94-4900. Medicare Program; Diagnosis Codes on Physician Bills

  • [Federal Register Volume 59, Number 43 (Friday, March 4, 1994)]
    [Unknown Section]
    [Page 0]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 94-4900]
    
    
    [[Page Unknown]]
    
    [Federal Register: March 4, 1994]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Health Care Financing Administration
    
    42 CFR Parts 405 and 424
    
    [BPD-610-F]
    RIN 0938-AE06
    
     
    
    Medicare Program; Diagnosis Codes on Physician Bills
    
    AGENCY: Health Care Financing Administration (HCFA), HHS.
    
    ACTION: Final rule.
    
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    SUMMARY: This final rule implements certain provisions of section 
    1842(p) of the Social Security Act regarding diagnosis codes on 
    physician bills. Under this final rule, each bill or request for 
    payment for a service furnished by a physician under Medicare Part B 
    must include appropriate diagnostic coding for the diagnosis or the 
    symptoms of the illness or injury for which the Medicare beneficiary 
    received care.
    
    DATES: Effective date: This final rule is effective April 4, 1994.
    
    FOR FURTHER INFORMATION CONTACT:
    Pat Brooks, R.R.A. (410) 966-5318.
    
    SUPPLEMENTARY INFORMATION:
    
    I. Background
    
        Medical services are furnished to Medicare beneficiaries by 
    providers, suppliers, physicians, and other specified practitioners. 
    Title XVIII of the Social Security Act (the Act) defines the term 
    physician. Under section 1861(r) of the Act, the term physician, 
    subject to limitations concerning the scope of practice by each State 
    and other provisions of title XVIII of the Act, means a doctor of--(1) 
    Medicine or osteopathy; (2) Dental surgery or dental medicine; (3) 
    Podiatry; (4) Optometry; or (5) Chiropractic.
        Under provisions of section 1848(g)(4) of the Act, as added by 
    section 6102(a) of the Omnibus Budget Reconciliation Act of 1989 (Pub. 
    L. 100-239), effective for services furnished on or after September 1, 
    1990, each physician must submit a standard claim form (HCFA-1500) 
    directly to the Medicare carrier on behalf of the beneficiary, 
    regardless of whether the physician provided the services on an 
    assignment-related basis. (Under Medicare Part B, a physician may bill 
    the patient directly for the physician's services, thus requiring the 
    beneficiary to seek reimbursement from Medicare. Alternatively, under 
    section 1842(b)(3)(B) of the Act, when a physician furnishes services 
    on an assignment-related basis, the physician bills Medicare directly 
    in exchange for the physician's agreement to accept the Medicare 
    approved amount as payment in full. (Rules concerning assignment of 
    claims are found at Secs. 424.55, 424.56 and 424.70 et seq.) The HCFA-
    1500, which is also used by most third-party payers, including Medicaid 
    and other Federal government health insurance programs, is, in effect, 
    an itemized bill.
        Before September 1, 1990, if a physician was not paid directly by 
    Medicare for physician services, the physician either billed the 
    Medicare beneficiary directly or billed another third-party payer. The 
    beneficiary then sought payment from Medicare for expenses incurred in 
    obtaining covered physician's services by submitting a Patient's 
    Request for Medicare Payment (HCFA-1490 S) to the carrier. This form 
    directs the beneficiary to attach itemized bills from his or her 
    physician to the form. In limited cases, as provided under section 
    1842(b)(6)(B) of the Act and 42 CFR part 424 when a third party made 
    payment to the physician, the third party sought reimbursement from 
    Medicare for this payment by submitting a Request for Medicare Payment 
    by Organizations which Qualify to Receive Payment for Paid Bills (HCFA-
    1490 U). We required the physician to fill out Part II of this form, 
    which was similar to an itemized bill.
        Previously, each bill or request for payment for physician services 
    furnished to a Medicare beneficiary had to include, among other 
    information, a narrative description of the diagnosis or the nature of 
    the illness or injury for which the beneficiary received care. Although 
    prior to April 1, 1989 there was no requirement for diagnostic coding 
    (that is, a description of the diagnosis or the nature of the illness 
    or injury in a numeric code), many physicians routinely provided this 
    information. In addition, all physicians provided a narrative 
    description of procedures, medical services, and supplies that were 
    furnished to a beneficiary.
    
    II. Legislation Requiring Diagnostic Coding
    
        Section 202(g) of the Medicare Catastrophic Coverage Act of 1988 
    (Pub. L. 100-360), enacted July 1, 1988, added paragraph (p) to section 
    1842 of the Act. Under the provisions of section 1842(p)(1) of the Act, 
    each bill or request for payment for physician services under Medicare 
    Part B must include the appropriate diagnostic code ``as established by 
    the Secretary'' for each item or service for which the Medicare 
    beneficiary received treatment.
        The conference report that accompanied Public Law 100-360 explained 
    clearly the purpose of the requirement for physician diagnostic coding. 
    After rejecting a Senate provision that would have required the use of 
    diagnosis codes on all prescriptions, because they felt that the 
    requirement would have been ``unduly burdensome,'' the conferees agreed 
    to require diagnostic coding for physician services under Part B. They 
    explained their reasons for this requirement as follows: ``This 
    information would be available for immediate use for utilization review 
    of physician services and could be used in the future to facilitate 
    drug utilization review by merging Part B with drug claims data.'' H.R. 
    Conf. Rep. No. 661, 100th Cong., 2nd Sess. 191 (1988).
        Section 1842(p)(2) of the Act authorizes a denial of payment for a 
    bill submitted by a physician on an assignment-related basis if it does 
    not include the appropriate diagnostic coding.
        Section 1842(p)(3) of the Act directs the Secretary to impose 
    penalties if a physician who is not paid on an assignment-related basis 
    fails to provide the appropriate diagnostic coding on the bill to the 
    Medicare beneficiary. That is, section 1842(p)(3)(A) of the Act 
    provides for a civil money penalty not to exceed $2,000 if the 
    physician knowingly and willfully fails to provide the appropriate 
    diagnostic coding. Section 1842(p)(3)(B) of the Act provides for a 
    sanction under 1842(j)(2)(A) of the Act if the physician ``knowingly, 
    willfully, and in repeated cases fails, after being notified by the 
    Secretary of the obligations and requirements of this subsection,'' to 
    furnish appropriate diagnostic coding. Section 1842(p)(3) of the Act 
    does not prohibit the payment of an unassigned claim solely because the 
    physician did not provide diagnosis codes. As explained in section I of 
    the preamble, effective for services furnished on or after September 1, 
    1990, regardless of whether they provide services on an assignment 
    related basis, physicians submit claim forms directly to the Medicare 
    carrier. The provisions of section 1848 of the Act, as added by 6102(a) 
    of Public Law 101-239, do not affect the penalties set forth in this 
    rule for failure to include diagnostic coding on physician bills. This 
    final rule implements the provisions of section 1842 (p)(1) and (p)(2) 
    of the Act.
    
    III. Provisions of the Proposed Rule
    
        On July 21, 1989 we published a proposed rule (54 FR 30558) to 
    implement the provisions of section 1842(p)(1) of the Act. We proposed 
    that each bill or request for payment for physician services under Part 
    B would have to include appropriate diagnostic coding ``as established 
    by the Secretary,'' relating to the nature of the illness or injury for 
    which the Medicare beneficiary received care.
        As noted above, generally, physician services furnished directly to 
    a beneficiary are paid under Medicare Part B. In addition, under the 
    regulations set forth at subpart D of 42 CFR part 405, we make payments 
    to hospitals under Part A for physician services related to the 
    supervision and teaching of interns and residents who participate in 
    the care of hospital inpatients. Also, the proposed rule did not apply 
    to suppliers or other providers whose services are covered under Part 
    B.
        We proposed that a physician would be required to furnish diagnosis 
    codes instead of the narrative description that was previously 
    required. We proposed to deny payment for a bill or request for payment 
    for physician services furnished on an assignment-related basis if the 
    bill or request for payment does not contain the appropriate diagnostic 
    coding. This would not be true for a claim for physician services not 
    furnished on an assignment-related basis. In other words, if the 
    beneficiary seeks Medicare reimbursement for payment for physician 
    services, we proposed not to deny payment solely because the claim does 
    not contain diagnosis codes. If enough information were provided to 
    enable a carrier to process the claim, it would be processed without 
    the diagnosis codes. As explained in section II of the preamble, 
    section 1842(p)(3)(B) of the Act provides for a sanction under section 
    1842(j)(2)(A) of the Act if the physician ``knowingly, willfully, and 
    in repeated cases fails, after being notified by the Secretary of the 
    obligations and requirements of this subsection,'' to furnish 
    appropriate diagnostic coding.
        We proposed to use the International Classification of Diseases, 
    Ninth Revision, Clinical Modification (ICD-9-CM) as the most 
    appropriate diagnostic coding system.
        The ICD is a classification system developed by the World Health 
    Organization (WHO) for recording morbidity and mortality information 
    for statistical purposes, for indexing hospital records by diseases, 
    and for storing and retrieving data. Effective with the Twentieth World 
    Assembly of WHO, nomenclature regulations were adopted on May 22, 1967. 
    Article 21(b)(2) of these regulations specifies that ``members 
    compiling mortality and morbidity statistics shall do so in accordance 
    with the current revision of the International Statistical 
    Classification of Diseases, Injuries and Causes of Death as adapted 
    from time to time by the World Health Assembly. This Classification may 
    be cited as the `International Classification of Diseases'.'' The 
    United States is signatory to the WHO's agreements, which include the 
    above nomenclature regulations binding the United States to the use of 
    the ICD system for official government health statistical purposes. The 
    nomenclature regulations became effective on January 1, 1968.
        The clinical modification of the ninth revision to ICD (that is, 
    ICD-9-CM) is a coding system for reporting diagnostic information and 
    procedures performed on patients in hospitals or other types of health 
    care delivery systems.
        ICD-9-CM was developed under the guidance of the National Center 
    for Health Statistics (NCHS) to adapt the ninth revision of the ICD 
    classification system to the needs of hospitals in the United States. 
    The modifications were intended to provide a mechanism to present a 
    clinical picture of the patient. Thus, ICD-9-CM codes are more precise 
    than those included in ICD-9 since greater detail is needed to describe 
    the clinical picture of a patient than for statistical groupings and 
    trend analysis.
        Effective January 1979, after nearly two years of development by 
    numerous national experts on clinical technical matters, the ICD-9-CM 
    became the single classification system intended for use by hospitals 
    in the United States. This system replaced several earlier related but 
    somewhat dissimilar classification systems. Once the ICD-9-CM 
    classification system was in place, several errors and omissions were 
    noted. Consequently, in September 1980 a second edition of ICD-9-CM was 
    published. The preface to the second edition noted that the continuous 
    maintenance of ICD-9-CM is the responsibility of the Federal 
    government. The preface also stated that no future modifications to 
    ICD-9-CM would be made by the Federal government without considering 
    the opinions of representatives of major users of the classification 
    system.
        In September 1985, the ICD-9-CM Coordination and Maintenance 
    Committee (the Committee) was formed. This is a Federal 
    interdepartmental committee that maintains and updates the ICD-9-CM. 
    This includes approving new coding changes, developing errata, addenda, 
    and other modifications to the ICD-9-CM to reflect newly developed 
    procedures and technologies and newly identified diseases. The 
    Committee is also responsible for promoting the use of Federal and non-
    Federal educational programs and other communication techniques with a 
    view toward standardizing coding applications and upgrading the quality 
    of the classification system.
        The Committee is co-chaired by NCHS and HCFA. NCHS has primary 
    responsibility for the ICD-9-CM diagnosis codes included in Volume 1--
    Diseases: Tabular List, and Volume 2--Diseases: Alphabetic Index. HCFA 
    has primary responsibility for the ICD-9-CM procedure codes included in 
    Volume 3--Procedures: Tabular List and Alphabetic Index.
        The Committee encourages participation in the development of 
    diagnosis and procedure codes by health-related organizations, 
    organizations in the coding field, and other members of the public. 
    During each Federal fiscal year (FY), the Committee holds three public 
    meetings during which coding changes are discussed. Taking into account 
    the public comments made at each meeting and the public correspondence 
    received after each meeting, the Committee formulates recommendations, 
    which must be approved by the co-chair agency heads, the Administrator 
    of HCFA and the Director of NCHS, before adoption for general use. 
    Coding changes approved by the Committee and agency heads are published 
    annually in the Federal Register.
        Only official volumes and addenda of ICD-9-CM are to be considered 
    in the assignment of diagnosis codes for Medicare patients. HCFA is not 
    responsible for mistakes made by businesses in the replication of these 
    official volumes and addenda, which are then sold to the public. 
    Official addenda have become effective on May 1, 1986, and subsequently 
    on October 1 of each year from 1986 through the present. Another 
    addendum, containing the Human Immunodeficiency Virus (HIV) Infection 
    Codes, became effective for Medicare patients discharged on or after 
    July 1, 1988.
        Before publication of the proposed rule on July 21, 1989, the GPO 
    exhausted its supply of previously published addenda and announced that 
    it had no plans to reprint more copies. However, the private sector 
    continues to publish changes to the ICD-9-CM coding system annually by 
    October 1st. The GPO also announced that it would no longer provide 
    addenda except to subscription purchasers of the third edition. ICD-9-
    CM, third edition, was published in March 1989; automatic addenda 
    updates expired in 1991. The third edition incorporates all addenda 
    that were previously published. We stated in the July 21, 1989 proposed 
    rule that if a physician had not yet obtained ICD-9-CM, second edition, 
    and had not updated the set with the addenda, he or she should obtain 
    the recently updated Volumes 1 and 2 (that include all the addenda) (54 
    FR 30560). The American Health Information Management Association 
    (AHIMA), previously known as the American Medical Records Association 
    (AMRA), the national professional association of medical records 
    practitioners, and the American Hospital Association (AHA) have 
    indicated that they intend to reprint these future addenda and make 
    them available for sale.
        The price for Volumes 1 and 2 of ICD-9-CM, fourth edition, is 
    $65.00 for delivery within the United States and $81.25 for delivery 
    outside of the United States. A purchaser must furnish an address other 
    than a post office box because the volumes will be delivered only to a 
    place of business or a residence. When ordering, the purchaser should 
    enclose a check, money order, or Visa or Mastercard account name, 
    number, and expiration date. Checks should be made out to the 
    Superintendent of Documents.
        Updated volumes 1 and 2 may be purchased by writing to the 
    following address: ICD-9-CM, Fourth Edition, Volumes 1 and 2, P.O. Box 
    371954, Pittsburgh, PA 15250-7954. (Telephone orders may be placed 
    through the GPO order desk at (202) 783-3238.)
        Section 424.32 sets forth the basic requirements for all claims. 
    (The term ``claim'' is used when referring to the regulatory language 
    instead of the term ``bill or request for payment''.) In 
    Sec. 424.32(a), all claims (including those filed directly with 
    Medicare by physicians, beneficiaries or other persons or entities for 
    physician services furnished to Medicare beneficiaries) must be filed 
    in accordance with HCFA instructions. Section 424.34 provides 
    additional requirements for claims filed with Medicare by 
    beneficiaries. Under Sec. 424.34(b)(4), the itemized bill must include 
    a listing of services in sufficient detail to permit determination of 
    reasonable charges. We proposed to make the following changes to the 
    regulations text:
         Revise Sec. 424.32(a) to state specifically that a claim 
    for physician services must include appropriate diagnostic coding using 
    ICD-9-CM.
         Revise Sec. 424.34(b)(4) to state specifically that an 
    itemized bill furnished by a physician to a beneficiary for physician 
    services must include appropriate diagnostic coding using ICD-9-CM.
         Add to Sec. 424.3 the definition of ICD-9-CM, which means 
    the International Classification of Diseases, Ninth Revision, Clinical 
    Modification.
        Coding and reporting requirements and instructions for diagnostic 
    coding were developed in order to take into account circumstances 
    unique to care furnished by physicians. These coding and reporting 
    requirements and instructions for completing bills and requests for 
    payment were developed before publication of the proposed rule and were 
    distributed to the carriers on March 3, 1989. The carriers then mailed 
    this information, in the form of a Medicare Bulletin, to the physicians 
    whom they service. During preparation of these procedures and 
    instructions, we consulted with the American Medical Association (AMA) 
    and provided the AMA an opportunity to comment on the material.
        In the proposed rule, we proposed a limited grace period during 
    which payments would not be denied and sanctions would not be imposed 
    for failure to use diagnosis codes. We provided for a 6-month grace 
    period until October 1, 1989 to allow physicians and their office staff 
    to obtain training and purchase books. On August 8, 1989, we notified 
    carriers of the extension of the grace period through a memorandum from 
    the HCFA Bureau of Program Operations. For the convenience of the 
    reader, we published the coding and reporting requirements as an 
    appendix to the proposed rule.
        AHIMA offered nationwide training classes and training materials 
    for physician office staff for ICD-9-CM diagnostic coding, as did the 
    AMA.
        Suggestions concerning modification of the ICD-9-CM codes, or 
    additions to the existing codes, may be submitted in writing to the 
    following address: National Center for Health Statistics, 6525 Belcrest 
    Road,room 9-58, Hyattsville, MD 20782.
        In this final rule, we are adopting the requirements as stated in 
    the proposed rule without modification.
    
    IV. Discussion of Public Comments
    
        In response to the proposed rule, we received 35 timely items of 
    correspondence. Comments were received from physicians, professional 
    health-related organizations, universities and colleges, medical 
    facilities, state governments, laboratories, durable medical equipment 
    suppliers and pharmaceutical companies.
        Although the majority of commenters were not opposed to the 
    diagnostic coding requirement in general, they were concerned with 
    certain aspects of the proposed rule.
    
    A. Coding Issues
    
        Comment: One commenter inquired about the possibility of an 
    indefinite delay of the ICD-9-CM diagnostic coding requirement. Another 
    commenter asserted that the diagnostic coding requirement should not be 
    implemented until final regulations are published, which should allow 
    for a training period of 60 days before any adverse actions.
        Response: The original implementation date of April 1, 1989 was 
    extended by a 60-day grace period to allow physicians and their office 
    staffs to purchase coding books and to obtain coding training. This 
    grace period was further extended until October 1, 1989, at which time 
    we required all physicians to use ICD-9-CM codes on bills or requests 
    for payment. On August 8, 1989, we notified carriers of the extension 
    through a memorandum from the HCFA Bureau of Program Operations. In 
    total, we allowed a 6-month grace period. We believe we provided a 
    reasonable time period for physicians and their staffs to prepare for 
    the new coding requirements.
        Comment: The American Psychiatric Association disagreed with HCFA 
    that the ICD-9-CM is the only classification system acceptable for 
    Medicare claims. They urged HCFA to allow the use of the Diagnostic and 
    Statistical Manual of Mental Disorders, Third Edition, Revised (DSM-
    III-R) coding system for mental disorders. The American Medical 
    Association also supports the DSM-III-R coding system for use by 
    psychiatrists.
        Response: DSM-III-R was designed to be compatible with ICD-9-CM, 
    but the two systems are not identical. Systems such as DSM-III-R 
    address only certain types of diagnoses, and cannot be used universally 
    by all types of practitioners to code all types of diagnoses on claims 
    submitted to Medicare. In fact, ICD-9-CM provides for greater 
    specificity in coding mental disorders that DSM-III-R. Within the 
    ``mental disorders'' range (codes 290-319) there are an additional 218 
    specific codes available in ICD 9-CM that are not in DSM-III-R. Thus, 
    we continue to believe that the ICD-9-CM system is the only 
    comprehensive diagnostic coding system that is suitable for Medicare 
    claims.
        Comment: The College of American Pathologists stated that the ICD-
    9-CM coding system is limited in its description of disease states. The 
    commenter asserted that the Systematized Nomenclature of Medicine 
    (SNOMED), which it publishes, is more specific.
        Response: The SNOMED is an excellent coding system. However, as 
    stated above, the Department of Health and Human Services is signatory 
    to the WHO's nomenclature regulations binding the United States to use 
    of the ICD for official government purposes. Even though ICD-9-CM has 
    recognized limitations, it can be updated as the need arises via the 
    ICD-9-CM Coordination and Maintenance Committee.
        Comment: One laboratory recommended that the burden of furnishing 
    the proper diagnosis codes be placed on the physician ordering a test 
    rather than the supplier of the service. The commenter expressed a 
    concern that the laboratory performing the test should not be held 
    responsible for performing a test that Medicare later determines to be 
    not medically necessary.
        Response: The proposed rule and this final rule address the 
    requirement for diagnostic coding of only physicians' bills. This new 
    coding requirement does not apply to bills from laboratories (except 
    for physician laboratory services--see Sec. 405.556).
        Comment: One commenter suggested that referring physicians provide 
    a reason for the biopsy or referral. It requested that this practice be 
    encouraged and emphasized through carrier communication with the 
    physicians.
        Response: We have always encouraged that the referring physician 
    communicate the reason for the referral or specimen so the proper 
    medical interpretation is made or test is performed. We will continue 
    to encourage carrier to convey this message to the physician community.
        Comment: Three commenters were concerned that providing for only 
    four diagnostic codes on the form HCFA-1500 is insufficient in many 
    cases to adequately describe a patient's condition.
        Response: Since the implementation of the diagnostic coding 
    requirement, we have received few complaints concerning the form HCFA-
    1500. Thus, we believe that four diagnosis codes are sufficient in most 
    instances. We note that this regulation is not intended to change the 
    structure of the form HCFA-1500. Moreover, our contractors' claims 
    processing systems, as currently constructed, would not be able to 
    accommodate more than four diagnosis codes on a single claim.
        The use of codes instead of a narrative description should enhance 
    the physician's ability to describe the patient's condition with 
    greater precision. If there are cases where the use of four codes is 
    not sufficient, we suspect that they would arise when more than one 
    procedure has been performed (for example, psychological counseling 
    provided to a trauma patient). In such cases, the physician could 
    submit one claim for the procedure that relates to four or fewer 
    diagnoses, and submit another claim for the other procedures with their 
    attendant diagnoses.
        Comment: The American Ambulance Association requested that the 
    final rule specify that the coding requirements do not apply to 
    ambulance services.
        Response: This final rule provides only that each bill or request 
    for payment for physician services must include diagnostic coding. 
    These provisions do not apply to ambulance services.
        Comment: One commenter interpreted the proposed rule to imply that 
    physicians must now submit claims for services that they would not have 
    normally billed under the previous guidelines. The commenter requested 
    that HCFA clarify this point in the final rule.
        Response: Although the ICD-9-CM coding system permits 
    classification of many services for which specific codes could be used, 
    the mere presence of an ICD-9-CM code does not, of itself, mean that a 
    bill or request for payment must include the code for that service. If 
    a physician generally would not have submitted a bill or request for 
    payment for a particular service prior to the physician diagnostic 
    coding requirement, the physician may not be required to submit a bill 
    for that service under the new rules. For instance, HCFA did not mean 
    to imply, under an example in the guidelines published in the proposed 
    rule (54 FR 30564), that a bill should be submitted for a service for 
    X.3, attention to surgical dressings and sutures, if this service is 
    included in the surgeon's global charge. However, if this service is 
    performed by another physician, unrelated to the surgeon, it might be 
    appropriate for the second surgeon to use this code to describe the 
    reason for the encounter.
        Comment: One commenter suggested that HCFA clarify in the final 
    rule whether the new regulations supersede or supplement individual 
    carrier coding policies since there are conflicts between the new and 
    old coding practices.
        Response: The requirements in this final rule supersede any 
    individual carrier coding policies. Those carrier coding policies have 
    been changed to comply with the requirements of this final rule.
        Comment: Both the AMA and the American Society of Internal Medicine 
    stated that supplying codes for signs and symptoms without also 
    supplying codes indicating diagnoses that the physician has ruled out 
    will not accurately describe the patient's conditions and explain the 
    reasons for the care provided. Another commenter recommended that we 
    allow the use of ``suspected'' and ``rule out'' codes.
        Response: The coding guidelines state that each visit must be coded 
    to describe the specific reason that the patient sought care or 
    treatment. The guidelines also state: ``Do not code diagnosis 
    documented as ``suspected,'' ``rule out,'' ``probable,'' or 
    ``questionable'' as if they are established. Rather, code the condition 
    to the highest degree of certainty for that encounter/visit to reflect 
    symptoms, signs, abnormal test results, or other reasons for the 
    visit.'' To require coding of ``probable,'' ``suspected,'' 
    ``questionable,'' or ``rule out'' conditions as if the conditions 
    existed would lead to significant overcounting of conditions. This 
    inaccurate recording would distort data and would artificially distort 
    disease statistics. Therefore, physicians should report diagnosis codes 
    for symptoms and signs but should exclude codes for diagnoses that the 
    physician either suspects or rules out.
        Comment: Several commenters asked how they should code for 
    situations in which a patient presents disabling symptoms but no 
    diagnosis exists for the patient. They recommended that the diagnosis 
    codes include codes for symptoms.
        Response: Diagnosis codes should reflect the diagnosis, condition, 
    problem, or other reason for the encounter or visit shown in the 
    medical record to be chiefly responsible for the services provided. 
    However, the carrier will also accept codes for symptoms when no other 
    more definite code can be given to describe the reason for the visit of 
    the patient. This is explained further in guideline number four of the 
    Appendix--Claims Review and Adjudication Procedures, published with the 
    proposed rule (54 FR 30564, July 21, 1989).
        Comment: Two commenters suggested that correlating the ICD-9-CM 
    diagnosis codes and the CPT-4 procedures codes is a redundant effort 
    since a procedure may be performed as the result of several conditions. 
    They urged that the requirement be deleted.
        Response: Correlating the narrative diagnosis and the CPT-4 
    procedure code is a requirement of the Medicare carrier, and has been a 
    standard requirement for years. It has only been modified by the new 
    physician diagnostic coding requirements. Physicians must now correlate 
    the ICD-9-CM code, instead of the narrative, to the CPT-4 code.
        Comment: One commenter stated that suppliers cannot be required to 
    include diagnostic coding on Part B bills even though they often 
    provide the diagnostic codes identified by the physician on bills for 
    equipment and supplies.
        Response: We have never required suppliers to include diagnostic 
    coding on their Part B bills. Section 1842(p)(1) of the Act requires 
    physicians, as defined in section 1861(r) of the Act, and subject to 
    limitations concerning the scope of practice by each State and other 
    provisions of title XVIII of the Act, to furnish diagnostic coding. 
    That is, only doctors of medicine or osteopathy, dental surgery or 
    dental medicine, podiatry, optometry, or chiropractic must furnish 
    diagnostic coding. Durable medical equipment suppliers are not included 
    in this requirement.
        Comment: One commenter inquired why his or her carrier included 
    messages in the explanation of the Medicare benefit worksheet regarding 
    both diagnostic coding requirements (ICD-9-CM) and procedural coding 
    requirements (CPT-4) since the proposed rule (54 FR 30559, July 21, 
    1989) stated that there is no current requirement for diagnostic 
    coding.
        Response: The statement on page 54 FR 30559 referred to the policy 
    before implementation of section 1842(p)(1) of the Act that requires 
    physician diagnostic coding instead of the written narrative that was 
    previously required. We are now conforming the regulations to the 
    previously issued administrative instructions.
        The CPT-4 coding (part of the HCFA Common Procedural Coding System) 
    describes physician services and supplies, not diagnoses. If either 
    fields 23 or 24c on the form HCFA-1500 are blank, the carrier will 
    communicate with the physician via the explanation of the Medicare 
    benefit worksheet requesting completion of this information.
        Comment: A commenter asserted that as an incentive all bills or 
    requests for payment without ICD-9-CM codes should be rejected and that 
    properly coded bills and requests for payment should be expedited.
        Response: The Act specifically provides for denial of payment for a 
    bill submitted by a physician on an assignment-related basis if it does 
    not include the appropriate diagnostic code. For a claim for an item or 
    service not submitted on an assignment-related basis, the Act 
    authorizes the Secretary to impose a civil money penalty, not to exceed 
    $2,000, against a physician seeking payment who knowingly and willfully 
    fails to promptly provide the appropriate diagnostic coding on the bill 
    to the Medicare beneficiary upon the request of the Secretary or a 
    carrier. If the physician knowingly, willfully, and in repeated cases 
    fails, after being notified by the Secretary of the statutorily 
    prescribed obligations, to include the requisite diagnostic codes, the 
    physician may also be subject to administrative sanctions. However, the 
    payment of an unassigned claim may not be prohibited solely because the 
    physician has not furnished the diagnosis codes.
        We considered, but rejected, the idea of expediting properly coded 
    bills and requests for payment since we do not handle properly coded 
    bills for Part A services in a special manner. Properly coding bills is 
    a standard requirement to receive payment for services. However, 
    payment would occur more quickly for properly coded bills because there 
    would be no need for resubmission because of errors in coding.
        Comment: A clinical laboratory stated that bills and requests for 
    payment with diagnostic coding can be processed electronically at a 
    much lower cost to Medicare than we projected in the proposed rule.
        Response: The cost projections in the proposed rule for 
    electronically processed claims are the expected costs for physicians 
    to comply with the requirement for diagnostic coding on all bills and 
    requests for payment rather than the costs of the carriers in 
    processing the bills and requests for payment.
        Comment: One association asked the implied meaning of the statement 
    ``* * * (diagnostic coding) could be used for prepayment screens'' (54 
    FR 30559, July 21, 1989). The commenter asked where the ICD-9-CM and 
    CPT-4 information is being collected and what future plans are being 
    implemented for the use of the information. The association was 
    informed by its carrier that the carrier does not believe the ICD-9-CM 
    and CPT-4 codes will eventually be used for a prospective payment 
    system for physicians.
        Response: Billing information is compiled by each carrier and then 
    electronically transmitted to HCFA's Bureau of Data Management and 
    Strategy in Baltimore, Maryland. This Bureau is largely responsible for 
    performing HCFA's mathematical and statistical programming and for 
    managing HCFA's statistical data bases to support program decisions by 
    various HCFA components. Current and possible applications for the ICD-
    9-CM and CPT-4 coding information include answering research queries 
    from private sources, development of quality assurance monitoring 
    mechanisms, assessment of the impact of proposals that affect health 
    care financing programs, or special research and evaluation studies. 
    The Bureau uses diagnostic coding information to design and develop 
    periodic statistical tabulations to assess the characteristics of 
    beneficiaries and the utilization and cost of program benefits. The 
    CPT-4 codes also are now used for payment purposes under the fee 
    schedule for physician services.
        Comment: One commenter was concerned about the increased costs for 
    manpower and the reformatting of her billing system associated with 
    implementation of the diagnostic coding requirement.
        Response: We cannot predict the increased costs or manpower that an 
    individual office would incur as a result of the diagnostic coding 
    requirement. However, in the impact analysis to this final rule, we 
    discuss our estimate of the aggregate costs associated with coding 
    training and ICD-9-CM coding books. Also, as discussed in the impact 
    analysis, we now estimate that about 90 percent of physicians included 
    diagnostic coding on bills before it was required by section 1842(p) of 
    the Act. These physicians may not have experienced as significant an 
    increase in costs as physicians who did not code before the requirement 
    was established.
        Comment: One commenter stated that since general practitioners care 
    for the whole patient, it is sometimes difficult to find an applicable 
    diagnosis even after looking through 2,000 pages of codes. The 
    physician recommended that we allow three digit codes to be used for 
    procedures for which physicians routinely charge less than $200.
        Response: We are aware that general practitioners are responsible 
    for coding a wide range of diagnoses. To determine the correct code, 
    Volume 2, Index, must be consulted first. After the correct code has 
    been determined, Volume 1 is then referenced to determine if there are 
    other coding conventions that apply, such as ``Includes'' or 
    ``Excludes'' notes.
        We cannot accept the recommendation to allow the use of three digit 
    codes in any circumstance where an applicable four or five digit code 
    exists. Codes must be used to their highest level of specificity; this 
    may include some three digit codes. If diagnoses are coded to the 
    highest level, using the same data base for all bills and requests for 
    payment will permit meaningful trend analysis and data comparisons.
        Comment: Several commenters stated that the estimate of 1 minute to 
    code a bill or request for payment is too short. The estimate does not 
    consider the time a physician spends with office staff to select the 
    correct diagnosis code.
        Response: The estimate of 1 minute to code a bill or request for 
    payment was made by AHIMA based on their professional coding experience 
    and expertise. We believe that this is a realistic figure for several 
    reasons. First, there are many physicians who are specialists, and who 
    will use only a small portion of the coding manuals during their normal 
    course of business. We anticipate that these physicians and their 
    office staffs will quickly identify those parts of the coding books 
    that apply to their practice. Additionally, many offices have developed 
    reference lists pertaining to the codes frequently used in their 
    particular practices. Once this list has been developed, very little 
    physician involvement is required for the coding process.
        The amount of time necessary for the physician to work with his or 
    her clerical staff in the selection of the correct diagnosis code(s) 
    was not factored into the estimate of 1 minute. That estimate reflected 
    the use of the code book or reference list and the documentation 
    process, whether manual or key entry. We anticipate that the diagnosis 
    code(s) will become as familiar to the office staffs as the recording 
    of the narrative diagnostic language, and that completion of the 
    billing form will proceed as smoothly as it did prior to the 
    implementation of this diagnostic coding requirement.
    
    B. Patient Information and Confidentiality
    
        Comment: The American Psychiatric Association (APA) stated that 
    there may be instances when the diagnosis information provided to the 
    patient (particularly in non-assigned claims) could have an adverse 
    impact on the patient and course of treatment. The APA suggests that 
    HCFA have an exceptions process that allows the physician to determine 
    whether diagnosis information should be directly provided to the 
    patient.
        Response: We agree, and note that there is already an established 
    procedure for such situations. The physician should file the form HCFA-
    1500 on behalf of the beneficiary as required by section 1848(g)(4) of 
    the Act. The form should include the appropriate diagnostic codes and 
    should be forwarded to the Medicare carrier. If a physician determines 
    that diagnostic information should not be released directly to a 
    patient, the physician may furnish bills to the patient without 
    diagnostic information. In addition to psychiatric diagnoses, 
    physicians also may choose to use this procedure for terminal illnesses 
    or other conditions of a sensitive nature.
        Comment: The APA expressed a concern that HCFA should have a 
    mechanism in place to assure that diagnostic information is kept 
    confidential and not released to third parties except when permitted by 
    law. It recommended that the regulations be amended to include privacy 
    protection.
        Response: We share the APA's concerns about the confidentiality of 
    patient information. To assure that the beneficiary is protected, when 
    we release medical data, the data do not include any patient-specific 
    identifiers. Patient-specific medical data in the custody of HCFA and 
    its intermediaries and carriers are fully protected by the Privacy Act 
    (5 U.S.C. 552a).
    
    C. Utilization Review
    
        Comment: A pharmaceutical company is concerned that utilization 
    review of physician services and future drug utilization review may be 
    less effective because of the limitation of four diagnostic codes on 
    the bill or request for payment.
        Response: Utilization review of physician services will be enhanced 
    by the diagnostic coding requirement since the information can be 
    categorized by code and made available for immediate use. At this time, 
    we have no plans to implement a drug utilization review program using 
    the diagnostic coding information on the form HCFA-1500. We will 
    consider the effect of the four diagnostic code limitations if we 
    propose a drug utilization review program.
        Comment: One commenter questioned the possibility of the physician 
    diagnostic coding requirement eventually becoming a tool to standardize 
    physician practice patterns nationwide without physician input.
        Response: The information obtained from the ICD-9-CM codes will be 
    used for compiling statistical information. Any new requirements or 
    procedures would not be implemented without physician input and, if 
    appropriate, a notice of proposed rulemaking.
        Comment: One commenter asserted that the ICD-9-CM coding system is 
    a bulky, unreliable system for gathering data.
        Response: The ICD-9-CM coding system was developed under the 
    guidance of the National Center for Health Statistics for greater 
    specificity in reporting illnesses and injuries in the United States. 
    The ICD-9-CM coding system is the best system available for recording 
    the diagnoses of Medicare beneficiaries. The system is not considered 
    unreliable by most users; however, errors do occur as a result of 
    physicians' incorrect application of the codes.
        To help make the coding system meet the needs of all users, we 
    welcome input from interested physicians, organizations and the public 
    through the ICD-9-CM Coordination and Maintenance Committee meetings.
        Comment: One commenter asked for the name of an agency that can 
    give advice and answer questions concerning coding issues.
        Response: The AHA is the official clearinghouse for questions 
    concerning the ICD-9-CM system. They accept written questions and will 
    provide a written reply. The AMA is also providing ICD-9-CM coding 
    advice to its members through their CPT Clearing House Hotline (312) 
    464-4737. In addition, each carrier has designated a contact person to 
    answer the concerns raised by the physicians they service. We encourage 
    close communication between a physician and the carrier to avoid coding 
    problems.
        Comment: Several commenters expressed concern that requiring coding 
    to the fifth digit is burdensome and will require a more skilled person 
    to properly code the diagnoses. One commenter stated that prior to the 
    new physician diagnostic coding requirement, coding by physicians was 
    generally limited to three digits.
        Response: We did not anticipate a significant burden upon 
    physicians as a result of coding to the fifth digit level when the 
    proposed rule was published, and have not had complaints from the 
    physician community since that time. We continue to believe that most 
    physicians or their office staff create reference lists of diagnoses 
    encountered most often. Since 1979, the ICD-9-CM coding system has been 
    in use and has contained five digit codes. Thus, we do not agree that 
    coding by physicians previously was limited to three digits.
        Comment: One commenter asserted that it would be advantageous if 
    the format requirements for submitting bills or requests for payment 
    are published with the proposed rule.
        Response: The Medicare Carriers Manual explains how to fill out 
    bills and requests for payment. Basically, the only format requirement 
    for the diagnostic coding is to put each appropriate code in the space 
    that is provided for those codes under the heading ``Nature of Illness 
    or Injury.''
        The form HCFA-1500 and accompanying sections of the Carriers Manual 
    are already subject to public comment, pursuant to the Paperwork 
    Reduction Act of 1980. In accordance with that Act, OMB reviews the 
    form HCFA-1500 and its instructions at least once every 3 years. The 
    Department publishes a notice in the Federal Register that informs the 
    public of OMB's review and solicits comments for OMB's consideration in 
    the course of its review.
        Comment: The AMA stated that pathologists have expressed a concern 
    that failure to list a second diagnosis after V72.6, Laboratory 
    examination, may lead to medical necessity review problems. The AMA 
    requested that we inform the carriers that V72.6 code meets the 
    Medicare coding requirements.
        Response: We agree that in many instances one code (V72.6) will 
    explain the reason for the patient's encounter. Carriers should 
    identify a way of determining the proper coverage policy issue through 
    the use of a screen. We recommend that all laboratory claims begin with 
    the code V72.6, Laboratory examination. However, by supplying a second 
    code to describe the reason for the referral, the bill or request for 
    payment can clearly be identified as referrals to evaluate symptoms, 
    signs, or diagnoses, instead of being part of a routine physical 
    examination that is not covered by Medicare.
        Comment: One commenter inquired about how the ``V'' codes should be 
    sequenced for diagnostic services on the bill or request for payment.
        Response: Ancillary diagnostic services, which are coded beginning 
    with a ``V,'' are provided in laboratories and radiology offices if the 
    patient's main reason for the visit is to get an x-ray, (V72.5, 
    Radiological examination, not elsewhere classified), or to have a test 
    conducted (V72.6, Laboratory examination.) The condition for which the 
    patient sought treatment will be reflected in the additional diagnoses. 
    In coding ancillary diagnostic services, it may be helpful to question 
    the reason for the encounter. The reason for the encounter is that the 
    patient visited the laboratory or radiology office to have either an 
    analysis performed or an x-ray taken.
    
    D. Training
    
        Comment: One commenter stated that HCFA's estimate that 70 percent 
    of physicians and office staff will need ICD-9-CM coding training is a 
    gross underestimate.
        Response: We do not believe that our estimate of 70 percent of 
    physicians and office staff in need of coding training was too low. In 
    fact, we believe that most physicians and office staff did not require 
    coding training. Immediately after implementation of the diagnostic 
    coding requirement, medical review at the intermediary level did not 
    reveal significant coding problems. Since that time, the majority of 
    physician bills using ICD-9-CM coding have passed intermediary edits 
    for accuracy. In addition, many physicians did not need training since 
    they submitted ICD-9-CM codes prior to April 1989 due to the 
    requirements of third party payers for non-Medicare patients. We 
    believe that the lack of coding problems indicates that, if anything, 
    we may have overestimated the proportion of physicians and office staff 
    that needed training.
        Comment: One commenter suggested that HCFA require the Medicare 
    carriers to provide ICD-9-CM training and technical assistance to 
    physicians and providers.
        Response: The Medicare carriers were required by HCFA to provide 
    initial ICD-9-CM coding training prior to the April 1, 1989 
    implementation date. A National Carriers Training program was held in 
    February 1989 in preparation for the training done in each State by 
    each carrier. The National Carriers Training was conducted by AHIMA, 
    with input on the program from the AMA. Subsequently, each carrier was 
    responsible for conducting its own training program on a state-by-state 
    basis. In many cases, carriers worked with the State medical societies 
    in conducting the training. Diagnostic coding training for physicians 
    and physician office staffs has been ongoing since the implementation 
    of this requirement, especially through courses and sessions sponsored 
    by the private sector. For further information concerning coding 
    training, physicians can contact their State medical society, the AMA, 
    AHIMA, their State component of the medical record or medical health 
    information association, or their carrier.
    
    E. Sanctions Process and Civil Money Penalties
    
        Comment: One commenter indicated that the sanction provisions for 
    noncompliance with the coding requirements are illogical since coding 
    bills or requesting payment with ICD-9-CM codes is essentially a 
    clerical function. The civil monetary penalties and sanction actions by 
    the Office of Inspector General are perceived as excessive since 
    clerical errors of omission and inaccurately coded diagnoses will be 
    inevitable. Another commenter recommended that the sanctions process 
    should not apply to the ICD-9-CM coding requirement.
        Response: Coding is a task routinely delegated by physicians to 
    billing clerks or staff. However, this delegation does not relieve the 
    physician of the responsibility to submit bills or requests for payment 
    that meet the requirements of the law.
        Comment: One medical association questioned whether the carrier 
    considers the remarks on the explanation of the Medicare benefit (EOMB) 
    form an advisement of a violation (for not including diagnostic coding 
    on a bill or request for payment) that will be referred to the OIG for 
    investigation and possible sanctions. The commenter asked why the 
    carrier includes a remark in the EOMB stating that they will process 
    this claim but will not process future claims. The association suggests 
    that the message on the EOMB should contain a more complete and 
    accurate statement.
        Response: Messages that appear on the EOMB have been revised and 
    are more clear and explanatory. It is not our intent to put the 
    beneficiary at risk by not paying a bill or request for payment lacking 
    an ICD-9-CM code. For claims submitted by physicians who do not accept 
    assignment, the carrier will process the bill or request for payment as 
    usual, substituting a ``dummy'' code for the ICD-9-CM coding.
        The carrier will collect physician-specific information about the 
    quantity of the dummy codes generated per physician. When a threshold 
    of ten bills or requests for payment is reached, the carrier is 
    instructed to contact the physician in order to explain the necessity 
    of providing diagnostic coding and to help with training. If the 
    physician subsequently knowingly, willfully, and in repeated cases 
    fails to supply the requested codes, the Office of the Inspector 
    General may invoke a civil money penalty.
    
    F. Availability of the ICD-9-CM
    
        Comment: Two commenters expressed concern that the Government 
    Printing Office (GPO) does not stock a sufficient supply of the ICD-9-
    CM coding books, which results in a 4-to-8 week delay in receiving the 
    books.
        Response: ICD-9-CM books are in stock at the special address 
    mentioned elsewhere in this preamble. We are aware of the potential 
    demand and have an adequate supply. All orders are sent by priority 
    mail.
    
    V. Impact Analysis
    
        Unless the Secretary certifies that a final rule will not have a 
    significant economic impact on a substantial number of small entities, 
    we generally prepare a regulatory flexibility analysis that is 
    consistent with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 
    through 612) . For purposes of the RFA, all physicians are considered 
    to be small entities.
        The statutory requirement that physicians use diagnostic coding has 
    been in effect since April, 1989, and we believe that the vast majority 
    of physicians were already using ICD-9-CM coding even before that time. 
    Thus, the economic impact of this final rule on the physician community 
    should be minimal.
        In the proposed rule, we prepared a voluntary impact analysis and 
    voluntary regulatory flexibility analysis because of our inability to 
    quantify with any degree of precision the estimated costs of these 
    provisions and the large number of physicians who were affected by the 
    provisions of section 1842(p) of the Act. These provisions require that 
    each bill or request for payment for a service furnished by a physician 
    include appropriate diagnostic coding related to the illness or injury 
    for which the Medicare beneficiary received treatment. Under section 
    1842(p) of the Act, a physician who is to be paid on an assignment-
    related basis will not be paid if he or she fails to include 
    appropriate diagnostic coding on the bill. In this final rule we have 
    revised the impact analysis based on public comment.
        With one exception, any effects of this final rule will be a direct 
    result of the legislative provisions in section 1842(p) of the Act. The 
    exception is a result of the discretion that section 1842(p)(1) of the 
    Act provides the Secretary in the choice of which system to use to code 
    diagnoses. We chose to use ICD-9-CM because it is the only 
    comprehensive coding system that includes all possible diagnoses for 
    Medicare beneficiaries. For that reason, it is already widely used by 
    physicians. Furthermore, we are already using ICD-9-CM in the Medicare 
    program for classifying DRGs for payment under the inpatient hospital 
    prospective payment system. Therefore, we believe that it is the 
    easiest coding system for physician use.
        Before April 1, 1989, physicians were not required to provide ICD-
    9-CM or any other type of diagnostic codes on their Medicare bills or 
    requests for payment. Therefore, we believe that physicians who were 
    not coding before the provisions of section 1842(p) of the Act were 
    affected through increased paperwork, the cost of training themselves 
    and their staff, and the probable need to purchase Volumes 1 and 2 of 
    the ICD-9-CM, fourth edition.
        As of December 31, 1986, there were 569,160 physicians practicing 
    in the United States (Physician Characteristics and Distribution in the 
    U.S., 1986. Department of Data Release Services, Division of Survey and 
    Data Resources, American Medical Association, 1987). In the proposed 
    rule, we estimated that at least 30 percent of physicians used ICD-9-CM 
    codes before the requirements of section 1842(p) were established, 
    presumably because of requirements of other third party payers that 
    ICD-9-CM diagnosis or procedure codes be used on their claims. Thus, we 
    estimated that up to 70 percent of practicing physicians did not report 
    codes before the requirement was established (that is, approximately 
    398,000 physicians).
        In this final rule, we have revised our estimate of the number of 
    physicians who reported ICD-9-CM codes before the requirements of 
    section 1842(p) of the Act were established. As stated in section III 
    of this preamble, we provided for a 6-month grace period following the 
    statutory implementation date of April 1, 1989, during which no claims 
    would be denied for lack of coding. The grace period ended on October 
    1, 1989. It has been our experience that, when grace periods are 
    established, providers usually do not comply with the required 
    provisions until the end of the grace period, presumably because of 
    lack of training or need for a preparation period. In this case, 
    however, approximately 90 percent of the claims were coded using ICD-9-
    CM during the first month of the grace period, and the compliance rate 
    remained at approximately 90 percent for the duration of the grace 
    period. Moreover, intermediary review of these claims revealed no 
    significant coding problems. Since the number of physicians that 
    complied with the coding requirement remained stable throughout the 
    grace period, we believe that the number of physicians who reported 
    codes during the grace period is indicative of the number of physicians 
    who were reporting codes before the requirement was established. 
    Therefore, we now estimate that approximately 90 percent of physicians 
    reported ICD-9-CM codes before April, 1989 (that is, approximately, 
    512,000 physicians). The discussion below reflects this revised 
    estimate.
        If all the physicians who did not report ICD-9-CM codes before 
    April 1989 needed new coding books, ICD-9-CM Volumes 1 and 2 at a cost 
    of $65.00 per set, the total cost would have been approximately 
    $3,700,000. In practice, however, we believe that not all of these 
    physicians needed to purchase new coding books. For example, some 
    physicians belonged to group practices, some worked for hospitals and 
    do not have their own patients, and some already owned coding books. 
    For purposes of this impact analysis, however, we assume that all 
    physicians who did not code before April, 1989 purchased new coding 
    books.
        In the proposed rule, in calculating costs of training and coding 
    for physicians who did not code before April 1989, we estimated the 
    average wages of a physician's office staff person at $4.50 an hour. In 
    response to the July 21, 1989 proposed rule, we received several 
    comments stating that we had underestimated the average hourly wages 
    for a physician's office staff member. We agree that our estimate of 
    $4.50 per hour was too low. In this final rule, we are revising our 
    estimate of the hourly rate based on comments received on the proposed 
    rule and our examination of the hourly wages of physicians' office 
    staff in the monthly publication ``Employment and Earnings'' (U.S. 
    Department of Labor Bureau of Labor Statistics, ``Employment and 
    Earnings'' Vol. 37, No. 4, April 1990, p. 131 (Washington, DC)). Our 
    revised estimate of the typical wage for a staff person at the time the 
    requirement was established is $9.65 per hour.
        Based on claims data, we believe there were approximately 320.1 
    million physician claims processed for the period from April 1, 1989 to 
    March 31, 1990. We estimated that the clerical cost of coding each 
    claim was $0.16 for a total of $51,216,000 for the first year that the 
    requirement was in effect. We arrived at the $0.16 figure by assuming 
    an hourly rate of the typical physician's office staff person to be 
    $9.65 per hour, as explained above. We believe that it takes 1 minute 
    to code a claim, therefore $9.65 divided by 60 minutes results in a 
    $0.16 cost per claim. However, we believe that 90 percent of the claims 
    were being coded prior to April 1, 1989. Thus, 10 percent of the cost 
    of coding claims (approximately $5,120,000) can be attributed to the 
    provision of section 1842(p) of the Act.
        We anticipated that each physician that did not report ICD-9-CM 
    codes before April 1, 1989 would either send one or more persons for 
    training, or may have determined that formal training was not needed. 
    Some of those physicians may not have sent any staff since they are in 
    a group practice, (in which case, one staff member may represent 
    several physicians), or because they work for hospitals (in which case 
    they would not submit Part B claims.)
        Below, in two examples, we are providing the extremes of estimated 
    training costs using the same methodology as set forth in the impact 
    analysis of the proposed rule. In the first example, we assume that all 
    physicians who did not code prior to April 1989 sent, on average, one 
    of their office staff to attend a half-day session sponsored by a 
    national firm. We anticipated that the cost of such a training session 
    could have been as high as $100.00. Thus, for this estimate, we are 
    assuming a cost of $100.00. Furthermore, we assume the physicians paid 
    an hourly rate of $9.65 per hour to their employees while they attended 
    the coding session. Given these assumptions, we estimated training 
    costs as follows:
        (All estimates are rounded to the nearest $10,000.)
    
    
    Half-day (4 hours) at $9.65 per hour=$38.60; $38.60 x                   
     57,000 employees..........................................   $2,200,000
    Session cost $100.00 x 57,000 employees....................    5,700,000
                                                                ------------
        Total training costs...................................   $7,900,000
                                                                            
    
        In the second example, we assume that physicians who did not code 
    before the requirement was established in April 1989 sent, on average, 
    one of their office staff to coding sessions sponsored by carriers or 
    insurance companies at no cost. Assuming that the office employee was 
    paid $9.65 an hour, we estimated the total training costs as follows:
    
    
    Half-day (4 hours) at $9.65 per hour=$38.60; $38.60 x                   
     57,000 employees..........................................   $2,200,000
    Session costs..............................................            0
                                                                ------------
        Total training costs...................................   $2,200,000
                                                                            
    
        Below, we show the total estimated first year costs for the two 
    examples.
         For the first example, the total estimated first year 
    costs consisted of:
    
    
    Coding costs...............................................   $5,120,000
    Training...................................................    7,300,000
    Books......................................................    3,700,000
                                                                ------------
        Total..................................................  $16,720,000
                                                                            
    
         For the second example, the total estimated first year 
    costs consisted of:
    
    
    Coding costs...............................................   $5,120,000
    Training...................................................    2,200,000
    Books......................................................    3,700,000
                                                                ------------
        Total..................................................  $11,020,000
                                                                            
    
        Therefore, we estimate that first year training costs were between 
    $11 million and $16 million. The cost of updated books will be an 
    ongoing expense. Training costs will be recurring to the extent that 
    staff turnover will occur. Coding costs will be ongoing. However, we 
    believe that coding time and costs will probably be reduced with 
    experience.
        Section 1102(b) of the Act requires the Secretary to prepare a 
    regulatory impact analysis if a final rule will have a significant 
    impact on the operations of a substantial number of small rural 
    hospitals. Such an analysis must conform to the provisions of section 
    604 of the RFA. For purposes of section 1102(b) of the Act, we define a 
    small rural hospital as a hospital that is located outside of a 
    Metropolitan Statistical Area and has fewer than 50 beds.
        We are not preparing a rural impact statement since we have 
    determined, and the Secretary certifies, that this final rule will not 
    have an impact on a significant number of small rural hospitals.
        This final rule was reviewed by the Office of Management and 
    Budget.
    
    V. Paperwork Reduction Act
    
        Regulations at Sec. 424.32(a) and Sec. 424.34(b) contain 
    information collection and recordkeeping requirements that are subject 
    to review by the Office of Management and Budget under the Paperwork 
    Reduction Act of 1980 (44 U.S.C. 3501 through 3511). These regulations 
    and the information collection and record keeping requirements apply to 
    the requirement that a physician provide appropriate diagnostic coding 
    on each bill or request for payment for a physician service furnished 
    under Medicare Part B. Public reporting burden for this collection of 
    information is estimated to average one minute per submitted Part B 
    claim. This includes time spent reviewing instructions, searching 
    existing data sources, gathering and maintaining needed data, and 
    completing and reviewing the collection of information. The information 
    and record keeping requirements associated with this final rule have 
    been approved by the Office of Management and Budget in accordance with 
    the Paperwork Reduction Act of 1980 (approval number 0938-0008).
    
    List of Subjects
    
    42 CFR Part 405
    
        Administrative practice and procedure, Health facilities, Health 
    professions, Kidney diseases, Medicare, Reporting and recordkeeping 
    requirements, Rural areas, X-rays.
    
    42 CFR Part 424
    
        Assignment of benefits, Physician certification, Claims for 
    payment, Emergency services, Plan of treatment.
    
        I. 42 CFR part 405, subpart E is amended as set forth below:
    
    PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED 
    Subpart E--Criteria for Determination of Reasonable Charges; 
    Payment for Services of Hospital Interns, Residents, and 
    Supervising Physicians
    
        A. The authority citation for Subpart E continues to read as 
    follows:
    
        Authority: Secs. 1102, 1814(b), 1832, 1833(a), 1834 (a) and (b), 
    1842 (b) and (h), 1848, 1861(b), (v), and (aa) 1862(a)(14), 1866(a), 
    1871, 1881, 1886, 1887, and 1889 of the Social Security Act as 
    amended (42 U.S.C. 1302, 1395f(b), 1395k, 1395l(a), 1395m (a) and 
    (b), 1395u (b) and (h), 1395 w-4, 1395x(b), (v), and (aa), 
    1395y(a)(14), 1395cc(a), 1395hh, 1395rr, 1395ww, 1395xx, and 
    1395zz).
    
        B. In Sec. 405.512 paragraph (c) introductory text is republished 
    and paragraph (c)(8) is revised to read as follows:
    
    
    Sec. 405.512  Carriers' procedural terminology and coding systems.
    
    * * * * *
        (c) Guidelines. The following considerations and guidelines are 
    taken into account in evaluating a carrier's proposal to change its 
    system of procedural terminology and coding:
    * * * * *
        (8) Compatibility of the proposed system with the carriers methods 
    for determining payment under the fee schedule for physicians' services 
    for services which are identified by a single element of terminology 
    but which may vary in content.
    * * * * *
        II. 42 CFR part 424 is amended as set forth below:
    
    PART 424--CONDITIONS FOR MEDICARE PAYMENT
    
        A. The authority citation for part 424 is revised to read as 
    follows:
    
        Authority: Secs. 216(j), 1102, 1814, 1815(c), 1835, 1842 (b) and 
    (p), 1861, 1866(d), 1870 (e) and (f), 1871, and 1872 of the Social 
    Security Act (42 U.S.C. 416(j), 1302, 1395f, 1395g(c), 1395n, 1395u 
    (b) and (p), 1395x, 1395cc(d), 1395gg (e) and (f), 1395hh, and 
    1395ii)
    
    Subpart A--General Provisions
    
        B. In Sec. 424.3, the introductory text is republished and a 
    definition for ``ICD-9-CM'' is added in alphabetical order to read as 
    follows:
    
    
    Sec. 424.3  Definitions.
    
        As used in this part, unless the context indicates otherwise--
        ICD-9-CM means International Classification of Diseases, Ninth 
    Revision, Clinical Modification.
    * * * * *
    
    Subpart C--Claims for Payment
    
        C. In Sec. 424.32, paragraph (a) is revised to read as follows:
    
    
    Sec. 424.32  Basic Requirements for all claims.
    
        (a) A claim must meet the following requirements:
        (1) A claim must be filed with the appropriate intermediary or 
    carrier on a form prescribed by HCFA in accordance with HCFA 
    instructions.
        (2) A claim for physician services must include appropriate 
    diagnostic coding using ICD-9-CM.
        (3) A claim must be signed by the beneficiary or the beneficiary's 
    representative (in accordance with Sec. 424.36(b)).
        (4) A claim must be filed within the time limits specified in 
    Sec. 424.44.
    * * * * *
        D. In Sec. 424.34, the introductory text of paragraph (b) is 
    republished and paragraph (b)(4) is revised to read as follows:
    
    
    Sec. 424.34  Additional requirements: Beneficiary's claim for direct 
    payment.
    
    * * * * *
        (b) Itemized bill from the hospital or supplier. The itemized bill 
    for the services, which may be receipted or unpaid, must include all 
    the following information:
    * * * * *
        (4) A listing of the services in sufficient detail to permit 
    determination of payment under the fee schedule for physicians' 
    services; for itemized bills from physicians, appropriate diagnostic 
    coding using ICD-9-CM must be used. (For example, a bill for ambulance 
    service must specify the pick-up and delivery points.)
    * * * * *
    (Catalog of Federal Domestic Assistance Program No. 93.773, 
    Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
    Supplementary Medical Insurance Program)
    
        Dated: November 22, 1993
    Bruce C. Vladeck,
    Administrator, Health Care Financing Administration.
        Dated: January 24, 1994.
    Donna E. Shalala,
    Secretary.
    [FR Doc. 94-4900 Filed 3-3-94; 8:45 am]
    BILLING CODE 4120-01-P
    
    
    

Document Information

Effective Date:
4/4/1994
Published:
03/04/1994
Department:
Health Care Finance Administration
Entry Type:
Uncategorized Document
Action:
Final rule.
Document Number:
94-4900
Dates:
Effective date: This final rule is effective April 4, 1994.
Pages:
0-0 (1 pages)
Docket Numbers:
Federal Register: March 4, 1994, BPD-610-F
RINs:
0938-AE06
CFR: (5)
42 CFR 405.512
42 CFR 424.3
42 CFR 424.32
42 CFR 424.34
42 CFR 424.44