Compliance with the provisions in this LCD may be monitored and addressed
through post payment data analysis and subsequent medical review audits.

**History/Background and/or General Information**

Parathyroid hormone (PTH), a polypeptide hormone produced in the parathyroid
gland, along with Vitamin D, are the principal regulators of calcium and
phosphorus homeostasis. The most important actions of PTH are (1) rapid
mobilization of calcium and phosphate from bone and the long-term acceleration
of bone resorption, (2) increasing renal tubular reabsorption of calcium, (3)
increasing intestinal absorption of calcium (mediated by an action on the
metabolism of vitamin D), and (4) decreasing renal tubular reabsorption of
phosphate. These actions account for most of the important clinical
manifestations of PTH excess or deficiency.

The PTH is normally measured concomitantly with serum calcium levels.
Abnormally elevated PTH values may indicate primary, secondary, or tertiary
hyperparathyroidism. Abnormally low PTH levels may result from
hypoparathyroidism and from certain malignant diseases such as squamous cell
carcinoma of the lung, renal carcinoma, pancreatic carcinoma, or ovarian
carcinoma.

**Covered Indications**

A Parathormone test will be considered medically reasonable and necessary
under any of the following circumstances:

  * Evaluation of patients with a combination of clinical signs and symptoms of hyperparathyroidism such as weakness, fatigue, bone pain, confusion, depression, nausea, vomiting, polyuria, etc. in which parathyroid disease is suspected;
  * Evaluation of patients with a combination of clinical signs and symptoms of hypoparathyroidism such as Chvostek's sign, Trousseau's sign, dysphagia, tetany, increased deep tendon reflexes, etc. in which parathyroid disease is suspected;
  * Evaluation of a patient with an abnormal total calcium level;
  * To distinguish nonparathyroid from parathyroid causes of hypercalcemia;
  * Evaluation of patients with previously diagnosed hyper or hypoparathyroidism;
  * Evaluation of patients with a magnesium deficiency and/or excessive Vitamin D;
  * Evaluation of patients with ectopic parathyroid hormone producing neoplasms;
  * To evaluate and monitor therapy of secondary hyperparathyroidism in chronic renal disease and/or status post renal transplantation;
  * Immediate follow-up of patients that have undergone thyroidectomy and/or parathyroidectomy; and 
  * Evaluation of a patient with osteoporosis to rule out parathormone involvement.

**Limitations  
**

It is expected that parathormone levels for patients diagnosed with chronic
kidney disease (CKD) will be performed according to Kidney/Dialysis Outcomes
Quality Initiative (K/DOQI) clinical practice guidelines for bone metabolism
and disease.

  * For stage 3 CKD patients with a glomerular filtration rate (GFR) of 30-59, it is expected that PTH level measurements will be performed every 12 months.
  * For stage 4 CKD patients with a glomerular filtration rate (GFR) of 15-29, it is expected that PTH level measurements will be performed every 3 months.
  * For stage 5 CKD patients with a glomerular filtration rate (GFR) less than 15 or dialysis, it is expected that PTH level measurements will be performed every 3 months.

It is expected that the frequency of parathormone level measurements will be
performed according to K/DOQI clinical guidelines. If the measurement of PTH
levels exceed recommended frequencies, documentation may be reviewed to
support the excess measurements.

Documentation supporting parathormone levels more frequently should include
the following:

  * Symptoms such as bone pain, weakness, fractures, difficulty walking, intractable itching, ectopic calcification, paresthesias, Chvostek's and/or Trousseau's signs, bronchospasm, laryngospasm, tetany and/or seizures;
  * Non-compliance with treatment of renal osteodystrophy; or
  * Need to monitor changes in therapy

As published in the CMS IOM Publication 100-08, _Medicare Program Integrity
Manual_ , Chapter 13, Section 13.5.4, an item or service may be covered by a
contractor LCD if it is reasonable and necessary under the Social Security Act
Section 1862 (a)(1)(A). Contractors shall determine and describe the
circumstances under which the item or service is considered reasonable and
necessary.

**Notice:** Services performed for any given diagnosis must meet all of the
indications and limitations stated in this LCD, the general requirements for
medical necessity as stated in CMS payment policy manuals, any and all
existing CMS national coverage determinations, and all Medicare payment rules.