Management & Compliance for Large/Academic Pathology Practices
Part 6 -
Compliance Planning for Pathologists
Black-Schaffer & Johnson
Compliance Planning for Pathologists
College of American Pathologists. Compliance Guidelines for Pathologists. Northfield , IL : CAP: Released December 1998; Reviewed August 31, 2005
Office of Inspector General, HHS, Publication of the OIG's Final Compliance Program Guidance for Individual and Small Group Physician Practices (65 FR 59434; October 5, 2000 ). [http://www.os.dhhs.gov/oig/oigreg/physician.htm]
Compliance for Pathologists
- Do pathology practices need a compliance program?
- What are the elements of a compliance program?
Requirement for a Compliance Plan
- A compliance plan, just for one pathology practice?
- Yes, per HHS OIG, but why?
- Compliance not easy
- compliance plan process rather than outcome requirement
- ameliorates practice responsibility to ensure all errors averted
- practice responsible for policies and procedures
- instead of perfection in performance.
Compliance Program - Major Areas
1) Prevention, detection, and correction of
2) Correct coding for pathology services:
- (a) fraud and abuse violations (including kickbacks or other unlawful incentives for referrals and Stark Law violations);
- (b) HIPAA, CLIA or licensing problems;
- (c) antitrust and other regulatory violations.
- (a) CPT-4;
- (b) ICD-9-CM;
- (c) LCD;
- (d) NCCI.
Compliance Program - Correct Coding
- Correct coding in CPT-4 and ICD-9-CM - the major factor in compliance (and reimbursement).
- Current CPT-4 terminology for the most part clear - important new gray areas relating to NCCI edits for specialized services and referral pathology practices.
- Program Memorandum clarified (and improved) ICD-9-CM coding for diagnostic services – lack of information and screening cases may still present some practical difficulties.
Compliance Program - Staff Basics
- All pathology staff need to understand basics of correct coding and how these relate to compliance.
- Basics include:
- Accessioning issues - intraoperative examination and routine specimen characterization;
- Coding issues - referral cases and special studies;
- Coding issues - pathological findings and clinical indications;
- Medical coverage issues - all of the above.
Compliance - Management Perspectives
- Pathology practice management also needs to know the regulatory basis and general structure of compliance programs for pathology practices.
- Compliance programs are composed of seven elements:
- Each addresses one or more regulatory basis for compliance;
- All elements to be considered in designing a program.
Seven elements of a complete compliance program:
- Written Procedures and Policies
- Designated Compliance Officer
- Education and Training Programs
- Open Lines of Communication
- Auditing and Monitoring Processes
- Internal Investigation and Enforcement
- Response to Identified Offenses
Physician practice compliance program:
- Written Procedures and Policies. A compliance program should include written procedures and policies to guide all practice employees on relevant regulatory issues.
- Designated Compliance Officer. The practice should name a Compliance Officer who will be responsible for all aspects of the compliance program.
- Education and Training Programs. A compliance program should include regular and effective education and training programs for all practice employees.
- Open Communication. Those associated with the practice should have an open line of communication with the Compliance Officer including access on an anonymous basis for asking questions, obtaining guidance, and reporting possible ethical and legal violations.
- Auditing and Monitoring. There should be regular audits and internal reviews to ensure that the compliance program is being successfully implemented and enforced throughout the practice.
- Internal Investigation and Enforcement. The practice should investigate and correct any problems identified, including the refund of any reimbursement inappropriately received. In addition, the practice should be prepared to consider whether self-reporting of specific violations may be appropriate.
- Response to Identified Offenses. There must be prompt disciplinary action, including the discharge of employees in appropriate cases, where individuals have failed to follow the practice's compliance program.
- Pathology practices must balance requirements for compliance among relevant HHS OIG "guidances" for
- physician practices,
- hospital services,
- third party billing entities, and
- laboratory service providers.
- CAP => guidelines specific to pathology practices and
- HHS OIG practice "guidance"
- CMS NCDs and carrier LCDs
- CMS PM on diagnostic test coding
- CMS NCCI edits and policy manual
Written Procedures and Policies
- CAP guidelines particularly helpful in providing written policies and procedures for a pathology practice:
- Employee Screening Policy
- Employee Education Policy
- Billing and Documentation Audit Policy
- Enforcement and Prevention Policy
- Procedure and Service Coding Policy
- Medical Necessity Coding Policy
- 9/26/01 CMS PM on diagnostic test coding
- Teaching Pathologist Billing Policy
Compliance Guidelines - ICD-9-CM Program Memorandum
- 9/26/01 Program Memorandum on ICD-9-CM coding for diagnostic tests
- pathologists entitled as physicians to make, code, and bill for their own medical diagnoses
- (may still code for clinical indications if specimen non-diagnostic).
Compliance Guidelines - HHS OIG Physician Practice "Guidance"
- HHS OIG's 10/5/00 "guidance" acknowledges at least small* practices need not immediately implement all seven elements of a compliance program.
- *"... a small practice ... cannot be determined by stating a particular number of physicians."
- Such practices may develop a program stepwise to fit their needs as determined by a structured and documented audit process.
Management and Compliance
- Review of practical guidelines from regulatory agencies and professional associations on
- Coding and compliance following
- Physician practice "guidance."
- Pathology professional services in descending order of procedure volume:
- Surgical pathology;
- Special studies;
- Laboratory medicine.