CVI and Lymphedema Patient Bill of Rights - Part II

Author: Linda Bily
Contributor(s): Cheri Hoskins and Cyndi Ortiz
Published on: Apr 28, 2005

Continuation of this important step towards legislation. They need YOUR input and support.

Contact them via http://lymphedema.omno.org

and then contact your political leaders and urge them to support a comprehensive piece of LE legislation.

Health Insurer’s Shall:

a. Provide policies, benefits, coverage guidelines, and provider contracting that will allow for coverage on all effective medical treatment and disease management for lymphatic and vascular disease.

b. Require providers to be certified lymphedema therapists or certified compression therapists.

c. Act in the best interest of providing a high quality of care and in the best interest of the beneficiary’s health care and quality of life.

d. Act in a fair, honest and ethical manner.

Prohibited Actions of and Requirements of

Insurers

a. Insurers shall approve treatment, and purchase of supplies and equipment needed to treat and manage vascular and lymphatic diseases as ordered by the treating physician, unless there is a clear indication that treatment would be contraindicated. Denials by insurers shall include a letter to the insured, the provider, and the ordering physician, and shall state a clear detailed reason for the denial, three or more clinical studies used in determining a reason for the denial, written guarantee that the patient will not suffer physical harm or exacerbation of their condition or further complication resulting from the denial, the credentials, training, and education specific to lymphatic and vascular disease of the person denying coverage, and shall be included with the letter of denial. Denials shall not be made due to a “lack of medical necessity”.

b. Insurer’s shall not engage in practicing medicine without a license or practicing medicine without physically examining a patient nor attempt to engage in such, by diagnosing or recommending treatment, by disputing the diagnosis of the examining and ordering physician, denying treatment exactly as ordered but agreeing to pay for a less expensive treatment, supply, or equipment.

c. Insurer’s may not obstruct a patients ability to receive effective treatment by requiring lease versus purchase of supplies and/or equipment when the treating physician’s order states a lifetime need, reducing allowed reimbursement below Medicare allowable, bundling fees, or imposing benefit limits of $350,000.00 or less per year per person, in addition to hospitalization benefits, on medical services, therapy or supplies and equipment deductibles exceeding $500.00 per year per person and less than 80% coverage for any treatment as ordered by the treating physician for lymphatic and vascular disease.

d. Insurers may not engage in down coding, or bundling reimbursement for treatment, supplies, or equipment ordered and billed as treatment for vascular and lymphatic disease.

e. Insurer’s may not engage in obstructing a patient’s ability to obtain effective treatment as ordered by the treating physician, in way.

f. Insurers may not delay treatment by requiring patient’s to obtain further testing, consult other physician’s and/or specialists, or requiring or recommending the trial of a less expensive treatment, supplies, or equipment.

g. Insurer’s may not exceed three business days in the approval of treatment, supplies, or equipment required for treatment, make every effort to act in the best interest of patient care, document such actions taken to act in the best interest of patient care, and provide such documentation to the patient, provider, and ordering physician within five business days upon their verbal or written request. Failure to comply with prior authorization deadline of three business days will result in the forfeiture of deductible and co-payment, or a penalty of $100.00 if coverage is 100% for each day exceeding the five day requirement of submission of documented actions taken to act in the best interest of patient care, and shall be paid to the beneficiary.

h. Insurers must require a physician’s prescription, a letter of medical necessity, but may not require copies of patients confidential medical records, history and physical, or any medical records that may violate a patient’s right to privacy in order to approve coverage. Insurers must require the physician’s letter of medical necessity to include diagnosis, and a treatment plan specific to each patient’s needs, lifestyle, and ability to apply treatment as ordered, and shall include risks if disease is not treated effectively, and prognosis with effective treatment.

i. Insurers may not deny coverage due to an assumption that the patient “may not be compliant”, or require a “equipment trial period to prove efficacy or to determine compliance”.

j. Insurers may not exceed twenty-five days upon receipt of a clean claim, or otherwise pay the claim at the full amount billed plus one-half times the amount billed for every thirty days the claim is overdue to be included in the payment of the claim to the provider, not through a separate process and department.

Insurers shall not engage in negotiating payment or reimbursement in contracting that will reimburse less than Medicare allowable, unless it is to the negotiated payment is due to an "early payment" discount, in which case payment to provider must be received by the provider with the agreed upon, pre-negotiated "early payment" deadline. Insurers shall participate in early payment discounted negotiation and submit payment based on early payment negotiated contract when the patient is required according to the policy to pay any portion of their treatment, supplies, or equipment

Insurers must contract with, and/or require provider’s who are providing treatment, supplies, and equipment for patients only through provider’s who are trained, and knowledgeable in vascular and lymphatic diseases. Insurers shall require and reimburse provider’s, including DME lymphatic and vascular specialists who are able to properly evaluate a patient’s needs, provide home set-up and instruction on supplies, or equipment provided, educate the patient on the application of treatment, supplies, and equipment, conduct pre-treatment, and post-treatment measurements, and provide at least one follow-up visit including measurements and documenting improvement after treatment has been used for four to six weeks based on patient availability. Insurers shall require providers to submit policy and procedure of outlining education and experience specific to lymphatic and vascular disease, set-up, and follow-up procedures to insurer with contract and/or prior authorization request and/or claim submission. Insurer’s must provide reimbursement to DME providers for a Certified Compression Therapist’s evaluation, set-up procedures and patient education, and follow-up evaluations, as ordered by the treating physician.

An insurer may not “bundle” reimbursement for physical therapy, application of MLD/CDP, and application of external compression with physical therapy as treatment for other rehabilitation, or diagnoses. Insurer’s must cover but not require MLD/CDP therapy if a patient is not able to attend therapy due to a physical inability, excessive employment schedule or other inhibiting factors, in order to cover DME home medical equipment.

Insurer’s may not allow the shipping of sequential compression pumps, external mechanical compression therapy, or gradient calibrated sequential compression pumps, except when item is a replacement item, but must require home set-up, hospital or rehab facility set-up, measurement and education procedures as outlined herein, by a Certified Compression Therapist. These devices may not be set-up by a Certified Lymphedema Therapist unless no Certified Compression therapist is available in the beneficiary’s area.

Insurer’s must change policies, procedures, plan benefits, reimbursement codes, allowable, reasonable and customary fees and contracts with providers to be in compliance with this law, and may not engage in contracted fees and allowable or reimbursement for any amount less than Medicare’s allowable, unless an early payment discount has been negotiated. Insurer’s may not at any time for any reason, change the plan of treatment or the prescribed treatment as ordered by the treating physician, by denying coverage for ordered treatment, supplies, or equipment and requiring, recommending, or otherwise offering other alternatives for treatment, but shall approve recommended treatment exactly, without any such variation of the prescription as written by the ordering physician. Any person(s) or company who engage in such activity will be criminally and legally subject to prosecution under federal and state insurance and medical malpractice laws, as well as financially responsible for any damages caused by this action.

Insurer’s must pay “in-network” benefits to “out-of-network” providers when an “in-network” provider is not available or qualified as per the guidelines outlined herein, to provide treatment as ordered by the treating physician. Insurer’s must provide coverage according to the policy even after the policy is no longer in force or effective when a claim or prior authorization request was submitted prior to the termination date, but inappropriately denied, which may be determined by a state’s insurance commissioner or by a state medical examiner’s board, if the decision to deny is made by a medical director who is a licensed physician. Insurer’s may not contact the patient or ordering physician for any reason other than to confirm basic information, such as mailing addresses, phone number, or date of birth. Insurer’s may not contact the patient or ordering physician to discuss treatment options or to suggest or request any revisions of the physician’s order. Insurer’s may not request or require providers to submit confidential or proprietary information including invoices, except in the case when reimbursement is cost times two, any financial records, or confidential patient records in order to approve coverage or reimburse for medical services, physical therapy, or durable medical equipment as outlined herein.

Insurer’s may not discriminate, prohibit, obstruct, mislead, defraud or prevent in any way for any reason, qualified and certified providers from providing, contracting, or obtaining reimbursement for services, supplies or treatment as ordered by the treating physician for their beneficiaries. Any person(s) or company or insurer which engages in this activity will be subject to Titles 14 and 18 of the US code. Physical Therapy with application of Manual Lymph

Drainage

a. shall be provided and applied by a licensed physical therapist, occupational therapist, licensed practical nurse, licensed message therapist, or registered nurse, LANA certified, with an additional 135 hours of certified training for manual lymph drainage and/or combined decongestive physiotherapy.

b. Physical therapy shall require the application of a reasonable amount of time for treatment, and not less than one hour of application of MLD/CDP, one hour for application of external compression, and one half hour for patient education on disease self-care, and home management. Insurers must allow for coverage on extended treatment time, application of external compression, and patient education on disease self-care when the condition is severe and/or more than one extremity or area of the body is affected, or when there are other circumstances requiring additional time, as determined, documented in a letter of medical necessity, and ordered by the treating physician.

c. As part of the discharge planning and home management program, physical therapy must also include of a consult with a Durable Medical Equipment Disease Management lymphatic and vascular specialist who specializes in providing durable medical equipment specific in treating lymphatic and vascular diseases together with the treating MLD/CDP therapist, two weeks after therapy has begun, and consult shall document the review of patient needs, and available home management tools and/or equipment, their contraindications, their function, and allow each patient consider recommendations made by the licensed therapist, and make an educated decision as to which modality of external compression would ensure treatment success.

Durable Medical Equipment Providers

a. who do not specialize in providing treatment for lymphatic and vascular disease may not participate in providing intermittent, sequential, or calibrated gradient sequential compression pumps or devices, external compression devices, directional flow devices, or supplies or items needed for treatment of vascular and lymphatic diseases other than compression bandaging or compression stockings, as well as any new treatments or technologies, supplies or equipment that have obtained FDA approval.

b. Any new treatments or technologies, supplies, or equipment that have obtained FDA approval specifically for treatment of lymphedema, chronic venous insufficiency, and peripheral vascular disease, or otherwise may not be marketed or used for treatment of such.

c. DME companies shall provide patients with an initial evaluation by a Certified Compression Therapist, in order to assess their needs, lifestyle, and all factors and considerations, and provide the ordering physician with a written evaluation assessment. Once the ordering physician outlines a treatment plan, the Certified Compression Therapist shall provide, upon insurance approval, items ordered by the physician. DME companies shall have policies and procedures in place, and implement such, as to set-up procedures including pre-treatment and post-treatment measurements, patient education, follow-up procedures, and long-term servicing. The DME company’s Certified Compression Therapist must also provide the ordering phyusician with a written report of the set-up of equipment, including measurements and reduction accomplished, as w4ell as a written report of the follow-up visit, also including measurements. DME companies may not engage in providing any equipment and/or supplies specific to treatment of lymphatic and vascular disease via shipment through the United States Postal Service, or other such shipping methods, unlessthe item is a replacement item, or compression bandaging. All equipment and/or supplies must be provided inthe home or rehab or hospital facility of the patient, unless such equipment is shipped, and not opened by the patient, until a Certified Compression therapist is able to apply a set-up for the patient. Equipment and/or supplies may be provided for a patient's use in a hospital, rehab, or physical therapy clinic.

Provider’s of DME equipment may not be held liable for fraud or otherwise when a patient obtaining equipment, and/or supplies for treatment of lymphatic and vascular disease, but has no signs or symptoms of such disease, when the DME lymphatic and vascular specialist has submitted a written letter to the ordering physician stating that the patient does not appear to have any signs or symptoms of vascular or lymphatic disease. The ordering physician is to be held liable for the accuracy or his or her diagnosis, treatment plan, and treatment ordered, regardless of the DME lymphatic and vascular disease specialists recommendations, as the final determination in making an accurate diagnosis, and treatment ordered is the physicians.

Each request for prior authorization shall include a written physician’s order, and a physician’s letter of medical necessity, including an outlined long-term disease management plan specific to each patient’s needs, lifestyle, physical ability to apply treatment as ordered, risks if disease is not treated effectively, and prognosis with effective treatment.

DME Companies providing IPC (Intermittent Pulse Compression or DVT pumps), or aircasts in lieu of lymphedema pumps, or billing items not supplied or items are supplied that do not fit the FDA description or code description of billed item shall be held liable for fraud. DME companies engaging in providing financial or monetary compensation to physician’s in exchange for fraudulent diagnosis or referrals shall be held liable for fraud. Lunches for in-services, or gifts during the holidays costing $100.00 or less are not considered financial or monetary compensation. DME companies billing for items that have not been delivered, with the exception of custom fit items refused by the patient after custom measurements were provided will be held liable for fraud. DME companies providing equipment or supplies for providing equipment or supplies for patient’s who do not display signs or symptoms common to lymphatic or vascular disease but have been diagnosed by a physician with lymphatic or vascular disease, as the liability for fraud lies with the diagnosing physician

DME companies may submit claims for custom fabricated items upon providing measurements, and are not required to provide actual delivery in order to submit billing. However, items must be ordered within twenty four hours of acquiring the measurements on custom fabricated items with a patient’s acceptance and/or signature assigning benefits, and shall be provided to the patient within five business days upon the custom fabricated garment’s arrival, or otherwise according to the patients availability. Individual States may not obstruct a patient’s ability to obtain treatment by imposing a sales tax, service tax, or gross receipts tax upon patients who have been diagnosed with lymphatic or vascular disease or on providers of evaluations, examinations, services, therapy, supplies, or equipment ordered by a physician for treatment of lymphatic or vascular disease. Providers of treatment, both MLD/CDP and DME specific to treatment for lymphedema, chronic venous insufficiency, and peripheral vascular disease shall receive reimbursement for services at the rate outlined in Exhibit “A” and “B”of this statute. Rates shall be uniform nationwide, and shall increase with the cost of doing business at a rate of 3% per year. Any provider who engages in price gouging related to compression stockings and sleeves shall be held liable for fraud. Pricing to insurers exceeding the nationally recognized mark up for compression stockings and sleeves of cost times two, shall be considered price gouging and fraudulent activity. Violations of the law and statute as stated herein shall be investigated and prosecuted under the jurisdiction of each state’s attorney general, state or federal insurance commissioner, federal inspector general, federal justice department, and/or federal trade commission. Each violation may be subject to a fine and or penalty and/or restitution to government agency investigating the violation, to the affected patient, ordering physician, and provider in amounts ranging from $11,000 per violation per government agency investigating the violation, the affected patient, provider, and ordering physician up to $600,000 per violation government agency investigating the violation, affected patient, provider and ordering physician. A provider or patient may submit a complaint to a state’s attorney general, insurance commissioner, and/or medical examiner’s board immediately upon the occurrence of any violation of this law for investigation, and shall not be subject to the insurer’s internal complaint process. No provider or insurer shall engage in any retaliatory activity or take retaliatory action towards the individual or entity filing the complaint.

Future Amendments to this law may only be made to improve the quality of healthcare, upon submission of substantial clinical studies and proof of efficacy for new therapies, to include coverage for new therapies and treatments. Amendments may not be made that would cause a reduction in coverage, care, or that should obstruct in any way, a patient’s rights to obtain treatment as ordered by their physician. Jurisdiction: This is a Federal bill and shall be reform for all fifty (50) states.