why post payment audit happening in insurances


BCBSKS conducts periodic post-payment audits of patient records and adjudicated claims to verify congruence with BCBSKS medical and payment policies, including medical necessity and established standards of care. Post-payment audits can range from a basic encounter audit to determine if the level of care is accurately billed, to a complete audit which thoroughly examines all aspects of the medical record and medical practice. Post-payment audits are performed after the service(s) is billed to BCBSKS and payments have been received by the provider. BCBSKS cannot go back further than 15 months following the date of claim adjudication to initiate an audit. Due to additional time allowed for provider appeals, as outlined in this policy memo, refunds would be applicable after the provider appeals have been exhausted, regardless of the time frame involved. BCBSKS provides education through policy memos, medical policy, newsletters, workshops, direct correspondence, peer consultant medical opinion, and on-site visits.

If medical necessity is not supported by the medical record, BCBSKS will deny as not medically necessary. When BCBSKS requests medical records for an audit and no documentation is received within the 30-day time limit, BCBSKS will deny for no documentation. Services denied for failure to submit documentation are not eligible for provider appeal, and are a provider write-off.

Post-payment Audit Appeals:

A. First-Level Appeal

Services denied not medically necessary as a part of the post-pay audit process may be appealed in writing within 30 days of notification of the findings. Written notification of disagreement highlighting specific points for reconsideration should be provided with the appeal. The BCBSKS determination will be made within 30 days of receipt of the appeal. Submit the appeal as instructed in the letter containing the determination.

B. Second-Level Appeal

A provider may request a second and final appeal in writing within 30 days of notification of the first-level appeal determination. The second and final appeal determination will be made by a physician or clinical peer within 30 days of receipt of the appeal. Submit the appeal as instructed in the letter containing the determination.

When findings reveal issues, which are presently specified in BCBSKS policy memos, billing guidelines or newsletters relating to content of service, multiple surgery guidelines, and other billing and/or reimbursement guidelines, the terms of this appeal are not available


Providers are not reimbursed for professional services they provide to an immediate family member (“immediate family member” means the husband or wife, children, parents, brother, sister, or legal guardian of the person who received the service) or themselves as specified in the member contract.

There are several categories of services, procedures, equipment and/or pharmaceuticals that may be considered non-covered services when designated by the member’s contract. These denials are billable to the member. (

Medicaid Laboratory Billing Guide


MDHHS follows Medicare’s current OPPS coverage policies as closely as possible and appropriate. In those instances where program differences require coverage disparity, the differences will be reflected through the application of the MDHHS specific status indicator. Procedure codes associated with the identified services will appear on the MDHHS OPPS Wraparound Code List available on the MDHHS website. (Refer to the Directory Appendix for website information.)

MDHHS policy covers hospitals for medically necessary laboratory tests when:

* Performed in a laboratory certified by the Clinical Laboratory Improvement Amendments (CLIA);

* Needed to diagnose a specific condition, illness, or injury; and

* Ordered by physicians (MD or DO), podiatrists, dentists, nurse practitioners, or nurse-midwives.

MDHHS requires medical record documentation of medical necessity. An explanation of the laboratory testing method or the results of diagnostic tests, whether normal or abnormal, is not considered documentation of medical necessity. For approval of payment, the laboratory procedure(s) must be specific and appropriate to the beneficiary's documented condition and diagnosis.

Reimbursement to the inpatient hospital is through the DRG payment. Reimbursement for outpatient services is billed using the appropriate HCPCS code and includes the collection of the specimen(s), the analysis, and the lab test results. MDHHS performs pre- and/or postpayment reviews to monitor laboratory procedures for medical necessity and appropriate practitioner
orders. Outpatient hospitals are subject to corrective action, including the recovery of funds, for laboratory services not specifically ordered by a practitioner.

MDHHS does not cover:

* Screening or routine laboratory testing, except as specified for EPSDT Program or by Medicaid policy;

* "Profiles", "batteries" or "panels" of tests that include tests not necessary for the diagnosis or treatment of the beneficiary's specific condition; or

* Multiple laboratory tests performed as a part of the beneficiary evaluation if the history and physical examination do not suggest the need for the tests.

Services performed by an outpatient hospital laboratory or its employees may not be billed to, or by, the ordering practitioner.


The obstetric profile must be ordered by the attending practitioner and billed as an allinclusive panel of tests for required prenatal laboratory services. It must include the following:

* Blood count, complete (CBC), automated and automated differential WBC count, or Blood count, complete (CBC), automated and appropriate manual differential WBC count

* Hepatitis B surface antigen (HBaAg)

* Antibody, rubella

* Syphilis test, qualitative (e.g., VDRL, RPR, ART)

* Antibody screen, RBC, each serum technique

* Blood typing, ABO

* Blood typing, Rh(D)

Only AMA-approved organ- or disease-oriented panels may be billed. All tests within the panel must be medically necessary. Unless the complete panel is ordered and performed, bill as individual tests.

Testing for HIV is covered separately when determined to be medically necessary and ordered by the practitioner.

Only practitioners should order the serum or urine HCG qualitative method when the beneficiary requires preliminary pregnancy testing.

Nurse-midwives may order only the laboratory tests listed below. Hospitals are not reimbursed for any other tests ordered by a nurse-midwife.

* Acetone and diabetic acid (ketone bodies); qualitative; semi-quantitative

* Albumin; qualitative, semi-quantitative, quantitative (such as Esbach)

* Antibody titer Rh system; albumin, saline and/or AHG technique

* Blood count; RBC, WBC, Hemoglobin, Hematocrit, indices (MCV, MCH, MCHC)

* Blood typing; ABO, Rh(D), RBC antibody screening

* Culture, presumptive (screening), for Neisseria gonorrhea, Candida, Hemophilus, or beta hemolytic Streptococcus group A, etc.

* Culture, urine, definitive; with or without colony count

* Cytopathology, vaginal and/or cervical smears (e.g., Papanicolaou type) screening (cytopathological examination for malignancy, microbial flora, inflammatory features and hormonal evaluation)

* Glucose; qualitative, quantitative, timed specimen, tolerance

* Hemoglobin, electrophoretic separation; qualitative

* Hepatitis B test

* Human immunodeficiency virus detection

* Pregnancy test

* Prenatal laboratory services; routine (Obstetric panel)

* Quantitative sediment analysis and quantitative protein (Addis count); 12- or 24-hour specimen Reticulocyte count, manual

* Rubella test; titer

* Sickle cell slide test

* Skin test, tuberculosis, tine test

* Susceptibility (sensitivity) for aerobes by Kirby-Bauer procedure for specific pathogens, using 10-12 discs per pathogen; also for susceptibility (sensitivity) for anaerobes by generally accepted standard techniques using 5-12 discs per pathogen (specify number of pathogens)

* Syphilis testing, flocculation or precipitin (VDRL, RPR, etc.); qualitative

* Trepanema antibodies, fluorescent, absorbed (FTA-abs)

* Urinalysis, complete (physical appearance, pH, specific gravity, microscopic examination, qualitative chemistry with or without semi-quantitative confirmation)

* Wet mount, smear, tissue; direct microscopic examination


MDHHS reimburses for blood handling only when a beneficiary is referred to an outpatient hospital for the sole purpose of drawing, packaging and mailing a blood sample to MDHHS for HIV-1 viral load analysis and/or CD4/CD8 enumeration. The State provides specimen containers and mailin  kits for the analysis. (Requests for supplies and samples for analysis should be sent to the MDHHS Blood Lead Laboratory. Refer to the Directory Appendix for contact information.)


A complete blood count (CBC) with white blood cell (WBC) differential includes the RBC and WBC count, Hgb, Hct, MCH, MCHC, MCV, RBC morphology, platelet estimate, and WBC differential only. If automated instrumentation yields additional test parameters, the results are not reimbursable unless medically necessary and specifically ordered by a practitioner.


MDHHS coverage and reimbursement for gram fluorescent/acid fast is included in the reimbursement for microbiology when performed on the same DOS for the same beneficiary.


Pap smear screening by a technologist under the supervision of a pathologist is a covered service. If a suspect smear requires additional interpretation by a pathologist, this service is also covered. Only one Papanicolaou test within a 12-month period is covered for each beneficiary, unless medical necessity or history of abnormal findings requires additional studies.


For direct-billed laboratory services ordered by an approved CA, the referring provider NPI number must be appropriately reported on the appropriate paper or electronic claim format.


Calculate and report the Glomerular Filtration Rate (eGFR) for tests processed for beneficiaries in outpatient settings and for beneficiaries 18 years of age and older. The eGFR test results must report two values on the lab report for beneficiaries: one for American and one for non-African-American, or one value if race is available and able to be used in calculating the value.

Hospice Service billing - Complete overview

Hospice Billing INTRODUCTION

Hospice is a health care program designed to meet the needs of terminally ill individuals when the individual decides that the physical and emotional toll of curative treatment is no longer in their best interest. These individuals choose palliative care, which is not a cure, but ensures comfort, dignity and quality of life. Hospice is intended to address the full range of needs of the individual with a terminal illness, while also considering family needs. Care must be consistent with the individual’s values, regardless of the location where care is provided.

The primary objective of the Medicaid Hospice Program is to ensure that essential medical/health services are available to those who would not otherwise have the financial resources to purchase them. Medicaid policies are designed to achieve this objective with fiscal responsibility. Hospice providers must verify eligibility before providing services. Hospice beneficiaries are identified in the eligibility response with the Benefit Plan ID of Hospice. (Refer to the Beneficiary Eligibility chapter for additional information.)


Hospice providers are bound to all rules, regulations, and policies specified in this chapter for program participation/enrollment of Medicaid beneficiaries. Hospice providers must also comply with the Medicare Conditions of Participation (42 CFR § 418) which generally apply to non-Medicare beneficiaries as well as to Medicare beneficiaries.

Additional information regarding federal Hospice requirements and guidelines is contained in the Centers for Medicare & Medicaid Services (CMS) State Operations Manual 2083.

Michigan Department of Health and Human Services (MDHHS) requires Hospice agencies to be licensed in Michigan by the state-licensing agency, certified by Medicare, and enrolled in Medicaid. (Refer to the General Information for Providers Chapter of this manual for additional information.)

Hospice providers cannot engage in any of the following marketing-related practices:

* Provide cash, gift incentives, or rebates to prospective covered persons;

* Claim superior medical care or provider skills; or

* Make untruthful statements regarding the merits of the hospice.

The use of marketing practices that mislead, confuse, or defraud either the beneficiary or MDHHS is considered grounds for terminating the hospice from participation in Medicaid. Such actions may also result in investigation leading to possible prosecution under applicable State and Federal statutes.



A terminally ill Medicaid beneficiary who lives in a hospice service area and whose life expectancy is six months or less (if the illness runs its normal course), as determined by a licensed physician and the Hospice Medical Director, has the option to enroll in a hospice program. A representative, such as a spouse, parent, legal guardian, or other authorized adult, may act on behalf of the beneficiary.

Medicaid does not cover Hospice services if the following conditions exist:

* The individual is not eligible for the Medicaid benefit.

* The beneficiary does not meet the hospice’s enrollment criteria.

* If the beneficiary is currently enrolled in a Medicaid Health Plan (MHP), the hospice services must be arranged and reimbursed by the MHP.

All Hospice enrollment activities must be conducted according to MDHHS policies and in such a manner as to maximize the beneficiary’s ability to make a choice between enrollment in hospice or maintaining current active treatment with Medicaid coverage. Such activities must assure that the beneficiary fully understands how to use hospice services and that all care must be received from or through the hospice (except those services not related to the terminal illness or services provided by his attending physician).

It is imperative that the Hospice provider read the Conditions of Enrollment on the Hospice Membership Notice form (DCH-1074) to the beneficiary and answer any questions raised by the beneficiary. (Refer to the Forms Appendix for an example of the DCH-1074 and instructions for its completion.)


Hospice providers are responsible for enrolling beneficiaries for hospice services. A DCH-1074 must be completed, including the signature of the beneficiary or his legally appointed representative. Fax the completed form to the MDHHS Enrollment Services Section. (Providers are not required to submit the form by US mail.) A copy of the form must be given to the beneficiary, and the original filed in the beneficiary’s record. Do not submit the form if the beneficiary is enrolled in the Adult Home and Community Based Waiver (MI Choice).

A copy of the following information must be retained in the beneficiary’s record:

* Hospice Membership Notice form (DCH-1074).

* Effective date of enrollment. (If the date entered on the DCH-1074 is changed, the hospice must contact the beneficiary to notify him of the new effective date.)

* Hospice enrollment identification card (if the hospice chooses to issue one to their beneficiaries).


Hospice providers must provide Medicaid beneficiaries with the following materials and written information within ten days of the effective date of enrollment in hospice:

* Conditions of enrollment, including:

* Scope, content, and duration of coverage;

* Enrollee grievance procedure; and

* Beneficiary responsibility for reporting coverage by any other insurance.

* Procedures for obtaining health care, including:

* Address, telephone number, and service hours of the health care providers;

* Emergency medical care (other than for the treatment of the terminal illness); and

* Health care provision outside of the hospice.



A beneficiary eligible for hospice may receive hospice services in their home. If the beneficiary is eligible for hospice services but does not have family or friends to provide the necessary home care, the beneficiary may live in a residential setting that may include an Adult Foster Care (AFC) facility, boarding home, Home for the Aged (HFA), or assisted living facility. The setting must be appropriate for the type of care required by the beneficiary. Medicaid does not pay room and board in these settings.

Beneficiaries may receive hospice services in these settings. The hospice is responsible for developing and implementing a coordinated plan of care to avoid duplication ofservices. These care settings are available for Medicare, Medicaid, and dually eligible beneficiaries.


When a dually enrolled Medicare/Medicaid beneficiary enters a nursing facility (NF), the beneficiary can elect the Medicare hospice benefit if that NF has hospice services available. In this case, the beneficiary revokes the 100 days of Medicare reimbursement for skilled NF care.

Revocation of the 100-day NF skilled care is a beneficiary’s decision and should not be influenced by the NF’s funding source for the bed.

The DCH-1074 is used as the benefit election form for Medicaid eligible beneficiaries.

This does not mean that the beneficiary has revoked the Medicare benefit for services not related to their terminal illness. The beneficiary remains eligible for Medicare, but has elected to use only the hospice portion of the Medicare benefit.

If the NF contracts to make hospice services available, the hospice must provide DCH-1074 forms to Medicaid, Medicare and dually eligible beneficiaries. The facility must provide room and board for the beneficiary, and the hospice must provide its normal services.

The Pre-Admission Screening/Annual Resident Review (PASARR) form (DCH-3877) must be completed for a hospice patient entering a NF unless the hospice beneficiary is entering for a five-day respite period. The DCH-3877 is not required for the respite
period. The DCH-3877 is to identify ind ividuals who may have a mental illness or intellectual disability. If the patient is on antipsychotic, antianxiety, or antidepressant medications for purposes of pain control/symptom relief for end of life, it should be noted on the DCH-3877. This allows the Community Mental Health Services Program (CMHSP) worker to better evaluate the need for further (Level II) screening. If the patient is on any of the above mentioned psychotropic medications for a related mental illness, the CMHSP will determine the need for a Level II screening.

Medicaid will reimburse the hospice for room and board for a hospice beneficiary who resides in a NF (including a beneficiary for whom a complex care authorization has been approved) or in a Ventilator Dependent Care Unit (VDCU). The hospice then reimburses the NF. The Medicaid reimbursement to the hospice for NF room and board is equal to 95% of the total Medicaid NF rate. For Class I, III, and V facilities, reimbursement also includes 100% of the Quality Assurance Supplement (QAS) amount due the NF through the Quality Assurance Assessment Program (QAAP). QAS funds are not included in the reimbursement for Hospital Swing Beds as they are not eligible for that program.

Per Medicare guidelines, the term "room and board" in a NF includes the performance of personal care services that a family caregiver would provide if the individual were at home. This includes assistance in the activities of daily living such as bathing, grooming, toileting, dressing, meal service, socializing, companionship, hobbies, administration of medication, maintaining the cleanliness of the beneficiary’s bed and room, and supervising/assisting in the use of durable medical equipment (DME) and prescribed therapies (e.g., range of motion, speech and language exercises). The NF may not include hospice staff to meet its staffing requirements.

Hospice covered beneficiaries residing in the NF must not experience any lack of NF services or personal care due to their status as a hospice beneficiary. NFs must offer the same drugs, services, medical supplies and DME to all residents who have  lected the hospice benefit in the same manner that services are provided to other residents in the facility who have not elected hospice care. If a service is normally furnished as part of the facility’s per diem, the service must also be provided to hospice beneficiaries. If services are provided for needs associated with a non-terminal illness and are normally furnished and billed by another provider, that practice would continue.


Medicaid hospice reimbursement includes payment for any hospitalizations related to the terminal illness. The hospice must contract with, and reimburse, a hospital for medically necessary inpatient services related to the beneficiary’s terminal illness. Medicaid does not reimburse the hospital separately unless the hospitalization is not related to the terminal illness.


Based on hospice eligibility criteria, the duration of hospice services is generally six months or less. There is no minimum period of hospice enrollment. A change in the beneficiary’s prognosis could eliminate the need for hospice care. A beneficiary may cancel his enrollment in the hospice at any time and without cause. Beneficiaries who become ineligible for Medicaid while enrolled in a hospice also become ineligible for Medicaid reimbursement for hospice services.


A beneficiary may disenroll or be discharged from hospice as noted below. A DCH-1074 indicating the reason for the disenrollment or discharge must be signed and dated by the beneficiary and/or authorized representative as proof of notification (unless the beneficiary has expired). The hospice must submit a copy of the disenrollment notice to the MDHHS Enrollment Services Section. (Refer to the Directory Appendix for contact information.)


When a hospice-enrolled beneficiary dies, the hospice must complete the DCH-1074 indicating the date the beneficiary expired and submit it to MDHHS.


A beneficiary may choose to disenroll from, or revoke their election of, hospice care at any time during an election period. The hospice must obtain written documentation, signed and dated by the beneficiary or their representative, stating they are revoking the hospice benefit for the remainder of that election period. The disenrollment or revocation is effective with the date of the beneficiary’s/representative’s signature. The hospice must give a copy of the disenrollment notice to the beneficiary when he signs it and retain another copy in the beneficiary’s record.


A beneficiary should not revoke, disenroll, or be discharged from hospice for the purpose of admission to the hospital for care related to the hospice diagnosis. Medicaid does not reimburse the hospital separately unless the hospitalization is not related to the terminal illness. When this is the case, the hospice may continue to provide care to the beneficiary under the routine hospice care benefit.


An enrolled beneficiary may have a change in condition and no longer qualify for hospice services. If the beneficiary is discharged for this reason, the hospice must send a copy of the DCH-1074 (indicating the disenrollment) to the beneficiary along with a letter explaining the reason and effective date for the disenrollment.


The hospice is responsible for verifying the beneficiary’s continued Medicaid eligibility once he is enrolled. Medicaid does not reimburse hospice services rendered to a Medicaid ineligible beneficiary.


At the time of enrollment, beneficiaries must be told to notify the hospice and their local MDHHS worker if their place of residence changes. If the new residence is located in the hospice’s normal service area, or if the hospice agrees to continue to provide services to the beneficiary, the move creates no changes except an address change. However, if the move is too far for the hospice to continue services for the beneficiary, the hospice must arrange a transfer of care for the beneficiary to another Medicaid enrolled hospice. The two hospices must work together to assure that no lapse occurs in services to the

The effective date of disenrollment for a beneficiary who has moved is the day that the beneficiary moves. It is preferable that the DCH-1074 indicating the disenrollment from the first hospice, and the DCH-1074 indicating enrollment for the second hospice be sent to MDHHS together. If the notices are sent separately, each hospice must place an explanation in the Remarks box on the DCH-1074 indicating the reason for the transition to the new hospice.


The hospice may discharge a beneficiary if the beneficiary violates any of the conditions of membership in the hospice. The decision to discharge a beneficiary and the effective date of the discharge aredetermined on an individual basis by the hospice Medical Director.

The hospice may request disenrollment of a beneficiary for any of the following reasons:

* Fraud;

* Abuse (including repeated instances of willfully and knowingly obtaining health care services for the terminal illness from non-hospice providers); or

* Misconduct (including violence that interferes with or interrupts the provider’s proper delivery of health care to the patient or other patients)



The duration of hospice coverage is measured in election periods, also known as benefit periods. A beneficiary may elect to receive hospice care during one or more of the following election periods:

* An initial 90-day period;

* A subsequent 90-day period; or

* An unlimited number of subsequent 60-day periods.


A hospice must obtain written certification of the terminal illness for each election period before a claim for services is submitted. If the hospice is unable to obtain a written certification within three days of initiation of hospice care, a verbal certification must be obtained, documented, and signed by the person receiving the certification. Statements covering a beneficiary’s initial certification must be obtained from the hospice medical director or the physician member of the Interdisciplinary Group (IDG), and the beneficiary’s attending physician if the beneficiary has an attending physician. The hospice medical director or the physician member of the IDG certifies the terminal illness for all subsequent election

Each written certification must include:

* A statement that the beneficiary’s life expectancy is six months or less if the terminal illness runs its normal course;

* Specific clinical findings and other documentation as needed to support the life expectancy of six months or less;

* A brief narrative summary;

* An explanation why the clinical findings of the face-to-face encounter support a life expectancy of six months or less (beginning with the third benefit period and thereafter); and

* Physician signature(s), date signed, and specific election period dates covered by the certification or recertification.

Documentation of all written/verbal certifications must be prepared no more than 15 calendar days prior to the effective date of election and must be kept in the beneficiary’s medical record.


Each hospice certification and recertification must be accompanied by a brief narrative describing the clinical findings supporting the beneficiary’s life expectancy of six months or less. Each narrative must reflect the clinical circumstances and should not contain checkboxes or non-specific, standard language.


A hospice physician, hospice-employed nurse practitioner (NP), or hospice-employed physician assistant  (PA) must have a face-to-face encounter with every hospice beneficiary prior to the 180th day of recertification of the beneficiary’s terminal illness for the purpose of determining continued eligibility. The 180th day recertification is defined as the recertification that occurs at the start of the third benefit (election) period or the benefit period following the second 90-day benefit period. Additionally, a face-toface must be conducted at each subsequent recertification (every 60 days thereafter) for as long as the beneficiary is in hospice. Face-to-face encounters must occur no more than 30 calendar days prior to the  start of the third benefit period and no more than 30 calendar days prior to each subsequent benefit period thereafter.

The hospice physician, NP, or PA must attest in writing to the face-to-face encounter with the beneficiary and include the date of the visit. A NP or PA is allowed to perform and attest to the face-to-faceencounter; however, the hospice physician must certify and recertify the terminal illness.

Failure to meet the face-to-face encounter requirements results in a failure by the hospice to meet the recertification of the terminal illness requirement. This results in the beneficiary no longer being eligible for the hospice benefit. If this should happen, the hospice must complete a Hospice Membership Notice (form DCH-1074), with the last date of the benefit period as the effective disenrollment date. A comment in the Remarks Section of the form is required to explain the reason for the disenrollment.

There may be an occasional case when a hospice admits a beneficiary who received services from another hospice provider, and the beneficiary chose to revoke or was discharged from that provider. When this occurs, the admitting hospice may begin their care with the beneficiary’s first benefit period unless the beneficiary is a direct transfer from the other hospice. When this is the case, the beneficiary’s benefit period remains the same, and the transferring hospice should provide the receiving hospice with all required documentation. A hospice resuming care for a beneficiary formerly served by their hospice must restart care in the next or subsequent benefit period.



The hospice must provide all or substantially all of the core services applicable for the terminal illness in the beneficiary’s home. (Home may include the beneficiary’s private dwelling, apartment, boarding home, assisted living facility, AFC facility, HFA, NF or hospice-owned NF.)

These core services are:

* Physician care

* Nursing care

* Social work

* Counseling

* Bereavement

* Spiritual

* Dietary


Other services that may be necessary due to the terminal illness and must be available but are not considered core services are:

* Drugs*/Biologicals

* Home Health Aide services

* Homemaker services

* Medical Supplies/Durable Medical Equipment (DME)

* Occupational Therapy

* Physical Therapy

* Short-Term Inpatient care

* Speech Therapy

These other services may be provided by contractual agreement or provided by the hospice directly and are not reimbursed separately.



If a beneficiary is dually enrolled in Medicare and Medicaid, he must receive hospice coverage under the Medicare benefit. (Medicaid is the payer of last resort.) If the beneficiary resides in a NF, Medicare may pay hospice services, with NF room and board paid for by Medicaid. When a beneficiary is receiving services through the Medicare hospice benefit, Medicaid does not pay for curative or duplicative services.

The hospice provider must complete the DCH-1074 whenever Medicaid is billed (i.e., coinsurance, deductibles, and room and board in the NF or hospice-owned NF).

If the hospice benefit is revoked under Medicare, the beneficiary cannot use the Medicaid hospice benefit as a replacement. Hospices should carefully explain this situation to the dually eligible beneficiary, especially during the fourth Medicare benefit period.* However, if the dually eligible beneficiary is no longer appropriate for hospice care and is disenrolled as a hospice beneficiary, that beneficiary is able to re-enroll with the hospice for the Medicaid benefit period if he becomes eligible for hospice again.


Hospice services are included in the Medicaid Health Plan (MHP) covered services package for Medicaid enrollees. If the terminally ill enrollee requests and meets the criteria for hospice services, the MHP must cover the requested hospice services. If the terminally ill enrollee does not request hospice services, theMHP may provide its own array of services for the terminally ill. If the beneficiary is enrolled in a MHP (eligibility response indicates the Benefit Plan ID of MA-MC or MA-HMP-MC), the hospice must contact the MHP immediately to receive prior authorization (PA) from the MHP before furnishing services. The MHP may require its enrollees to receive hospice services through a contracted hospice with which they have made arrangements. MHPs are responsible for the hospice care arrangement and payment if the eligibility response indicates a Benefit Plan ID of MA-MC or MA-HMP-MC for the beneficiary.

If a fee-for-service (FFS) Medicaid beneficiary is automatically enrolled in a MHP while receiving hospice care, the beneficiary or his representative should contact the MDHHS Hospice Enrollment Coordinator if he wishes to continue receiving services from his current hospice provider. (Refer to the Directory Appendix for contact information.) The hospice enrollment coordinator initiates the process of disenrollment from the MHP. It is not the intent of MDHHS to disrupt a hospice beneficiary’s care through automatic enrollment in a MHP. If the beneficiary subsequently disenrolls or is discharged from hospice care, the beneficiary may be offered the opportunity to join a MHP. If the MHP enrollee requires hospice services in a NF or hospice-owned NF, the MHP pays a negotiated rate for room and board in addition to the payment for the hospice services. The hospice must contact the MHP prior to enrolling the beneficiary to request authorization by the MHP.


MDHHS employs the following standards when reimbursing for hospice care:

MDHHS uses the Medicaid hospice payment base rates established and provided by CMS and applies the appropriate local wage adjustors provided by CMS for the four categories of hospice care in each Core Based Statistical Area (CBSA). Medicaid Fee for Service hospice providers who have not submitted required quality data to the Centers for Medicare & Medicaid Services (CMS) in compliance with the Hospice Quality Reporting Program (HQRP) will receive reduced reimbursement. Medicaid publishes and implements rate updates each fiscal year or when directed by CMS. (Refer to the MDHHS Hospice Reimbursement Rates on the MDHHS website.)


When a Medicaid beneficiary is receiving hospice services under Medicare, the hospice may bill Medicaid for the coinsurance, as well as room and board, if the beneficiary resides in a NF or hospice-owned NF. Coinsurance and/or room and board cannot be billed to a Medicaid beneficiary, his family, or his representative.


Hospice services are reimbursable for day of discharge if services were rendered, regardless of the setting in which the services were provided. This includes the t ransfer of the beneficiary from one hospice provider to another as long as services were provided by both agencies. (This will be randomly verified by post payment audit and as indicated.) If the beneficiary has hospice as of 12:01 am, the hospice is responsible for the payment of services provided to the beneficiary until midnight. The hospice will continue, for payment purposes, as the primary provider for the full day of discharge.

Room and board for a hospice/nursing facility (NF) resident is reimbursable on the day of discharge if the discharge is due to resident death or the resident is discharged from hospice but remains in the NF. Room and board reimbursement for the day of discharge from the NF for any other reason is not covered.


Reimbursement for administrative duties performed by the Medical Director is included in normal hospice rates. Direct patient care provided by the Medical Director, hospiceemployed physician or consulting physician may be billed by the hospice and is separately reimbursable based on the lesser of Medicaid’s maximum allowable amount for the service or the charge. Claims must reflect the Healthcare Common Procedure Coding System (HCPCS) procedure codes for the physician’s direct patient care.


If the Medicaid beneficiary residing in a NF has a patient-pay amount (PPA), the hospice must collect that amount each month and apply it toward the beneficiary’s Medicaid covered services, and non-covered services as allowed by Medicaid. While the hospice is responsible for collecting the PPA, this duty may be delegated to the NF (via contract with the hospice) as long as the amount is applied to the room and board bill. The PPA must be exhausted each month (even if services do not span the entire month) before any Medicaid payment can be made. Whenever the hospice collects a PPA, a receipt must be given to the beneficiary (or family).

The provider must bill Medicaid for services rendered even if the PPA exceeds the Medicaid reimbursement rate resulting in a zero dollar payment. The Hospice Claim Completion Section of the Billing & Reimbursement for Institutional Providers Chapter
contains examples of the application of the PPA.

CHAMPS handles the PPA in the following manner: When a beneficiary has a monthly PPA and a level of care (LOC) for nursing facility (02) and hospice (16) on file, the PPA will be deducted from the first claim received in CHAMPS. This will occur regardless of whether the PPA is located on the eligibility segment for LOC 02 or LOC 16, and the higher PPA amount will be deducted. If the PPA is greater than the amount of the first submitted claim, the difference will be applied to subsequent claims until the total PPA for that month is met. The PPA must be exhausted each month before any Medicaid payment will be made. The nursing facility and hospice must bill in sequence according to the level of care the beneficiary was at on the first of the month. This will prevent the PPA from being deducted from the wrong claim.


For necessary medical or remedial care recognized under State law but not covered by Medicaid, the Medicare Catastrophic Coverage Act of 1988, Public Law 100-360, allows NF beneficiaries to access their patient-pay amount to pay for these services as allowed by Medicaid. If Medicare covers the beneficiary’s need for medical services, then Medicaid continues to cover the Medicare deductible and coinsurance in the event it does not exceed the Medicaid fee screen.


The hospice must verify eligibility before providing hospice services to the beneficiary in a home setting. (Refer to the Beneficiary Eligibility chapter for additional information.) If the eligibility response indicates a Benefit Plan ID of Spend-down, the hospice should askthe beneficiary or their responsible person for a copy of the MDHHS letter sent the first of each month which indicates the dollar amount the beneficiary must spend before becoming Medicaid-eligible for services. Medicaid may not be billed until the Medicaid deductible obligation is met and the eligibility response indicates a Benefit Plan ID of MA or MA-HMP.


When Medicaid reimburses the hospice for room and board in a NF, the beneficiary must be placed in a bed certified by Medicaid (i.e., a Medicare/Medicaid certified bed or one certified Medicaid-only). If the beneficiary is not placed in a bed certified for Medicaid, MDHHS does not pay for any services. MDHHS pays the hospice 95 percent of the individual or specific facility’s Medicaid rate for room and board plus 100 percent of the nursing facility’s Quality Assurance Supplement (QAS) rate. Hospice reimbursement to  the NF for room and board must be outlined in the contract established between the hospice and the NF.

* Holding a Bed (Hospital Leave and Therapeutic Leave). For NF beneficiaries on hospice, Medicaid reimburses the hospice for holding a NF bed as indicated below.  Hospice reimbursement to the NF for bed holds must be outlined in the contract between the NF and the hospice.

Family members/responsible parties for the hospice/NF beneficiary must be informed of the bed hold and readmission policy of the NF. If the beneficiary refuses to have a family member/responsible party notified, this must be documented in the beneficiary’s medical record.

* Hospital Leave Days. For Hospital Leave Days, Medicaid will pay to hold a beneficiary’s bed only when the facility’s total available bed occupancy is at 98 percent or more on the day the beneficiary leaves the facility. Facilities at 97.5 percent occupancy may round up to 98 percent. Medicaid reimburses during a beneficiary's temporary absence (up to 10 days) from the NF for admission to the hospital for emergency medical treatment as documented by the attending physician in the beneficiary’s medical record.

The facility must hold the bed, and the hospice may bill Medicaid, if the attending physician documents a reasonable expectation at the point of admission to the hospital that the beneficiary will return to the NF by the end of the 10th day.

The beneficiary must return to the NF within 10 days for the hospice to bill for hospital leave days. If the beneficiary is in the hospital for more than 10 days, the NF is released from its obligation to hold the bed and the hospice cannot bill Medicaid for any leave days. Reimbursement to the hospice is at 100 percent of the class wide NF hospital leave day rate. This rate, determined annually by MDHHS, is available on the MDHHS website. (Refer to the Directory Appendix for website information.)

If the beneficiary is expected to be in the hospital for 10 days or fewer, and dies while in the hospital, the hospice may bill Medicaid for the hospital leave days up to the day before the beneficiary died.

If the beneficiary returns to the NF under Medicare coverage and still elects hospice care, the hospice may bill Medicaid for the hospital leave days if the emergency hospitalization was for no more than 10 consecutive days.

Patient-pay amounts and billing methods are not affected by this hospital leave day policy. The hospice/NF should continue to collect any patient-pay amount, typically on the first day of the month, and indicate the amount collected on the Medicaid claim.

CHAMPS automatically deducts the patient-pay amount and reimburses the provider for the balance. If the hospice bills Medicaid for hospital leave days that occur at the beginning of the month, then the hospice should collect the patient-pay amount as usual.

The hospice should charge the amount against the patient-pay that Medicaid pays for that day. For example, if a beneficiary has a patient-pay of $200 and is in the hospital for an emergency condition for the first five days of the month (the stay totals no more than 10 consecutive days), the hospice should collect the patient-pay amount from the beneficiary and then submit a Medicaid claim. Medicaid reimburses the hospice for the hospital leave day per diem rate, minus the patient-pay amount. The hospice reimbursement, based on 2003 rates, would be $132.80 [($66.56 x 5) - $200].

* Therapeutic Leave Days. If the beneficiary has a temporary absence from the NF for therapeutic reasons approved by the attending physician, the hospice may be reimbursed by Medicaid to hold the bed open for up to a total of 18 days during a 365-day period.

Therapeutic leave is for nonmedical reasons such as overnight stays with friends/relatives, Make-a-Wish Foundation trips, etc. The beneficiary’s POC must provide for such absences. There is no limit to the number of therapeutic leave days that may be reimbursed at one time as long as the total does not exceed 18 days in a 365-day period. If a beneficiary does not return from a therapeutic leave, the beneficiary must be discharged on the date he left the facility. The date of admission and the date of discharge may not be billed as therapeutic leave days.

Reimbursement is at 95 percent of the individual or specific NF’s daily per diem rate, just as the customary room and board rate is reimbursed.

* Hospice Revocation or Decertification. If a Medicaid hospice beneficiary who resides in a NF revokes his hospice services or is deemed no longer certifiable for the Medicaid hospice benefit, the hospice may bill for services on the day of revocation/ decertification, as well as the hospice/NF room and board, as long as the beneficiary is in the facility at the midnight census.

* Ventilator Dependent Care Unit (VDCU) or Complex Care Case. Refer to the Place of Service subsection of this chapter for information regarding payment of room and board for these hospice beneficiaries.


Medicaid does not reimburse for room and board in these settings. Reimbursement is  made directly to the facility provider in the normal manner (i.e., Supplemental Security Income, Personal Care/Supplemental Payment). This payment is made in full. The AFC or HFA cannot seek additional restitution from the beneficiary or the hospice provider.


Medicaid does not reimburse for room and board in these settings.


Medicaid does not reimburse for room and board in these settings.


Medicaid does not apply an aggregate dollar capitation. (The Medicare program establishes the maximum total dollar amount per year that Medicare pays for hospice services. Medicaid does not apply this policy to beneficiaries receiving hospice care.)
Medicaid applies the same number of inpatient respite days as Medicare (i.e., no more than five consecutive days are allowed). If more than five consecutive days are billed, the number is reduced to five days, and the excess days must be billed as routine care by the hospice.

Reimbursement for routine, non-emergent transportation is included in the per diem (room and board amount) negotiated between the hospice and the NF.

CPT code for wound care - 97597, 97598

Billing Guidelines

*A. Wound Care (CPT Codes 97597, 97598 and 11042-11047)

1. Active wound care is performed to remove devitalized and/or necrotic tissue to promote healing of a wound on the skin. These services are billed when an extensive cleaning of a wound is needed prior to the application of dressings or skin substitutes placed over or onto a wound that is attached with dressings.
2. Debridement is the removal of foreign material and/or devitalized or contaminated tissue from or adjacent to a traumatic or infected wound until surrounding healthy tissue is exposed.
*3. CPT 97597 and/or CPT 97598 are typically used for recurrent wound debridements.
*4. CPT 97597 and/or CPT 97598 are not limited to any specialty.

Coding Guidelines
1. Active wound care, performed with minimal anesthesia is billed with either CPT code 97597 or 97598.

*2. Debridement of a wound, performed before the application of a topical or local anesthesia is billed with CPT codes 11042 - 11047.

*3. CPT code 11044 or CPT code 11047 may only be billed in place of service inpatient hospital, outpatient hospital or ambulatory care center (ASC).

4. The following HCPCS codes are considered a dressing and therefore bundled into the procedure.

Q4104 Integra BMWD skin sub
Q4105 Integra DRT skin sub
Q4107 Graftjacket skin sub
Q4108 Integra matrix skin sub
Q4110 Primatrix skin sub
Q4111 Gammagraft skin sub
Q4112 Cymetra allograft
Q4113 Graftjacket express allograf
Q4114 Integra flowable wound matri
*Q4115 Alloskin, per square centimeter
*Q4116 Alloderm, per square centimeter
*Q4117 Hyalomatrix, per square centimeter
*Q4118 Matristem micromatrix, 1 mg
*Q4119 Matristem wound matrix, per square centimeter
*Q4120 Matristem burn matrix, per square centimeter
*Q4121 Theraskin, per square centimeter

• Electrical Stimulation and Electromagnetic Therapy of Specified Wounds

For the purposes of this LCD, wound care is defined as care of wounds that are refractory to healing or have complicated healing cycles either because of the nature of the wound itself or because of complicating metabolic and/or physiological factors. This definition excludes the following:
• management of acute wounds, or

• the care of wounds that normally heal by primary intention such as clean, incised traumatic wounds, or
• surgical wounds that are closed primarily and other postoperative wound care not separately payable during the surgical global period.

Various methods to promote wound healing have been devised over time. Physicians and health care providers must understand that many of these methods are expensive and unproven by valid scientific literature, and would be considered investigational. Wound care involves the evaluation and treatment of a wound, including identifying potential causes of delayed wound healing and the modification of treatment when indicated. Wound evaluations may require a comprehensive medical evaluation, vascular evaluation, orthopedic evaluation, functional evaluation, metabolic/nutritional evaluation, and a plan of care. Reduction of pressure and/or control of infection have been shown to facilitate healing and may reduce the need for repeated debridement services.

Medicare coverage for wound care on a continuing basis for a given wound in a given patient is contingent upon evidence documented in the patient's record that the wound is improving in response to the wound care being provided. Evidence of improvement includes measurable changes in the following:

• Drainage
• Inflammation
• Swelling
• Pain and/or tenderness
• Wound dimensions (surface measurements, depth)
• Granulation tissue
• Necrotic tissue/slough
• Tunneling or undermining

Wound care must be performed in accordance with accepted standards for medical and surgical treatment of wounds. The goal of most chronic wound care should be eventual wound closure with or without grafts, skin replacements, or other surgery (such as amputation, wound excision, etc.). Adjunctive measures include but are not limited to appropriate control of complicating factors such as pressure (e.g., off-loading, padding, appropriate footwear), infection, vascular insufficiency, metabolic derangement and/or nutritional deficiency. With appropriate management, it is expected that, in most cases, a wound will reach a state at which its care should be performed primarily by  the patient

and/or the patient’s caregiver with periodic physician assessment and supervision. Wound care that can be performed by the patient or the patient’s caregiver will be considered to be maintenance care. In rare instances, due to severe underlying debility or other factors such as operability, the goal of wound care provided in outpatient settings may be only to prevent progression of the wound.

Dressing Changes for Wound Debridement

• Wet dressings: Water and medication can be applied to the skin with dressings (finely woven cotton, linen, or gauze) soaked in solution. Wet compresses, especially with frequent changes, provide gentle debridement.

• Dry dressings: Used to provide gentle debridement, protect the skin, hold medications against the skin, keep clothing and sheets from rubbing, or keep dirt and air away. Such dressings may also prevent patients from scratching or rubbing the wound.

• Advanced dressings: Used with increasing frequency to provide gentle debridement in the treatment of acute wounds, chronic venous, diabetic and pressure ulcers. A variety of dressings are available including transparent films, foams, hydrocolloids, and hydrogels.

• Dressing changes (removal and subsequent reapplication) alone do not require the skills of physicians, podiatrists, physical therapists, occupational therapists or wound care nurses and in fact are usually performed by non-physician providers.

1. Medicare would expect that wound care may be necessary for the following types of wounds:
o Surgical wounds that must be left open to heal by secondary intention.
o Infected open wounds induced by trauma or surgery.
o Wounds associated with complicating autoimmune, metabolic, vascular or pressure factors.

Active Wound Care Management 

Debridement is indicated whenever necrotic tissue is present on an open wound. Debridement may also be indicated in cases of abnormal wound healing or repair. This procedure includes wound assessment; debridement; application of ointments, creams, sealants, and other wound coverings; and instructions for ongoing care. The routine application of a topical or local anesthetic does not elevate active wound care management to surgical debridement. Debridement may be categorized as selective or non-selective.

o Wound Care Selective Debridement (CPT codes 97597, 97598) includes:

* Removal of specific, targeted areas of devitalized or necrotic tissue from a wound along the margin of viable tissue by sharp dissection including scissors, scalpel, curettes, and tweezers/forceps. This procedure typically requires no anesthesia and there is generally no bleeding associated with it.

o Wound Care Non-Selective Debridement (CPT code 97602) includes:

* Blunt Debridement: Blunt debridement is the removal of necrotic tissue by cleansing, scraping, chemical application or wet to dry dressing technique. It may also involve the cleaning and dressing of small or superficial lesions. Generally this is not a skilled service and does not require the skills of a physician, podiatrist, therapist, or wound care nurse.

* Enzymatic Debridement: Debridement with topical enzymes is used when the necrotic substances to be removed from a wound are protein, fiber and collagen. The manufacturer’s product insert contains indications, contraindications, precautions, dosage and administration guidelines; it is the clinician’s responsibility to comply with those guidelines.

* Autolytic Debridement: This type of debridement is indicated where manageable amounts of necrotic tissue are present, and there is no infection. Autolytic debridement occurs when the enzymes that are naturally found in wound fluids are sequestered under synthetic dressings.

* Mechanical Debridement: Wet-to-dry or dry-to-dry dressings may be used with wounds that have a high percentage of necrotic tissue. Wet-to-dry dressings should be used cautiously as maceration of surrounding tissue may hinder healing.

Wound Care Surgical Debridements (CPT codes 11000, 11001, 11004, 11005, 11006, 11008, 11010, 11011, 11012, 11042, 11043, 11044, 11045, 11046, and 11047)

o Conditions that may require surgical debridement of large amounts of skin include: rapidly spreading necrotizing process (sometimes seen with aggressive streptococcal infections), severe eczema, bullous skin diseases, extensive skin trauma (including large abraded areas with ground-in dirt), or autoimmune skin diseases (such as pemphigus).

o Surgical debridement occurs only if material has been excised and is typically reported for the treatment of a wound to clear and maintain the site free of devitalized tissue including but not limited to necrosis, eschar, slough, infected tissue, abnormal granulation tissue etc., and should be accomplished to the margins of viable tissue. Surgical excision includes going slightly beyond the point of visible necrotic tissue until viable bleeding tissue is encountered in some cases.

o These procedures can be very effective but represent extensive debridement. They may be complex in nature and may require the use of general anesthesia.

Negative Pressure Wound Care (NPWT), electrically powered (CPT codes 97605, 97606)

o Negative pressure wound therapy (NPWT) is a method of wound care to manage wound exudates and promote wound closure. The vacuum assisted drainage collection (i.e., NPWT) cleanses the wound by removing fluids and stimulates the wound bed, reduces localized edema, and improves local oxygen supply.

o Electrically powered NPWT (CPT codes 97605, 97606) involves the application of controlled or intermittent negative pressure to a properly dressed wound cavity. Suction (negative pressure) is applied under airtight wound dressings to promote the healing of open wounds resistant to prior treatments.

o Electrically powered NPWT (CPT codes 97605, 97606) for nonhealing wounds is medically necessary when at least ONE of the following conditions is met:

* There are complications of a surgically created wound (e.g., dehiscence, post sternotomy disunion with exposed sternal bone, post sternotomy mediastinitis, or postoperative disunion of the abdominal wall).

* There is a traumatic wound (e.g., preoperative flap or graft, exposed bones, tendons, or vessels) and a need for accelerated formation of granulation tissue not achievable by other topical wound treatments (e.g., the individual has comorbidities that will not allow for healing times usually achievable with other available topical wound treatments).

* There is a chronic, nonhealing ulcer with lack of improvement for at least the previous 30 days despite standard wound therapy, including the application of moist topical dressings, debridement of necrotic tissue (if present), maintenance of an adequate nutritional status, and weekly evaluations with documentation of wound measurements (i.e., length, width, and depth) in ONE of the following clinical situations:

- Chronic Stage III or Stage IV pressure ulcer - Chronic diabetic neuropathic ulcer - Chronic venous ulcer Wound care should employ comprehensive wound management including appropriate control of complicating factors such as unrelieved pressure, infection, vascular and/or uncontrolled metabolic derangement, and/or nutritional deficiency in addition to appropriate debridement. Medicare payment for professional wound care procedures requires that all applicable adjunctive measures are also employed as part of comprehensive wound management. Wound care in the absence of such measures, when they are indicated, is not considered to be medically reasonable and necessary.

2. Debridement will be considered not reasonable and necessary for a wound that is clean and free of necrotic tissue or in the absence of abnormal wound healing.

3. Debridements are considered selective or non-selective unless the medical record supports that a surgical excisional debridement was performed.

4. Selective debridement should only be provided under a certified plan of care.

5. Since the overall goal of care is healing and not palliation, it is neither reasonable nor medically necessary to continue a given type of wound care if evidence of wound improvement as outlined in this LCD cannot be shown in two to four weeks.

6. It would not be expected that an individual wound would be repeatedly debrided of skin and subcutaneous tissue because these tissues typically do not regrow very quickly. Such debridements performed more frequently than once a week could be subject to medical review. Coverage for prolonged, repetitive debridement services will be considered through the redetermination process.

The medical record must contain adequate documentation of complicating circumstances to support additional services as reasonable and necessary.

7. Autolytic debridement is contraindicated for infected wounds.

8. Debridement of extensive eczematous or infected skin, represented by CPT codes 11000 and 11001 is not appropriate for debridement of a localized amount of tissue normally associated with a circumscribed lesion. Examples of this are ulcers, furnucles, and localized skin infections.

9. The use of a sharp instrument does not necessarily substantiate the performance of surgical excisional debridement.

10.Surgical debridement will be considered not reasonable and necessary when documentation indicates the wound is without infection, necrosis, devitalized, fibrotic, nonviable tissues or foreign matter and has pink to red granulated tissue. When utilized, it is expected that the frequency of debridement will decrease over time.

11. Wound debridement utilizing experimental or investigational methods are considered not reasonable and necessary. Therefore, it would not be reasonable and necessary to report these services with any CPT code.

12.Investigational treatments are noncovered by Medicare as not medically necessary. The patient can be requested to pay for investigational treatment under waiver of liability provisions of Medicare law, but an Advance Beneficiary Notice must be obtained for the beneficiary to be liable for such payment.

13.When performed in conjunction with another wound care service, the dressing change is considered an integral component of that service and is not separately billable.

14.A wound that shows no improvement after 30 days requires a new approach, which may include a physician reassessment of underlying infection, metabolic, nutritional, or vascular problems inhibiting wound healing, or a new treatment approach.

15.Procedures performed for cosmetic reasons or to prepare tissues for cosmetic procedures are statutorily excluded from coverage by Medicare.

16.Local infiltration, metacarpal/metatarsal/digital block or topical anesthesia are included in the reimbursement for wound care services and are not separately payable.

17.The following procedures are considered part of an E/M service or wound care management services, and are not separately covered:

o removal of necrotic tissue by cleansing and dressing, including wet or dry-todry dressing changes;
o cleaning and dressing small or superficial lesions; and
o removal of coagulated serum from normal skin surrounding an ulcer.

18.Disposable non-powered mechanical or single use non-electrically powered or battery powered NPWT (CPT codes 97607, 97608) for any indication is considered not medically reasonable and necessary.

19.NPWT is contraindicated for the following wound types/conditions:

o Necrotic tissue with eschar present
o Untreated osteomyelitis
o Non-enteric and unexplored fistulas
o Malignancy in the wound
o Exposed vasculature
o Exposed nerves
o Exposed anastomotic site
o Exposed organs

CPT feraheme j code , Q0138, Q0139, J1750, 11756, J2916

Ferumoxytol (Feraheme)

Ferumoxytol is covered for the FDA-approved ages – 18 years of age and older.

a. FDA-Approved Indications

Ferumoxytol is covered for all of the following FDA-approved indications:
1. iron deficiency anemia in adult beneficiaries who are hemodialysis dependent with chronic kidney disease (HDD-CKD);
2. iron deficiency anemia in adult beneficiaries who are non-dialysis dependent with chronic kidney disease (NDD-CKD); and
3. iron deficiency anemia in adult beneficiaries who are peritoneal dialysis dependent with chronic kidney disease (PDD-CKD).

Billing Units

The appropriate procedure code(s) used determines the billing unit(s).
1. Ferumoxytol (Feraheme) and iron sucrose (Venofer): 1 billing unit = 1 mg.
2. Iron dextran (INFeD and DexFerrum): 1 billing unit = 50 mg.
3. Sodium ferric gluconate complex in sucrose (Ferrlecit): 1 billing unit = 12.5 mg.
4. Medicaid covers appropriate administration codes when billed with Q0138, Q0139, J1750, J1756, or J2916 on the same day of service.

National drug codes (NDC) 59338-0775-01 Feraheme 510 mg/17 mL, 1 vial 59338-0775-10 Feraheme 510 mg/17 mL, 10 vials

Indication and contraindication

• Feraheme® (ferumoxytol) Injection for intravenous (IV) use is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease.

• Feraheme is contraindicated in patients with known hypersensitivity to Feraheme or any of its components. Warnings and precautions

• Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Feraheme. Observe patients for signs and symptoms of hypersensitivity during and after Feraheme administration for at least 30 minutes and until clinically stable following completion of each administration.

Only administer the drug when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. Anaphylactic-type reactions, presenting with cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, and unresponsiveness have been reported in the post-marketing experience. In clinical studies, serious hypersensitivity reactions were reported in 0.2% (3/1,726) of subjects receiving Feraheme. Other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria or wheezing) were reported in 3.7% (63/1,726) of subjects. • Severe adverse reactions of clinically significant hypotension have been reported in the post-marketing experience. In clinical studies, hypotension was reported in 1.9% (33/1,726) of subjects, including three patients with serious hypotensive reactions. Monitor for signs and symptoms of hypotension following each  Feraheme administration.

• Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Patients should be regularly monitored for hematologic response during parenteral iron therapy, noting that lab assays may overestimate serum iron and transferrin bound iron values in the 24 hours following administration of Feraheme.

• As a superparamagnetic iron oxide, Feraheme may transiently affect magnetic resonance diagnostic imaging studies for up to 3 months following the last Feraheme dose. Feraheme will not affect X-ray, CT, PET, SPECT, ultrasound, or nuclear imaging. Adverse reactions

• In clinical trials, the most commonly occurring adverse reactions in Feraheme treated patients versus oral iron treated patients reported in = 2% of chronic kidney disease patients were diarrhea (4.0% vs. 8.2%), nausea (3.1% vs. 7.5%), dizziness (2.6% vs. 1.8%), hypotension (2.5% vs. 0.4%), constipation (2.1% vs. 5.7%) and peripheral edema (2.0% vs. 3.2%).

• In clinical trials, adverse reactions leading to treatment discontinuation and occurring in 2 or more Feraheme treated patients included hypotension, infusion site swelling, increased serum ferritin level, chest pain, diarrhea, dizziness, ecchymosis, pruritus, chronic renal failure, and urticaria. Post-marketing safety experience

• The following adverse reactions have been identified during post-approval use of Feraheme. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

• The following serious adverse reactions have been reported from the post-marketing spontaneous reports with Feraheme: life-threatening anaphylactic-type reactions, cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, unresponsiveness, loss of consciousness, tachycardia/rhythm abnormalities, angioedema, ischemic myocardial events, congestive heart failure, pulse absent, and cyanosis. These adverse reactions have occurred up to 30 minutes after the administration of Feraheme. Reactions have occurred following the first dose or subsequent doses of Feraheme

Feraheme, when added to intravenous infusion bags containing either Sodium Chloride Injection, USP (normal saline), or 5% Dextrose Injection, USP, at concentrations of 2-8 mg elemental iron per mL, should be used immediately, but may be stored at controlled room temperature (25°C ± 2°C) for up to 4 hours.

The dosage is expressed in terms of mg of elemental iron, with each mL of Feraheme containing 30 mg of elemental iron. Evaluate the hematologic response (hemoglobin, ferritin, iron and transferrin saturation) at least one month following the second Feraheme injection. The recommended Feraheme dose may be readministered to patients with persistent or recurrent iron deficiency anemia.

For patients receiving hemodialysis, administer Feraheme once the blood pressure is stable and the patient has completed at least one hour of hemodialysis. Monitor for signs and symptoms of hypotension following each Feraheme injection. Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration.

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Feraheme. Observe patients for signs and symptoms of hypersensitivity during and after Feraheme administration for at least 30 minutes and until clinically stable following completion of each administration. Only administer the drug when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions [see Adverse Reactions (6.1)].

Anaphylactic type reactions presenting with cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, and unresponsiveness have been reported in the post-marketing experience [see Adverse Reactions from Postmarketing Spontaneous Reports (6.2)]. In clinical studies, serious hypersensitivity reactions were reported in 0.2% (3/1,726) of subjects receiving Feraheme. Other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria or wheezing) were reported in 3.7% (63/1,726) of these subjects.

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