Article - Billing and Coding: Approved Drugs and Biologicals; Includes Cancer Chemotherapeutic Agents (A53049)

CMS National Coverage PolicyInternet-Only Manuals (IOMs):CMS IOM Publication 100-02,Medicare Benefit Policy Manual,Chapter 15, Sections 50 Drugs and Biologicals and 60.1 Incident To Physician's Professional ServicesChapter 16, Section 10 General Exclusions from CoverageCMS IOM Publication 100-03,Medicare National Coverage Determinations (NCD) Manual,Chapter 1, Part 4, Section 280.14 Infusion PumpsCMS IOM Publication 100-04,Medicare Claims Processing Manual,Chapter 12, Sections 20.3 Bundled Services/Supplies, 30.5 Payment for Codes for Chemotherapy Administration and Nonchemotherapy Injections and Infusions, 30.6.6 Payment for Evaluation and Management Services Provided During Global Period of Surgery and 30.6.7 Payment for Office or Other Outpatient Evaluation and Management (E/M) Visits (Codes 99202-99215)Chapter 17 Drugs and BiologicalsChapter 23, Section 20.9 National Correct Coding Initiative (NCCI)Social Security Act (Title XVIII) References:Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider of services or other person under this part unless there has been furnished such information as may be necessary in order to determine the amounts due such provider or other person under this part for the period with respect to which the amounts are being paid or for any prior period.Title XVIII of the Social Security Act, Section 1861(t)(1) Drugs and Biologicals.Title XVIII of the Social Security Act, Section 1861(v)(1)(A) Reasonable Cost.Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment may be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.Article TextNotice:It is not appropriate to bill Medicare for services that are not covered as if they are covered. When billing for non-covered services, use the appropriate modifier.In reading this document, please note that there is a difference between the section of the statute which defines the overall Medicare benefit for coverage of drugs and biologicals, and the section of the statute which states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury. This article gives information about the overall Medicare benefit for coverage of drugs and biologicals. This contractor, when necessary, develops Local Coverage Determinations (LCDs), to define medically reasonable and necessary uses of particular drugs and biologicals.Generally, drugs and biologicals are covered only if all of the following requirements are met:They meet the definition of drugs or biologicals;They are of the types that are not usually self-administered by the patients who take them;They meet all the general requirements for coverage of items as incident to a physician's services;They are medically reasonable and necessary for the diagnosis or treatment of the illness or injury for which they are administered according to accepted standards of medical practice;They are not excluded as noncovered immunizations; andThey have not been determined by the United States (U.S.) Food and Drug Administration (FDA) to be less than effective.Definition of Drug or BiologicalDrugs and biologicals must be determined to meet the statutory definition. Under the statute Section 1861(t)(1), payment may be made for a drug or biological only where it is included, or approved for inclusion, in the latest official edition of one of the statutorily named compendia. Due to changes in the pharmaceutical reference industry, some of the statutorily named compendia are no longer published. Examples of compendia that are currently in publication include the United States Pharmacopoeia (USP), the United States Pharmacopoeia National Formulary (USP-NF), or the Homeopathic Pharmacopoeia of the United States (HPUS), or the American Dental Association (ADA) Guide to Dental Therapeutics (except for those drugs and biologicals unfavorably evaluated in the ADA Guide to Dental Therapeutics). Combination drugs are also included in the definition of drugs if the combination itself or all of the therapeutic ingredients of the combination are included, or approved for inclusion, in any of the above drug compendia.Drugs and biologicals are considered approved for inclusion in a compendium if approved under the established procedure by the professional organization responsible for revision of the compendium.Self-Administered DrugsDrugs that can be self-administered by the patient, such as those in pill form or in self-injection form, are generally not covered by Part B. However, there are a limited number of self-administered drugs that are covered because the Medicare statute explicitly provides coverage. Examples of drugs that are usually self-administered by the patient and are covered include: blood clotting factors, drugs used in immunosuppressive therapy, erythropoietin for dialysis patients, osteoporosis drugs for certain homebound patients, and certain oral cancer drugs.Generally, when a physician gives a patient pills or other oral medication, these drugs are excluded from coverage since the form of the drug is self-administered. Similarly, if a physician gives a patient an injection that is usually self-injected, this drug is excluded from coverage. If a drug is available in both oral and injectable forms, the injectable form of the drug must be medically reasonable and necessary as compared to using the oral form.In the past, Medicare Administrative Contractors (MACs) may have provided payment for one or perhaps several doses of a drug that would otherwise not be paid for because the drug is usually self-administered. For example, during a brief time when the patient is being trained under the supervision of a physician in the proper technique for self-administration.Medicare will no longer pay for such doses.In addition,Medicare will no longer pay for any drug when it is administered on an outpatient emergency basis if the drug is excluded because it is usually self-administered by the patient.To determine if a drug or biological cannot be self-administered, please refer to the CMS IOM Publication 100-02, Chapter 15, Section 50.2. For additional information, please refer to Local Coverage Articles A53127, Self-Administered Drug Exclusion List.Incident To RequirementsIn order to meet all the general requirements for coverage under the incident-to provision, an FDA approved drug or biological must be of a form that is not usually self-administered, must be furnished by a physician and must be administered by a physician or by auxiliary personnel employed by him/her under his/her personal supervision. To be covered, drugs and biologicals must be an expense to the physician billing for the service.If a patient purchases a drug and the physician administers it, the physician cannot bill Medicare for the drug. However, the administration of the drug, regardless of the source, is a service that represents an expense to the physician. Therefore, administration of the drug is payable if the drug would have been covered when purchased by the physician.Whole blood is a biological that cannot be self-administered and is covered when furnished incident to a physician's service. Payment may also be made for blood fractions if all coverage requirements are satisfied.Approved Use of DrugUse of the drug or biological must be safe and effective and otherwise medically reasonable and necessary. Drugs or biologicals approved for marketing by the FDA are considered safe and effective for purposes of this requirement when used for indications specified on the labeling. Therefore, payment may be made for an FDA approved drug or biological if:It was injected on or after the date of the FDA's approval;It is medically reasonable and necessary for the individual patient; andAll other applicable coverage requirements are met.Unlabeled Use of DrugAn unlabeled use of a drug is a use that is not included as an indication on the drug's label as approved by the FDA. The FDA approved drugs used for indications other than what is indicated on the official label may be covered under Medicare if the contractor determines the use to be medically accepted, taking into consideration the major drug compendia, authoritative medical literature and/or accepted standards of medical practice. The following guidelines identify three categories in which medications would not be medically reasonable and necessary according to accepted standards of medical practice.Not for a Particular Illness - Medications given for a purpose other than the treatment of a particular condition, illness, or injury are not covered (except for certain immunizations).Injection Method Not Indicated - Medication given by injection (parenterally) is not covered if standard medical practice indicates that the administration of the medication by mouth (orally) is effective and is an accepted or preferred method of administration.Excessive Medications  Medications administered for treatment of a disease which exceed the frequency or duration of injections indicated by accepted standards of medical practice are not covered.If a medication is determined not to be medically reasonable and necessary for diagnosis or treatment of an illness or injury according to these guidelines, the entire charge will be excluded (i.e., for both the drug and its administration). Also excluded from payment is any charge for other services (such as office visits) which are primarily for the purpose of administering a noncovered injection (i.e., an injection that is not medically reasonable and necessary for the diagnosis or treatment of an illness or injury).Payment for Antigens and ImmunizationsAntigens - Payment may be made for a reasonable supply of antigens (defined as not more than a 12-month supply) that have been prepared for a particular patient at any one time if:the antigens are prepared by a physician who is a doctor of medicine or osteopathy, andthe physician who prepared the antigens has examined the patient and has determined a plan of treatment and a dosage regimen.Antigens must be administered in accordance with the plan of treatment and by a doctor of medicine or osteopathy or by a properly instructed person (who could be the patient) under the supervision of the doctor.Please refer to LCDs L36240, Allergen Immunotherapy for reasonable and necessary requirements.Immunizations - Vaccinations or inoculations are excluded as immunizations unless they are directly related to the treatment of an injury or direct exposure to a disease or condition, such as antirabies treatment, tetanus antitoxin or booster vaccine, botulin antitoxin, antivenin sera, or immune globulin. In the absence of injury or direct exposure, preventive immunization (vaccination or inoculation against such diseases as smallpox, polio, diphtheria, etc.) is not covered. However, pneumococcal, hepatitis B, and influenza vaccines are exceptions to this rule.For additional information, please refer to Billing and Coding Articles A58872, Tetanus Immunization.Less Than Effective DrugA drug that is less than effective is not eligible for reimbursement (i.e., a drug that the FDA has determined to lack substantial evidence of effectiveness for all labeled indications). Any other drug product that is identical, similar, or related, will also be ineligible.If a physician is contemplating the off-label use of an FDA approved drug or biological in an anti-cancer chemotherapeutic regimen, the subsequent steps should be followed:Initially, one of the CMS approved drug compendia should be consulted to find a list of approved agents and their list of indications.Note:Refer to the CMS IOM Publication 100-02, Chapter 15, Section 50.4.5.B for recent revisions to the Compendia List. Authoritative lists of Compendia will be adjusted, as needed, according to the process defined in the CMS IOM Publication 100-02, Chapter 15, Section 50.4.5.1.In review of these compendia, if the use of the chemotherapeutic agent is supported by any one of these compendia AND the use is NOT listed as not indicated, unsupported, not recommended or equivalent terms in any of the other approved compendia, the agent may be approved.In those circumstances when the off-label use of the chemotherapeutic agent is not listed in any of the compendia or is listed as having insufficient data or as investigational, the use of the drug may be supported by clinical research that appears in peer-reviewed medical literature. Peer-reviewed medical literature includes scientific, medical, and pharmaceutical publications in which original manuscripts are published, only after having been critically reviewed for scientific accuracy, validity, and reliability by unbiased independent experts prior to publication. In-house publications of pharmaceutical manufacturing, sales, or distribution companies or abstracts (including meeting abstracts) are excluded from consideration.In determining whether an off-label use is supported, the contractor will consider (among other things) the following:Whether the clinical characteristics of the beneficiary and the cancer are adequately represented in the published evidence.Whether the administered chemotherapy regimen is adequately represented in the published evidence.Whether the reported study outcomes represent clinically meaningful outcomes experienced by patients.Whether the study is appropriate to address the clinical question.The contractor will consider:Whether the experimental design, in light of the drugs and conditions under investigation, is appropriate to address the investigative question. (For example, in some clinical studies, it may be unnecessary or not feasible to use randomization, double blind trials, placebos, or crossover);that non-randomized clinical trials with a significant number of subjects may be a basis for supportive clinical evidence for determining accepted uses of drugs; andthat case reports are generally considered uncontrolled and anecdotal information and do not provide adequate supportive clinical evidence for determining accepted uses of drugs.Coverage will be determined based on the results of peer reviewed medical literature published in the regular editions of the following publications, not to include supplement editions privately funded by parties with a vested interest in the recommendations of the authors: