With those goals in mind, we wish to specifically address enteral nutrition.

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1 March 24, 2014 Marilyn Tavenner Administrator, Centers for Medicare & Medicaid Services Baltimore, MD Re: CMS-1460-ANPRM We thank you for the opportunity to submit comments regarding the DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 414 [CMS-1460-ANPRM] Medicare Program; Methodology for Adjusting Payment Amounts for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) using Information from Competitive Bidding Programs. As an introduction, the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) is an inter-disciplinary society of over 6000 clinicians whose mission is to improve patient care by advancing the science and practice of clinical nutrition and metabolism. Our Public Policy Agenda calls for A.S.P.E.N. to: Work on patient access to nutrition care through changing reimbursement and/or improving product shortages; Improve the safety and quality of all patients/consumers receiving nutrition support therapy, resulting in improved patient outcomes; Advocate for fair reimbursement to ensure that beneficiaries of government funded health programs receive the highest quality nutrition support care; Sponsor the concept of a fair marketplace that does not jeopardize the provision of safe and quality nutrition support; and Advocate for health system reform that benefits the efficacious delivery of nutrition support. With those goals in mind, we wish to specifically address enteral nutrition. Questions for Generating Public Comments and A.S.P.E.N. Responses (In Bold) A. Methodology for Adjusting Medicare Payment Amounts for DMEPOS Items and Services Based on Information from Competitive Bidding Programs

2 Do the costs of furnishing various DMEPOS items and services vary based on the geographic area in which they are furnished? The costs should not vary by geographic region. For a provider the costs will vary depending on the contracts/pricing the provider has with manufacturers. Do the costs of furnishing various DMEPOS items and services vary based on the size of the market served in terms of population and/or distance covered or other logistical or demographic reasons? Section 1847(a)(1)(D)(iii) of the Act prohibits establishing competitive bidding programs in MSAs with a population of less than 250,000 or in areas outside MSAs prior to Given the mandate to use information on the payment determined under competitive bidding programs to adjust payment amounts in areas that are not competitive bidding areas by no later than January 1, 2016, what alternative information, if any, should we rely on to determine the relative costs of furnishing items and services in these areas compared to areas where competitive bidding programs have already been implemented? The number one factor affecting cost in more rural areas is the delivery cost. The further the patient is from the provider, the more costly to deliver if the provider uses a local courier, their own delivery drivers etc. Cost of shipping can also be costly if there is no other way to deliver enteral formula and supplies. (The 30 day shipments/cases of enteral are heavy and cumbersome). Depending on who the providers are, other than delivery services, their costs of the actual products have nothing to do with geography. How should any future adjustments or payment methodology treat payment amounts for items that have not been included in all competitive bidding programs (for example, items such as transcutaneous electrical nerve stimulation (TENS) devices that have only been phased into the nine Round 1 areas thus far)? Not within our scope. Should competitive bidding programs be established in all areas of the country for a few high volume items in order to gather information regarding the costs of furnishing DMEPOS items, in general, in different areas of the country (for example, rural areas as well as urban areas)? Not relevant to A.S.P.E.N. B. Changes to the Payment Methodologies and Rules for Durable Medical Equipment and Enteral Nutrition Furnished Under Competitive Bidding Programs We are requesting comments on testing or phasing in bundled payments under competitive bidding programs whereby suppliers would submit one bundled bid for the delivery of all enteral nutrients, supplies, and equipment needed for one month by a beneficiary as well as one bundled bid for furnishing certain DME, including all related

3 supplies, accessories, and services on a monthly basis. Under such an approach, monthly rental payments for DME or enteral nutrition equipment would no longer reach a cap, while separate payment for supplies, accessories, enteral nutrients, or maintenance and servicing would no longer be made. Suppliers would retain title to all equipment regardless of length of need and beneficiaries would be able to switch from supplier to supplier on a monthly basis. The monthly payments for DME and enteral nutrition would continue for as long as medical necessity and Part B coverage continues and the bid limits would be based on the average monthly costs per beneficiary for the bundle of items and services. We are soliciting comments on the following list of questions regarding proposals we may make to change the payment rules and other rules for DME and enteral nutrition under the DMEPOS competitive bidding program. Are lump sum purchases and capped rental payment rules for DME and enteral nutrition equipment that were implemented to prevent prolonged rental payments still needed now that monthly payment amounts can be established under competitive bidding programs for furnishing everything the beneficiary needs each month related to the covered DME item or enteral nutrition? NO, but the payment should be set fairly for the provider in order to cover purchase and maintenance of this enteral nutrition equipment. The equipment provided to the patient must be fairly new and maintained properly on a regular schedule according to Joint Commission/ACHC standards. (Many providers also rent the pumps so the lump sump must cover the cost of purchase and/or rental fee paid by the provider for the pump.) Are there reasons why beneficiaries need to own expensive DME or enteral nutrition equipment rather than use such equipment as needed on a continuous monthly basis? NO, the Patient should not have to buy their enteral pump and then be responsible for maintaining it. Would there be any negative impacts associated with continuous bundled monthly payments for enteral nutrients, supplies, and equipment or for certain DME? If so, please explain. In terms of enteral nutrients, supplies and equipment, the DME cannot discriminate against patients who require higher cost therapy such as those who need a specialized higher cost formula and /or enteral pump. Such practices would limit patient s access to care. We would suggest a lump sump payment for a standard pump and any non-formula enteral supplies not including feeding tubes--with the enteral formula broken out separately due to the huge variation in cost of formula based on the category of formula. For many providers today, the reimbursement under CMS for any elemental/specialized formula is below the cost to purchase it by the provider. Certain DME items such as speech generating devices and specialized wheelchairs may be adjusted or personalized to address individual patient needs. Would payment

4 on a bundled, continuous rental basis adversely impact access to these items and services? If so, please provide a detailed explanation regarding how this method of payment would create a negative impact on access to these items and services or other items and services currently subject to competitive bidding. OUT OF OUR SCOPE If payment on a capped rental, rent-to-own basis or lump sum purchase basis is maintained for certain items under the competitive bidding program, should a requirement be added to the regulations specifying that the supplier that transfers title to the equipment to the beneficiary is responsible for all maintenance and servicing of the beneficiary-owned equipment for the remainder of the equipment s reasonable useful lifetime with no additional payment for these services? The cost of such a mandatory supplier warranty would be factored into the bids submitted by the suppliers and the payment amounts established based on the bids for the items. If such a requirement was established, should the term maintenance and servicing be defined to include all necessary maintenance, servicing and repairs that are currently paid for separately under the Medicare program in addition to any additional adjustments or personalization of the equipment that may be needed once title transfers to the patient? We believe these requirements may be necessary to safeguard the beneficiary and access to necessary services related to beneficiary-owned DME. We agree with this to protect the beneficiary, however would not suggest this type of scenario of capped rental, rent-to-own or lump sum purchase be put into place. (None of this is in the patient s best interest. In the home setting with all other payers, patients do not end up owning their equipment. The per day rate includes whatever technology/equipment is necessary to infuse the pump). Would payment on a bundled, continuous rental basis for certain items adversely impact the beneficiary s ability to direct their own care, follow a plan of care outlined by a physician, nurse practitioner or other medical provider (for example, occupational, physical or speech therapist), or provide for appropriate care transitions? If so, please explain. Bundled continuous rental of an enteral pump should not adversely impact the beneficiary as long as the type of enteral pump that is ordered by the provider is delivered to the beneficiary and maintained/replaced on a regular basis as needed according to policy and procedure and nationally accredited standards. What are the advantages or disadvantages for beneficiaries and suppliers of bundled bidding and payments for enteral nutrients, supplies, and equipment or DME? Advantages would be that the patient on short term enteral nutrition would not own a pump that is no longer needed. The beneficiary would not be responsible for maintenance of an enteral pump and thus temporary cessation of therapy would not occur while said pump is being repaired. Disadvantages to the beneficiary might be if a DME does not accept a more complex patient that requires a more expensive specialized enteral formula and/ or enteral pump. We suggest at least three levels of payment one for patients requiring a standard (intact protein) formula without a pump, one who requires a

5 standard, intact protein formula with a pump, and the highest where a patient requires a specialized/elemental formula AND an enteral pump. Should competitive bidding programs utilizing bundled payments be established throughout the entire United States so that all beneficiaries are included under programs where suppliers have an obligation to furnish covered items and all related items and services? YES Is a continuous bundled monthly payment used by commercial payers or State Medicaid programs for enteral nutrients, supplies, and DME and do these approaches inform this potential new payment arrangement for Medicare.???? Many payers utilized bundled DAILY payments ie a daily per diem, not a MONTHLY per diem (having a monthly bundled payment would seem to be a billing difficulty when a pt goes into the hospital, is discharged from service etc. The enteral formula itself is almost always separate from the daily per diem, with the daily per diem including pump, tubing/bags, IV pole/backpack, gauze, tape etc. In very few circumstances where payers have bundled formula, access has been limited since providers walked away from the contract because the rate was less than cost. Sincerely, Jay M. Mirtallo, MS, RPh, BCNSP, FASHP, FASPEN Chair, Public Policy Committee American Society for Parenteral and Enteral Nutrition 8630 Fenton St. Suite 412 Silver Spring, MD 20910