. In order for a beneficiary's
immunosuppressive drugs to be eligible for reimbursement, the reasonable and
necessary (R&N) requirements set out in the related Local Coverage
Determination must be met. In addition, there are specific statutory payment
policy requirements, discussed below, that also must be met (CMS Claims
Processing Manual, Internet-Only Manual, CMS Pub. 100-04, Chapter 17, Section
80.3):

Prescription drugs used in immunosuppressive therapy are covered only if all
of the following criteria (I-V) are met:

    1. Immunosuppressive drugs are prescribed following transplants either:  

      1. Kidney, heart, liver, bone marrow/stem cell, lung, or heart/lung transplant; or,
      2. Whole organ pancreas transplant performed concurrent with or subsequent to a kidney transplant because of diabetic nephropathy (performed on or after July 1, 1999); or
      3. Intestinal transplant (performed on or after April 1, 2001); or
      4. Pancreatic islet cell transplant or partial pancreatic tissue transplantation performed on or after October 1, 2004 that is conducted as part of a National Institutes of Health (NIH)-sponsored clinical trial; or
      5. Pancreas transplants alone (performed on or after April 26, 2006) that meet the following criteria: 
        1. The transplant is performed in a facility that is Medicare-approved for kidney transplantation; and
        2. Beneficiary must have a diagnosis of type I diabetes and: 
          1. Must be beta cell autoantibody positive; or
          2. Must demonstrate insulinopenia, (fasting C-peptide level that is less than or equal to 110% of the lower limit of normal of the laboratory's measurement method). A fasting glucose must be obtained when performing a fasting C-peptide determination. Fasting C-peptide levels are considered valid when a concurrently obtained fasting glucose is _ <_225 mg/dL; and
        3. Must have a history of labile (brittle or medically-uncontrollable) insulin-dependent diabetes mellitus resulting in documented recurrent, severe, acutely life-threatening metabolic complications requiring hospitalization(s). Complications may include frequent hypoglycemia where the beneficiary is unaware, recurring severe ketoacidosis, or recurring severe hypoglycemic attacks; and
        4. Must have been under the care of an endocrinologist and have clinical documentation denoting optimal and intensive management was provided for at least 12 months, having received the most medically-recognized advanced insulin formulations and delivery systems; and
        5. Must demonstrate being able to emotionally and mentally understand the significant risks associated with surgery and be able to effectively manage the lifelong need for immunosuppression; and,
        6. Must otherwise be a suitable candidate for transplantation; and
    2. The transplant met Medicare coverage criteria in effect at the time (e.g., approved facility for kidney, heart, intestinal, liver, lung, or heart/lung transplant; national and/or local medical necessity criteria; etc.); and
    3. The beneficiary was enrolled in Medicare Part A at the time of the transplant; and
    4. The beneficiary is enrolled in Medicare Part B at the time that the drugs are dispensed; and
    5. Delivery requirements:   

      * For DOS prior to August 1, 2016 the drugs are furnished on or after the date of discharge from the hospital following a covered organ transplant. 
      * For DOS on or after August 1, 2016 through April 2, 2019, mail-order deliveries may be mailed one or two days prior to a beneficiary's discharge from an inpatient facility to a qualified place of service (such as home or custodial facility). The DOS on the claim must be the date of discharge.
      * For DOS on or after April 3, 2019 mail-order deliveries may be mailed one or two days prior to a beneficiary's anticipated date of discharge from an inpatient facility to a qualified place of service or alternate address, such as the inpatient hospital that performed the transplant or alternative location where the beneficiary is temporarily staying (such as temporary housing). The DOS on the claim must be the date of discharge.

If criteria I-V are not met, the drug(s) will be denied as noncovered.

If criteria I, II, and III are met, the transplant is considered a "covered
transplant" for purposes of this policy whether payment for the transplant was
made by Medicare or by another insurer.

For islet cell transplants or partial pancreatic tissue transplants conducted
as part of an NIH-sponsored clinical trial, Medicare will pay for the routine
costs, as well as transplantation and appropriate related items and services.
The term "routine costs" means reasonable and necessary routine beneficiary
care costs, including immunosuppressive drugs and other follow-up care. In
addition, Medicare will cover transplantation of pancreatic islet cells.
Coverage includes the costs of acquisition and delivery of the pancreatic
islet cells, as well as clinically necessary inpatient and outpatient medical
care and immunosuppressants.

Immunosuppressive drugs used following partial pancreatic tissue
transplantation or islet cell transplantation performed outside the context of
a clinical trial or performed before October 1, 2004 will continue to be
noncovered.

Immunosuppressive drug coverage is limited to 36 months for beneficiaries
whose Medicare entitlement is based solely on end-stage renal disease (ESRD)
and enrolled in other types of coverage (e.g., group health plan, TRICARE, or
a Medicaid state plan that covers immunosuppressive drugs). Coverage continues
beyond 36 months for beneficiaries eligible and enrolled in the Medicare Part
B immunosuppressive drug benefit (PBID). See the Medicare General Information,
Eligibility and Entitlement Manual (CMS Pub. 100-01), Chapter 2, Section 40.9.  

Immunosuppressive drugs are denied as noncovered when used for the treatment
of beneficiaries with non-transplant related diagnoses (e.g., rheumatoid
arthritis, connective tissue diseases, vasculitis).

Immunosuppressive drugs are denied as noncovered if they are used following a
whole organ pancreas transplant that was not simultaneous with or preceded by
a kidney transplant for diabetic nephropathy unless the beneficiary meets the
criteria for pancreas transplant alone listed above in I(E). Coverage of
immunosuppressive drugs already exists and will continue for beneficiaries who
have had a pancreas transplant simultaneous with a kidney transplant because
in these situations, coverage is based on the kidney transplant.

There is no coverage under the immunosuppressive drug benefit for supplies
used in conjunction with the administration of parenteral immunosuppressive
drugs.

SUPPLY FEE INFORMATION:

One unit of service of supply fee code Q0511 is covered for the first covered
immunosuppressive drug that is dispensed in a 30-day period. If covered drugs
are dispensed by more than one pharmacy during a 30 day period, one unit of
Q0511 is covered for each pharmacy. One unit of service of supply fee code
Q0512 is covered for each subsequent covered immunosuppressive drug that is
dispensed in that 30-day period (See exception below when Q0510 is covered in
place of Q0511 or Q0512.) If two dosage strengths of the same drug are
dispensed on the same day, one unit of service of the appropriate supply fee
is payable for each one. If more than one unit of service of code Q0511 is
billed per 30 days by a single pharmacy, the excess units of service will be
denied as incorrect coding. If the billed units of service of Q0511 or Q0512
exceed the number of drugs on the claim, the excess units will be denied as
not separately payable.

One unit of service for code Q0510 is payable in place of Q0511 or Q0512 for
one drug on the first claim for immunosuppressive drugs following a
transplant. For example, if three drugs are dispensed, the correct coding for
the supply fees on the first claim is one unit of service of Q0510 and two
units of service of Q0512. If more than one organ is transplanted at the same
time (e.g., heart-lung transplant), only one unit of service of Q0510 is
payable. Q0510 is payable to only one supplier after each transplant. If the
beneficiary has another transplant at a later date, another unit of service of
code Q0510 is payable. If more than one unit of service of code Q0510 is
billed per beneficiary per transplant, the excess units of service will be
denied as incorrect billing/coding.

There is no separate coding or payment for a compounding fee.

If the drug on the claim is denied as noncovered, the supply fee will be
denied as noncovered.

The supply fee must be billed on the same claim as the drug. If it is not, it
will be denied as incorrect billing.

**REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed.
Reg Vol 217)**

Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a
Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the
DME MACs provide a list of the specified codes, which is periodically updated.
The required Face-to-Face Encounter and Written Order Prior to Delivery List
is available [here](https://www.cms.gov/Research-Statistics-Data-and-
Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Medical-
Review/FacetoFaceEncounterRequirementforCertainDurableMedicalEquipment).

Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol
217) that do not meet the face-to-face encounter and WOPD requirements
specified in the LCD-related Standard Documentation Requirements Article
(A55426) will be denied as not reasonable and necessary.

If a supplier delivers an item prior to receipt of a WOPD, it will be denied
as not reasonable and necessary. If the WOPD is not obtained prior to
delivery, payment will not be made for that item even if a WOPD is
subsequently obtained by the supplier. If a similar item is subsequently
provided by an unrelated supplier who has obtained a WOPD, it will be eligible
for coverage.

**POLICY SPECIFIC DOCUMENTATION REQUIREMENTS**

In addition to policy specific documentation requirements, there are general
documentation requirements that are applicable to all DMEPOS policies. These
general requirements are located in the DOCUMENTATION REQUIREMENTS section of
the LCD.

Refer to the LCD-related Standard Documentation Requirements article, located
at the bottom of this Policy Article under the Related Local Coverage
Documents section for additional information regarding GENERAL DOCUMENTATION
REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed
below.

**CONTINUED MEDICAL NEED**

For all DMEPOS items, the initial justification for medical need is
established at the time the item(s) is first ordered, therefore, beneficiary
medical records demonstrating that the item is reasonable and necessary are
created just prior to, or at the time of, the creation of the initial
prescription.

Ongoing immunosuppressive medication need is assumed to be established by the
performance of the transplant and the successful maintenance of its function.
There is no requirement for further documentation of continued need for the
life of the transplant.

**CONTINUED USE**

Continued use describes the ongoing utilization of immunosuppressive
medications by a beneficiary.

Ongoing immunosuppressive medication use is assumed to be established by the
performance of the transplant and the successful maintenance of its function.
Continued use of immunosuppressive medication is demonstrated by meeting the
Refill Documentation requirements.

**MODIFIERS**

KX and GY MODIFIERS:

The KX modifier must be added to the claim line(s) for the immunosuppressive
drug(s) only if all of the following four requirements are met:

  1. The supplier has obtained from the treating practitioner  the specific date of the organ transplant, and
  2. The supplier is retaining this documentation of the transplant in its files, and
  3. The beneficiary was enrolled in Medicare Part A, at the time of the organ transplant (whether or not Medicare paid for the transplant), and
  4. The transplant date precedes the date of service on the claim.

If these four requirements are not met, the KX modifier must not be added to
the claim.

If any of criteria I - V listed above have not been met, the GY modifier must
be added to the claim line(s).

The diagnosis code(s) that justify the need for these items must be included
on the claim. See the below list for covered transplant diagnosis codes.

A new order is required if a new drug(s) is added to the beneficiary's
immunosuppressive regimen or if there is a change in dose or frequency of
administration of an already allowed drug.

If code J7599 is billed, the claim must list the name of the drug, the dosage
strength, number dispensed and administration instructions.

**CODING GUIDELINES**

The following instructions apply to claims billed using J codes. When claims
are billed in NCPDP format using NDC numbers, different instructions may
apply. Refer to the NCPDP Companion Document available through the CMS
website.

Code J7599 should be used for immunosuppressive drugs that do not have a
specific HCPCS code.

For all immunosuppressive drugs, the number of units billed must accurately
reflect the definition of one unit of service in each code narrative. For
example, if fifty 10 mg prednisolone tablets are dispensed, bill J7510, 100
units (1 unit of J7510 = 5 mg). If fifty 2.5 mg prednisolone tablets are
dispensed, bill J7510, 25 units.

Suppliers should contact the Pricing, Data Analysis and Coding (PDAC)
Contractor for guidance on the correct coding of these items.