PAMA Headquarters

XIFIN Responds to Draft 2018 CLFS

Proposed Fee Schedule Reveals Fundamental Flaws in PAMA Reporting Exercise; Time to Take Action

Countdown to PAMA


January 1, 2018. That's when the new clinical laboratory fee schedule (CLFS) will go into effect based on information reported under the 2014 Protecting Access to Medicare Act (PAMA). PAMA will substantially revise the Medicare reimbursement methodology for clinical diagnostic laboratory tests, and stands to significantly impact laboratory margins in the coming months. Understanding both reporting requirements and how the reported results will impact laboratory bottom lines is crucial to survival in this competitive space. By one estimate, a 10% cut in the CLFS will result in a 3-4% drop in laboratory profit margins. Are you ready?

As a leader and trusted source of laboratory reimbursement, XIFIN has been actively working to respond to and prepare for PAMA for over three years, both in terms of ensuring XIFIN clients are prepared to report as required, and that they understand and respond to the financial ramifications.

Featured Dark Daily Webinar

Sizing up PAMA's Preliminary 2018 Payment Rates: What's the Bottom Line for Your Lab?

Join Lâle White, XIFIN's Executive Chairman & CEO and other industry experts on October 11, 2017 as they address the most critical issues for lab and pathology interests regarding PAMA's preliminary 2018 payment rates.

Register Now

Deep Medicare Fee Cuts Are Coming to your Clinical Laboratory in 157 Days

Join Lâle White, XIFIN's Executive Chairman & CEO for this can't-miss webinar by Dark Daily. This webinar will provide you with an insider’s perspective on the essential market intelligence and knowledge you need to respond to the loss of important revenue that your lab will experience as of January 1.

View On Demand

Industry Responds to Proposed Fee Schedule

ACLA Invites You to Contact Your Member of Congress!

The laboratory community needs your help to delay the Centers for Medicare and Medicaid Services (CMS) from implementing inappropriate new Clinical Laboratory Fee Schedule (CLFS) rates.

As you may know, in 2014 Congress passed the Protecting Access to Medicare Act (PAMA) to base Medicare CLFS reimbursement rates on laboratory-reported private market rates. Unfortunately, current Medicare rules would exclude 95 percent of clinical laboratories from reporting their private market rates, including most physician office and hospital laboratories. This September, CMS is planning to publish preliminary CLFS rates that would reflect unrepresentative data from only 5 percent of laboratories. Unless there is a change, these rates will go into effect on January 1, 2018, and if they do, Medicare beneficiary access to clinical laboratory services will be put at risk.

COLA launches new website to explain how PAMA threatens lab infrastructure and public health, visit:

We need you to contact your Members of Congress and ask them to urge CMS to delay PAMA implementation until CMS can develop CLFS rates that factor in the full laboratory market and are truly market-based.

Current PAMA Schedule

Under the final rule:

  • January 1, 2016 through June 30, 2016: First data collection period for determining calendar year (CY) 2018 CLFS payment rates.
  • January 1, 2017 through March 31, 2017: First data reporting period for reporting entities to report private payor rate data to CMS for determining CY 2018 CLFS payment rates. Note: on March 30, CMS announced it will exercise enforcement discretion until May 30, 2017 with respect to the data reporting period for reporting applicable information under the CLFS. View the full announcement.
  • Mid-July 2017: Annual laboratory public meeting for new tests. CMS will use cross walking or gap-filling to set rates for new tests (that are not new ADLTs ) for which there is no private payor data collected for CY 2018.
  • Early September 2017: CMS publishes preliminary CLFS rates for CY 2018. The public will have approximately 30 days, through early October 2017, to submit comments on the preliminary CY 2018 rates.
  • Early November 2017: CMS makes final CY 2018 rates available on the CMS website.
  • January 1, 2018: Implementation date of new CLFS.

XIFIN and PAMA—In the News

G2 Intelligence

As XIFIN predicted, the PAMA reporting exercise has resulted in significant proposed laboratory fee cuts. In fact, the multi-year decrease for the top 20 laboratory tests is 28%–4% higher than the... more


The lower-than-expected 2018 Medicare prices for lab tests released under the Protecting Access to Medicare Act last week could reshape the lab industry, as some labs would be hit harder than... more

Clinical OMICs

Proposed 2018 Medicare payment rates for clinical diagnostics, calculated under the Protecting Access to Medicare Act (PAMA), have drawn fire from laboratories processing the tests.

Cap Today

Under the Protecting Access to Medicare Act of 2014, Medicare rates for laboratory tests will be recalculated to reflect “market-based pricing” as reported by “applicable laboratories.” But are... more


The Centers for Medicare & Medicaid Services (CMS) soon will implement its new clinical laboratory fee schedule (CLFS) as part of the Protecting Access to Medicare Act, (PAMA) which mandates... more

Clinical OMICs

Clinical laboratories will learn later this year how much less Medicare will pay them for clinical diagnostic lab tests as a result of the Protecting Access to Medicare Act (PAMA). The... more

Dark Daily

In an interview with The Dark Report, XIFIN Inc. of San Diego, a revenue cycle management company for clinical labs, stated that the data being collected and sent to CMS by most labs will... more

Dark Daily

All hospital labs need to understand the negative financial impact to their labs and have a plan to absorb the fee cuts and remain clinically and financially viable. If you believe some experts,... more

Complimentary Dark Report Articles

XIFIN Analysis of Its Price Data Shows Hospital Lab Price Effect

Why Small Labs, Hospitals Are at Risk From PAMA Cuts

Complete the form below for instant access to both Dark Report articles.

Lâle White
Executive Chairman & CEO

XIFIN's Lâle White Speaks at Executive War College 2017

General Session Presentation:
Preparing for PAMA’s Part B Price Cuts: What XIFIN’s Impact Analysis Predicts for Labs Like Yours in 2018

Preparing for the Financial Impact of PAMA Market Price Reporting and New Developments with Medicare and Private Payers

Panel Details

Reduce and Minimize The PAMA Impact With XIFIN By Your Side

There has been growing concern about the implications of the new Protecting Access to Medicare Act (PAMA). The final PAMA rule was released June 2016 and will require laboratories and physician offices to begin reporting information on the payments they receive from private payers starting January 1, 2017. This regulation will transform Medicare's payment system for clinical laboratory testing while establishing new compliance demands.

XIFIN is here to help minimize the PAMA impact on your bottom line while empowering you in the ever-changing healthcare universe to comply with the new rules and succeed in the new reimbursement environment. 

XIFIN's Revenue Performance Management (RPM) solution is designed to meet the needs of today's margin challenged diagnostic environment. XIFIN RPM is powered by the health economics optimization (HEO) platform that meets the high-volume data and transaction needs of laboratories. Deliver optimized billing for maximized revenue with:

  • Unparalleled managed services
  • Automated workflows and business rules
  • Visibility into business intelligence
  • Managed medical claims filing to ensure upfront, clean claim submissions in the shortest possible time

XIFIN RPM is designed to help laboratories and diagnostic service providers succeed in the new paradigm by maximizing operational efficiencies, reimbursements, and revenue opportunities to satisfy regulatory requirements. Labs and diagnostic groups that have the XIFIN infrastructure and solutions in place will best position themselves for the future.


With XIFIN RPM, a true financial system, XIFIN clients have an enterprise-class data warehouse that can fulfill all their reporting needs—including PAMA—all at no extra charge. Be sure you have the technology infrastructure in place to assist with PAMA regulations and other reporting requirements. 

XIFIN clients are uniquely prepared to meet the reporting demands of PAMA. XIFIN RPM is more than a billing system; it's a financially structured, cloud-based, revenue cycle management solution that helps laboratories optimize their billing and collection practices and delivers full referential integrity and visibility. It enables laboratories to automate their accounts receivable workflow, manage medical claim filing, and reduce regulatory compliance risk. XIFIN uniquely understands laboratory data, which is reflected in the care that's been taken to preserve integrity, accuracy, auditability, and visibility at every step. Ensure accurate and timely PAMA reporting with XIFIN RPM.

Learn More


What is 'PAMA'?

PAMA stands for Protecting Access to Medicare Act of 2014 and was published by The White House Office of Management and Budget to modify the Medicare reimbursement rate methodology for lab services. The Final Rule was published on June 17, 2016.

Full details here,

How is PAMA related to the Clinical Laboratory Fee Schedule (CLFS)?

CMS created the CLFS to guarantee the new fee schedule continues to ensure adequate access to lab services for Medicare beneficiaries. But, the current Medicare Clinical Lab Fee Schedule (CLFS) payments are based on 1984 cost data and sometimes updated for inflation. There currently is a limited reconsideration process for new tests.

CMS is currently working on a new CLFS, but CMS made a decision to delay the implementation of the new payment system until January 1, 2018.

Does PAMA apply to me?

PAMA applies to an “applicable laboratory.” An applicable laboratory is a laboratory that receives a majority of its Medicare revenue under the CLFS, the Physician Fee Schedule (“PFS”), or the new section 1834A of the Social Security Act, as added by PAMA.  Those are:

Hospital Labs:

  • Inpatients
  • Outpatients
  • Non-Patients (“Outreach”)

Physician Office Labs:

  • Point of Care/Traditional Tests
  • Provider-Performed Microscopy
  • Pathologists’ Practices

Independent Labs:

  • Standard Tests
  • Drug Abuse Testing
  • Molecular Diagnostics

The Final Rule defines it as:

  • A laboratory, as defined in CLIA, that bills Medicare Part B under its own NPI
  • And receives the majority of its Medicare revenue from the PFS or CLFS
  • And receives more than $12,500 Medicare revenue from the CLFS in a year
  • The $12,500 threshold does not apply to a single laboratory that furnishes an ADLT (but does apply to any CDLTs that the laboratory performs)
What happens if I do not comply?

Submission accuracy will be the responsibility of senior official and penalties could be $10,000 a day per line item.

What role does CMS play in the PAMA regulation?

CMS is involved in the proposal to change payment rates which is linked to Congress passing the first major reform of the Clinical Laboratory Fee Schedule (CLFS) in April 2014─ § 216 of Protecting Access to Medicare Act of 2014 (PAMA).

CMS is needed to develop or clarify definitions of several key terms, determine when private payor rates must be reported and for what timeframe, build a technology platform capable of accepting millions of discrete pieces of data, and establish coding processes for certain new tests.

Why should I care about PAMA?

The PAMA legislation will have a substantial impact on the rates and transform Medicare's payment system for clinical laboratory testing while establishing significant new compliance demands. It also has the potential to impact other payors’ rates, as many private payors and state Medicaid programs base their reimbursement levels on Medicare rates.

Medicare rates for lab services are best determined when payment and volume data reflect true market rates for clinical lab testing.

What information do I need to submit?

PAMA requires laboratories to report private payor rates, excluding price concessions. Every rate paid by every payor for each test on a laboratory's test menu adds up to a lot of data. The applicable information required is:

  • Volume of tests paid at each private payor rate
  •  Include changes in rate during period – volume at rate 1, volume at rate 2

This data is required for each test on test menu, excluding unlisted / NOC codes/CPCS Code. In addition, the reporting entity executive (President, CEO, or CFO, or designee) must attest that data is accurate, complete, and truthful, and meet all the reporting parameters.

To report applicable information, reporting entities must:

    • Register in the Enterprise Identity Management system (EIDM)
    • Request a CLFS submitter or certifier role in the Fee-for-Service Data Collection System
    • The CLFS Submitter must be certified in PECOS as a User or Authorized User on the PECOS Medicare Enrollment forms (CLFS submitters must have their name appear within one of the following 855 application forms: A,B,C,I,R).
What do I need to do immediately? How can I prepare?

It's important to have a financial management system, specifically a revenue cycle management system, that gives you the ability to respond to these new reporting requirements. It will be very difficult to use manual spreadsheets. You need a system that can capture the following information and aggregate the data into timely buckets:

  • Date paid
  • Payor / payor type
  • Number of tests for each procedure code
  • Amount allowed – $ paid by insurer plus patient share of cost
  • Contractual rates, where applicable, including volume and other discounts

It is imperative to have a revenue cycle management system that can capture the necessary information, and that has been capturing the information for the capture/reporting periods.

Resources: Industry Webinars

To help you better understand the legislation and what will be required, Arnold & Porter and XIFIN have partnered to create a series of in-depth webinars, "Compliance with Final PAMA Rules" that help laboratories prepare to comply with the rules and succeed in the new reimbursement environment.

Part 1: Applicable Laboratories: Is Your Lab Required to Report?

CMS proposed to define an applicable laboratory so as to exclude many hospital laboratories and nearly all physician office laboratories. Will CMS change its policy and require more entities to submit private payer rates? Will median Medicare payment rates be more representative of the market as a result?

Part 2: Private Payer Data Reporting: What Information Must Be Reported, When, and How?

PAMA requires laboratories to report the rates paid by health plans in the commercial, Medicare and Medicaid markets, excluding price concessions. Every rate paid by every plan for each test on a laboratory’s test menu adds up to a lot of data. What are the immediate operational concerns for laboratories? How much time will they have to comply?

Part 3: Advanced Diagnostic Laboratory Tests: What Considerations for Launching a New Test?

PAMA gives special treatment to advanced diagnostic laboratory tests (ADLTs) including unique billing codes, Medicare payment at their list price at launch, and annual rate changes. CMS revised its definition of ADLT to include analyses of proteins, but to obtain ADLT status, tests must still provide new clinical information that can’t be gotten from other tests. What evidence will labs need to prove this, and what criteria will CMS use to evaluate it?