Highmark Medicare Services received the following comments to our draft Local Coverage Determinations (LCDs). Highmark Medicare Services would like to thank those who shared their knowledgeable comments with us. The comments received were invaluable in revising the draft policies to their present form. Following are our responses to the comments we received.

G-24M, Obesity

Comment #1:  Several commenters wrote in agreement with the draft LCD as written.

Comment #2:  One commenter specifically agreed that the efficacy and safety of gastric pacing for the treatment of obesity is not proven.

Response:  Policy is in agreement with these comments.

Comment #3:  One commenter suggested the addition of polycystic ovary syndrome and pseudotumor cerebri as covered indications.  This commenter also suggested that vertical band surgeries should be covered for a select patient population; i.e., patients with HTN and Crohn’s disease.

Response:  These are unusual conditions.  When these clinical scenarios occur, the request/case can be reviewed under individual consideration.   

Comment #4:  One commenter advised that there were 3 typos in the draft policy, and provided the page numbers and sections.

Response:  Typographical errors have been corrected.

Comment #5:  One commenter advised that these procedures should only be allowed at Centers that are designated by either the American Society of Bariatric Surgery or the American College of Surgeons, and the physicians and support staff associated with these centers should be the only clinicians allowed to perform the patient follow-up care.

Response:   Medicare has designated centers that are only authorized to perform bariatric procedures.

Comment #6:  One commenter advised that the issue of who is eligible for the various the various bariatric procedures is under discussion, but this commenter advised that the general consensus is that these procedures work moderately well for the younger population.

Response:  Yes, it is true that these procedures work best for the younger population and not the elderly.  They are some younger beneficiaries, notably those who are disabled by their obesity or other conditions who would qualify for these procedures.

Comment #7:  One commenter advised that gastric pacing is still premature.

Response:  Based on our review data from the clinical trials in the Unites States of gastric pacing for the treatment of obesity is still not available.  There is little scientific evidence in the Unites States literature to support the use of this procedure at this time.

I-19J, Interferon alfa-2b

Comment #1:  Several commenters wrote in agreement with the draft LCD as written.

Comment #2:  One commenter suggested that ICD-9 228.01 (Hemangioma of skin and subcutaneous tissue) be added as a covered indication. 

Response:  This indication was added to the final LCD.

Comment #3:  One commenter advised that the draft policy was unclear regarding treatment of refractory condyloma acuminate (078.11), and suggested that we mandate that at least one conventional treatment had been tried and failed. 

Response:  The wording was updated on the final LCD to provide coverage as stated below:

“When Interferon alfa-2b is used to treat refractory condyloma acuminate (ICD-9 078.11), it is expected that at least one conventional mode of treatment has been tried and failed.  Conventional methods of treatment may include any of the following:

1. Cyrotherapy; 
2. Electrodesiccation;
3. Currettage;  
4. Surgical excision; 
5. Carbon dioxide laser treatment;
6. Drugs such as podophyllum resin, podofilox (condylox), tri or bicholoracetic acids. Less commonly used drugs include: 5-flourouracil or bleomycin.”

Comment #4:  One commenter advised that “we are living in a hepatitis C epidemic with over 4 million Americans affected.”  This commenter advised that the “non-A, non B” terminology is old and should be deleted as over 90% of these cases are due to Hepatitis C which can be confirmed by appropriate serologic testing.

Response:  This indication was taken directly from the USPDI wording and; therefore, it is maintained in the final LCD.

Comment #5:  One commenter requested that we add ICD-9 233.7 (carcinoma in situ of the bladder) as a covered indication.

Response:  This is not an FDA approved indication, or noted as an “acceptable” indication in the USPDI; and therefore, is not included in the final LCD.  Individual consideration of coverage for this indication will be provided on a case-by-case basis with supporting documentation and clinical literature.

M-18I, Cardiac Ablation Procedures

Comment #1:  Several commenters wrote in agreement with the draft LCD as written.

Comment #2:  One commenter posed the following question:  “Until treatment of IDL’s are shown to change outcomes, why bother to measure them “routinely”?

Response:  After contacting the author of the comment, it was withdrawn as it was not pertinent to the proposed LCD.

Comment #3:  One commenter opined that there are patients (non-Medicare, etc.) and arrhythmia where ablation can reasonably be first line of treatment.

Response:  The Policy has been revised to broaden the indications for cardiac ablation as a first line treatment for many arrhythmias.

Comment #4:  One commenter advised that he was “unimpressed with a ‘mini-maze’ as an ‘add on’ at open heart surgery in terms of long term prevention of Afib.”

Response:  The Policy states that the operative treatment for atrial fibrillation would only be authorized if the patient has had atrial fibrillation for 6 months and had an enlarged atrium, was resistant or intolerant to drug therapy, and was at a high risk for thromboembolism. This represents a patient who has exhausted medical management of the arrthymmia. 

Comment #5:   One commenter suggested the following coding changes:  “atrial flutter coded as 93651, instead of 93799; and 3D mapping system coded as 93613.  This commenter also noted that “intravascular ultrasound code 93663 [93662], 427.69 will offer ablation if more than a 20,000 ventricular premature contraction in a 24 hour period.”

Response:  Policy was revised to reflect the changes in medical care for atrial flutter and for the coding required for 3D mapping systems.

Comment #6:  One commenter suggested that for patients with PVDT failure of antiarrhythmic drugs is not a necessary prerequisite for catheter ablations (93650-93652) when used as the first line of treatment.  This same commenter advised failure of antiarrhythmic drugs is again not a necessary prerequisite for patients with atrial flutter catheter ablation (93799) when used as the first line of treatment.

Response:  The Policy has been revised to broaden the indications for cardiac ablation as a first line treatment for many arrhythmias including atrial flutter.

Comment #7:  One commenter advised that CPT code 33253 was deleted by the AMA for 2007.

Response:  Highmark Medicare Services did not eliminate 33253.  The AMA deleted this code and added CPT codes 33254, 33255, and 33256 effective January 1, 2007.

Comment #8:  One commenter quoted the AHA/ACC Guidelines from JACC 2003: 42:1493:  “AV nodal reentrant tachycardia, atrial tachycardia, and accessory A-V pathways:  catheter ablation can be performed as primary therapy without the need to fail medicines.

Response:  Policy was revised to reflect the changes in medical care for these arrhythmias.

Comment #9:  Several commenters found it interesting that we eliminated CPT code 33253 which was an effective procedure.

Response:  Highmark Medicare Services did not eliminate 33253.  The AMA deleted this code and added CPT codes 33254, 33255, and 33256 effective January 1, 2007.

Comment #10:  Several commenters noted that the covered indications include “drug resistant” or “drug intolerance,” but anticoagulants.

Response:  The Policy was revised to include an indication for certain procedures when the patient has a contraindication to anticoagulants.

S-134C, Blepharoplasty

Comment #1:  Several commenters wrote in agreement with the draft LCD as written.

Comment #2:  One commenter referred to the list of criteria under “General Information,” and advised that reviewers are requiring all or most of the criteria, even though it states, “one or more of the following.”  This commenter also provided rationale supporting why the upper eyelid margin cannot be seen and measured in some patients.

Response:  The indications and limitations section clearly describes the indications and limitations for the procedure.  There are individual criteria that describe when a procedure may be done; multiples of these criteria are not required to perform a procedure.  

Comment #3:  One commenter advised that “the visual field study requirements are rather insensitive and the necessary changes (untapped vs. tapped) are less than practical.”  This commenter also opined that the documentation requirements be expanded upon since “surgeons are often administratively inept and perform multiple procedures, e.g., both ptosis repair and blepharoplasty, without firm, written explanations of functional need.” 

Response:  Visual fields are the best available method of objectively determining the need for and the potential improvement possible by performing the requested operative procedure.   Blepharoplasty is only authorized if there is a functional need for the procedure and that must be clearly documented in the medical record.

Comment #4:  One commenter provided an opinion regarding the asterisked 99285 note in the CPT/HCPCS Codes section, which states, “This procedure code is not intended, nor is it reimbursable, for the photographic documentation for a blepharoplasty procedure.”   It was this individual’s opinion that “While they are demanding of these two procedures, I find it extremely irritating that Medicare will cover and reimburse the visual field, but not the photographic documentation.”

Response:  Photographic documentation of the patient’s preoperative state is the best objective evidence.  This is seen as integral to the preoperative evaluation of the patient.

Comment #5:  One commenter provided the following ICD-9 comments:  1)  eyelid ptosis is 374.30, 2) blepharochalasis is 374.34, 3)  368.44 (visual field defect) should be added since it is on page 2 under indications as one of the criteria for visual impairment, and 4) at this time, there is no code for brow ptosis.

Response:  The codes 374.30 and 374.34 are included in the ICD-9 section of the LCD as proposed.  The CPT code 368.44 (visual field defect) is used to characterize visual field defects that would not be corrected by a blepharoplasty or brow lift, so it was not included in the list of eligible ICD-9 codes. 

Comment #6:  One commenter advised that often a brow ptosis correction and a blepharoplasty are performed at the same time – “the evidence would be based on the eyelid and brow positions that would otherwise be abnormal on an individual basis.”

Response:  The LCD states, “If both a blepharoplasty and a ptosis repair are planned, the need for both must be documented.” 

Comment #7:  One commenter referred to “when the physician determines the patient requires a bilateral blepharoplasty, bilateral blepharoptosis repair, it is expected that the procedures will be performed on the same date of service,” and advised that some surgeons perform staged surgery on one eye at a time due to the patient’s lack of a support system at home.

Response:  If the patient requires staged procedures, the documentation should adequately reflect the medical need for this and can always be reviewed under individual consideration.  It is anticipated that most bilateral procedures can be done in the same day.

Comment #8:  One commenter felt that the requirement, “the photograph should show the brow ptosis below the superior orbital rim,” to be too narrow of a definition of brow ptosis.  It was this commenter’s opinion that brow ptosis is indicated if the brow position interferes with correction of ptosis or dermatochalasis, and he suggested, “’the brow is ptotic’ as you can certainly have significant brow ptosis without it actually being below the orbital rim.”

Response:  The photographic depiction of brow ptosis is not too narrowly defined.  The specifically described case represents a rather unique circumstance and when it occurs can be reviewed under individual consideration.

Comment #9:  One commenter advised that stating that the visual field “must demonstrate 1 or more of the following,” is too strong of a statement.  He further stated, “There are certainly some patients who clearly have significant ptosis or dermatochalasis according to the photographs who perform better than expected on automatic visual field testing because of elevating their brows excessively during the test.”  Therefore, he suggested that the requirement should state that the visual fields “should demonstrate one or more of the following.”  He further suggested that if the visual field does not demonstrate this loss of field other reference should be made to the photographs if they clearly show significant lie or brow abnormalities.

Response:  This is a relatively unique situation.  If this visual fields studies (taped and untapped) do not demonstrate an objective improvement in the patient’s vision, this case can always be reviewed under individual consideration.  

Comment #10:  Several commenters noted that the “Indications and Limitations of Coverage and/or Medical Necessity” section of the draft policy is limited to the coverage of upper lid procedures.  These commenters noted that a blepharoplasty can also involve the lower lids for non-cosmetic reasons, and that the lower lids have their own set of criteria and indications.  These commenters provided indications and procedures involving the lower lids, and supporting their request for coverage of blepharoplasty of the lower lids.

Response:  The need for a lower lid blepharoplasty is not a common request.    If this specific procedure is required, submitted documentation indicating the functional need for the procedure can be submitted and reviewed under individual consideration. 

Comment #11:  One commenter provided the following and suggesting a rewording of the “Indications and Limitations of Coverage and/or Medical Necessity” section:  “Tapping the lids upward frequently will improve the visual field study, and therefore, is an indication for surgical treatment.  Brow ptosis repair also involves a number of different types of repair, but are indicated for displacement of the brow below the orbital rim frontalis ocular fatigue.  Brow and/or brow fat resting on the eyelashes whereby tapping temporarily improves the symptoms.  Visual impairment on an automated visual study is very difficult to isolate simply to the brow, and therefore, I would recommend that wording be changed as it is not uncommon for a brow mal-position to hinder a blepharoplasty or a blepharoptosis repair treatment.”

Response:  The clinical documentation should describe in detail those situations where brow and/or brow fat hinders the ability to do a blepharoplasty or blepharoptosis repair.  When this occurs the case can be reviewed on an individual basis.

Comment #12:  One commenter suggested that we add “prosthesis difficulties in an anophthalmic socket” under blepharoplasty and blepharoptosis repair in the Indications and Limitations of Coverage and/or Medical Necessity section of the policy.

Response:  This indication is currently in the proposed revision of the policies.

Y-1CC, Physical Therapy and Rehabilitation Services

Comment #1:  Several commenters wrote in agreement with the draft LCD as written.

Comment #2:  (Note:  This comment and response is repeated in Y-2R and Y-13A.) 

One commenter advised that the draft policies for Physical Therapy and Rehabilitation Services, Occupational Therapy Services, and Speech-Language Pathology Services are not consistent.  This commenter provided the following list of items that should be consistent in these three policies:

• If the signed order includes a plan of care, no further certification of the plan is required.
• Evaluation and treatment may occur on the same day or at the subsequent visit.
• The provider should obtain certification as soon as possible after the plan of care is established, meaning the physician/NPP should certify the plan as soon as it is obtained, or before the end of the first interval beginning at the initial therapy treatment.
• Subsequent re-certifications should be completed before or during the next interval, unless they are delayed.
• It is not intended that needed therapy be stopped or denied when certification is delayed.  The delayed certification of otherwise covered services should be accepted unless the contractor has reason to believe that there was no physician involved in the patient’s care, or treatment did not meet the patient’s need.

Response:  After much review of the content area, in consideration of recent CMS instructions in the content area, and in consideration of all the comments received, Highmark Medicare Services has decided to consolidate several LCDs into a single LCD, Y-1EE, now entitled: Physical Medicine and Rehabilitation Services, PT and OT.  This LCD will update and replace coverage information previously found in our Part B (Carrier) LCDs Y-1DD, Y-2S, Y-4L, Y-11C, and Y-12F; and our Part A (Fiscal Intermediary) LCDs 99-04R12, Y-2S, and Y-1DD.

Regarding the specific comments above:  This LCD was updated after the draft LCD was posted, to comply with CMS instructions issued in Change Request 5478: Outpatient Therapy Cap Exceptions Process for Calendar Year (CY) 2007.  The areas discussed in the comments were recently removed as they are now addressed in the CMS instructions. Additional guidance can be found in the Highmark Medicare Services Specialty Billing Guides for Physical and Occupational Therapy which were updated on February 21, 2007.

Comment #3:  One commenter suggested that in the “Patients Receiving Outpatient Therapy Services Must Be Under the Care of a Physician” section when we refer to chiropractors and doctors of dental surgery, we should change the wording to “nor establish physical therapy plans of care.”  Likewise, this commenter suggested adding the word “physical” to the phrase “plans of care for therapy services” in the “Coverage Limitations” section. 

Response:  See the response to Comment #2, above, regarding removal of certain sections of the draft LCD.  In those areas where such phrases remain, the wording has been changed.

Comment #4:  One commenter opined that the paragraph above “Physical medicine procedure (CPT 97139)” is in the wrong place in the draft policy.

Response:  This has been corrected.

Comment #5:  One commenter advised that the last sentence in the third paragraph under “Manual Therapy (CPT code 97140)” is not complete.

Response:  This has been corrected.

Comment #6:  One commenter advised that under “Manual therapy (CPT code 97140) the reporting instructions in the last paragraph are not consistent with the current billing and coding guidelines for physical therapy and rehabilitation services (i.e., the “rule of 8’s”).

Response:  See the response to Comment #2, above, regarding removal of certain sections of the draft LCD. 

Comment #7:  Several commenters noted that the draft policy refers to Veritus or VMS, instead of Highmark Medicare Services.

Response:  This has been corrected.

Comment #8:  One commenter advised that the statement, “the CORF services benefit does not recognize a NPP for orders and certification” is not addressed in the draft policies for Occupational Therapy Services and Speech-Language Pathology Services.

Response:  See the response to Comment #2, above, regarding removal of certain sections of the draft LCD. 

Comment #9:  One commenter addressed the statement, “The services provided must be provided by, or under the supervision of, a physician/NPP or therapist who is legally authorized to practice physical therapy services by the State in which he practices,” by stating that the state does not specify a type of practice.  It was this commenter’s suggestion that we eliminate the words “physical therapy,” unless this was an error and should have said physical therapist.

Response:  See the response to Comment #2, above, regarding removal of certain sections of the draft LCD. 

Comment #10:  One commenter requested that we add ICD-9 codes V-54.13-V54.16 and V54.23-V54.26 as eligible diagnosis codes for gait training, CPT code 97116.

Response:  These codes, and additional codes, have been added.

Comment #11:  One commenter advised that the clinical literature does not support the clinical effectiveness of Iontophoresis (CPT code 97033).

Response:  While utilization of this modality is less than some other modalities, and has trended downward, it is still actively in use.  The literature referred to was not submitted for review.  At this time, no changes have been made.

Comment #12:  One commenter advised that Guillain-Barre syndrome should be added as a covered indication.

Response:  The code was already available, this has been clarified.

Comment #13:  One commenter advised that electrical stimulation should be reasonable and necessary for stroke patients when it is determined that there is a potential for improvement in function including reduction in spasticity of antagonistic muscle groups.

Response:  This comment relates to a statement in the Coverage Limitations section of the LCD.  There are several National Coverage Determinations (NCDs) regarding electrical stimulation, including specific direction for Neuromuscular Electrical Stimulation (NMES).  The Indications and Limitations Section of the LCD has been revised to more clearly explain coverage as directed by the NCDs.

Comment #14:  One commenter suggested that Anodyne should be considered in specific situations as part of a therapy program to improve gait.

Response:  CMS issued a National Coverage Determination (NCD) on this topic which has been incorporated into the LCD.  The specific clinical situation would need to be eligible under the NCD to be considered.

Comment #15:  One commenter advised that the time period under “Progress Report” should be consistent with the requirement for recertification time period which is every 30 days, and that the terminology (“progress report”) should be compatible terminology with the billing codes which is a “re-evaluation.”  This commenter argued that if the work is required, it should be able to be billed.  Finally, this commenter suggested that the Progress Report should be at least once every 12 treatment days, not 10, and it should be billed as a re-evaluation.

Response:  See the response to Comment #2, above, regarding removal of certain sections of the draft LCD. 

Comment #16:  One commenter suggested that ICD-9 780.4 (Vertigo) should be added as covered condition.

Response:  This has been added.

Comment #17:  One commenter inquired if there is a separate occupation therapy policy.

Response:  On January 18, 2007, Highmark Medicare Services posted on our website three draft Local Coverage Determinations (LCDs) on therapies; i.e., LCD Y-1CC, Physical Therapy and Rehabilitation Services, LCD Y-2R, Occupational Therapy Services; and LCD Y-13A, Speech-Language Pathology Services.  However, see the response to comment #2, above, regarding consolidation of several LCDs, including the one for Occupational Therapy Services, into one LCD for Physical Medicine and Rehabilitation Services, PT and OT.

Comment #18:  One commenter opined that a 60-day period of certification is too long.  This commenter suggested 30 days.

Response:  See the response to Comment #2, above, regarding removal of certain sections of the draft LCD. 

Comment #19:  One comment suggested that “therapy to prevent deterioration is appropriate during a time period in which the patient receives other medical treatment (examples: chemotherapy or radiation therapy for carcinoma) that is likely to debilitate the patient or cause loss of function.  This is true, even if no measurable progress is made.” 

Response:  The section regarding maintenance programs has been revised.  While treatment in a specific clinical situation may not result in measurable progress, the other requirements for skilled services must still be met, e.g., the development of and instruction in the maintenance program must require the skills of the clinician/therapist.

Comment #20:  One commenter opined that the term “insignificant” should be defined better.

Response:  See the response to Comment #, above, regarding removal of certain sections of the draft LCD.  In any area where such wording was still present, it has been revised.

Comment #21:  One commenter advised that the sentence, “Short wave diathermy is probably the most effective modality for heating skeletal muscle.” is debatable and probably should be left out.  This commenter suggested that a better sentence would be, “Short wave diathermy is an appropriate modality for heating skeletal muscle.”

Response:  This area has been revised.

Comment #22:  One commenter requested clarification regarding the following phrases used under “Electrical Stimulation”:  “typical treatment,” and “services beyond this number.” 

Response:  This area has been revised.

Comment #23:  One commenter suggested under “Ultrasound Therapy” the term “heating” should replace “irradiation.”

Response:  This area has been revised.

Comment: #24:  One commenter suggested under “Therapeutic Procedures” that “other health care professions (such as a social worker or nurse) be changed to “such as a physician, social worker, nurse, or other therapist).”

Response:  This area has been revised.

Comment #25:  One commenter suggested under “Therapeutic Exercises” that the examples include “lumbar stabilization exercises (for flexibility and/or trunk strengthening).” 

Response:  This area has been revised.

Comment #26:  One commenter suggested under “Therapeutic Exercises” that the parenthetical “(secondary to coordination deficits)” be changed to “(secondary to coordination deficits, spasticity, or injury).”

Response:  This area has been revised.

Comment #27:  One commenter requested clarification of the term “BAP’s boards” under “Neuromuscular reeducation.”

Response:  The term has been clarified (Biomechanical Ankle Platform System boards).

Comment #28:  One commenter suggested that under “Gait training therapy” the term “manner and style” is vague; therefore, he suggested rewording the sentence to read:  “Gait training is the training of the biomechanical and kinesiological components of walking, including balance, cadence, symmetry, motor control, speed, energy efficiency, and endurance.” 

Response:  This area has been revised.

Comment #29:  One commenter requested that we add the following indication under “Gait training therapy”:  “the patient, having become unsafe to walk, requires assistance of a caregiver or family member who requires training to safely assist the patient with mobility.”

Response:  The issue raised in this specific context is relevant overall – when are therapy services eligible for coverage for training of a caregiver, because the patient cannot perform an activity safely without the caregiver’s assistance?  Language has been added to the Indications and Limitations section of the LCD to clarify coverage in these situations overall.

Comment #30:  One commenter requested that we add the following indication under “Manual traction”:  cervicalgia to cervical radiculopathy.

Response:  This area has been revised.

Comment #31:  One commenter stated provided the following objection regarding “Work hardening”:  “I strongly disagree with the statement that these services do not provide any diagnostic or therapeutic benefit for the patient that requires physical rehabilitation.  They are definitely restorative, and fulfill other medical necessity criteria listed earlier in this policy, starting on page 2.  If they are not to be covered, then I recommend that you find another way to describe your reasons.” 

Response:  This area has been revised.

Comment #32:  One commenter suggested under “Coverage Limitations/Electrical stimulation” that coverage be provided for multiple sclerosis, “if the ailment being addressed is an upper motor neuron syndrome with decreased motor control and weakness.”  This commenter suggested the following sentence rewording, “Electrical stimulation (97032, G0283) used for the treatment of facila nerve paralysis (e.g., Bell’s Palsy) or other lower motor neuron disorders is considered investigational, and therefore non-covered by Medicare.”

Response:  This comment relates to a statement in the Coverage Limitations section of the LCD.  There are several National Coverage Determinations (NCDs) regarding electrical stimulation, including specific direction for Neuromuscular Electrical Stimulation (NMES).  The Indications and Limitations Section of the LCD has been revised to more clearly explain coverage as directed by the NCDs.

Comment #33:  Several commenters provided rationale for the addition of the following ICD-9 codes:  290.0, 290.10-290.13, 290.20-290.21, 290.3, 290.40-290.43, 294.10-294.11, 331.0, 331.11, 331.19, 331.2, 331.82, 331.83, 333.4, 438.0, 438.6, 438.7, 438.81, 438.84, 438.85, 438.89, 729.2, 736.71, 780.4, 780.79, 780.93, 780.97, 780.99, and V15.88.  

Comment #34:  One commenter requested that we add the depressive disorders (296 series) as covered indications, because of the associated debility, especially for CPT codes 97110 and 97116.

Response:  This grouping of codes includes a wide range of items, such as neuropsychiatric disorders, pain syndromes, acquired physical deformities, a variety of symptoms, and a history of falls.  This LCD has undergone many past revisions, and the current ICD-9-CM lists are similarly wide in range. 

The final version of this LCD has added indications. Those items which more directly align with rehabilitation goals for most individuals, i.e. those codes that readily identify a functional problem or limitation, impairment, or disability that the rehabilitative service can improve in a predictable period of time, have been identified.  In those instances where the primary code does not define a condition that aligns with the rehabilitative goals and can be improved within a predictable period of time, a secondary code that defines such a condition will be required.

Comment #35:  One commenter recommended five areas of the draft policy where the term “physician” should be changed to “physical therapist.” 

1. “The services must be provided by or under the direct supervision of a physician who is legally authorized to practice physical therapy services by the State in which he practices.”
2. “The services must be of a level of complexity that requires there they be performed by or under the direct supervision of a physician.”
3. “These services maintain function and generally do not involve complex physical therapy procedures nor do they require physician judgment and skill for safety and effectiveness.”
4. “Where there is an identified risk to the patient, the professional skill of a physician may be required to manage and periodically evaluate the appropriateness of a therapy maintenance program.”
5. “…treatment goals/objectives of the physician;”

Response:  See the response to Comment #2, above, regarding removal of certain sections of the draft LCD.

Comment #36:  One commenter suggested that the following sentence under “Therapeutic Activities” “should also include qualified personnel, specifically a physical therapist assistant:”  “The patient’s condition is such that he/she is unable to perform therapeutic activities except under the direct supervision of a physician or physical therapist; and…”

Response:  This comment raises the broader issue of when the “incident-to” rules apply, and when “direct supervision” rules apply to therapy services and providers.  Please see Highmark Medicare Services Specialty Billing Guides for Physical Therapy and Occupational Therapy; these documents explain in great detail the CMS rules and regulations on these topics. This area of the LCD has been revised for clarification.

Y-2R, Occupational Therapy Services

Comment #1:  Several commenters wrote in agreement with the draft LCD as written.

Comment #2:  (Note:  This comment and response is repeated in Y-1CC and Y-13A.)

One commenter advised that the draft policies for Physical Therapy and Rehabilitation Services, Occupational Therapy Services, and Speech-Language Pathology Services are not consistent.  This commenter provided the following list of items that should be consistent in these three policies:

• If the signed order includes a plan of care, no further certification of the plan is required.
• Evaluation and treatment may occur on the same day or at the subsequent visit.
• The provider should obtain certification as soon as possible after the plan of care is established, meaning the physician/NPP should certify the plan as soon as it is obtained, or before the end of the first interval beginning at the initial therapy treatment.
• Subsequent re-certifications should be completed before or during the next interval, unless they are delayed.
• It is not intended that needed therapy be stopped or denied when certification is delayed.  The delayed certification of otherwise covered services should be accepted unless the contractor has reason to believe that there was no physician involved in the patient’s care, or treatment did not meet the patient’s need.

Response:  After much review of the content area, in consideration of recent CMS instructions in the content area, and in consideration of all the comments received, Highmark Medicare Services has decided to consolidate several LCDs into a single LCD, Y-1EE, now entitled: Physical Medicine and Rehabilitation Services, PT and OT.  This LCD will update and replace coverage information previously found in our Part B (Carrier) LCDs Y-1DD, Y-2S, Y-4L, Y-11C, and Y-12F; and our Part A (Fiscal Intermediary) LCDs 99-04R12, Y-2S, and Y-1DD.

Regarding the specific comments above:  This LCD was updated after the draft LCD was posted, to comply with CMS instructions issued in Change Request 5478: Outpatient Therapy Cap Exceptions Process for Calendar Year (CY) 2007.  The areas discussed in the comments were removed as they are now addressed in the CMS instructions. Additional guidance can be found in the Highmark Medicare Services Specialty Billing Guides for Physical and Occupational Therapy which were recently updated.

Comment #3:  Several commenters provided rationale for adding ICD-9 codes to the policy as covered indications, including diagnosis for Alzheimer’s disease and related dementias.  These recommended conditions are:  290.0 -290.43, 290.10-290.13, 290.20-290.21, 290.3, 290.40-290.43, 294.10-294.11, 331.0, 331.11, 331.19, 331.2, 331.82, 331.83, 333.4, 368.14, 438.0, 706.2, 716.94, 733.82, 736.1, 733.81, 780.93, 780.97, 780.99, 784.61, 784.69, and V15.88.

Comment #4:  Several commenters provided rationale for adding the following pain diagnosis codes as covered indications:  338.0, 338.11, 338.12, 338.18, 338.19, 338.21, 338.22, 338.28, 338.29, 338.3, 338.4, and 780.96.

Response to #3 and #4:  This grouping of codes includes a wide range of items, such as neuropsychiatric disorders, pain syndromes, acquired physical deformities, a variety of symptoms, and a history of falls.  This LCD has undergone many past revisions, and the current ICD-9-CM lists are similarly wide in range. 

The final version of this LCD has added indications. Those items which more directly align with rehabilitation goals for most individuals, i.e. those codes that readily identify a functional problem or limitation, impairment, or disability that the rehabilitative service can improve in a predictable period of time, have been identified.  In those instances where the primary code does not define a condition that aligns with the rehabilitative goals and can be improved within a predictable period of time, a secondary code that defines such a condition will be required.

Comment #5:  Several commenters provided rational for adding the following low vision diagnosis codes as covered indications:  336.01-362.06, 362.50, 366.11-366.46, 365.00-365.65, 368.14, 368.15, 368.44, 369.3, 369.4, 369.61-369.63, 369.65-369.66, 369.68-369.69, 369.71-369.73, 369.75-369.76, 369.8, 784.61, and 784.69.  It was also requested that we add a note to this list of ICD-9 codes indicating that these codes are not all inclusive of the eligible low vision diagnosis codes.

Response:  Low vision services were in a separate LCD, Y-12.  See response to Comment #2, above.

Comment #6:  A commenter requested that we add CPT codes 92610 and 92526, and further suggested we add the dysphagia diagnosis codes 438.82 and 787.2 as covered indications for these added CPT codes.

Response:  There is a separate LCD dealing with swallowing disorders/dysphagia.  However, it is not yet aligned across the contractor’s jurisdiction.  It will be presented for comment in the near future.

Comment #7:  Several commenters provided rationale for the addition of the following CPT codes and HCPCS codes as covered conditions:  G0329, G0281, 64550, 90901, 90911, 92526, 92610, 92611, 97026, 97033, 97034, 97124, 97504, 97533, 97537, 97545, 97546, 97533, 97537, 97597, 97598, 97703, 97750, 97755, 97760, 97761and 97762. 

Response:  See responses to Comments #2 and #6, above.

Comment #8:  Several commenters advised that under “Coverage Limitations” the term “physical therapy procedures” should be change to “occupational therapy procedures.”  This same commenter suggested the change from “physical therapy services” to “occupational therapy services” under “Documentation Requirements.”

Response:  See the response to Comment #2, above, regarding removal of certain sections of the draft LCD.

Comment #9:  One commenter advised that the re-evaluation and the number of allotted re-evaluations per patient per course of injury/illness should be consistent with good practice and recertification requirements.

Response:  See the response to Comment #2, above, regarding removal of certain sections of the draft LCD.

Comment #10:  One commenter advised that we should factor in 2% administrative costs.

Response:  LCD content is directed by the CMS Program Integrity Manual (PIM), IOM Pub. 100-08, Chapter 13.  LCD content is to describe reasonable and medically necessary coverage parameters; it does not include pricing or cost calculations.

Comment #11:  One commenter advised that the policy fails to cover hand surgery and injury.

Response:  See response to Comment #2, above.

Comment #12:  One commenter questioned the necessity of including guidelines specific to occupational therapy procedures in Private Practice.

Response:  Highmark Medicare Services is a contractor with multiple jurisdictions.  As directed by the CMS Program Integrity Manual (PIM), IOM Pub. 100-08, Chapter 13, we are aligning our LCDs across our jurisdictions.  Additional information can be found in Highmark Medicare Services Specialty Billing Guide for Occupational Therapy.

Comment #13:  One commenter advised that it is inaccurate that occupational therapy assistants must practice under the “direct” supervision of an occupational therapist; rather, they require general supervision.

Response:  The Medicare Benefit Policy Manual, IOM pub. 100-02, Section 230.2C describes services of occupational therapy support personnel.  It states: “An occupational therapist must supervise OTAs.  The level and frequency of supervision differs by setting (and by state and local law).  General supervision is required for OTAs in all settings except private practice (which requires direct supervision) unless state practice requirements are more stringent, in which case state or local requirements must be followed.”  This area of the LCD has been revised for clarity.

Comment #14:  One commenter questioned the inclusion of the evaluation and management (E/M) services on the policy.

Response:  See the response to Comment #2, above, regarding removal of certain sections of the draft LCD.

Comment #15:  One commenter questioned the inclusion of the therapy cap exceptions on this policy, but not on the physical therapy services (LCD Y-1CC) and the speech-language pathology services (LCD Y-13A) policies.

Response:  See the response to Comment #2, above, regarding removal of certain sections of the draft LCD.

Comment #16:  One commenter advised that we did not include on the draft policy the requirement that a clinician must actively participate in at least one treatment session during the interval of treatment.

Response:  It is not clear what the intent of this comment is, because “clinician” is not further defined.  The Medicare requirements for evaluations, care plans, certifications, etc., must be met before treatment begins.  Therapy treatment services can be performed by several different types of providers. Either the “incident-to” rules or the “direct supervision” rules apply; both require active clinician participation.  Please see Highmark Medicare Services Specialty Billing Guides for Physical Therapy and Occupational Therapy; these documents explain in greater detail the CMS rules and regulations.

Comment #17:  One commenter stated that the policy’s definition of occupational therapy services addresses mainly “physical functioning,” and request that the policy refer to the “cognitive performance as well as behavioral performance (mental health) in its definition of occupational therapy.”  This commenter also provided updated definitions of occupational therapist and occupational therapy assistant for inclusion in the final policy.

Response:  See the response to Comment #2, above, regarding removal of certain sections of the draft LCD.

Comment #18:  One commenter provided a list of sources for their recommendations, and requested that we update the sources on the final policy to include their list of sources.

Response:  The listing is appreciated.  The actual sources were not provided, only the listing, therefore the LCD section was not updated.

Y-13A, Speech-Language Pathology Services

Comment #1:  Several commenters wrote in agreement with the draft LCD as written.

Comment #2:  (Note:  This comment and response is repeated in Y-1CC and Y-2R)

One commenter advised that the draft policies for Physical Therapy and Rehabilitation Services, Occupational Therapy Services, and Speech-Language Pathology Services are not consistent.  This commenter provided the following list of items that should be consistent in these three policies:

• If the signed order includes a plan of care, no further certification of the plan is required.
• Evaluation and treatment may occur on the same day or at the subsequent visit.
• The provider should obtain certification as soon as possible after the plan of care is established, meaning the physician/NPP should certify the plan as soon as it is obtained, or before the end of the first interval beginning at the initial therapy treatment.
• Subsequent re-certifications should be completed before or during the next interval, unless they are delayed.
• It is not intended that needed therapy be stopped or denied when certification is delayed.  The delayed certification of otherwise covered services should be accepted unless the contractor has reason to believe that there was no physician involved in the patient’s care, or treatment did not meet the patient’s need.

Response:  After much review of the content area, in consideration of recent CMS instructions in the content area, and in consideration of all the comments received, Highmark Medicare Services (HMS) has decided to consolidate several LCDs into a single LCD, Y-1EE, now entitled: Physical Medicine and Rehabilitation Services, PT and OT.  This LCD will update and replace coverage information previously found in our Part B (Carrier) LCDs Y-1DD, Y-2S, Y-4L, Y-11C, and Y-12F; and our Part A (Fiscal Intermediary) LCDs 99-04R12, Y-2S, and Y-1DD.  The Speech-Language Pathology Services LCD, Y-13C, remains a separate LCD. HMS also has LCDs discussing dysphagia and VitalStim therapy.

Regarding the specific comments above:  This LCD was updated after the draft LCD was posted, to comply with CMS instructions issued in Change Request 5478: Outpatient Therapy Cap Exceptions Process for Calendar Year (CY) 2007.  The areas discussed in the comments were removed as they are now addressed in the CMS instructions. Additional guidance can be found in the CMS IOM Pub. 100-02 Medicare Benefit Policy Manual, sections 220 and 230, and in Highmark Medicare Services Part B Reference Manual.

Comment #3:  One commenter requested that we add “However, the SLP may make infrequent but periodic reevaluations of the plan.” to the second paragraph under “Maintenance Program.”

Response:  See the response to Comment #2, above, regarding removal of certain sections of the draft LCD.  Also, the section regarding maintenance programs has been revised. 

Comment #4: One commenter suggested that we change a sentence in the third paragraph under “Maintenance Program” from “instructed the patient, or family members” to “instructed the patient, family members and /or unskilled personnel.”

Response:  See the response to Comment #2, above, regarding removal of certain sections of the draft LCD.  Also, the section regarding maintenance programs has been revised. 

Comment #5:  One commenter requested that we add the following sentence to the end of the paragraph under “Provider Qualification Requirements”:  “The services SLPs may also be billed by physical and occupational therapists in private practice.”

Response:  See the response to Comment #2, above, regarding removal of certain sections of the draft LCD. 

Comment #6:  One commenter requested that we change the heading “Aides” to “Aides/Assistants” under “Supervision Requirements.”

Response:  See the response to Comment #2, above, regarding removal of certain sections of the draft LCD. 

Comment #7:  One commenter requested that we expand the “Students” paragraph under “Supervision Requirements,” and provided wording from the CMS manuals.

Response:  See the response to Comment #2, above, regarding removal of certain sections of the draft LCD. 

Comment #8:  One commenter suggested advised that it is not appropriate for SLP services to be under the care of a podiatrist or optometrist; therefore, the commenter requested that we remove wording pertain to this affect under “Patients Receiving Outpatient Therapy Services Must Be Under the Care of Physician/Non-physician Practitioner (NPP).”

Response:  See the response to Comment #2, above, regarding removal of certain sections of the draft LCD.    

Comment #9:  One commenter suggested wording changes in the first paragraph under “Review of the Plan and Certification in the Outpatient Setting” in order to indicate that registered nurses may enter changes to the treatment plan in the patient record.

Response:  See the response to Comment #2, above, regarding removal of certain sections of the draft LCD. 

Comment #10:  One commenter suggested the deletion of the parenthetical sentence in Item G under “SLP Therapeutic Services” since voice prosthetics are not programmed and reprogrammed.

Response:   This area has been revised. 

Comment #11:  Several commenters provided rationale for the addition of the following ICD-9 codes as covered conditions:  146.0-146.9, 148.0-148.9, 212.10, 235.6, 290.0, 290.10-290.13, 290.20-290.21, 290.3, 290.40-290.43, 294.10-294.11, 307.0, 307.23, 315.1, 331.0, 331.11, 331.19, 331.2, 331.82, 331.83, 332, 333.0, 333.2, 333.4, 333.5, 333.6, 333.81-333.89, 333.90-333.99, 335.20, 341.00-341.90, 342.00-342.92, 436, 476, 478.4, 478.6, 507.2, 748.2, 748.3, 749.00, 749.01, 749.02, 749.03, 749.04, 749.10, 749.20, 758, 780.57, 786.01, 786.2, and 787.2.  In addition, one commenter suggested that we delete the following ICD-9 codes from the covered conditions:  438.82 and V41.6.

Comment #12:  One commenter suggested that we add the following ICD-9 codes as covered conditions that are associated with cognitive impairment:  290.0, 290.10-290.13, 290.20-290.21, 290.3, 290.40-290.43, 294.8, 294.10-294.11, 310.0, 331.0, 331.11, 331.19, 331.2, 331.82, 331.83, and 333.4.

Response to #11 and #12:  The final version of this LCD has added many indications, and deleted the two codes suggested above. Those items which more directly align with rehabilitation goals for most individuals, i.e. those codes that readily identify a functional problem or limitation, impairment, or disability that the rehabilitative service can improve in a predictable period of time, have been identified.  In those instances where the primary code does not define a condition that aligns with the rehabilitative goals and can be improved within a predictable period of time, a secondary code that defines such a condition will be required.  Dysphagia / swallowing disorders and VitalStim therapy are in other LCDs.

Comment #13:  One commenter suggested that we add examples provided to further explain CPT codes 97530 and 97832 and under “SLP Therapeutic Services.”

Response:  These areas have been revised.

Comment #14:  One commenter advised that CPT code 97532 is an evaluation code; therefore, “with interpretation and report” should be deleted in the “SLP Therapeutic Services” section.

Response:  This area has been revised.

Comment #15:  One commenter suggested verbiage changes in the descriptions of a number of codes listed in the “CPT/HCPCS Codes” section.

Response:   LCD content is directed by the CMS Program Integrity Manual (PIM), IOM Pub. 100-08, Chapter 13.  Code descriptors are not created by the local fiscal intermediary or carrier.  However, the text in the Indications and Limitations section of the LCD has been revised.

Comment #16:  One commenter questioned the requirement that a clinician must provide an order for a referral for SPL.

Response:  See the response to Comment #2, above, regarding removal of certain sections of the draft LCD.  Additional guidance regarding the specific question above can be found in the IOM Pub. 100-02 Medicare Benefit Policy Manual, sections 220 and 230.

Comment #17:  One commenter advised that the review of the treatment plan per the State has been based on the calendar days, rather than every 30 days, as stated in the policy.

Response:  See the response to Comment #2, above, regarding removal of certain sections of the draft LCD. 

Z-8L, Sleep Disorder Testing

Comment #1:  Several commenters wrote in agreement with the draft LCD as written.

Comment #2:  One commenter advised that the policy provides guidelines for providing these diagnostic services under the “incident to” guidelines, when the appropriate guidance is under general supervision.

Response: 

1. Unattended sleep studies (CPT 95806) are non-covered by Medicare.
2. Both the draft and final LCD notes:  “Diagnostic testing routinely performed in sleep disorder laboratories may be covered even in the absence of direct supervision by a physician when data is interpreted by a physician.”

Comment #3:  One commenter advised that the requirement that a patient be referred by a physician to a sleep disorder center for the services to be eligible should be removed from the policy since some patients do not have access to a primary care physician.

Response:  The referral to a sleep study does not have to be from a “primary care physician.”  However, it is expected and required that patients are referred to the sleep disorder center by a physician, and the center maintains a record of the physician’s order and referral.

Comment #4:  Several commenters provided opinion regarding the following statement in the “Covered Indications” section:  “Diagnostic sleep testing is appropriate only when the patient is in a baseline or ‘steady state’.  Testing performed during the acute phase of an illness or injury is not appropriate.”  The commenters opined that the terms “baseline,” and “steady state” are unclear and not in keeping with what brought the person to the sleep center or made the primary care doctor give a referral.

Response:  The final LCD was updated to state:   “Sleep disorder testing performed during the acute phase of an illness or injury is not appropriate.”  The terms “baseline” and “steady state” were removed, but it is expected that sleep disorder testing would not be performed (or covered) during the acute phase of an illness or injury.

Comment #5:  One commenter advised that there is no rationale for the differences provided in the policy regarding the associated medical conditions for the full PSG followed by CPAP titration vs. CPAP titration via split-night study.  In addition, this commenter requested that we expand the minimum criteria to include an AHI of less than 5, if apneas are repeatedly accompanied by either sever SaO2 decrements to values less than 88% or cardiac dysrhythmias.

Response:  Follow-up PSG is not routinely indicated in patients treated with CPAP whose symptoms continue to be resolved with CPAP treatment.  In addition, there are clinically separate indications for a diagnostic PSG, PSG with CPAP titration, and a split-night study as noted in the final LCD.

Comment #6:  One commenter provided rationale for allowing coverage of a polysomnography, testing for patients with periodic limb movement disorder; however, the draft policy does not provide coverage for this indication.  Another commenter agreed, and added that restless leg syndrome should also be a covered indication since both are “common finding[s] associated with sleep apnea.”

Response:  Restless leg syndrome by itself is not a covered indication for sleep studies, although restless leg syndrome can accompany the covered indications noted in the final LCD.

Comment #7:  Several commenters advised that requiring that a detailed patient history of sleep disorder and a physical examination must be obtained and documented within 72 hours of the sleep study is unreasonable, and will result in undue expense and inconvenience for the patients, .  Another commenter questioned if this documentation requirement referred to “showing the indications for the sleep study?”  Another commenter requested that we further clarify the 72 hours (i.e., does this mean working hours, and does the detailed history and examination need to be performed by a physician, or can it be performed by a qualified sleep technician?).  One commenter advised that delays in obtaining a detailed H&P from the physician’s office are not always the fault of the sleep lab; however, these delays affect the eligibility of a medically necessary sleep study.  Finally, one commenter suggested a more realistic time is 90 days or longer.

Response:  The 72 hour requirement on our draft LCD was requested by our clinical consultants as often no patient history, exam, and functional limitations leading to the request for a sleep study are obtained or provided.  The final LCD eliminated the requirement for this information to be obtained within 72 hours of the sleep study, but did not eliminate the need, and requirement for the documentation requirements (see the final LCD for the specific documentation requirements). 

Comment #8:  One commenter advised that ICD-9 codes 278.01-278.02 (Morbid obesity and overweight) should not be removed from the policy as covered indications.  Another commenter advised that deleting ICD-9 codes does not decrease the number of sleep studies, and requested that we reconsider the deletion of codes.

Response:  Morbid obesity or overweight is not in itself a covered indication for sleep studies.  The patient must have one of the covered indications listed in the final policy and the documentation requirements must fully delineate the necessity (as per the final LCD).

Comment #9:  One commenter advised that the denial of 95810 and/or 95811 with 94375 (Respiratory flow volume loop) is not addressed in the policy.

Response:  Addressed in the accompanying coding and billing article.

Comment #10:  One commenter inquired about the documentation that should be submitted, if requested; to support the “minimum of 2 hours of sleep recorded by PSG” under “Sleep Apnea,” i.e., should the provider submit the full diagnostic results including total sleep time, or only the diagnostic AHI.  This commenter also asked for a clarification of this requirement – i.e., is it recording only or actual sleep time?

Response:    Addressed in the accompanying coding and billing article.

Comment #11:  One commenter opined that the statement, “The necessity for diagnostic testing should be confirmed by medical evidence, e.g., physical examinations and laboratory tests,” should be deleted since there are no laboratory tests or physical findings associated with sleep disorders.

Response:  Final LCD updated to state:  “The need for diagnostic testing is confirmed by medical evidence.  To include physician history and examination (for example including the sleep history, and exams of the respiratory, cardiovascular, and neurological systems), and any applicable laboratory/diagnostic tests, all documented in the patient’s clinical records.”

Comment #12:  One commenter suggested that term “direct personal” used to described the type of supervision in the “Coverage of Therapeutic services in a sleep disorder clinic” section is redundant.

Response:  The correct verbiage of “direct supervision” was updated in the final LCD.

Comment #13:  One commenter opined that the following two statements in this policy are contrary to the requirements by another Medicare contractor; i.e., Medicare Part B does not allow for duplicate studies, but the Medicare DME contractor requires duplicate studies:

“Sleep Apnea” Section:  “Follow up Polysomnography is not routinely indicated in patients treatment with CPAP whose symptoms continue to be resolved with CPAP treatment”

“Coverage Limitations” Section:  “Diagnostic testing that is duplicative of previous sleep testing, to the extent the results are still pertinent, is not covered if there have been no significant clinical changes in medical history since the previous study”. 

Response:  The statements are not in conflict with DMERC coverage criteria.