Billing and Coding: Approved Drugs and Biologicals; Includes Cancer
Chemotherapeutic Agents

**Notice:** 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; and
  * They have not been determined by the United States (U.S.) Food and Drug Administration (FDA) to be less than effective.

  
**Definition of Drug or Biological**

Drugs 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 Drugs**

Drugs 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 Requirements**

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 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 Drug**

Use 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; and
  * All other applicable coverage requirements are met.

  
**Unlabeled Use of Drug**

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. 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
non-covered 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 Immunizations**

Antigens - 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, and
  * 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.

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 Drug**

A 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:**

  1. 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.

  2. 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:  
  

    1. 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);
    2. 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; and
    3. that 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:  
  

    * _American Journal of Medicine_
    * _Annals of Internal Medicine_
    * _Annals of Oncology_
    * _Annals of Surgical Oncology_
    * _Biology of Blood and Marrow Transplantation_
    * _Blood_
    * _Bone Marrow Transplantation_
    * _British Journal of Cancer_
    * _British Journal of Hematology_
    * _British Medical Journal_
    * _Cancer_
    * _Clinical Cancer Research_
    * _Drugs_
    * _European Journal of Cancer (formerly The European Journal of Cancer and Clinical Oncology)_
    * _Gynecologic Oncology_
    * _International Journal of Radiation, Oncology Biology, and Physics_
    * _The Journal of the American Medical Association_
    * _Journal of Clinical Oncology_
    * _Journal of the National Cancer Institute_
    * _Journal of the National Comprehensive Cancer Network (NCCN)_
    * _Journal of Urology_
    * _Lancet_
    * _Lancet Oncology_
    * _Leukemia_
    * _The New England Journal of Medicine_
    * _Radiation Oncology  
  
_

  3. When the provider decides to use an FDA approved chemotherapeutic agent off-label, the evidence used to make that decision (information in the compendia, established guidelines [for example, guidelines developed by the NCCN], research studies in approved peer-reviewed medical journals, etc.) must be available upon request. Physicians or suppliers are expected to 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 approved compendia, or the unlabeled use is listed in the compendia as having insufficient data or as investigational. Abstracts, opinions, or book chapters are not acceptable.  
  

  4. If a use is identified as not indicated by the CMS or the FDA, specifically identified as not indicated in one or more compendia listed, or the contractor determines, 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. Therefore, the drug is not covered.

  
**Hydration Administration (CPT codes 96360 and 96361)**

Medicare currently allows separate payment of hydration therapy provided
sequentially (but not concurrently) to chemotherapy infusion.

CPT codes 96360 and 96361 are intended to report a hydration intravenous (IV)
infusion consisting of a prepackaged fluid and/or electrolyte solutions (e.g.,
normal saline, D5-1/2 normal saline +30 mEq KC1/liter) but are not used to
report infusion of drugs or other substances. Hydration IV infusion typically
requires direct physician supervision for purposes of consent, safety
oversight or intra-service supervision of staff. Typically, such infusions
require little special handling to prepare or dispose of, and staff which
administer these do not typically require advanced training. After initial set
up, infusion typically entails little patient risk and thus little monitoring.
Further instructions regarding hydration and its use may be found in the CPT
Manual, particularly with regard to facilities. In addition, certain coding
combinations are not permissible by the National Correct Coding Initiative
(NCCI) edits.

**JW Modifier Requirement**

The CMS encourages physicians, hospitals and other providers and suppliers to
care for and administer drugs and biologicals to patients in such a way that
they can use drugs or biologicals most efficiently, in a clinically
appropriate manner. According to the Social Security Act (SSA) Section
1861(v)(1)(A), the reasonable cost of any service is the cost actually
incurred, excluding any part of an incurred cost found to be unnecessary in
the efficient delivery of needed health services. On this basis, the
definition of a reasonable cost for a drug or biological is met when the
beneficiary is administered the required dose of the drug or biological in an
efficient manner.

Effective January 1, 2017, when billing for drugs and biologicals (except
those provided under the Competitive Acquisition Program for Part B drugs and
biologicals [CAP]), **the use of the JW modifier to identify unused drugs or
biologicals from single use vials or single use packages that are
appropriately discarded is required.** The discarded amount shall be billed on
a separate claim line using the JW modifier. Providers are required to
document the discarded amounts of drugs or biologicals in the patient's
medical record.

The following elements must be followed in order for the discarded amount to
be covered.

  1. The vial/package must be a single-use vial/package.
  2. The units billed must correspond with the smallest dose (vial) available for purchase from the manufacturer/supplier that could provide the appropriate dose for the patient.
  3. The left-over amount must actually be discarded and may not be used for another patient regardless of whether or not that other patient has Medicare.

A situation in which the JW modifier is not permitted is when the actual dose
of the drug or biological administered is less than the billing unit. For
example, one billing unit for a drug is equal to 10mg of the drug in a single
use vial. A 7mg dose is administered to a patient while 3mg of the remaining
drug is discarded. The 7mg dose is billed using one billing unit that
represents 10mg on a single line item. The single line item of 1 unit would be
processed for payment of the total 10mg of drug administered and discarded.
Billing another unit on a separate line item with the JW modifier for the
discarded 3mg of drug is not permitted because it would result in overpayment.
Therefore, when the billing unit is equal to or greater than the total actual
dose and the amount discarded, the use of the JW modifier is not permitted.  
  
**JZ Modifier Requirement**

Effective 07/01/2023, providers must report the JZ modifier (Zero drug amount
discarded/not administered to any patient) when there is no wastage to report.
This must be reported on all claims that bill for drugs separately payable
under Part B when there is no discarded amount from single-dose containers or
single-use packages. For the amount administered, the claim line must include
the billing and payment code, the JZ modifier showing no discarded amounts,
and the number of units administered in the units' field.

The JW and JZ modifier policy does not apply for drugs that are not separately
payable, such as packaged OPPS or ASC drugs, or drugs administered in the FQHC
or RHC setting or to drugs assigned status indicator N (Items and Services
Packaged into APC Rates) under the OPPS. Similarly, the JW and JZ modifiers do
not apply to drugs assigned payment indicator "N1" (ASC).  
  
**Coding Guidance**

The HCPCS/CPT code(s) may be subject to NCCI edits. This information does not
take precedence over NCCI edits. Please refer to the NCCI for correct coding
guidelines and specific applicable code combinations prior to billing
Medicare.

All injection claims must include the specific name of the drug and dosage.
Identification of the drug enables proper payment for the services.

Services related to non-covered services or drugs are also not covered (e.g.,
administration services).

When the drug is purchased by the beneficiary, or when the drug was supplied
without charge by the manufacturer, it should NOT be billed to Medicare by the
provider, even with a submitted charge of $0.00.  
  
**Reporting the Appropriate Number of Units**

If the "J" code descriptor can be multiplied to reflect the dosage being
administered, use the J-code, with the appropriate number of units which
reflect the dosage given.

It is not appropriate to use the "J" code with a multiplier in the units field
when there is another "J" code which more closely describes the amount given.

It is not appropriate to bill for the full amount of a drug when it has been
split between two or more patients. Bill only for the amount given to each
beneficiary.  
  
**Reporting Not Otherwise Classified (NOC) Code(s)**

Please refer to Billing and Coding Articles A59073, Complex Drug
Administration Coding for information regarding billing NOC codes.  
  
**Reporting Evaluation and Management (E/M) Visit on the Same Day as Drug
Administration Services**

The E/M service for CPT code 99211 cannot be paid if it is billed with a drug
administration service. This includes a chemotherapy or nonchemotherapy drug
infusion service, as well as a therapeutic or diagnostic injection code.

When a medically necessary, significant and separately identifiable E/M
service (which meets a higher complexity level than CPT code 99211) is
performed, in addition to drug administration service(s), the appropriate E/M
CPT code should be reported with modifier -25. Documentation should support
the level of E/M service billed. For an E/M service provided on the same day,
a different diagnosis is not required.

Please refer to the CMS IOM Publication 100-04, Chapter 12, Sections 20.3.B,
30.5.C, D, F, 30.6.6 and 30.6.7.D for additional information on E/M services
furnished on the same day as drug administration services.

Please refer to Billing and Coding Articles A59073, Complex Drug
Administration Coding for information regarding chemotherapy and
nonchemotherapy drug administration codes.  
  
**Reporting Multiple Infusions or Injections**

When administering multiple infusions, injections, or combinations, only one
"initial" drug administration service code should be reported per patient per
day, unless protocol requires that two separate IV sites must be used. The
initial code is the code that best describes the key or the primary reason for
the encounter and is reported irrespective of the order in which the infusions
or injections occur.

If an injection or infusion is of a subsequent or concurrent nature, even if
it is the first such service within that group of services, the subsequent or
concurrent code from the appropriate section should be reported (e.g., the
first IV push given subsequent to an initial one-hour infusion is reported
using a subsequent IV push code).

Report separate codes for each parenteral method of administration employed
when therapy is administered by different techniques. Medications (e.g.,
antibiotics, steroidal agents, antiemetics, narcotic analgesics) administered
independently or sequentially as supportive management of chemotherapy or
certain monoclonal antibody administration should be separately reported using
CPT codes 96360, 96361, 96365 or 96379 as appropriate. Report the specific
service as well as the code(s) for the specific substance or drug(s) provided.

There is no code for concurrent administration of chemotherapeutic drugs.
Multiple drugs given at the same session are considered to be sequential,
rather than concurrent. The services are reported with CPT code 96411 for IV
push administration of additional drugs/substances at the same session and CPT
code 96417 for IV infusion administration of additional drugs/substances at
the same session.  
  
**Modifier EJ - Subsequent Dose in a Series**

To distinguish between the initial dose of a drug and subsequent doses of that
same drug used in a sequential series in the treatment of a condition, the
modifier EJ should be used to identify the subsequent doses. Do not report an
initial dose of a drug with the -EJ modifier.  
  
**Reporting Infusion Time(s) and Fluid**

When reporting codes for which infusion time is a factor, use the actual time
over which the infusion is administered. Services leading up to the infusion
and to conclude the infusion are included in the infusion service and not
separately reported. The services include starting the IV and monitoring the
patient post-infusion. Standard clinical practice is to document the actual
start and stop times in the patient's medical records. This would ensure that
the times are accurate in the event there are interruptions or delays during
the infusion process. Flow sheets kept by personnel during infusion services
help to identify proper infusion times. Time may be documented with start and
stop times or with total time.

The first hour initial codes are defined as "up to one hour". This eliminates
the need to report the 52 modifier to inform Medicare of durations of less
than one hour.

Report the additional hour of chemotherapy administration with CPT code 96415
for infusion intervals of greater than 30 minutes beyond one hour increments.
Report CPT code 96415 in conjunction with the initial chemotherapy
administration CPT code 96413.

The fluid used to administer the drug(s) is considered incidental hydration
and is not separately reportable. An infusion consisting of three substances
in a single bag is not intended to be reported as three separate infusion
services.

Do not report the initial hydration CPT code 96360 if performed as a
concurrent infusion service. Report the additional hour of hydration with CPT
code 96361 to identify hydration furnished as a secondary or subsequent
service after a different initial service is administered through the same IV
access.

Report the additional hour or additional sequential CPT code 96366, 96367,
96375 or 96376 (as applicable) to identify therapeutic, prophylactic or
diagnostic nonchemotherapy drug infusion or injection when provided as a
secondary or subsequent service in association with chemotherapy
administration CPT code 96413.

Report the additional sequential infusion chemotherapy administration CPT code
96417 in conjunction with the initial chemotherapy administration CPT code
96413. Report CPT code 96417 only once per sequential infusion.

Report irrigation CPT code 96523 if it is the only service provided that day.
If there is an E/M visit or other drug administration service provided on the
same day, payment for CPT code 96523 is included in the payment for the other
service.

Report CPT code 36593 for declotting a catheter or port.

Please refer to Billing and Coding Articles A59073, Complex Drug
Administration Coding for additional information regarding chemotherapy and
nonchemotherapy drug administration codes.  
  
**Services Not Separately Reportable**

If performed to facilitate an infusion or injection of a drug or biological,
the following are included and are not reported separately:

  * Use of local anesthesia
  * IV start
  * Access to indwelling IV, subcutaneous catheter or port
  * Flush at conclusion of infusion
  * Standard tubing, syringes and supplies
  * Preparation of chemotherapy agent(s)

  
**Biosimilar Modifiers**

Effective on April 1, 2018, providers and suppliers will no longer be required
to report modifiers with HCPCS codes for biosimilars (reference the CMS
Transmittal 3966, CR 10454).  
  
**Compounded Drugs**

Compounded drugs are drugs not reconstituted as labeled in order to create a
combination of drugs or vary the concentration/volume. As such, compounded
medications do not have a National Drug Code (NDC) number, an average sales
price (ASP) or an average wholesale price (AWP). Compounded drugs are
contractor priced on invoice.

Compounded medications created by a pharmacist in accordance with the Federal
Food, Drug and Cosmetic Act may be covered under Medicare. A compounded drug
is defined as a combination of drugs mixed by a pharmacist. This definition
does not include a simple reconstitution of a drug as directed by the package
insert. Compounded drugs that are self-administered are not a covered Medicare
service.

**Coding Guidance:**

  1. Compounded drugs should be reported with HCPCS code J7999 on a single claim line.
  2. Place quantity = '1' on the line billed for J7999. 
    1. Enter the name, total dose (in mg or mcg) of each drug of the refill, and invoice amount in Box 19 of the CMS 1500 or the appropriate comment loop of electronic claims.
    2. Covered compounded single or combination drugs should be billed on a single detail line.
  3. Do not list the drug separately from the dosage, such as morphine bupivacaine baclofen sufentanil 20mg 6mg 4mcg 5mcg. This format will be denied.
  4. List each drug with the applicable dosing amount, for example morphine 20mg, bupivacaine 6 mg, baclofen 4 mcg, sufentanil 5 mcg.
  5. The ICD-10-CM code used on each detailed line must represent the condition treated by the drug(s) billed on that detail line.
  6. Drug doses used in narrative description must be in mgs or mcgs only. Do not report gs.

  
**Use of Infusion Pumps**

Medicare will consider infusion pumps and associated services medically
reasonable and necessary for the conditions listed in the Medicare National
Coverage Determination Manual Pub.100-03, Chapter 1, Section, 280.14.

The use of compounded drugs has been especially prevalent in the filling of
infusion pumps. The following methods are appropriate when billing for drugs
used in infusion pumps:

  1. When submitting a claim for compounded drug(s) for a single agent or a combination of agents, providers must use HCPCS code J7999. Even though the compound is similar to or includes a drug with a specific HCPCS code, providers must use HCPCS code J7999, Compounded drug, not otherwise classified, for reimbursement of the compounded drug. **The KD modifier must be appended to indicate the drug will be administered through Durable Medical Equipment (DME) such as an infusion pump**.
  2. When a non-compounded drug is used (a true 'off -the -shelf' product without compounding), the specific HCPCS code for the drug may be used. 

**Note:** Compounded drugs and/or combination drugs used in infusion pumps
should be reported with HCPCS code J7999 and **appended with modifier KD to
indicate the drugs were infused through DME**.

**Documentation Requirements**

  1. All documentation must be maintained in the patient's medical record and made 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 documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
  3. The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.