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The Centers for Medicare & Medicaid Services (CMS) is charged with the implementation and oversight of the DMEPOS program.[1]  Since the rollout of the DMEPOS competitive bidding program (CBP) in July, 2008, there has been confusion over what constitutes delivery and set-up of specific DMEPOS items.[2]  In some instances, beneficiaries have experienced delays in obtaining the necessary DMEPOS items. In other instances, beneficiaries have received items through the mail that have not been set-up or assembled.

As part of its monitoring and oversight functions related to the CBP, the Government Accountability Office (GAO) and the Department of Health and Human Services' Office of the Inspector General (HHS OIG) issued three reports regarding CBP's implementation.[3]  Contrary to the experience of advocates and beneficiaries, the GAO and OIG reports indicate that the CBP has generally been a success.[4]

Thus, as in our June 26 Alert on a related DMEPOS topic, we ask again that you let us know of problems that you and or your clients are experiencing.  Statements of problems can be sent to: DMEPOS@medicareadvocacy.org.

Examples of Recurring DMEPOS Delivery and Set-Up Issues Brought to the Attention of the Center for Medicare Advocacy

  • DMEPOS orders are taking an unduly long time to be delivered.

Suppliers are not always providing a timely delivery of DMEPOS.  Delivery of necessary medical items such as reclining wheelchairs has taken as long as a month or more and only occurs after repeated calls to the supplier and re-faxing of orders.  Such delays are stressful, can impede a timely hospital discharge, and can impair a beneficiary's quality of life.

  • Some suppliers are refusing to provide certain DMEPOS items.

After receiving a bid contract, some DMEPOS suppliers either stop supplying a certain item, or Medicare beneficiaries are no longer able to use the same DMEPOS supplier they have used in years past.  The beneficiary then has to find a new supplier, one that is covered by Medicare and has their required DMEPOS.  Unfortunately, this often proves difficult, and beneficiaries suffer in the meantime, either using equipment that they are not accustomed to or that is not optimal for their medical situation. This has been experienced with liquid oxygen and ostomy supplies.

  • Some suppliers are refusing to deliver prescribed DMEPOS items.

Some suppliers will refuse to have DMEPOS items delivered directly to a beneficiary after a hospital or skilled nursing facility discharge, which means the beneficiary may go home without their needed DMEPOS, and must wait until that DMEPOS is delivered by mail.  Sending a beneficiary home from the hospital or skilled nursing facility without their necessary medical equipment is unsafe and inappropriate.

  • Some suppliers do not honor their repair obligations.

DMEPOS suppliers are obligated to assist beneficiaries with necessary repairs of their DMEPOS equipment, yet some suppliers are avoiding this responsibility. Beneficiaries, or their caregivers, are forced to search to find a supplier who will repair their wheelchairs.

DMEPOS Supplier's Set-Up and Delivery Obligations

The following guidelines, gathered from CMS's instruction manuals to DMEPOS suppliers and from the regulations implementing the DMEPOS competitive bidding program, aim to help beneficiaries understand a supplier's delivery and set-up responsibilities.  The relevant statue is 42 U.S.C. §1395w–3(Competitive acquisition of certain items and services).  Federal regulations describing DMEPOS supplier standards are available at 42 C.F.R. 424.57(c)(12(delivery).  See http://www.gpo.gov/fdsys/pkg/CFR-2005-title42-vol2/pdf/CFR-2005-title42-vol2-sec424-57.pdf.  Federal regulations setting out contract terms for suppliers are available at 42 C.F.R. §§414.422(e)(furnishing items) and 414.422(g)(breach of contract).  See http://www.gpo.gov/fdsys/pkg/CFR-2011-title42-vol3/pdf/CFR-2011-title42-vol3-sec414-422.pdf. Other important regulatory guidance is available in CMS's Outreach and Education/MedLearn Series as indicated below.

1. General Set-Up and Delivery Requirements of DMEPOS Suppliers: 

According to CMS, a supplier of DMEPOS equipment is generally responsible for delivering and assembling all equipment items according to a timeframe that has been agreed upon by the Medicare beneficiary and/or their supplier, caregiver, and prescribing physician.[5]  If the supplier is not able to deliver and set-up the equipment, it may coordinate the set-up with another supplier.[6]  The supplier must provide the beneficiary with "all equipment and item(s) that are necessary to operate the equipment or item(s) and is to perform any adjustments as applicable."[7]  With the exception of orthotics and prosthetics, the supplier is also responsible for providing and arranging for replacement equipment while the original equipment is being repaired.[8]

2. General Follow-Up Procedures:

CMS states that "[T]he supplier shall provide follow-up services to the beneficiary and/or caregiver(s), consistent with the type(s) of equipment, item(s), and service(s) provided, and recommendations from the prescribing physician or health care team member(s)."[9]  All DMEPOS product suppliers must comply with this general follow up guideline.[10] 

3. Product Specific List of DMEPOS Set-Up and Delivery Requirements:

  • Respiratory Equipment, Supplies, and Services:  The supplier must comply with the general set-up and delivery requirements mentioned above.  The supplier must also comply with the following guidelines for certain specific technology.[11]
  • Manual Wheelchairs:  The supplier must comply with the general set-up and delivery requirements mentioned above. In addition the supplier must confirm that the positioning and seating, and ensure that any specialty assistive technology has been assessed and recorded in the beneficiary's record.
  • Power Mobility Devices (PMDs): Again, the supplier must comply with the general set-up and delivery requirements mentioned above.  They must also confirm the positioning and seating, and ensure that any specialty assistive technology has been assessed and recorded in the beneficiary's record.
  • Complex Rehabilitative Wheelchairs and Assistive Technology:  In addition to complying with the general set-up and delivery requirements mentioned above, the supplier must also have one qualified Rehabilitative Technology Supplier (RTS) per location.  An RTS is either an Assistive Technology Professional or a Certified Rehabilitative Technology Supplier.  The RTS is responsible for both creating set-up and delivery procedures and ensuring that the final product conforms to what has been recommended by the prescribing physician. Suppliers must also confirm the positioning and seating, and ensure that necessary specialty assistive technology has been assessed and the assessment recorded in the beneficiary's record.

4. Products with No Set-Up and Delivery Requirements:

  • Prosthetic and Orthotic Devices and Therapeutic Shoes: Prosthetic devices are typically devices that substitute part or all of an internal body organ, excluding dental devices.[12]  Orthotic devices are devices that are used to support weak body parts or restrict movement in injured or deformed parts of the body.[13]

Orthotic and prosthetic devices include custom fabricated (made specifically for the patient); molded-to-patient (either a model molded through plaster or digital imaging technology); positive model of the patient (negative impression of patient taken and used to construct the part); custom fitted (made without a specific patient in mind but customized for a specific patient on an as needed basis); prosthetic devices (made to replace a certain body part, including ocular prostheses, facial prostheses, somatic prosthesis, and external breast prostheses.); orthotic devices (made to support a patients injured or weak body part); and therapeutic shoes and inserts.[14] 

Although no set up is required for prosthetic and orthotic devices, the supplier is still obligated to provide the beneficiary or their caregiver with appropriate training and/or instructions. This consists of telling the beneficiary: how to use, clean and adjust the device; how to inspect the skin for any adverse reactions to the device such as breakdown or irritation; how to report problems with the device and schedule any necessary follow-up appointments; and how to create an appropriate schedule for wearing the device.  Finally, the supplier must provide tools necessary for the maintenance of the device, such as cleaning tools.[15]

  • Follow Up Procedures for Prosthetic and Orthotic Devices:  In addition to the general follow up procedures, suppliers must: (a) have access to a facility that can effectively modify an orthotics or prostheses and provide follow-up care; (b) solicit feed-back on the treatment from the beneficiary or caregiver and modify the orthotics or prostheses as necessary; and (c) review product maintenance procedures with the caregiver and/or beneficiary.  In addition, the supplier is obligated to assist the beneficiary until the device has reached what is determined to be an optimal level of function and fit in accordance with the patient's treatment plan. 
     
  • Diabetic Testing Supplies:  These supplies include blood glucose test strips, lancets, lancet devices and glucose control solutions.[16]  They can be sent by mail or purchased at a Medicare-enrolled supplier storefront that has been accredited to sell diabetic testing supplies.  Additionally, a physician may prescribe a certain mode of delivery or brand if they believe it will help in avoiding an adverse medical reaction.[17]  If the physician choses to do this, the supplier must make sure the beneficiary has received the prescribed item through either: furnishing the brand and/or mode of delivery; contacting the physician to find a different brand or mode of delivery and receive a revised prescription; or aid the beneficiary in finding a supplier that can provide the beneficiary with the prescribed brand or mode of delivery.[18]  
     
  • More Information on Diabetic Testing Supplies:

Resources to Find More Helpful Tools and Information:

Conclusion

It is important for beneficiaries and their advocates to be aware of the delivery and set-up requirements for particular DMEPOS.  This knowledge can be an important resource in assuring that beneficiaries are able to receive necessary delivery and set-up services, and the functioning items they need, from DMEPOS suppliers. 

Again, please contact the Center for Medicare Advocacy with examples of DMEPOS delivery and set-up problems at: DMEPOS@medicareadvocacy.org.  Together we will work to ensure delivery and set-up requirements are understood, and followed, by DMEPOS suppliers.

Thank you to Sophia Schechner, CMA Health Policy Fellow, for her work on thi

 

 

 

 


[1] The statue authoring the DMEPOS program is located at 42 U.S.C.§1395w-3 available at http://www.gpo.gov/fdsys/pkg/USCODE-2010-title42/pdf/USCODE-2010-title42-chap7-subchapXVIII-partB-sec1395w-3.pdf (Site visited July 7, 2014).
[2] Please review the Center for Medicare Advocacy’s Weekly Alert, “The DMEPOS Competitive Bidding Process: Is It Working?” at “http://cma.benfredaconsulting.com/the-dmepos-competitive-bidding-process-is-it-working/ (June 26, 2014)
[3] See http://www.gao.gov/assets/670/661474.pdf, http://oig.hhs.gov/oas/reports/region5/51200067.pdf, and http://www.gao.gov/assets/670/661474.pdf.  A memo summarizing the GAO and HHS OIG reports and the limitations of their findings is available at: http://cma.benfredaconsulting.com/memorandum-gao-and-oig-reports-note-no-problems-in-beneficiary-access-to-dmepos-beneficiary-advocates-disagree/.
[4] Id.
[5] Available at http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/DMEPOS_Qual_Stand_Booklet_ICN905709.pdf (Site visited June 26, 2014).
[6] Available at http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/DMEPOS_Qual_Stand_Booklet_ICN905709.pdf (Site visited June 26, 2014).
[7] Available at http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/DMEPOS_Qual_Stand_Booklet_ICN905709.pdf (Site visited June 26, 2014).
[8] Available at http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/DMEPOS_Qual_Stand_Booklet_ICN905709.pdf (Site visited June 26, 2014).
[9] Available at http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/DMEPOS_Qual_Stand_Booklet_ICN905709.pdf (Site visited June 26, 2014).
[10] Available at http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/DMEPOS_Qual_Stand_Booklet_ICN905709.pdf (Site visited June 26, 2014).
[11] Available at http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/DMEPOS_Qual_Stand_Booklet_ICN905709.pdf (Site visited June 26, 2014); see also http://www.ssa.gov/OP_Home/ssact/title18/1861.htm#act-1861-n (Site visited July 7, 2014).
[12] Available at http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/DMEPOS_Qual_Stand_Booklet_ICN905709.pdf (Site visited June 26, 2014); see also Section 1861(s)(8) available at http://www.ssa.gov/OP_Home/ssact/title18/1861.htm#act-1861-s-8 (Site visited June 26, 2014).
[13] Available at http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/DMEPOS_Qual_Stand_Booklet_ICN905709.pdf (Site visited June 26, 2014); see also Section 1861(s)(9) available at http://www.ssa.gov/OP_Home/ssact/title18/1861.htm#act-1861-s-9 (site visited June 26, 2014).
[14] Available at http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/DMEPOS_Qual_Stand_Booklet_ICN905709.pdf (Site visited June 26, 2014).
[15] Available at http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/DMEPOS_Qual_Stand_Booklet_ICN905709.pdf (Site visited June 26, 2014).
[16] Available at http://cma.benfredaconsulting.com/medicares-national-mail-order-program-for-diabetic-testing-supplies/. (Site visited June 26, 2014).
[17] See 42 C.F.R. §414.420(a)-(b) available at http://www.gpo.gov/fdsys/pkg/CFR-2011-title42-vol3/pdf/CFR-2011-title42-vol3-sec414-422.pdf (Site visited June 26, 2014).
[18] Available at http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/DME_Mail_Order_Factsheet_ICN900924.pdf  (Site visited June 26, 2014); see also 42 C.F.R. §414.422(e)(3) available at http://www.gpo.gov/fdsys/pkg/CFR-2010-title42-vol3/pdf/CFR-2010-title42-vol3-sec414-422.pdf (Site visited June 26, 2014). 

 

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