Persius/hicric huggingface dataset:
In order to accurately apply the criteria in the [Medicare Benefit Policy
Manual](https://www.cms.gov/Regulations-and-
Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs-Items/CMS012673),
Chapters 6, 20.4.1, or Chapter 15, Covered Medical and Other Health
Services, 60.1, the Medicare Administrative Contractor (MAC) gives
consideration to the physical proximity of the institution and physicians
office. When his office is located within a facility, a physician may not be
reimbursed for services, supplies, and use of equipment which fall outside the
scope of services commonly furnished in physicians offices generally, even
though such services may be furnished in his institutional office.
Additionally, make a distinction between the physicians office practice and
the institution, especially when the physician is administrator or owner of
the facility. Thus, for their services to be covered under the criteria in the
[Medicare Benefit Policy Manual](https://www.cms.gov/Regulations-and-
Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs-Items/CMS012673), Chapter
6, 20.4.1, or the [Medicare Benefit Policy
Manual](https://www.cms.gov/Regulations-and-
Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs-Items/CMS012673), Chapter
15, Covered Medical and Other Health Services, 60.1, the auxiliary medical
personnel must be members of the office staff rather than of the institutions
staff, and the cost of supplies must represent an expense to the physicians
office practice. Finally, services performed by the employees of the physician
outside the office area must be directly supervised by the physician; his
presence in the facility as a whole would not suffice to meet this
requirement. (In any setting, of course, supervision of auxiliary personnel in
and of itself is not considered a physicians professional service to which
the services of the auxiliary personnel could be an incidental part, i.e., in
addition to supervision, the physician must perform or have performed a
personal professional service to the patient to which the services of the
auxiliary personnel could be considered an incidental part.) Denials for
failure to meet any of these requirements would be based on 1861(s)(2)(A) of
the Social Security Act.

Establishment of an office within an institution would not modify rules
otherwise applicable for determining coverage of the physicians personal
professional services within the institution. However, in view of the
opportunity afforded to a physician who maintains such an office for rendering
services to a sizable number of patients in a short period of time or for
performing frequent services for the same patient, claims for physicians
services rendered under such circumstances would require careful evaluation by
the MAC to assure that payment is made only for services that are reasonable
and necessary.
A physician is eligible to receive Group C drugs from the Divison of Cancer
Treatment only if the following requirements are met:

  * A physician must be registered with the NCI as an investigator by having completed an FD-Form 1573;
  * A written request for the drug, indicating the disease to be treated, must be submitted to the NCI;
  * The use of the drug must be limited to indications outlined in the NCI's guidelines; and
  * All adverse reactions must be reported to the Investigational Drug Branch of the Division of Cancer Treatment.

In view of these NCI controls on distribution and use of Group C drugs, A/B
Medicare Administrative Contractors (MACs) may assume, in the absence of
evidence to the contrary, that a Group C drug and the related hospital stay
are covered if all other applicable coverage requirements are satisfied.

If there is reason to question coverage in a particular case, the matter
should be resolved with the assistance of the Quality Improvement Organization
(QIO), or if there is none, the assistance of the MAC's medical consultants.

Information regarding those drugs which are classified as Group C drugs may be
obtained from:

Chief, Investigational Drug Branch  
Cancer Therapy Evaluation Program  
Executive Plaza North, Suite 7134  
National Cancer Institute  
Rockville, Maryland 20852-7426
**

Indications

**

Multiple tumor markers are available for monitoring the response of certain
malignancies to therapy and assessing whether residual tumor exists post-
surgical therapy.

Levels are useful in following the course of patients with established
diagnosis of pancreatic and biliary ductal carcinoma. The test is not
indicated for diagnosing these two diseases.

**

Limitations

**

These services are not covered for the evaluation of patients with signs or
symptoms suggestive of malignancy. The service may be ordered at times
necessary to assess either the presence of recurrent disease or the patient's
response to treatment with subsequent treatment cycles.

Note: Scroll down for links to the quarterly Covered Code Lists (including
narrative).
Transfer factor is the dialysate of an extract from sensitized leukocytes
which increases cellular immune activity in the recipient. It is not covered
as a treatment for multiple sclerosis because its use for the purpose is still
experimental.
Granulocyte transfusions to patients suffering from severe infection and
granulocytopenia are a covered service under Medicare. Granulocytopenia is
usually identified as fewer than 500 granulocytes/mm3 whole blood. Accepted
indications for granulocyte transfusions include:

  * Granulocytopenia with evidence of gram negative sepsis; and
  * Granulocytopenia in febrile patients with local progressive infections unresponsive to appropriate antibiotic therapy, thought to be due to gram negative organisms.
The use of transcutaneous electrical nerve stimulation (TENS) for the relief
of acute post-operative pain is covered under Medicare. TENS may be covered
whether used as an adjunct to the use of drugs, or as an alternative to drugs,
in the treatment of acute pain resulting from surgery.

The TENS devices, whether durable or disposable, may be used in furnishing
this service. When used for the purpose of treating acute post-operative pain,
TENS devices are considered supplies. As such they may be hospital supplies
furnished inpatients covered under Part A, or supplies incident to a
physicians service when furnished in connection with surgery done on an
outpatient basis, and covered under Part B.

It is expected that TENS, when used for acute post-operative pain, will be
necessary for relatively short periods of time, usually 30 days or less. In
cases when TENS is used for longer periods, contractors should attempt to
ascertain whether TENS is no longer being used for acute pain but rather for
chronic pain, in which case the TENS device may be covered as durable medical
equipment as described in [160.27](https://www.cms.gov/medicare-coverage-
database/details/ncd-
details.aspx?NCDId=354&ncdver=1&DocID=160.27&kq=true&SearchType=Advanced&bc=EAAAAAgAAAAA&).
The use of EDTA as a chelating agent to treat atherosclerosis,
arteriosclerosis, calcinosis, or similar generalized condition not listed by
the FDA as an approved use is not covered. Any such use of EDTA is considered
experimental.
While ice-filled bags or bandages or other devices used for scalp hypothermia
during chemotherapy may be covered as supplies of the kind commonly furnished
without a separate charge, no separate charge for them would be recognized.
The FDA has approved one lymphocyte immune globulin preparation for marketing,
lymphocyte immune globulin, anti-thymocyte globulin (equine). This drug is
indicated for the management of allograft rejection episodes in renal
transplantation. It is covered under Medicare when used for this purpose.
Other forms of lymphocyte globulin preparation which the FDA approves for this
indication in the future may be covered under Medicare.
The Food and Drug Administration has determined that the only purpose for
which DMSO is safe and effective for humans is in the treatment of the bladder
condition, interstitial cystitis. Therefore, the use of DMSO for all other
indications is not considered to be reasonable and necessary. Payment may be
made for its use only when reasonable and necessary for a patient in the
treatment of interstitial cystitis.
Anti-inhibitor coagulant complex, AICC, is a drug used to treat hemophilia in
patients with factor VIII inhibitor antibodies. AICC has been shown to be safe
and effective and has Medicare coverage when furnished to patients with
hemophilia A and inhibitor antibodies to factor VIII who have major bleeding
episodes and who fail to respond to other, less expensive therapies.
A form-fitting conductive garment (and medically necessary related supplies)
may be covered under the program only when:

1\. It has received permission or approval for marketing by the Food and Drug
Administration;

2\. It has been prescribed by a physician for use in delivering covered TENS
or NMES treatment; and

3\. One of the medical indications outlined below is met:

  * The patient cannot manage without the conductive garment because there is such a large area or so many sites to be stimulated and the stimulation would have to be delivered so frequently that it is not feasible to use conventional electrodes, adhesive tapes and lead wires;
  * The patient cannot manage without the conductive garment for the treatment of chronic intractable pain because the areas or sites to be stimulated are inaccessible with the use of conventional electrodes, adhesive tapes and lead wires;
  * The patient has a documented medical condition such as skin problems that preclude the application of conventional electrodes, adhesive tapes and lead wires;
  * The patient requires electrical stimulation beneath a cast either to treat disuse atrophy, where the nerve supply to the muscle is intact, or to treat chronic intractable pain; or
  * The patient has a medical need for rehabilitation strengthening (pursuant to a written plan of rehabilitation) following an injury where the nerve supply to the muscle is intact.

A conductive garment is not covered for use with a TENS device during the
trial period specified in 160.3 unless:

4\. The patient has a documented skin problem prior to the start of the trial
period; and

5\. The B/Medicare Administrative Contractors medical consultants are
satisfied that use of such an item is medically necessary for the patient.

(See conditions for coverage of the use of TENS in the diagnosis and treatment
of chronic intractable pain in 160.3, [160.13](https://www.cms.gov/medicare-
coverage-database/details/ncd-
details.aspx?NCDId=151&ncdver=1&DocID=160.13&kq=true&SearchType=Advanced&bc=EAAAAAgAAAAA&),
and [160.27](https://www.cms.gov/medicare-coverage-database/details/ncd-
details.aspx?NCDId=354&ncdver=1&DocID=160.27&kq=true&SearchType=Advanced&bc=EAAAAAgAAAAA&),
and the use of NMES in the treatment of disuse atrophy in 150.4.)
**

Indications

**

PSA is of proven value in differentiating benign from malignant disease in men
with lower urinary tract signs and symptoms (e.g., hematuria, slow urine
stream, hesitancy, urgency, frequency, nocturia and incontinence) as well as
with patients with palpably abnormal prostate glands on physician exam, and in
patients with other laboratory or imaging studies that suggest the possibility
of a malignant prostate disorder. PSA is also a marker used to follow the
progress of prostate cancer once a diagnosis has been established, such as in
detecting metastatic or persistent disease in patients who may require
additional treatment. PSA testing may also be useful in the differential
diagnosis of men presenting with as yet undiagnosed disseminated metastatic
disease.

**

Limitations

**

Generally, for patients with lower urinary tract signs or symptoms, the test
is performed only once per year unless there is a change in the patient's
medical condition.

Testing with a diagnosis of in situ carcinoma is not reasonably done more
frequently than once, unless the result is abnormal, in which case the test
may be repeated once.

Note: Scroll down for links to the quarterly Covered Code Lists (including
narrative).
**

Indications

**

  1. To provide information about known or suspected hepatobiliary disease, for example: 
    1. Following chronic alcohol or drug ingestion.
    2. Following exposure to hepatotoxins.
    3. When using medication known to have a potential for causing liver toxicity (e.g., following the drug manufacturer's recommendations).
    4. Following infection (e.g., viral hepatitis and other specific infections such as amoebiasis, tuberculosis, psittacosis, and similar infections).
  2. To assess liver injury/function following diagnosis of primary or secondary malignant neoplasms.
  3. To assess liver injury/function in a wide variety of disorders and diseases known to cause liver involvement (e.g., diabetes mellitus, malnutrition, disorders of iron and mineral metabolism, sarcoidosis, amyloidosis, lupus, and hypertension).
  4. To assess liver function related to gastrointestinal disease.
  5. To assess liver function related to pancreatic disease.
  6. To assess liver function in patients subsequent to liver transplantation.
  7. To differentiate between the different sources of elevated alkaline phosphatase activity.

**

Limitations

**

When used to assess liver dysfunction secondary to existing non-hepatobiliary
disease with no change in signs, symptoms, or treatment, it is generally not
necessary to repeat a GGT determination after a normal result has been
obtained unless new indications are present.

If the GGT is the only "liver" enzyme abnormally high, it is generally not
necessary to pursue further evaluation for liver disease for this specific
indication.

When used to determine if other abnormal enzyme tests reflect liver
abnormality rather than other tissue, it generally is not necessary to repeat
a GGT more than one time per week.

Because of the extreme sensitivity of GGT as a marker for cytochrome oxidase
induction or cell membrane permeability, it is generally not useful in
monitoring patients with known liver disease.

Note: Scroll down for links to the quarterly Covered Code Lists (including
narrative).
**B. Policy Governing Transfusions

**

For Medicare coverage purposes, it is important to distinguish between a
transfusion itself and preoperative blood services; e.g., collection,
processing, storage. Medically necessary transfusion of blood, regardless of
the type, may generally be a covered service under both Part A and Part B of
Medicare. Coverage does not make a distinction between the transfusion of
homologous, autologous, or donor-directed blood. With respect to the coverage
of the services associated with the preoperative collection, processing, and
storage of autologous and donor-directed blood, the following policies apply.

1\. Hospital Part A and B Coverage and Payment

Under _ 1862(a)(14) _of the Act, non-physician services furnished to hospital
patients are covered and paid for as hospital services. As provided in _
1886_ of the Act, under the prospective payment system (PPS), the diagnosis
related group (DRG) payment to the hospital includes all covered blood and
blood processing expenses, whether or not the blood is eventually used.

In a situation where the hospital operates its own blood collection
activities, rather than using an independent blood supplier, the costs
incurred to collect autologous or donor-directed blood are recorded in the
whole blood and packed red blood cells cost center. Because the blood has been
replaced, Medicare does not recognize a charge for the blood itself. Under
PPS, the DRG payment is intended to pay for all covered blood and blood
services, whether or not the blood is eventually used.

Under its provider agreement, a hospital is required to furnish or arrange for
all covered services furnished to hospital patients. Medicare payment is made
to the hospital, under PPS or cost reimbursement, for covered inpatient and
outpatient services, and it is intended to reflect payment for all costs of
furnishing those services.

**

2\. Nonhospital Part B Coverage

**

Under Part B, to be eligible for separate coverage, a service must fit the
definition of one of the services authorized by _ 1832 _of the Act. These
services are defined in _42 CFR 410.10_ and do not include a separate category
for a supplier's services associated with blood donation services, either
autologous or donor-directed. That is, the collection, processing, and storage
of blood for later transfusion into the beneficiary is not recognized as a
separate service under Part B. Therefore, there is no avenue through which a
blood supplier can receive direct payment under Part B for blood donation
services.

**

C. Perioperative Blood Salvage

**

When the perioperative blood salvage process is used in surgery on a hospital
patient, payment made to the hospital (under PPS or through cost
reimbursement) for the procedure in which that process is used is intended to
encompass payment for all costs relating to that process.
For antigens provided to patients on or after November 17, 1996, Medicare does
not cover such antigens if they are to be administered sublingually, i.e., by
placing drops under the patient's tongue. This kind of allergy therapy has not
been proven to be safe and effective. Antigens are covered only if they are
administered by injection.
Effective December 1, 2000, Medicare covers sodium ferric gluconate complex in
sucrose injection as a first line treatment of iron deficiency anemia when
furnished intravenously to patients undergoing chronic hemodialysis who are
receiving supplemental erythropoeitin therapy.

Effective October 1, 2001, Medicare also covers iron sucrose injection as a
first line treatment of iron deficiency anemia when furnished intravenously to
patients undergoing chronic hemodialysis who are receiving supplemental
erythropoeitin therapy.
Effective October 1, 2002, IVIg is covered for the treatment of biopsy-proven
(1) Pemphigus Vulgaris, (2) Pemphigus Foliaceus, (3) Bullous Pemphigoid, (4)
Mucous Membrane Pemphigoid (a.k.a., Cicatricial Pemphigoid), and (5)
Epidermolysis Bullosa Acquisita for the following patient subpopulations:

  * Patients who have failed conventional therapy. Medicare Administrative Contractors (MACs) have the discretion to define what constitutes failure of conventional therapy;
  * Patients in whom conventional therapy is otherwise contraindicated. Contractors have the discretion to define what constitutes contraindications to conventional therapy; or
  * Patients with rapidly progressive disease in whom a clinical response could not be affected quickly enough using conventional agents. In such situations IVIg therapy would be given along with conventional treatment(s) and the IVIg would be used only until the conventional therapy could take effect.

In addition, IVIg for the treatment of autoimmune mucocutaneous blistering
diseases must be used only for short-term therapy and not as a maintenance
therapy. Contractors have the discretion to decide what constitutes short-term
therapy.
Intravenous levocarnitine, for one of the following indications, will only be
covered for those ESRD patients who have been on dialysis for a minimum of
three months.

Patients must have documented carnitine deficiency, defined as a plasma free
carnitine level <40 micromol/L (determined by a professionally accepted method
as recognized in current literature), along with signs and symptoms of:

  * Erythropoietin-resistant anemia (persistent hematocrit <30% with treatment) that has not responded to standard erythropoietin dosage (that which is considered clinically appropriate to treat the particular patient) with iron replacement, and for which other causes have been investigated and adequately treated, or
  * Hypotension on hemodialysis that interferes with delivery of the intended dialysis despite application of usual measures deemed appropriate (e.g., fluid management). Such episodes of hypotension must have occurred during at least 2 dialysis treatments in a 30-day period.

Continued use of levocarnitine will not be covered if improvement has not been
demonstrated within 6 months of initiation of treatment. All other indications
for levocarnitine are non-covered in the ESRD population.

For a patient currently receiving intravenous levocarnitine, Medicare will
cover continued treatment if:

  * Levocarnitine has been administered to treat erythropoietin-resistent anemia (persistent hematocrit <30 percent with treatment) that has not responded to standard erythropoietin dosage (that which is considered clinically appropriate to treat the particular patient) with iron replacement, and for which other causes have been investigated and adequately treated, or hypotension on hemodialysis that interferes with delivery of the intended dialysis despite application of usual measures deemed appropriate (e.g., fluid management) and such episodes of hypotension occur during at least 2 dialysis treatments in a 30-day period; and
  * The patient's medical record documents a pre-dialysis plasma free carnitine level <40 micromol/L prior to the initiation of treatment; or
  * The treating physician certifies (documents in the medical record) that in his/her judgment, if treatment with levocarnitine is discontinued, the patient's pre-dialysis carnitine level would fall below 40 micromol/L and the patient would have recurrent erythropoietin-resistant-anemia or intradialytic hypotension.
**NOTE:** These new guidelines are limited to lithium battery-powered
pacemakers, because mercury-zinc battery-powered pacemakers are no longer
being manufactured and virtually all have been replaced by lithium units. MACs
still receiving claims for monitoring such units should continue to apply the
guidelines published in 1980 to those units until they are replaced.

There are two general types of pacemakers in current use - single-chamber
pacemakers which sense and pace the ventricles of the heart, and dual-chamber
pacemakers which sense and pace both the atria and the ventricles. These
differences require different monitoring patterns over the expected life of
the units involved. One fact of which MACs should be aware is that many dual-
chamber units may be programmed to pace only the ventricles; this may be done
either at the time the pacemaker is implanted or at some time afterward. In
such cases, a dual-chamber unit, when programmed or reprogrammed for
ventricular pacing, should be treated as a single-chamber pacemaker in
applying screening guidelines.

The decision as to how often any patients pacemaker should be monitored is
the responsibility of the patients physician who is best able to take into
account the condition and circumstances of the individual patient. These may
vary over time, requiring modifications of the frequency with which the
patient should be monitored. In cases where monitoring is done by some entity
other than the patients physician, such as a commercial monitoring service or
hospital outpatient department, the physicians prescription for monitoring is
required and should be periodically renewed (at least annually) to assure that
the frequency of monitoring is proper for the patient. Where a patient is
monitored both during clinic visits and transtelephonically, the MAC should be
sure to include frequency data on both types of monitoring in evaluating the
reasonableness of the frequency of monitoring services received by the
patient. Since there are over 200 pacemaker models in service at any given
point, and a variety of patient conditions that give rise to the need for
pacemakers, the question of the appropriate frequency of monitoring is a
complex one. Nevertheless, it is possible to develop guidelines within which
the vast majority of pacemaker monitoring will fall and MACs should do this,
using their own data and experience, as well as the frequency guidelines which
follow, in order to limit extensive claims development to those cases
requiring special attention.