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
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)
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
New Opioid Law Hits Labs Paying Sales Commissions
CEO SUMMARY: At the last minute, Congress added all clinical laboratories to a far-reaching anti-kickback provision in the newly-enacted Support for Patients and Communities Act. This provision applies to all payers, both government and private. Lab experts say this new law could have a negative effect on patient care because it could make relatively innocuous
Are More Criminal Charges Coming in Theranos Case?
CEO SUMMARY: As a going business, Theranos may have been dissolved in September, but it continues to be in the news. The biggest development was a disclosure in federal court earlier this month by federal prosecutors that there may be additional criminal charges to come that go beyond the indictments of former CEO Elizabeth Holmes
Defunct, Oft-Troubled Calloway Labs Hit with $1.4M Federal Judgement
HOW OFTEN IS A DEFUNCT LAB COMPANY IN THE NEWS? That was the odd development last week when it was announced that a U.S. District Court had entered a $1.4 million civil judgement against Calloway Laboratories, Inc., a toxicology lab company formerly based in Woburn, Mass., for business practices during the period May 2014 through
Peeking at Whistleblower Claims: How Labs Induce Physicians
IN RECENT DECADES, probably no sector of the U.S. healthcare system has seen the level of fraud and abuse that seems to pervade the clinical laboratory industry. The common perception is that illegal inducements between lab companies and referring physicians are rampant and federal prosecutors have failed to bring enough violators to justice to effectively
Judge Rules ‘Pull-Through’ Is Illegal Inducement
CEO SUMMARY: In a ruling issued Sept. 12, a U.S. District Court judge decided that two common clinical laboratory business practices are illegal inducements that can lead to charges of ling false claims. The practices occur when labs pay physicians to package and mail patients’ specimens and when labs waive copays and deductibles for patients.
Attorney Explains 70/30 Rule, Pass-Through Bill Arrangements
HOW THE LAB OUTREACH BUSINESSES of rural hospitals originate lab specimens and bill for lab tests is getting increased scrutiny. The reason for this rise in interest is that a growing number of rural hospitals are generating almost as much revenue from laboratory outreach testing as they get from all other inpatient services.
Most rural hospitals