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Diagnostics: Other

CMS Grants CLIA Exemption to All State-Licensed Laboratories in Washington State

September 27, 2019

CMS grants CLIA exemption to Washington state laboratories.

The Latest from our Diagnostics Resource Center

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Diagnostics: Other

CMS Releases Full Agenda for June 24 CLFS Public Meeting

June 20, 2019

On June 20, CMS released the full agenda for the annual public CLFS meeting.

EXTERNAL LINK

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Diagnostics: Other

CMS Posts Agenda for June 24 CLFS Annual Public Meeting

June 07, 2019

On June 7, CMS posted the agenda for the annual public CLFS meeting.

POST

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GAO Finds Significant Medicare & Medicaid Overpayments in Laboratory and Other Services

Diagnostics

GAO Finds Significant Medicare & Medicaid Overpayments in Laboratory and Other Services

April 25, 2019

GAO releases report criticizing CMS’s oversight of its medical documentation requirements.

POST

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CMS Opens Registration for CLFS Public Meeting

Diagnostics: Payment Rates

CMS Opens Registration for CLFS Public Meeting

April 25, 2019

CMS has opened registration for the June 24, 2019 CLFS Public Meeting.

POST

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CMS Releases Codes Up for Review at the CLFS Public Meeting

Diagnostics: Payment Rates

CMS Releases Codes Up for Review at the CLFS Public Meeting

April 25, 2019

CMS has released its list of new and reconsidered Clinical Diagnostic Laboratory codes for review at the CY 2020 Lab Public Meeting.

POST

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CMS Releases List of New CLIA-Waived Tests

Diagnostics: Other

CMS Releases List of New CLIA-Waived Tests

April 16, 2019

CMS releases list of 12 new CLIA-waived tests

EXTERNAL LINK

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Diagnostics: Regulation

CMS Extends Comment Period on Proposed Changes to Proficiency Testing

April 04, 2019

The Centers for Medicare and Medicaid Services has extended the comment period on proposed changes to proficiency testing to June 4.

EXTERNAL LINK

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Diagnostics: PAMA

CMS Responds to Senator Grassley’s Inquiry on PAMA implementation

March 29, 2019

EXTERNAL LINK

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Diagnostics: Other

CMS Announces 2019 CLFS Public Meeting

March 29, 2019

The CLFS Public Meeting will be June 24, 2019 at CMS headquarters in Baltimore, MD.

POST

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Diagnostics: PAMA

Senator Grassley quizzes CMS about PAMA implementation

March 27, 2019

Here is the link to the inquiry.

EXTERNAL LINK

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CMS Releases MLN Article to Assist with Determining Applicable Laboratory Status

Diagnostics: Guidance

CMS Releases MLN Article to Assist with Determining Applicable Laboratory Status

March 04, 2019

CMS releases MLN Article on determining applicable laboratory status

EXTERNAL LINK

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Diagnostics: PAMA

CMS Releases Laboratory Data Collection FAQ

February 28, 2019

CMS has released a new set of frequently asked questions addressing lab data collection.

EXTERNAL LINK

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Diagnostics: Payment Rates

CMS Posts HCPCS Codes for Collecting/Reporting Applicable Lab Info

February 08, 2019

CMS posts HCPCS codes for collecting and reporting applicable lab information for the 2019 data collection period.

EXTERNAL LINK

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CMS Proposes Rule on Proficiency Testing

Diagnostics: Regulation

CMS Proposes Rule on Proficiency Testing

February 04, 2019

On February 4, 2019 CMS released the “Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance” proposed rule on.

POST

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CMS Holds Informational Call on PAMA Data Collection

Diagnostics: Guidance

CMS Holds Informational Call on PAMA Data Collection

January 24, 2019

CMS hosts informational Open Door Forum to discuss the 2019 PAMA Data Collection process and related requirements.

POST

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Diagnostics: Date of Service

CMS Extends Enforcement Discretion of “Date of Service” Rule

January 03, 2019

CMS extends enforcement discretion of “Date of Service” Rule until July 1, 2019.

EXTERNAL LINK

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CMS Publishes CLIA User Fee Update

Diagnostics: Guidance

CMS Publishes CLIA User Fee Update

January 02, 2019

On December 28, 2018 CMS published its CLIA User Fee Update.

EXTERNAL LINK

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CMS Releases CY 2019 CLFS Payment Rates

Diagnostics: Payment Rates

CMS Releases CY 2019 CLFS Payment Rates

December 17, 2018

CMS has released the final CY 2019 payment rates for clinical diagnostic services along with supporting instructional materials.

POST

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Diagnostics: Payment Rates

Medicare Laboratory Tests: Implementation of New Rates May Lead to Billions in Excess Payments

November 30, 2018

EXTERNAL LINK

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FDA Releases Draft Guidance and Announces Webinar on CLIA Waiver Applications

Diagnostics: Guidance

FDA Releases Draft Guidance and Announces Webinar on CLIA Waiver Applications

November 28, 2018

The FDA has updated and released two draft guidance documents that aim to help manufacturers of in vitro diagnostic devices apply for and receive CLIA waivers.

POST

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CMS Releases 2019 Preliminary CLFS Payment Determinations

Diagnostics: Payment Rates

CMS Releases 2019 Preliminary CLFS Payment Determinations

September 21, 2018

CMS releases CY 2019 preliminary recommendations for codes reviewed during summer the 2018 Lab Public Meeting.

EXTERNAL LINK

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Medicare Payments for Clinical Diagnostic Laboratory Tests in 2017: Year 4 of Baseline Data

Diagnostics: OIG

Medicare Payments for Clinical Diagnostic Laboratory Tests in 2017: Year 4 of Baseline Data

September 20, 2018

OIG releases the fourth in a series of data briefs looking at Medicare spending under the Clinical Laboratory Fee Schedule.

POST

CMS Finalizes Next Implementation Phase of Medicare Appropriate Use Criteria Program for Advanced Diagnostic Imaging Services

Insight: original analysis

CMS Finalizes Next Implementation Phase of Medicare Appropriate Use Criteria Program for Advanced Diagnostic Imaging Services

July 26, 2018

Beginning January 1, 2020, when submitting claims to Medicare for advanced diagnostic imaging services furnishing professionals and entities must certify that professionals ordering services consulted AUC applicable to the imaging modality

ORIGINAL ANALYSIS

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Diagnostics: Date of Service

Laboratory Test Codes Subject to Date of Service Exception (Updated 6/25/18)

July 19, 2018

EXTERNAL LINK

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CMS Announces Period of Enforcement Discretion on Date of Service Rule

Diagnostics: Date of Service , Original Analysis

CMS Announces Period of Enforcement Discretion on Date of Service Rule

July 09, 2018

EXTERNAL LINK

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Diagnostics: Payment Rates

CMS Posts Preliminary Gapfill Pricing Determinations

June 21, 2018

CMS Posts Preliminary Gapfill Pricing Determinations

EXTERNAL LINK

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Diagnostics: Regulation

Frequently Asked Questions, CMS 1621 F, Medicare Program

May 14, 2018

Frequently Asked Questions, CMS 1621 F, Medicare Program – Medicare Clinical Diagnostic Laboratory Tests Payment System, Final Rule.

PDF DOWNLOAD

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Diagnostics: Guidance

CMS releases April CLFS pricing file

April 05, 2018

EXTERNAL LINK

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Diagnostics: Payment Rates

CMS releases list of lab codes for review at Annual CLFS Public Meeting

April 02, 2018

PDF DOWNLOAD

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CMS announces meeting of Advisory Panel on Clinical Diagnostic Tests

Diagnostics: Payment Rates

CMS announces meeting of Advisory Panel on Clinical Diagnostic Tests

March 29, 2018

PDF DOWNLOAD

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CMS announces Annual CLFS Public Meeting, June 25, 2018

Diagnostics: Payment Rates

CMS announces Annual CLFS Public Meeting, June 25, 2018

March 29, 2018

PDF DOWNLOAD

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Diagnostics: PAMA

Guidance for Laboratories on ADLTs

March 23, 2018

PDF DOWNLOAD

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CMS releases application for ADLT status

Diagnostics: PAMA

CMS releases application for ADLT status

March 23, 2018

PDF DOWNLOAD

Insight: original analysis

ACLA Files Lawsuit Challenging CMS Implementation of PAMA Section 216

December 12, 2017

ORIGINAL ANALYSIS

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Diagnostics: Litigation

ACLA Files Lawsuit Challenging CMS Implementation of PAMA Section 216

December 12, 2017

On Monday December 11, the American Clinical Laboratory Association (ACLA) filed a legal challenge to CMS’s implementation of the revised Clinical Laboratory Fee Schedule (CLFS) required under Section 216 of the Protecting Access to Medicare Act (PAMA) of 2014.

ORIGINAL ANALYSIS

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Diagnostics: Payment Rates

CMS Releases Final CY 2018 CLFS Payment Rates

November 22, 2017

Zip file available for download.

EXTERNAL LINK

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Diagnostics: Guidance

CMS Releases Final CY 2018 Crosswalk and Gapfill Determinations

November 22, 2017

PDF DOWNLOAD

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Diagnostics: PAMA

Unlisted procedure code data collection

November 01, 2017

PDF DOWNLOAD

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Diagnostics: Guidance

CMS instructs contractors to stop applying Automated Test Panel edits to claims effective January 1, 2018

October 20, 2017

PDF DOWNLOAD

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Diagnostics: Guidance

CMS Instruction to Contractors to Report Claims Data for “Not-OtherwiseClassified” Lab Codes

October 13, 2017

PDF DOWNLOAD

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Diagnostics: Guidance

OIG releases report on Medicare payments for Lab Tests

October 04, 2017

EXTERNAL LINK

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Diagnostics: Payment Rates

CMS releases Panel recommendations from September 25, 2017 meeting

September 29, 2017

PDF DOWNLOAD

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Diagnostics: Payment Rates

CMS Releases Preliminary PAMA Based Payment Rates

September 22, 2017

EXTERNAL LINK

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Diagnostics: Payment Rates , Regulation

CMS Releases Agenda for September 25 virtual meeting of Advisory Panel.

September 20, 2017

CMS Releases Agenda for September 25 virtual meeting of Advisory Panel.

PDF DOWNLOAD

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Diagnostics: Payment Rates

CMS Announces Virtual Meeting of CDLT Advisory Panel

September 13, 2017

PDF DOWNLOAD

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Diagnostics: Guidance

CMS solicitation of comments on 60 codes without reported data

August 08, 2017

PDF DOWNLOAD

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Diagnostics: Payment Rates

CLFS Public Meeting

June 15, 2017

PDF DOWNLOAD

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Diagnostics: Payment Rates

CDLT Advisory Panel Meeting

June 15, 2017

PDF DOWNLOAD

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Diagnostics: PAMA

CMS Announces Enforcement Discretion for PAMA Reporting Requirements

March 30, 2017

PDF DOWNLOAD

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Diagnostics: PAMA

Updated FAQs addressing determination of “applicable laboratory” status

March 01, 2017

Updated FAQs addressing determination of “applicable laboratory” status.

PDF DOWNLOAD

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Diagnostics: Payment Rates

CLFS User guide

January 09, 2017

PDF DOWNLOAD

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Diagnostics: PAMA

Additional Guidance for Clinical Laboratories as Data Reporting Begins

January 05, 2017

PDF DOWNLOAD

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Diagnostics: PAMA

Additional Support Materials from Data Reporting Call

November 23, 2016

EXTERNAL LINK

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Diagnostics: Payment Rates

CMS MLN Matters: FISS Implementation of the Restructured Clinical Lab Fee Schedule

November 18, 2016

PDF DOWNLOAD

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Diagnostics: Regulation

CMS instructs Medicare claims system maintainer to be ready for PAMA based CLFS

November 18, 2016

CMS instructs Medicare claims system maintainer to be ready for PAMA based CLFS.

POST

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Diagnostics

PUB 100-04 Medicare Claims Processing – FISS Implementation of the Restructured Clinical Lab Fee Schedule

November 08, 2016

PDF DOWNLOAD

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Diagnostics: Guidance

CMS Presentation on Data Reporting Required by PAMA

November 02, 2016

PDF DOWNLOAD

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Diagnostics: PAMA

CMS Hosting Conference Call on Data Reporting Required by PAMA

October 12, 2016

The Protecting Access to Medicare Act requires certain laboratories to submit payment data for certain clinical diagnostic laboratory tests to CMS by March 31, 2017.  CMS has promised labs that an online portal would be available to help them submit data and that CMS would provide assistance in helping labs understand their requirements.

ORIGINAL ANALYSIS

Insight: original analysis

CMS Releases Final 2016 Gapfill Lab Payment Rates, CY 2017 Preliminary Crosswalk and Gapfill Determinations

October 05, 2016

The final lab payment amounts for several well-established tests fall well below current Medicare pricing. Stakeholders have until October 30, 2016, to request reconsideration of these rates.

ORIGINAL ANALYSIS

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Diagnostics: Guidance

Changing How Medicare Pays for Clinical Diagnostic Laboratory Tests: An Update on CMS’s Progress (OEI-09-16-00100)

October 04, 2016

PDF DOWNLOAD

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Diagnostics: Guidance

Medicare Payments for Clinical Diagnostic Laboratory Tests in 2015: Year 2 of Baseline data (OEI-09-16-00040)

October 01, 2016

PDF DOWNLOAD

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Diagnostics: Payment Rates

CMS Released Preliminary Crosswalk and Gapfill determinations for CY 2017

September 30, 2016

PDF DOWNLOAD

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Diagnostics: PAMA

CMS Releases Final 2016 Gapfill Determinations

September 30, 2016

EXTERNAL LINK

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Diagnostics: PAMA

Fee-For-Service Data Collection System: Clinical Laboratory Fee Schedule Data Reporting Template

September 12, 2016

PDF DOWNLOAD

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Diagnostics: PAMA

CMS Releases Reporting Template for PAMA Data Reporting

September 12, 2016

CMS has released a reporting template to assist laboratories with fee-for-service data collection.

POST

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Diagnostics: PAMA

Guidance to Laboratories for Collecting and Reporting Data for the Private Payor Rate-Based Payment System

August 10, 2016

PDF DOWNLOAD

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Diagnostics: Guidance

Shape the CPT® Proprietary Lab Analyses Code Set

August 05, 2016

EXTERNAL LINK

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Diagnostics: PAMA

Codes subject to reporting during the first reporting period.

August 05, 2016

Codes subject to reporting during the first reporting period (January 1 – March 30, 2017) (File requires WinZIP to open).

EXTERNAL LINK

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Diagnostics: Payment Rates

September 12th Clinical Diagnostic Laboratory Test Advisory Panel Meeting

August 01, 2016

September 12th Clinical Diagnostic Laboratory Test Advisory Panel Meeting

POST

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Diagnostics: Regulation

CY 2017 Medicare OPPS – Proposed Rule (CMS-1656-P)

July 14, 2016

CMS discusses their proposed laboratory test packaging policy on page 45,628

PDF DOWNLOAD

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Diagnostics: Payment Rates

New and substantially revised test codes to be priced under the (nonPAMA) CLFS beginning January 1, 2017

July 08, 2016

EXTERNAL LINK

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Diagnostics: Regulation

Overview of CMS-1621-F: Medicare Clinical Diagnostic Laboratory Test Payment System Final Rule

July 06, 2016

PDF DOWNLOAD

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Diagnostics

+Dx Webinar: Examining the New Medicare Lab Payment System

June 23, 2016

ORIGINAL ANALYSIS

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Diagnostics: Regulation

Medicare Clinical Diagnostic Laboratory Tests Payment System – Final Rule (CMS-1621-F)

June 23, 2016

PDF DOWNLOAD

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Diagnostics: Payment Rates

Medicare Will Use Private Payor Prices to Set Payment Rates for Clinical Diagnostic Laboratory Tests Starting in 2018

June 17, 2016

EXTERNAL LINK

Insight: original analysis

CMS Finalizes Medicare Laboratory Payment Overhaul

June 03, 2016

Implementing modernization of Medicare payment for lab services

ORIGINAL ANALYSIS

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Diagnostics: Regulation

Diagnostic Tests and Laboratory Operations Hearing Rescheduled

October 26, 2015

E&C Hearing on “Examining the Regulation of Diagnostic Tests and Laboratory Operations” has been rescheduled to Tuesday, November 17, 2015

POST

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Diagnostics: Guidance

Clinical Laboratory Payment System

October 05, 2015

PDF DOWNLOAD

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Diagnostics: Regulation

Medicare Clinical Diagnostic Laboratory Tests Payment System – Proposed Rule (CMS-1621-P)

October 01, 2015

PDF DOWNLOAD

Insight: original analysis

CMS Releases Proposed Plan to Overhaul Medicare Laboratory Payment

September 30, 2015

ORIGINAL ANALYSIS

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Diagnostics: Regulation

Breaking: CMS Releases Anticipated PAMA 216 Regulations

September 25, 2015

The Centers for Medicare and Medicaid Services today posted the long-awaited proposed rule to implement section 216 of the Protecting Access to Medicare Act.

POST

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Diagnostics: Guidance

Medicare Payments for Clinical Laboratory Tests in 2014: Baseline Data

August 01, 2015

PDF DOWNLOAD

Insight: original analysis

Anticipated Framework for Regulatory Oversight of Laboratory Developed Tests

August 07, 2014

ORIGINAL ANALYSIS

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Diagnostics: Legislation

Protecting Access to Medicare Act (PL 113-93)

April 01, 2014

PDF DOWNLOAD

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Diagnostics: Guidance

Comparing Lab Test Payment Rates: Medicare Could Achieve Substantial Savings

June 05, 2013

PDF DOWNLOAD

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Diagnostics: Regulation

42 CFR 414 Subpart G: Medicare Program

October 01, 2011

PDF DOWNLOAD

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Diagnostics: Guidance

Report on Variation in the Clinical Laboratory Fee Schedule

July 05, 2009

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