Medicare & Medicaid

The Centers for Medicare & Medicaid Services (CMS) recently released an MLN Matters special edition article providing guidance for clinical laboratories about data reporting. The data reporting period opened on January 1.

Here are six things from the article for clinical laboratories to know about data reporting.

1. CMS has developed the online data collection system to assist laboratories in submitting data to CMS, which are due by March 31. A detailed user guide on how to access and use this system is available by clicking here.

2. Laboratories must designate both a Clinical Laboratory Fee Schedule (CLFS) submitter and CLFS certifier in the data collection system. These must be two different individuals. The CLFS submitter must be registered in Medicare's Provider Enrollment, Chain and Ownership System (PECOS) as a "user" or "authorized user" on the PECOS Medicare Enrollment forms (in other words, CLFS submitters must have their name appear within one of the following 855 application forms: A, B, C, I, R). The CLFS certifier does not need to be registered in PECOS.

A data reporting template is available here. Laboratories seeking to upload their data to the CLFS data collection system should use this template.

3. It is advisable to follow the formatting guidelines outlined in the user guide and on the data collection template. The CLFS data collection system will identify formatting errors in your file before you are able to certify the data and submit it. However, for large volumes of data, this process may take several hours to validate. Thus, those files with fewer formatting errors will be processed more efficiently.

4. It is advisable to use the CLFS Applicable Information HCPCS Codes file available here. The system will only accept HCPCS codes listed on this file.

5. The cleaner the file, the smoother the upload process will be.

6. If your laboratory expects to submit over 100,000 lines of data in the .csv template, first contact the CMS/CLFS helpdesk at This email address is being protected from spambots. You need JavaScript enabled to view it. .

Organizations looking for assistance with clinical laboratory billing can contact PGM Billing, a leading, national provider of lab billing services, by calling (877) 857-8981.

The Centers for Medicare & Medicaid Services (CMS) has released a video that contains guidance to help providers bill correctly for enteral infusion pumps.

Medicare Part B covers enteral nutrition supplies and equipment (feeding pump) under the prosthetic device benefit.

The two-minute video discusses Medicare coverage criteria for enteral infusion pumps and the four pieces of information necessary for proper documentation.

As CMS noted in September, there are a number of reasons for denial:

  • The patient must have a permanent (ordinarily at least three months) non-function or disease of the structures that normally permit food to reach the small bowel or a disease of the small bowel which impairs digestion and absorption of an oral diet. Either condition must require tube feedings to provide sufficient nutrients to maintain weight and strength commensurate with the patient’s overall health status.
  • When the method of administration is via enteral infusion pump, there must be documentation in the medical record to justify the use (for example, gravity feeding is not satisfactory due to reflux and/or aspiration, severe diarrhea, dumping syndrome, administration rate less than 100 ml/hr, blood glucose fluctuations, circulatory overload, gastrostomy/jejunostomy tube used for feeding). If the medical necessity of the pump is not documented, the pump will be denied as not reasonable and necessary.
  • The enteral nutrition must be infused 7 days per week. Documentation requirements include a detailed written order (DWO) for each item billed that must be signed and dated by the treating physician and a DME information form (DIF), which has been completed, signed, and dated by the supplier. Both of these must be kept on file by the supplier and made available upon request.
  • A new initial DIF for a pump is required when: a formula billed with a different code, which has not been previously certified, is ordered; enteral nutrition services involving use of a pump are resumed after they have not been required for two consecutive months; or a beneficiary receiving enteral nutrition by the syringe or gravity method is changed to administration using a pump
  • A revised DIF for enteral nutrients is required when: the number of calories per day is changed; the number of days per week administered is changed; the method of administration (syringe, gravity, pump) changes; the route of administration is changed from tube feedings to oral feedings (if billing for denial); or the HCPCS code for the current nutrient changes.

The video is part of a series intended to help providers improve in areas identified with a high degree of noncompliance.

Struggling to get paid for your gastroenterology medical billing claims? Contact PGM, which has a long history of success with both gastroenterology billing and endoscopy billing.

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