PAMA Update: CMS Guidance and Reporting Information Trickles In

The Centers for Medicare & Medicaid Services (CMS) promised more details would be coming once it released the final rule implementing the Protecting Access to Medicare Act of 2014 (PAMA) this past June. To date, it has issued some of those details and labs should be in the thick of preparations to comply with the reporting requirements. In fact, in the first subregulatory guidance issued this summer, CMS advised labs should be using this six-month period between the data collection period which has ended (Jan. 1 to June 30, 2016) and next year's data reporting period (Jan. 1 to March 31, 2017) to determine if the lab is an applicable lab and to "review and validate applicable information before it is reported to CMS."

CMS has released the following additional information since the June final rule:

• The list of HCPCS codes to be used in reporting. That list was accompanied by a short explanatory key to the Medicare Status Indicators that apply to the codes.
• Medicare Part B Clinical Laboratory Fee Schedule: Guidance to Laboratories for Collecting and Reporting Data for the Private Payor Rate-Based Payment System.
• Fee-for-Service Data Collection System: Clinical Laboratory Fee Schedule Data Reporting Template.

CMS's guidance on collecting and reporting data described four steps to determining applicable laboratory status. CMS advises labs ask the following four questions to determine if they are an applicable lab:

1. Does the lab have a CLIA certificate?
2. Does the lab have its own National Provider Identifier under which it bills Medicare?
3. Does the lab get more than 50 percent of its total Medicare revenue under the CLFS and the Physician Fee Schedule (PFS)? CMS offers this equation: CLFS revenue + PFS revenue/total Medicare Revenues > 50 percent
4. Does the lab get at least $12,500 in CLFS Medicare revenue (NOT including PFS revenue) during the six month data collection period?

The July guidance also provides seven examples of scenarios involving labs to show how the calculations work in hypothetical situations.

The information collected and reported for Clinical Diagnostic Laboratory Tests (CDLTs) is defined in the final rule to include private payor rates "for which final payment has been made" during the collection period plus the number of tests performed at that rate and the HCPCS code for the test. CMS' guidance document clearly lays out for labs in the July guidance what does and doesn't qualify as reportable:

Here's what does need to be reported:

• Tests paid under the CLFS
• Secondary insurance payments
• Non-contracted or out of network payments for lab services
• Patient cost sharing amounts are included in determining the final payment amount
• Final payments determined as a result of an appeal and paid within the data collection period

The following don't get reported:

• Private payor payments for test codes payable only under the PFS
• Payment rates adjusted by waivers of patient' deductibles, copays or coinsurance
• Denied payments (what CMS calls "zero payments")
• Any claims still under review or under appeal during that data collection period (even appeals concluded in the data collection period aren't reported if the payment isn't made within the data collection period)
• Capitated payments
• Payments made when the volume of tests associated with that payment can't be determined
• Bundled payments –where HCPCS codes are bundled into single encounter that isn't characterized by a single HCPCS code

Finally, this month CMS provided a template for reporting the data. The template doesn't provide new information, simply addressing the four elements that must be reported: HCPCS Code, payment rate, volume of tests, and the lab's NPI. It does provide a User Guide however, addressing how to navigate the template. CMS notes that the data collection system is undergoing testing and won't be accessible to labs until November 2016.

All these documents and future guidance can be found on the CMS website.

Takeaway: As PAMA's reporting deadlines draw closer, CMS has shared HCPCS Codes and reporting templates to help labs begin preparing.