Centers for Medicare & Medicaid Services

The United States does not have a national, single-payer health insurance system. Rather, U.S. citizens obtain health insurance from a variety of federal or private carriers. The Centers for Medicare & Medicaid Services (CMS), formerly called the Health Care Financing Administration (HCFA), is a federal agency that provides health insurance to qualified individuals through the Medicare and Medicaid programs. Together, Medicare and Medicaid provide health care to one in three Americans (more than 100 million people). Besides Medicare and Medicaid, CMS also administers the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) and Health Insurance Portability and Accountability Act of 1996 (HIPAA) programs, as well as some other national health programs.

CMS is 1 of 11 divisions of the U.S. Department of Health and Human Services (DHHS). Some of the other divisions of DHHS are the National Institutes of Health (NIH), the U.S. Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC). DHHS is a Cabinet-level department created in 1953, originally as the Department of Health, Education, and Welfare (HEW). In 1979, HEW became DHHS when the Department of Education split off as a separate department.

The Joint Commission

The Joint Commission (formerly, the Joint Commission on Accreditation of Healthcare Organizations) is an independent, not-for-profit organization that evaluates and accredits more than 20,000 health care organizations and 3000 laboratories in the United States. It is governed by a Board of Commissioners that includes physicians, consumers, and administrators, and its corporate members include professional societies like the American Medical Association (AMA) and the American Hospital Association.

Founded in 1951, The Joint Commission has developed standards for evaluating hospitals, assisted living facilities, outpatient services, and clinical laboratories. It has been accrediting hospitals since 1953 and laboratories since 1979. Laboratories surveyed by The Joint Commission have been deemed certifiable under CLIA 88 requirements. To earn accreditation, a hospital or laboratory undergoes an onsite survey. To maintain accreditation, hospitals are surveyed every 3 years and laboratories every 2 years. Surveys have been unannounced since 2006.

In 2004, The Joint Commission initiated a new survey process that uses patient “tracers,” an evaluation method that focuses on service processes and traces patients through the care they have received. Surveyors also conduct systems tracers to analyze key operational systems that directly impact the quality and safety of patient care. The new process has shifted the emphasis from survey preparation to continuous improvement of operational systems that enhance safety and reduce medical errors.

College of American Pathologists

The College of American Pathologists (CAP) is a professional society of pathologists that offers a Laboratory Accreditation Program that inspects more than 7000 laboratories in the United States and worldwide. Surveys are performed every 2 years and have been unannounced since 2006. Volunteer surveyors use inspection checklists that undergo regular revision to reflect federal regulations and professional standards. Like those inspected by The Joint Commission, CAP-inspected laboratories are eligible for a CLIA certificate.

Commission on Accreditation of Allied Health Education Programs

The Commission on Accreditation of Allied Health Education Programs (CAAHEP) (formerly, the Committee on Allied Health Education and Accreditation [CAHEA]), is an independent certifying agency for health education programs. It accredits cytotechnology training programs in the United States upon the recommendation of the Cytotechnology Programs Review Committee of the American Society of Cytopathology.

Occupational Safety and Health Administration

The Occupational Safety and Health Administration (OSHA) was created by Congress in 1971 under the Occupational Safety and Health Act, also known as “the safety bill of rights,” a response to public outcry in the 1960s against rising workplace-related injuries and deaths. A division within the Department of Labor, OSHA’s mission is to prevent injuries, illnesses, and deaths on the job. OSHA conducts inspections in response to reports of high injury rates or imminent dangers, fatalities or serious accidents, and employee complaints. Violations of standards can result in stiff monetary penalties.

Of particular relevance to cytology laboratories are the OSHA Bloodborne Pathogens Standard and the OSHA Laboratory Standard, which are available on the OSHA website.

National Fire Protection Association

Despite its name, the National Fire Protection Association (NFPA) is an international nonprofit organization, founded in 1896, and serving as the premier advocate of fire protection. Its more than 300 safety codes and standards influence the design and construction of every building in the United States. The cytologist must be familiar with applicable safety codes to ensure that they are being observed.

Of the numerous standards published by NFPA, the two of greatest relevance to cytology laboratories are the Standard for Health Care Facilities and the Standard on Fire Protection for Laboratories Using Chemicals.

Clinical Laboratory Improvement Amendments of 1988

In the 1980s there was an extraordinary flurry of media attention on the problem of false-negative Papanicolaou tests (Paps). The sentinel article appeared on the front page of the Wall Street Journal.¹ These media reports were a driving force behind legislation enacted by the U.S. Congress called the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88). (A less stringent act, CLIA 67, had been passed in the 1960s, which mandated rescreening of 10% of negative Paps.) The final regulations of CLIA 88 were published in 1992, and minor modifications appeared in 2003.^2,3 They can be found at http://wwwn.cdc.gov/clia/regs/toc.aspx. Congress charged CMS with the implementation of these standards.

To bill for and receive Medicare or Medicaid payments, a clinical laboratory must have a CLIA certificate. To obtain a certificate, a laboratory must be accredited by one of two approved accrediting organizations, The Joint Commission or the CAP. In a few states like Washington and New York, a laboratory may obtain a state license in lieu of a CLIA certificate.⁴

Specialized surveys, required by CLIA 88, are performed by the American Society for Cytotechnology (ASCT) on a small proportion of cytology laboratories with CLIA certificates.⁵ A laboratory is selected either at random or if a complaint has been lodged against it with the CMS.⁴ The survey team evaluates the laboratory’s operations and reviews at least 100 Pap cases. If applicable, a statement of deficiencies is forwarded to the laboratory via the CMS Regional Office, and the laboratory is given an opportunity to respond with a plan of correction. For example, between 1988 and 2006 a total of 616 laboratories were surveyed, and 32% were found to be noncompliant with CLIA. After filing a plan of correction, only 4% of laboratories received sanctions, had their certificates revoked, or voluntarily withdrew from the program.⁶

An advisory committee known as the Clinical Laboratories Improvement Advisory Committee (CLIAC) consists of 20 members, including laboratorians and consumer advocates. CLIAC meets at least twice yearly and advises CMS and other governmental agencies on the need for and nature of any revisions to the standards that govern laboratory testing.

Health Insurance Portability and Accountability Act of 1996

HIPAA is a comprehensive law that regulates several unrelated areas of health care, like the protection of (1) health care coverage for those who change jobs and (2) the privacy of medical information. The law asked Congress to pass comprehensive privacy legislation by August 1999. Because Congress did not do so, the law required DHHS to write the Privacy Rule/Regulation. DHHS published the Final Rule on December 28, 2000, which took effect on April 14, 2001, requiring compliance by health care providers by April 14, 2003.

The Rule governs the use of so-called individually identifiable health information and is intended to ensure that a patient’s health information is used only for health purposes, unless permission is obtained for other purposes. This information includes, for example, a cytologic diagnosis linked to an identifier such as a social security number, medical record number, and/or accession number. The DHHS Office of Civil Rights (OCR) is responsible for implementing the Rule and has issued written guidelines for health care providers which can be viewed at http://www.hhs.gov/ocr/hipaa.

HIPAA also requires that every provider who does business electronically use the same health care transactions, code sets, and identifiers. Code sets (e.g., current procedural terminology [CPT], Healthcare Common Procedure Coding System [HCPCS], and International Classification of Diseases, 9th Revision, Clinical Modification [ICD-9-CM]) are the codes used to identify specific diagnoses and procedures on claims and encounter forms.

Laboratory Director

Every laboratory performing so-called high-complexity testing (cytology falls into this category under CLIA 88 regulations) must have a laboratory director. This is the individual who is named the laboratory director on the CLIA certificate. (Institutions might also designate individuals as laboratory directors of Cytology, Microbiology, etc., but they are not the “laboratory director” in the eyes of CMS if they do not hold the CLIA certificate.) He or she may direct more than one laboratory but no more than five. It is the laboratory director who has ultimate responsibility for the work performed in the laboratory.

Technical Supervisor

The TS, as defined by CLIA 88, is the pathologist responsible for the “technical and scientific” oversight of the laboratory. He or she is not required to be on site at all times but must be available on an as-needed basis. The TS may perform the duties of a general supervisor (GS) and a cytotechnologist (CT).

The TS of a cytology laboratory is usually someone that the institution (but not necessarily CLIA) considers the “laboratory director” of cytology. The TS may delegate some of his or her responsibilities to a trainee in the final year of training in anatomic pathology.

The American Society of Cytopathology no longer certifies cytopathologists; the last examination was in 1978. The TS need not have specialty qualification (“boards”) in cytopathology. In any given laboratory, more than one individual may qualify as a TS.

General Supervisor

Each cytology laboratory must have a GS. The GS is responsible for the day-to-day oversight of operations and personnel. He or she must be accessible to provide onsite, telephone, or electronic consultation to resolve problems in accordance with procedures established by the TS. The same individual may fulfill the roles of both TS and GS.

Cytotechnologist

The job description of a CT varies depending on the laboratory where he or she works. Most are involved in slide examination. In some laboratories, they are also involved in quality control (QC) activities, teaching, research, cytopreparation, and assistance with preparation of smears and adequacy assessments during fine-needle aspirations (FNAs). The following responsibilities of a CT are the minimum established by CLIA 88.

Cytotechnologists are not required under CLIA 88 to be certified by a certifying agency, so long as they have graduated from an approved school. But the Board of Certification (BOC) (formerly the Board of Registry) of the American Society of Clinical Pathologists offers two certificates: “cytotechnologist (CT)” and “specialist in cytotechnology” (SCT). The SCT certificate requires a higher-level examination. As of 1988, a bachelor’s degree, plus graduation from an accredited cytotechnology program, is required for eligibility for a certificate. The BOC used to offer an “experience route,” but this is no longer the case, and CTs who have not attended an approved school of cytotechnology can no longer sit for the BOC examination.

A few years ago, the certificates offered by the American Society for Clinical Pathology (ASCP) BOC became time-limited. As a result the ASCP BOC now offers a Certification Maintenance Program (CMP). The CT certifications that were issued effective 2004 and beyond are valid only for a 3-year period. The same expiration applies to the SCT certifications issued effective 2006 and beyond. For these individuals, recertification is required every 3 years to maintain valid certification. Voluntary participation in the CMP is encouraged for those certified as CT before 2004.

The former Department of Health, Education, and Welfare (HEW, now DHHS) once offered CT certification, but this ended many years ago. Certification by the International Academy of Cytology (IAC) is not sufficient for those who wish to practice in the United States, because the IAC is not an approved certifying agency.

Some states in the United States require licensure of CTs, but most do not.

Procedure Codes

A medical bill submitted to an insurer for payment needs to describe the medical procedure/service that is being billed. The common language that is used in the United States to communicate the vast majority of procedures is called CPT, for current procedural terminology, a registered trademark of the AMA. The AMA owns and maintains CPT. The first edition was published by the AMA in 1966 when the (then new) Medicare program needed a terminology for describing medical services. To this day, CMS, which administers the Medicare program for DHHS, agrees via contract with the AMA to use the CPT codebook as the main source of codes and descriptors for processing medical claims. With the implementation of the HIPAA regulations in 2003, CPT became the language that must be used by all providers, government agencies, and private insurers.

According to the AMA, the objective of CPT is to provide “a uniform language that will accurately describe medical, surgical, and diagnostic services, and will thereby provide an effective means for reliable nationwide communication among physicians, patients, and third parties.”¹⁰ A CPT code has been assigned to virtually every type of physician and laboratory service, including cytologic slide preparation and interpretation. (For example, CPT code 10021 describes the procedure of performing an FNA without image guidance.) CPT codes describe even the most complex of medical procedures in the form of a simple 5-digit numeric code. Tell a knowledgeable person, for example, that you just performed an 88164, and he or she will know immediately that this was a manual screening of a cervical/vaginal smear (not a liquid-based preparation); that Bethesda terminology was used to report the result; and that the procedure included only the so-called technical component (staining, coverslipping, CT review, but not a pathologist’s interpretation)—all this from a 5-digit code!

CPT codes are the foundation for determining facility (“technical”) and physician (“professional”) payments, in conjunction with Medicare’s Resource-Based Relative Value System (RBRVS) or its clinical laboratory fee schedule (CLFS). The RBRVS is a system for comparing the relative value of medical services across all specialties, based on work, practice expense, and other factors. By doing so, the RBRVS establishes a relative value unit (RVU) for every current medical procedure. The dollar value of any given medical service or procedure is determined by its composite relative weight, multiplied by a nationally set (by CMS) dollar conversion factor. The RVUs and conversion factor for physician services are published annually in the Federal Register by CMS. Various geographic cost-of-living adjustments and other factors are also applied to obtain the specific allowed charge for any given procedure and locale, and therefore the process is not so simple as multiplying an RVU by the conversion factor. (It is not within the scope of this chapter to elaborate on the detailed formula.) CMS provides an allowed charge lookup system on its website. Medicare’s CLFS is briefly described below in conjunction with Pap test technical services.

HCPCS codes are a separate set of codes used to describe drugs, supplies, and certain other services not included in CPT. Like CPT codes, HCPCS codes have 5 characters, but the first is a letter and the rest are numbers (e.g., G0123). The HCPCS codes are administered not by the AMA but by CMS. Responsibility for maintaining and updating them is vested in a national panel composed of representatives from CMS, the Blue Cross and Blue Shield Association, and America’s Health Insurance Plans. Cytologists need to be concerned with only a small number of HCPCS codes, those for routine and high-risk Pap tests for Medicare beneficiaries.

In some circumstances, CPT and HCPCS codes require the use of modifiers to avoid filing a false claim and to assure accurate and prompt payment by payers. A complete discussion of modifiers is beyond the scope of this chapter, but familiarity with the concept of modifiers is important. Some commonly used modifiers for cytology cases deserve mention.

CPT Modifier 26. This is the most widely used in pathology. It denotes that only the physician professional component of the service is being billed.

CPT Modifier 52. This modifier denotes a reduced service from the customary procedure. In cytology, a good example is the manual review of a slide that was intended for evaluation by the ThinPrep Imaging System but rejected for technical reasons. A laboratory can still bill the automated screening code 88175, but with modifier 52 (i.e., 8817552).

CPT Modifier 59. Modifier 59 denotes a “separate procedure,” such as a different specimen (e.g., washing versus brushing) or anatomic site. Payers often require this modifier when two or more codes are considered mutually exclusive or duplicative. For example, reporting 8810459 for a direct smear bronchial brushing with 88108 for a cytospin bronchial washing is often necessary to avoid having the former charge denied.

HCPCS Modifier GC. Teaching physicians must append modifier GC to CPT and HCPCS codes on Medicare claims when a resident or fellow actively participates in performing the underlying medical service. The modifier declares that the teaching physician personally performed the “critical” portion of the procedure and is thus entitled to bill for it.

HCPCS Modifiers GA, GY and GZ. These modifiers are applied to Pap test HCPCS codes when billing Medicare. They clarify the laboratory’s right (or lack thereof) to bill the Medicare beneficiary for the charge if it is denied by the contractor.

HCPCS Modifier TC. This modifier denotes the facility technical component of the service being billed, and thus is the counterpart of the CPT 26 modifier.

A few points about procedure codes are worth noting:

International Classification of Diseases, 9th Revision, Clinical Modification Codes

The ICD-9 is the taxonomy used by all health care professionals and insurers in the United States when discussing medical conditions.¹¹ The version of ICD-9 used for billing purposes in the United States is “clinical modification” (CM). (For example, in ICD-9-CM “speak,” hematuria is 599.7x [the fifth character denotes gross, microscopic, or unspecified], and a solitary thyroid nodule is 241.0.) ICD-9-CM coding is used to determine whether or not a procedure billed to an insurer is medically necessary, in which case it is a covered benefit for the patient. With the passage of the Medicare Catastrophic Coverage Act of 1988, diagnostic coding using ICD-9-CM became mandatory for Medicare claims, and when HIPAA was implemented in 2003, ICD-9-CM coding became universal, meaning that private insurers as well as government agencies are required to use it. For convenience, hereinafter we refer to ICD-9-CM simply as ICD-9.

In the United States, all health care providers must furnish an ICD-9 code to justify the medical necessity of a diagnostic test. For example, if a urine cytology test is ordered for a patient with hematuria, the patient’s physician will furnish ICD-9 code 599.7x (which, as noted, denotes hematuria, with the fifth digit delineating gross, microscopic, or unspecified) on the requisition form that accompanies the urine specimen. Similarly, when your laboratory bills an insurer for having performed a cytologic examination of a specimen, the bill must include an appropriate ICD-9 code to justify the medical necessity of the test. (It might be the same “clinical code” you received from the ordering physician, or it might be different, a “pathologic code,” as discussed further on.) Payers have lists of approved ICD-9 codes for many laboratory tests, and will deny payment if a nonapproved code is provided. In the earlier example, if you supply a wrong ICD-9 code, such as 784.0 (denoting “headache”) with the bill for the urine cytology, it is likely that Medicare will deny the claim, because 784.0 does not justify the medical necessity of urine cytology. Pointers for selecting the appropriate ICD-9 code for cytology specimens are provided further on.

The provider who sends a cytology sample to the laboratory does not have to provide a literal ICD-9 code. It is acceptable for the referring physician to write a narrative diagnosis (e.g., “hematuria”) on the requisition form, which the laboratory can then translate into an ICD-9 code (in this example, 599.7x) by consulting the codebook.

The ICD-9 codebook consists of three volumes. The entire three-volume set is used by hospitals to bill for inpatient services. All other providers, and hospitals billing for outpatient services use only the first two volumes of the set. Volume 1 is a tabular list of hundreds of 3- 4-, and 5-digit numeric codes, each accompanied by a description of the corresponding condition. Volume 1 is arranged by systems. Volume 2 is an alphabetical list of the conditions included in volume 1. Volumes 1 and 2 are distributed by the National Center for Health Statistics, a branch of the CDC. You need to be alert for changes in the ICD-9 codes (i.e., watch the CMS and professional associations’ websites), because the codes are eligible for update twice a year (April 1 and October 1). Volume 3, with rules for inpatient coding, is not of concern to pathologists and independent labs.

A few points about ICD-9 coding for nongynecologic cytology services, including FNAs, are worth noting:

The ICD-9 codebook includes a series of so-called health status codes called V-codes because they always start with the letter V. They are used when a patient receives health services in the absence of any current sign or symptom of disease or injury. One example is a Pap test for a healthy woman. In such a circumstance, you most likely will report a code such as V76.2 (screening Pap test in absence of sign, symptom, or history) because the Pap is normal and the referring physician furnished no information regarding abnormal signs, symptoms, or history.

Parenthetically, CMS has been planning for some years to transition from ICD-9-CM to ICD-10-CM for Medicare reporting purposes. At present, the transition effective date set by CMS is October 1, 2014. Notwithstanding, provider representatives continue to encourage CMS to further delay the conversion date, or to stay with ICD-9-CM, or to adopt some other diagnosis coding system owing to the complexities of ICD-10-CM, among other issues.

Coding Pap Tests

Because of recent advances in technology, it is impossible to talk about a generic Pap test, certainly with regard to procedure coding. One or two codes would be inadequate to describe the variety of ways in which a Pap might be evaluated today—as a smear or liquid-based preparation; manually or with computer assistance; computerized screening only or with manual review; with or without physician interpretation. Thus, assigning a procedure code to a Pap test follows a rather complex algorithm. As of 2013, there are 21 different CPT/HCPCS codes for a Pap test. Those most commonly used are described in Table 18.2.

Anal Pap tests are considered nongynecologic specimens and are discussed as such.

Another aspect of Paps that makes them unique is that, most of the time, they are ordered as a screening test in the absence of any history, signs, or symptoms related to the cervix or vagina. For Medicare beneficiaries, Pap tests are therefore divided into three categories according to medical indication, thus very significantly affecting CPT/HCPCS procedure and ICD-9 diagnosis coding. These categories have implications for the frequency of beneficiary coverage and direct payment to the laboratory by Medicare (as opposed to beneficiary financial liability), and thus the categories affect procedure coding, as seen in Table 18.2.

The three categories of Pap tests and their implications for Medicare beneficiary coverage are:

The coding rules for these three categories of Pap tests are described in the sections that follow. Note that most Medicaid agencies and private insurers do not differentiate between routine and high-risk screening Pap tests, although screening versus diagnostic testing distinction is often made, including to the extent of insured coinsurance requirements.

The Screening (Routine) Pap Test

The “routine screening Pap test” is defined by Medicare as follows.

Definition of a screening (routine) Pap test

• no current sign, symptom, or complaint referable to the reproductive organs

• no previous abnormal Pap

• no high-risk factors for cervical or vaginal cancer

A screening (routine) Pap is one ordered solely as part of a preventive health care visit (e.g., periodic check-up). If the woman has not had a Pap paid for by Medicare within the past 2 years, the laboratory can expect payment by Medicare and should post one of the four accepted ICD-9 codes, V72.31, V76.2, V76.47, or V76.49 (see Table 18.3 for definitions), as it has been supplied (hopefully!) by the referring physician. (Should the pathologist report an abnormality not expected by the referring physician, the ICD-9 code for that atypia would be posted as a secondary diagnosis on the claim. This is how Medicare becomes aware that the beneficiary is to move to a high-risk or diagnostic category, because in the future she will have a history of an abnormal Pap.) If the woman has already had a Pap paid for by Medicare within the past 2 years, the test is not payable by Medicare. The laboratory may then bill the patient directly, but only if it has a signed Advance Beneficiary Notice of Noncoverage (ABN) from the patient on file. By signing an ABN, the patient authorizes the laboratory to bill her directly if a service is not covered by Medicare. The laboratory generally relies on the referring physician to obtain the ABN signatures it needs, because it almost never has direct contact with the patient in advance of a Pap test. (Medicare states that an ABN is valid—and the patient is financially liable for the service—only if the ABN is signed in advance of the test; post-test ABN signatures are not valid or binding on the beneficiary.) It is advisable, however, not to rely on the referring physician to store ABNs for you. Many laboratories have solved this problem by making the ABN a part of the requisition form itself. The content and specific wording of the ABN form is prescribed by CMS and changes from time to time, so you should periodically check with your compliance advisor to make sure you are using the latest authorized form.

TABLE 18.3

COMMONLY-USED ICD-9 CODES FOR PAP TESTS

V76.2	Screening Pap of cervix in the absence of signs, symptoms, or history
V72.31	Screening Pap of cervix in the absence of signs, symptoms, or history, collected as part of gynecologic examination
V76.47	Screening Pap of vagina in the absence of signs, symptoms, or history
V76.49	Screening Pap in the absence of signs, symptoms, or history, woman without a cervix
V15.89	Screening Pap, woman at high risk for developing cervical or vaginal cancer
616.0	Cervicitis
616.10	Vaginitis
622.10	Histologic cervical intraepithelial neoplasia (CIN), unspecified
622.11	Histologic CIN I (mild dysplasia)
622.12	Histologic CIN II (moderate dysplasia)
233.1	Histologic CIN III (severe dysplasia)
795.00	Abnormal glandular Pap
795.01	Abnormal Pap: atypical squamous cell, undetermined significance (ASC-US)
795.02	Abnormal Pap: atypical squamous cell, cannot exclude high-grade squamous intraepithelial lesion (ASC-H)
795.03	Abnormal Pap: low-grade squamous intraepithelial lesion (LSIL)
795.04	Abnormal Pap: high-grade squamous intraepithelial lesion (HSIL)
795.05	High-risk human papillomavirus DNA–positive (cervix)
795.06	Malignant cells, without histologic confirmation
795.08	Unsatisfactory Pap
795.09	Other abnormal Pap smear (includes reactive/reparative changes)
112.1	Candidiasis
623.5	Vaginal discharge
626.2	Menometrorrhagia
626.4	Irregular menstrual cycle
626.6	Metrorrhagia
626.8	Dysfunctional uterine bleeding
627.1	Postmenopausal bleeding

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