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Dec 10, 2021: The PAMA cuts that were scheduled to go into effect on Jan 1, 2022 have been officially delayed until 2023. The PAMA reporting requirements that were scheduled for 2022 have also been delayed to 2023. The next data reporting period of January 1, 2023 through March 31, 2023, will be based on the original data collection period of January 1, 2019 through June 30, 2019.


Introduction of SALSA Seeks to Set Medicare Reimbursement Back on A Sustainable Path

New legislation called the Saving Access to Laboratory Service Act (SALSA) stands to make major permanent modifications to PAMA requirements related to determining the Medicare Clinical Laboratory Fee Schedule (CLFS) lab testing rates. There is hope that SALSA can get passed as part of the larger end-of-year Medicare spending package making it critical for lobbying efforts to happen now.

Key Provisions of SALSA:

CMS Required to Use Statistically Representative Samples

Requiring CMS to use a statistically representative sample of private payor rates from the laboratory market to determine clinical lab test rates. The maximal brewer selection method, as described in the June 2021 Medicare Payment Access Commission Report will be used to establish a statistically valid sample. Sampling would also reduce the reporting burden by requiring fewer laboratories to report.

ADLTs to Remain Under Current PAMA Requirements

Reporting on widely-available laboratory tests, defined as tests with reimbursement rates on the clinical lab fee schedule under $1,000 and offered by more than 100 laboratories. ADLTs are non-widely available tests and will remain under current PAMA requirements. An ADLT is a test only offered by a single lab.

Removal of the “Majority of Medicare Revenues” Definition

Removing the “Majority of Medicare Revenues” definition, which described applicable laboratories as laboratories that receive at least $12,500 in payments under this section during the first 6 months of the calendar year immediately preceding the applicable data collection period.

Time Between Data Collection Periods Changes

Increasing the length of time between data collection periods to four years (currently three years) with the first reporting period in 2026 on 2025 data.

Lower Annual Reduction Rate Cuts

Freezing the CLFS in 2023 and lowering the cap on annual reduction rate cuts to 2.5% in 2024 and to 5% in 2025 and each subsequent year.

CLFS Rates to Reflect the Market

Excluding Medicaid managed care rates and physically mailed remittances if these remittances do not exceed more than 10% of the lab’s claims, from required reporting. Changing the definition of “applicable information” required for reporting would help ensure the CLFS rates are more reflective of the market and ease the significant reporting burden.

Clinical Diagnostic Laboratory Test Rates Under PAMA Versus SALSA

2022 PAMA Reporting Requirements and Reimbursement Cuts Impacting Hospital and Independent Labs Delayed to 2023

PAMA reporting has once again been delayed; applicable laboratories (including hospital outreach laboratories) need to now plan for 2023 PAMA reporting requirements and payment cuts.

Between January 1, 2023 and March 31, 2023, applicable labs are required to report on data collected during January 1, 2019 and June 30, 2019. This data will be utilized to determine 2024 to 2026 CLFS rates. Data collection is scheduled to occur on a three-year cycle, however in 2020 the LAB Act delayed PAMA reporting to 2021, in 2021 the CARES Act delayed PAMA reporting until 2022, and in 2021 Congress voted for another one-year delay. 

While hospital-based outreach laboratories were impacted by the 10% CLFS cut between 2019 and 2020, the flawed definition of an applicable laboratory in the original legislation excluded most hospital laboratories from the 2017 round one data reporting requirement. 

Under the updated definition of an applicable laboratory, established in 2019, most hospital-based outreach laboratories will be required to report.

Updated Clinical Diagnostic Laboratory Test (CDLT) Rates Schedule

Year for CDLT Rates Based on Data Collection Period Based on Data Reporting Period Reduction Cap
2020 January 1, 2016 – June 30, 2016 January 1, 2017 – May 30, 2017 10%
2021 January 1, 2016 – June 30, 2016 January 1, 2017 – May 30, 2017 0.0%
2022 January 1, 2016 – June 30, 2016 January 1, 2017 – May 30, 2017 0.0%
2023 January 1, 2016 – June 30, 2016 January 1, 2017 – May 30, 2017 15%
2024 January 1, 2019 – June 30, 2019 January 1, 2023 – March 21, 2023 15%
2025 January 1, 2019 – June 30, 2019 January 1, 2023 – March 21, 2023 15%
2026 January 1, 2019 – June 30, 2019 January 1, 2023 – March 21, 2023 N/A


Buried in the Coronavirus Aid, Relief, and Economic Security (CARES) Act are provisions that affect how clinical laboratories will be paid by Medicare in the coming years:

CARES Act delays when applicable laboratories (including hospital outreach laboratories) must report private payor data for PAMA. Under the CARES Act, the next reporting period will be January 1, 2022 to March 31, 2022. This reporting period will be based on the original data collection period of January 1, 2019 through June 30, 2019.

Previously, up until the end of 2019, all applicable laboratories were required to collect this data from January 1, 2019, to June 30, 2019, and report the data to CMS during the period of January 1, 2020, to March 31, 2020. However, with Congress passing the Laboratory Access for Beneficiaries (LAB) Act as part of an end-of-year spending package at the end of 2019, PAMA reporting requirements were delayed for 1 year until January 1, 2021, to March 31, 2021.

The CARES Act passed in March 2020 further delays the reporting period by an additional year, until January 1, 2022, to March 31, 2022. This means that Medicare payment rates determined by data reported in 2017 will continue through December 31, 2022.

The CARES Act also delays the 15% further cuts dictated by PAMA, that were to become effective January 1, 2021. Medicare Clinical Laboratory Fee Schedule reimbursement amounts will not be further cut in 2021, but the 15% cuts will go into effect January 1, 2022. 

After the next data reporting period, there is a three-year data reporting cycle for CDLTs that are not ADLTs, (that is 2025, 2028, etc.). The statutory phase-in of payment reductions resulting from private payor rate implementation is extended, that is, through CY 2024. There is a 0.0 percent reduction for CY 2021, and payment may not be reduced by more than 15 percent for CYs 2022 through 2024.

See CMS MLN document dated September 24, 2020, for more information.

Visit the XIFIN COVID-19 Resource Center for more information on the CARES Act.

Lâle White
Executive Chairman & CEO

Ugly Truth about Payers and PAMA: XIFIN's Lâle White Speaks at Executive War College 2019

What Labs Can Expect and How to Respond
Executive War College         May 1, 2019

View Presentation


Under the final rule:

  • January 1, 2016 – June 30, 2016: Labs collected the private payor amounts and volumes for all their tests.
  • January 1, 2017 – May 30, 2017: Labs reported the private payor amounts and volumes to CMS.
  • Late Summer/Early Fall: CMS published the draft 2018 Medicare rates.
  • January 1, 2018 – December 31, 2020: New Medicare rates in effect. Rates are equal to the median weighted private payor’s rate (limited to a -10% year-over-year decline).
  • January 1, 2019 – June 30, 2019: Round 2 - Labs collect the private payor amounts and volumes for their tests.;>
  • January 1, 2023 – March 31, 2023: Labs will report the private payor amounts and volumes to CMS that was collected for period Jan-Jun 2019.
  • After the next data reporting period, there is a three-year data reporting cycle for CDLTs that are not ADLTs, (that is 2025, 2028, etc.)
  • The data collection and reporting periods will repeat every three years indefinitely.

Under the final rule:

  • January 1, 2016 – June 30, 2016: Labs collected the private payor amounts and volumes for all their tests.
  • January 1, 2017 – May 30, 2017: Labs reported the private payor amounts and volumes to CMS.
  • Late Summer/Early Fall: CMS published the draft 2018 Medicare rates.
  • January 1, 2018 – December 31, 2020: New Medicare rates in effect. Rates are equal to the median weighted private payor’s rate (limited to a -10% year-over-year decline).
  • January 1, 2019 – June 30, 2019: Round 2 - Labs collect the private payor amounts and volumes for their tests.;>
  • January 1, 20202022 – March 31, 20202022: Labs will report the private payor amounts and volumes to CMS that was collected for period Jan-Jun 2019.
  • January 1, 2021 – December 31, 2023: New Medicare rates go into effect. Rates are equal to the weighted median private payor’s rate (limited to a -15% year-over-year decline). After the next data reporting period, there is a three-year data reporting cycle for CDLTs that are not ADLTs, (that is 2025, 2028, etc.)
  • The data collection and reporting periods will repeat every three years indefinitely.

PAMA 2019 Strategies Moving Forward

Now that the next data collection and reporting round is underway, make sure your laboratory is ready

Get the Guide!

PAMA for Hospital Outreach - What You Need to Know and Do NOW

WEBINAR: Hospital Outreach Labs—PAMA Has Come to Your Door

PAMA for Hospital Outreach: What You Need to Know and Do NOW!

Hear from XIFIN's Executive Chairman and CEO, Lâle White and Financial Analyst, Craig Young in this complimentary webinar as they walk you through what you need to know to prepare, collect, and report.

Watch Now

'The post PAMA world is going to be one where laboratorians need to be directly involved with where their money is going and where it’s coming from. Revenue cycle management represents a key area that needs to be focused on if you’re going to sustain the laboratory business for the long term.'

Liana Romero, PhD, MBA, MT (ASCP)

Senior Director, Strategic Marketing and Clinical Affairs, Siemens Healthineers

XIFIN and PAMA—In the News

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Dark Report

There are positives and negatives for laboratories as CMS moves forward with PAMA price reporting.

Dark Report Starting in July 2019, to comply with PAMA, medical laboratories are expected to analyze their private payer price data to help ensure clean, complete, and accurate reporting by March 31, 2020
Dark Report

All clinical labs required to report their private payer lab test price data are now in the midst of collecting that data. One big change in PAMA reporting is that the federal Centers... more

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Dark Report Will clinical labs heed the lessons learned from the first PAMA private payer market price reporting cycle that CMS conducted in 2017?

 In the first year of new reduced Medicare prices...but smaller labs have been forced to cut services and sometimes staff.

G2 Intelligence

Compliance Perspectives: PAMA Pitfalls & Survival Strategies


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Blog Post: Congress Passes LAB Act; PAMA Reporting Delayed by One Year
Congress has officially passed the Laboratory Access for Beneficiaries Act, also known as the LAB Act. This bill delays the reporting of lab payment data required by PAMA (Protecting Access to Medicare Act) by one year.


Blog Post: Compliance is a Living Process: "Set it and Forget it" Can Lead to Trouble
Most of today's laboratories and diagnostic providers are running on even slimmer profit margins. This is due in great part to lower reimbursements resulting from the Protecting Access to Medicare Act (PAMA) clinical laboratory fee schedule (CLFS) that came into effect in early 2018.

Blog Post: Keys to Countering PAMA
The second round of PAMA cuts are projected to cut individual test payment rates by up to 15%. With this in mind, now is the time that labs should be looking to market trends and strategies in order to prosper.

Blog Post: PAMA’s Payment Impact & Strategies To Protect Your Lab's Revenue
Medicare's new pricing plan under the Protecting Access to Medicare Act (PAMA) is damaging to the bottom line for most clinical laboratories.

Blog Post: Understanding PAMA Changes and Managing its Effects
Recently, XIFIN, Inc. Executive Chairman and CEO Lâle White presented on recent PAMA pricing cuts, and the implications for laboratory billing.


Blog Post: PAMA Strategies Moving Forward

Moving forward in light of the impact of the Protecting Access to Medicare Act (PAMA) of 2014 requires laboratories to demonstrate fiscal acumen in terms of their contracting process and reimbursement due diligence.

Reduce and Minimize the PAMA Impact with XIFIN by Your Side

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 reporting requirements 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's powerful technology platform 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
  • Timely and actionable 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 other diagnostic service providers succeed in the new paradigm by maximizing operational efficiencies, reimbursements, and revenue opportunities while satisfying regulatory requirements. Having XIFIN RPM is your best path for success.


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 pre-PAMA Medicare Clinical Lab Fee Schedule (CLFS) payments were based on 1984 cost data and sometimes updated for inflation. A limited reconsideration process was in place for new tests. 

The hope for the new CLFS was that by performing a market-based pricing exercise, pricing could be brought up to date and in-line with current practices. 

Does PAMA pricing apply to me?

ALL Part B Medicare FFS lab billings are subject to pricing determined by PAMA, even if the laboratory was not required to participate in the reporting effort.

Does PAMA reporting apply to me?

PAMA reporting requirements apply to any “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?

With the new fee schedule in place and ongoing reporting obligations, it's more important than ever to have a financially grounded revenue cycle management system that gives you the necessary visibility and auditability. 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, XIFIN has partnered to create a series of in-depth webinars that help laboratories prepare to comply with the rules and succeed in the new reimbursement environment.

Medicare's PAMA-Based CLFS Payment Impact: Strategic Options to Protect Revenue

Listen to and arm yourself now with this webinar which has critical information on the current CLFS's impact to your lab; potential disruptors; and what actions to take to protect revenue and maximize reimbursement.

View On Demand

Medicare's Market-Based Payment Startup: Strategic Options & Compliance Red Flags for Labs

Listen to Laboratory Economics webinar "Medicare's Market-Based Payment Startup: Strategic Options & Compliance Red Flags for Labs" which discusses how the future structure of the lab market will be fundamentally altered by Medicare's new market-based payment system.

View On Demand

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

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

View On Demand

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

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 payor 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?

Industry Response

On November 17, 2017, CMS released its final ruling and new clinical laboratory fee schedule reimbursement rates, effective January 1, 2018. On December 11, ACLA filed a lawsuit against the Department of Health and Human Services (HHS), asking the US federal district court to stop HHS from implementing PAMA and halt newly issued lab test prices from going into effect in January until the agency aligns its interpretation of "applicable laboratory" with statutory language and congressional intent. In the lawsuit, ACLA alleged that more than 99.3% of hospitals were prohibited from reporting their market-rate data.

More than 20 other organizations have also urged CMS not to implement the new pricing. 

PAMA CLFS Reform As Implemented

PAMA changed the CLFS from a static fee schedule to a fee schedule based on the private market rates of Medicare lab providers. CMS, however, has implemented PAMA in an arbitrary way that ignores Congressional intent and threatens beneficiary access.

PAMA's Intent PAMA as CMS Implemented Detail
Market-based system CMS cherry-picked highest volume, lowest priced tests in market-place System neither follows private market make-up nor the Medicare market make-up
Data from all market segments Skewed data excluding market segments Over 99% of laboratories were prohibited from reporting, especially hospital labs
Predictable and sustainable Arbitrary and unsustainable Agency cherry-picked lowest pricing labs to report and arbitrarily applied regulations to the data set, resulting in unpredictable and unsustainably low reimbursement
Fair and accurate rate-setting Rate cuts 3-4x greater than government estimates Top 25 test cut by average of 32%, rural hospital labs cut by average of 28.5%
Medicare beneficiary access Beneficiary access threatened Vulnerable beneficiaries at greatest risk of losing access to laboratory services, including rural, nursing home and home health patients

Source: "National Update on Issues Affecting Laboratories" by Sharon West, ACLA at NYSCLA Conference in June 2018.

ADLT Status
Along with the new guidance, CMS published the actual form that labs are supposed to use when applying for ADLT status. Read this article for an overview and it will also point you to the instructions set out in the application.