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These products are facing increased scrutiny, though they are still not officially approved by any US government regulatory agency

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(iii) For single source drugs and biological products previously crosswalked to a grouped billing and payment code: (A) If crosswalked to a grouped billing and payment code during the full year, CMS will calculate the average total allowed charges per individual per year for the drug using allowed charges and the number of individuals who used the drug or biological product based on claims for the previously grouped billing and payment code during the year

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