DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Centers for Medicare & Medicaid Services 

42 CFR Part 440 

[CMS 2348-P] 

RIN 0938-AQ36 

Medicaid Program; Face-to-Face Requirements for Home Health 

Services; Policy Changes and Clarifications Related to Home 

Health 

AGENCY: Centers for Medicare & Medicaid Services (CMS), 

HHS.

ACTION: Proposed rule. 

SUMMARY: This proposed rule would revise the Medicaid home 

health service definition as required by section 6407 of the 

Affordable Care Act to add a requirement that physicians 

document the existence of a face-to-face encounter 

(including through the use of telehealth) with the Medicaid 

eligible individual within reasonable timeframes. This 

proposal would align the timeframes with similar regulatory 

requirements for Medicare home health services in accordance 

with section 6407 of the Affordable Care Act and reflects 

CMS’ commitment to the general principles of the President’s 

Executive Order 13563 released January 18, 2011, entitled 

“Improving Regulation and Regulatory Review.” In addition, 

this rule proposes to amend home health services regulations 

to clarify the definitions of included medical supplies, 
CMS-2348-P 2 

equipment and appliances, and clarify that States may not 

limit home health services to services delivered in the 

home, or to services furnished to individuals who are 

homebound. 

DATES: To be assured consideration, comments must be 

received at one of the addresses provided below, no later 

than 5 p.m. [Insert 60 days after date of publication in the

Federal Register]. 

ADDRESSES: In commenting, please refer to file code 

CMS-2348-P. Because of staff and resource limitations, we 

cannot accept comments by facsimile (FAX) transmission. 

 You may submit comments in one of four ways (please 

choose only one of the ways listed): 

1. Electronically. You may submit electronic comments 

on this regulation to http://www.regulations.gov. Follow 

the "Submit a comment" instructions. 

 2. By regular mail. You may mail written comments to 

the following address ONLY: 

 Centers for Medicare & Medicaid Services, 

Department of Health and Human Services, 

Attention: CMS-2348-P, 

P.O. Box 8016, 

Baltimore, MD 21244-8016. 

Please allow sufficient time for mailed comments to be 

received before the close of the comment period. 
CMS-2348-P 3 

3. By express or overnight mail. You may send written 

comments to the following address ONLY: 

 Centers for Medicare & Medicaid Services, 

 Department of Health and Human Services, 

 Attention: CMS-2348-P, 

 Mail Stop C4-26-05, 

 7500 Security Boulevard, 

Baltimore, MD 21244-1850. 

4. By hand or courier. If you prefer, you may deliver 

(by hand or courier) your written comments before the close 

of the comment period to either of the following addresses: 

 a. For delivery in Washington, DC-- 

 Centers for Medicare & Medicaid Services, 

Department of Health and Human Services, 

Room 445-G, Hubert H. Humphrey Building, 

 200 Independence Avenue, SW., 

 Washington, DC 20201 

(Because access to the interior of the 

Hubert H. Humphrey Building is not readily available to 

persons without Federal Government identification, 

commenters are encouraged to leave their comments in the CMS 

drop slots located in the main lobby of the building. A 

stamp-in clock is available for persons wishing to retain a 

proof of filing by stamping in and retaining an extra copy 

of the comments being filed.) 
CMS-2348-P 4 

b. For delivery in Baltimore, MD-- 

 Centers for Medicare & Medicaid Services, 

Department of Health and Human Services, 

7500 Security Boulevard, 

Baltimore, MD 21244-1850. 

If you intend to deliver your comments to the Baltimore 

address, please call telephone number (410) 786-7195 in 

advance to schedule your arrival with one of our staff 

members. 

 Comments mailed to the addresses indicated as 

appropriate for hand or courier delivery may be delayed and 

received after the comment period. 

Submission of comments on paperwork requirements. You 

may submit comments on this document's paperwork 

requirements by following the instructions at the end of the 

"Collection of Information Requirements" section in this 

document. 

For information on viewing public comments, see the 

beginning of the "SUPPLEMENTARY INFORMATION" section. 

FOR FURTHER INFORMATION CONTACT: 

Melissa Harris, (410) 786-3397. 

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: All comments received before 

the close of the comment period are available for viewing by 

the public, including any personally identifiable or 

confidential business information that is included in a 
CMS-2348-P 5 

comment. We post all comments received before the close of 

the comment period on the following Web site as soon as 

possible after they have been received: 

http://www.regulations.gov. Follow the search instructions 

on that Web site to view public comments. 

 Comments received timely will also be available for 

public inspection as they are received, generally beginning 

approximately 3 weeks after publication of a document, at 

the headquarters of the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, Baltimore, Maryland 

21244, Monday through Friday of each week from 8:30 a.m. to 

4 p.m. To schedule an appointment to view public comments, 

phone 1-800-743-3951. 

I. Background 

A. General Information

Title XIX of the Social Security Act (the Act) requires 

that, in order to receive Federal Medicaid matching funds, a 

State must offer certain basic services to the categorically 

needy populations specified in the Act. Home health care 

for Medicaid-eligible individuals who are entitled to 

nursing facility services is one of these mandatory 

services. Individuals “entitled to” nursing facility 

services include the basic categorically needy populations 

that receive the standard Medicaid benefit package, and can 

include medically needy populations if nursing facility 

services are offered to the medically needy within a State. 
CMS-2348-P 6 

Home health services include skilled nursing, home health 

aide services, medical supplies, equipment, and appliances, 

and may include therapeutic services. Current Medicaid 

regulations require an individual’s physician to order home 

health services as part of a written plan of care reviewed 

every 60 days. 

B. Summary of New Medicare Home Health Face-to-Face 

Statutory Requirements

Section 6407 of the Patient Protection and Affordable 

Care Act of 2010 (the Affordable Care Act), (Pub. L. 

111-148, enacted on March 23, 2010), as amended by section 

10605 of the Affordable Care Act, affects the home health 

benefit under both the Medicare and Medicaid programs. 

Section 6407(a) of the Affordable Care Act (as amended 

by section 10605 of the Affordable Care Act) added new 

requirements to section 1814(a)(2)(C) of the Act under Part 

A of the Medicare program, and section 1835(a)(2)(A) of the 

Act, under Part B of the Medicare program, that the 

physician, or certain allowed nonphysician practitioners 

(NPPs), document a face-to-face encounter with the 

individual (including through the use of telehealth, subject 

to the requirements in section 1834(m) of the Act), prior to 

making a certification that home health services are 

required under the Medicare home health benefit. Section 

1814(a)(2)(C) of the Act indicates that in addition to a 

physician, a nurse practitioner or clinical nurse specialist 
CMS-2348-P 7 

(as those terms are defined in section 1861(aa)(5) of the 

Act) who is working in collaboration with the physician in 

accordance with State law, or a certified nurse-midwife (as 

defined in section 1861(gg) of the Act, as authorized by 

State law), or a physician assistant (as defined in section 

1861(aa)(5) of the Act), under the supervision of the 

physician, may conduct the face-to-face encounters prior to 

the start of home health services. 

Section 6407(b) of the Affordable Care Act amended 

section 1834(a)(11)(B) of the Act to require documentation 

of a similar face-to-face encounter with a physician or 

specific NPPs by a physician ordering durable medical 

equipment (DME). The NPPs authorized to conduct a face-toface encounter on behalf of a physician are the same for 

this provision as for the provision described above, with 

one exception. We interpret sections 6407(b) and 6407(d) of 

the Affordable Care Act to prohibit certified nurse-midwives 

from conducting the face-to-face encounter prior to the 

physician ordering DME. The timing of this face-to-face 

encounter is specified as being within the 6-month period 

preceding the written order for DME, or other reasonable 

timeframe specified by the Secretary. This provision also 

maintains the role of the physician in the actual ordering 

of DME. 

C. Application of Home Health Face-to-Face Requirements to

Medicaid 
CMS-2348-P 8 

Section 6407(d) of the Affordable Care Act provides 

that the requirements for face-to-face encounters in the 

provisions described above “shall apply in the case of 

physicians making certifications for home health services 

under title XIX of the Social Security Act in the same 

manner and to the same extent as such requirements apply in 

the case of physicians making such certifications under 

title XVIII of such Act.” The purpose of this regulation is 

to implement that statutory directive. 

In implementing the face-to-face encounter requirements 

of section 6407 of the Affordable Care Act, we take into 

consideration the existing regulatory requirements under 

§440.70 that provide that a physician must order an 

individual’s services under the Medicaid home health 

benefit. We read the term “order” to be synonymous with the 

Medicare term “certify.” For purposes of this rule, we use 

the term “order” in place of the Affordable Care Act’s use 

of “certify.” 

We do not view implementation of section 6407 of the 

Affordable Care Act as supplanting the existing Medicaid 

regulatory requirements related to physician orders but as 

consistent with those requirements. The provisions of 

section 6407 of the Affordable Care Act make clear that the 

physician’s order must be based on a face-to-face encounter. 

In addition, section 6407 of the Affordable Care Act 

provides that specific NPP may perform the face-to-face 
CMS-2348-P 9 

encounter with the individual in lieu of the physician, and 

inform the physician making the initial order for service 

under the Medicaid home health benefit. 

Consistent with that view, in the proposed regulation, 

we would provide that the physician must document the faceto-face encounter regardless of whether the physician 

himself or herself or one of the permitted NPPs performed 

the face-to-face encounter. The timing of this face-to-face 

encounter is specified as being within the 6-month period 

preceding the written order for home health services, or 

other reasonable timeframe specified by the Secretary. 

Similarly, in implementing the requirements under 

section 6407(b) of the Affordable Care Act, relating to DME, 

we take into account existing Medicaid regulatory 

requirements under §440.70 requiring physician orders. 

Because DME is not a term used in Medicaid in the same 

manner as in Medicare, we use the Medicaid term “medical 

supplies, equipment and appliances” or the shortened version 

“medical equipment.” The NPPs authorized to conduct a faceto-face encounter on behalf of a physician are the same for 

this provision as for the provision described above, with 

one exception. Certified nurse-midwives are not permitted 

to conduct the face-to-face encounter prior to the physician 

ordering medical equipment. Therefore, we are proposing to 

amend the Medicaid regulations at §440.70 to incorporate 
CMS-2348-P 10 

both the general home health and the medical equipment faceto-face requirements. 

D. Other Medicaid Home Health Policy Changes

1. Clarification that home health services cannot be 

restricted to individuals who are homebound or to services 

furnished in the home. 

We are proposing to incorporate in regulation that home 

health services may not be subject to a requirement that the 

individual be “homebound.” In addition, we are proposing to 

clarify that home health services cannot otherwise be 

restricted to services furnished in the home itself. 

On July 25, 2000, we issued a letter to State Medicaid 

Directors, Olmstead Update No: 3, in which we discussed 

Federal policies relevant to State efforts to comply with 

the requirements of the Americans with Disabilities Act 

(ADA) in light of the Supreme Court decision in Olmstead v. 

L.C., 527 U.S. 581 (1999). In attachments to that letter, 

we set forth specific policy clarifications to allow States 

more flexibility to serve individuals with disabilities in 

various ways and in different settings. 

Attachment 3-g of the letter: “Prohibition of Homebound 

Requirements in Home Health” clarified that the use of a 

“homebound” requirement under the Medicaid home health 

benefit violates Federal regulatory requirements at 

§440.230(c) and §440.240(b). These requirements provide 

that mandatory benefits must be sufficient in amount, 
CMS-2348-P 11 

duration and scope to reasonably achieve their purpose, may 

not be arbitrarily denied or reduced in scope based on 

diagnosis, type of illness, or condition, and that the same 

amount, duration and scope must be available to any 

individual within the group of categorically needy 

individuals and within any group of medically needy 

individuals. In the attachment, we stated that the 

restriction of home health services to individuals who are 

homebound to the exclusion of other individuals in need of 

these services ignores the reality that individuals with 

disabilities can and do live and function in the community. 

We further noted that developments in technology and service 

delivery made it possible for individuals with even the most 

severe disabilities to participate in a wide variety of 

activities in the community with appropriate supports. We 

also expressed the importance of ensuring that Medicaid is 

available to provide medically necessary home health 

services to individuals in need of those services who are 

not homebound and continue to be an important part of 

efforts to offer individuals with disabilities services in 

the most integrated setting appropriate to their needs, in 

accordance with the ADA. 

We are clarifying in this rule that Medicaid home 

health services may not be limited to services furnished in 

the home. This policy reflects prior court cases on the 

subject. In Skubel v. Fuoroli, 113 F.3d 330 (2d. Cir. 1997)
CMS-2348-P 12 

the court found that the Medicaid statute did not address 

the site of care for the mandatory home health benefit. The 

court found that the State could not limit coverage of home 

health services to those provided at the individual’s 

residence. In 1990, the same court ruled invalid an 

interpretation that limited the provision of private duty 

nursing services to an individual’s residence. The case, 

Detsel v. Sullivan, 895 F.2d 58 (2d Cir.1990), involved 

children suffering from severe medical conditions. Following 

the Detsel case, CMS, then the Health Care Financing 

Administration, ultimately adopted the court’s standard and 

issued nationwide guidance eliminating the at-home 

restriction on private duty nursing. To date, we have not 

issued similar guidance requiring nationwide adoption of the 

Skubel ruling. We are using our authority through this 

rulemaking opportunity to do so. 

2. Clarification of the definition of medical supplies, 

equipment and appliances. 

An important component of the Medicaid home health 

benefit is medical supplies, equipment and appliances, under 

§447.70(b)(3). The current wording of the regulation does 

not further define these terms, except to indicate that 

these items should be “suitable for use in the home.” 

Although this phrase could be read to refer only to the type 

of items included in the benefit, it has been susceptible to 

reading as a prohibition on use of covered items outside the 

home. We are using this opportunity to revise that phrase 
CMS-2348-P 13 

to make clear that it is not a limitation on the location in 

which items are used, but rather refers to items that are 

necessary for everyday activities and not specialized for an 

institutional setting. Thus we would indicate that these 

items must be “suitable for use in any non-institutional 

setting in which normal life activities take place.” This 

would clarify that although States may continue to establish 

medical necessity criteria to determine the authorization of 

these items, States may not deny requests for these items 

based on the grounds that they are for use outside of the 

home. 

Current Medicaid regulations do not contain any 

specific definition of medical supplies, equipment, and 

appliances under the home health benefit, other than the 

language discussed in the prior paragraph. States have 

adopted reasonable definitions of those terms, for example, 

based on the Medicare definition. But in the absence of a 

generally applicable definition of the term, there has been 

confusion as to the proper scope of the benefit. 

We believe that a consistent approach to categorizing 

home health medical supplies, equipment, and appliances will 

ensure beneficiaries are receiving needed items and provide 

clear and consistent guidance to States to ensure the use of 

the appropriate benefit category. We are now taking this 

opportunity to propose criteria defining home health 

supplies, equipment, and appliances, to better align with 
CMS-2348-P 14 

the Medicare program’s definition of durable medical 

equipment found at §414.202. We propose that supplies are 

defined as “health care related items that are consumable or 

disposable, or cannot withstand repeated use by more than 

one individual.” We propose that medical equipment and 

appliances are “items that are primarily and customarily 

used to serve a medical purpose, generally not useful to an 

individual in the absence of an illness or injury, can 

withstand repeated use, and can be reusable or removable.” 

We believe these standard definitions will ensure that 

such items will be available to all who are entitled to the 

home health benefit, and not restricted to individuals 

eligible for targeted benefits through home and 

community-based services (HCBS) waivers or the section 

1915(i) HCBS State Plan option. Items that meet the 

criteria for coverage under the home health benefit must be 

covered as such. States will not be precluded from covering 

items meeting this definition through a section 1915(c) HCBS 

waiver service, such as a home modification, or through a 

section 1915(i) State Plan option. However, the State must 

also offer those items as home health supplies, equipment 

and appliances. 

3. Other issues. 

We note that we are considering whether other 

clarifications to the home health regulations are warranted. 

In particular, we are considering whether it would be useful 
CMS-2348-P 15 

to include language to reflect the policies set forth in a 

September 4, 1998 letter to State Medicaid Directors, 

responding in part to a Second Circuit decision in Desario 

v. Thomas, 139 F. 3d 80 (1998), about the use of lists or 

other presumptions in determining coverage of items under 

the home health benefit for medical equipment. In that 

letter, we indicated that a State could use such lists or 

presumptions, but must provide individuals the opportunity 

to rebut the list or presumption with a process that employs 

reasonable and specific criteria to assess coverage for an 

item based on individual medical needs, and determine 

whether the list or presumption is based on an arbitrary 

exclusion based on diagnosis, type of illness, or condition. 

We have not proposed any language to reflect this policy in 

part because the principles at issue are not specific to 

home health medical equipment. We invite comment on this 

issue. 

In addition, in the May 5, 2010 Federal Register (75 FR 

24437), we issued the “Medicare and Medicaid Programs: 

Changes in Provider and Supplier Enrollment, Ordering and 

Referring, and Documentation Requirements; and Changes in 

Provider Agreements”, interim final rule which was effective 

on July 6, 2010. Although we have not incorporated changes 

to the scope of providers that may order medical supplies, 

equipment and appliances in the Medicaid program, as section 

6405(a) of the Affordable Care Act was not applicable to 
CMS-2348-P 16 

Title XIX, we are specifically soliciting comments through 

this rule on the merits of doing so. 

II. Provisions of the Proposed Regulations 

Please note that although the Affordable Care Act uses 

the term “individual” to refer to the Medicaid beneficiary, 

throughout this proposed rule we have used “recipient” to 

mirror the regulation text in the current Medicaid home 

health regulations. At this time, we do not intend to 

modify this term. 

For the reasons discussed above, we propose to modify 

§440.70(b)(3) to say the following: “medical supplies, 

equipment and appliances suitable for use in any noninstitutional setting in which normal life activities take 

place.” 

In §440.70(b)(3)(i) and (ii), we propose revising the 

current text to define what constitutes medical supplies, 

equipment, and appliances. We propose to indicate that 

supplies are defined as “health care related items that are 

consumable or disposable, or cannot withstand repeated use 

by more than one individual.” We propose to indicate that 

medical equipment and appliances are “items that are 

primarily and customarily used to serve a medical purpose, 

generally not useful to an individual in the absence of an 

illness or injury, can withstand repeated use, and can be 

reusable or removable.” We are specifically soliciting 

comment on these proposed provisions. 
CMS-2348-P 17 

For the reasons discussed above, we propose to modify 

§440.70(c), to add the following text to the end of the 

current provision: “Nothing in this section should be read 

to prohibit a recipient from receiving home health services 

in any non-institutional setting in which normal life 

activities take place.” Although the Court indicated that 

individuals would be limited to the same number of service 

hours they would have received if the home health services 

were provided only in their place of residence, in an 

effort to not limit the ability of States to offer a more 

robust home health benefit, we propose to allow States the 

option to authorize additional services or hours of 

services to account for this new flexibility. We also 

propose to add more text at the end of this provision as 

follows: “Additional services or service hours may, at the 

State’s option, be authorized to account for medical needs 

that arise in these settings”. This will incorporate both 

the Skubel and Olmstead decisions into the provision of 

home health services. This State flexibility would be 

applied to the State’s Medicaid program as a whole, and 

would not be a person-specific flexibility. State medical 

necessity criteria would continue to be applied uniformly 

to all Medicaid individuals. We note that any such 

additional hours of service that are authorized by the 

State would be matched at the State’s current Federal 

Medical Assistance Percentage (FMAP). 
CMS-2348-P 18 

The remainder of this section pertains to proposed 

changes to §440.70 to incorporate provisions of the 

Affordable Care Act. 

Section 6407 of the Affordable Care Act requires, as a 

condition for payment for home health services, 

documentation of a face-to-face encounter prior to an order 

for such services. Section 6407 of the Affordable Care Act 

requires that the timing of the face-to-face encounter for 

home health services must occur within the 6-month period 

preceding certification, or other reasonable timeframe 

determined by the Secretary. Based on the same reasoning 

set out in the Medicare final rule, Medicare Program; Home 

Health Prospective Payment System Rate Update for Calendar 

Year 2011; Changes in Certification Requirements for Home 

Health Agencies and Hospices as published in the 

November 17, 2010, Federal Register, we propose to determine 

a reasonable timeframe for the face-to-face encounter that 

is shorter than 6 months. The statutory goal is to achieve 

greater physician accountability in ordering home health 

services. To achieve this goal, the encounter must occur 

close enough to the start of home health services to ensure 

that the clinical conditions exhibited by the recipient 

during the encounter are related to the primary reason for 

the recipient’s need for home health services. As such, we 

believe that encounters would need to occur closer to the 

start of home health services rather than the 6-month period 
CMS-2348-P 19 

initially indicated, but not required by the Affordable Care 

Act. 

Consistent with the Medicare program’s implementation 

of this provision, we propose to indicate in a new 

§440.70(f)(1) that for the initial ordering of home health 

services, the physician must document that a face-to-face 

encounter that is related to the primary reason the 

individual requires home health services has occurred no 

more than 90 days prior to the start of services under the 

Medicaid home health benefit. We believe that in most 

cases, a face-to-face encounter with a recipient within the 

90 days prior to the start of home health services will 

provide the physician and/or specified NPPs with a current 

clinical presentation of the recipient’s condition such that 

the physician can accurately order home health services and 

establish an effective care plan, based on the encounter 

conducted by either the physician or allowed NPP. We also 

believe that a face-to-face encounter which occurs within 90 

days prior to the start of services would be generally 

relevant to the reason for the recipient’s need for home 

health services, and therefore such a face-to-face encounter 

would be sufficient to meet the goals of this statutory 

requirement. We recognize, however, that there may be 

circumstances when it may not be possible to meet this 

general requirement, and the individual’s access to needed 

services must be protected. To account for these 
CMS-2348-P 20 

circumstances, we also propose in §440.70(f)(1) to allow an 

opportunity to meet the face-to-face encounter requirement 

through an encounter with the recipient within 30 days after 

the start of home health services. 

While we recognize the necessity of permitting face-toface encounters to occur after the start of services in the 

instances described above, we emphasize that the timing of 

the face-to-face encounter in normal circumstances should 

occur within the 90 days prior to the start of home health 

services. 

The statute describes NPPs who may perform this faceto-face encounter as a nurse practitioner or clinical nurse 

specialist, as those terms are defined in section 

1861(aa)(5) of the Act, who is working in collaboration with 

the physician in accordance with State law, or a certified 

nurse-midwife (as defined in section 1861(gg) of the Act, as 

authorized by State law), or a physician assistant (as 

defined in section 1861(aa)(5) of the Act), under the 

supervision of the physician. 

 The statutory provision allows the permitted NPPs to 

perform the face-to-face encounter and inform the physician, 

who documents the encounter. 

Based on the same reasoning set out in the Medicare 

proposed rule, Medicare Program; Home Health Prospective 

Payment System Rate Update for Calendar Year 2012; published 

elsewhere in this Federal Register, for individuals admitted 
CMS-2348-P 21 

to home health upon discharge from a hospital or post-acute 

setting, we propose to also allow the physician who attended 

to the individual in the hospital or post-acute setting to 

inform the ordering physician regarding their encounters 

with the individual to satisfy the face-to-face encounter 

requirement, much like an NPP currently can. 

We propose to add a new §440.70(f)(2) to list the 

practitioners that may perform the face-to-face encounters. 

These practitioners include the physician already referenced 

in §440.70(a)(2), and the following NPPs: a nurse 

practitioner or clinical nurse specialist (as those terms 

are defined in section 1861(aa)(5) of the Act) who is 

working in collaboration with the physician in accordance 

with State law, or a certified nurse-midwife (as defined in 

section 1861(gg) of the Act, as authorized by State law), or 

a physician assistant (as defined in section 1861(aa)(5)of 

the Act), under the supervision of the physician, and for 

recipients admitted to home health immediately after an 

acute or post-acute stay, the attending acute or post-acute 

physician. 

We also propose to add a new §440.70(f)(3) to indicate 

that if an attending acute or post-acute physician or 

allowed NPP conducts the face-to-face visit, the attending 

acute or post-acute physician or practitioner is required to 

communicate the clinical findings of the face-to-face 

encounter to the physician, in order for the physician to 
CMS-2348-P 22 

document the face-to-face encounter accordingly. This 

requirement is necessary to ensure that the physician has 

sufficient information to determine the need for home health 

services, in the absence of conducting the face-to-face 

encounter himself or herself. We are also proposing to 

specify that these clinical findings must be reflected in a 

written or electronic document included in the recipient’s 

medical record (whether by the physician or by the NPP). We 

are not prescribing at the Federal level the specific 

elements necessary to document the face-to-face encounter, 

as that is a matter of clinical judgment that could vary 

according to the individual circumstance. However, States 

may choose to implement a minimum list of required 

information to adequately document the encounter. 

In a new §440.70(f)(4)(i), we propose to require that 

the physician’s documentation of the face-to-face encounter 

must be either a separate and distinct area on the written 

order, an addendum to the order that is easily identifiable 

and clearly titled, or a separate document easily 

identifiable and clearly titled in the recipient’s medical 

record. The documentation must also describe how the health 

status of the recipient at the time of the face-to-face 

encounter is related to the primary reason the recipient 

requires home health services. In a new §440.70(f)(4)(ii), 

we propose to require that the physician’s documentation of 

the face-to-face encounter be clearly titled, and state that 
CMS-2348-P 23 

either the physician himself or herself, or the applicable 

NPP, has conducted a face-to-face encounter with the 

recipient and include the date of that encounter. 

Finally, we propose to add a new §440.70(f)(5) to 

indicate that the face-to-face encounters may be performed 

through the use of telehealth. We are aware that many 

States currently make use of telehealth or telemedicine in 

the delivery of Medicaid services. Medicaid has issued 

informal guidance on the parameters of telehealth and 

telemedicine that is modeled after Medicare requirements. 

We are proposing to allow States to continue utilizing their 

current telehealth technologies as they apply to the 

implementation of this provision, however we are cognizant 

that State Medicaid telehealth policies may not align with 

Medicare’s. We wish to minimize duplication and 

fragmentation of services for beneficiaries who are duallyeligible for Medicare and Medicaid, and therefore we are 

specifically soliciting comment on approaches to telehealth 

policy that would further this goal. 

In a new §440.70(g), we propose to apply all of the 

requirements of §440.70(f) to the provision of supplies, 

equipment and appliances as described in §440.70(b)(3) to 

the extent that a face-to-face encounter would be required 

under the Medicare program for durable medical equipment, 

with one exception from the requirements at §440.70(f). The 

Affordable Care Act does not permit certified nurse midwives 
CMS-2348-P 24 

to conduct face-to-face encounters required for these items. 

This is reflected in our proposed §440.70(g)(2). 

The proposal to limit the face-to-face requirements to 

items that would be subject to such requirements as durable 

medical equipment under the Medicare program is based on the 

aim of maximizing consistency with the Medicare program’s 

implementation of section 6407 of the Affordable Care Act 

and reducing administrative burden on the provider 

community. Thus we would only require that, for items of 

durable medical equipment specified by CMS under the 

Medicare program as subject to a face-to-face encounter 

requirement, the physician must document that a face-to-face 

encounter that is related to the primary reason the 

individual requires the item has occurred no more than 90 

days before the order is written or within 30 days after the 

order is written. We intend to issue guidance to States 

indicating how they, and providers, can access the current 

Medicare list of specific durable medical equipment items 

subject to the face-to-face requirement. 

Medical supplies, equipment and appliances for which a 

face-to-face encounter would not be required under the 

Medicare program as durable medical equipment, would not 

require a face-to-face encounter prior to the ordering of 

items under the Medicaid program. These items will be of a 

smaller dollar value, and at a decreased risk for fraud, 
CMS-2348-P 25 

waste and abuse. We welcome public comment on this 

approach. 

We recognize the difficulty that some recipients with 

complex medical needs may face in participating in a faceto-face encounter (such as issues with accessing 

transportation, obtaining caregiver support, etc.,) 

particularly in rural areas. Once this rule is finalized, 

we expect States to implement this provision in a way that 

does not result in barriers to service delivery, as this is 

not the intent of the legislation. The statute specifically 

references telehealth as an alternative for ensuring that 

this new requirement is implemented in a way that protects 

continuity of services. We encourage States to work with 

the home health provider community to incorporate these 

face-to-face visits in creative and flexible ways to account 

for individual circumstances. We are available to provide 

technical assistance to States in achieving this goal. 

In keeping with a movement across all Medicaid 

services, we expect the plans of care developed to address a 

recipient’s home health needs be done in a way that embraces 

a person-centered philosophy. For clarification and 

consistency among programs, our expectation regarding the 

person-centered philosophy is that the plan of care reflects 

what is important to the recipient and for the recipient. 

The person-centered approach is a process, directed by the 

recipient with long-term support needs, or by another person 
CMS-2348-P 26 

important in the life of the recipient who the recipient has 

freely chosen to direct this process, intended to identify 

the strengths, capacities, preferences, needs, and desired 

outcomes of the recipient. The person-centered process 

includes the opportunity for the recipient to choose others 

to serve as important contributors to the planning process. 

This process and the resulting service plan will assist 

the recipient in achieving personally defined outcomes in 

the most integrated community setting in a manner that 

reflects what is important to the recipient to ensure 

delivery of services in a manner that reflects personal 

preferences and choices, and what is important for the 

recipient to meet identified support needs. 

III. Collection of Information Requirements 

Under the Paperwork Reduction Act of 1995, we are 

required to provide 60-day notice in the Federal Register

and solicit public comment before a collection of 

information requirement is submitted to the Office of 

Management and Budget (OMB) for review and approval. In 

order to fairly evaluate whether an information collection 

should be approved by OMB, section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995 requires that we solicit 

comment on the following issues: 

● The need for the information collection and its 

usefulness in carrying out the proper functions of our 

agency. 
CMS-2348-P 27 

● The accuracy of our estimate of the information 

collection burden. 

● The quality, utility, and clarity of the information 

to be collected. 

● Recommendations to minimize the information 

collection burden on the affected public, including 

automated collection techniques. 

We are soliciting public comment on each of these 

issues for the following sections of this document that 

contain information collection requirements (ICRs): 

Proposed §440.70(f)(3) and (g)(1) require NPPs and 

attending acute or post-acute physicians to communicate the 

clinical findings of the face-to-face encounter to the 

ordering physician. The burden associated with these 

requirements would be the time and effort required for the 

NPP and attending acute or post-acute physicians to complete 

this communication. This is estimated at 10 minutes for 

each encounter. We estimate that there would be 1,143,443 

initial home health episodes in a year based on our 2008 

claims data. As such, the estimated burden for the NPP and 

attending acute or post-acute physicians documenting, 

signing, and dating the recipient’s face-to-face encounter 

would be 190,574 hours for CY 2011. 

Proposed §440.70(f)(4) and (g)(1) would require that 

physicians document the existence of a face-to-face 

encounter with the Medicaid eligible recipient. The burden 
CMS-2348-P 28 

associated with these requirements would be the time and 

effort required for the physician to complete and maintain 

this documentation. The ordering physician’s burden for 

composing the face-to-face documentation, which would 

include determining how the clinical findings of the 

encounter support eligibility; writing, typing, or dictating 

the face-to-face documentation; signing, and dating the 

recipient’s face-to-face encounter is estimated at 10 

minutes for each encounter. We estimate that there would be 

1,143,443 initial home health episodes in a year based on 

our 2008 claims data. As such, the estimated burden for the 

physician documenting, signing, and dating the recipient’s 

face-to-face encounter would be 190,574 hours for CY 2011. 

We acknowledge that this figure is inflated by the instances 

in which the physician himself or herself conducted the 

face-to-face encounter with the individual, making this 

second 10-minute documentation burden unnecessary. 

This notice of proposed rulemaking also serves as the 

required 60-day Federal Register notification for 

aforementioned information collection requirements. To 

obtain copies of the supporting statement and any related 

forms for the proposed paperwork collections referenced 

above, access CMS’ Web site at 

http://www.cms.gov/PaperworkReductionActof1995/PRAL/list.asp

#TopOfPage or email your request, including your address, 

phone number, OMB number, and CMS document identifier, to 
CMS-2348-P 29 

Paperwork@cms.hhs.gov, or call the Reports Clearance Office 

at 410-786–1326. 

If you comment on these information collection and 

recordkeeping requirements, please do either of the 

following: 

 1. Submit your comments electronically as specified in 

the ADDRESSES section of this proposed rule; or 

 2. Submit your comments to the Office of Information 

and Regulatory Affairs, Office of Management and Budget, 

 Attention: CMS Desk Officer, [CMS-2348-P]

 Fax: (202) 395-6974; or 

 Email: OIRA_submission@omb.eop.gov 

IV. Response to Comments 

Because of the large number of public comments we 

normally receive on Federal Register documents, we are not 

able to acknowledge or respond to them individually. We 

will consider all comments we receive by the date and time 

specified in the "DATES" section of this preamble, and, when 

we proceed with a subsequent document, we will respond to 

the comments in the preamble to that document.

V. Regulatory Impact Statement 

A. Statement of Need 

This regulation is necessary to implement Section 6407 

of the Patient Protection and Affordable Care Act of 2009 

(the Affordable Care Act), (Pub. L. 111-148, enacted on 

March 23, 2010), as amended by section 10605 of the 
CMS-2348-P 30 

Affordable Care Act which affects the home health benefit 

under both the Medicare and Medicaid programs. 

Section 6407(a) of the Affordable Care Act (as amended 

by section 10605) added new requirements to section 

1814(a)(2)(C) of the Act under Part A of the Medicare 

program, and section 1835(a)(2)(A) of the Act, under Part B 

of the Medicare program, that the physician, or certain 

allowed nonphysician practitioners (NPPs), document a 

face-to-face encounter with the individual (including 

through the use of telehealth, subject to the requirements 

in section 1834(m) of the Act), prior to making a 

certification that home health services are required under 

the Medicare home health benefit. Section 1814(a)(2)(C) of 

the Act indicates that in addition to a physician, a nurse 

practitioner or clinical nurse specialist (as those terms 

are defined in section 1861(aa)(5) of the Act) who is 

working in collaboration with the physician in accordance 

with State law, or a certified nurse-midwife (as defined in 

section 1861(gg) of the Act, as authorized by State law), or 

a physician assistant (as defined in section 1861(aa)(5) of 

the Act), under the supervision of the physician, may 

conduct the face-to-face encounters prior to the start of 

home health services. 

Section 6407(b) of the Affordable Care Act amended 

section 1834(a)(11)(B) of the Act to require documentation 

of a similar face-to-face encounter with a physician or 
CMS-2348-P 31 

specific NPPs by a physician ordering durable medical 

equipment (DME). The NPPs authorized to conduct a face-toface encounter on behalf of a physician are the same for 

this provision as for the provision described above, with 

one exception. Certified nurse-midwives are not permitted 

to conduct the face-to-face encounter prior to the physician 

ordering DME. The timing of this face-to-face encounter is 

specified as being within the 6-month period preceding the 

written order for DME, or other reasonable timeframe 

specified by the Secretary. This provision also maintains 

the role of the physician in the actual ordering of DME.

B. Overall Impact 

We have examined the impacts of this rule as required 

by Executive Order 12866 on Regulatory Planning and Review 

(September 30, 1993), Executive Order 13563 on Improving 

Regulation and Regulatory Review (January 18, 2011), the 

Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. 

L. 96-354), section 1102(b) of the Social Security Act, 

section 202 of the Unfunded Mandates Reform Act of 1995 

(March 22, 1995, Pub. L. 104-4), and Executive Order 13132 

on Federalism (August 4, 1999), and the Congressional Review 

Act (5 U.S.C. 804(2)). 

Executive Orders 12866 and 13563 direct agencies to 

assess all costs and benefits of available regulatory 

alternatives and, if regulation is necessary, to select 

regulatory approaches that maximize net benefits (including 
CMS-2348-P 32 

potential economic, environmental, public health and safety 

effects, distributive impacts, and equity). Executive Order 

13563 emphasizes the importance of quantifying both costs 

and benefits, of reducing costs, of harmonizing rules, and 

of promoting flexibility. A regulatory impact analysis 

(RIA) must be prepared for major rules with economically 

significant effects ($100 million or more in any 1 year). We 

tentatively estimate that this rulemaking may be 

“economically significant” as measured by the $100 million 

threshold, and, therefore, may be a major rule under the 

Congressional Review Act. Accordingly, we have prepared a 

Regulatory Impact Analysis which to the best of our ability 

presents the costs and benefits of the rulemaking. 

 The CMS Office of the Actuary estimated Section 6407 as 

having no potential impact on Federal Medicaid costs and 

savings. According to the CMS Actuarial estimates, Section 

6407 would bring an estimated $350 million in savings to the 

Medicare program from 2010-2014 and $870 million in savings 

from 2010-2019. Although this provision applies to Medicaid 

in the same manner and to the same extent as the Medicare 

program, no estimates (costs or savings) were noted for the 

Medicaid program. 

 Although there is no quantitative data to arrive at a 

specific dollar figure to attribute to the additional 

medical supplies, equipment, and appliances that may now be 

authorized in accordance with §440.70(b)(3), we acknowledge 
CMS-2348-P 33 

the potential for this provision to surpass the threshold 

for economic significance. We wish to note however, that 

this provision may result in offsetting benefits to both 

beneficiaries and State budgets, including the ability for 

individuals to return to or enter the workforce, thereby 

increasing the pool of taxpayers, and decreasing reliance on 

other Medicaid benefits, including institutional care. 

Although there is no specific estimate regarding these 

benefits, they nonetheless should be taken into account. We 

are specifically soliciting comment on the potential 

increased costs and benefits associated with this provision, 

as well as the various sections throughout the RIA. 

The RFA requires agencies to analyze options for 

regulatory relief for small entities, if a rule has a 

significant impact on a substantial number of small 

entities. For purposes of the RFA, small entities include 

small businesses, nonprofit organizations, and small 

government jurisdictions. Most hospitals and most other 

providers and suppliers are small entities, either by 

nonprofit status or by having revenues of $7.0 million to 

$34.5 million in any 1 year. For details, see the Small 

Business Administration’s final rule that set forth size 

standards for health care industries, (65 FR 69432, 

November 17, 2000). Individuals and States are not included 

in the definition of a small entity. We are not preparing 

an analysis for the RFA because the Secretary has determined 
CMS-2348-P 34 

that this proposed rule would not have a significant 

economic impact on a substantial number of small entities. 

In addition, section 1102(b) of the Social Security Act 

requires us to prepare a regulatory impact analysis if a 

rule may have a significant impact on the operations of a 

substantial number of small rural hospitals. This analysis 

must conform to the provisions of section 603 of the RFA. 

For purposes of section 1102(b) of the Act, we define a 

small rural hospital as a hospital that is located outside 

of a Metropolitan Statistical Area and has fewer than 100 

beds. We are not preparing an analysis for section 1102(b) 

of the Act because the Secretary has determined that this 

proposed rule would not have a significant impact on the 

operations of a substantial number of small rural hospitals. 

 Section 202 of the Unfunded Mandates Reform Act (UMRA) 

of 1995 also requires that agencies assess anticipated costs 

and benefits before issuing any rule that may result in 

expenditure in any one year of $100 million in 1995 dollars, 

updated annually for inflation. In 2011, that threshold 

level is approximately $136 million. This proposed rule 

will not result in an impact of $136 million or more on 

State, local or tribal governments, in the aggregate, or on 

the private sector. 

Executive Order 13132 establishes certain requirements 

that an agency must meet when it promulgates a proposed rule 

(and subsequent final rule) that imposes substantial direct 
CMS-2348-P 35 

requirement costs on State and local governments, preempts 

State law, or otherwise has Federalism implications. Since 

this regulation does not impose any costs on State or local 

governments, the requirements of Executive Order 13132 are 

not applicable. 

C. Conclusion 

We tentatively estimate that this rule may be 

“economically significant” as measured by the $100 million 

threshold as set forth by Executive Order 12866, as well as 

the Congressional Review Act. The analysis above provides 

our initial Regulatory Impact Analysis. We have not 

prepared an analysis for the RFA, section 1102(b) of the 

Act, section 202 of the UMRA, and Executive Order 13132 

because the provisions are not impacted by this rule. 

In accordance with the provisions of Executive Order 

12866, this regulation was reviewed by the Office of 

Management and Budget. 
CMS-2348-P 36 

List of Subjects in 42 CFR Part 440

 Grant programs-health, Medicaid. 
CMS-2348-P 37 

 For the reasons set forth in the preamble, the Centers 

for Medicare & Medicaid Services proposes to amend 42 CFR 

chapter IV as set forth below: 

PART 440—SERVICES: GENERAL PROVISIONS 

1. The authority citation for part 440 continues to 

read as follows:

Authority: Sec. 1102 of the Social Security Act (42 

U.S.C. 1302). 

Subpart A - Definitions

2. Section 440.70 is amended by-- 

A. Redesignating paragraphs (b)(3)(i) and (ii) as 

(b)(3)(iii) and (iv), respectively. 

B. Revising the introductory text of paragraph (b)(3). 

C. Adding new paragraphs (b)(3)(i) and (ii). 

D. Adding paragraphs (c)(1) and (2). 

E. Adding paragraphs (f) and (g). 

The revisions and additions read as follows: 

§440.70 Home health services. 

 * * * * * 

 (b)* * * 

(3) Medical supplies, equipment, and appliances 

suitable for use in any non-institutional setting in which 

normal life activities take place. 

(i) Supplies are defined as health care related items 

that are consumable or disposable, or cannot withstand 

repeated use by more than one individual. 
CMS-2348-P 38 

 (ii) Equipment and appliances are defined as items 

that are primarily and customarily used to serve a medical 

purpose, generally not useful to an individual in the 

absence of an illness or injury, can withstand repeated use, 

and can be reusable or removable. 

 * * * * * 

 (c)* * * 

(1) Nothing in this section should be read to prohibit 

a recipient from receiving home health services in any noninstitutional setting in which normal life activities take 

place. 

(2) Additional services or service hours may, at the 

State’s option, be authorized to account for medical needs 

that arise in these settings. 

 * * * * * 

 (f) No payment may be made for services referenced in 

paragraphs (b)(1), (2), and (4) of this section, unless the 

physician referenced in paragraph (a)(2) of this section 

documents that there was a face-to-face encounter with the 

recipient that meets the following requirements: 

 (1) For the initiation of services, the face-to-face 

encounter must be related to the primary reason the 

recipient requires home health services and must occur 

within the 90 days prior to or within the 30 days after the 

start of the services. 
CMS-2348-P 39 

 (2) The face-to-face encounter may be conducted by one 

of the following practitioners: 

(i) The physician referenced in paragraph (a)(2) of 

this section; 

(ii) A nurse practitioner or clinical nurse 

specialist, as those terms are defined in section 

1861(aa)(5) of the Act, working in collaboration with the 

physician described in paragraph (a) of this section, in 

accordance with State law; 

(iii) A certified nurse midwife, as defined in section 

1861(gg) of the Act, as authorized by State law; 

(iv) A physician assistant, as defined in section 

1861(aa)(5) of the Act, under the supervision of the 

physician described in subparagraph (a) of this section; or 

(v) For recipients admitted to home health immediately 

after an acute or post-acute stay, the attending acute or 

post-acute physician. 

(3) The allowed nonphysician practitioner, as described 

in paragraph (f)(3)(ii) through (iv) of this section, or the 

attending acute or post-acute physician, as described in 

paragraph (f)(3)(v) of this section, performing the face-toface encounter must communicate the clinical findings of 

that face-to-face encounter to the ordering physician. 

Those clinical findings must be incorporated into a written 

or electronic document included in the recipient’s medical 

record. 
CMS-2348-P 40 

(4) To assure clinical correlation between the face-toface encounter and the associated home health services, the 

physician responsible for ordering the services must: 

(i) Document the face-to-face encounter as a separate 

and distinct area on the order itself, as an easily 

identifiable and clearly titled addendum to the order, or a 

separate document easily identifiable and clearly titled in 

the recipient’s medical record, to describe how the health 

status of the recipient at the time of the face-to-face 

encounter is related to the primary reason the recipient 

requires home health services. 

(ii) Must indicate the practitioner who conducted the 

encounter, and be clearly titled and dated on the 

documentation of the face-to-face encounter.

(5) The face-to-face encounter may occur through 

telehealth, as implemented by the State.

(g)(1) No payment may be made for medical equipment, 

supplies, or appliances referenced in paragraph (b)(3) of 

this section to the extent that a face-to-face encounter 

requirement would apply as durable medical equipment under 

the Medicare program, unless the physician referenced in 

paragraph (a)(2) of this section documents a face-to-face 

encounter with the recipient consistent with the 

requirements of paragraph (f) of this section except as 

indicated below. 
CMS-2348-P 41 

(2) The face-to-face encounter may be performed by any 

of the practitioners described in paragraph (f)(2)of this 

section, with the exception of certified nurse-midwives, as 

described in paragraph (f)(2)(iii)of this section. 
CMS-2348-P 

Authority: (Catalog of Federal Domestic Assistance Program 

No. 93.778, Medical Assistance Program) 

Dated: March 2, 2011

 _______________________________

Donald M. Berwick, 

Administrator, 

 Centers for Medicare & Medicaid 

Services. 

Approved: June 3, 2011

 __________________________________ 

Kathleen Sebelius, 

Secretary, 

Department of Health and Human 

Services.

BILLING CODE 4120-01-P 
CMS-2348-P 43 

[FR Doc. 2011-16937 Filed 07/05/2011 at 4:15 pm; Publication 

Date: 07/12/2011]