Distinguishing Between Clinical Guidelines and Covered Services.

Health care expenditures in the United States that are attributed to osteoporotic fractures reach greater than $10 billion annually. Detection of osteoporosis by screening can lead to early treatments that can maintain bone mass, lowering the risk of osteoporotic fractures. [1] The Department of Health and Human Services' Health Care Financing Administration (HCFA) realized that the physician treating the beneficiary should be afforded flexibility and be given the option of ordering the most appropriate bone mass measurement for a patient in a particular set of circumstances. With regard to estrogen-replacement therapy (ERT), HCFA recognized the difficulty of trying to define the estrogen-deficient statutory category precisely. Rather than attempting to define the category, HCFA left the determination of whether the patient is estrogen-deficient and at clinical risk of osteoporosis to the treating physician. This risk is calculated based on medical history or other findings.

Before the enactment of the Balanced Budget Act of 1997 (BBA), Medicare coverage of bone mass measurements and the related physician interpretation of the procedures were available for only some Medicare beneficiaries. The Bone Mass Measurement Act (BMMA) set forth regulations to provide uniform coverage for bone mass measurements under Medicare Part B. [2] This law authorized Medicare coverage of those medically necessary approved measurements that are performed for a qualified individual. The term "qualified individual" means a Medicare beneficiary who meets the medical indications for at least one of the five categories listed below:

* A woman who has been determined by the physician or qualified nonphysician practitioner treating her to be estrogen-deficient and at clinical risk for osteoporosis, based on her medical history and other findings;

* An individual with vertebral abnormalities as demonstrated by an x-ray to be indicative of osteoporosis, osteopenia (low bone mass), or vertebral fracture;

* An individual receiving (or expecting to receive) glucocorticoid (steroid) therapy equivalent to prednisone 7.5 mg or greater per day for more than 3 months;

* An individual with primary hyperparathyroidism; or

* An individual being monitored to assess the response to or efficacy of an FDA-approved osteoporosis drug therapy.

Medicare and other health plans will pay only for services that meet their medical necessity standards. Medical necessity standards are hotly debated in health care. What makes a medical procedure reasonable and necessary and who decides are frequently asked questions. Medical necessity is established with physician documentation and the proper assignment of ICD-9-CM codes based solely on documentation available at the time of code assignment. Proper documentation, along with communication of this documentation, is essential for reimbursement. The tools for communication are CPT codes and ICD-9-CM codes. These codes are reported through Medicare and other payer's claim forms. Data from these forms can then be reviewed to establish reimbursement coverage standards and regulations.

There is a prospective aspect to coding that warrants mentioning. Coded data are used for more than reimbursement purposes. Medicare claims data are used in statistical grouping and trend analysis, as well as in basic health statistics. The coded data are used to establish priorities in planning and budgeting. It also provides policymakers with the tools to monitor and improve quality of care. A new ICD-9-CM code for 2001 has been developed to communicate disease status in women with osteoporosis. The National Osteoporosis Foundation requested the creation of a new code for screening for osteoporosis. [1] The code is V82.81 "Special screening for Osteoporosis." There is an instruction included that serves as a reminder to use the existing code of V07.4 "postmenopausal hormone replacement therapy status" or the new code V82.89 "postmenopausal (natural) status." By using these codes, physicians could be documenting evidence to support the cost-effectiveness of routine screening or the effectiveness of early ini tiation of preventive drugs.

Medicare defines "medical necessity" as a determination of a service that is reasonable and necessary for the diagnosis or treatment of illness or injury. Although most third-party payers abide by Medicare's definition of medical necessity, some insurance providers have more comprehensive definitions. There are two steps in determining medical necessity. The first step is to determine whether services are covered or noncovered. Once the determination has been made that the service is covered, the second step is to judge whether the service is medically necessary or not medically necessary. Medical necessity issues underscore the importance of clear physician documentation. [3]

Covered services may be diagnostic or preventive. Medicare reimburses for very few preventive services. When reimbursement is allowed for certain services, payers may also determine a specific allowance for frequency of coverage. Covered services can be deemed "medically unnecessary" or "not medically reasonable or necessary" for the diagnosis and treatment of a disease or condition. A review of medical literature and a review of the available Medicare claim data for 1995 and 1996 resulted in the expansion of Medicare coverage to include additional preventive benefits for bone mass measurement. [2]

CLINICAL INDICATIONS FOR BONE DENSITY STUDY

Coverage is provided for the following indications when the results of these tests are used to make a clinical decision to begin treatment for osteoporosis for loss of bone mineral density:

* A patient with a recent fracture that is suspected to be associated with osteoporosis.

* A patient with long-term corticosteroid therapy, which is defined as greater than three months or the equivalent of cortisone 30 mg or greater per day.

* A patient on long-term (greater than one month) heparin therapy.

* A patient on long-term (greater than three months) phenytoin therapy. This is drug therapy for the treatment of seizures.

* A patient with known hyperparathyroidism when the test result is used to determine if the patient needs a parathyroidectomy.

* A patient with excessive doses of thyroid replacement (for this indication the test is covered only if the patient has a subnormal TSH level while on thyroid replacement).

* A woman with primary ovarian failure or post-ablative ovarian failure before the age of 40, who is suspected of having osteoporosis.

* A patient with known osteoporosis or osteopenia.

* A woman with documented estrogen deficiency and at clinical risk for osteoporosis.

GENERAL UTILIZATION PARAMETERS

Coverage is limited as follows when one of the clinical indicators above is met:

* One study per day when multiple bone mineral studies of different sites are performed per same method.

* Initial testing may be performed using the appendicular DXA (76076) or other approved bone mineral density study (CPT 76075, 76070).

* Appendicular DXA coverage is limited to once every 24 months. If the test is negative then testing is covered again after 24 months if a clinical indication is present.

* If the appendicular DXA is positive or equivocal then a confirmatory test is covered. (The appendicular DXA is not considered confirmatory testing.)

* If the same provider performs the appendicular DXA and confirmatory test, reimbursement is made only for the greater service (confirmatory test).

* If the confirmatory test is negative, repeat testing is covered after 24 months if a clinical indication is present.

* If the confirmatory test is positive and pharmacological therapy is documented, repeat testing will be covered after 12 months while on prescription drug therapy.

* If the confirmatory test is positive but pharmacological therapy is not present, repeat testing will be covered after 24 months.

* If a new clinical indicator presents during the period of waiting for retesting, the testing will be covered based on the new indicator (without waiting for the time period to be served).

REASONS FOR DENIAL

* Medicare is prevented by statute from paying for screening for osteoporosis. For example, bone densitometry would be non-covered if the only reason for doing the test is that the patient is or has been a user of tobacco or alcohol products, has now or has ever had a diagnosis of depression, or does not have any of the conditions described under "Coverage.

* Broadband Ultrasound Attenuation--CPT code 76977 (Heel ultrasonography)--The DXA and ultrasound correlation coefficient is relatively modest. The comparison between the DXA and ultrasound to determine treatment cannot be extrapolated and, therefore, this test is not covered.

* DXA done with portable units (no CPT or HCPCS code) is considered investigational until more data are available to determine its accuracy, precision and benefit in predicting bone density. [2]

CONCLUSION

Defined covered services, utilization parameters, medical necessity, and accurate coding procedures present the framing for the most advantageous economic landscape for today and for prospective applications for the diagnosis and treatment of osteoporosis.

References

(1.) Prophet S: Summary of ICD-9-CM coordination and Maintenance Committee meeting. JAHIMA 1999; 70(2): 64-70

(2.) Fed Regist 1998 Jun 24; 63(121):34320-8

(3.) Gregg C, Mallet S: Who answers the medical necessity question? JAHIMA 2000; 71 (6): 50-53

CPT CODE  ICD-9-CM CODE     TERM
78350                       Bone density (bone mineral content)
                            study, one or more sites; single
                            photon absorptiometry.
76070                       Computerized tomography bone
                            mineral density study, one or more
                            sites.
76075                       Dual energy x-ray absorptiometry
                            (DXA), bone density study, one or
                            more sites; axial skeleton (eg,
                            hips, pelvis, spine).
76076                       Dual energy x-ray absorptiometry
                            (DXA), bone density study, one or
                            more sites; appendicular skelton
                            (peripheral) (eg, radius, wrist,
                            heel).
76977                       Ultrasound bone density measurement
                            and interpretation, peripheral
                            site(s), any method. ****
                            The DXA and untrasound correlation
                            coefficient is relatively modest.
                            The comparison between the DXA and
                            ultrasound to determine treatment
                            cannot be extrapolated and,
                            therefore, this test is not
                            covered. ****
          781.92            Abnormal posture.
          733.09            Drug induced osteoporosis. Use
                            additional E code to indentify drug.
          V67.51            Follow-up exam, following completed
                            treatment with high-risk
                            medications, NEC
          252.0             Hyperparathyroidism
          252.0             Hyperparathyroidism (primary)
          733.02            Idiopathic osteoporosis
          737.41            Kyphosis (code osteoporosis 1st)
          V58.61            Long term (current) drug use of
                            anticoagulants
          V58.69            Long term (current) drug use of
                            high risk medication
          781.91            Loss of height. **** Should not be
                            assigned for osteoporosis.
          627.2             Menopause or female climacteric
                            states
          805.00 - 805.9    Open and closed vertebral fractures
                            w/o spinal cord injury
          268.2             Osteomalacia, unspecified
          733.90            Osteopenia
          733.00 - 733.09   Osteoporosis
          733.09, F.932.0   Osteoporosis secondary to
                            glucocoritcoids use
          733.09, E944      Osteoporosis secondary to use of
                            Lasix
          733.00            Osteoporosis, unspecified
          627.9             Other specified menopausal and
                            postmenopausal disorders
          E936.1            Phenytoin (therapeutic use of)
          V82.89            Postmenopausal (natural) status
          V07.4             Postmenopausal hormone replace-
                            ment therapy status
          V49.81            Postmenopausal status (age-related)
                            (natural)
          256.3             Premature menopause
          256.2             Premature menopause, surgical
                            (Postablative ovarian failure)
          588.8             Secondary hyperparathyroidism
                            (of renal origin)
          V82.81            Special screening for Osteoporosis
          627.4             Surgical menopause

To be valid, comparative experiments have to be made at the same time and on as comparable patients as possible. Comparative experiment is the sine qua non of scientific experimental medicine: without it, a physician walks at random and becomes the play thing of endless illusions. A physician, who tries a remedy and cures his patients, is inclined to believe that the cure is due to his treatment. But the first thing to ask them is whether they have tried doing nothing, i.e., not treating other patients: for how can they otherwise know if the remedy or nature cured them.

Claude Bernard

An Introduction to the Study of Experimental Medicine, 1865