Highmark Medicare Services

12102, 12202, 12302, 12501, 12301, 12201

MAC Part A & B

L27473

Approved Drugs and Biologicals

L27473

CPT codes, descriptions and other data only are copyright 2007 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

Title XVIII of the Social Security Act, Section 1862(a)(1)(A) 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.

Title XVIII of the Social Security Act, Section 1862(a)(7).  This section excludes routine physical examinations.

Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

CMS On-line Manual Pub. 100-2, Chapter 1, Section 120.

CMS On-line Manual Pub. 100-2, Chapter 15, Section 50, 50.1, 50.2, 50.3, 50.4, 50.4.1, 50.4.2, 50.4.3, 50.4.4, 50.4.4.1, 50.4.4.2, 50.5, 50.5.2.1, 60, 60.1

CMS On-line Manual Pub. 100-2, Chapter 16, Section 10.

CMS On-line Manual Pub. 100-2, Chapter 16, Section 180.

CMS On-line Manual Pub. 100-4, Chapter 12, Section 30.5F

CMS On-line Manual Pub. 100-4, Chapter 17, Section 10.

Pennsylvania, Maryland, District of Columbia, Delaware

Central Office

For services performed on or after 07/11/2008

N/A

For services performed on or after 08/01/2008

08/31/2008

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.

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 type 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 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 immunizations; and
• They have not been determined by the FDA to be less than effective.

Drugs that are usually self-administered by the patient, such as those in pill form, or are used for self-injection, 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, and osteoporosis drugs for certain homebound patients.

Note: Payment for the administration of a nonchemotherapy injection or infusion may be paid when provided on the same day as an E and M service, other than 99211, if the E and M service represents a separate and significantly identifiable service. Modifier 25 must be used. A different diagnosis code is not required.

Indications

1. Drugs and biologicals must be determined to meet the statutory definition. Under the statute, payment may be made for a drug or biological only where it is included, or approved for inclusion, in the latest official edition of the United States Pharmacopoeia-National Formulary (USP-NF), the United States Pharmacopoeia Drug Information (USP DI), 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. Inclusion in such a reference is a necessary condition for a product to be considered a drug or biological under the Medicare program. However, the product must also meet all other program requirements to be determined to be a drug or biological.

   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.

2. To determine if a drug or biological cannot be self-administered, please consult CMS Internet Only Manual (IOM) Pub. 100-2, Chapter 15, Section 50.2. This information is also available at http://www.highmarkmedicareservices.com/drug-bio/drug-regs.html.

   Whole blood is a biological that cannot be self-administered and is covered when furnished incident to a physician's services. Payment may also be made for blood fractions if all coverage requirements are satisfied.

3. In 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 cannot be self-administered 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. For example, if a patient purchases a drug and the physician administers it, the drug is not covered. 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 if the physician purchased it.

4. Use of the drug or biological must be safe and effective and otherwise reasonable and necessary. Drugs or biologicals approved for marketing by the Food and Drug Administration (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 reasonable and necessary for the individual patient; and
   • All other applicable coverage requirements are met.

   An 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. 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 reasonable and necessary according to accepted standards of medical practice.

   • Not for 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 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 reasonable and necessary for the diagnosis or treatment of an illness or injury).

   Antigens -- Payment may be made for a reasonable supply of antigens that have been prepared for a particular patient if:

   1. the antigens are prepared by a physician who is a doctor of medicine or osteopathy, and
   2. the 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.

   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 virus vaccines are exceptions to this rule.

5. Drugs that are usually self-administered by the patient are not covered by Medicare Part B unless the statute provides for such coverage. This includes blood clotting factors, drugs used in immunosuppressive therapy, erythropoietin for dialysis patients, and certain oral anti-cancer drugs, and oral anti-nausea drugs when used in certain situations.

Limitations

A drug that is less than effective is not eligible for reimbursement, i.e., one that the Food and Drug Administration 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.

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, unless administered to the patient in an emergency situation.

If a use is identified as not indicated by CMS or the FDA or if a use is specifically identified as not indicated (in one or more of the three compendia mentioned) or if it is determined (based on peer reviewed medical literature) that a particular use of a drug is not safe and effective, the off-label usage is not supported and, therefore, the drug is not covered. In this instance, the administration is also not covered.

For Cancer Chemotherapeutic Agent Coverage, see LCD L27477.

Chemotherapy (Outpatient) Doctor Office Visits

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

N/A

Conditions that are not listed in the "ICD-9-CM Codes that Support Medical Necessity" section of this policy.

1. All documentation must be maintained in the patient’s medical record and available to the contractor upon request.
   
   
2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name dates of service(s)). The record must include the physician or non-physician practitioner responsible for and providing the care of the patient.
   
   
3. The submitted medical record should support the use of the selected ICD-9-CM code(s). The submitted CPT/HCPCS code should describe the service performed.
   
   
4. When a portion of the drug is discarded, the medical record must clearly document the amount administered and the amount wasted.
   
   
5. Physicians or suppliers must be able to produce copies of relevant supporting full-text articles, guidelines, and/or supporting literature when an unlabeled use does not appear in at least one of the three major compendia mentioned or is listed as insufficient data or investigational. Abstracts, opinions, or book chapters are not acceptable. Availability of this specifically required documentation is indicated by use of the KX modifier on the submitted claim. This material must be submitted whenever requested.

In accordance with CMS Ruling 95-1 (V), utilization of these services should be consistent with locally acceptable standards of practice.

Other Contractor’s Policies

Highmark Medicare Services Contractor Medical Directors

This policy does not reflect the sole opinion of the contractor or Contractor Medical Directors. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups, which includes representatives from the appropriate specialty (ies).

CAC/IAC Distribution:  04/01/2008

05/15/2008

05/23/2008

L27473

07/31/2008

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