PAMA (Protecting Access to Medicare Act) and SALSA (Saving Access to Laboratory Services Act)

Latest News

September 13, 2022
The following is a letter from 37 patient advocacy groups supporting SALSA. Click here to view letter.

September 8, 2022
NILA joined a total of 26 organizations in submitting a letter to Congress calling for passage of the bill this year.

June 22, 2022
NILA Applauds Introduction of the Saving Access to Lab Services Act

PAMA – Fact Sheet

Learn more about the effects of PAMA – NILA's PAMA Fact Sheet (pdf)


SALSA – URGENT Advocacy Needed

Learn more about the SALSA Act – NILA's SALSA Fact Sheet (pdf)
Talking points for NILA Members

We have prepared a new template email and instructions that you can use to write to your legislators.

Contact your House Representative and Senators and urge them to cosponsor SALSA and work with their colleagues to ensure SALSA is enacted before Congress adjourns in December 2022.

NILA Member Talking Points (pdf)

NILA members should continue to urgently advocate for the Saving Access to Laboratory Services Act (SALSA). SALSA is sponsored by both Democrat and Republican House and Senate members and would protect community and regional independent laboratories from extreme cuts to reimbursement scheduled for January of 2023. Congress must act on the legislation before the end of this year to ensure the next round of cuts do not go into effect.

For the long-term, SALSA would repair the flawed data reporting and rate setting methodology implemented by the Protecting Access to Medicare Act (PAMA), protecting laboratories from drastic cuts to Medicare's Clinical Laboratory Fee Schedule (CLFS) and creating a more sustainable reimbursement system for future years. NILA’s Washington Representatives are meeting with key Capitol Hill staffers who work for committees with jurisdiction over SALSA. There is little time left on the legislative calendar this year, and Congress must prioritize numerous competing priorities. It is essential that NILA Members make their voices heard on Capitol Hill and in your home states and district. NILA encourages all members to contact your House Representative and Senators and urge them to cosponsor SALSA and work with their colleagues to ensure SALSA is enacted before the end of the year.

Please take some time to call and/or email your U.S. House Representatives and U.S. Senators. If your legislators are hosting town halls at home during the recess (you can learn more on their websites), consider attending and explaining to them why the enactment of SALSA is critical to sustaining our country’s laboratory infrastructure. NILA has prepared talking points, and we ask that you share the results of your outreach with NILA at nila@nila-usa.org


On April 1, 2014, the Protecting Access to Medicare Act (PAMA) was signed into law. PAMA completely overhauls the Medicare Part B clinical laboratory fee schedule (CLFS). Under PAMA, many (but not all) clinical laboratories must report their private payor rates on a test-by-test basis along with associated test volumes. CMS will calculate "weighted medians" for each CLFS billing code from this data.

The weighted median became the new CLFS payment rates beginning 1/1/18. Reductions in laboratory reimbursement of up to 10% per year were implemented in 2018, 2019 and 2020. Many commonly performed tests were reduced by 30% over this period of time. Reductions of up to 15% per year in 2021 and 2022 were postponed by Congress, however a 15% reduction scheduled to take effect on January 1, 2023, is still in effect. NILA is continuing its efforts to persuade Congress to "fix" the PAMA legislation by modifying how the median payment rates are determined.

These significant reimbursement decreases may have extreme consequences for community laboratories, threatening their ability to provide services to the most vulnerable Medicare beneficiaries, including those in small and rural communities, and those who receive home health care or reside in assisted living or skilled nursing facilities.

PAMA – An Urgent Threat to Laboratory Infrastructure

NILA's PAMA Fact Sheet


Quick Links


Guidances (Subregulatory)

Data Reporting

Additional Guidance for Clinical Laboratories as Data Reporting Begins, MLN Matters® Number SE17002, January 4, 2017. View/download PDF

MLN’s Clinical Diagnostic Laboratory Test Payment System: Data Reporting Call, November 2, 2016. CMS officials explained how to report data and included a system demonstration of data submission and data certification of private payor rates. A link to the audio recording and written transcript of the call will be posted as soon as it is available. Visit page here.

Recording Template

Fee-For-Service Data Collection System: Clinical Laboratory Fee Schedule Data Reporting Template, MLN Matters® Number SE1620, Revised September 14, 2016. View/Download PDF.

Overview of CMS-1621-F

Overview of CMS-1621-F Medicare Clinical Diagnostic Laboratory Test Payment System Final Rule, July 6, 2016, MLN Connects National Provider Call. Slides (PDF) . Transcript (PDF) .

Billing Codes To Be Reported

HCPCS Codes for Collecting and Reporting Applicable Information for the January 1, 2016, through June 30, 2016, Data Collection Period. Download Excel file. Key to Medicare Status Indicators. View/Download PDF.

Collecting/Reporting Data - General Information

Medicare Part B Clinical Laboratory Fee Schedule -- Guidance to Laboratories for Collecting and Reporting Data for the Private Payor Rate Based Payment System, July 20, 2016. View/Download PDF.

  • This guidance was reprinted as an MLN Matters Special Edition Article on August 18, 2016. View/Download PDF.

 

Regulations

Final Rule

CMS Final Rule Implementing Section 216 of the Protecting Access to Medicare Act (PAMA) – Revises the Medicare Payment System for Clinical Diagnostic Laboratory Tests, published in the June 23, 2016, Federal Register. View/Download PDF.

Proposed Rule

Proposed PAMA Rule Published in the October 1, 2015, Federal Register. View/Download PDF.

 

Statute

Laboratory Provisions (Section 216)

Section 216 of the Protecting Access to Medicare Act (PAMA) - Changes to Medicare Part B Payments for Clinical Laboratory Services. View/Download PDF.

Entire Statute

The Protecting Access to Medicare Act (PAMA). View/Download PDF.

 

Frequently Asked Questions

FAQs

NILA's Questions and Answers Document Regarding the Final Regulations Implementing Section 216 of the Protecting Access to Medicare Act (PAMA). View/Download PDF.

 

Letters from Senators, Representatives Regarding PAMA

2018

36 Societies Forward Letter Asking Congress To Fix PAMA (8/2/18). View/download letter(PDF ).

2017

Rep. Raja Krishnamoorthi Letter to CMS Secretary Verma Regarding PAMA (12/29/17). View/download letter(PDF ).

Seven Senators Sign Letter to CMS Secretary Verma Regarding PAMA (12/22/17). View/download letter (PDF ).

Rep. Bill Pascrell, Jr., Letter to CMS Secretary Verma Regarding PAMA (11/9/17). View/download letter(PDF ).

Rep. Scott H. Peters Letter to CMS Secretary Verma Regarding PAMA (11/8/17). View/download letter(PDF ).

Eight Senators Sign Letter to CMS Secretary Verma Regarding PAMA (11/3/17). View/download letter (PDF ).

NILA Advocacy

2018

NILA Report Reveals PAMA’s Adverse Impact on Community, Regional Labs, and Patient Access. View/download NILA Report (PDF ); View/download NILA Press Release (PDF ).

2017

NILA signs on to October 6, 2017, letter to CMS Administrator Seema Verma urging suspension of proposed PAMA cuts. View/Download letter (PDF ).

NILA issues joint press release with POCTA, ACLA, and AdvaMedDx. View/Download PDF .

NILA Issues Press Release on Proposed 2018 Medicare CLFS Rates. View/download PDF .

NILA Comments – Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program (CMS-1676-P). View/download PDF .

NILA Comments – Medicare Program; Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs Request for Information (CMS-1678-P). View/download PDF .

NILA Comments – Advisory Panel Meeting on Clinical Diagnostic Laboratory Tests. View/download PDF .

NILA Joins with Other Major Organizations to Request a Meeting with Secretary Price Concerning PAMA Regulations. View/download PDF

2016

Press Release: NILA Applauds House Freedom Caucus Recommendation on Immediate Repeal of Medicare Lab Payment Reform Rule. View/download PDF

Statement on behalf of the National Independent Laboratory Association (NILA) to the PAMA Advisory Panel, September 12, 2016. View /Download PDF.

NILA Comments on Hospital Outpatient Prospective Payment System (HOPPS), September 6, 2016. View/Download PDF.

NILA Comments to Support Reconsideration for Final Payment Determinations for Toxicology Codes G0840, G0481, G0482, G0483. View/Download PDF.

2015 PAMA Advisory Panel Meeting on October 19, 2015. View/Download PDF.

November - NILA Comments on CLFS Proposed Payment System (PAMA Regs).View/Download PDF. .

May - Overview of PAMA – Presentation to the Executive War College.View/Download PDF.

2014

September - NILA Comments to CMS. View/Download PDF.

June - NILA Comments to CMS. View/Download PDF.

 

PAMA Advisory Panel Meetings

September 12, 2016 Public Meeting of the Advisory Panel on Clinical Diagnostic Laboratory Tests

Announcement of the Advisory Panel on Clinical Diagnostic Laboratory Tests Meeting. View/download PDF.

Agenda for the Advisory Panel on Clinical Diagnostic Laboratory Tests Meeting. View/download PDF.

Public Meeting of the Advisory Panel on Clinical Diagnostic Laboratory Tests YouTube Video (Morning Session – 2:40:25). View video here.

2016, Public Meeting of the Advisory Panel on Clinical Diagnostic Laboratory Tests YouTube Video (Afternoon Session 2:49:22). View video here.

July 19, 2016 Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests Advanced Diagnostic Laboratory Tests Subcommittee (ADLTSC) Meetings

Advanced Diagnostic Laboratory Tests Subcommittee Report. View/download PDF.

Subcommittee on Automated Profile Tests (ATP)/Disease Oriented Panels for the Medicare Advisory Committee on Clinical Diagnostic Laboratory Tests Report. View/download PDF.

July 18, 2016 Public Meeting Regarding New and Reconsidered Clinical Diagnostic Laboratory Test Codes for the Clinical Laboratory Fee Schedule for Calendar Year 2017 / Advisory Panel on Clinical Diagnostic Laboratory Tests

Announcement of the Advisory Panel on Clinical Diagnostic Laboratory Tests Meeting. View/download PDF.

Agenda for the Advisory Panel on Clinical Diagnostic Laboratory Tests Meeting. View/download PDF.

July 18, 2016, Clinical Laboratory Public Meeting YouTube Video (Morning Session – 3:29:10) NILA Testimony: 45:28 - 54:36. View video here.

July 18, 2016, Clinical Laboratory Public Meeting YouTube Video (Afternoon Session – 1:39:21) Panel Discussion: 1:43:42, Reporting of Vote: 2:13:00. View video here.

October 19, 2015 Advisory Panel on Clinical Diagnostic Laboratory Tests Meeting

Announcement of the Advisory Panel on Clinical Diagnostic Laboratory Tests Meeting. View/download PDF.

Agenda for the Advisory Panel on Clinical Diagnostic Laboratory Tests Meeting. View/download PDF.

Recommendations from the Clinical Diagnostic Laboratory Test Panel Meeting. View/download PDF.

October 19, 2015, Public Meeting of the Advisory Panel on Clinical Diagnostic Laboratory Tests Meeting, YouTube Video (Morning Session – 3:30:34). View video here.

October 19, 2015, Public Meeting of the Advisory Panel on Clinical Diagnostic Laboratory Tests Meeting, YouTube Video (Afternoon Session – 11:55:00). View video here.

August 26, 2015 Advisory Panel on Clinical Diagnostic Laboratory Tests Meeting

Membership and Public Meeting Announcement for the Advisory Panel on Clinical Diagnostic Laboratory Tests. View/download PDF.

Agenda for the Advisory Panel on Clinical Diagnostic Laboratory Tests Meeting. View/download PDF.

Recommendations from the Clinical Diagnostic Laboratory Test Panel Meeting. View/download PDF.

 

OIG Progress Reports

2016

OIG Releases Reports on Medicare Payments for Lab Tests in 2015; Update on CMS’s Progress on Changing How Medicare Pays for Lab Tests. Visit page here.

Historical Record of the PAMA Legislation

  • Introduced in the House as "H.R. 4302" by Joe Pitts (R-PA) on March 26, 2014
  • Passed the House on March 27, 2014 (Voice Vote)
  • Passed the Senate on March 31, 2014 (Roll Call Vote 93: 64 Yea - 35 Nay )
  • Signed into law by President Barack Obama on April 1, 2014
  • Proposed PAMA Regulations Published in the Federal Register on October 1, 2015
  • Final PAMA Regulations Published in Federal Register on June 23, 2016
  • Charter for the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests