Persius/hicric huggingface dataset:
Vacuum Erection Devices (VED) - Policy Article

**NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES**

For any item to be covered by Medicare, it must 1) be eligible for a defined
Medicare benefit category, 2) be reasonable and necessary for the diagnosis or
treatment of illness or injury or to improve the functioning of a malformed
body member, and 3) meet all other applicable Medicare statutory and
regulatory requirements. Information provided in this policy article relates
to determinations other than those based on Social Security Act 1862(a)(1)(A)
provisions (i.e. "reasonable and necessary").

Vacuum erection devices (L7900) and related supplies are considered Prosthetic
Devices under the Prosthetic Devices benefit category (Social Security Act
1861(s)(8)). For dates of service on or after July 1, 2015, codes L7900 and
L7902 are statutorily non-covered based on the Achieving a Better Life
Experience (ABLE) Act of 2014 (see Social Security Act 1834(a)(1)(I)).

**REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO FINAL RULE 1713 (84 Fed.
Reg Vol 217)**

Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a
Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the
DME MACs provide a list of the specified codes, which is periodically updated.
The required Face-to-Face Encounter and Written Order Prior to Delivery List
list is available [here](https://www.cms.gov/Research-Statistics-Data-and-
Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Medical-
Review/FacetoFaceEncounterRequirementforCertainDurableMedicalEquipment).

Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol
217) that do not meet the face-to-face encounter and WOPD requirements
specified in the LCD-related Standard Documentation Requirements Article
(A55426) will be denied as not reasonable and necessary.

If a supplier delivers an item prior to receipt of a WOPD, it will be denied
as not reasonable and necessary. If the WOPD is not obtained prior to
delivery, payment will not be made for that item even if a WOPD is
subsequently obtained by the supplier. If a similar item is subsequently
provided by an unrelated supplier who has obtained a WOPD prior to delivery,
it will be eligible for coverage.

**POLICY SPECIFIC DOCUMENTATION REQUIREMENTS**

In addition to policy specific documentation requirements, there are general
documentation requirements that are applicable to all DMEPOS policies. These
general requirements are located in the DOCUMENTATION REQUIREMENTS section of
the LCD.

Refer to the LCD-related Standard Documentation Requirements article, located
at the bottom of this Policy Article under the Related Local Coverage
Documents section for additional information regarding GENERAL DOCUMENTATION
REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS.

Suppliers should contact the Pricing, Data Analysis and Coding (PDAC)
contractor for guidance on the correct coding of these items.
Billing and Coding: Nerve Blockade for Treatment of Chronic Pain and
Neuropathy

The following billing and coding guidance is to be used with its associated
Local Coverage Determination.

LCD L35457 states, "Nerve blockade and/or electrical stimulation are non-
covered for the treatment of metabolic peripheral neuropathy. The peer-
reviewed medical literature has not demonstrated the efficacy or clinical
utility of nerve blockade or electrical stimulation, alone or used together,
in the diagnosis and/or treatment of neuropathic pain."

The use of peripheral nerve blocks for treating diabetic neuropathy is not
considered reasonable and/or necessary and is not covered by Medicare Part A
or B. Such use of peripheral nerve blocks is not supported by the current peer
reviewed, published, evidence based scientific literature nor by specialty
society guidelines. Claims are subject to review and recoupment.  
  
This notification does not affect those regional/local blocks done as part of
an operative procedure (for example wound debridement in the operating room)
when performed as an adjunct to or the sole means of regional/local anesthesia
for the procedure.

For somatic nerve blocks, it is inappropriate to bill for fluoroscopy (CPT
codes 77002 or 77003) with a 59 modifier when the procedure(s) billed on that
date of service for the same patient by the same provider are included in the
CPT description of the procedure(s) performed.

**Documentation Requirements**

  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 diagnosis code(s). The submitted CPT/HCPCS code should describe the service performed. 

**Sources:**

  1. Neurology 2011;76;1758; V. Bril, J. England, G.M. Franklin, et al. Evidence-based guideline: [Treatment of painful diabetic neuropathy: Report of the American Academy of Neurology, the American Association of Neuromuscular and Neurodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3100130/) This information is current as of February 7, 2013
  2. American Family Physician 2010;82(2):151-158 T. Lindsay, B. Rodgers, V. Savath, K. Hettinger [Treating Diabetic Peripheral Neuropathic Pain](https://www.aafp.org/afp/2010/0715/p151.html)
Non-Payment for Prefabricated Splints

Noridian has noted that providers have been advised by some coding sources to
report a splint application code for the application of "off the shelf" or
pre-packaged splints. While it may be appropriate to bill for the actual
splint, Noridian strongly disagrees with the advice to bill separately for the
application of these splints. The application of the pre-packaged splint is a
packaged service when performed on the same day as an E/M service or other
procedure but, in no case, may this type of splint application be separately
billed.  
  
The CPT codes: 29105, 29125, 29126, 29130, 29131, 97760, 97799 are not
appropriate to bill in addition to a splint code that has a "fitting" included
in the descriptor. Be aware that a large range of "L" codes do include
"fitting" in the descriptor
Therapy Driving Evaluations Medicare does not reimburse evaluations performed
solely to assess a beneficiary's ability to drive a vehicle. In order for a
service to be covered, the service must have a benefit category in the statute
Title 18 of the Social Security Act (SSA), it must not be excluded, and it
must be reasonable and necessary. There is no benefit category for driving
evaluations.  
  
In addition, both screening (except as specifically exempted by statute) and
routine physical examinations are excluded from coverage. 42 United States
Code (USC) 1395y (a) describes routine physical checkups as:  
  
1\. Examinations performed for a purpose other than treatment or diagnosis of
a specific illness, symptom, complaint, or injury.  
2\. Examinations required by insurance companies, business establishments,
government agencies or other third parties.  
  
For Medicare purposes, when services provided are related solely to driving,
they are not reasonable or necessary for the diagnosis or treatment of an
illness or injury and are excluded from coverage under the program by SSA
1862(a)(1).  
  
This is a statutory exclusion. The beneficiary is liable for the charges and
no Advance Beneficiary Notice of Noncoverage (ABN) is required. However,
providers are encouraged to provide a voluntary ABN. Append modifier GX
(Notice of Liability Issue, Voluntary under Payer Policy) to any billed line
item.  
  
**Sources:**  
  
 CMS Internet Only Manual (IOM), Medicare Claims Processing Manual,
Publication 100-04, Chapter 1 Section 60  
 Social Security Act (SSA) Sections 1861 and 1862(a)(1)  
 42CFR 411.15(a)
Billing and Coding: Therapy Driving Evaluations Medicare does not reimburse
evaluations performed solely to assess a beneficiary's ability to drive a
vehicle. In order for a service to be covered, the service must have a benefit
category in the statute Title 18 of the Social Security Act (SSA), it must not
be excluded, and it must be reasonable and necessary. There is no benefit
category for driving evaluations.  
  
In addition, both screening (except as specifically exempted by statute) and
routine physical examinations are excluded from coverage. 42 United States
Code (USC) 1395y (a) describes routine physical checkups as:  
  
1\. Examinations performed for a purpose other than treatment or diagnosis of
a specific illness, symptom, complaint, or injury.  
2\. Examinations required by insurance companies, business establishments,
government agencies or other third parties.  
  
For Medicare purposes, when services provided are related solely to driving,
they are not reasonable or necessary for the diagnosis or treatment of an
illness or injury and are excluded from coverage under the program by SSA
1862(a)(1).  
  
This is a statutory exclusion. The beneficiary is liable for the charges and
no Advance Beneficiary Notice of Noncoverage (ABN) is required. However,
providers are encouraged to provide a voluntary ABN. Append modifier GX
(Notice of Liability Issue, Voluntary under Payer Policy) to any billed line
item.  
  
**Sources:**  
  
 CMS Internet Only Manual (IOM), Medicare Claims Processing Manual,
Publication 100-04, Chapter 1 Section 60  
 Social Security Act (SSA) Sections 1861 and 1862(a)(1)  
 42CFR 411.15(a)
Investigational Device Exemption Requests - Medical Policy Article ** Clinical
Study Request**  
Compliance with the instructions contained in the Medicare Claims Processing
Manual (Publication 100-04, chapter 32, sections 68 and 69) is a requirement
for both National Government Services and our providers. Providers are
required to notify Medicare about clinical studies under four conditions:  
  
Effective for dates of service on or after January 1, 2015, providers that
participate in an IDE clinical study may file claims for CMS category B IDEs
approved by CMS (or its designated entity) and listed on the CMS Coverage
Website. This applies to all IDEs assigned an identifying number beginning
with a G and a CMS category B (B1, B2, B3, or B4) by the Food and Drug
Administration (FDA).  
  
Effective for dates of service on or after January 1, 2015, Institutional
providers and practitioners shall submit claims only for routine care items
and services in Category A IDE device studies approved by CMS (or its
designated entity) and listed on the CMS Coverage Website.  
  
Effective for dates of service on or after January 1, 2015, providers
participating in post-market approval studies or registries of carotid stents
may file claims for studies approved by CMS (or its designated entity) and
listed on the CMS Coverage Website.  
  
Effective for dates of service on or after January 1, 2015, poviders
participating in studies for proximal embolic protection devices (EPDs) in
carotid artery stenting (CAS) procedures may file claims for studies approved
by CMS (or its designated entity) and listed on the CMS Coverage Website.  
  
 _Effective for Category A and B IDE studies approved by the FDA on or after
January 1, 2015, interested parties (i.e., study sponsors) that wish to seek
Medicare coverage in Category A or B IDE studies must submit a request for
review and approval via email to clinicalstudynotification@cms.hhs.gov or via
hard copy to the following address:  
  
Centers for Medicare and Medicaid Services Center for Clinical Standards and
Quality Director, Coverage and Analysis Group ATTN: Clinical Study
Certification  
Mail Stop: S3-02-01  
7500 Security Blvd. Baltimore, MD 21244_  
  
National Government Services will review renewal or modified clinical study
requests from hospitals and physicians in Connecticut, Illinois, Maine,
Massachusetts, Minnesota, New Hampshire, New York, Rhode Island, Vermont, and
Wisconsin. Clinical coverage determinations are applied uniformly across these
regions. If a study has been reviewed for another facility you may not be
required to submit study specific information. To reduce the amount of
information you are required to submit, please send the following inquiry to
National Government Services electronically prior to submitting a request for
authorization.  
  
 **Send email to** : NGS-IDE-Request@wellpoint.com OR fax to 315-442-4257.  
  
 **E-mail or FAX Subject line should include the type of request (Renewal or
Modifications) and the IDE Number.**
Billing and Coding: Drugs and Biologicals

This article contains coding and other guidelines that complement the Local
Coverage Determination (LCD) for Drugs and Biologicals, Coverage of, for Label
and Off-Label Uses.

**Coding Information:  
  
 _General Information_**  
  
Procedure codes may be subject to National Correct Coding Initiative (NCCI)
edits or OPPS packaging edits. Refer to NCCI and OPPS requirements prior to
billing Medicare.  
  
A claim submitted without a valid ICD-10-CM diagnosis code will be returned to
the provider as an incomplete claim under Section 1833(e) of the Social
Security Act.  
  
The diagnosis code(s) must best describe the patient's condition for which the
service was performed.

**_Intravenous in Lieu of Oral Formulation_**  
  
When billing for an IV drug which has an available oral form, please also
report an additional ICD-10-CM code to indicate that the oral route is not
appropriate, for example:  
  

K91.2 | POSTSURGICAL MALABSORPTION, NOT ELSEWHERE CLASSIFIED  
---|---  
K90.9 | INTESTINAL MALABSORPTION UNSPECIFIED  
T50.995A | ADVERSE EFFECT OF OTHER DRUGS, MEDICAMENTS AND BIOLOGICAL
SUBSTANCES, INITIAL ENCOUNTER  
Y63.6 | UNDERDOSING AND NONADMINISTRATION OF NECESSARY DRUG, MEDICAMENT OR
BIOLOGICAL SUBSTANCE  
Y63.8 | FAILURE IN DOSAGE DURING OTHER SURGICAL AND MEDICAL CARE  
Z87.19 | PERSONAL HISTORY OF OTHER DISEASES OF THE DIGESTIVE SYSTEM  
  
**  
Documentation Requirements:  
**  
The patient's medical record must contain documentation that fully supports
the medical necessity for services included within the LCD. (See "Indications
and Limitations of Coverage.") This documentation includes, but is not limited
to, relevant medical history, physical examination, and results of pertinent
diagnostic tests or procedures.  
  
The medical record must include the following information:

  * The name of the drug or biological administered;
  * The route of administration;
  * The dosage (e.g., mgs, mcgs, cc's or IU's);
  * The duration of the administration (for CPT codes that are time based); and

When modifier -JW is used to report that a portion of the drug or biological
is discarded, from single use vials, the medical record must clearly document
the amount administered and the amount wasted or discarded.  Effective July 1,
2023 (CR 13056) JZ Modifier is required on all claims that bill for drugs
separately payable under Medicare Part B when there are no discarded amounts
from single-dose containers or single-use packages.

**For claims submitted to the Part B MAC:**

**_Drugs with No Charges  
  
_ Effective for dates of service on or after 05/07/2018,** when a drug is
purchased by the beneficiary, or when the drug was supplied without charge by
the manufacturer, the drug should be billed using the appropriate HCPCS code
with a billed amount of $0.01.  

**For  dates of service prior to 05/07/2018,** drugs with no charge will be
accepted by Medicare even with a submitted charge of $0.00. However, the name
and dosage of the drug should be listed in the narrative record of the claim,
to avoid requests for additional information on the claim.
Coverage of Foot Care Services Noridian has noted, through Medical Review,
billing of foot care services as non-covered when documentation supports the
patient has complaints of associated foot pain. The purpose of this
educational article is to clarify coverage of foot care services related to
pain.  
  
The Medicare Benefit Policy Manual (MBPM) Chapter 15 section 290.C.1
_(http://www.cms.hhs.gov)_ states, "In certain circumstances, services
ordinarily considered to be routine may be covered if they are performed as a
necessary and integral part of otherwise covered services, such as diagnosis
and treatment of ulcers, wounds, or infections." In this regard, foot care
services associated with a patient's complaints of pain would _not_ be
considered routine in nature. Pain may indicate a problem, such as an ulcer or
infection, which is necessary to evaluate. If pain is associated with the
reason for the foot care, it is reasonable and necessary for the medical
professional to assess and evaluate the pain, and subsequently treat both the
pain and the cause of the pain if possible.  
  
For all other covered indications for foot care services, including
presumption of coverage guidelines, as well as foot care excluded from
Medicare coverage, refer to the MBPM Chapter 15 section 290.  
**  
Source:  
Medicare Benefit Policy Manual (MBPM) Chapter 15 section 290  
Social Security Act (SSA) Title XVIII section 1862(a)(1)(A)**
Sipuleucel-T (Provenge) - Coverage Criteria for Prostate Cancer 
Clarification

Sipuleucel-T (Provenge) is an autologous cellular immunotherapy, FDA-approved
for the treatment of asymptomatic or minimally symptomatic metastatic castrate
resistant (hormone refractory) prostate cancer.

  
The production of Sipuleucel-T involves collection of the patient's own cells
(leukapheresis), culture with a proprietary antigen complex, and re-infusion
of the "antigen-activated" patient cells back to the donor. Provenge is
administered as three intravenous infusions, generally two weeks apart. When
infused back into the patient, usually three days after leukapheresis, the
patient-specific medication (autologous cellular therapy) stimulates a
positive immunogenic response against the prostate cancer.  
__  
For coverage, patient records must document that the product is being used
according to the NCD 110.22.  
__

___  
**_If the documentation does not describe the criteria above, does not meet
all the requirements of the NCD on sipuleucel-T,is inconsistent with the FDA
label and/or is not received, the services will be denied. Off-label use of
this treatment is not covered unless it meets the requirements for off-label
use of chemotherapeutic drugs in the Internet Only Manual 100-02 (Benefit
Policy), Chapter 15 (Covered Services), Section 50.4.5._**  
  
Noridian may cover _sipuleucel-T_ for the above condition when all
requirements are met including the following coding instructions. (NOTE:
Noridian will not allow payment for any off-label use of this treatment):  
  
For dates of service on/after July 1, 2011, use the following HCPCS code:
Q2043 Sipuleucel-T auto CD54+.  
  
For dates of service prior to July 1, 2011, use one of the following HCPCS
code: J3490, J3590 or C9273 (being replaced by Q2043).  
  
The payment of HCPCS Q2043 includes collection of patients' cells, activation
with PAP-CM-CSF, including leukapheresis and all other preparatory procedures
associated with **_sipuleucel-T_**. The code Q2043 does not include the
_administration_ of the treatments. CPT code 96365, intravenous infusion for
therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to
one (1) hour will be allowed for the administration of Q2043.  
  
Medicare will allow a maximum of three (3) infusions per lifetime.  
  
_____  
  
**Sources: Internet Only Manual (IOM) Medicare National Coverage
Determinations (NCD) Manual, Publication 100-03, Chapter 1, Section 110.22,
IOM Medicare Claims Processing Manual, Publication 100-04, Chapter 32, Section
280; Transmittal 133, Change Request (CR)7431 dated July 8, 2011; Transmittal
2254, CR 7431 dated July 8, 2011.  
**__
Sterilization Sterilization means any medical procedure, treatment or
operation for the sole purpose of rendering an individual permanently
incapable of reproducing and not related to the repair of a
damaged/dysfunctional body part.  
  
Under the Medicare Program guidelines the coverage of sterilization is limited
to necessary treatment of an illness or injury. An example of necessary
treatment is the removal of a uterus or removal of diseased ovaries (bilateral
oophorectomy) because of a tumor, or bilateral orchiectomy in the case of
prostate cancer.  
  
Elective hysterectomy, tubal ligation and vasectomy in the absence of a
disease for which sterilization is considered an effective treatment is not
covered. In addition, no payment would be made for sterilization procedures if
it is a preventive measure e.g., a physician believes pregnancy would cause
overall endangerment to a woman's health, or as a measure to prevent the
possible development of, or effect on a mental condition, should pregnancy
occur. (Section 1862(a)(1)(A) of the Social Security Act and 42 CFR 411.15(k).  
  
Claims will be denied on postpay review and payment recouped if the
pathological evidence of the necessity to perform any of these procedures to
treat an illness or injury is absent and/or when the primary objective is to
achieve sterilization.
Billing and Coding: Non-Invasive Cerebrovascular Arterial Studies

**Coding Guidelines  
  
** Please refer to the Novitas Local Coverage Determination (LCD), Non-
Invasive Cerebrovascular Arterial Studies, L35397 for reasonable and necessary
requirements and frequency limitations.  
  
The HCPCS/CPT code(s) may be subject to National Correct Coding Initiative
(NCCI) edits. This information does not take precedence over NCCI edits.
Please refer to NCCI for correct coding guidelines and specific applicable
code combinations prior to billing Medicare.  
  
 **Note:** When an uninterpretable study results in performing another type of
study, only the successful study should be billed.  
  
When billing these procedures **after a carotid endarterectomy** , provide in
the narrative the date of the surgery and the verbiage "carotid
endarterectomy."  
  
Duplex post-interventional follow-up studies are typically limited in scope
and unilateral in nature. The "complete/bilateral" duplex scan codes should
seldom be used, while the "unilateral or limited study" codes should be used
(except for the patient who had bilateral intervention).  
  
Do not report procedure codes 93890-93893 in conjunction with code 93888.  
  
All non-invasive vascular study CPT codes are considered bilateral codes
unless otherwise indicated in the CPT definition. The 150% payment adjustment
for bilateral procedures does not apply. Modifier -50 and/or the anatomic
modifiers, -LT/-RT should not be used.  
  
Append the modifier -52 to report a unilateral study as appropriate.
Information explaining the reduced service should be included in Item 19 of
the CMS-1500 form or the electronic equivalent. Any appropriate documentation
may be submitted with the claim to support the reduced service.