VA Rule: Prosthetic, Rehabilitative Items, Services

WASHINGTON, Dec. 29 -- The Veterans Affairs Department has issued a rule (38 CFR Part 17), published in the Federal Register on Dec. 28, entitled: "Prosthetic and Rehabilitative Items and Services".

The rule was issued by Luvenia Potts, Regulation Development Coordinator, Office of Regulation Policy & Management, Office of the Secretary, Department of Veterans Affairs.

DATES: This rule is effective on January 27, 2021.

FOR FURTHER INFORMATION CONTACT: Penny Nechanicky, National Program Director for Prosthetic and Sensory Aids Service (10P4RK), Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420; [email protected]; (202) 461-0337. (This is not a toll-free number.)

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This rulemaking adopts as final, with changes, proposed amendments to VA's regulations governing the provision of prosthetic and rehabilitative items and services as medical services to veterans.

This rulemaking establishes a new section for the provision of prosthetic and rehabilitative items and services, clarifies eligibility for such items and services, and defines the types of prosthetic and rehabilitative items and services available to eligible veterans.

SUPPLEMENTARY INFORMATION:

Background

On October 16, 2017, VA published a proposed rule in the Federal Register (82 FR 48018) to revise VA's regulations governing the provision of prosthetic and rehabilitative items and services to eligible veterans. The proposed rule set forth revisions to reorganize and update the regulations on prosthetic and rehabilitative items, and define the types of items and services available to eligible veterans. The proposed rule also put forward the elimination of existing prosthetics regulations at Section 17.150 of title 38, Code of Federal Regulations (CFR) and the establishment of entirely new sections at Sections 17.3200 through 17.3250. VA provided a 60-day comment period for the public to respond to the proposed rule. The comment period for the proposed rule ended on December 15, 2017, and VA received 305 comments.

Based on a review of the public comments received on the proposed rule, VA drafted and published a Supplemental Notice of Proposed Rulemaking (SNPRM) in the Federal Register (83 FR 61137) on November 28, 2018. The SNPRM provided clarification about provisions of the proposed rulemaking, included additional proposed amendments to Section 17.3240 as proposed, and provided a 30-day comment period for the public to respond to the SNPRM and summit comments. The comment period for the SNPRM ended on December 28, 2018, and VA received 8 comments on the SNPRM. The SNPRM also provided notice regarding certain communications between VA and external parties regarding the proposed rule, and a summary of those communications were added to the public docket of the rulemakings.

We appreciate the comments we received on the proposed rule and SNPRM, and have considered them when adopting this rulemaking as final.

Several comments commended and supported revisions to the regulations identified in the proposed rule and the SNPRM. VA appreciates these comments for their support of these rules. All of the issues raised by the comments that concerned at least one portion of the rule can be grouped together by similar topic, and we have organized our discussion of the comments accordingly. For the reasons set forth in the proposed rule, in the SNPRM, and in further detail below, we are adopting the proposed rule as modified by the SNPRM and with additional changes as final.

Medical Alert Devices and Medical Identification Bracelets

Several comments opposed the proposed elimination of the provision of medical alert devices. One comment stated that emergency assistance through cell phones is limited among the elderly population, which may not have cell phones and may have limited ability in making a cell phone call and identifying their location. This comment noted that the Freedom Alert device allows for easier and quicker notification of a medical emergency to emergency services or a family member than a cell phone, in particular because the device can be used to answer a call, and would also reduce costs of emergency services. Additionally, this comment suggested that the Freedom Alert device would be a small investment that would allow many veterans to remain in their homes, thus reducing the costs for institutionalized care, home health aide care, and assisted living. Another comment also noted that life alerts do not directly provide medical information, but rather allow a veteran to stay in their home with some safety measure versus having to be placed in a facility which is more costly. One comment also opined that these devices should not be eliminated as veterans may not have alternative technology or financial resources available to them. Additional comments noted other benefits of providing these devices, including that the device can: Be used to answer phone calls; be programmed to contact family first (thus reducing emergency response costs); allow those with limited dexterity to push a simple button; ensure the well-being of veterans and reduce anxiety; be used as a substitute for cell phones in rural areas with unreliable cell service; and prevent exacerbation of serious falls or health conditions. Comments also noted that eliminating these devices under this regulation would reduce quality of life and pose potential risk to veterans to everyday hazards, medical complications, and life-threatening situations; and comments further asserted that if a treating physician requests such a device, it should be provided.

Similarly, some comments opposed elimination of the provision of medical identification bracelets pursuant to the proposed rule. A comment opined that no longer providing such items would reduce a veteran's quality of life and may result in those who need monitoring or who have communication limitations being unable to convey medical issues. This inability to communicate medical information can affect an individual's peace of mind and emotional and mental functioning. Additionally, in response to the SNPRM, another comment expressed high concern about the elimination of medical identification bracelets, as veterans have been provided these bracelets for years, and these bracelets help veterans receive better care and better outcomes in emergencies when a veteran may not be able to communicate about conditions, allergies, etc. This comment also noted that in a survey of VA clinicians, 97 percent of them believed VA should continue to provide medical identification bracelets to veterans.

We agree with the comments that medical alert devices as well as medical identification bracelets can be an important component of ensuring prompt medical response to emergency situations a veteran may encounter outside a hospital or clinic environment. However, when such devices and bracelets are purely communication devices that do not actively or directly treat or rehabilitate a veteran's health condition or limitation, they do not meet the direct and active component standard as described in the proposed rule. Medical identification bracelets particularly are entirely passive and do not actively communicate any information about a veteran, but merely provide a source of information about the existence of a condition of a veteran. Although many of the comments identified general benefits of providing medical alert devices and identification bracelets, such comments also failed to provide examples of how these devices would meet the direct and active component standard, and one comment averred that these devices do not contribute directly to an individual's treatment or rehabilitation. However, there were also some comments that did provide examples of benefits in providing these devices that may, in fact, rise to the level of meeting the direct and active component test. For example, some comments noted that some individuals need to be safe in their homes due to medical conditions, it may be possible for a clinician to determine that a medical alert device is the appropriate item to directly and actively contribute to the treatment of that medical condition. Therefore, in response to comments, we now revise the definition of the term home medical equipment in Section 17.3210 as proposed to remove the restriction on medical alert devices, and we further delete the proposed definition of medical alert device as it will no longer be needed. This revision will allow the prescribing clinician to assess a medical alert device under the same direct and active component standard as all other prosthetic and rehabilitative items and services. We note that this change will permit a clinician to assess clinical needs on a case by case basis as with all other types of home medical equipment as provided in the definition under Section 17.3210 as revised in this final rule, this change does not ensure that medical alert devices will be prescribed merely if they are requested or thought needed by a veteran. This change also does not reverse VA's rationale as stated in the proposed and supplemental proposed rules for not prescribing or approving the furnishing of these items in any case in which they serve merely in a monitoring or preventive function, as opposed to actively and directly contributing to treatment. When such devices and bracelets are purely communication devices that do not actively or directly treat or rehabilitate a veteran's health condition or limitation, they would not meet the direct and active component standard established in this rule and therefore would not be provided.

As a result of this change, VA will ensure that applicable Veterans Health Administration (VHA) policy or guidance is revised or rescinded accordingly. For example, VHA Directive 2009-007, Provision of Medical Identification (ID) Bracelets and Pendants, provides that medical identification bracelets or pendants containing pertinent medical information (allergies or diagnoses) must be available, upon appropriate request from VA clinicians through VHA's Prosthetics Service, for veteran patients whose pertinent medical information would be valuable to emergency medical care providers. Although VA's proposed rule stated that VA would rescind VHA Directive 2009-007, upon this final rule being effective, we will instead revise VHA Directive 2009-007 to clarify that medical alert devices and medical identification bracelets will be made available to veterans under the direct and active component standard as with all other prosthetic and rehabilitative items and services. We note that the direct and active component standard is explained more fully in the next section of this final rule that addresses comments on the proposed changes to Section 17.38 and Section 17.3230.

Section 17.38, Medical Benefits Package and Section 17.3230, Authorized Items and Services

We received multiple comments to the proposed revisions to current Section 17.38 and criteria in new proposed Section 17.3230. To aid in summarizing and responding to these comments, we first provide the following background and summary of what was proposed. The medical benefits package at Section 17.38 defines medical services that are available from VA to eligible veterans. Paragraph (a) of Section 17.38 addresses the hospital, outpatient, and extended care services that constitute the medical benefits package, and prosthetic devices are included in the medical benefits package at Section 17.38(a)(1)(viii). We proposed amending Section 17.38(a)(1)(viii) to state that the medical benefits package includes prosthetic and rehabilitative items and services as authorized under proposed Sections 17.3200 through 17.3250, to reference the new proposed criteria in Sections 17.3200 through 17.3250, versus extensive and likely confusing additional revisions to Section 17.38 that would apply only to prosthetic and rehabilitative items and services. Current Section 17.38(b) provides that care referred to in the medical benefits package at Section 17.38(a) will be provided by VA only if it is determined by appropriate healthcare professionals that the care is needed to promote, preserve, or restore the health of the individual and is in accord with generally accepted standards of medical practice. We proposed amending the introductory sentence to Section 17.38(b) to exclude prosthetics and rehabilitative items and services from the requirements in Section 17.38(b) (specifically, not subject to the promote, preserve, or restore standard in Section 17.38(b)), and proposed a different standard in proposed Section 17.3230(a) that VA would provide prosthetic and other rehabilitative devices where VA determines that such items and services serve as a direct and active component of a veteran's medical treatment and rehabilitation and do not merely support the comfort or convenience of the veteran.

In addition to the background above, we will summarize and discuss below those comments that related to proposed revisions to Section 17.38 and to Section 17.3230(a) as proposed in two general categories: (1) Those comments related more directly to VA's standards in determining medical necessity for prosthetic and rehabilitative items and services; and (2) those comments related more directly to VA's practices and continued provision of prosthetic and rehabilitative items and services.

Comments Related to VA's Standards in Determining Medical Necessity for Prosthetic and Rehabilitative Items and Services

We received several comments that generally opposed VA's consideration of medical necessity in its determination to provide prosthetic and rehabilitative items and services, and one comment specifically objected to the proposed rule's interpretation of 38 U.S.C. 1701(6)(F)(i)-(iii) to find that prosthetic and rehabilitative items are considered medical services to require VA to consider medical necessity. At least one comment also stated that because non-VA programs and studies have struggled with defining medical necessity, VA should not consider medical necessity in the provision of prosthetic and rehabilitative items and services, and further stated that considering medical necessity is contrary to VA's policy, mission, and public statements.

We first address those comments that generally opposed VA's consideration of medical necessity in its determination to provide prosthetic and rehabilitative items and services. We reiterate from the proposed rule that VA is required to consider medical necessity in the provision of prosthetic and rehabilitative items and services, as 38 U.S.C. 1710(a) provides that VA shall furnish, or is authorized to furnish, hospital care and medical services that the Secretary determines to be needed.

In response to another comment, we note that the term medical services is further defined in 38 U.S.C. 1701(6)(F) to include: (i) Wheelchairs, artificial limbs, trusses, and similar appliances; (ii) special clothing made necessary by the wearing of prosthetic appliances; and (iii) such other supplies or services as VA determines to be reasonable and necessary, where VA has interpreted section 1701(6)(F)(i)-(iii) to authorize the provision of prosthetic and rehabilitative items generally. To address the comment that objected to the proposed rule's interpretation of section 1701(6)(F) to find that prosthetic and rehabilitative items are considered medical services to require VA to consider medical necessity, we reiterate from the proposed rule that VA has interpreted section 1701(6)(F)(iii) to authorize the provision of other supplies and services if they are similar or related to the expressly listed items in sections 1701(6)(F)(i) and (ii) (i.e., wheelchairs, artificial limbs, trusses or similar appliances, and special clothing made necessary by the wearing of prosthetic appliances) because such other supplies and services are similarly required to assist a veteran to compensate for the loss of mobility or loss of other functional abilities. 82 FR 48019. We base this interpretation on tenets of statutory construction and opinions of VA's Office of General Counsel. See 2A Norman J. Singer, Statutes and Statutory Construction Section 47.17 (6th ed. 2000) (explaining that as a matter of statutory interpretation, where general words follow specific words, the general words are construed to embrace only objects similar in nature to those objects enumerated by the preceding specific words). See also VAOPGCADV 7-2009, VAOPGCADV 9-2005, VAOPGCCONCL-8-98.

We next address the comment that asserted VA struggles with defining medical necessity and therefore should not consider it when determining whether to provide prosthetic or rehabilitative items or services, and that further asserted consideration of medical necessity is contrary to VA's practice, mission, or messaging. We reiterate from the proposed rule that durable medical equipment and prosthetic and orthotic devices are expressly listed as medical services available to eligible veterans as part of VA's medical benefits package in Section 17.38(a)(1)(viii). When VA promulgated Section 17.38, we explained that the promote, preserve, or restore standard in Section 17.38(b) would be used to determine whether health care and services available under Section 17.38(a) were medically needed for a veteran. See 63 FR 37300. VA's assessment of medical need for prosthetic and rehabilitative items and services is clearly stated in Section 17.38(a)(1)(viii) and (b) and is longstanding VA practice.

We received other comments that did not object to VA's consideration of medical necessity per se in providing prosthetic and rehabilitative items and services, but that opposed replacement of the promote, preserve, or restore standard in current Section 17.38(b) with the direct and active component standard in Section 17.3230(a) as proposed. We note that a few of these comments did not indicate an understanding that the current promote, preserve, or restore standard already required VA to consider medical necessity in the provision of medical services generally, so we again clarify that it has been longstanding VA practice to use the promote, preserve, or restore standard under Section 17.38(b) when determining medical necessity for care and services provided in the medical benefits package under Section 17.38(a), to include prosthetic and rehabilitative items under Section 17.38(a)(1)(viii). We reiterate from the proposed rule that VA has found it necessary, however, to more specifically characterize medical necessity in the context of providing prosthetic and rehabilitative items and services through establishing the more specific direct and active component standard in Section 17.3230(a) as proposed. 82 FR 48019. The direct and active component standard in Section 17.3230(a) as proposed is more appropriately descriptive of VA's assessment of veterans' medical need for prosthetic and rehabilitative items and services because these items and services are durable medical equipment, which is a unique category of care under Section 17.38(a) that functions as an extension of the direct provision of clinical treatment from a provider to a veteran. The extended use of reusable, durable medical equipment by a veteran as part of their treatment or rehabilitation warrants additional considerations on VA's part to ensure such equipment is not merely beneficial but is also medically necessary.

Although we believe the direct and active component standard in Section 17.3230(a) as proposed provides for the appropriate assessment of medical necessity in the context of prosthetic and rehabilitative items and services, we have reconsidered the exclusion of prosthetic and rehabilitative items and services from the requirements in Section 17.38(b) based on public comments. Based on comments, we now find that the direct and active component test in Section 17.3230(a) as proposed should supplement the promote, preserve, and restore standard as well as all other requirements in Section 17.38(b). We therefore now remove the parenthetical exception for prosthetics and rehabilitative items and services from Section 17.38(b) as proposed, to leave the reading of Section 17.38(b) as it is in its current state with regard to the application of the promote, preserve, or restore standard to all care and services available under Section 17.38(a), to include prosthetic and rehabilitative items and services under Section 17.38(a)(1)(viii). To further ensure it is clear that VA considers both the promote, preserve, and restore standard under Section 17.38(b) as well as the supplemental direct and active component standard in Section 17.3230(a) as proposed when assessing medical need, we now revise Section 17.3230(a) as proposed to clearly reference the assessment of medical need under Section 17.38(b). Section 17.3230(a) will now state that VA will provide veterans with prosthetic and rehabilitative items and services if VA determines that such items and services are needed under Section 17.38(b), serve as a direct and active component of the veteran's medical treatment and rehabilitation, and do not solely support the comfort or convenience of the veteran. We note that revisions to Section 17.38(a)(1)(viii) as proposed indicated that prosthetic and rehabilitative items and services will be available as authorized by Sections 17.3200 through 17.3250, and we are retaining that language in this final rule to ensure it is clear that the prescription of prosthetic and rehabilitative items is subject not only to the promote, preserve, or restore standard in Section 17.38(b), but also subject to the direct and active component standard in Section 17.3230(a) as proposed. We additionally revise the reference to " Sections 17.3200-.3250" in Section 17.38(a)(1)(viii) as proposed, to remove the dash and insert the word through, to indicate the range of applicable sections from Sections 17.3200 through 17.3250. To further ensure consistency between the medical necessity standards in Sections 17.38(b) and 17.3230, we are revising and moving the language in the note at the end of Section 17.3230 as proposed to further clarify that Section 17.3230 supplements determinations of need for items and services listed in Section 17.3230(a) in addition to the requirements in Section 17.38(b). The revised language in the former note at the end of Section 17.3230 as proposed will now be lcoated in Section 17.3230(a)(2), and we will renumber Section 17.3230(a) as proposed to Section 17.3230(a)(1), and renumber Section 17.3230(a)(1) through (15) as proposed to Section 17.3230(a)(1)(i) through (xv), respectively. We are also revising Section 17.3240(a)(1) as proposed to remove the phrase that indicated items will be prescribed based on the veteran's clinical needs and replace it with a clearer reference to the clinical needs assessments in Section 17.3230(a) (which are the needs assessment under both Sections 17.38(b) and 17.3230(a)). Lastly, we are removing extraneous language that alludes to a specific item or service listed in Section 17.3230(a)(1) through (15) as being separately or additionally assessed for necessity, as this would be duplicative of the clarifications and revisions explained above. Specifically, we are revising Section 17.3230(a)(12) and (15) as proposed to remove such extraneous language. However, we reiterate from the proposed rule that an item under Section 17.3230(a) could be repaired if it is determined that the item meets the needs assessment in Section 17.3230(a). 82 FR 48018, 48024. The same logic follows for Section 17.3230(a)(15) with regards to fitting and training, that such fitting and training for an item will be provided as long as such item is found to meet the needs assessment under Section 17.3230(a).

Because the proposed rule did not indicate that the direct and active component test in Section 17.3230(a) should supplement, versus replace, the requirements in Section 17.38(b), we now provide an example of VA's assessment of both the medical necessity standards under Sections 17.38(b) and 17.3230(a) as proposed and made final in this rulemaking. In this example, a provider who is treating a veteran may determine that a number of clinical approaches are medically necessary to treat a veteran's sleep apnea by assisting the veteran to maintain a less obstructed airway while sleeping, such as lifestyle changes (losing weight or quitting smoking), or treatment for nasal allergies or other upper respiratory ailments or illnesses. Under the medical benefits package in Section 17.38(a), the veteran could receive weight management and smoking cessation counseling, and could be prescribed allergy medications as needed, where all of these care and services meet the promote, preserve, or restore standard in Section 17.38(b). None of these care and services would be considered prosthetic or rehabilitative items under Section 17.38(a)(1)(viii), and the assessment of clinical need would be fully met under the Section 17.38(b) promote, preserve, or restore standard. This veteran's provider, however, may also determine that a continuous positive airway pressure (CPAP) machine would be necessary for the veteran to maintain an unobstructed airway while sleeping. A CPAP machine is a durable piece of equipment that would be considered a prosthetic or rehabilitative item under Section 17.38(a)(1)(viii). As such, the provider would assess medical need under the requirements in Section 17.38(b) and could specifically find the standard under Section 17.38(b)(3) to be met because the CPAP machine could be found to restore the daily functional level of the veteran's airway that has been obstructed due to illness or injury. The provider would then also assess the CPAP machine under the direct and active component standard in Section 17.3230(a) as proposed and could find this standard to be met because the CPAP machine delivers air pressure through a mask to directly and actively assist a veteran to maintain an unobstructed airway while sleeping. A CPAP machine would also meet the requirement under Section 17.3230(a) as proposed as not being solely for the comfort or convenience of the veteran.

We believe the considerations under Section 17.3230(a) as proposed establish additional context that is necessary when assessing medical need for prosthetic and rehabilitative items and services, where the promote, preserve, or restore standard in Section 17.38(b) by itself may not provide adequate context. In the example above of the veteran with sleep apnea, for instance, a durable item could be provided under Section 17.38(b)(1) because it promotes health, even if it merely makes the act of sleeping seem subjectively easier for a veteran but does not directly address the medical issue of an obstructed airway while sleeping. A white noise machine is a durable item that may tend to make a veteran with sleep apnea feel that it is easier to fall or stay asleep, but a white noise machine does not address the medical issue of the veteran's obstructed airway while sleeping. Without the additional consideration of the direct and active component standard in Section 17.3230(a), it could be possible for a white noise machine to be provided under the standard in Section 17.38(b)(1) because it promotes health by enhancing the quality of life or daily functional level of a veteran.

The additional consideration that prosthetic and rehabilitative items and services must be a direct and active component of treatment in Section 17.3230(a) as proposed helps ensure that VA only furnishes durable items that are medically necessary. This is consistent with current and longstanding VA practice that requires all prescriptions for prosthetic and rehabilitative items to include a medical justification that draws a nexus between the item and the function it will perform for that condition. As we will respond more directly in this rule in relation to the comfort and convenience language from Section 17.3230(a) as proposed, this nexus between an item and its function to medically address a condition does not mean that items may not be both beneficial and necessary; but, there must be a medical need for an item, and the additional considerations in Section 17.3230(a) as proposed help ensure that is the case.

Several comments further opposed elimination of the promote, preserve, or restore standard due to concern that the direct and active component standard could reduce services to veterans, eliminate most quality of life items, and reduce veterans' quality of life. As clarified above, the direct and active component standard in Section 17.3230(a) as proposed will supplement and not replace VA's assessment of medical need under Section 17.38(b). Although it is the case that the direct and active component standard will not support VA's provision of comfort or convenience items that are not medically required, this additional standard should not result in any reduction of medically necessary items or services currently being provided to veterans. Most items currently provided will continue to be provided so long as they are determined by VA health care providers or authorized non-VA providers to be medically necessary using both the promote, preserve, and restore standard under Section 17.38(b) and the direct and active component standard in Section 17.3230(a) as proposed.

For the reasons stated in the proposed rule and above, we adopt as final the direct and active component standard and other language in Section 17.3230(a) as proposed with some revisions. We reiterate that removing the parenthetical exception from the proposed revision to Section 17.38(b), as well as the additional revisions to Section 17.3230(a) and the note at the end of Section 17.3230 (to reference Section 17.38(b)) will clarify that we are supplementing rather than replacing the promote, preserve, or restore standard in Section 17.38(b).

Luvenia Potts,

Regulation Development Coordinator, Office of Regulation Policy & Management, Office of the Secretary, Department of Veterans Affairs.

[FR Doc. 2020-27014 Filed 12-23-20; 8:45 am]

BILLING CODE 8320-01-P

The document is published in the Federal Register: https://www.federalregister.gov/documents/2020/12/28/2020-27014/prosthetic-and-rehabilitative-items-and-services

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