Laboratory Regulation & Clinical Standards
The CAP advocates for pathologists and laboratories on the regulatory issues shaping practice today.
About Laboratory Regulation & Clinical Standards
Laboratories and pathologists operate within a complex and shifting regulatory landscape — from Medicare reimbursement policy to oversight of laboratory-developed tests. The CAP advocates on your behalf across these fronts, working to ensure that regulations protect patients without creating unnecessary barriers to practice. Below, you’ll find resources on key issues including Medicare and PAMA compliance, laboratory-developed test oversight, self-referral law, billing policy, and the federal public health issues affecting laboratories nationwide. Whether you’re tracking a specific regulation or want a broader view of CAP’s advocacy priorities, these resources are designed to keep you informed and equipped to navigate change.
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Workforce & Professional Practice Issues
Regulatory Compliance Resources
The CAP provides resources to comply with federal regulations regarding advanced beneficiary notice, Medicare reassignment, Medicare Part A, and more.
Laboratory-Developed Test Oversight
The CAP advocates for strengthened oversight of laboratory-developed tests to protect patients by ensuring every laboratory-developed test is reported to an oversight body.
Protecting Access to Medicare Act (PAMA) for Laboratories
The CAP advocates on behalf of pathologists on healthcare reimbursement changes for laboratories such as PAMA reforms, and is providing additional information to help laboratories comply with new rules.
PAMA Requirements for Applicable Labs
Infographic explaining how to determine if your laboratory is a Protecting Access to Medicare Act or PAMA applicable laboratory.
Federal Public Health Information and Advocacy
CAP believes genomic medicine is a continuation of pathologists’ practice of medicine, and impacts all areas of pathology. We work to assure pathologists may continue to practice medicine in the best interest of their patients.
Self-Referral (Stark Law)
Comprehensive resources to help CAP members, patients, physicians, and policymakers understand self-referral and its implications.
Patents and Gene-Based Tests
State Advocacy and Billing For Pathology Services
Th CAP supports direct billing for anatomic and clinical pathology services for all payers, public, and private