This bulletin is an update to Provider Notice 05-014.

PURPOSE:

The purpose of this notice is to update the provider community of issues surrounding the Progressive Correct Action (PCA) service wide review for Pamidronate Disodium conducted by Highmark Medicare Services and to remind providers of the indications and limitations of coverage and medical necessity guidelines for Pamidronate Disodium as described in LCD 06-034.  This notice is also intended to assist in decreasing the claims error rate and to avoid provider denials for the above listed service.

BACKGROUND:

Pamidronate disodium is a bone-resorption inhibitor which either directly blocks the dissolution of calcium phosphate in bone, or which inhibits osteoclast activity.

Pamidronate disodium may be indicated for the treatment of hypercalcemia associated with malignancy, with or without bone metastases; Paget's disease; Osteolytic bone metastases of breast cancer; and Osteolytic lesions of multiple myeloma.

Pamidronate disodium may also be indicated for very select cases of disabling osteoporosis. In order for disabling osteoporosis to be covered, all of the following patient selection criteria must be met and documented:

• The patient must have severely disabling osteoporosis;
• The patient's T- scores should be less than or equal to -2.5;
• The patient has documented compression fractures of the axial skeleton, or peripheral fractures;
• The patient has pain and difficulty with Activities of Daily Living (ADLs) and/or ambulation, secondary to the osteoporosis;
• The patient is allergic to shellfish and/or salmon derivatives or has had a trial of calcitonin without improvement; or has a contraindication to the use of calcitonin; or
• The patient has intolerance to two or more antiresorptive agents or has had a 12 month trial of oral biphosphonates without documented improvement;
• The patient’s condition has severely deteriorated and their osteoporosis is so significant that a trial of oral biphosphonates is not medically warranted.

Pamidronate may be considered for very select individuals with low bone density or osteopenia. Osteopenia is defined as a hipbone mineral density measurement (BMD) that is between 1-2.5 standard deviations below the young adult female mean (T-score less than -1 and greater than -2.5). In order for osteopenia to be considered for coverage, the following selection criteria must be met and documented:

• The diagnosis must be made by central DEXA scan measurement with a T-score less than -1 and greater than -2.5;
• The patient has intolerance to two or more antiresorptive agents or has had a 12 month trial of oral biphosphonates without documented improvement; and
• The patient must have the associated risk factors for fracture.

Pamidronate disodium may also be indicated in the treatment of osteogenesis imperfecta in pediatric patients.

CPT/HCPCS Codes

Italicized and/or quoted material is excerpted from the American Medical Association, Current Procedural Terminology (CPT) codes.

REVIEW SUMMARY:

In the Provider Information section of the Medicare Services website, “What’s New”, November 22, 2005, a service wide notification for Pamidronate Disodium was posted. 

The progressive corrective action review was initiated for Pamidronate Disodium based on Medical Review findings indicate a persistent high probe error rate after education on Pamidronate disodium.  

In April 28, 2006 the revision for LCD 06-034 for Pamidronate Disodium was posted.  Please reference:

• Provider Notice 05-172: Pamidronate Disodium for Use in Osteoporosis, Original Issue Date: October 28, 2005
• Provider Notice 05-173:  Pamidronate Disodium For Use in Hypercalcemia Associated With Malignancy, With Or Without Bone Metastases Original Issue Date: October 28, 2005 
• Provider Notice 05-014, Pamidronate Disodium.

The information provided below is based on the review of submitted claims for 10/01/2006-02/06/2007:

Medical review of claims for Pamidronate for the above mentioned dates continue to show an overall error rate of 29%.  The majority of the denials were due to a lack of documentation to support that treatment with Pamidronate Disodium was medically reasonable and necessary.  Specific documentation that is helpful in determining the rationale for the use of Pamidronate Disodium is as follows:

History, progress notes and/or clinical data.  The history, progress notes and clinical data present a comprehensive overview of the patient’s disease process and serve to support the medical necessity and rationale for the use of Pamidronate Disodium.  Progress notes should be recent enough to indicate that the patient is being evaluated at appropriate intervals regarding the effectiveness of the treatment.  The history submitted should be relevant to the disease process for which the patient is receiving the Pamidronate Disodium.

Uses of Pamidronate Disodium that may be reasonable and necessary are described in LCD 06-034.

Specifically, for those patients who are receiving Pamidronate Disodium for the treatment of disabling osteoporosis, all criteria must be met, documented and submitted.  The patient must have severely disabling osteoporosis, T-scores should be less than or equal to –2.5, documentation of compression fractures of axial or peripheral fracture, difficulty with Activities of Daily Living, allergic to shellfish and/or salmon derivatives or a trial of calcitonin without improvement or trial without documented improvement or the patients condition is severely deteriorated so that a trial or oral biphosphonates is not medically warranted.

Please review the Local Coverage Determination (LCD), which discusses the indications and limitations for the use of Pamidronate Disodium. 

The review revealed that most providers are sending in documentation when requested by the Additional Development Request (ADR) in a timely manner.  Significant pieces of the documentation are often missing, such as the history and physical and current progress notes or other clinical data to support the rationale for use of the drug and to validate the use of Pamidronate Disodium.  For disabling osteoporosis to be covered, all patient criteria must be met and documented.

Incorrectly billing of units is found frequently.  The medication record must indicate the correct dosage given.  The correct dosage is 1 unit = 30 mg of Pamidronate, therefore: 90 mg of Pamidronate = 3 units.

It is very important that providers obtain necessary medical documentation from third parties such as physicians or other providers, health care facilities, or suppliers to fully support the services billed to Medicare.  It is the responsibility of the provider submitting the claim for payment to obtain all the requested documentation, regardless of where the records are kept.

The ADR generated for Pamidronate Disodium is specific to the documentation required for the review.  Listed below is a sample of the documentation requested:

1. Physician’s orders.
2. History/progress notes or other clinical data to support the medical necessity/rationale for the use of Pamidronate and to validate the claim.
3. Treatment/medication record with dosage and method of administration and progress notes of the response to treatment.
4. Results of all testing/services billed.
5. Clinic/treatment room records.
6. Itemized bill.

When a request for Additional Development Request (ADR) is received, please review and provide the requested documentation prior to submission of claims in order to ensure appropriate review of all information supporting medical necessity for the services billed.

In summary, the purpose of this notice is to update the provider community of issues surrounding the Progressive Corrective Action (PCA) service wide review for Pamidronate Disodium conducted by Highmark Medicare Services to assist in decreasing the claims error rate and to avoid provider denials of the above listed service.

Please continue to check the Highmark Medicare Services website for informational bulletins, provider notices and policy updates.

For breaking news, join the Highmark Medicare Services listserv.

If you have any questions regarding this bulletin, please contact our Customer Contact Center at 1-800-560-6170.

REFERENCES:

• Provider Notice 05-014: Pamidronate Disodium
  
  
• LCD 06-034: Pamidronate Disodium
  
  
• Provider Notice 06-066: The Need for Accurate, Complete, and Timely Responses to Additional Development Requests (ADRS)
  
  
• Provider Notice: 05-173: Pamidronate Disodium For Use in Hypercalcemia Associated With Malignancy, With Or Without Bone Metastases