Compliance Guidance Issued for Individual and Small Group Physician Practices

Development of a Compliance Program generally remains a voluntary action but is highly encouraged. The OIG states that “all health care providers have a duty to ensure that the claims submitted to Medicare and other Federal health care program are true and accurate. The development of effective compliance programs will go a long way toward achieving this goal.”

Compliance programs have become commonplace in most larger health care institutions in the past few years. Several compliance guides have been issued by the Office of Inspector General (OIG) to aid providers in development of effective Compliance Plans and the latest was issued on June 12, 2000 and is titled A Program Guide for Individual and Small Group Physician Practices.

Information on this Program Guidance includes the 7 Basic Elements of a Compliance Plan.

1. Establishing compliance standards through the

development of a Code of Conduct and written

policies and procedures.

2. Assigning compliance monitoring efforts to a

designated compliance officer or contact.

3. Conducting effective training and education on

practice ethnics and policies and procedures.

4. Conducting internal monitoring and auditing

focusing on high-risk billing and coding issues

through performance of periodic audits.

5. Developing effective lines of communication,

such as discussions at staff meetings

regarding fraudulent or erroneous conduct

issues and community bulletin boards, to keep

practice employees updated regarding

compliance activities.

6. Enforcing disciplinary standards by making

clear or ensuring employees are aware that

compliance is treated seriously and that

violations will be dealt with consistently and

uniformly.

7. Responding appropriately to detected

violations and developing corrective actions.

This guidance states, “That although there is no one size fits all compliance program, especially for physicians practices. It is advised that each practice should undertake reasonable steps to respond to each of the seven elements listed above.”

This draft Program Guidance is available at the following web site: www.hhs.gov/oig/modcomp/cpgphysiciandraft.htm.

Negotiated Rulemaking in Plain English

The Balanced Budget Amendment has single-handedly affected health care more than any other piece of legislation in recent times. Though persistent lobbying by various laboratory representatives, HCFA agreed to negotiate with laboratory industry representatives on a variety of issues and to arrive at an “I can live with” rule.

This proposed rule, published March 10, 2000, developed national coverage and administrative policies for the clinical laboratory industry. As part of this process, 23 national coverage decisions (policies specifically covering when and under what circumstances specific laboratory tests are to be used) where developed and incorporated in the proposed rule.

So What is Important?

1. Diagnostic Information Requirements

Through this process, submission of diagnostic information by the ordering health care practitioner is encouraged for all claims. The ordering health care practitioner is expected to willingly provide diagnostic information, either ICD9-CM codes or a narrative for each test ordered. It is ultimately the responsibility of the billing entity to obtain and to provide the contractor with acceptable and appropriate diagnostic information. Laboratory constituents would have preferred that the ordering health care practitioner be required to provide diagnostic information but had to live with the physician being expected to voluntarily provide the information.

2. Date of Service

The committee’s consensus on the definition of date of service was determined to be the date the specimen was collected. Much discussion centered on the laboratory industry’s ability to comply with this definition because of laboratory information system issues. All committee members agreed that an opportunity must be given for extensive public comment before a decision was made.

3. ICD9-CM Codes and How They Support Medical Necessity

There are codes described in each nationally coverage decision that, in and of themselves, support the medical necessity for a particular test.

This is not to say that other codes could not support medical necessity. However, those codes would require additional supportive documentation provided by the ordering health care provider and, even then, coverage would not be guaranteed. Exclusionary and inclusionary ICD9-CM codes:

• Exclusionary codes. Tests such as CBC’s have a large number of codes that support its medical necessity. It is therefore more efficient for these types of tests to list only those ICD9-CM codes that do not support their medical necessity.

• Inclusionary codes. These national coverage decisions list only those ICD9-CM codes that support medical necessity. These tests have fewer codes that support medical necessity and, therefore, listing them is more manageable.

4. Modifier 59

According to the rule, this modifier is added to a test code to alert the contractor that the provider (the entity submitting the claim) is identifying a service which may not be ordinarily encountered or performed on the same day, but that is medically justifiable. This is one we can’t figure out how to implement! If you have developed a mechanism to successfully use this modifier with automated information systems, please contact Kathy Ayres, CLMA Health-Care Policy Manager at (610) 995-9580.

5. Maintenance of Documentation

HCFA considers both the physician office chart the laboratory request slip to the official medical record.

The entity submitting the claim to the contractor for reimbursement is still ultimately and unequivocally responsible for possessing documentation that supports test medical necessity. CLMA tried to establish that the medical record in fact resides with the ordering health care practitioner, and not the laboratory. This section, as negotiated, was very difficult to “live with”. If the diagnosis submitted with the claim does not support medical necessity, then it is the responsibility of HCFA or its agent to request additional supporting documentation from the submitting laboratory or the ordering health care practitioner. If the medical necessity cannot be substantiated, the claim will be denied and, if already paid, recoupment requested.

6. Need for Ordering Practitioner’s Signature on the Laboratory Requisition for Medicare Participants

Most laboratories do not comply with current Medicare regulations that require the ordering provider’s signature on the requisition. If you are one of these labs, you do not need to change your practice now. When this rule becomes effective, a signature will no longer be required for Medicare purposes.

7. Matching Diagnostic Procedures and Submissions of Claims

The committee reached consensus that the narrative description provided by the ordering practitioner need not match the description supplied in the ICD9-CM coding guidelines as long as laboratories put forth a “best effort” to translate the narrative diagnosis. HCFA will instruct its contractors to analyze all diagnostic codes supplied with the claim to look for an appropriate code for medical necessity. The laboratory will not need to match each test with the appropriate ICD9-CM code. The contractor also will be instructed to permit separate and discrete filing of claims known by the laboratory to be a non-approved screening test. This will cause the contractor to issue a rejection so the beneficiary may submit this denied claim to a secondary payer.

8. Frequency Screens

A frequency screen is a tool used by contractors to review claims for egregious over-utilization of specific tests. Concern was expressed by the committee

members that these screens were being used to automatically deny claims and providers had no guidance as to acceptable utilization. Many of the National Coverage Decisions do not contain Frequency sections which would have stated how many times a test may be ordered within a defined period of time. There simply was not enough time for the task forces of the committee to develop this section for each of the policies. Therefore, where the National Coverage Decisions are “silent”, such as Frequency, local medical review policies (LMRP) may be developed and implemented. Before a contractor can deny the payment of a claim(s) owing to a laboratory exceeding an established frequency screen, the contractor must publish guidelines defining appropriate utilization, or must stop using the screen. The limits used for frequency screens may not be more restrictive that either the limits set forth in national coverage decisions or in LMRP’s (if appropriate as described above).

When will this happen?

This rule will go into effect 12 months after the publication of the final rule. In addition, there will be an additional 12-month grace period to phase in any changes required by this rule. This rule is expected to be published as final by September 2000.

TIDBITS

MEDICARE DEFINITIONS OF FRAUD AND ABUSE.

Fraud: Intentional deception or misrepresentation that an individual or organization makes such as a false statement/claim to Medicare.

Abuse: Incidents or practices which are inconsistent with accepted business or fiscal practices and directly or indirectly create unnecessary costs to the Medicare program.

FROM THE EDITOR...

I hope this issue has been as informative to you as it was to us. The next issue will contain information on safer needle devices and update on the new Dr. Chart computer software.

Travel safely on your vacations and remember water safety if you plan on boating and swimming.

Enjoy the rest of the summer and do something special with your loved ones!

Pam Hegge

Proficiency Testing: A CLIA Requirement

Lorrianne Shatter, MT - Avera Sacred Heart

Proficiency testing (PT) is a CLIA requirement to help verify and ensure quality laboratories. Many aspects of a laboratory’s specimen processing: reagent quality, analyzer, receiving and storing of specimens, personnel competency, and clerical processing are being evaluated, so this is why a PT specimen must be run the same as a patient specimen. A PT program can also be used to monitor potential problems in a laboratory.

To organize analysis of PT specimens, a standard worksheet outlining the aspects of both the preanalytical and the postanalytical processing is a useful tool. It will make any follow-up of unsatisfactory results easier.

Any surveyor will be able to quickly and easily review the PT program.

The worksheet should note the test, date received, mailing date, and the tech who received it. The major steps of the preanalytical processing are handling, preparation, processing (analysis), and reporting of results. The postanalytical processing steps are evaluation, and corrective action of any unsatisfactory results.

Preanalytical processing:

Handling:

When the PT kit arrives in the laboratory, note the condition of the specimens. Were they cold, damaged, or incomplete? State the storage temperature requirements. If any specimens were unsatisfactory, was the PT agency notified?

Preparation:

Note the date specimens were prepared, by whom, and how many days they are viable. Were reconstitution instructions followed on the kit information sheet? Was a Class A pipette used?” Was allotted time after reconstitution given before analysis?

Processing (Analysis): Note date of analysis and by whom. Were specimens integrated into normal laboratory workload and tested as a routine patient? Were specimens tested according to written procedures? Were tests performed on-site? Were reference books used to help evaluate Kodachrome slides? Which ones?

Reporting of Results: Were the instruments and testing methods selected accurately from the master list and documented on the reporting form? Were all test results and tests “not performed” documented on the reporting form? Was the report signed by testing personnel? Was a copy made? Note the date the report was sent and by whom. Keep all results from analyzer with the worksheet.

Postanalytical processing: Evaluation of results: Note the date the evaluation was received. Did the laboratory director, manager and section supervisor review it? Were “not graded” test results evaluated to identify potential problems? Were there any unacceptable results?

Corrective Action:

Was there clerical error or any misidentification? Were quality control results acceptable the day of testing? Were there any recent shifts? When was the last calibration? Was it verified as being successful? Note any equipment problems, and when preventative maintenance was done. Was it done according to schedule? Were specimens reconstituted properly? Were any problems noted with the PT material? Was the procedure followed correctly? Was there any correlation with past history of previous testing results? Note any other problems.

These are basic questions and details that a tech and a laboratory need to follow to properly analyze PT specimens. How ever a laboratory chooses to organize its’ proficiency testing program, the ultimate goal is to ensure that safe, reliable, and timely results are given to the physicians to facilitate the best possible patient care.

PROTHROMBIN TIME AND PARTIAL HROMBOPLASTIN TIME

Claims data analysis has continued to show that repeated same day testing on outpatients for PTT (85730) and Prothrombin Time (PT) (85610) remains high. Medical policies established by this carrier effective May 1, 1998, for states Alaska, Arizona, Colorado, Hawaii, Iowa, Nevada, North Dakota, Oregon, South Dakota, Washington and Wyoming. With the exception for Iowa, Prothrombin Time testing and Partial Thromboplastin Time testing clearly identified the role of each test in the long-term management of anticoagulation therapy. For Iowa, the Medical policy for PT was effective October 15, 1997, and the policy for PTT was effective April 15, 1998.

To reiterate, patients on long term outpatient heparin therapy are best monitored by PTT to determine the efficacy of anticoagulation. Patients on long term Coumadin therapy, on the other hand, are best monitored by the prothrombin time and INR, to determine efficacy of anticoagulation.

The only time that both the PTT and the Prothrombin Time would be appropriately measured on the same day would be during the period of transition of medications from heparin to Coumadin or when a patient is being evaluated for an undiagnosed bleeding or clotting disorder.

Repeated testing of both the PTT and Prothrombin Time, either on the same day or sequentially, on a patient receiving anticoagulation therapy may be subject to both medical review and denial of payment.

Reference: Medicare B News, No. 182; 6/26/2000

2 Doctors & HMO Manager

Two doctors and an HMO manager died and lined up at the pearly gates for admission to heaven. St. Peter asked them to identify themselves.

One doctor stepped forward and said, “I was a pediatric spine surgeon and helped kids overcome their deformities.”

St. Peter said, “You can enter.”

The second doctor said “I was a psychiatrist. I helped people rehabilitate themselves.”

St. Peter also invited him in.

The third applicant stepped forward and said, “I was an HMO manager. I helped people get cost-effective health care.”

St. Peter said, “You can come in too.” But as the HMO manager walked by, St. Peter added, “You can stay three days. After that, you will be released.”

CLIENT SERVICES STARS

Sandy Severson

Sandy has been employed by Avera McKennan for 5 years as a Client Services Representative. She received her Certified Laboratory Technician degree from Lake Area Vocational School in Watertown, and later completed testing for her Medical Laboratory Technician certification.

Sandy and her husband, who is deceased, have two children. Her son and daughter-in-law live in Watertown and have 3 children. Her daughter and son-in-law live in Grand Island, NE and have 1 child. Sandy has a 7¹/₂ year old tortoise shell cat named Peggy, and a 2 year old orange 3-legged cat named Sasha.

Sandy’s hobbies include riding her Yamaha Virago 750 motorcycle. She belongs to 3 clubs: GWRRA, or Gold Wing Road Riders Association, Sooland Goldwing, and CMA, the Christian Motorcycle Association. She also enjoys cookbooks, and walking. She has a collection on pigs that she says has overtaken her little house.

She also raised pigs for 27 years before “going to work.”

Sandy enjoys her work in the Client Service department and says “Every questions is different and a challenge. The billing is very interesting with compliance issues.

CYTOMEGALOVIRUS

Cytomegalovirus is a member of the herpes virus family and is transmitted through saliva, sexual contact, perinatally, or through blood transfusion or organ transplantation. Nearly 50-75 percent of the populations in developed countries are infected with CMV. Nearly all CMV infections are asymptomatic or subclinical and are transmitted without knowledge by the carrier, and in most cases does little harm to healthy individuals. CMV infection may, however, produce life-threatening illness in newborns and immunodeficient or immunocompromised patients. Babies may be infected before birth by virus in the mother’s blood, during the birth through CMV infection of the mothers’ cervix, or by ingesting CMV-infected maternal milk. Each year in the United States as many as 7000 CMV-infected newborns may suffer central nervous system involvement with resultant hearing loss and mental retardation.

In individuals with defected immune systems, CMV may be responsible for ocular disease, pneumonia, neurological disorders, febrile illness and hepatitis. CMV infection in AIDS patients may give rise to interstitial pneumonia or to vision loss due to ocular disease. For transplantation patients who are on immunosuppressive medications, CMV infection may pose a life-threatening situation. This is due to the fact that like EBV infection, CMV infection may persist for life in a latent state and may become reactivated following transplantation.

Upon initial infection, IgM antibodies are produced against antigens. IgM antibodies remain for 3 to 4 months during active infection but do not reappear on reactivation of infection from a latent state. IgG antibodies appear shortly after the emergence of IgM antibodies. IgG antibodies peak at 2-3 months. Antibody to late viral antigens may persist after recovery from active infections and may be detected in the infected individual for several years or even for life. Only IgG antibodies are found in reactivated infection.

Laboratory testing methods for CMV range from culture and cytologic techniques to DNA probes, PCR, and serological methods. The detection of antibodies to CMV is a good indicator or active or very recent infection, even though antibodies may not develop until a week or more after the patient shows clinical signs. Microscopic examination of biopsy specimens, urine sediment, or peripheral blood may reveal the typical cytomegalic cell with “owl’s eye” appearance due to a large central intranuclear inclusion. Since cytomegalic cells may be rarely seen because of possible sampling error or variation in the spread of infection, detection of CMV antigens in infected cells is more readily accomplished through immunofluorescent techniques that use monoclonal antibodies to early or late viral antigens. In newborns, immunofluorescent techniques have been especially helpful in detecting CMV infection, and either a urine or saliva sample may be used in testing. Nucleic acid probes may also be used to detect CMV-infected cells, but this usually requires culturing of the specimen, which may consist of cells, tissues, or body fluids.

PCR may be used to detect CMV in a sample as small as 1 mL of urine. PCR is considered more sensitive and less expensive than culturing and does not require the presence of infectious virus. A problem with PCR may be the presence of contaminating DNA. If a PCR test is contaminated, the results may be ambiguous or misleading. Even with this testing disadvantage, PCR may prove to be an effective and reliable procedure for detecting CMV in blood products.

Serological assays include ELISAs, RIA and indirect hemagglutination (IHA) tests. Rapid screening kits using latex agglutination are available, and results compare favorably to the more technically complex methods. Serological assays are intended to detect the presence of IgM antibody or IgG antibody, or a combination of both. Some problems associated with serological assays include false positives resulting from the presence of IgM rheumatoid factors and cross-reaction with IgM Epstein-Barr antibodies. Serological tests may also give only retrospective information and may not allow a clinician to distinguish between present and past CMV infections.

Case Study:

Dr. Raed Suliaman and Tonya Klingaman - Avera Queen of Peace

A 78-year old white male presented with sore throat and pancytopenia. Bone marrow aspiration and biopsy were done.

Peripheral blood and bone marrow results:

WBC........................................... 2.9 10 3/uL

RBC........................................... 3.35 10 6/uL

HGB................................................ 11.7 g/dL

HCT..................................................... 34.2 %

MCV.................................................... 102.3 fl

MCH................................................... 35.0 pg

MCHC............................................. 34.2 g/dL

PLT............................................. 119 10 3/uL

RDW.................................................. 14.0 CV

DIFFERENTIAL

SEGS.................................................... 36 %

BANDS................................................... 21 %

BLAST....................................................... 1 %

LYMPHS................................................. 19 %

ATYPICAL LYMPHS............................... 4 %

MONOS.................................................. 19 %

TOTAL RETIC COUNT....................... 0.3 %

PERIPHERAL BLOOD

There is mild macrocytic anemia with mild anisopoikilocytosis. There is mild neutropenia and 1% circulating blasts. The blasts are large with a moderate amount of cytoplasm, an enlarged and hyperchromatic nuclei, and occasional multiple nucleoli. No Auer rods are identified. Occasional hyposegmented neutrophils are noted with very rare pseudo-Pelger Huet cells.

The platelets are mildly decreased in number and have unremarkable morphology.

BONE MARROW

The bone marrow aspirate shows the following cell differential: erythroblasts 10.8%, neutrophil promyelocytes 1%, neutrophils and precursors 12%, eosinophils and precursors 0.2%, basophils and precursors 0.2%, lymphocytes 8%, plasma cells 0.4%, and blasts 67.4%. The blasts are large and have a moderate amount of basophilic cytoplasm with occasional vacuolations. The nuclei are large and have occasional multiple prominent nucleoli. Maturation is focally and minimally observed. No Auer rods are identified. The great majority of the blasts are positive for both stains (MPO and SBB). The TdT(terminal deoxynucleotidyl transferase) by immunofluorescent technique is positive,(65%).

Sections from the bone marrow core biopsy and clot material show slightly hypercellular bone marrow, approximately 55% with multiple clusters of interstitial infiltration by large atypical cells with prominent nucleoli, consistent with blasts. Therefore the diagnosis of acute myeloblastic leukemia with maturation (AML-M2) was made.

The flow cytometry analysis of the bone marrow aspirate specimen indicates that the myeloblasts express CD13, CD15, CD33, CD34 and HDL-Dr, with small amount of CD11b and CD14 expressions, confirming the myelogenous leukemia diagnosis.

The chromosome analysis shows complex karytotype abnormality: 50,XY,+8,+8,+21,+22[6]/51,idem,+9[8]/46,XY[6], supporting the diagnosis of acute

myeloblastic leukemia.

Discussion:

Leukemias are malignant neoplasms of the hematopoietic cells arising in the bone marrow. Generally the involved bone marrow is hypercellular and infiltrated by leukemia cells. The primary sites of involvement in leukemia are the blood and bone marrow; other organs such as lymph nodes, spleen, liver, central nervous system, skeletal muscles and skin can be simultaneously or eventually infiltrated by the tumor cells. Leukemias can be divided phenotypically into two types: lymphoid and myeloid (myeloblastic). Biphenotypic cases are rare. Clinically, leukemias are divided into acute and chronic. Acute myelocytic (myeloblastic) leukemia account for 40% of all leukemias. It is the most common leukemia in the 15 - 59 year age group.

Three major types of myeloblasts are recognized: types I,II, and III. The type I myeloblast is characterized by a moderate rim of agranular pale to basophilic cytoplasm, a centrally located nucleus, fine nuclear chromatin and usually two or more distinct nucleoli. The type II myeloblast is a cell similar to type I, with the addition of several (up to 20) azurophilic granules in the cytoplasm. The type III myeloblast contains numerous cytoplasmic azurophilic granules and lacks a well-developed GolgI zone. To differentiate it from promyelocytes, the later usually contain numerous cytoplasmic azurophilic granules, demonstrate a well-defined Golgi zone and have an eccentric nucleus with or without prominent nucleoli.

Acute Myeloblastic Leukemia with Maturation (AML-M2) is one of the most frequent variants, representing about 30% of acute myeloblastic leukemias (AML M0 thru M7). Myeloblasts account for 30% or greater of bone marrow cells but 90% or less of the nonerythroid cells. Blast cells are commonly heterogenous, and often show a few clusters of primary granules. Phenotypically the blasts express HLA-Dr, CD13, CD33, CD11 and CD15 and are strongly myeloperoxidase (MPO) and Sudan black B (SBB) positive and nonspecific esterase negative. Auer rods may be present not only in myeloblasts, but in more mature myeloid cells. The most frequent karyotypic abnormalities in AML-M2 is t(8;21)(q22;q22), reported in up to 20% of the cases. Complex defects are also reported in myeloid leukimias and usually have unfavorable progonostic implication. Acute myeloblastic leukemias are treated with chemotherapy with up to 70% remission. Older individuals (>60 years) have a poorer prognosis than that of younger individuals.

MEDICARE COVERAGE FOR SCREENING PROCEDURES FOR PROSTATE CANCER

PSA is a tumor marker for adenocarcinoma of the prostate which can predict residual tumor in the post-operative phase of prostate cancer. Three to six months after prostatectomy, PSA is a sensitive indicator of residual disease. PSA can also be useful in distinguishing patients with favorable response to antiandrogen therapy from those with a limited response.

PSA is not a diagnostic test, however once a diagnosis has been established, it serves as a marker for following the progress of most prostate tumors. It also aids in managing cancer patients and in detecting metastatic or persistent disease following treatment. PSA is of proven value in differentiating benign from malignant disease in men with lower urinary tract sign and symptoms.

Section 4104 of the Balanced Budget Act of 1997 provides for coverage of certain prostate cancer screening tests, subject to certain limitations. Medicare will cover prostate cancer screening tests/procedures for the early detection of prostate cancer for services furnished on or after January 1, 2000. Medicare covers both screening digital rectal examination and screening prostate specific antigen tests.

• Screening Digital Rectal Examinations (DRE) are

covered once every 12 months for men who have

reached the age of 50.

• Screening Prostate Specific Antigen (PSA) blood

tests are covered once every 12 months for men who

have reached the age of 50.

Once a beneficiary has received the covered prostate cancer screening tests/procedures, he may receive another (or all) of these tests/procedures after 11 full months have elapsed. Counting starts with the month after the last exam. For example, if the last covered test were performed on January 5, 2000, counting would begin with February 2000. The beneficiary would then be eligible for the next test on or after January 5, 2001.

Diagnosis Requirements

There are no specific diagnosis requirements for prostate screening tests/procedures. If screening is the reason for the test/procedure, the appropriate screening (“V”) diagnosis code must be chosen when billing Medicare.

Reasons for Denial

Medicare may deny prostate screening tests/procedures if:

- the beneficiary has not reached the age of 50

- the beneficiary has exceeded frequency parameters

for the test/procedure

- the beneficiary received a covered Evaluation and

Management service on the same day on which the

DRE was performed (only the DRE will be denied;

the PSA will be covered).

SKIN CANCER ALERT

One in every five Americans will develop skin cancer at some point in his or her life, according to the American Cancer Society, and more than one million new cases will be diagnosed in the United States this year, making the condition the most common type of cancer. Melanoma, the deadliest form of the disease (and the fastest rising in incidence of all tumors), is the leading cause of cancer death in women ages 25 to 29 and will kill an estimated 7,500 people this year. Yet when detected early, it is extremely curable.

The 30 Minute Rule

“It’s not enough simply to use sunscreen with SPF 30. It’s important to apply the lotion half an hour before going into the sun so that it has a chance to be absorbed by the skin. Then re-apply even waterproof sunscreen after getting out of the water or every three or four hours,” says Scott Dinehart, MD, a member of the American Academy of Dermatology (AAD) and associate professor of dermatology at the University of Arkansas in Little Rock. Even better: Avoid the sun from 10 a.m. to 3 p.m. when UV rays are harshest.

Sunscreen Scoop

AAD recommends broad-spectrum sunscreens that block both UVA and UVB rays. The ingredient Parsol 1789 was recently approved by the FDA as UVA protective. It is often combined with other ingredients for full coverage lotions. Another ingredient, Z-Cote, contains microfine zinc oxide and blocks UVA and UVB rays.