Bone Loss Assessment Recommendations
Regardless of score patients should be considered for a bone loss test. Medicare and the Osteoporosis Foundation recommend bone loss tests as a preventive measure, (even with patients that are considered low risk). And urine tests, i.e. NTx, offer an easier, faster way to determine whether bone loss is occurring. The following step guide will help determine the best course of action based on age, risk profile, and as recommended by Medicare and CPT billing guidelines. STEP 1: Bone Loss Assessment (completed by patient in the waiting room, staff should include copy in patient file) For billing, use CPT 99420 – Administration and Interpretation of health risk assessment questionnaire. A copy of the report should be included with the recommendations. Negative screens can be reviewed by staff person. The additional questions included in this document should be completed by doctor and patient during visit. Both documents should be including in a request for reimbursement. In order to be reimbursed for the A/I code, Positive screens require provider to review risk responses during visit. STEP 2: Review Risk Responses with patient and obtain HPI1 (history of present illness/symptoms) During patient interview. Any score of 1 or more, should be considered for a bone density test and/or a NTx rate of bone loss test. NOTE: a confirmed risk response on any weighted question(s), meet the minimum criteria for testing according to Medicare reimbursement guidelines and the National Osteoporosis Foundation (see questions 6, 82, 103, 11, 12).
During visit with patient, review risk responses highlighted on the PPES, and confirm risk status. For example, if patient responds, “yes” to question 3, “physically inactive for prolonged periods of time,” further qualify the statement by determining, timing, duration, severity, context, modifying factors, or associated signs and symptoms, contributing to the inactivity. If yes on question 8 or 10, determine if reason for response is early, or surgically induced menopause, (before age 40). If so, patient meets minimum criteria for a BMD test. When you have reviewed and confirmed risk responses from screen, ask and record responses to the following additional
1 Include completed Bone Loss Assessment with confirmed risk factors, with any additional questionscompleted during visit to obtain PFSH for ensuing E/M work related to treatment and/or counseling toprevent further bone loss. 2 Meets minimum criteria for BMD test if reason for yes response is early or surgically inducedmenopause (under age 40)3 Meets minimum criteria for BMD test if reason for yes response is early or surgically inducedmenopause (under age 40)
medical history questions to obtain all pertinent information related to the history of presentillness/symptoms, before ordering labs/tests or developing a treatment plan.
ASK… **1. Do you have any of the following: Type 1 diabetes? Liver disease? Kidney disease? Or Thyroid disease?4
2. Have you ever taken oral contraceptives? If yes,
what was your age at first use? How long?3. Any issues with depression? Either clinicallydiagnosed or untreated?4. History of eating disorder? Anorexia or bulimia?Extreme or starvation dieting?5. High protein diet?6. Are you, or have you ever been lactose intolerant?7. Any current or past diseases of the small intestine?Colitis or Crohn’s?8. For women with no children, ask, “Have you everbeen pregnant? If yes, move onto next question; if no,then add as additional risk factor. 9. And for women with children, how old were youwhen you had your first child? (Patients with ateenage pregnancy should also be evaluated for boneloss.)10. Were you ever tested for bone loss or bone densityunder the care of another physician?
**A confirmed yes response on question 1 meets minimum requirement for a BMD test. . A risk response on any of the subsequent questions 2-10 should be considered for test to determine if bone loss is occurring and at what rate. Add risk factors from the Bone Loss screen, and the items addressed during the visit, and evaluate to determine next steps. BMD test or NTx tests? Bone Density versus Bone Loss If patient is pre-menopausal, and has few risk factors (1 or 2), NTx is recommended because it gives patient a faster response than a bone density test, and can determine whether bone loss is occurring. However, if patient is menopausal, and has multiple risk factors, it is recommended patient receive both tests. BMD gives patient a definitive answer as to the exact density, so that the best course of treatment can be selected. Whereas, NTx will inform patient if bone loss is occurring, and at what rate. NTx tests can helpful before menopause (as a litmus whether bone loss is occurring) and after menopause, (if bone loss has been diagnosed, and a medication is being used to prevent further loss that could result in osteoporosis). NTx tests are used in tandem with treatment of bone loss to determine the efficacy of the selected medication.
4 Any one of these diseases meets minimum requirement for BMD test. STEP 3: Order Diagnostic Labs/Tests (use the following key to help guide decision)
Pre-menopausal, + any non-weighted question: As a preventive measure, order NTx test todetermine if bone loss is occurring, and at what rate.
Pre-menopausal + any weighted question: Order both tests. Consider beginning some form ofabatement, through lifestyle modification and/or Rx. Use NTx to measure efficacy ofTreatment.
Menopausal + any non-weighted question(s): As a preventive measure, order NTx to determineif bone loss is occurring, and at what rate. Discuss
reasons for test. Counsel re: lifestyle changes (ifapplicable).
Menopausal + any weighted question(s): Order BMD. Consider beginning prescription drug treatment. Consider NTx to determine if treatment is efficacious.
According to Medicare Billing Recommendation, anyof the following conditions meet the minimumrequirement for testing:
Or, younger women with one of the followingconditions should also be tested:
Postmenopausal and have at least one risk factor forosteoporosis, including having fractured a bone (Yes on Question 10 plus one other risk factor)
A vertebral abnormality (yes on Question 12)
Take medications, such as prednisone (see Question 6)
Any of the following: Type 1 diabetes, liver disease, kidney disease, or thyroid disease
Afamily history of osteoporosis (see Question 11)
Experienced early menopause (see questions 8 and/or 10; must determine that “yes” response onquestion 8 or 10 is due to early menopause, before age 40)
(For Information about types of tests and reimbursement guidelines, see below: LABS/TESTSBONE DENSITY)
Labs/Tests Bone Density
Bone density is usually studied by using one of various types of diagnostic bone mass measurement techniques that have been recognized by the FDA for that purpose. Bone density can be measured at the wrist, spine, hip, or calcaneus (heel). Various single and combined methods of measurement may be required to diagnose bone disease, monitor the course of bone changes with disease progression, or monitor the course of bone changes with therapy.
If patient meets criteria for a bone density test, you mayuse one of the following FDA approved diagnostic tests:Urine tests: fasting calcium/creatinine, fastinghydroxyproline/creatine (NTx)Blood testsCalcium/phosphorous: 1,25(OH)2Vitamin D3Progesterone; Estrogens (estradiol, estrone)Serum Gla-proteinPhoton Absorptiometry: single, dualComputed tomography
Is Bone Mass Testing Reimbursable?
Providers unclear on payment criteria may wish to useMedicare criteria as a preliminary guide, however, private payers may use other criteria, and thefollowing guidelines should only be used as a general compass. Medicare covers preventive tests for patients who meet the following criteria: A “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 non-physician
practitioner treating her to be estrogen-deficient and at clinical risk for osteoporosis, based on her medical history5 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 an average of 5.0 mg of prednisone, or greater, per day, for more than threemonths;
5 Include completed Bone Loss Assessment with any additional questions included in this document, to satisfyPFSH for any ensuing E/M work related to treatment and/or counseling to prevent further bone loss. Seesuggestions for lifestyle modification specific to each area of risk
An individual with known primary hyperparathyroidism; or
An individual being monitored to assess the response to, or efficacy of, an FDA-approvedosteoporosis drug therapy.
In addition, all of the coverage criteria listed below must be met:
The individual’s physician or qualified non-physician practitioner treating the beneficiary mustprovide an order, following an evaluation of the need for a bone mass measurement that includesa determination as to the medically appropriate measurement to be used for the individual. NOTE: A physician or qualified non-physician practitioner treating the beneficiary for the purpose of the bone mass measurement benefit is one who provides a consultation or treats a beneficiary for a specific medical problem, and who uses the results in the management of the patient. For the purposes of the bone mass measurement benefit, qualified non-physician practitioners include physician assistants, nurse practitioners, clinical nurse specialists, and certified nurse midwives.
The service must be a radiologic or radioisotopic procedure (or other procedure) that meet thefollowing requirements:
Is performed with a bone densitometer (other than dual photon absorptiometry (DPA)) or abone sonometer (i.e., ultrasound) device approved or cleared for marketing by the FDAIs performed for the purpose of identifying bone mass, detecting bone loss, or determiningbone quality; andIncludes a physician’s interpretation of the results of the procedure. The service must be furnished by a qualified supplier or provider of such services under theappropriate level of supervision by a physician. The service must be reasonable and necessary for diagnosing, treating, or monitoring anindividual as defined above.
Medicare provides coverage of a bone mass measurement that meets the criteria as described above once every 2 years (i.e., at least 23 months have passed following the month in which the last Medicare-covered bone mass measurement was performed). NOTE:If medically necessary, Medicare may provide coverage for a beneficiary more frequently than every 2 years.
NTX versus BMD testing (bone loss can be measured by using NTX over shorter periods oftime, 60 to 90 days, while BMD is used to diagnose Osteoporosis (and is measured in 12 to 24month increments)
Is NTx test reimbursable? http://www.medscape.com/viewarticle/508542_4 The Centers for Medicare and Medicaid Services (CMS) has established a national policy for reimbursement of collagen crosslink testing, as of November 25, 2002. The Medicare NCD for urine based collagen crosslink tests (CPT 82523) lists three uses under 'Indications':
1. Identify individuals with elevated bone resorption, who have osteoporosis in whom responseto treatment is being monitored;2. Predict response (as assessed by bone mass measurements) to FDA approved anti-resorptivetherapy in postmenopausal women;3. Assess response to treatment of patients with osteoporosis, Paget's disease of the bone, or riskof osteoporosis where treatment may include FDA approved anti-resorptive agents, anti-estrogens or selective estrogen receptor moderators.
STEP 4: Diagnosis/Treatment Support
With a completed bone density test, use the chart below to determine the proper diagnosis. This will also help determine whether more rigorous treatment is indicated. As a general rule, Hormone Treatment is more effective with perimenopausal, menopausal and post menopausal patients experiencing mild to moderate bone loss, whereas, bophosphonates and SERMs tend to be more effective in treating severe bone loss, and/or patients diagnosed with osteoporisis.
World Health Organization standards for the diagnosis
1.0 SD (Standard Deviation) = Normal Bone Mass 1.0 SD to -1.0 SD = Mild or Borderline Osteopenia -1.0 SD to -2.5 SD = Low Bone Mass or ModerateOsteopenia -2.5 SD or Lower = Osteoporosis.
In 2008, the American College of Physicians made thesenew recommendations:
Doctors should prescribe medication to people
who have known osteoporosis and people whohave experienced a fragility fracture (when abone breaks without significant trauma)
Doctors should consider preventive treatment for
Doctors should take into account a patient's individual risk and benefits when selecting
among drug treatment options for osteoporosis
For mild bone loss or as a preventive measure, adjustments in lifestyle should be considered forfirst course of treatment. Several questions in the Bone Loss Screen (1-5) address lifestylechoices that can be addressed during visit. If patient is at increased risk due to a “yes” response
on a lifestyle question, inform patient that changes in behavior, even seemingly minor changesnow, can have a profound effect on her general health later in life.
Included in this document are recommendations specific to each risk response, and offercounseling suggestions that will help encourage patients to make changes in their behavior orlifestyle choices. Remind patient that the appropriate amount of calcium can help mitigate somerisk factors, but it should not be perceived as a panacea.
For low, moderate or severe rates of bone loss in pre-menopausal patients, medication should beconsidered (in addition to lifestyle adjustments) as a preventive measure to decrease the rate ofbone loss. Individuals with bone loss at earlier stages in their life should be considered foralternative therapies e.g. low-dose bioidentical HRT. NTx tests can measure the efficacy of theselected treatment and can be administered at 60 to 90 day intervals, so that patient and providerare able to try different methods until they discover the most effective method for managingbone loss.
For low, moderate, or severe rates of bone loss in perimenopausal or menopausal women (whoare managing their symptoms with a hormone replacement therapy) should consider modifyingor changing medications. She may also consider adding a medication as there are new drugsbeing used to treat bone loss and osteoporosis. Ideally suited for individualized therapy, becausefor various reason, they may be adversely affected by their current HRT.
Recommend changes that can be made versus changes that cannot. While it’s important to pointout genetic risk factors e.g. ethnicity or family history, time should not be used discussing them;instead, use that time to counsel patient on mitigating behaviors like cutting down on alcohol,and monitoring daily calcium intake. Treatment Options for Bone Loss, Osteopenia and Osteoporosis Hormone therapy: Hormone Replacement Therapy (synthetic) or Bioidentical Hormone Therapy. HRT can be effective at slowing bone loss in menopausal women. Alternative forms of hormone therapy include patches, creams and the vaginal ring (see chart below for suggestions). Synthetic and Bioidentical Estrogen Preparations Available in the United States Bioidentical 17-beta estradiol (E2)
Alora®, Climara®, Estraderm®, Fempatch®, Oesclim®,Vivelle® (all E2 patches); Combi Patch® (E2 +norethindrone); Emcyt® (capsule); Estrace® (vaginalcream and tablet); Femring® and Estring® (vaginalrings); Estrasorb® and Estragel® (transdermalpreparations); and available generically in troches,sublingual drops, suppositories, creams, gels, orcapsules from compounding pharmacies.
Available generically in troches, sublingual drops,suppositories, creams, gels, or capsules fromcompounding pharmacies.
Ogen® (tablet and vaginal cream); Ortho-Est® (tablet);generic tablet
Available generically in troches, sublingual drops,suppositories, creams, gels, or capsules fromcompounding pharmacies.
Non Bioidentical (Synthetic)Ethinyl estradiol
Brevicon®, Demulen®, Levlen®, Lo-Ovral®, Loestrin®,Modicon®, Nordette®, Norinyl®, Ortho-Cept®, Ortho-Cyclen®, Ortho-Novum®, Ortho-Tri-Cyclen®, Ovcon®,Tri-Levlen®, Tri-Norinyl®, Triphasil®, Nelova® (alltablets in combination with synthetic progestins);Estinyl® and Feminone® (tablet)
Estratab® (tablet, vaginal cream); PremPro® (tablet incombination with MPA); PremPhase® (tablet incombination with MPA); generic (tablet)
Premarin® (tablet, vaginal cream); PremPro® (tablet in
PROGESTOGEN/PROGESTERONE BRAND NAME Bioidentical (Progesterone) Progesterone (P4)
Crinone® and Utrogestan® (vaginal gels); Pro-Gest®and other brands (transdermal cream); Prometrium®(capsule); and available generically in troches,sublingual drops, suppositories, creams, gels, orcapsules from compounding pharmacies.
Non-Bioidentical (Progestogen)Medroxyprogesterone acetate
Provera®, Amen®, Curretab®, and Cycrin® (tablet);
PremPro® and PremPhase® (tablet in combination withCEE)
Aygestin®, Micronor®, Norlutate®, Nor-QD® (tablet)
Ortho-Tri-Cyclen® (tablet in combination with EE)
With more severe bone loss in menopausal and post-menopausal patients, and a diagnosis ofosteopenia or osteoporosis using WHO standards, there are additional drugs that may be moreeffective at reversing the rate of bone loss, including the following:
If HT is unsuccessful or patient requests an alternative approach, and lifestyle changes don't helpcontrol osteoporosis, the following drugs can help slow bone loss and may even increase bone
Bisphosphonates: Much like estrogen, this group of drugs can inhibit bone breakdown, preserve bone mass, and even increase bone density in spine and hip, reducing the risk of fractures. Raloxifene (Evista). This medication belongs to a class of drugs called selective estrogen receptor modulators (SERMs). Raloxifene mimics estrogen's beneficial effects on bone density in postmenopausal women, without some of the risks associated with estrogen, such as increased risk of uterine cancer and, possibly, breast cancer. Calcitonin. A hormone produced by the thyroid gland, calcitonin reduces bone resorption and may slow bone loss. It may also prevent spine fractures, and may even provide some pain relief from compression fractures. Because calcitonin isn't as potent as bisphosphonates, it's normally reserved for people who can't take other drugs. Teriparatide (Forteo). This powerful drug, an analog of parathyroid hormone, treats osteoporosis in postmenopausal women and men who are at high risk of fractures. Unlike other available therapies for osteoporosis, it works by stimulating new bone growth, as opposed to preventing further bone loss. Teriparatide is given once a day by injection under the skin on the thigh or abdomen. Tamoxifen. This synthetic hormone is used to treat breast cancer and is given to certain high- risk women to help reduce their chances of developing breast cancer. Although tamoxifen blocks estrogen's effect on breast tissue, it has an estrogen-like effect on other cells, including bone cells. As a result, tamoxifen appears to reduce the risk of fractures, especially in women older than 50. Emerging therapies: A new physical therapy program has been shown to significantly reduce back pain, improve posture and reduce the risk of falls in women with osteoporosis who also have curvature of the spine. The program combines the use of a device called a spinal weighted kypho-orthosis (WKO) — a harness with a light weight attached — and specific back extension exercises. The WKO is worn daily for 30 minutes in the morning and 30 minutes in the afternoon and while performing 10 repetitions of back extension exercises.
Sources:AAFP (American Academy of Family Physicians)http://www.nlm.nih.gov/medlineplus/osteoporosis.htmlACOG (American Academy of Obstetricians and Gynecologists)http://www.iofbonehealth.org/patients-public/about-osteoporosis/prevention/exercise.html
Step 5: Counseling Support
The following recommendations are specific to each risk response from the screen. Use inconjunction with any preventive measures/medications, or treatment measures (with patientswho are diagnosed with bone loss and/or osteoporosis). If bone loss is tested and the results are
negative for bone loss, preventive measures are suggested for any patients entering menopause orreceiving treatment for menopausal symptoms, as they are at greater risk for developing boneloss in the near future.
Remind patient that even minor changes in lifestyles choices can have profound impact on overall health, and can abate or reverse the rate of bone loss. Use the following for counseling support, in tandem with any treatment or preventive measures (including test results and Rx management). Document by initialing item and include a copy of all reviewed items in patient records and the request for reimbursement.
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