evekhm/cms_iom_500 huggingface dataset:
(Medicare Benefit Policy Manual)
as a supply when furnished incident to a physicians service.)  Examples of prosthetic devices include artificial limbs, parenteral and enteral (PEN) nutrition, cardiac pacemakers, prosthetic lenses (see subsection B), breast prostheses (including a surgical brassiere) for postmastectomy patients, maxillofacial devices , and devices which replace all or part of the ear or nose.  A urinary collection and retention system with or without a tube is a prosthetic device replacing bladder function in case of permanent urinary incontinence.  The foley catheter is also considere d a prosthetic device when ordered for a patient with permanent urinary incontinence.  However, chucks, diapers, rubber sheets, etc., are supplies that are not covered under this provision.  Although hemodialysis equipment is a prosthetic device, payment for the rental or purchase of such equipment in the home is made only for use under the provisions for payment applicable to durable medical equipment.  An exception is that if payment cannot be made on an inpatients behalf under Part A, hemodialysis equipment, supplies, and services required by such patient could be covered under Part B as a prosthetic device, which replaces the function of a kidney.  Se e the Medicare Benefit Policy Manual, Chapter 11, End Stage Renal Disease, for payment for hemodialysis equipment used in the home. See the Medicare Benefit Policy Manual, Chapter 1, Inpatient Hospital Services, 10, for additional instructions on hospitalization for renal dialysis.
(Medicare Benefit Policy Manual)
NOTE:   Medicare does not cover a prosthetic device dispensed to a patient prior to the time at which the patient undergoes the procedure that makes necessary the use of the device.  For example, the A/B MAC (B) does not make a separate Part B payment for an intraocular lens (IOL) or pacemaker that a physician, during an office visit prior to the actual surgery, dispenses to the patient for his or her use.  Dispensing a prosthetic device in this manner raises health and safety issues.  Moreover, the need for the device cannot be clearly established until the procedure that makes its use possible is successfully performed.  Therefore, dispensing a prosthetic device in this manner is not considered reasonable and necessary for the treatment of the patients con dition.  Colostomy (and other ostomy) bags and necessary accouterments required for attachment are covered as prosthetic devices.  This coverage also includes irrigation and flushing equipment and other items and supplies directly related to ostomy care, whether the attachment of a bag is required.
(Medicare Benefit Policy Manual)
Accessories and/or supplies which are used directly with an enteral or parenteral device to achieve the therapeutic benefit of the prosthesis or to assure the proper functioning of the device may also be covered under the prosthetic device benefit subject to the additional guidelines in the Medicare National Coverage Determinations Manual.  Covered items include catheters, filters, extension tubing, infusion bottles, pumps (either food or infusion), intravenous (I.V.) pole, needles, syringes, dressings, tape, Heparin Sodium (parenteral only), volumetric monitors (parenteral only), and parente ral and enteral nutrient solutions.  Baby food and other regular grocery products that can be blenderized and used with the enteral system are not covered.  Note that some of these items, e.g., a food pump and an I.V. pole, qualify as DME.  Although covera ge of the enteral and parenteral nutritional therapy systems is provided on the basis of the prosthetic device benefit, the payment rules relating to lump sum or monthly payment for DME apply to such items.  The coverage of prosthetic devices includes replacement of and repairs to such devices as explained in subsection D.  Finally, the Benefits Improvement and Protection Act of 2000 amended 1834(h)(1) of the Act by adding a provision (1834 (h)(1)(G)(i)) that requires Medicare payment to be made for the replacement of prosthetic devices which are artificial limbs, or for the replacement of any part of such devices, without regard to continuous use or us eful lifetime restrictions if an ordering physician determines that the replacement device, or replacement part of such a device, is necessary.   Payment may be made for the replacement of a prosthetic device that is an artificial limb, or replacement part of a device if the ordering physician determines that the replacement device or part is necessary because of any of the following:  1. A change in the physiological condition of the patient;  2. An irreparable change in the condition of the device, or in a part of the device; or  3. The condition of the device, or the part of the device, requires repairs and the cost of such repairs would be more than 60 percent of the cost of a replacement device, or, as the case may be, of the part being replaced.
(Medicare Benefit Policy Manual)
This provision is effective for items replaced on or after April 1, 2001.  It supersedes any rule that that provided a 5- year or other replacement rule with regard to prosthetic devices.   B.  Prosthetic Lenses   The term internal body organ includes the lens of an eye.  Prostheses replacing the lens of an eye include post-surgical lenses customarily used during convalescence from eye surgery in which the lens of the eye was removed.  In addition, permanent lense s are also covered when required by an individual lacking the organic lens of the eye because of surgical removal or congenital absence.  Prosthetic lenses obtained on or after the beneficiarys date of entitlement to supplementary medical insurance benefits may be covered even though the surgical removal of the crystalline lens occurred before entitlement.   1.  Prosthetic Cataract Lenses   One of the following prosthetic lenses or combinations of prosthetic lenses furnished by a physician (see 30.4 for coverage of prosthetic lenses prescribed by a doctor of optometry) may be covered when determined to be reasonable and necessary to restore essentially the vision provided by the crystalline lens of the eye:   Prosthetic bifocal lenses in frames;    Prosthetic lenses in frames for far vision, and prosthetic lenses in frames for near vision; or   When a prosthetic contact lens(es) for far vision is prescribed (including cases of binocular and monocular aphakia), make payment for the contact lens(es) and prosthetic lenses in frames for near vision to be worn at the same time as the contact lens(es), and prosthetic lenses in frames to be worn when the contacts have been removed.   Lenses which have ultraviolet absorbing or reflecting properties may be covered, in lieu of payment for regular (untinted) lenses, if it has been determined that such lenses are medically reasonable and necessary for the individual patient.   Medicare does not cover cataract sunglasses obtained in addition to the regular (untinted) prosthetic lenses since the sunglasses duplicate the restoration of vision function performed by the regular prosthetic lenses.  2.  Payment for Intraocular Lenses (IOLs) Furnished in Ambulatory Surgical Centers (ASCs)
(Medicare Benefit Policy Manual)
Effective for services furnished on or after March 12, 1990, payment for intraocular lenses (IOLs) inserted during or subsequent to cataract surgery in a Medicare certified ASC is included with the payment for facility services that are furnished in connection with the covered surgery.  Refer to the Medicare Claims Processing Manual, Chapter 14, Ambulatory Surgical Centers, for more information.  3.  Limitation on Coverage of Conventional Lenses   One pair of conventional eyeglasses or conventional contact lenses furnished after each cataract surgery with insertion of an IOL is covered.  C.  Dentures   Dentures are excluded from coverage.  However, when a denture or a portion of the denture is an integral part (built -in) of a covered prosthesis (e.g., an obturator to fill an opening in the palate), it is covered as part of that prosthesis.  D.  Supplies, Repairs, Adjustments, and Replacement   Supplies are covered that are necessary for the effective use of a prosthetic device (e.g., the batteries needed to operate an artificial larynx).  Adjustment of prosthetic devices required by wear or by a change in the patients condition is covered when ordered by a physician.  General provisions relating to the repair and replacement of durable medical equipment in 110.2 for the repair and replacement of prosthetic devices are applicable. (See the Medicare Benefit Policy Manual, Chapter 16, General Exclusions from Coverage, 40.4, for payment for devices replaced under a warranty.)  Replacement of conventional eyeglasses or contact lenses furnished in accordance with 120.B.3 is not covered.   Necessary supplies, adjustments, repairs, and replacements are covered even when the device had been in use before the user enrolled in Part B of the program, so long as the device continues to be medically required.   130 - Leg, Arm, Back, and Neck Braces, Trusses, and Artificial Legs, Arms, and Eyes  (Rev. 1, 10- 01-03) B3-2133, A3- 3110.5, HO -228.5, AB -01-06 dated 1/18/01
(Medicare Benefit Policy Manual)
These appliances are covered under Part B when furnished incident to physicians services or on a physicians order.  A brace includes rigid and semi -rigid devices which are used for the purpose of supporting a weak or deformed body member or restricting or eliminating motion in a diseased or injured part of the body.  Elastic stockings, garter belts, and similar devices do not come within the scope of the definition of a brace.  Back braces include, but are not limited to, special corsets, e.g., sacroiliac , sacrolumbar, dorsolumbar corsets, and belts.  A terminal device (e.g., hand or hook) is covered under this provision whether an artificial limb is required by the patient. Stump stockings and harnesses (including replacements) are also covered when these  appliances are essential to the effective use of the artificial limb.   Adjustments to an artificial limb or other appliance required by wear or by a change in the patients condition are covered when ordered by a physician.  Adjustments, repairs and replacements are covered even when the item had been in use before the user enrolled in Part B of the program so long as the device continues to be medically required.  140 - Therapeutic Shoes for Individuals with Diabetes  (Rev. 241, Issued: 02-02-18, Effective: 04-01-18, Implementation: 04-02-18)  Coverage of therapeutic shoes (depth or custom-molded) along with inserts for individuals with diabetes is available as of May 1, 1993.  These diabetic shoes are covered if the requirements as specified in this section concerning certification and prescrip tion are fulfilled.  In addition, this benefit provides for a pair of diabetic shoes even if only one foot suffers from diabetic foot disease.  Each shoe is equally equipped so that the affected limb, as well as the remaining limb, is protected.  Claims fo r therapeutic shoes for diabetics are processed by the Durable Medical Equipment Medicare Administrative Contractors (DME MACs).   Therapeutic shoes for diabetics are not DME and are not considered DME nor orthotics, but a separate category of coverage under Medicare Part B. (See 1861(s)(12) and 1833(o)  of the Act.)  A.  Definitions   The following items may be covered under the diabetic shoe benefit:  1.  Custom- Molded Shoes
(Medicare Benefit Policy Manual)
A.  Definitions   The following items may be covered under the diabetic shoe benefit:  1.  Custom- Molded Shoes   Custom-molded shoes are shoes that:   Are constructed over a positive model of the patients foot;   Are made from leather or other suitable material of equal quality;   Have removable inserts that can be altered or replaced as the patients condition warrants; and   Have some form of shoe closure.   2.  Depth Shoes   Depth shoes are shoes that:    Have a full length, heel -to-toe filler that, when removed, provides a minimum of 3/16 inch of additional depth used to accommodate custom -molded or customized inserts;   Are made from leather or other suitable material of equal quality;   Have some form of shoe closure; and    Are available in full and half sizes with a minimum of three widths so that the sole is graded to the size and width of the upper portions of the shoes according to the American standard last sizing schedule or its equivalent. (The American standard last s izing schedule is the numerical shoe sizing system used for shoes sold in the United States.)   3.  Inserts  Inserts are total contact, multiple density, removable inlays that are directly molded to the patients foot or a model of the patients foot or directly carved from a patient -specific, rectified electronic model and that are made of a suitable material wi th regard to the patients condition.   B.  Coverage   1.  Limitations   For each individual, coverage of the footwear and inserts is limited to one of the following within one calendar year:    No more than one pair of custom -molded shoes (including inserts provided with such shoes) and two additional pairs of inserts; or    No more than one pair of depth shoes and three pairs of inserts (not including the noncustomized removable inserts provided with such shoes).  2.  Coverage of Diabetic Shoes and Brace
(Medicare Benefit Policy Manual)
 No more than one pair of depth shoes and three pairs of inserts (not including the noncustomized removable inserts provided with such shoes).  2.  Coverage of Diabetic Shoes and Brace  Orthopedic shoes, as stated in the Medicare Claims Processing Manual, Chapter 20, Durable Medical Equipment, Surgical Dressings and Casts, Orthotics and Artificial Limbs, and Prosthetic Devices, generally are not covered.  This exclusion does not apply to orthopedic shoes that are an integral part of a leg brace.  In situations in which an individual qualifies for both diabetic shoes and a leg brace, these items are covered separately.  Thus, the diabetic shoes may be covered if the requirements for this section are met, while the brace may be covered if the requirements of 130 are met.    3.  Substitution of Modifications for Inserts   An individual may substitute modification(s) of custom -molded or depth shoes instead of obtaining a pair(s) of inserts in any combination.  Payment for the modification(s) may not exceed the limit set for the inserts for which the individual is entitled.  The following is a list of the most common shoe modifications available, but it is not meant as an exhaustive list of the modifications available for diabetic shoes:   Rigid Rocker Bottoms  - These are exterior elevations with apex positions for 51 percent to 75 percent distance measured from the back end of the heel.  The apex is a narrowed or pointed end of an anatomical structure.  The apex must be positioned behind the metatarsal heads and tapered off sharply to the front tip of the sole.  Apex height helps to eliminate pressure at the metatarsal heads. Rigidity is ensured by the steel in the shoe.  The heel of the shoe tapers off in the back in order to cause the heel  to strike in the middle of the heel;   Roller Bottoms (Sole or Bar)  - These are the same as rocker bottoms, but the heel is tapered from the apex to the front tip of the sole;   Metatarsal Bars  - An exterior bar is placed behind the metatarsal heads in order to remove pressure from the metatarsal heads.  The bars are of various shapes, heights, and construction depending on the exact purpose;
(Medicare Benefit Policy Manual)
 Metatarsal Bars  - An exterior bar is placed behind the metatarsal heads in order to remove pressure from the metatarsal heads.  The bars are of various shapes, heights, and construction depending on the exact purpose;   Wedges (Posting)  - Wedges are either of hind foot, fore foot, or both and may be in the middle or to the side.  The function is to shift or transfer weight bearing upon standing or during ambulation to the opposite side for added support, stabilization, equalized weight distribution, or balance; and    Offset Heels  - This is a heel flanged at its base either in the middle, to the side, or a combination, that is then extended upward to the shoe in order to stabilize extreme positions of the hind foot.  Other modifications to diabetic shoes include, but are not limited to flared heels, Velcro closures, and inserts for missing toes.  4.  Separate Inserts   Inserts may be covered and dispensed independently of diabetic shoes if the supplier of the shoes verifies in writing that the patient has appropriate footwear into which the insert can be placed.  This footwear must meet the definitions found above for depth shoes and custom -molded shoes.  C.  Certification   The need for diabetic shoes must be certified by a physician who is a doctor of medicine or a doctor of osteopathy and who is responsible for diagnosing and treating the patients diabetic systemic condition through a comprehensive plan of care.  This mana ging physician must:    Document in the patients medical record that the patient has diabetes;    Certify that the patient is being treated under a comprehensive plan of care for diabetes, and that the patient needs diabetic shoes; and    Document in the patients record that the patient has one or more of the following conditions:   o Peripheral neuropathy with evidence of callus formation;   o History of pre -ulcerative calluses;   o History of previous ulceration;   o Foot deformity;   o Previous amputation of the foot or part of the foot; or   o Poor circulation.   D.  Prescription   Following certification by the physician managing the patients systemic diabetic condition, a podiatrist or other qualified physician who is knowledgeable in the fitting of diabetic shoes and inserts may prescribe the particular type of footwear necessary .  E.  Furnishing Footwear
(Medicare Benefit Policy Manual)
E.  Furnishing Footwear   The footwear must be fitted and furnished by a podiatrist or other qualified individual such as a pedorthist, an orthotist, or a prosthetist.  The certifying physician may not furnish the diabetic shoes unless the certifying physician is the only qualified individual in the area.  It is left to the discretion of each A/B MAC (B) to determine the meaning of in the area.   150 - Dental Services  (Rev.  11995; Issued: 04- 21-23; Effective: 01 -01-23; Implementation: 05 -12-23)  As indicated under the general exclusions from coverage in 42 CFR 411.15(i), and subject to exceptions, items and services in connection with the care, treatment, filling, removal, or replacement of teeth or structures directly supporting the teeth are not  covered. Structures directly supporting the teeth means the periodontium, which includes the gingivae, dentogingival junction, periodontal membrane, cementum of the teeth, and alveolar process. Two statutory exceptions to this policy allow for Medicare payment for inpatient hospital services in connection with the provision of dental services if the individual, because of the individuals underlying medical condition and clinical status or because of the severity of the dental procedure, requires hospita lization in connection with the provision of such services.
(Medicare Benefit Policy Manual)
There are some other instances where medical services necessary to diagnose and treat the individuals underlying medical condition may require the performance of certain dental services and the dental exclusion may not apply. Dental services that are inextricably linked to, and substantially related and integral to the clinical success of, certain covered medical services are not excluded. Such non- excluded dental services could include dental and oral examinations as well as medically necessary diagnostic and treatment services to eliminate an oral or dental infection. We note that the necessary treatment to eradicate an infection may not include the totality of recommended dental services for a given patient. For example, if an infected tooth is identified in a patient requiring  an organ transplant, cardiac valve replacement, or valvuloplasty procedure, the necessary treatment would be to eradicate the infection, which could result in the tooth being extracted. Additional dental services, such as a dental implant or crown, may not be considered immediately necessary to eliminate or eradicate the infection or its source prior to surgery. Therefore, such additional services would not be inextricably linked to, and substantially related and integral to the clinical success of, the or gan transplant, cardiac valve replacement, or valvuloplasty services. As such, no Medicare payment would be made for the additional services that are not immediately necessary prior to surgery to eliminate or eradicate the infection.   Payment may be made under Medicare Parts A and B for dental services, prior to or, in certain circumstances, contemporaneously with, certain covered medical services furnished in the inpatient or outpatient setting. Scenarios in which Medicare payment for dental services is not excluded include, but are not limited to, the examples below.   EXAMPLE 1:
(Medicare Benefit Policy Manual)
EXAMPLE 1:   Dental or oral examination performed as part of a comprehensive workup in either the inpatient or outpatient setting prior to Medicare -covered organ transplant, cardiac valve replacement, or valvuloplasty procedures; and, medically necessary diagnostic and treatment services to eliminate an oral or dental infection prior to, or contemporaneously with, the organ transplant, cardiac valve replacement, or valvuloplasty procedure. For purposes of this manual only, hematopoietic stem cell and bone marrow transpl ants have a similar risk of infection to organ transplants, and an oral examination and subsequent necessary diagnostic and treatment services, performed in either the inpatient or outpatient setting would be payable under this example. (The term organ tr ansplant may not be considered to include bone marrow or hematopoietic stem cell transplants in all contexts. These services are not considered organs for purposes of the definition of organs in 42 CFR 486.302 or Medicare payment policies for organ procur ement organizations.)   EXAMPLE 2:   The reconstruction of a ridge performed as a result of and at the same time as the surgical removal of a tumor.  The reconstruction of a ridge performed primarily to prepare the mouth for dentures is a noncovered procedure.   EXAMPLE 3:   The stabilization or immobilization of teeth in connection with the reduction of a jaw fracture, and dental splints only when used in conjunction with covered treatment of a covered medical condition such as dislocated jaw joints.   EXAMPLE 4:   The extraction of teeth to prepare the jaw for radiation treatment of neoplastic disease.    See Pub 100- 01, the Medicare General Information, Eligibility, and Entitlement Manual, Chapter 5, Definitions for provisions applicable to doctors of dental surgery or dental medicine.   CMS makes payment for covered dental services furnished by a physician, including a doctor of dental medicine or dental surgery, or a non- physician practitioner in accordance with state law and scope of practice in the state where the service is furnished.