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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case.
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101.
The rules say that Medicare may cover a drug or biological if it is safe and effective and otherwise reasonable
and necessary. You can find this rule in the Medicare Benefit Policy Manual, Chapter 15, Section 50.4.1.
The rules also state that Prolia for Men and Postmenopausal Women with Osteoporosis is allowed under the
following circumstances:
- criteria for the diagnosis of osteoporosis is met, and
- there is a history of treatment as related to progression of disease and ongoing risk factors, and
- treatment failure of oral or self-administered drugs for osteoporosis as applicable to the patient that supports
IV therapy in lieu of standard oral treatment protocol
- The patient meets the definition of osteoporosis with high risk for fracture, or
- The patient has failed or is intolerant of other available osteoporotic therapy
Limitations:
If the drug use is not indicated on the FDA label, and is not included in one of the compendium approved by
CMS (American Hospital formulary Services (AHFS), Clinical Pharmacology, NCCN Drugs and Biologicals
Compendium and/or Thomson Micromedex DrugDex) and the off-label use is not listed above, the drug use
would not be considered reasonable and necessary, and, therefore is not allowed. Not only does the indication
for the use of the drug need to meet medical necessity requirements, but the route of administration is also
subject to medical necessity criteria.
Medical necessity is not demonstrated in the cases where a patient has not taken the oral form of a medication
before the IV form of the drug, either for patient or provider convenience purposes, or for financial or
emotional reasons, and these claims will be denied.
Combination use of a bisphosphonate and a monoclonal antibody for the treatment of osteoporosis during an
episode of care is not considered reasonable and necessary, and therefore, is not covered. Combination use of
IV and/or oral forms of bisphosphonate therapy as treatment for osteoporosis during an episode of care is not
covered. An episode of care includes the duration and frequency of the IV drugs in accordance with FDA
labels.
Hypocalcemia, hypovitaminosis D, and other disturbances of bone and mineral metabolism must be effectively
treated before starting therapy. Patients must receive supplemental calcium and vitamin D.
The optimal duration of the use of the drugs listed in this LCD has not been determined. It is expected that
treatment with these drugs in a Medicare beneficiary meets the evidence-based peer reviewed literature and
standards of care in the medical community.
Prolia is contraindicated for the following conditions:
- Hypocalcemia
- Patients receiving Xgeva
You can find this in the Local Coverage Determination (LCD): Bisphosphonates (Intravenous [IV]) and
Monoclonal Antibodies in the Treatment of Osteoporosis and Their Other Indications (L33270).
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.