NEW FDA APPROVALS

  • 0
  • May 29, 2013

5/29/2013
Medicare Updates
On May 15, 2013, the FDA approved radium Ra 223 dichloride (Xofigo Injection, Bayer HealthCare Pharmaceuticals Inc.) for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Xofigo is an alpha-particle emitting radiotherapeutic drug which mimics calcium and forms complexes with hydroxyapatite at areas of increased bone turnover, such as bone metastases.  More Information:  http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm352393.htm

On May 14, 2013, the FDA approved erlotinib (Tarceva, Astellas Pharma Inc.) for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) patients whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.  This indication for erlotinib is being approved concurrently with the cobas EGFR Mutation Test, a companion diagnostic test for patient selection.  More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm352317.htm

CMS PUBLISHES NEW EHR FAQ
On 4/26/2013, CMS published the new EHR FAQ #8231, which clarifies the criteria for numerators that fall outside the EHR reporting period timeframe:
Q. While the denominator for measures used to calculate meaningful use in the Medicare and Medicaid Electronic Health Records (EHR) Incentive Programs is restricted to patients seen during the EHR reporting period, is the numerator also restricted to activity during the EHR reporting period or can actions for certain meaningful use measures be counted in the numerator if they took place after the EHR reporting period has ended?

  1. The criteria for a numerator is not constrained to the EHR reporting period unless expressly stated in the numerator statement for a given meaningful use measure. The numerator for the following meaningful use measures should include only actions that take place within the EHR reporting period:  Preventive Care (Patient Reminders) and Secure Electronic Messaging. For all other meaningful use measures, the actions may reasonably fall outside the EHR reporting period timeframe but must take place no later than the date of attestation in order for the patients to be counted in the numerator.

NEW EDITS FOR NEW PATIENT CODES
Medicare Recovery Auditors (RAs – previously known as RACs) have identified claims with new patient evaluation and management (E/M) services as having improper payments because the new patient services were billed for the same patient two or more times within three years by the same physician or physician group. This resulted in overpayments, as the E/M services should have been paid as established patient E/M services.

To address these improper payments, CMS announced in MLN Matters® Number: MM8165 that they will implement changes to the Common Working File (CWF) to prompt CMS contractors to establish edits that would prevent payment for two new patient CPTs within a three year period of time.

As stated in the Medicare Claims Processing Manual, (Chapter 12, Section 30.6.7), a new patient  is one who has not received any professional services, i.e., E&M service or other face-to-face service such as a surgical procedure, from the physician or physician group practice (same physician specialty) within the previous three years. For example, if a professional component of a previous procedure is billed in a three-year period, e.g., a lab interpretation, and no E&M service or other face-to-face service with the patient is performed, then this patient remains a new patient for the initial visit.

CMS reports that the new patient CPT codes that will be checked in these edits include 99201-99205, 99218-99223, 99304-99306, 99324-99328, 99341-99345, 99381-99387, 99460-99461, 99468, 99471, 99475, 99477, G0245, G0402, and G0344.

The new edits will be implemented October 7, 2013. As always, the implementation of new edits may result in errors of application so please watch carefully to make sure the edits are being applied appropriately.