CEO SUMMARY: When CMS and the OIG issued proposed rules last fall to make it easier for providers to participate in value-based and coordinated care arrangements, they considered excluding clinical labs, pharma companies, and DME firms because of concerns that the proposed rules could promote lab test fraud. Now, labs will have to wait for
Laboratory Compliance
Skip to articlesLaboratory compliance is the ongoing effort of clinical labs to meet certain standards of practice set by various government agencies. Most prominent of these are the Clinical Laboratory Improvement Amendments (CLIA), which establish Quality Assurance (QA) standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed.
CLIA requires clinical laboratories to be certified by their state as well as the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing. Laboratories can obtain multiple types of CLIA certificates, based on the kinds of diagnostic tests they conduct.
Certification is also required to receive reimbursements from Medicare or Medicaid.
CLIA 88 requires Quality Assurance assessment of all labs for these QA standards:
- Patient test management
- Quality control
- Proficiency testing
- Test comparisons
- Relate results to clinical data
- Personnel
- Communications
- Complaints
- Staff review
- Records
These QA standards for laboratory compliance encompass a range of activities that enable laboratories to achieve and maintain high levels of accuracy and proficiency despite changes in test methods and the volume of specimens tested. According to the CDC, good QA system achieves these four things:
- Establishes standard operating procedures (SOPs) for each step of the laboratory testing process, ranging from specimen handling to instrument performance validation
- Defines administrative requirements, such as mandatory recordkeeping, data evaluation, and internal audits to monitor adherence to SOPs
- Specifies corrective actions, documentation, and the persons responsible for carrying out corrective actions when problems are identified
- Sustains high-quality employee performance
Three federal agencies are responsible for CLIA and laboratory compliance: The Food and Drug Administration (FDA), Center for Medicaid Services (CMS) and the Center for Disease Control (CDC). Each agency has a unique role in assuring quality laboratory testing.
FDA
- Categorizes tests based on complexity
- Reviews requests for Waiver by Application
- Develops rules/guidance for CLIA complexity categorization
CMS
- Issues laboratory certificates
- Collects user fees
- Conducts inspections and enforces regulatory compliance
- Approves private accreditation organizations for performing inspections, and approves state exemptions
- Monitors laboratory performance on Proficiency Testing (PT) and approves PT programs
- Publishes CLIA rules and regulations
CDC
- Provides analysis, research, and technical assistance
- Develops technical standards and laboratory practice guidelines, including standards and guidelines for cytology
- Conducts laboratory quality improvement studies
- Monitors proficiency testing practices
- Develops and distributes professional information and educational resources
- Manages the Clinical Laboratory Improvement Advisory Committee (CLIAC)
UTC Labs to Pay $41.6 Million in a Civil Settlement With DOJ
ONE MORE LAB COMPANY has settled allegations of fraud and abuse. Last month, UTC Laboratories agreed to pay a fine of $41.6 million and will be excluded from all federal healthcare programs for 25 years.
Announced Oct. 9, the settlement resolves allegations that UTC violated the False Claims Act by paying kickbacks in exchange for laboratory
Medicare Affiliation Rule Targets Criminal Behavior
CEO SUMMARY: Under a new federal rule in effect this month, all healthcare providers—including clinical laboratories and pathology groups—will need to scour the records of all officers, directors, and affiliates to identify any that have had negative dealings with CMS or other federal enforcement agencies. Under the rule, the Medicare program is likely to target
Labs Must Respond to New CMS Anti-Fraud Rule
CEO SUMMARY: Clinical labs and pathologists providing tests for patients in Medicare, Medicaid, or Children’s Health Insurance Program should become acquainted with new enrollment rules that go into effect Nov. 4. The new rules allow CMS to revoke or deny enrollment to help stop fraud before it occurs in the federal healthcare programs. CMS intends
CMS Sanctioned Three Houston Hospitals, Labs
CEO SUMMARY: At MD Anderson Cancer Center and Baylor St. Luke’s Medical Center, blood transfusion errors led to two patients’ deaths in separate incidents last fall. Then, this spring, a patient died in the emergency department of Ben Taub Hospital following “an ineffective process in patient monitoring and communication of critical lab values.” State and
Bill Would Delay PAMA Reporting for One Year
CEO SUMMARY: For all laboratories that must report private payer price data under the Protecting Access to Medicare Act (PAMA), a new bill in congress would delay the next round of data reporting for one year and require the National Academy of Medicine to recommend ways to improve the data collection and market-rate setting processes
ACLA: NCCI Guidelines Are a ‘Step Backwards’
CEO SUMMARY: In a letter to the National Correct Coding Initiative, the American Clinical Laboratory Association (ACLA) raised significant concerns about new language in the policy manuals for Medicare and Medicaid. ACLA said the new NCCI guidelines for molecular and other tests requiring multiple steps for one specimen reduce transparency, increase the administrative burden on
Labs Get High Denial Rates Under New NCCI Rules
CEO SUMMARY: Under guidelines the National Correct Coding Initiative issued last year, many clinical laboratories are not getting paid for some tests. The rates of denial for labs running mostly molecular tests could range from 40% to 100% of revenue, one billing expert said. Implemented Jan. 1, the guidelines apply to labs running tests in
Pathology Firm Pays $63M to Settle Qui Tam Case
CEO SUMMARY: Inform Diagnostics, formerly Miraca Life Sciences, settled the federal qui tam case while denying wrongdoing. The $63.5 million settlement will by paid by the former owner, Miraca Holdings, a Japanese company. The federal Department of Justice alleged that the company—then known as Miraca Life Sciences—violated the False Claims Act by engaging in what
Attorney Explains Risks from New ‘Support Act’
CEO SUMMARY: Legislation signed into law on Oct. 24 was designed to stem the nation’s opioid crisis. But in addition to applying to sober homes and addiction treatment centers, the law also applies to clinical laboratories. Called the ‘Support for Patients and Communities Act,’ the law could authorize criminal penalties for labs that pay sales