LCD L34018

Coverage Guidance

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for Parathormone (Parathyroid Hormone). Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for Parathormone (Parathyroid Hormone) and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site.

IOM Citations:

• CMS IOM Publication 100-02, Medicare Benefit Policy Manual,

• Chapter 11, Section 20 Renal Dialysis Items and Services, Section 20.2 Laboratory Services, Section 30.1 Home Dialysis Items and Services, Section 30.2 Home Dialysis Training, Section 40 G. Renal Dialysis Services Furnished During the Creation or Revision of a Vascular Access, and Section 100.5 Renal Dialysis Services Included in the AKI Payment Rate

• Chapter 15, Section 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests

• CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual,

• Chapter 1, Part 3, Section 190.10 Laboratory Tests - CRD Patients

• CMS IOM Publication 100-04, Medicare Claims Processing Manual,

• Chapter 8, Section 50.1 Laboratory Services Included in the End Stage Renal Disease Prospective Payment System (ESRD PPS), Section 60 Separately Billable ESRD Items and Services, and Section 60.1 Lab Services

• Chapter 16 Laboratory Services

• Chapter 23, Section 40 Clinical Diagnostic Laboratory Fee Schedule

• CMS IOM Publication 100-08, Medicare Program Integrity Manual,

• Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD

Social Security Act (Title XVIII) Standard References:

• Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.

• Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

• Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

Code of Federal Regulations (CFR) References:

• CFR, Title 42, Volume 2, Chapter IV, Part 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.

Indications and Limitations of Coverage

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.

Summary of Evidence

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Analysis of Evidence

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Associated Information

Please refer to the related Local Coverage Article: Billing and Coding: Parathormone (Parathyroid Hormone) (A57122) for documentation requirements, utilization parameters and all coding information as applicable.

Bibliography

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