New HCFA Guidelines 7/1/98

Federal Register June 24, 1998, 63(121):34320-34328

[HCFA-3004-IFC], RIN 0938-AI89

Effective July 1, 1998, the Federal Health Care Financing Administration (HCFA) has issued new guidelines for Medicare coverage and payment for bone mass measurements. These guidelines have been issued as an Interim Final Rule (with comments due by August 24, 1998). There are a number of important points in these rules that will affect the clinical use of bone mass measurements in general, and central (QCT and DXA) measurements in particular.

Uniform Coverage

“In recent years, various new bone mass measurements have been developed and gained acceptance in the medical community. Since they have not been excluded from coverage under section 50–44 of the CIM, most Medicare contractors have begun to pay for the medically necessary use of these measurements, but some Medicare contractors have not. As a result, Medicare coverage of bone mass measurements has been inconsistent in its application with regard to the types of (1) beneficiaries eligible, (many Medicare contractors have considered bone mass measurements of estrogen-deficient women to be screening services and not covered under Medicare) and (2) bone mass measurements considered to be clinically effective.”

“Section 4106(a)(1) of the BBA adds section 1861(s)(15) to provide for uniform coverage of bone mass measurements under the Part B program for services furnished on or after July 1, 1998. The law defines a “bone mass measurement” to mean (1) a radiologic, radioisotopic, or other procedure approved by the Food and Drug Administration (FDA) for the purpose of identifying bone mass, detecting bone loss, or interpreting bone quality, and (2) it includes a physician's interpretation of the results of those bone mass measurement procedures. The law also authorizes Medicare coverage of those medically necessary approved measurements that are performed for a “qualified individual” that fall into at least one of five diagnostic categories. These include (1) an estrogen-deficient woman at clinical risk for osteoporosis, (2) an individual with vertebral abnormalities, (3) an individual receiving long-term glucocorticoid (steroid) therapy, (4) an individual with primary hyperparathyroidism, and (5) an individual being monitored to assess the response to, or efficacy of, an approved osteoporosis drug therapy.”

The effect of this rule is to bring all Medicare providers to the same level of coverage for bone mass measurements. What this means for the provider of bone mass measurements is that a single standard will now be used among insurers, and this should reduce the necessity of having to fight with some insurers over reimbursement for the tests.

Preferred Use of Central Measurements

“In regard to the clinical utility of peripheral versus central bone density devices, there is a consensus that measurements of the central skeletal sites is the preferred method of assessment. The American College of Radiology reports that central techniques are associated with relatively higher predictive relative risk ratios for hip fractures than peripheral techniques, and allow for more frequent evaluations because of their intrinsic ability to better assess bone metabolic activity. Although either central or peripheral techniques may be used for most bone mass measurement indications, experts representing the National Osteoporosis Foundation have suggested clinical situations in which only central studies should be performed (that is, vertebral abnormalities, glucocorticoid maintenance, and monitoring the response to osteoporosis drug treatment).”

“In view of these uncertainties about the clinical role of the peripheral measurement, we plan to monitor the Medicare use of these measurements. Based on data on the effectiveness of these measurements, we will reconsider our coverage policy in this regard if warranted. Although peripheral bone mass measurements have some apparent advantages in terms of access and convenience, if, over time, these parameters become more relatively favorable for central bone mass measurement, then our policies will be correspondingly updated.”

Even though the rules allow physicians to make use of peripheral measurements for monitoring therapy under some circumstances, they make clear that central measurements are the procedure of choice both for diagnosis of osteoporosis and for monitoring therapy. The role of peripheral measurements in these rules is relegated primarily to large-scale testing of populations at risk and for single point measurements for preliminary diagnosis of low bone mass.

Coverage for a Second “Baseline” Study, Measurement Frequency

Based on the differences among methodologies, and especially between peripheral and central measurements, the rules allow for a second (more accurate and precise) measurement to be reimbursed if the first measurement is not sufficiently accurate or precise to make a definitive diagnosis or be used to monitor therapy.

“Furthermore, in Sec. 410.31(c), we are setting forth limitations on the frequency for covering a bone mass measurement. Generally, we will cover a bone mass measurement for a beneficiary if at least 23 months have passed since the month the last bone mass measurement was performed. However, we will allow for coverage of follow-up bone mass measurements performed more frequently than once every 23 months when medically necessary. Examples of situations where more frequent bone mass measurements procedures may be medically necessary include, but are not limited to, the following medical circumstances: (1) Monitoring beneficiaries on long-term glucocorticoid (steroid) therapy of more than 3 months; and (2) allowing for a confirmatory baseline bone mass measurement (either central or peripheral) to permit monitoring of beneficiaries in the future if the initial test was performed with a technique that is different from the proposed monitoring method.”

A nominal frequency for BMD tests has been set at 2 years based on the statement by the American College of Clinical Endocrinologists for use of DXA that a change in bone mass “of 5% is considered clinically significant and is usually not observed in less than 2 years.” Note that this statement was derived using DXA, but for QCT done with a precision of 1–1.5% the 5% change in bone mass can be seen in less than a year, so QCT measurements could be indicated more frequently if the precision is shown to be high enough.

Addition of a Significant Patient Population

The original coverage of 5 categories of patients (see the Uniform Coverage section above) explicitly stated Medicare coverage for “a woman who has been determined by the physician or a qualified nonphysician practicioner treating her to be estrogen-deficient and at clinical risk for osteoporosis, based on her medical history and other findings.” In the past, FDA and other guidelines have stated that there is no need for monitoring bone density in women receiving “adequate hormone replacement therapy”, that is, the assumption has been made that any prescribed hormone replacement therapy removes a woman from the “estrogen-deficient” category. This has been interpreted to deny coverage for monitoring of those women taking estrogen replacement therapy. The new rules explicitly address this.

“In regard to the definition of estrogen-deficient women at clinical risk for osteoporosis, there is agreement among medical experts in the United States regarding the efficacy of the use of estrogen-replacement therapy (ERT) in preventing and treating post-menopausal bone loss and osteoporosis. According to the American Association of Clinical Endocrinologists “Clinical Practice Guidelines for the Prevention and Treatment of Post-Menopausal Osteoporosis” (March 1996), ERT “is the standard of care for preventing and treating post-menopausal bone loss and should be considered for all estrogen-deficient women without contradictions.” In addition, the guidelines provide that “for maximal skeletal protection, therapy should begin at the time of menopause or oophorectomy, although therapy can be initiated at any time after menopause. Studies indicate that correction of estrogen deficiency at any age prevents or slows bone loss in post-menopausal women with osteoporosis.”

“However, based on our review of the medical literature and other information, it appears that not every woman who has been prescribed ERT may be receiving an “adequate” dose of the therapy and, thus, may not be sufficiently protected against further bone loss. In view of the difficulty of trying to define the estrogen-deficient statutory category precisely, we have decided in this interim final rule to allow a woman's treating physician or other treating practitioner to determine whether she is estrogen-deficient and at clinical risk of osteoporosis, based on her medical history or other findings.”

The effect of this rule is to allow followup bone density measurements in any woman on estrogen replacement therapy and in whom the risk of osteoporosis is suspected.

Payment Codes

The payment codes for peripheral bone mass measurements (peripheral DXA, SXA, SPA, peripheral QCT, ultrasound and radiographic absorptiometry) all carry the same RVU and payment amounts as published in the Medicare physician fee schedule final rule of October 31, 1997. The payment codes for central bone mass measurements (QCT, DXA) are also listed under that rule, with the new QCT code G0131 using the older CPT 76070 amount payable. Of note for the DXA and QCT codes is that they are explicitly stated as “Dual energy x-ray absorptiometry, bone density study, one or more sites; axial skeleton (e.g. hips, pelvis, spine)” and “Computerized tomography bone mineral density study, one or more sites; axial skeleton (e.g. hips, pelvis, spine).” In practice, this means that if spine, hip, or both are measured either by DXA or QCT, the exam will be reimbursed as a single procedure at the published level.

Summary

We hope this brief summary of the new HCFA/Medicare rules as of July 1, 1998 will provide help in deciding how to maximize use of QCT in the assessment of osteoporosis. As can be seen from a number of the new rules, HCFA is recognizing that as peripheral bone mass measurements become more widespread, currently offered in many drugstores and fitness centers as a quick, simple, inexpensive test, the results of those tests will lead to the identification of a significantly larger fraction of the population at risk for osteoporosis, much as routine screening for high cholesterol did for heart disease. These identified high-risk patients will need confirming diagnoses or followup if put on therapy, and central BMD measurements have been identified as the procedure of choice for this. If a population bone density testing program exists in your area, it can be a very good source of referrals for QCT BMD, as can the primary care physician's office who has installed their own ultrasound or pDXA device.

For those who would like more information, the new rules can be downloaded from the internet from the Federal Register Online via GPO Access (wais.access.gpo.gov/su_docs/, and click on Federal Register).

MEDICARE EXPANDS COVERAGE FOR BONE DENSITY MEASUREMENT AND DIABETES SELF-MANAGEMENT

Overview: Starting July 1, 1998, Medicare will expand coverage of preventive benefits for beneficiaries at risk for osteoporosis and other bone abnormalities and for people with diabetes. Medical experts agree early detection and management of disease can lead to substantial reductions in life-threatening and serious illness.

The Clinton Administration is committed to making sure Medicare beneficiaries get recommended preventive screening tests. That is why the President worked with Congress to expand the preventive benefits available to Medicare beneficiaries in the Balanced Budget Act of 1997. As of January 1, 1998, Medicare expanded coverage of mammograms, pap smears, and colorectal cancer screening. Today, President Clinton highlighted these exciting preventive tests at the seventh Family Reunion Conference, hosted by Vice President and Mrs. Gore, in Tennessee.

Bone Mass Measurement. The National Osteoporosis Foundation estimates that more than 10 million people in the United States have this disease and another 18 million are at risk for it. As of July 1, 1998, Medicare will cover bone density measurement for beneficiaries at risk for osteoporosis and other bone abnormalities. Through earlier detection of low bone mass and the use of appropriate prevention and treatment measures, the ravaging effects of this disease will be reduced.

Eligible beneficiaries will be able to have their bone mass measured once every two years, or more often, if medically necessary. Doctors will be able to use all of the FDA-approved or cleared bone densitometry and sonometry devices that are currently available in the United States. Beneficiaries should consult with their doctors about whether and when they might need one of these tests.

In the past, bone mass measurement coverage was decided by the many regional contractors that process Medicare claims, resulting in wide variations across the country. The new law makes sure that all beneficiaries who need this testing, no matter where they live, will be covered.