—  SHORT COURSE #36  —

Management & Compliance for Large/Academic Pathology Practices

Part 9 - HIPAA and DOS - Two Technical Issues in Pathology Practice Billing

Black-Schaffer & Johnson


HIPAA and DOS - Two Technical Issues in Pathology Practice Billing

Application of HIPAA Privacy Regulations to Pathologists and Laboratories. Published by the College of American Pathologists on October 10, 2002 [http://www.cap.org/apps/docs/hipaa/hipaa_articles.html]


HIPAA-Related Definitions. Published by the College of American Pathologists on October 21, 2003 [http://www.cap.org/apps/docs/hipaa/hipaa_tools.html]


Medicare Program Final Rule, Department of Health and Human Services (DHHS), Centers for Medicare & Medicaid Services (CMS), 42 CFR Part 410 [CMS-3250-F], Date: NOVEMBER 23, 2001, RIN 0938-AL03, SUBJECT: Negotiated Rulemaking: Coverage and Administrative Policies for Clinical Diagnostic Laboratory Services.


Medicare Program Proposed Notice, Department of Health and Human Services (DHHS), Centers for Medicare & Medicaid Services (CMS), FR Doc. 03–30756 [CMS-3119-PN], Date: DECEMBER 24, 2003, RIN 0938-AM36, SUBJECT: Procedures for Maintaining Code Lists in the Negotiated National Coverage Determinations for Clinical Diagnostic Laboratory Services.

HIPAA Compliant Billing for Pathology Practices



The Health Insurance Portability and Accountability Act of 1996 (HIPAA) regulations:


1. Establish use and disclosure practices with respect to Protected Health Information (PHI);

2. Afford certain rights to patients; and

3. Document certain administrative steps that a Covered Entity must take to ensure that PHI is properly protected.

Covered Entity


A health plan, a health care clearinghouse, or a health care provider who transmits any health information in electronic form in connection with a HIPAA transaction.

Direct Treatment Provider


A health care provider who treats a patient directly, rather than based on the orders of another provider, and/or provides health care services or test results directly to patients.

Indirect Treatment Provider


A health care provider who:

1) delivers health care to the individuals based on the orders of another health care provider; and

2) typically provides services or products, or reports the diagnosis or results associated with the health care, directly to another health care provider who provides the services or products or reports to the individual.

Notice of Privacy Practices


Most health care providers must obtain from the patient a written acknowledgement of the Notice of Privacy Practices in order to use or disclose an individual's PHI for Treatment, Payment, or health care Operations (TPO) purposes.

Significantly, this requirement does not apply to providers that have an indirect treatment relationship with patients.

Pathologists and laboratories are Indirect Treatment Providers when they perform tests on the orders of a clinician and report the results to the clinician.

In these circumstances, a pathologist or laboratory may use or disclose PHI for TPO purposes without obtaining permission from the patient.

If, however, a pathologist or laboratory performs a test at the direction of a patient and reports the results to the patient, the pathologist or laboratory would be considered a Direct Treatment Provider.

In this situation, an acknowledgement of Notice of Privacy Practices must be obtained before PHI can be used for TPO.

Minimum Necessary Standard


Except in certain situations, a pathologist or laboratory must limit use and disclosure of PHI to the minimum information necessary to accomplish the purpose of the use or disclosure.

For disclosures made or requested on a regular basis, a pathologist must implement policies and procedures that ensure such disclosures or requests comply with the minimum necessary requirement.

The minimum necessary requirement does not apply in every situation.

The minimum necessary requirement does apply when a pathologist submits billing information to a third-party payer.

When a request for information is made by another Covered Entity, the pathologist or laboratory may rely on the requesting entity to request only the minimum amount of information.

For example, if an insurer requests certain information, the pathologist or laboratory may rely on the insurer's representation that the request conforms to the minimum necessary standard.

Date of Service for Archived Pathology Specimens



Federal Register / Vol. 66, No. 226 / Friday, November 23, 2001 / Rules and Regulations [CMS–3250–F]


"In order to promote uniformity, we proposed that the date of service for laboratory tests that is reported on the claim be the date the tested specimen was collected. The person obtaining the specimen must furnish the date of collection of the specimen to the entity billing Medicare."

"We believe that the date of collection most closely relates to the date the test was ordered and that the use of only one date of service is consistent with the goal of promoting program integrity and national uniformity. We also agree that in order to promote national uniformity, the claims processing instruction implementing this provision needs to include clarifications regarding handling of special circumstances, such as archived specimens and tests requiring extended acquisition time."

Federal Register / Vol. 68, No. 247 / Wednesday, December 24, 2003 / Notices [CMS–3119–PN]


"Consequently, we are proposing to further clarify the date of service provision for clinical diagnostic laboratory services. We propose that a specimen must be stored for more than 30 calendar days to be considered "archived." The date of service for these archived specimens would be the date the specimen was obtained from storage. Specimens stored 30 days or less would have a date of service of the date the specimen was collected."