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American Clinical Laboratory Association

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uuid000bfu6

Namestring
American Clinical Laboratory Association
Legal namestring
American Clinical Laboratory Association
Websiteurl
acla.com
Company typeenum
Private
Founded yearint
1971
Operating statusenum
Operating
Ownership categoryenum
Headcount rangeband
1–10
akta.pro rankint
HeadquartersWashington, United States
HQ citystring
Washington
HQ countrystring
United States
HQ regionstring
North America
Markets served

Serves global market

Offices1 record

Each record includes

City, Country, Type, Description, Source

Keyword5 values
clinical laboratory advocacy, trade association services, healthcare policy advocacy, Medicare reimbursement reform, laboratory industry representation
NAICS code1 code
  • Business Associations813910
SIC code1 code
  • Services-Membership Organizations8600
Product category
Healthcare Trade Association Services
Revenue model1 record
1Membership Dues
TypeSubscription Recurring
Description

ACLA generates revenue through membership dues based on annual revenue. Membership eligibility requires clinical laboratory facilities certified by CLIA and accredited by the College of American Pathologists. Membership includes representation before legislative and regulatory bodies, participation in active committees, weekly conference calls, and meetings with key policymakers.

acla.com
Marketing channels6 records

Each record includes

Title, Type, Stage, Description, Source

Distribution channels1 record

Each record includes

Title, Type, Scope, Target buyer, Description, Source

Cost components5 values
Personnel, Operations, Marketing or Sales, Others, Technology or R&D
Pricing details1 tier
1Membership dues based on annual revenue
ModelSubscriptionBilling cadenceAnnual
Notes

Fee schedule determined by Board of Directors. Revenue-based tiering structure.

acla.com
GTM typeB2B
B2B
Offering typeServices
Services
Core offering1 text field

American Clinical Laboratory Association (ACLA) is a national trade association that represents leading national, regional, and local clinical laboratories through policy advocacy before Congress, federal and state regulatory bodies, and other healthcare organizations. Its core deliverables include direct representation in PAMA/Medicare payment reform, regulatory advocacy (e.g., Laboratory Developed Tests), active member committees, weekly policy briefings, and engagement programs such as the Annual Membership Meeting.

Differentiator
Functional benefit
Problem solved
Quantifiable outcome1 of 3 values shown
  • Six in ten adults in the U.S. living with a chronic disease require routine monitoring supported by clinical laboratory tests
+2 more records
Product overview1 text field

American Clinical Laboratory Association (ACLA) is a national trade association representing clinical laboratories, not a product company. It provides advocacy services, policy reform initiatives (including PAMA reform and the RESULTS Act), publishes resources and research on clinical laboratory value, and organizes events such as annual meetings for its member organizations. ACLA does not offer commercial products or services in the traditional sense.

Product and service3 records
1Clinical Laboratory Membership
CategoryMembership / Advocacy
Description

Subscription membership for clinical laboratories providing representation before federal and state legislative and regulatory bodies, active committee participation (government reimbursement, state issues, CPT coding, legal, environmental/laboratory issues), weekly conference calls, and meetings with key policymakers. Available to CLIA-certified, CAP-accredited laboratories.

2Associate Membership
CategoryMembership / Advocacy
Description

Membership offering for manufacturers of diagnostic tests and technologies, pharmaceutical manufacturers, and professional service firms that support the laboratory industry, providing advocacy engagement and policy participation.

3ACLA Annual Membership Meeting
CategoryEvents / Conferences
Description

Annual membership event delivering policy briefings, panel discussions with congressional staff, payers (BCBSA, AHIP), CMS, FDA, and AMA representatives, and networking across the clinical laboratory industry.

Scale indicator6 records

Each record includes

Type, Value, Description, Source

Partnership14 partners
Strategic tierCoreTypeStrategic or Co-development PartnerAnnounced on2026-01-01
Description

60+ patient and provider organizations have endorsed the RESULTS Act to protect patient access to clinical laboratory testing. These organizations represent millions of Americans and work with ACLA on legislative advocacy efforts.

Strategic tierCoreTypeStrategic or Co-development Partner
Description

Partnered on state-level biomarker legislation advocacy efforts that have led to the passage of groundbreaking biomarker laws in 20 states requiring Medicaid and private insurers to cover biomarker testing.

Strategic tierMinorTypeStrategic or Co-development Partner
Description

Political experts Amy Walter and David Wasserman provided perspectives on political trends, midterm election forecasts, and health care policy debates at the 2026 ACLA Annual Meeting.

Strategic tierCoreTypeStrategic or Co-development Partner
Description

Barb Liwosz, Director of Laboratory and Precision Medicine, discussed evolving payer strategies related to prior authorization, coverage policy, and laboratory reimbursement at the 2026 Annual Meeting.

Strategic tierCoreTypeStrategic or Co-development Partner
Description

Kate Berry, Senior Vice President, outlined AHIP's work in advocacy, policy, and education including a collaborative initiative with Blue Cross Blue Shield and other insurers to streamline prior authorization.

Strategic tierCoreTypeStrategic or Co-development Partner
Description

Paul Sheives, Vice President of Government Affairs at Myriad Genetics, co-presented on state-level advances in biomarker legislation with the American Cancer Society Cancer Action Network.

Strategic tierCoreTypeStrategic or Co-development Partner
Description

Sarah Harding, Health Insurance Specialist at CMS, discussed Clinical Laboratory Fee Schedule payment policy and upcoming requirements for laboratories to report commercial market data.

Strategic tierCoreTypeStrategic or Co-development Partner
Description

Zach Hochstetler, Vice President of CPT Coding and Payment at AMA, discussed processes that influence Clinical Laboratory Fee Schedule payment policy and coding decisions.

9U.S. Senate Finance Committee and House Energy and Commerce Committee
Strategic tierCoreTypeStrategic or Co-development Partner
Description

Senior bipartisan health staff from key Senate and House committees discussed health policy priorities for the 119th Congress, including foundational PAMA reform at the 2026 ACLA Annual Meeting.

acla.com
Strategic tierCoreTypeImplementation/ SI/ Consulting Partner
Description

Jane Lucas, former White House Counsel official and current Partner at Alston & Bird, discussed the federal health policy environment. Joyce Gresko, Partner and ACLA's General Counsel, moderated payer perspectives panel. Lori Denham and Mark Rayder provided legislative analysis.

11The Hargan Group
Strategic tierMinorTypeImplementation/ SI/ Consulting Partner
Description

Eric Hargan, former Deputy Secretary of HHS during the first Trump Administration and current CEO of The Hargan Group, discussed the Administration's approaches to health policy with Jane Lucas.

acla.com
Strategic tierCoreTypeImplementation/ SI/ Consulting Partner
Description

Amy Leiser, Special Counsel at Covington & Burling, discussed the future of regulation following the landmark ACLA v. FDA decision that vacated the FDA's LDT final rule.

Strategic tierCoreTypeStrategic or Co-development Partner
Description

Dr. Elias Zerhouni, former Director of the National Institutes of Health and current President of OPKO Health, discussed leadership, innovation, and the future of biomedical research at the 2026 Annual Meeting.

Strategic tierCoreTypeStrategic or Co-development Partner
Description

Dr. William Morice, Board Chair of ACLA and President and CEO of Mayo Clinic Laboratories, led AI policy discussions and highlighted the ACLA Innovation Advisory Forum's work.

Recent move6 records

Each record includes

Date, Type, Title, Description, Source

Expansion highlight6 records

Each record includes

Type, Description

Peers10 records
TypeBroad incumbent
Description

BIO represents the broader biotechnology industry and engages on regulatory, reimbursement, and innovation policy relevant to clinical laboratory diagnostics and precision medicine—competitively adjacent to ACLA's advocacy remit.

TypeBroad incumbent
Description

AMA represents physicians and operates the CPT coding process that underpins Clinical Laboratory Fee Schedule payment policy; ACLA and AMA overlap directly on coding and reimbursement advocacy through ACLA's CPT Committee.

TypeEmerging player
Description

ASM represents microbiologists and infectious disease laboratory professionals, engaging on laboratory practice and public health preparedness themes that align with ACLA's clinical laboratory and pandemic-response advocacy.

TypeBroad incumbent
Description

AdvaMed represents medical device and diagnostics manufacturers and overlaps with ACLA on diagnostic test regulation, LDT policy, and Medicare coverage—working both alongside and at times at arm's length from ACLA on shared issues.

TypeBroad incumbent
Description

AHA is the national trade association for hospitals and health systems and engages on Medicare reimbursement, regulatory, and public health preparedness policies that parallel ACLA's federal advocacy interests.

TypeBroad incumbent
Description

PhRMA represents biopharmaceutical manufacturers and works the same federal advocacy channels on Medicare, FDA regulation, and reimbursement frameworks that ACLA engages, with diagnostic-pharma convergence on personalized medicine.

TypeOthers
Description

CAP is the accreditation body whose CAP accreditation status, alongside CLIA certification, governs ACLA member eligibility. It engages on laboratory standards, inspection, and pathology practice policy complementary to ACLA's advocacy.

TypeDirect peer
Description

ASCP represents board-certified pathologists and laboratory professionals and engages on workforce, certification, and laboratory policy issues that directly intersect ACLA's advocacy mission for clinical laboratories.

TypeDirect peer
Description

ADLM is a scientific and medical professional society for clinical laboratory medicine, with overlapping focus on laboratory practice standards, reimbursement, and regulatory advocacy for the clinical laboratory community served by ACLA.

10National Independent Laboratory Association (NILA)
TypeDirect peer
Description

NILA represents independent and regional community clinical laboratories and pursues the same PAMA, CLFS, and LDT regulatory advocacy as ACLA, often with shared member companies and overlapping policy coalitions.

Market position
Strengths5 records

Each record includes

Headline, Details, Source

Weaknesses5 records

Each record includes

Headline, Details, Source

Competitive moat5 records

Each record includes

Type, Details

Key risks5 records

Each record includes

Headline, Details, Source

Key highlights7 records

Each record includes

Headline, Details, Source

Customer concentration

Classification, Details

Named customers1 record

Each record includes

Name, Industry, Type, Use case, Source, UUID

Segment2 records

Each record includes

Title, Type, Primary, Description, Pain point addressed, Use case, Source

Ideal customer profile2 records

Each record includes

Profile, Firmographic size, Sales motion, Sales cycle length, Buying structure, Purchase trigger, Buyer persona, Geography, Industry vertical, Primary use case, Description, Pain points, Evidence proof points, Target buyer

Technology focused
No
API detail
Has APIbool
No

Docs URL, Description

AI maturity
App detail

Has app

Core technology
Revenue estimate
Valuation estimate
Number of profiles
Profiles6 records

Each record includes

Name, Designation, Designation category, Overview, Profile commentary, Source

No data
No data
Funding overview

Funding stage, Last funding date, Total funding USD

Funding rounds

Each record includes

Round, Amount USD, Date, Pre money valuation, Total investors, Investors, News

Investors

Each record includes

Name, Type, Date of entry, Rounds participated, Website

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Each record includes

Name, Acquisition type, Announced date, Completed date, Status, Website, News

Investment

Each record includes

Name, Round, Announced date, Lead investor, Website, News

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

American Clinical Laboratory Association

Healthcare Trade Association Servicesacla.com

American Clinical Laboratory Association firmographics

Firmographics
Name
American Clinical Laboratory Association
Legal name
American Clinical Laboratory Association
Website
https://acla.com
Company type
Private
Founded year
1971
Operating status
Operating
Headcount range
1–10 employees
Ownership category
akta.pro rank

Where American Clinical Laboratory Association is headquartered

Location

Headquarters

HQ city
Washington
HQ country
United States
HQ region
North America

Offices1 record

Markets served

American Clinical Laboratory Association business model

Business model
GTM type
B2B
Offering type
Services
Cost components
Personnel, Operations, Marketing or Sales, Others, Technology or R&D

Revenue model

  1. Membership Dues: ACLA generates revenue through membership dues based on annual revenue. Membership eligibility requires clinical laboratory facilities certified by CLIA and accredited by the College of American Pathologists. Membership includes representation before legislative and regulatory bodies, participation in active committees, weekly conference calls, and meetings with key policymakers.

Pricing tiers

ModelBillingPrice
SubscriptionAnnualMembership dues based on annual revenue

Distribution channels1 record

Marketing channels6 records

American Clinical Laboratory Association product offering

Product offering

Core offering

American Clinical Laboratory Association (ACLA) is a national trade association that represents leading national, regional, and local clinical laboratories through policy advocacy before Congress, federal and state regulatory bodies, and other healthcare organizations. Its core deliverables include direct representation in PAMA/Medicare payment reform, regulatory advocacy (e.g., Laboratory Developed Tests), active member committees, weekly policy briefings, and engagement programs such as the Annual Membership Meeting.

Product overview

American Clinical Laboratory Association (ACLA) is a national trade association representing clinical laboratories, not a product company. It provides advocacy services, policy reform initiatives (including PAMA reform and the RESULTS Act), publishes resources and research on clinical laboratory value, and organizes events such as annual meetings for its member organizations. ACLA does not offer commercial products or services in the traditional sense.

Differentiator

Problem solved

Functional benefit

Products and services

  • Clinical Laboratory Membership Subscription membership for clinical laboratories providing representation before federal and state legislative and regulatory bodies, active committee participation (government reimbursement, state issues, CPT coding, legal, environmental/laboratory issues), weekly conference calls, and meetings with key policymakers. Available to CLIA-certified, CAP-accredited laboratories.
  • Associate Membership Membership offering for manufacturers of diagnostic tests and technologies, pharmaceutical manufacturers, and professional service firms that support the laboratory industry, providing advocacy engagement and policy participation.
  • ACLA Annual Membership Meeting Annual membership event delivering policy briefings, panel discussions with congressional staff, payers (BCBSA, AHIP), CMS, FDA, and AMA representatives, and networking across the clinical laboratory industry.

Quantifiable outcome

  • Six in ten adults in the U.S. living with a chronic disease require routine monitoring supported by clinical laboratory tests
  • +2 more outcomes

Companies that use American Clinical Laboratory Association

Customer profile

Named customers1 record

Segments2 records

Ideal customer profiles2 records

American Clinical Laboratory Association technology and API

Technology

Technology focussed No

API detail

Has API
No
API docs
API detail

Core technology

AI maturity

App detail

American Clinical Laboratory Association partnerships and signals

Strategic signal

Partnerships

14 partnerships are on record, tiered core and minor.

  • Patient and Provider OrganizationscoreStrategic or Co-development Partner · 1 January 202660+ patient and provider organizations have endorsed the RESULTS Act to protect patient access to clinical laboratory testing. These organizations represent millions of Americans and work with ACLA on legislative advocacy efforts.
  • American Cancer Society Cancer Action NetworkcoreStrategic or Co-development PartnerPartnered on state-level biomarker legislation advocacy efforts that have led to the passage of groundbreaking biomarker laws in 20 states requiring Medicaid and private insurers to cover biomarker testing.
  • The Cook Political Report with Amy WalterminorStrategic or Co-development PartnerPolitical experts Amy Walter and David Wasserman provided perspectives on political trends, midterm election forecasts, and health care policy debates at the 2026 ACLA Annual Meeting.
  • Blue Cross Blue Shield AssociationcoreStrategic or Co-development PartnerBarb Liwosz, Director of Laboratory and Precision Medicine, discussed evolving payer strategies related to prior authorization, coverage policy, and laboratory reimbursement at the 2026 Annual Meeting.
  • America's Health Insurance Plans (AHIP)coreStrategic or Co-development PartnerKate Berry, Senior Vice President, outlined AHIP's work in advocacy, policy, and education including a collaborative initiative with Blue Cross Blue Shield and other insurers to streamline prior authorization.
  • Myriad GeneticscoreStrategic or Co-development PartnerPaul Sheives, Vice President of Government Affairs at Myriad Genetics, co-presented on state-level advances in biomarker legislation with the American Cancer Society Cancer Action Network.
  • Centers for Medicare & Medicaid Services (CMS)coreStrategic or Co-development PartnerSarah Harding, Health Insurance Specialist at CMS, discussed Clinical Laboratory Fee Schedule payment policy and upcoming requirements for laboratories to report commercial market data.
  • American Medical Association (AMA)coreStrategic or Co-development PartnerZach Hochstetler, Vice President of CPT Coding and Payment at AMA, discussed processes that influence Clinical Laboratory Fee Schedule payment policy and coding decisions.
  • U.S. Senate Finance Committee and House Energy and Commerce CommitteecoreStrategic or Co-development PartnerSenior bipartisan health staff from key Senate and House committees discussed health policy priorities for the 119th Congress, including foundational PAMA reform at the 2026 ACLA Annual Meeting.
  • Alston & Bird LLPcoreImplementation/ SI/ Consulting PartnerJane Lucas, former White House Counsel official and current Partner at Alston & Bird, discussed the federal health policy environment. Joyce Gresko, Partner and ACLA's General Counsel, moderated payer perspectives panel. Lori Denham and Mark Rayder provided legislative analysis.
  • The Hargan GroupminorImplementation/ SI/ Consulting PartnerEric Hargan, former Deputy Secretary of HHS during the first Trump Administration and current CEO of The Hargan Group, discussed the Administration's approaches to health policy with Jane Lucas.
  • Covington & Burling LLPcoreImplementation/ SI/ Consulting PartnerAmy Leiser, Special Counsel at Covington & Burling, discussed the future of regulation following the landmark ACLA v. FDA decision that vacated the FDA's LDT final rule.
  • OPKO HealthcoreStrategic or Co-development PartnerDr. Elias Zerhouni, former Director of the National Institutes of Health and current President of OPKO Health, discussed leadership, innovation, and the future of biomedical research at the 2026 Annual Meeting.
  • Mayo Clinic LaboratoriescoreStrategic or Co-development PartnerDr. William Morice, Board Chair of ACLA and President and CEO of Mayo Clinic Laboratories, led AI policy discussions and highlighted the ACLA Innovation Advisory Forum's work.

Scale indicators6 records

Recent moves6 records

Expansion highlights6 records

American Clinical Laboratory Association competitors and assessment

Company assessment

Broad incumbents

  • Biotechnology Innovation Organization (BIO): BIO represents the broader biotechnology industry and engages on regulatory, reimbursement, and innovation policy relevant to clinical laboratory diagnostics and precision medicine—competitively adjacent to ACLA's advocacy remit.
  • American Medical Association (AMA): AMA represents physicians and operates the CPT coding process that underpins Clinical Laboratory Fee Schedule payment policy; ACLA and AMA overlap directly on coding and reimbursement advocacy through ACLA's CPT Committee.
  • AdvaMed (Advanced Medical Technology Association): AdvaMed represents medical device and diagnostics manufacturers and overlaps with ACLA on diagnostic test regulation, LDT policy, and Medicare coverage—working both alongside and at times at arm's length from ACLA on shared issues.
  • American Hospital Association (AHA): AHA is the national trade association for hospitals and health systems and engages on Medicare reimbursement, regulatory, and public health preparedness policies that parallel ACLA's federal advocacy interests.
  • Pharmaceutical Research and Manufacturers of America (PhRMA): PhRMA represents biopharmaceutical manufacturers and works the same federal advocacy channels on Medicare, FDA regulation, and reimbursement frameworks that ACLA engages, with diagnostic-pharma convergence on personalized medicine.

Emerging players

  • American Society for Microbiology (ASM): ASM represents microbiologists and infectious disease laboratory professionals, engaging on laboratory practice and public health preparedness themes that align with ACLA's clinical laboratory and pandemic-response advocacy.

Others

  • College of American Pathologists (CAP): CAP is the accreditation body whose CAP accreditation status, alongside CLIA certification, governs ACLA member eligibility. It engages on laboratory standards, inspection, and pathology practice policy complementary to ACLA's advocacy.

Direct peers

  • American Society for Clinical Pathology (ASCP): ASCP represents board-certified pathologists and laboratory professionals and engages on workforce, certification, and laboratory policy issues that directly intersect ACLA's advocacy mission for clinical laboratories.
  • Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC): ADLM is a scientific and medical professional society for clinical laboratory medicine, with overlapping focus on laboratory practice standards, reimbursement, and regulatory advocacy for the clinical laboratory community served by ACLA.
  • National Independent Laboratory Association (NILA): NILA represents independent and regional community clinical laboratories and pursues the same PAMA, CLFS, and LDT regulatory advocacy as ACLA, often with shared member companies and overlapping policy coalitions.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

American Clinical Laboratory Association social profiles

Digital presence

American Clinical Laboratory Association financial estimates

Financial estimate

Revenue estimate

Valuation estimate

American Clinical Laboratory Association leadership team

Management profile

Number of profiles

Profiles6 records

American Clinical Laboratory Association funding detail

Funding detail

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

American Clinical Laboratory Association M&A and investment

M&A and investment

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about American Clinical Laboratory Association

What does American Clinical Laboratory Association do?

American Clinical Laboratory Association (ACLA) is a national trade association that represents leading national, regional, and local clinical laboratories through policy advocacy before Congress, federal and state regulatory bodies, and other healthcare organizations. Its core deliverables include direct representation in PAMA/Medicare payment reform, regulatory advocacy (e.g., Laboratory Developed Tests), active member committees, weekly policy briefings, and engagement programs such as the Annual Membership Meeting.

Is American Clinical Laboratory Association a public or private company?

American Clinical Laboratory Association is a private company. It is classified as nonprofit foundation owned and is currently operating.

When was American Clinical Laboratory Association founded?

American Clinical Laboratory Association was founded in 1971. It employs 1 to 10 people.

Where is American Clinical Laboratory Association based?

American Clinical Laboratory Association is headquartered in Washington, United States, in the North America region.

How does American Clinical Laboratory Association make money?

One revenue line is on record: membership Dues.

Who are American Clinical Laboratory Association's main competitors?

Broad incumbents on record are Biotechnology Innovation Organization (BIO), American Medical Association (AMA), AdvaMed (Advanced Medical Technology Association), American Hospital Association (AHA) and Pharmaceutical Research and Manufacturers of America (PhRMA). American Society for Microbiology (ASM) is listed as an emerging player. College of American Pathologists (CAP) is listed as an others. Direct peers are American Society for Clinical Pathology (ASCP), Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) and National Independent Laboratory Association (NILA).

Does American Clinical Laboratory Association have an API?

No public API is recorded for American Clinical Laboratory Association.

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Live signals
Healthcare DiveTrump administration sets preliminary cuts to Medicare lab reimbursement ratesCMS posted preliminary Medicare lab reimbursement rates, cutting payments by up to 15% in 2027. The cuts would save $1 billion annually, but the American Clinical Laboratory Association warned they threaten patient access and innovation. Final 2027 rates are expected in November.JamanetworkPublic Health Implications of Legal Challenges to the FDA’s Regulation of Laboratory-Developed TestsA US District Court vacated the FDA's 2024 regulations on laboratory-developed tests (LDTs) in March 2025, ruling that the agency lacked statutory authority to regulate these diagnostics as medical devices. The decision, brought by the American Clinical Laboratory Association and the Association of Molecular Pathology, asserts that LDTs are services overseen by CMS under CLIA standards rather than products requiring FDA premarket review. This ruling removes a key layer of federal oversight for LDTs, potentially impacting public health safety and regulatory precedent.AxiosCourt tosses rule on lab-developed testsA federal judge in Texas threw out an FDA rule that would have increased federal regulation of diagnostic tests, ruling that the agency overstepped its authority since Congress established a special framework for overseeing lab-developed tests. The ruling was a win for testing giants Quest Diagnostics and Labcorp as well as academic medical centers, which had argued the rule would squelch innovation and drive up compliance costs by more than $1 billion a year. The American Clinical Laboratory Association and Association for Molecular Pathology filed lawsuits to block the rule.PR NewswireARUP Files Declaration to Support Lawsuit Challenging the FDA's Rule to Regulate Lab-Developed TestsARUP Laboratories has filed declarations supporting a federal lawsuit by the American Clinical Laboratory Association (ACLA) challenging the FDA's final rule to regulate laboratory-developed tests as medical devices. The legal action argues that the FDA lacks congressional authority and that the regulation imposes unreasonable costs while threatening patient access to critical testing services. This represents a coordinated effort by major reference laboratories to strike down the regulatory framework.AxiosFDA testing rule revives push for VALID ActThe FDA's proposed rule to regulate lab-developed tests as medical devices has not dampened congressional interest, reviving the VALID Act. The bill, dropped last year, faces uncertain prospects this session, with lawmakers citing legal certainty and innovation concerns. Opponents, including the American Clinical Laboratory Association, oppose the rule and want diagnostic-specific legislation.AxiosCoronavirus testing is again overwhelmed by massive U.S. caseloadU.S. testing capacity is overwhelmed as labs receive more orders than they can process daily, prompting the American Clinical Laboratory Association to urge prioritization of hospitalized and symptomatic patients. The situation mirrors March, when testing was limited to the sickest, and the failure to act on rising cases has left the country without adequate information to stop spread.PR NewswireCAP Files Legal Brief Supporting Challenge to Correct Scheme for Setting Medicare Fees for Clinical Laboratory TestsThe College of American Pathologists (CAP) filed an amicus brief on December 11, 2018, supporting the American Clinical Laboratory Association's (ACLA's) appeal to overturn a September district court decision that dismissed ACLA's lawsuit challenging how the Department of Health and Human Services (HHS) implemented market-based reforms to Medicare's clinical laboratory fee schedule under the Protecting Access to Medicare Act (PAMA) of 2014. The CAP argues that HHS improperly excluded the vast majority of laboratories from data collection—only 2,000 of 61,000 were included—relying predominantly on independent laboratory data rather than hospital laboratories, which resulted in artificially low Medicare reimbursement rates that now threaten patient access to clinical laboratory tests, particularly in rural markets, nursing facilities, and hospitals. The CAP is also working with Congress to amend PAMA to ensure reimbursements accurately reflect the costs of patient care.PR NewswireCAP Statement on US District Court Opinion on Lawsuit Against HHSThe U.S. District Court for the District of Columbia dismissed the American Clinical Laboratory Association's lawsuit challenging Medicare's clinical laboratory payment system reforms under PAMA, a decision the College of American Pathologists supported. The CAP warned that the broken payment system and drastic Medicare cuts threaten seniors' access to vital laboratory services, particularly in health care shortage areas and rural communities. The organization is now calling on Congress to amend PAMA to ensure reimbursements accurately reflect the costs of clinical tests.GlobeNewswirePolicymakers, Patient Advocates, and Clinical Laboratory Leaders Discuss the Future of Clinical Laboratory Testing at ACLA's 23rd Annual MeetingThe American Clinical Laboratory Association held its 23rd annual meeting in Washington, D.C., on March 6, 2018, bringing together policymakers, patient advocates, and industry leaders to discuss clinical laboratory testing. Speakers included FDA Commissioner Scott Gottlieb, Representative Diana DeGette, and former HHS Secretary Michael Leavitt, with panel discussions on public health preparedness and compliance. The meeting also covered Medicare and private insurance trends.PR NewswireCAP Files Amicus Brief in Support of ACLA Motion for Summary Judgement in PAMA LawsuitThe College of American Pathologists (CAP) filed an amicus brief supporting the American Clinical Laboratory Association's lawsuit against the Department of Health and Human Services regarding the implementation of clinical laboratory fee reforms under the Protecting Access to Medicare Act. The brief argues that HHS improperly excluded hospital-based laboratories from its data collection, despite these facilities accounting for nearly half of the market share by test volume. This legal action seeks to ensure comprehensive pricing data is used to determine Medicare reimbursement rates.