[Federal Register Volume 81, Number 21 (Tuesday, February 2, 2016)]
[Rules and Regulations]
[Pages 5530-5567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01585]
[[Page 5529]]
Vol. 81
Tuesday,
No. 21
February 2, 2016
Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Part 440
Medicaid Program; Face-to-Face Requirements for Home Health Services;
Policy Changes and Clarifications Related to Home Health; Final Rule
Federal Register / Vol. 81 , No. 21 / Tuesday, February 2, 2016 /
Rules and Regulations
[[Page 5530]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 440
[CMS-2348-F]
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: Final rule.
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SUMMARY: This final rule revises the Medicaid home health service
definition consistent with section 6407 of the Patient Protection and
Affordable Care Act of 2010 (the Affordable Care Act) and section 504
of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) to
add requirements that, for home health services, physicians document,
and, for certain medical equipment, physicians or certain authorized
non-physician practitioners (NPP) document the occurrence of a face-to-
face encounter (including through the use of telehealth) with the
Medicaid eligible beneficiary within reasonable timeframes. This rule
also aligns the timeframes for the face-to-face encounter with similar
regulatory requirements for Medicare home health services. In addition,
this rule amends the definitions of medical supplies, equipment, and
appliances. We expect minimal impact with the implementation of section
6407 of the Affordable Care Act and section 504 of MACRA. We recognize
that states may have budgetary implications as a result of the amended
definitions of medical supplies, equipment and appliances.
Specifically, this rule may expand coverage of medical supplies,
equipment and appliances under the home health benefit. There will be
items that had previously only been offered under certain sections of
the Act that will now be covered under the home health benefit.
DATES: Effective date: This rule is effective on July 1, 2016.
Compliance date: Based on public comments, we recognize that there
may be operational and budgetary implications with this rule and that
states and providers may need time to implement this provision. To
ensure that states and providers are implementing the rule
appropriately, we are delaying compliance with this rule for up to one
year if legislature has met in that year, otherwise 2 years.
Exception for State Legislation.--In the case of a State plan under
title XIX of the Social Security Act (42 U.S.C. 1396 et seq.), which
the Secretary determines requires state legislation in order for the
respective plan to meet one or more additional requirements imposed by
this rule, the respective state shall not be regarded as failing to
comply with the requirements of this rule solely on the basis of its
failure to meet such an additional requirement before the first day of
the first calendar quarter beginning after the close of the first
regular session of the state legislature that begins after the date of
enactment of this rule. For purposes of the previous sentence, in the
case of a state that has a 2-year legislative session, each year of the
session shall be considered to be a separate regular session of the
state legislature. States will be expected to be in compliance by July
1, 2017 or July 1, 2018 based on legislative timeframes as described
above.
FOR FURTHER INFORMATION CONTACT: Ali Smilow, (410) 786-0790.
SUPPLEMENTARY INFORMATION:
I. Executive Summary and Background
A. Executive Summary
1. Purpose
This final rule implements section 6407 of the Patient Protection
and Affordable Care Act of 2010 (the Affordable Care Act) (Pub. L. 111-
148), which adds the requirement that physicians document the
occurrence of a face-to-face encounter (including through the use of
telehealth) with the Medicaid eligible beneficiary within reasonable
timeframes when ordering home health services. More specifically,
section 6407(b) of the Affordable Care Act applies to Medicaid face-to-
face encounter requirements set forth in the Medicare statute.
Additionally, on April 16, 2015, the Medicare Access and CHIP
Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10), became law.
Section 504 of this law amended the underlying Medicare requirements at
section 1834(a)(11)(B)(ii) of the Social Security Act (the Act) to
allow certain authorized non-physician practitioners (NPP) to document
the face-to-face encounter. This final rule adopts in large part the
provisions proposed in the proposed rule issued on July 12, 2011 (76 FR
41032), but includes conforming changes to the provisions of the
proposed rule to reflect the revisions made by MACRA to the underlying
Medicare face-to-face encounter requirements. In addition, this final
rule clarifies that Medicaid home health services and items are not
limited to home settings, and makes additional changes to the
requirements for coverage of medical supplies, equipment and appliances
under the home health benefit.
2. Summary of the Major Provisions
The final rule requires 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 beneficiary
requires home health services occurred no more than 90 days before or
30 days after the start of services. The final rule requires that for
the initial ordering of certain medical equipment, the physician or
authorized NPP must document that a face-to-face encounter that is
related to the primary reason the beneficiary requires medical
equipment occurred no more than 6 months prior to the start of
services. The face-to-face encounter for home health and medical
equipment may be performed by the physician or certain authorized NPPs.
The final rule maintains the role of the physician in ordering Medicaid
home health services and medical equipment.
The rule also codifies current Medicaid policies for coverage of
home health services, including clarifying in the definition of medical
supplies, equipment, and appliances that items must be suitable for use
in any setting in which normal life activities take place, other than a
hospital; nursing facility, intermediate care facility for individuals
with intellectual disabilities; or any setting in which payment is or
could be made under Medicaid for inpatient services that include room
and board. Additionally, the rule defines home health supplies,
equipment, and appliances, to better align with the Medicare program's
definition of durable medical equipment (DME) at Sec. 414.202.
The rule codifies the policies set forth in September 4, 1998
guidance, about the use of lists or other presumptions in determining
coverage of items under the home health benefit for medical equipment,
including the following three points: (1) States may have a list of
preapproved medical equipment, supplies and appliances for
administrative ease, but not as an absolute limit on coverage; (2)
States must provide and make available to individuals a reasonable and
meaningful procedure for beneficiaries to request medical equipment,
supplies or appliances not on the list based on a showing of medical
necessity; and (3) Individuals must be informed of their
[[Page 5531]]
right to a fair hearing to appeal an adverse action. Additionally, the
rule clarifies our interpretation that the Medicaid statute does not
permit absolute exclusions of coverage as medical equipment, supplies,
or appliances.
These clarifications reflect the principles embodied in the
holdings of the Skubel v. Fuoroli, 113 F.3d 330 (2d. Cir. 1997) and
Detsel v. Sullivan, 895 F.2d 58 (2d Cir.1990) decisions into the
requirements for the provision of home health services by clarifying
that Medicaid home health services may not be limited to services
furnished in the home and revising the current regulatory language to
specify that home health services may be provided, as appropriate, in
any setting in which normal life activities take place, other than a
hospital, nursing facility; intermediate care facility for individuals
with intellectual disabilities; or any setting in which payment is or
could be made under Medicaid for inpatient services that include room
and board.
3--Summary of Costs and Benefits
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Provision description Total costs Total benefits
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Physician and certain non- Although this The overall benefit
physician practitioners provision applies of this rule is the
(NPP) for DME documentation to Medicaid in the expected increase
of face-to-face encounter same manner and to in program
with the Medicaid eligible the same extent as integrity resulting
beneficiary within the Medicare in more quality
reasonable timeframes when program, no home health
ordering home health estimates (costs or services for
services. savings) were noted Medicaid
for the Medicaid beneficiaries.
program as data to Additionally, this
determine these rule will
estimates is potentially serve
unavailable. For to provide
Medicare, the individuals with
overall economic disabilities a
impact of this greater ability to
provision is an engage in normal
estimated $920 activities of daily
million in savings living.
to the Medicare
program from 2010-
2014 and $2.29
billion in savings
from 2010-2019.
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B. Background
Title XIX of the Act requires that, 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
is a mandatory services for Medicaid-eligible individuals who are
entitled to nursing facility services, which includes the basic
categorically needy populations who receive the standard Medicaid
benefit package, and can also include medically needy populations if
nursing facility services are offered to the medically needy within a
state. Home health services include nursing services, home health aide
services, medical supplies, equipment, and appliances, and may include
therapy services (physical therapy, occupational therapy, speech
pathology and audiology services). For a state to receive federal
Medicaid matching payments for such services, current Medicaid
regulations require a beneficiary's physician to order home health
services as part of a written plan of care reviewed every 60 days.
At section 6407 of the Affordable Care Act, new Medicare
requirements were set forth for face-to-face encounters to support
claims for home health services, and for DME, which were also made
applicable to Medicaid.
Specifically, sections 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 were amended to require that the physician, or
certain allowed 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), before 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 (NP) or clinical nurse
specialist (CNS) (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 (PA) (as defined in section 1861(aa)(5) of the
Act), under the supervision of the physician, may conduct the face-to-
face encounters before the start of home health services.
Section 6407 of the Affordable Care Act also amended section
1834(a)(11)(B) of the Act to require that physician orders for DME must
be supported by documentation by the physician of a similar face-to-
face encounter with a physician or specified NPPs. The NPPs authorized
to conduct a face-to-face encounter on behalf of a physician are the
same for DME as for home health services, except that certified nurse-
midwives are not included.
The timing of the face-to-face encounter for either home health or
DME is specified as being within the 6-month period preceding the
written order for DME, or other reasonable timeframe specified by the
Secretary.
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 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 this statutory
directive in the Medicaid program.
II. Summary of Provisions of the Proposed Rule
1. New Home Health Face-to-Face Requirements
In the proposed rule, we sought to implement the face-to-face
requirements of section 6407 of the Affordable Care Act in a manner
consistent with existing Medicaid requirements and practices. For
example, in implementing the face-to-face encounter requirements of
section 6407 of the Affordable Care Act with respect to home health
services generally, we took into consideration the longstanding
regulatory requirements under Sec. 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 used the term
``order'' in place of the Affordable Care Act's use of ``certify.''
We did not view implementation of section 6407 of the Affordable
Care Act as supplanting these existing Medicaid regulatory requirements
related to physician orders; the new face-to-face process is consistent
with those requirements. We proposed amending the Medicaid regulations
at Sec. 440.70 to incorporate both the general home health and the
medical equipment face-to-face requirements. Because DME is
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not a term used in Medicaid in the same manner as in Medicare, we
proposed to use the Medicaid term ``medical supplies, equipment, and
appliances'' or the shortened version ``medical equipment.''
Additionally, we proposed that the face-to-face encounter can be
performed through the use of telehealth, which is described in more
detail in section I. of this final rule.
As previously indicated, we proposed that for home health services,
the face-to-face encounter occurred no more than 90 days before or 30
days after the start of services. To align with Medicare timing
requirements at Sec. 424.22(a)(1)(v), we revised the timeframes for
medical equipment and the final rule requires that for the initial
ordering of medical equipment, the physician must document that a face-
to-face encounter that is related to the primary reason the beneficiary
requires medical equipment occurred no more than 6 months prior to the
start of services. These timeframes are applicable to face-to-face
encounters performed through telehealth.
2. Specification of Non-Physician Practitioners (NPPs) Authorized To
Perform Face-to-Face Encounters
Under sections 1814(a)(2)(C) and 1835(a)(2)(A) of the Act, face-to-
face encounters for home health services may be conducted by a NP or
CNS (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 PA (as defined in section
1861(aa)(5) of the Act), under the supervision of the physician. A
similar definition of NPPs applies for DME under section 1834(a)(11)(B)
of the Act, with one exception: Certified nurse-midwives are not
included in the list of NPPs.
3. Other Medicaid Home Health Policy Changes
a. Codification That Home Health Services Cannot Be Restricted to
Individuals Who Are Homebound or to Services Furnished Solely in the
Home
We proposed that home health services may not be subject to a
requirement that the individual be ``homebound.'' In addition, we
proposed that home health services cannot otherwise be restricted to
services furnished in the home itself. These policies reflect
longstanding CMS interpretations of the scope of the home health policy
and were discussed in a July 25, 2000 letter to State Medicaid
Directors, Olmstead Update No. 3 setting forth federal interpretations
of applicable law 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
Attachment 3-g to that letter, we set forth our interpretation that a
requirement that home health recipients be homebound was inconsistent
with the mandatory nature of the home health benefit, and the
longstanding regulatory provisions at 42 CFR 440.230 and 440.240. These
regulatory provisions provide that mandatory benefits must be
sufficient in amount, 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.
We also proposed that Medicaid home health services may not be
limited to services furnished in the home. This policy reflects the
principles set forth in prior court cases on whether home health
services and private duty nursing can be limited to services furnished
in the home. In Skubel v. Fuoroli, 113 F.3d 330 (2d. Cir. 1997) 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. Previously, in 1990, the Second Circuit had
applied similar principles to invalidate a regulation 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,
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.
b. Clarification of the Definition of Medical Supplies, Equipment, and
Appliances
An important component of the Medicaid home health benefit is
coverage of medical supplies, equipment, and appliances, under Sec.
440.70(b)(3). The current regulation does not further define the terms,
except to indicate that the items should be suitable for use in the
home. Although CMS has read this phrase to refer only to the type of
items included in the benefit (excluding those types of items that are
only furnished in institutional or provider settings), it has been
susceptible to reading as a prohibition on use of covered items outside
the home. We proposed revisions to this section to clarify 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 proposed to indicate
that the 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 the items, states may not
deny requests for the 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 greater alignment of the definitions of home health
medical supplies, equipment and appliances with the Medicare definition
of DME will help to streamline beneficiaries' access to receive needed
items and provide clear and consistent guidance to states to ensure the
use of the appropriate benefit category. Therefore, we proposed to
define home health supplies, equipment, and appliances, to better align
with the Medicare program's definition of DME at Sec. 414.202, 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. Unlike Medicare, however, we did not propose to define the
expected life of a piece of equipment and did not propose to limit
equipment to items used in the home. We also proposed to define
supplies as health care related items that are consumable or
disposable, or cannot withstand repeated use by more than one
individual, based loosely on Medicare principles, but we did not
propose to require that supplies be incidental to other covered
services.
The proposed standard definitions were intended to ensure that such
items
[[Page 5533]]
will be available to all who are entitled to the mandatory home health
benefit, and not restricted to individuals receiving targeted benefits
through section 1915(c) 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 would be
covered as such.
c. Other Issues
In the proposed rule, we noted that we were considering whether
other clarifications to the home health regulations were warranted. In
particular, we invited comments on whether it would be useful 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 our interpretation of the mandatory coverage provisions to
mean that a state could use such lists or presumptions as an
administrative convenience but not as an absolute coverage limitation,
and must provide individuals the opportunity to rebut the list or
presumption using a process that employs reasonable and specific
criteria to assess coverage for an item based on individual medical
needs.
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 did not incorporate
changes in the proposed rule 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 Title
XIX of the Act, we specifically solicited comments through this rule on
the merits of doing so. We will address comments received below.
III. Analysis of and Responses to Public Comments
We received a total of 94 timely items of correspondence from home
health provider representatives and other professional associations,
State Medicaid Directors, states, beneficiaries, and other individuals.
Comments ranged from general support or opposition to the proposed
rule, to specific questions and detailed comments and recommendations
regarding the proposed changes. A summary of the public comments and
our responses are set forth below.
A. General
Comment: Some commenters expressed general support for the rule.
One commenter supported CMS' goal of promoting accountability and
program integrity. Other commenters supported the efforts of the
Department to move toward consistency between the Medicare and Medicaid
programs and ensure that home health services are delivered in
accordance with sound clinical guidelines and recommendations.
Response: We appreciate the commenters' support.
Comment: Many commenters recommended that CMS specify that Medicaid
home health services cannot be contingent upon a beneficiary needing
skilled nursing care or therapy. Other commenters suggested revising
Sec. 441.15(c) to specify that Medicaid home health services cannot be
contingent upon the beneficiary needing skilled nursing care or
therapy.
Response: We have revised Sec. 440.70(b) to clarify that coverage
of Medicaid home health services cannot be contingent upon the
beneficiary needing nursing or therapy services. We do not believe it
is an accurate reading of section 1902(a)(10)(D) or the Act, or Sec.
441.15 to impose such a requirement; the language of those provisions
requires that the state provide the home health benefit to individuals
whose benefit package includes nursing facility services, but does not
require that the individual actually need such services. While it is
beyond the scope of this rule to clarify and revise Sec. 441.15(b),
the clarification in Sec. 440.70(b) will inform the reading of Sec.
441.15(b).
Comment: Many commenters proposed that CMS amend Sec. 440.230,
which governs amount, duration, and scope to include language that
reflects the policies set forth in the 1998 State Medicaid Director's
letter related to the Desario case.
Response: We agree with commenters that the principles set forth in
that letter should be incorporated into Medicaid regulations, although
we disagree that these principles should be incorporated into Sec.
440.230 as opposed to the Medicaid home health regulation at Sec.
440.70. Accordingly, we are revising Sec. 440.70 to include the three
points made in that letter: (1) States may have a list of preapproved
medical equipment, supplies, and appliances for administrative ease but
not as an absolute limit; (2) States must provide and make available to
individuals a reasonable and meaningful procedure for individuals to
request items not on the list; and (3) Individuals are informed of
their right to a fair hearing.
Comment: Several commenters requested that CMS specify that states
cannot require a 60-day plan of care for medical supplies, equipment
and appliances. The commenters also requested that CMS specify that
states may not impose additional state restrictions that are not part
of the federal requirements for supplies, equipment, and appliances
such as requiring that they be limited to services for temporary
recovery from specific incidents, be limited to non-routine supplies
necessary for the delivery of a participant's nursing care and
described in the plan of care, or any other state requirement that is
not a federal requirement for receiving equipment and supplies.
Response: As stated in the existing provisions of Sec.
440.70(a)(2), home health services are required to be provided to a
beneficiary on his or her physician's orders as part of a written plan
of care that the physician reviews every 60 days, except as specified
in paragraph (b)(3). That exception states that a beneficiary's need
for medical supplies, equipment, and appliances need only be reviewed
on an annual basis, with more frequent review to be determined on a
case-by-case basis based on the nature of the item prescribed. It would
be inappropriate for states to require additional review of medical
equipment, supplies, and appliances except where indicated on a case-
by-case basis (for example, for supplies that are needed on a short
term basis).
Additionally, states may place limits on the amount and duration of
medical equipment, supplies and appliances, but the limits must meet
sufficiency requirements set forth at Sec. 440.230. And, as with all
Medicaid services, states are not required to cover medically
unnecessary services, and have the discretion to develop medical
necessity criteria, but these must be based on accepted medical
practices and standards.
Comment: Some commenters suggested that CMS apply the proposed
prohibition on applying a ``homebound'' limitation to all Medicaid home
care related program benefits, with one commenter suggesting that CMS
audit state Medicaid programs for noncompliance with the homebound
prohibition rule. That commenter stated that CMS should specifically
review whether those state programs that
[[Page 5534]]
utilize a medical necessity standard as proxy for homebound.
Response: It is beyond the scope of this regulation to revise the
requirements or definitions applicable to services other than home
health care services. We are prohibiting the application of a homebound
requirement for Medicaid home health because we have concluded that the
resulting benefit would be insufficient to meet the needs of the
population, and would not achieve the purposes of the mandatory
benefit. We appreciate the commenters' suggestion and will take under
advisement as part of our overall compliance strategy. We are revising
Sec. 440.70(c)(1) to codify the homebound prohibition for Medicaid
home health services.
Comment: One commenter requested that CMS pursue the expansion of
the Medicaid provision of home health services to meet the needs of our
elderly citizens.
Response: Medicaid enrollees, regardless of their eligibility
category, are not required to be homebound to qualify for home health
benefits. Therefore, the clarification of the definition of medical
equipment and supplies, and the requirement that home health services
cannot be restricted to the home helps support the ability of Medicaid
to best meet the needs of all eligible individuals, including the
elderly.
Comment: One commenter believed that models for health care homes
that compensate medical practices for complex care of chronically ill
Medicaid beneficiaries should be promoted.
Response: We agree with the commenter. We have provided states with
guidance and technical assistance on many initiatives that promote
better care for the beneficiaries with chronic illness, including
disease management strategies, health homes, and primary care case
management systems. In 2014, we established the Medicaid Innovation
Accelerator Program to support and focus resources on such models. More
information can be found on our Web site at http://www.medicaid.gov/state-resource-center/innovation-accelerator-program/innovation-accelerator-program.html. Related guidance is also found on our Web
site at http://www.medicaid.gov/state-resource-center/innovation-accelerator-program/related-tools-and-guidance/related-tools-and-guidance.html. Such models are beyond the scope of this regulation but
we intend to continue our efforts to provide technical assistance and
guidance on these models.
Comment: One commenter recommended that states be required to cover
certification of home health care (at least initial certification) and
ongoing care plan oversight as a medical benefit for Medicaid
beneficiaries and to compensate physicians consistent with Relative
Value Units for such work.
Response: Physician certification of the need for home health care
could be covered by the state as a physician service or could be
covered as a component part of home health care services. States have
substantial flexibility to design payment methodologies for covered
services. These payment methodologies can be tailored to the service
delivery system in each state.
Comment: One commenter indicated that the rule should note that
states must develop a strategy to educate physicians about the
extension of the face-to-face requirement to Medicaid.
Response: We recognize the importance of education and expect
states to educate the physician community on the new requirements
implemented through the Affordable Care Act. We disagree that this
administrative activity should be included as a requirement in the
regulation. It is implicit with any regulation change to a benefit or
to provider responsibilities that states educate impacted providers and
beneficiaries about the new requirements.
Comment: One commenter endorsed adding the phrase ``medically
necessary'' to Sec. 440.70(b), to read as ``Home health services
include the following medically necessary services and items.''
Response: We agree that states may limit covered services to only
include medically necessary services. This flexibility is already
provided in regulation at Sec. 440.230(d). Medical necessity is not
determined by us, but is determined by medical professionals. Many
states employ medical professionals to establish medical necessity
criteria and then review individual circumstances in light of those
criteria. The phrase suggested by the commenter suggests that we would
review medical necessity determinations. We do not intend to do so, and
thus we are not accepting the suggestion.
Comment: One commenter indicated that there are no Current
Procedural Terminology (CPT) or International Classification of
Diseases (ICD) codes that specifically represent an evaluation for home
health services; therefore, another model of demonstrating that a face-
to-face encounter took place is needed.
Response: The face-to-face encounter can be demonstrated through
the pre-existing ``evaluation and management'' codes.
Comment: One commenter expressed concern about how this provision
will be implemented for those that are dually eligible for Medicare and
Medicaid. Another commenter urged CMS to consider regulatory waivers,
demonstrations or other initiatives to consolidate services for a dual
eligible into a separate program for those beneficiaries with
proportional funding from the existing federal and state programs. The
commenter also indicated that CMS should undertake a significant
education and outreach campaign to reach state officials, physicians,
hospitals, home health providers, and organizations representing
beneficiaries. The focus of the campaign would include Medicaid face-
to-face requirements, and important similarities and differences with
the Medicare face-to-face requirements.
Response: To the maximum extent possible, we have intentionally
aligned the Medicaid rule with the Medicare requirements to reduce
disparities in care and coverage for individuals who are eligible for
both programs and to make it easier for providers to understand and
implement the applicable rules. Currently, we are working on and
publicizing a number of initiatives that speak directly to dual
eligibles, increasing their continuity of care, and addressing ways in
which Medicaid and Medicare rules might be better aligned. Such
initiatives are out of the scope of this rule.
Comment: One commenter requested that CMS clarify or amend the
definition of home health services such that this rule would not be
applicable to non-medical services such as personal care attendant
services.
Response: Personal care services are separately defined at Sec.
440.167. We recognize the potential overlap between personal care
services and home health aide services authorized under Sec. 440.70.
However, we disagree with the commenter's suggestion that this rule
should not be applicable to services qualifying as home health aide
services.
Comment: One commenter requested that CMS provide a significant
amount of time before making effective, or enforcing, the final rule so
that the state may prepare an accurate budget with sufficient funds for
implementation and compliance.
Response: The requirements of section 6407 of the Affordable Care
Act were effective upon enactment, and applied for home health services
certified after January 1, 2010, as
[[Page 5535]]
specified in the Affordable Care Act and CMCS Informational Bulletin
dated July 13, 2011; http://www.medicaid.gov/Federal-Policy-Guidance/downloads/CIB-7-13-11.pdf. However, we will be delaying compliance for
up to one year from the effective date of the rule if the state's
legislature has met in that year, otherwise 2 years. Our expectation is
that states and providers are compliant with the requirements of the
final rule within the timeframes explained above. We intend to work
collaboratively with states to ensure compliance with these
requirements within a reasonable timeframe.
Comment: One commenter recommended that more productive emphasis be
placed on training physicians in the home health assessment process so
that physicians are held accountable for ordering appropriate services.
The commenter also recommended that a process be put into place to
audit home health services, and if a home health agency is abusing the
system by providing questionable services, then a heightened
authorization system be put into place for those identified high-risk
agencies.
Response: As previously stated, it is implicit with any regulation
change to a benefit that states inform impacted providers of new
requirements and procedures. In response to the second comment, home
health agencies must meet conditions of participation as determined
through our survey process. The structures are designed to ensure that
such agencies are qualified to furnish high-quality services that are
medically necessary. To the extent that any provider, including a home
health agency, is determined through the survey process to be
furnishing inappropriate or unnecessary services, compliance actions
can be pursued.
Comment: One commenter believed that home health services should be
delivered in a consumer directed manner; the individual should be
allowed to choose an agency or a consumer directed delivery option.
Response: A service plan based on a person-centered philosophy will
support the beneficiary in achieving personally defined outcomes in the
most integrated community setting available. This approach will reflect
what is important to the individual receiving the services in terms of
personal preferences and choices to meet identified support needs.
Formal participant direction requirements for a home health service
plan may be required by states as they determine appropriate, and
consistent with the service delivery and payment system used by the
state. We did not propose to change the requirement that certain
components of the home health benefit (specifically nursing, home
health aide services, and therapy services) must be furnished by a home
health agency. This requirement is based on the premise that these
services must be properly supervised and coordinated, consistent with
the beneficiary's plan of care. Changing this requirement is beyond the
scope of this rulemaking.
Comment: One commenter sought CMS guidance on the responsibility of
the Medicaid Agency as it relates to oversight and monitoring of home
health agencies to ensure compliance with the regulations.
Response: Overall compliance with home health agency certification
requirements is conducted by the state's survey agency, in partnership
with us. It is expected that State Medicaid Agencies collaborate with
State Survey Agencies to ensure compliance of all home health providers
with appropriate requirements, including all aspects of this
regulation.
Comment: Some commenters discussed transportation costs. One
commenter requested clarification on Medicaid coverage of physician
non-medical transportation costs for face-to-face encounters. One
commenter stated that the increased need to provide transportation
services for the face-to-face encounters will result in increased
costs. Another commenter raised a concern related to the problem of
transportation costs, stating that the mandate of existing Sec. 431.53
``that the Medicaid agency will ensure necessary transportation for
beneficiaries to and from providers,'' when read in connection with the
proposed Sec. 440.70(c)(1), significantly increases the states'
financial obligation for service delivery. Additionally, the commenter
requested that CMS clarify that Sec. 431.53 does not apply for
location-independent providers such as home health agencies.
Response: States are required under Sec. 431.53 to assure
necessary transportation for beneficiaries to and from medical
providers, and that applies to transportation costs necessary for face-
to-face encounters. This requirement includes transportation to and
from an appointment with a physician or allowed NPP to receive an
evaluation for home health services. States may reimburse physicians
for transportation costs when necessary to make house calls through
payment rate adjustments. Physicians cannot claim separately for
transportation costs, since Medicaid reimbursement is not available
specifically for physician transportation costs. However, many states
factor in the costs of doing business into the payment rates for
physician services, and may have higher payment rates to reflect
physician house calls. Additionally, in response to the commenter's
concern about transportation, we would note that the face-to-face
encounter can be performed through the use of telehealth, and states
may have payment rates that apply specifically for telehealth services
and take into account the costs of communication lines and other
necessary components of a telehealth encounter (on both sides of the
telehealth encounter).
Comment: Two commenters requested that CMS specify that medical
supplies, equipment, and appliances are a separate stand-alone home
health service. The commenter also suggested that CMS emphasize that,
even if a particular item cannot be covered as medical equipment,
supplies, or appliances, states should determine whether it can be
covered under another Medicaid service category, such as prosthetics or
rehabilitation services. Additionally, the commenter suggested that CMS
should state explicitly that satisfying the criteria of either one of
the two definitions (equipment and appliances, or supplies) is
sufficient to require coverage when the item is medically necessary.
Response: We appreciate the commenter's suggestions. As indicated
in the proposed rule, items and services that meet the criteria for
coverage under the home health benefit must be covered according to
home health coverage parameters. To ensure full coverage for medical
equipment and appliances, we will require that, to the extent that
there is overlap in coverage with another benefit, states must
nevertheless provide for the coverage of these items under the
mandatory home health benefit. We understand that this policy may
require that some states revise their claims processing systems, and we
will work with those states to assist them in meeting this requirement.
We reiterate that individuals only requiring medical equipment and
appliances, and not other components of the home health benefit, may
receive those services from DME providers authorized by the state,
without necessitating a relationship with a home health agency. The
nature of medical supplies and their ability to be provided in a
variety of situations calls for a more flexible approach. Supplies
incident to another mandatory benefit, such as physician services or an
inpatient benefit such as hospital or nursing facility, may be covered
under that benefit category. Additionally, supplies incident to the
clinic benefit may be covered under that benefit
[[Page 5536]]
category. However, regardless of coverage category, the expectation
remains that individuals receive all medically necessary medical
supplies meeting the definition finalized under this regulation. We are
available to provide technical assistance to states to work through
operational issues.
We added this clarification to the regulatory text at Sec.
440.70(b).
Comment: Two commenters indicated that the substantial number of
hours required for compliance with this rule, in combination with the
relatively low reimbursement typical for care of Medicaid
beneficiaries, will lead to barriers to compliance among physicians.
Commenters anticipated resistance from practitioners and physicians due
to the additional administrative time it will take to meet the face-to-
face requirement. One commenter indicated that many doctors are stating
that they do not like the additional documentation requirements and are
simply not ordering home health services. One commenter stated that
early indications from the Medicare requirements are that physicians
have been hostile to the new requirement, particularly the
documentation standards. Another commenter stated that already there
are many doctors who do not accept Medicaid beneficiaries. The
commenter believed that adding additional paperwork and documentation
requirements like this means there will likely be even more doctors who
do not participate or who do not order home health services. One
commenter reported that the home health industry is having problems
with some doctors not wanting to do the face-to-face, therefore they
are refusing to refer any beneficiaries to home health. One commenter
indicated that since the Medicare requirement went into effect their
members have seen a significant drop in referrals, some as much as 25
percent. The commenter further stated that unlike Medicare, Medicaid is
actually 50 different programs with varying sets of rules from state to
state. The commenter expressed concern that this will cause uneven
application of the rule across the country and could lead to more
problems with access to care.
Response: We fully expect that physicians will comply with the
requirements and that they will be reasonably compensated for the time
needed to provide and document the face-to-face encounter. The face-to-
face encounters can be performed by NPPs, as well as done through
telehealth. Additionally, as previously indicated, for medical
equipment, NPPs are now authorized to complete the documentation
requirements. To the extent that physicians may be avoiding ordering
home health services, or are not cooperating with the home health
industry on face-to-face documentation requirements, these may be
temporary responses stemming from the unfamiliarity of the
requirements. States, home health agencies and DME suppliers may need
to work with physicians and NPPs to help them to understand the
requirements. In particular, home health agencies and DME suppliers may
need to develop ongoing relationships with physicians and NPPs to
ensure that face-to-face encounters occur and are properly documented.
Comment: We received many comments pertaining to access to care.
Commenters expressed that the face-to-face requirement in Medicare
seems to be doing little to improve oversight of the benefit and is
instead reducing access to home health for otherwise eligible patients,
as physicians either refuse to accept the additional paperwork burden
or do so only after agencies spend additional time and resources to
obtain the documentation. One commenter believed the manner in which
CMS is implementing the statutory requirement will significantly affect
Medicaid beneficiaries' access to care. The commenter further stated
that they can cite anecdotal examples of physicians who have simply
decided to no longer refer individuals for home health services because
of the hassle involved. One commenter believed that Medicaid
beneficiaries will be the victims of this proposal because citizens who
are elderly and those with disabilities are at risk for not receiving
home health services if agencies have concerns about compliance with
the face-to-face requirement and cannot deliver care. One commenter
supported the need to align Medicare and Medicaid rules whenever
possible, but was concerned about requirements that cause barriers to
access by requiring a face-to-face encounter to initiate and receive
payment for home health services. Another commenter was not supportive
of applying the face-to-face requirements under Medicare to Medicaid.
Another commenter believed that this requirement will negatively impact
access and serve as a barrier to care because of the additional
administrative burden to physicians filling out the face-to-face form.
One commenter indicated that physicians, hospitals, discharge planners,
home health agencies, and beneficiary groups agree that the physician
requirements are a barrier to access to home health care for bona fide
beneficiaries who meet coverage standards. One commenter believed that
the face-to-face requirement is reducing access to home health for
otherwise eligible individuals. One commenter was concerned that the
face-to-face requirement will impede access and provide marginal
benefit as a tool to eliminate ordering of questionable services.
Response: The face-to-face requirement is mandated by statute. We
have attempted to permit maximum flexibility in how the statutory
requirement can be met and believe that the requirement can be
accommodated without significant additional burden. We are aligning
Medicaid requirements with Medicare requirements to maximize
consistency in service delivery, as well as reduce administrative
burden on the provider community. As discussed in this final rule, we
expect states to offer appropriate provider training and for states and
providers to work together to ensure this provision is implemented in a
manner that supports the goal of ensuring program integrity while not
serving as a barrier to access to medically necessary services.
Comment: One commenter stated that well-mom and baby visits do not
meet the intent of the physician face-to-face encounter for
establishing the primary reason for which home health services are
required and which will ultimately result in the development of a home
health plan of care.
Response: If, in the course of such a visit, the physician or other
practitioner determines that home health services or medical equipment
is required to address the condition of the mother or child, such a
visit could be the basis for a documented face-to-face encounter to the
extent that the visit involves examining the condition of the mother or
child.
Comment: One commenter believed that the proposed rule fails to
take into account the fact that a significant proportion of home health
services furnished to Medicaid beneficiaries under managed care
programs are primarily the financial responsibility of managed care
organizations. Another commenter suggested that, given the increased
cost associated with the face-to-face encounter requirements, CMS
should query states as to how they will be adjusting rates paid to
managed care plans to adjust for the increased costs in an actuarially
sound manner. Other commenters requested clarification regarding the
application of the regulation to home health services
[[Page 5537]]
provided through Medicaid managed care plans.
Response: As previously stated, neither the law nor this rule
requires that the face-to-face requirement apply to Medicaid managed
care. We defer to states to determine the application of the face-to-
face requirement in managed care plans to best meet the needs of their
beneficiaries.
Comment: One commenter was concerned that more services will be
shifted to personal care attendant services resulting in potential
Medicare savings at the expense of state Medicaid budgets.
Response: We believe that the concern about potential cost shifting
between Medicare and Medicaid can be address by ensuring that home
health plans of care include all needed home health aide services.
Additionally, as indicated in a previous response, to the extent that
there is overlap in coverage with an optional benefit, states must
provide for the coverage of services that meet the parameters of home
health services under the mandatory home health benefit.
Comment: One commenter stated that the proposed rule at Sec.
440.70 goes well beyond the scope of statutory authority and should not
be issued. This commenter requested that CMS revisit its position that
home health services are a mandatory service.
Response: We disagree with the commenter. Section 1902(a)(10)(D) of
the Act sets forth the requirement that a state plan for medical
assistance must provide for the inclusion of home health services for
any individual who, under the state plan, is entitled to nursing
facility services. Because nursing facility services are mandatory for
categorically needy individuals and the medically needy--if a state
chooses to cover the medically needy--home health services are
mandatory for the populations.
Upon consideration of public comments received, we are finalizing
Sec. 440.70 with the following revisions:
We are revising Sec. 440.70(b) to state that home health
services cannot be contingent upon the beneficiary needing nursing or
therapy services.
We are revising Sec. 440.70(b) to codify that items and
services that meet the criteria for coverage under the home health
benefit must be covered according to home health coverage parameters.
We are incorporating into Sec. 440.70(b)(3)(v), three
basic points set forth in our 1998 guidance relating to the DeSario
decision: (1) States may have a list of preapproved medical equipment,
supplies, and appliances for administrative ease but not as an absolute
limit on coverage; (2) States must provide and make available to
individuals a reasonable and meaningful procedure for individuals to
request items not on the list; and (3) Individuals must be informed of
their right to a fair hearing. Additionally, we are including in the
final rule the underlying interpretation implicit in these principles
that the mandatory coverage of this benefit prohibits absolute
exclusions of coverage as medical equipment, supplies, or appliances.
We are revising Sec. 440.70(c)(1) to codify our
longstanding policy that home health services may not be subject to a
requirement that the individual be homebound.
B. Introductory Text--Medical Supplies, Equipment, and Appliances
(Sec. 440.70(b)(3))
Section 440.70(b)(3) proposed to revise the wording of the
regulation to further define medical equipment, supplies, and
appliances as suitable for use in any non-institutional setting in
which normal life activities take place. We also proposed in Sec.
440.70(b)(3)(i) and (ii) more detailed definitions of the terms
``medical supplies, equipment, and appliances''.
Comment: We received many comments in support of revising the
introductory text of paragraph (b)(3). Several commenters supported the
policy that medical equipment cannot be restricted to items that are
useful in the home. One commenter further stated that potentially
essential products are necessary not only for individuals to function
in the home but to carry out activities of daily living while out of
the home and in the community. One commenter stated that such standard
is consistent with the requirements under the Americans with
Disabilities Act, the Supreme Court Decision in Olmstead v. LC, and
good healthcare policy. Another commenter stated that substituting
suitable for use in any non-institutional setting in which normal life
activities take place will improve understanding of this required
characteristic of medical supplies, equipment, and appliances. Another
commenter stated that this acknowledges that individuals engage in
daily activities in which they may need such equipment not only in
their homes, but also as they go about their daily activities in the
community. Another commenter suggested including this language not only
in the preamble, but also in the final regulations. Additionally,
several commenters commended CMS for its statement in the preamble to
the proposed rule that ``[i]tems that meet the criteria for coverage
under the home health benefit must be covered as such. States will not
be precluded from covering items through a section 1915(c) HCBS waiver
service, such as 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.''
Response: We appreciate the perspectives the commenters had in
support of the proposed revisions to the introductory language in Sec.
440.70(b)(3). This language has been included in the final regulation.
Comment: Many commenters requested clarification of the phrase
``normal life activities.'' One commenter requested that CMS clarify or
define normal life activities as absent a definition there will likely
be considerable confusion between this term and activities of daily
living. Another commenter reported that some states include the
terminology of activities of daily living in their DME definition which
enables a focus on a defined area of medical necessity. The commenter
suggested that this standard is more clearly defined and thus
preferable. Another commenter indicated that the term ``normal life
activity,'' if not clearly defined, will result in duplication of
services and increased expenditures. Another commenter indicated that
``in which normal life activities take place'' is a subjective
statement where the state's administration may have to continually
define and defend its interpretation in utilization management
practices.
Response: To clarify, the phrase ``normal life activities'' refers
to activities that could occur in or out of an individual's home. We
proposed to revise the phrase ``suitable for use in the home'' to
``suitable for use in any non-institutional setting in which normal
life activities take place'' to clarify that although states may
continue to establish medical necessity criteria to determine the
authorization of the items, states may not deny requests for the items
based on the grounds that they are for use outside of the home. This
clarification would not preclude states from continuing to use
activities of daily living as medical necessity criteria.
Comment: One commenter indicated concern with the proposed
``expansive'' new definition of Medicaid supplies, equipment, and
appliances which appears to require states to provide supplies,
equipment, and appliances in any non-institutional setting. Thus,
states would be required to provide, as just one example, wheelchair
ramps in
[[Page 5538]]
settings outside the home as well as in the home.
Response: The new definition of Medicaid supplies, equipment, and
appliances establishes a framework to serve as a companion to the
requirement that the benefit is not limited to services and/or items
suitable for use in the home, rather it is a benefit that is available
to people in any setting in which normal life activities take place,
other than facilities specified at Sec. 440.70(c)(1). States may not
deny requests for the items based on the grounds that they are for use
outside of the home. States will continue to have flexibility to
establish a reasonable definition of medical supplies, equipment and
appliances that is consistent with the regulatory framework, to apply
medical necessity criteria, and to have reasonable utilization control
standards. We note that we do not regard this definition to expand the
scope of medical equipment to include environmental or structural
housing modifications. Nor does it include equipment that is designed
to have a general use and will serve more people than just the Medicaid
beneficiary. And a state's medical necessity and utilization control
standards could reasonably preclude coverage of duplicative items or
could provide coverage for rental rather than purchase of items when
cost effective.
Comment: One commenter stated that what CMS characterizes in the
proposed rule as clarifying language in Sec. 440.70(b)(3) is a
substantive change to the rule that goes well beyond what is
statutorily allowed under Medicaid. The commenter stated that the
present language of Sec. 440.70(b)(3) correctly sets forth the scope
of coverage of medical supplies and equipment as being ``suitable for
use in the home'' as home health care is the purpose of this coverage
category.
Response: We disagree that the proposed changes go beyond the
statutory authority for CMS to interpret the meaning of the home health
benefit and establish a framework for states to implement that benefit.
In addition, while the changes are substantive, the changes incorporate
principles that have been applied to Medicaid coverage in a number of
court cases and CMS guidance, as discussed in the Background section
above. As a result, the changes update the regulations to incorporate
principles that are already applicable in practice.
Comment: One commenter raised concern regarding DME issues related
to abuse of the equipment provided to Medicaid beneficiaries, or
requests for equipment that exceeds the practical needs of the member.
Response: States may review requests to ensure that only medically
necessary equipment is covered. The proposed provisions do not replace
the existing Medicaid regulatory requirements at Sec. 440.70(a)(2) and
Sec. 440.70(b)(3)(i) related to physician ordering and review of
necessary medical equipment. An additional safeguard against
unnecessary utilization is the face-to-face requirement and subsequent
documentation requirement, which provides that physicians must describe
how the health status of the beneficiary at the time of the face-to-
face encounter is related to the primary reason the beneficiary
requires home health services. This process should identify requests
for equipment that exceed the practical needs of the individual. With
regard to abuse of equipment provided to Medicaid beneficiaries, we
believe it would be reasonable for states to require that the face-to-
face encounter include instruction on how to properly use and care for
the medical equipment at issue.
Comment: One commenter requested clarification as to whether the
existing 16-bed or fewer size standard for determining whether a
residential setting is an institution will be considered in determining
whether supplies are suitable for use in ``non-institutional settings''
and the applicability for DME that would be used in a school setting.
Response: This provision does not change the standard for
determining whether a residential setting is an institution (the16-bed
standard discussed by the commenter applies only to whether a setting
is an institution for mental diseases, not whether it is
institutional). Home health services do not include services for
individuals receiving inpatient services in a hospital, nursing
facility, intermediate care facility for individuals with intellectual
disabilities, or other setting in which payment is or could be made
under Medicaid for inpatient services that include room and board. Home
health services would be covered for individuals residing in other
types of facilities in accordance with this regulation.
Comment: Several commenters requested clarification about whether a
state that offers a unique service under a section 1915(c) waiver or
section 1915(i) state plan amendment must also offer those items as
home health supplies, equipment, and appliances. Commenters stated that
on its face, this would suggest the addition of all unique section 1915
services would also become regular home health services, available to
all state plan beneficiaries. If this is the intent, it would seem a
welcome expansion of services, if it is not, then clarification would
be helpful. Another commenter requested clarification that HCBS waiver
beneficiaries are exempt from the proposed rule under Sec. 440.310.
Another commenter asked if the assumption is correct that certain
equipment and appliances may require installation and would be included
in the cost of the equipment and appliances. If so, the commenter
requests a distinction be made between basic installation required for
equipment and appliances (medical supplies) and structural
modifications required for HCBS home and vehicle modification.
Response: States may not restrict access to equipment that meets
the criteria for coverage under the home health benefit by carving
certain equipment out of home health and offering it only to
individuals who qualify for services under a state's section 1915(i)
and section 1915(c) program. States may implement standards to
determine coverage under the home health benefit of medical equipment
based on medical necessity and utilization control. While a state can
use presumptions in applying medical necessity and utilization control
criteria, which CMS does not review, the state must provide an
opportunity for an individualized hearing as to whether the item is
medically necessary in the particular circumstances. There will be
items currently coverable under sections 1915(c) and 1915(i) that will
instead be covered under the home health benefit, but there are other
items that will not meet the new federal or state definitions of home
health medical equipment or that may be outside of the coverage
limitations in the state's approved state plan. These latter items may
remain covered under a section 1915(c) or 1915(i) benefit. In response
to the commenter's inquiry regarding the exemption of HCBS waiver
beneficiaries, to clarify, the requirement of this rule applies to all
individuals receiving state plan home health services, including those
eligible for state plan services based on enrollment in a HCBS waiver
program. We defer to states to establish medical necessity criteria to
meet the needs of their beneficiaries.
Comment: One commenter stated concern about the implication that
states cannot limit the home health benefit to those services and items
that are sufficient to achieve the purpose of the benefit, as is well
established in statute, regulation, and case law and
[[Page 5539]]
that the final regulation should clarify that only those items that the
state chooses to cover within the home health benefit must be provided
to Medicaid enrollees. The commenter also stated that they were
concerned about the implication that some home modifications may be
mandatory through the home health benefit. The commenter suggested that
CMS should consider limiting that statement to the installation of
certain appliances and equipment such as grab bars and other items that
are available through home health agencies, and clarify that home
remodels and other expensive modifications are not included in the home
health benefit.
Response: This regulation clarifies the permissible scope of the
home health benefit, particularly as it relates to medical supplies,
equipment, and appliances. But this regulation does not remove state
flexibility to adopt a reasonable definition of medical supplies,
equipment, and appliances that is consistent with the regulatory
framework; nor does it preclude state flexibility to include coverage
limitations that do not interfere with the overall sufficiency of the
benefit. Home health is a mandatory benefit and was so before this rule
or the statutory changes that led to this rule. States may establish
limits on mandatory benefits in their approved state plan, but must
demonstrate that, despite the proposed limits, the covered benefits are
sufficient in amount, duration, and scope. In addition, as we discussed
in our Desario guidance, because of the unique nature of medical
supplies, equipment and appliances, scope limitations within the
applicable federal and state definitions are not consistent with
sufficiency of the benefit. States should not be implementing policies
that unreasonably restrict access to specific items of medical
equipment. We are available to provide technical assistance to states
looking to implement amount, duration, and scope limitations in home
health.
In response to the commenter's concern about the implication that
some home modifications may be mandatory through the home health
benefit, we would like to clarify that costs of structural home
modifications are not covered under the home health benefit because
they would not be within the new regulatory definition of medical
equipment, but instead would be costs of shelter. Similarly, vehicular
modifications are not within the definition of medical equipment; they
are a component of a vehicle that is not medical in nature.
In addition, we are clarifying that states may implement standards
to determine coverage of equipment based on presumptions about medical
necessity and utilization control, but must provide for an opportunity
for individuals to have an individualized medical necessity analysis
that takes into consideration the individual's person-centered plan of
care. While a state can use presumptions in making applying medical
necessity and utilization control criteria, which CMS does not review,
the state must provide an opportunity for an individualized hearing as
to whether the item is medically necessary in the particular
circumstances.
Comment: One commenter stated that the source of confusion as to
the proper scope of the DME benefit has not been the state's DME
definition. Since CMS is proceeding on an assumption without factual
basis, the commenter does not support the proposal to establish a
regulatory definition of DME.
Response: This final rule does not define medical equipment,
supplies and appliances; rather it sets out a framework under which a
state can adopt a reasonable definition of these items. The framework
provides some criteria which the state must include in its reasonable
definition. We believe this framework will provide a more consistent
approach to categorizing home health medical supplies, equipment, and
appliances that with this guidance, states will ensure the sufficiency
of the benefit so that beneficiaries will receive needed items. We have
aligned the Medicaid definition of medical equipment, supplies, and
appliances to the best extent possible using key components of
Medicare's definition which we believe will achieve consistency for
beneficiaries, providers, and program administration and ensure that
beneficiaries are receiving needed items.
Comment: One commenter raised a concern with home modification
equipment. Specifically, the commenter stated that home modification
equipment currently is not considered DME in the commenter's state and
has been covered as an additional service under HCBS waiver programs.
The commenter asserted that inappropriately expanding the definition to
non-medical services will deplete public funding requiring states to
again look at the services they provide and the rates they pay to
maintain balanced budgets.
Response: As discussed above, home modifications are not a part of
this new definition of medical supplies, equipment, and appliances.
Comment: One commenter stated that the current definition of
medical supplies, equipment, and appliances includes the verbiage
``suitable for use in the home'' which is consistent with Medicare's
requirement ``appropriate for use within the home.'' This definition
does not restrict the beneficiary to the home but defines the type of
equipment that is appropriate for reimbursement under the DME
outpatient program.
Response: We believe that the revision to the definition of medical
supplies, equipment, and appliances will clarify the breadth of the
current definition to include covered items outside of the home.
After consideration of the public comments, this section is being
finalized without revisions.
C. Definition--Medical Supplies, Equipment and Appliances (Sec.
440.70(b)(3)(i) and (ii))
In Sec. 440.70(b)(3)(i) and (ii), we proposed to revise the
current regulation text to define what constitutes medical supplies,
equipment, and appliances.
Comment: Some commenters expressed support of the revised
definition. Commenters supported the alignment with Medicare's
definition of DME. One commenter specifically supported CMS's effort to
streamline and standardize the requirements for DME across the Medicare
and Medicaid program, especially as they may apply to dual eligible
beneficiaries. Another commenter believed the changes will promote
consistency among different payer groups. A few commenters supported
the concept advanced by CMS to define medical ``equipment'' separately
from medical ``supplies.''
Response: We appreciate the support of the commenters.
Comment: Many commenters requested that CMS further clarify the
proposed definition of medical equipment and appliances. CMS's proposed
language defining medical equipment as ``reusable or removable'' could
be interpreted by states to allow exclusion of items that are custom
made or customized, such as wheelchair components for the seating and
positioning for individuals with the most severe orthopedic
impairments. The commenters recommended that CMS eliminate this
restrictive criterion from its definition of medical equipment. Many
commenters further requested the substitution of the term ``reusable''
with ``non-disposable.'' One commenter requested that this rulemaking
process clarify that items of DME that meet an established definition
of the service must be covered by
[[Page 5540]]
Medicaid when medically necessary. Additionally, the commenter
requested that the rules clarify that states cannot characterize items
of DME as non-covered through the home health benefit because this
equipment may be eligible through HCBS waiver programs.
Response: As stated in the preamble to the proposed rule, we have
set out a framework for the definition of medical equipment and
appliances to align with Medicare to achieve consistency for
beneficiaries who may be eligible in both programs, simplify program
administration and ensure that beneficiaries are receiving needed
items. But, we have left considerable flexibility for reasonable state
definitions of the benefit within that framework. We do not agree that
the terms ``reusable or removable'' should be deleted from the
framework for medical equipment because these terms have meanings that
are generally understood based on use in the Medicare program. Although
we appreciate commenters raising the concern that these terms could be
read to prohibit the customization of equipment, we do not agree that
customization would necessarily make the items unusable for other
individuals.
In response to the further comment, the home health benefit is
distinct from items and services that may be available through HCBS
waiver programs. Medicaid coverage of medical supplies, equipment, and
appliances under the home health benefit is mandatory and must be
provided under the state plan to HCBS waiver enrollees. To the extent
that items are not included under the approved state plan, extended
coverage could be provided under section 1915(c) waiver programs. We
also reiterate our statement from the proposed rule that items meeting
the state plan definition of a medical supply, equipment or appliance
must be provided under the home health benefit, and may not be
restricted to enrollees under a section 1915(c) HCBS waiver.
Comment: We received many comments pertaining to the language
``illness or injury.'' Many commenters requested that CMS clarify this
definition to ensure that individuals with congenital conditions or
developmental disabilities are not denied coverage of equipment or
appliances because a state determines that they do not have an illness
or injury.
Response: It is not our intent to deny coverage of supplies,
equipment, or appliances to individuals with congenital conditions or
developmental disabilities. We expect that anyone who is determined,
based on medical necessity, to need medical supplies, equipment, and
appliances will receive it. Therefore, in accordance with the comments,
we are revising the regulation text to include ``disability, illness,
or injury.''
Comment: Many commenters raised concern with the proposed criteria
defining home health supplies, equipment, and appliances to better
align with the Medicare program's definition of DME. Several commenters
were concerned that states may take the adoption of a regulatory
definition for medical supplies, equipment, and appliances as a signal
to make their policies for covering medical equipment, appliances, and
supplies more restrictive than they are at present. Commenters urged
CMS to state in the preamble that this is not the intention of adopting
this definition. Additionally, the commenters specified their concern
that the intent to align the definition with the Medicare program will
lead states to erroneously deny coverage of home health services
because Medicare does not cover them. Commenters further stated that
one of the primary purposes of the Medicaid program is to ``furnish . .
. rehabilitation and other services to help such families and
individuals attain or retain capability for independence and self-
care'' and there is no corresponding requirement in the Medicare Act.
One commenter stated that he strongly disagrees with the alignment with
the Medicare definition and that distinct definitions of ``medical
equipment and appliances'' between the two programs are warranted.
Another commenter stated that in the instance of defining medical
equipment and appliances, alignment between the Medicare and Medicaid
definition is ill-advised and unnecessary. Another commenter stated
that he does not believe this clarification meets the goal of better
alignment with Medicare's program definition and that, in fact, this
proposed change will cause fragmentation between Medicare and Medicaid.
Response: We appreciate the commenters' concerns, but 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.
Additionally, we believe that the alignment with Medicare's definition
is useful to help minimize inconsistencies between the two programs. We
confirm that it is not our intent to have this standard restrict the
receipt of medical supplies, equipment, and appliances, and we have
included language in the regulation indicating that Medicaid coverage
of medical equipment is not restricted to items covered as DME in the
Medicare program. Furthermore, states may choose to cover items that
are not within the coverage under the home health benefit under other
authorities, including section 1915(c) waivers or section 1915(i) state
plan; nothing in this regulation is meant to curtail a state's
innovation or expansion.
Comment: Several commenters recommended revisions to the
definition. One commenter recommended revising the definition to state:
``equipment and appliances are defined as items that are used to serve
a medical purpose for the beneficiary, can withstand repeated use, and
can be reusable or removable''. Many other commenters recommended
revising the definition of medical equipment and appliances to state
that 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 or disabling
condition, can withstand repeated use, and can be reusable or
removable. Another commenter recommended utilizing the current industry
accepted Medicare definition: (1) Can withstand repeated use; (2) Is
primarily and customarily used to serve a medical purpose; (3)
Generally is not useful to an individual in absences of an illness or
injury; and (4) Is appropriate for use in the home.
Response: We appreciate the commenters' suggestions and we made a
change in this final rule that responds to the second suggestion by
incorporating a reference to disability. We did not accept the first
suggested revision because it would require coverage of items that were
not generally regarded as medical in nature, and we did not accept the
third suggested revision because it would exclude coverage of items
that would be used in normal life activities outside the home (such as,
for example, walkers or wheelchairs). As indicated above, we are
revising the definition of equipment and appliances to reference
``disability, illness, or injury.'' Otherwise, we will not be revising
the definitions in the proposed rule.
Comment: One commenter disagreed with the proposed definition of
equipment and appliances. The commenter stated that the proposed
definition is improperly dependent upon how equipment and appliances
are ``primarily and customarily used,'' and how they might be
``generally'' not
[[Page 5541]]
useful in the absence of an illness or injury. The standards should be
dependent upon how equipment and appliances are needed by the
particular Medicaid beneficiary. Another commenter stated that the
proposed rule defines covered medical equipment by how an item is
``primarily and customarily'' or ``generally'' used, rather than
adopting a person-centered approach that recognizes that people might
have different medical needs.
Response: While we agree that the need for equipment and appliances
should be based on an individual's needs in accordance with a person-
centered plan of care, we are not accepting the suggested change
because it would require coverage of items that were not generally
regarded as medical in nature.
Comment: One commenter stated that the proposed definition of
medical equipment and appliances would allow individuals in need of
certain devices greater chance of approval.
Response: We appreciate the commenter's perspective, but it is not
clear how the proposed definition would favor some devices over others.
While a covered device must be within the scope of the definition of
medical equipment and appliances, the approval of devices within that
scope is based on a physician judgment of medical need and any state
prior authorization review process. Moreover, as discussed elsewhere in
this preamble, we have revised the final regulations to make clear that
it sets forth a framework for coverage but that there is flexibility
within that framework for states to define the precise scope of the
benefit.
Comment: One commenter recommended adding language to further
support the use of medically necessary and appropriate DME that has a
well-established history of efficacy or, in the case of novel or unique
equipment, valid peer-reviewed evidence that the equipment corrects or
ameliorates a covered medical condition or functional disability. The
commenter also suggested that the definition of DME should include
equipment that is proven, safe, and appropriate for the treatment of a
medical condition or illness.
Response: We do not believe that this additional language is
necessary. This rule does not change the requirement that medical
equipment must be ordered by a physician. We expect that the physician
would determine medical necessity based on individual need. We further
expect that physicians would order appropriate and safe medical
equipment for individuals that have demonstrated effectiveness. Nothing
in this rule, however, would preclude a state from establishing a prior
authorization process to review claims for medical equipment (denying
authorization when medical necessity is not established, subject to the
individual's right to an appeal) and to initiate a dialogue with the
treating physician to ensure appropriate treatment and control
unnecessary utilization.
Comment: Some commenters indicated that state Medicaid programs
should not be restricted to the definition of equipment that is
consistent with items covered as DME under the Medicare program. The
commenters recommended that CMS amend the proposed rule to set the
Medicare coverage standard as the minimum scope of benefits relative to
coverage of medical equipment, but allow states to provide more
expansive coverage. Many other commenters cautioned the Secretary in
applying Medicare's medical equipment definition to Medicaid because of
the different standards that apply to the coverage of their respective
home health benefits. The commenters further stated that Medicaid's
definition of ``equipment and appliances'' should be flexible so that
beneficiaries' needs can be met.
Response: We believe that this Medicaid framework for equipment and
appliances is flexible so that individuals' needs can be met. But, in
response to this and other comments, we have revised the final
regulation text to make clear that coverage of medical equipment and
appliances under state Medicaid programs are not restricted to the
items covered as DME in the Medicare program. The alignment of the
Medicaid framework with the Medicare definition is intended to achieve
consistency for beneficiaries who are eligible in both programs,
simplify program administration and ensure that beneficiaries are
receiving needed items. The final regulation text makes clear that
coverage of medical equipment and appliances are items that meet the
listed criteria, but that states can elect to cover other items,
including items that are not covered under the Medicare DME benefit.
Comment: Many commenters encouraged CMS to include language in the
final regulation to reflect the policies set forth in the September 4,
1998 State Medicaid Director letter responding to the DeSario v. Thomas
decision. One commenter stated that it is essential that CMS restate
the validity of the DeSario SMD letter: That states may not use
exclusive lists or irrefutable presumptions to limit or bar coverage of
items under the DME benefit; and that states must have a reasonable
process for requesting coverage of items the state has not otherwise
expressly identified as covered. Another commenter stated that language
should be provided in this rule if action is necessary to prevent
states from employing lists and presumptions to deny coverage of
appropriate medical equipment. Many commenters stated that it is
necessary that the Secretary incorporate the letter's policy into
regulation. Several commenters commended CMS for reemphasizing in the
preamble that states may not use lists or presumptions in limiting
coverage of items under the home health benefit unless states have a
reasonable process for requesting exceptions to such lists or
presumptions that are based upon specific criteria. One commenter
further stated that codifying the interpretation by CMS contained in
its State Medicaid Director Letter of September 4, 1998 would enable
more people with Medicaid who rely upon DME to remain in their homes
and active in their communities. Another commenter believed that it
would be highly beneficial to include the principles espoused in the
September 4, 1998 State Medicaid Director letter in the regulation.
Another commenter supported the suggestion that federal Medicaid
regulations should require that if states confine allowable medical
equipment to items from a list, they allow beneficiaries to appeal for
items not on that list by demonstrating that the items are medically
necessary. One commenter stated that CMS appears to conflate a state's
ability to limit the amount, duration, and scope of a benefit, with a
determination of whether an item or service falls within the state's
definition of a covered item or service. The commenter further stated
that if CMS chooses to add the 1998 guidance to the regulation, it
should clearly distinguish between benefit exclusions and the use of
administrative lists for classes of supplies and equipment that are
covered under the state's benefit.
Response: We have revised the final rule at Sec. 440.70(b)(3)(v)
to make clear that the principles we set forth in the 1998 SMD are
still applicable. If a state has a predetermined list of covered,
supplies, equipment and appliances, it must have a reasonable process,
with an opportunity for a fair hearing to allow beneficiaries to
request and receive items that are not on the state's list.
Beneficiaries must be afforded the opportunity to establish that the
item in question is medically necessary and within the overall state
definition of covered medical equipment, and
[[Page 5542]]
consistent with the federal regulatory framework.
Comment: One commenter believed that the use of presumptions by
their very nature moves coverage determinations away from individual-
based considerations and substitutes efficiency for person-based,
medical necessity determinations.
Response: Coverage determinations for medical supplies, equipment,
and appliances should be based on medical necessity criteria as
established by the state as applied to the individual's particular
needs. The need for medical supplies, equipment, and appliances should
be identified by the physician and reviewed at least annually.
Upon consideration of the public comments received, we are
finalizing Sec. 440.70(b)(3)(ii) with revisions. We are revising the
definition of equipment and appliances to include the term
``disability'' and to specify that state Medicaid programs are not
restricted to the items covered under DME in the Medicare program.
Additionally, we have clarified that structural or home modifications
are not covered under the Medicaid home health benefit and that states
may not limit access to equipment eligible for coverage under home
health benefits by restricting some items to only those who qualify for
section 1915(i) or (c) programs. States may implement standards to
determine coverage of the specific items previously funded under
sections 1915(c) or (i), such as ceiling lifts or chair lifts, that
could now be seen in appropriate circumstances to meet the home health
definition and be medically necessary for an individual. We have also
clarified that medical equipment and appliances already coverable under
the home health benefit will continue to be covered. Not all medical
equipment and appliances currently coverable under section 1915(c) and
section 1915(i) will be coverable under the state plan under the
standards set forth in this rule.
D. Setting Description (Sec. 440.70(c)(1) & (c)(2)
To reflect the principles expressed by the courts in both the
Skubel and Detsel decisions discussed above, we proposed to incorporate
in regulation the longstanding policy that home health services may not
be subject to a requirement that the individual be ``homebound.'' In
addition, we proposed to clarify that home health services cannot
otherwise be restricted to services furnished in the home itself.
Additionally, 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 flexibility.
Comment: Many commenters supported the proposal to specify in the
regulations that Medicaid home health services must not be limited to
beneficiaries who are ``homebound.'' Additionally, many commenters
supported the conclusion that Medicaid home health services should not
be limited to services furnished in the home. One commenter indicated
that this proposed change provides flexibility for adults to receive
medically necessary services at the workplace and children to
participate in the community with their families while receiving
necessary supports. The commenter further stated that allowing people
to access home health services in the community will contribute to
overall health and a reduction in costs for acute services. Commenters
stated that the clear ability of people with disabilities to use their
home health benefit in ``any non-institutional setting in which normal
life activities take place'' will make community integration feasible
for many people.
Response: We appreciate the perspectives the commenters provided
about medically necessary home health services. We also believe that
with home health services provided in conjunction with other optional
state plan and section 1915(c) waiver services people can be supported
to fully integrate into their communities.
Comment: Many commenters recommended that the regulatory language
specifically indicate that a homebound requirement is not permitted.
One commenter suggested revising Sec. 441.15(c) to establish clearly
that Medicaid home health coverage cannot be contingent on the
beneficiary being ``homebound.'' Other commenters suggested the
following language: ``Nothing in this section should be read to
prohibit a beneficiary from receiving home health services in any non-
institutional setting in which normal life activities take place or to
permit a state to require that an individual be homebound or unable to
leave his home to receive home health services.'' One commenter
recommended that the final regulation amend paragraph (a)(1). The
commenter believed that it is contradictory and confusing in paragraph
(a)(1) to state that home health services must be provided ``[a]t [the
beneficiary's] place of residence,'' and then in paragraph (c)(1) to
state that services can be provided ``in any non-institutional setting
in which normal life activities take place.'' The commenter also
recommended that the proposed language for paragraph (c)(2) be revised
to specify that services and/or service hours must be authorized to
account for medical needs arising out of the home.
Response: We are revising Sec. 440.70(c)(1) to indicate that a
homebound requirement is not permitted. We believe this revision also
addresses the request to revise Sec. 441.15(c), as Sec. 441.15(c)
cross-references Sec. 440.70. In response to the request that we amend
paragraph (a)(1) as it is contradictory and confusing when read with
paragraph (c)(1), we do not believe that this revision is necessary as
Sec. 440.70(a)(1) references paragraph (c) to specify ``place of
residence.'' While we understand the recommendation that the language
for paragraph (c)(2) be revised to specify that services and/or service
hours must be authorized to account for medical needs arising out of
the home, as long as the amount and duration limits applied by the
state are either authorized under the approved state plan as consistent
with a sufficient benefit, or based on an individualized medical
necessity determination, we do not think such language is appropriate.
We would, however, allow states the option to authorize additional
services or hours of services to account for this flexibility to make
clear that such a policy would not violate comparability requirements.
Comment: One commenter expressed concerns regarding homebound
status and beneficiaries who are dually eligible for Medicare and
Medicaid. The commenter stated that they support the ability of
Medicaid-enrolled individuals to receive home health services without
an artificial barrier based on their homebound status. However, because
the prohibition on requiring a homebound status does not apply to the
Medicare program, the commenter raised concern about how this will be
implemented for those that are dual eligibles.
Another commenter stated that the regulation would require that
certain programs revise or update existing policies to reflect that
home health services cannot otherwise be restricted to services
furnished in the home itself.
Response: Individuals who are dually eligible for Medicare and
Medicaid will benefit from this regulation. While the prohibition on
requiring a homebound status in Medicaid is not new to this regulation,
codifying the prohibition and strengthening the community integration
philosophy of the home health benefit will ensure the individuals
receive quality Medicaid home health services. Individuals eligible for
both Medicare and Medicaid
[[Page 5543]]
who are not determined to be homebound may not qualify for Medicare
home health services. Such individuals would still qualify for Medicaid
home health services, if they meet the state's medical necessity
criteria for the service. We understand that some state program
policies may have to be modified or updated to comport with the rule,
but do not believe that this task will be overly burdensome.
Comment: One commenter recommended against using the phrase
``normal life activities.'' The commenter believed that it contains a
value judgment and could be read as devaluing people who are living in
institutional settings as not ``normal.'' Therefore, the commenter
recommended striking the term ``normal'' and simply using ``life
activities.''
Response: The phrase ``normal life activities'' is used in this
rule to clarify that home health services cannot be limited based on
the location in which home health services are used. We do not believe
that the term ``normal'' needs to be removed from this phrase. There is
no negative connotation intended.
Comment: One commenter suggested a new classification of care.
Rather than ``home care,'' the commenter suggested that care for
beneficiaries of covered home-care services when the beneficiary is not
homebound be called ``community care.'' The commenter further stated
that better distinguishing between home care and not-at-home-but-in-
the-community care will help with the application of that care. While a
community-based benefit can be provided within the existing
infrastructure of home health care, it needs to be administered with
more scrutiny and monitoring of beneficiaries. Just tracking where the
care is to be delivered will require more scheduling and monitoring.
Response: Developing a new classification of care is beyond our
statutory authority.
Comment: Some commenters suggested prohibiting any home care
coverage standard that results in a different and/or greater scope of
benefits for beneficiaries residing in facility-type residences than
the scope of benefits for individuals in their own private homes.
Commenters recommended that CMS clarify its suggestion/allowance that
states can provide a higher level of home care benefit to individuals
who reside outside an individual private home such as a rest home or
assisted living facility. As written, it may be possible for a state to
interpret the CMS reference on higher levels of coverage for such
individuals as permitting states to have a different benefit for
Medicaid beneficiaries in a facility-type residence than for those in a
private home.
Response: This rule does not affect or change comparability rules,
and therefore, we do not believe that individuals will receive a
different and/or greater scope of benefit based on where an individual
resides. We also remind commenters that the scope of a benefit that a
beneficiary is authorized to receive is based on medical necessity, not
the setting where the beneficiary resides. States have the flexibility
to determine medical necessity criteria and therefore, the level of
services a beneficiary receives is based on medical necessity, not
setting.
Comment: One commenter indicated that CMS should clarify in
regulation that Medicaid home health services should not be limited to
services furnished in the home.
Response: We clarify that home health services cannot be limited to
services furnished in the home. Additionally, we have revised Sec.
440.70(c)(1) to indicate that home health services can be provided in
any setting in which normal life activities take place, other than a
hospital, nursing facility; intermediate care facility for individuals
with intellectual disabilities; or any setting in which payment is or
could be made under Medicaid for inpatient services that include room
and board. Therefore, we believe that we have sufficiently communicated
and regulated the prohibition on restricting services to the home.
Comment: One commenter requested that CMS clarify whether states
can specify settings in which home health care can be received. The
commenter stated that states should be allowed to specify that skilled
tasks associated with bathing be limited to the client's place of
residence.
Response: The purpose of this provision is to ensure the delivery
of home health services not only in the home, but also in the community
when the beneficiary is participating in normal life activities. It is
not meant to mandate service provision in any particular setting. We
are also permitting states to authorize additional hours of home health
services to account for medical needs that arise in the setting
furnished. And, while states may set limits on the amount, duration,
and scope of home health services, subject to our approval, we do not
agree that states may put arbitrary limits on the places where home
health services can be received.
Comment: One commenter asked, if a child is approved for services
which will be provided in a school setting, is the school responsible
for the nursing services, or will a nurse from the approved home health
agency be required to provide services in a school setting.
Response: This does not change policy for Medicaid services
provided in schools. Under the existing rule, nursing services under
the home health benefit must generally be provided by a home health
agency. The rule does not limit agreements and arrangements between
home health agencies and schools to facilitate the provision of such
services. Nor does it preclude coverage of nursing services provided in
schools under another benefit category.
Comment: One commenter reported that currently their state does not
contract with out-of-state home health providers and inquired as to
whether a state home health nurse would be required to travel with the
family, how the state would reimburse the nurses' travel.
Response: Nothing in this final rule specifically addresses this
issue but, in general, nursing services are provided under the home
health benefit only when provided through a home health agency in
accordance with an physician's order as part of a written plan of care.
To the extent that there is a medical need documented in the plan of
care for out of state travel accompanied by a home health nurse, and
the service can be provided consistent with the approved state plan,
payment would be made to the home health agency as set forth in the
approved state plan. We note that coverage of out-of-state services may
be limited by a state as long as the requirements of 42 CFR 431.52 are
met.
Comment: One commenter requested that the plan of care designate
the home health services as In-Home or Out-of-Home services after a
physician evaluation of medically necessary accommodations and staffing
levels to insure the safety of beneficiaries and success of out of home
services. One commenter raised concern with settings that cannot be
evaluated as safe, and settings that may result in unnecessary
duplication of services. The commenter also was concerned with access
to care issues related to out of state care, as current state policy
requires that the setting be a safe setting, and may not approve
services if all health and safety issues cannot be met in the setting.
The commenter believed that the rule does not address any limitations
of services outside of the home and wondered whether states would be
permitted to
[[Page 5544]]
restrict certain services. Another commenter requested that CMS
consider further clarification of the site of care for home health
services to acknowledge and reduce the personal risks to health care
workers and to ensure the site of care selected is appropriate for the
safe delivery of home health services.
Response: The plan of care should assist in identifying services
and settings appropriate for the individual's need. Assessment of
receipt of the services is based on medical necessity. This regulation
does not set forth detailed requirements for plans of care; there are
other resources for guidance on the best practices for person-centered
care planning. We understand and appreciate the commenters' concerns
for the personal safety of home care workers. Such concerns exist with
any home care program, and are not new with this regulation. We
encourage home care agencies to take measures to reduce risks to
employees. With regards to duplication of services, section
1902(a)(30)(A) of the Act requires that payments are economic and
efficient; payments which duplicate payment for the same service would
not be economic and efficient, and therefore, would not comport with
federal statute.
Comment: We received many comments pertaining to costs within this
component of the regulation. One commenter stated that Medicare
regulations continue to require that a beneficiary be ``confined to the
home'' to qualify for Medicare-covered home health services. Therefore,
for any dual eligible, state Medicaid programs will bear the entire
financial burden for home health services provided in another setting
outside the home. Another commenter believed that the proposed
regulation goes beyond states' limits and would appear to apply to
waiver and state plan benefits alike. The commenter was concerned about
the potential downstream effect of expanding services available through
HCBS waivers, which are case managed, to coverage of state plan
benefits, which are not case managed. The commenter also stated that
expanding beyond the current case-managed limitations on services or
service hours would have a real and substantial fiscal effect on the
state's Medicaid program. One commenter expressed concern that the new
requirement would result in a large increase in cost for Medicaid home
health services. Another commenter indicated that deleting the existing
``at home'' requirement for Medicaid home health services represents a
substantial and unjustified expansion of states' financial liability
for home health services.
Response: While most of the Medicare/Medicaid rules are aligned,
this is an area in which there is a statutory difference between the
programs. As a result, the rules differ. Sections 1814(a) and 1835(a)
of the Act impose the Medicare homebound requirement for home health
services, but there is no parallel homebound requirement under
Medicaid. We understand that there may be consequences for Medicaid
programs, but these consequences do not arise from this rulemaking;
they are inherent in the difference between the two statutes.
Additionally, we note that we would permit states the flexibility to
authorize additional hours of home health services to account for
medical needs that may arise outside of the home.
Comment: One commenter stated that while the proposed regulation
purports to incorporate and comply with federal court decisions, the
new provisions go beyond anything required or contemplated by the
decisions. The commenter further stated that the proposed regulation
would vastly expand the program so that the health care provided to
Medicaid beneficiaries far exceeds anything available to the general
population. Under the proposed regulations, a beneficiary could receive
health care anywhere, including the grocery store, a museum, or even an
amusement park. The proposed regulations essentially transform Medicaid
from a health care program to a social services program. The commenter
also believed that the proposed regulations appear to be based on an
incorrect interpretation of the Olmstead decision. Olmstead cannot
reasonably be read to require the dramatic expansion that would follow
from the final issuance of the proposed regulations. The commenter
stated they believe that the proposed regulations are not supported by
the cost-neutral rationale espoused by the Skubel decision, and they
establish a more expansive coverage policy (both substantively and
geographically), when compared to the Detsel and Skubel decisions and
CMS's own stated policies.
Response: This final rule does not mandate provision of services in
any particular setting, but removes a barrier to the provision of home
health services outside of the home itself. Removal of this barrier may
permit individuals whose medical needs are such that they require home
health services to participate in normal life activities not to be
restricted to the home. The community integration underpinning of the
home health benefit is appropriate for the Medicaid program and we
refer to the principles set forth in court cases discussed herein as
support for this final rule. Those principles are based on readings of
the Medicaid statute, and we are adopting those readings. Furthermore,
in response to the comment that we are expanding the scope of coverage
more than is required by the court cases, to the extent that this is
the case it is because such expanded coverage is consistent with both
the overall purposes of the Medicaid statute, as section 1901 of the
Act specifies to help families and individuals attain or retain
capability for independence or self-care, and under section 1902(a)(19)
of the Act that specifies care and services will be provided, in a
manner consistent with simplicity of administration and the best
interests of beneficiaries.
Comment: Some commenters disagreed with the proposed revision to
the setting description. One commenter stated that the term ``home
health care services'' as used in federal Medicaid law has never been
further defined. In the absence of a definition, it should be assumed
that the Congress intended it to mean exactly as written--health care
services delivered in a beneficiary's home. Nothing in the ``face-to-
face'' provision or elsewhere in the Affordable Care Act suggests the
Congress intended to depart from the clear meaning and long-standing
interpretation of this term. The commenter also believed that that the
suggestion that covering home health services outside the home is
necessary for compliance with ADA as interpreted in the Olmstead
decision is without foundation. The proposed rule's directive that
states cover home health services in non-home settings directly
contravenes the flexibility that was at the heart of the Olmstead
decision. Additionally, the commenter stated that as CMS acknowledges
in the preamble, under the proposed rule, ``home health services may
not be limited to services furnished in the home,'' and ``states may
not limit home health services to services delivered in the home.'' Any
language in the proposed rule suggesting a contrary result is
misleading, and presumably intentionally so. Another commenter stated
that the proposed regulations go well beyond long-established policy
and the decisions in Detsel and Skubel, as well as CMS's own stated
policies.
Response: As we have indicated previously, we are adopting the
principles underlying the holdings of the Skubel and Detsel court
decisions in this final rule. We believe this reading is consistent
with the purposes of the Medicaid statute. We are being clear
[[Page 5545]]
that home health services may not be limited to services literally
provided in the home. But we are not mandating that services be
provided in any particular setting; that is an issue that must be
addressed in a plan of care that accounts for the individual's needs,
and may be subject to review by the state.
Comment: One commenter reported that the regulation would require
that the Children's Services Program of the state revise or update
existing policies to reflect that home health services cannot be
otherwise restricted to services furnished in the home itself.
Response: While we understand that some state policies may need to
be revised; such as the restriction of home health services to an
individual's home. We do not believe that this will be overly
burdensome.
Comment: One commenter was concerned with the lack of control in
non-institutional settings. The commenter believed that issues may
arise in certain settings considered non-institutional such as college
dormitories. Additionally, the commenter believed restrictions based on
funding, safety, distance of travel, and practical feasibility need to
be addressed.
Response: Home health services are authorized based on medical
necessity, not setting. However, we do recognize that there may be
circumstances in which an individual and/or provider's health or
welfare may be at risk, and we urge home health agencies and states to
address the issues on an individual basis should they occur. We are
available to provide technical assistance and guidance as needed.
Comment: One commenter stated that, under proposed Sec.
440.70(c)(1), home health services would be significantly broadened by
offering services in ``any non-institutional setting in which normal
activities take place.'' The commenter was concerned that this new
requirement would result in a large increase in cost for Medicaid home
health services and DME, prosthetics, orthotics, and supplies.
Response: As previously stated, home health services, including
DME, are authorized based on medical necessity, not setting. We
acknowledge the increased cost associated with our standardizing the
definition of medical supplies, equipment, and appliances, both
narratively, and in our characterization of the proposed rule as being
economically significant, with a likely financial impact of greater
than $100 million. However, we continue to stand by the necessity of
the regulatory revisions to ensure that beneficiaries receive the home
health benefits to which they are entitled under the Medicaid statute.
Upon consideration of the public comments received, we are revising
Sec. 440.70(c)(1) to indicate that a homebound requirement is not
permitted. Additionally, we are clarifying the settings in which
individuals may receive home health services. Specifically, individuals
may receive home health services in any setting in which normal life
activities take place, other than a hospital, nursing facility;
intermediate care facility for individuals with intellectual
disabilities; or any setting in which payment is or could be made under
Medicaid for inpatient services that include room and board.
E. Face-to-Face Encounter (Sec. 440.70(f))
Section 440.70(f)(1) specifies 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 before the start
of services. 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 circumstances, we proposed to allow an opportunity to meet
the face-to-face encounter requirement through an encounter with the
beneficiary within 30 days after the start of home health services.
Comment: Some commenters supported the proposed timeframes. One
commenter stated that they believe that this timeframe is appropriate
for authorization of most types of home health services. Another
commenter stated that the requirements for face-to-face encounters with
an individual's physician or NPP for approval of home health services
90 days prior or 30 days after administration will allow for the most
up-to-date patient information to be incorporated into their plan of
care.
Response: We appreciate the commenters' support of the proposed
timeframes.
Comment: Many commenters requested that CMS delay implementation.
Commenters stated that with regard to Medicare, CMS delayed
implementation of the regulation to afford sufficient time for
beneficiaries, physicians, hospitals and other providers to understand
the parameters of the new rule. The commenters recommended that CMS
employ the same caution in implementing the face-to-face requirement
for Medicaid's home health benefit. One commenter further suggested
delaying implementation at least one year.
Response: We recognize that there may be operational and budgetary
implications with this rule and that states and providers may need time
to implement this provision. In order to ensure that states and
providers are implementing the rule appropriately we have revised the
effective date of the rule to July 1, 2016 and will delay compliance
with the rule for up to one year if the state's legislature has met in
that year, otherwise 2 years. Our expectation is that states and
providers are compliant with the requirements of the final rule based
on the timeframes explained above.
Comment: Many commenters expressed opposition to the face-to-face
requirement with one commenter requesting that CMS drop the face-to-
face requirement altogether. The commenter believed that it has only
been a barrier to service for beneficiaries who need care and cannot
get in to see their physician. Another commenter urged CMS to remove
the face-to-face requirement for home health services in the Medicaid
program. One commenter stated that his state expresses opposition to
CMS' proposed expansion of face-to-face requirement to Medicaid at this
time. Another commenter stated that CMS's conclusion that the Congress
intended the face-to-face requirement to apply to physicians' orders
for home health under Medicaid is unreasonable. The commenter further
stated that to require a face-to-face encounter within a prescribed
period of time before a physician orders or prescribes a particular
course of care or treatment calls into question the physician's
exercise of professional judgment under applicable state practice acts,
and undermines the physician-patient relationship. One commenter
indicated that he does not support the need for a face-to-face contact
by a physician or other designated health professional prior to the
initiation of home health services. The commenter stated that the
proposed regulation cites no substantive reason for this requirement.
The commenter also recognized that this requirement may be specifically
mandated by the Affordable Care Act, but reported that he does not see
how such a requirement will actually serve any beneficial purpose for
the beneficiary.
Response: We believe that our interpretation of the applicability
of the face-to-face requirement in the same manner and to the same
extent as it applies to Medicare is consistent with,
[[Page 5546]]
and required by, section 6407 of the Affordable Care Act.
Comment: One commenter supported aligning the timeframes with
similar regulatory requirements for Medicare home health services.
Another commenter specified that any face-to-face requirement for
Medicaid should mirror in timing, information and signature
requirements for the Medicare program and the one exception should be
the requirement of homebound criteria which the commenter agrees should
not be required for Medicaid beneficiaries. Another commenter
recommended that the Medicaid requirement match the Medicare
requirement, which would be the 6-month timeframe. One commenter
recommended that CMS remove the 90-day timeframe and replace it with
the 6-month timeframe found in the statute. One commenter stated that
CMS halving the permissible timeframe for the face-to-face encounters
from 6 months to 90 days is inconsistent with Congressional intent. The
commenter also stated that requiring a face-to-face encounter within 90
days of a physician ordering home health services for a Medicaid
beneficiary is not consistent with the nature and needs of the Medicaid
population. Additionally, the commenter believes that the provision of
the proposed rule that would allow for a face-to-face encounter
``within the 30 days after the start of the services'' is inconsistent
with the purpose of the Medicaid rule requiring a physician order for
coverage of home health services. One commenter urged CMS to maintain
the timeframe window to be 6-months preceding the start of care to 30
days after the start of care under Medicaid.
Response: We agree with commenters who asked for alignment between
Medicare and Medicaid face-to-face timing requirements. In this final
rule, Medicaid requirements for the timeframes of the face-to-face
requirement for home health services generally are aligned with
timeframes adopted for Medicare home health. To maximize the alignment
between the programs, in this final rule we have also aligned with
Medicare the timeframe for the face-to-face encounter for Medicaid
medical equipment, which is 6 months prior to the start of service.
Comment: A commenter stated that the proposed timeframes for face-
to-face encounters may prove problematic if the visit can occur up to
30 days after the start of home health services, because under the fee-
for-service system, authorizations for services would be already
approved and there would be no easy way to make sure this visit,
complete with documentation requirements was performed. Another
commenter stated that the timeframes will be much harder to comply with
for the Medicaid population.
Response: To clarify, we have extended the face-to-face encounter
timeframes to permit the encounter to occur within 30 days after the
start of home health services to account for individual circumstances.
But we would expect that ordinarily the face-to-face encounter would
occur before the start of home health services. We understand that in
the individual circumstances, when the face-to-face encounter occurs
after the start of services, additional coordination of the medical/
home health team may be required to ensure that the visit, along with
the required documentation was performed. We encourage states to work
with the home health provider community to incorporate the 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.
Comment: One commenter suggested allowing longer timeframes for
Medicaid face-to-face encounters and extending the 30-day post-start of
care, especially for beneficiaries without a primary care physician.
Response: The timeframes proposed in this rule are aligned with
Medicare's timeframes to promote consistency. Additionally, we do not
agree that the 30-day post-start of care timeframe should be extended.
The expectation of the rule is that that the timing of the face-to-face
encounter in normal circumstances should occur within the 90 days
before the receipt of services. We are providing for the 30-day post-
start of care timeframe to accommodate extenuating circumstances that
require immediate commencement of home health services before a
physician encounter can be scheduled.
Comment: One commenter suggested that CMS state that CMS encourages
the face-to-face encounter occur within 90 days prior to the start of
home health services.
Response: We do not believe that a change in regulation language is
necessary. We emphasized in the proposed rule and in the responses to
comments that the timing of the face-to-face encounter in normal
circumstances should occur within the 90 days before the start of home
health services.
Comment: We received many comments regarding the face-to-face
encounter for individuals who are dually eligible for Medicare and
Medicaid. One commenter asked whether CMS would accept documentation of
a face-to-face encounter reimbursed under Medicare when a dually-
eligible individual begins home health services under Medicare and
transitions to Medicaid. Specifically, since Medicaid does not require
the beneficiary to be homebound, the commenter questioned whether
another face-to-face encounter would need to be completed for Medicaid
home health services. Several commenters recommended that CMS amend the
proposal to deem the Medicare qualifying face-to-face encounter
documentation as meeting Medicaid face-to-face requirements or
establish a standard that the switch to Medicaid as the payer is not a
``start of care'' that would require a Medicaid qualifying face-to-face
encounter. Commenters requested that CMS clarify whether there are
circumstances under which an additional face-to-face encounter would be
needed when beneficiaries move between Medicare and Medicaid coverage.
One commenter noted that some individuals are dually eligible and may
face greater challenges accessing care and services.
Response: To clarify, the face-to-face encounter is required for
initial orders for home health services and for all episodes initiated
with the completion of a Start-of-Care OASIS assessment. OASIS is the
``Outcome and Assessment Information Set'' applicable for Medicare home
health services and Medicaid home health services. If a face-to-face
encounter was performed at the start of home health services, or to
support the order for medical equipment, a new face-to-face encounter
is not required if the source of payment has changed to Medicaid.
Therefore, if a dually eligible individual begins home health services
under Medicare and transitions to Medicaid, the Medicare face-to-face
encounter documentation will meet the Medicaid face-to-face
requirement. Our expectation is that Medicaid providers are aware that
there is no homebound requirement to be eligible for Medicaid home
health services. Dually-eligible individuals not meeting Medicare's
homebound criteria would not be eligible for Medicare home health, but
could still be eligible for Medicaid home health, assuming medical
necessity criteria are met. In these cases, the beneficiary's physician
or authorized NPP would conduct and document the face-to-face
encounter, and Medicaid home health reimbursement would be appropriate.
Comment: Some commenters encouraged CMS to provide states with
flexibility to extend the permissible period for the Medicaid
beneficiary to secure the required encounter after the
[[Page 5547]]
start of care because of the unique problems often facing Medicaid
beneficiaries in accessing a physician. This can be done by extending
the allowable timeframe for compliance or permitting states to apply an
exception process. Commenters recommended that CMS revise the proposal
and specifically provide for exceptions, or provide direct authority to
the states to do so. Some suggestions for exceptions included: (1)
Medical contraindications to the beneficiary leaving his or her home to
see a physician/NPP; (2) the beneficiary resides in a frontier area;
(3) the beneficiary resides in an area designated as medically-
underserved by the state; (4) the beneficiary was discharged from an
inpatient setting directly into home health services; (5) the home
health agency is not at fault in the failure to meet the face-to-face
requirement and noncompliance is beyond the control of the agency; (6)
the beneficiary enters the hospital before the encounter; or (7) the
beneficiary is referred to home health from a school nurse or elder
service networks.
Another commenter urged CMS to give specific guidance to states
maximizing the flexibility in timing of face-to-face encounters,
allowing the timeline to be extended, and allowing states to provide a
good cause exceptions process in cases where beneficiaries have not
been able to meet this requirement. One commenter viewed good cause
exemptions as extremely important and urged that they be put in place
immediately. Such good cause exemptions might include, but not be
limited to, situations where the state or federal government declares a
state of emergency such as a natural disaster or terrorist attack. In
such a circumstance, lack of electricity, phones and equipment, and
navigable roads might delay the achievement of a face-to-face encounter
for more than 30 days. Another commenter indicated that there needs to
be more flexibility in the timeframes after the start of care.
Response: We appreciate the comments, but do not believe revising
the regulation to build in exceptions to the timeframes is necessary.
We believe that the proposed timeframes will provide states, providers,
and beneficiaries with the necessary flexibility to meet the face-to-
face requirement. On an individual basis, circumstances beyond control
(natural disaster, terrorist attack, etc.) would be taken into account
if the timeframes for a face-to-face encounter for home health services
were not met.
Comment: One commenter requested adding some special circumstances
that allow for payment to the home care agency for efforts made to get
the face-to-face documentation completed and/or get the beneficiary to
seek the encounter appointment, but circumstances outside the control
of the agency occur and the encounter is not completed. Another
commenter stated that there needs to be flexibility in those situations
where a Medicaid beneficiary is accepted for care in good faith that a
face-to-face requirement will be met by the close of the qualifying
period yet circumstances beyond provider control occur that result in
failure to comply with this requirement on a timely basis. One
commenter requested that the final rule provide good-cause exceptions
in cases where beneficiaries have not been able to meet this
requirement despite the best efforts of the agency seeking to serve
them. Another commenter believed there needs to be clearer discussion
of a hold harmless provision that would allow temporary services to be
put into place pending the face-to-face encounter.
Response: We disagree that there is a need to add circumstances or
situations that allow for payment to home care agencies based on
unsuccessful efforts made to timely obtain the necessary face-to-face
documentation, or to otherwise allow for good-cause exceptions. The
timeframes provided allow enough flexibility to meet the face-to-face
requirement in a timely manner. We encourage home health agencies to
document efforts to facilitate face-to-face encounters before home
health services are furnished, and to collaborate with physicians to
ensure timely completion of encounter documentation.
Comment: One commenter stated that in certain circumstances, it
should suffice that the personal physician's original diagnosis of the
condition for which the individual needs home health services was based
on a face-to-face encounter, irrespective of when the face-to-face
encounter took place.
Response: The statute requires that a face-to-face encounter must
occur within prescribed timeframes in relation to the ordering of home
health services. Therefore, it is beyond our authority to allow an
encounter that took place outside of those timeframes to suffice.
Comment: One commenter recommended a more flexible approach for
states and health plans to follow in verifying the need for home health
services.
Response: We believe that the rule provides states and health plans
with flexibility while adhering to the statutory requirements.
Comment: One commenter indicated that clarification is necessary
regarding the face-to-face encounter in reference to the ``start of
services'' and ``initiation of services,'' because home health services
can be intermittent, even though the services relate to the same
episode. The commenter recommended that the face-to-face encounter for
a service or item can relate back to an encounter with the primary care
provider that occurred outside the 6-month timeframe, if the service or
item relates to the same episode of care that occurred within the 6-
month timeframe.
Response: To clarify, we are aligning Medicaid face-to-face
requirements with Medicare's face-to-face requirements. A face-to-face
encounter is required for the initial ordering of a home health service
and for all episodes initiated with the completion of a Start-of-Care
OASIS assessment. However, as previously stated, this rule does not
replace current regulatory requirements, and therefore, the physician
should be reviewing the plan of care for home health services every 60
days.
Comment: One commenter questioned what CMS's guidance would be on
the face-to-face documentation when the medical condition of the
beneficiary changes before recertification. The primary reason for
ordering home health will be different than what was indicated on the
initial certification of the face-to-face encounter. The commenter
further questioned if another face-to-face would be required to
continue home health based upon the change in the individual's
condition. The commenter also asked what the penalty is if the
beneficiary is not able to see the physician within the 30 days after
the start of care. Another commenter questioned whether long-term
beneficiaries that receive certified nursing assistant (CNA) visits
need a face-to-face encounter, and if so, whether it would be a one-
time requirement or have to be renewed.
Response: A face-to-face encounter is required for the initial
ordering of a home health service and for all episodes initiated with
the completion of a Start-of-Care OASIS assessment. and must be related
to the primary reason the patient requires home health services. If an
individual's medical condition changes and this results in the need for
an additional home health service, our expectation is that the Home
Health Agency would communicate the need with the ordering physician
who would revised the plan of care/orders accordingly. An additional
face-to-face encounter would not be required. In response to the issue
regarding a penalty if the beneficiary is not able to see the physician
within the 30 days after the start of care, we clarify that no payment
[[Page 5548]]
for home health services can be made for which a timely face-to-face
encounter was not documented. However, we believe that the flexibility
included in the regulations, allowing NPPs in addition to physicians to
perform the face-to-face encounter, as well as allowing the use of
telehealth, should prevent the scenario from happening in a majority of
cases. The timeframes established in this final rule meet the program
integrity and quality goals associated with the provision. In response
to the question about CNA visits, all beneficiaries needing home health
services are subject to the face-to-face requirement.
Comment: One commenter requested clarification of the effective
date for the face-to-face requirement for certification for Medicaid
home health and DME.
Response: The statutory provision became effective upon enactment
on March 23, 2010, but for home health the statute indicated that the
face-to-face requirements applied to physician certifications after
January 1, 2010. The provisions specific to this regulation are
applicable prospectively starting on the effective date. We intend to
work with states and the provider community to ensure compliance. As
previously indicated, we are delaying the effective date to July 1,
2016 and compliance with the rule for up to one year if the state's
legislature has met in that year, otherwise 2 years. Our expectation is
that states and providers are compliant with the requirements of the
final rule based on the timeframes explained above.
Comment: Commenters requested that CMS clarify the circumstances
where it is acceptable to perform the face-to-face encounter within 30
days after the start of home health services. One commenter requested
clarification regarding the definition or description of circumstances
precluding a face-to-face visit within the 90 days prior to the start
of home health services. One commenter recommended that CMS clarify
that the ``under normal circumstances'' standard reflects permission to
allow a state flexibility to extend the encounter timetable, but not
make it more restrictive. Alternatively, the commenter suggested that
the phrase should be removed to avoid the imposition of stricter
timetable standards. Another commenter requested that we not use the
wording ``under normal circumstances,'' as unless this term is defined,
it can lead to different and varied interpretations and confusion and
could possibly allow states to impose a strict guideline on allowing
the encounter within 30 days after the start of care.
Response: We do not agree that it is necessary to be prescriptive
in defining ``under normal circumstances'' or the circumstances in
which it is acceptable to perform the face-to-face encounter within 30
days after the start of home health services. Allowing flexibility in
these terms is in the best interest of the beneficiaries. There could
never be an exhaustive list of circumstances or parameters defining the
term, and while we encourage face-to-face encounters to occur before
the start of care, we do not want to unnecessarily restrict the ability
of the encounter to occur within 30 days after.
Comment: A few commenters requested that CMS clarify whether the
face-to-face encounter is only required for the initial visit or for
recertification as well. Another commenter asked whether the rule would
also identify recertification timelines such as an annual face-to-face
thereafter and whether the physician would be required to see the
beneficiary to reevaluate the need for care after 6 months or the
proposed 90 day face-to-face encounter timeline. One commenter
indicated that the requirement that the face-to-face encounters be
related to the primary reason the beneficiary requires home health
services will result in additional office visits. The requirement would
seem to not consider beneficiaries with chronic conditions, as persons
with chronic, even lifelong conditions would not need such regular
monitoring for some home health services. One commenter requested
clarification regarding whether or not the proposed face-to-face visits
will be a billable item for providers. Another commenter requested that
CMS clarify or amend the definition of home health services such that
this rule would not be applicable to non-medical services such as
personal care attendant services.
Response: As previously stated, the face-to-face encounter is
required for the initial ordering of a home health service and for all
episodes initiated with the completion of a Start-of-Care OASIS
assessment. There is no recertification face-to-face requirement. This
final rule has not changed current Medicaid regulations which require
an individual's physician to review the individual's plan of care every
60 days. In response to the commenter's question regarding billing for
the face-to-face encounter, the encounter will be a billable item for
providers, under the Medicaid physician benefit or the benefit
authorizing payment for services provided by licensed practitioners.
Amending or clarifying the definition of home health services in this
rule is beyond our authority.
Comment: One commenter requested additional clarification to
address differences between Medicare and Medicaid regarding ``episode
of care.'' The commenter indicated that many states use systems other
than Prospective Payment Systems (PPS) and stated that in these cases,
additional guidance on the frequency of face-to-face encounters may be
warranted.
Response: Regardless of the payment methodology system used by
states, as indicated in the response above, the face-to-face encounter
is required for the initial ordering of a home health service and for
all episodes initiated with the completion of a Start-of-Care OASIS
assessment.
Comment: One commenter indicated that their current state Medicaid
rules require parents to supplement care up to 8 hours in addition to
the approved direct services hours and questioned whether the proposed
rule would revise the parent supplementation of care requirement.
Response: The Medicaid program, rather than the beneficiary or the
beneficiary's family, is responsible for the provision of medical
assistance for covered benefits. Although a state can take into account
available resources in determining the amount of medical assistance
required by the beneficiary, including any legal liability of third
parties to provide care, it cannot impose requirements for parents to
provide care as a condition of a child receiving Medicaid benefits. Nor
can a state impose an in-kind deductible charge (requiring the
provision of a certain amount of services as a condition for coverage
of other services. The face-to-face encounter requirement does not
change these requirements.
Comment: Some commenters requested clarification pertaining to
managed care plans. One commenter requested that CMS clarify that the
Medicaid face-to-face requirements for home health services required
under the proposed regulations apply only for home health services
provided through fee-for-service, and not to home health services
provided under a Medicaid managed care plan. Another commenter
requested clarification on how this rule would apply when members are
enrolled in Medicaid managed care plans and the responsibility of plans
to report physician encounters to the state.
Response: To clarify, at a minimum, benefits offered in managed
care must be the same as the benefits offered in the state plan.
Therefore, the approved state plan home health benefit must be offered
in managed care. States must
[[Page 5549]]
follow statutory and regulatory requirements related to the benefits.
Comment: Commenters were concerned that the face-to-face encounter
requirement will erect a barrier to timely care for individuals who are
homebound and have difficulty traveling to a provider. Another
commenter wanted to ensure that the face-to-face visit requirements do
not impede access to necessary home health care.
Response: We recognize that some individuals may have difficulty
meeting the face-to-face requirement. We believe we have accounted for
these circumstances while meeting statutory requirements, by extending
the timeframe of the face-to-face encounter to 30 days after the start
of home health services, by allowing for NPPs to complete the face-to-
face encounter, and by encouraging telehealth as an alternative for
ensuring that this new requirement is implemented in a way that
protects continuity of services. Additionally, as previously stated,
the face-to-face encounter is required for the initial ordering of a
home health service and for all episodes initiated with the completion
of a Start-of-Care OASIS assessment.
Comment: One commenter recommended that CMS create a standard that
establishes eligibility for Medicaid coverage of home health services
30 days prior to the face-to-face encounter.
Response: Home health services may be covered by Medicaid for up to
30 days before the face-to-face encounter is conducted; but such
services are not covered if the required face-to-face encounter is not
conducted within those 30 days. Furthermore such services are not
covered in the absence of a physician order for the services, or a
written plan of care. Medicaid payment is not available if these
conditions are not met.
Comment: One commenter urged CMS to provide guidance to health
professionals who order such care and providers who deliver the care to
encourage them to include their mutually shared beneficiary in the
process of creating the service order and care plan. The commenter also
urged implementation that reasonably encourages a robust three-way
dialogue among the beneficiary, the ordering health care professional
and the service provider to promote person-centered and efficient care
driven by the needs and preferences of the beneficiary.
Response: We agree with the commenter. It is our expectation that
services are provided to individuals in a person-centered manner and
that all providers work collaboratively to ensure that services are
meeting the needs of the beneficiaries.
After consideration of the public comments, we are revising this
section to clarify that for the initial ordering of Medicaid medical
equipment, the physician must document that a face-to-face encounter
that is related to the primary reason the beneficiary requires medical
equipment occurred no more than 6 months prior to the start of
services. Additionally, we are clarifying that a face-to-face encounter
is required for initial ordering of both home health services and
medical equipment. Furthermore, for home health services, a face-to-
face encounter is required for the initial order and for all episodes
initiated with the completion of a Start-of-Care OASIS assessment. We
have also delayed compliance with the rule for up to one year if the
state's legislature has met in that year, otherwise 2 years. Our
expectation is that states and providers are compliant with the
requirements of the final rule based on the timeframes explained above.
F. Practitioners (Sec. 440.70(f)(2))
The statute describes NPPs who may perform this face-to-face
encounter as an NP or CNS, 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 PA (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 reasoning outlined
in the Medicare Program; Home Health Prospective Payment System Rate
Update for Calendar Year 2012; Final Rule (76 FR 68525), for
beneficiaries admitted to home health upon discharge from a hospital or
post-acute setting, we proposed to also allow the physician who
attended to the beneficiary in the hospital or post-acute setting to
inform the ordering physician regarding their encounters with the
beneficiary to satisfy the face-to-face encounter requirement, much
like an NPP. We proposed to add a new Sec. 440.70(f)(2) to list the
practitioners that may perform the face-to-face encounters.
Comment: Some commenters supported this interpretation of the face-
to-face encounter requirement.
Response: We appreciate the support of the commenters.
Comment: Several commenters requested clarification on the
guidelines for patients having a face-to-face encounter from a
physician in another state. One commenter requested that CMS clarify
whether a state may, through a state plan amendment, choose to limit
the performance of the face-to-face encounter to a subset of the
allowed NPPs. Many commenters requested that the rule clarify whether
the Medicaid face-to-face must be performed by a physician, and also if
that physician must be registered in the CMS PECOS or any other system.
If so, the physician community should be alerted, instructed and
registrations confirmed well before the rule goes into effect.
Response: Many states have reciprocity agreements with neighboring
states, which allow Medicaid beneficiaries in one state to receive
services in another state. Section 431.52 provides the federal
requirements for payment for services furnished out of state. If the
beneficiary has a face-to-face encounter with a physician in a
neighboring state that has a reciprocity agreement, then this would be
allowed. If a physician practices in a different state that does not
have a reciprocity agreement, the physician would need to be a
qualified Medicaid provider in the state in which the beneficiary
resides. States cannot choose to limit the NPPs approved to complete
the face-to-face encounter, as the practitioners are mandated through
statute. We are also clarifying that the face-to-face encounter does
not need to be conducted by a physician. Per the regulations, any
physician would need to be qualified to furnish physician services. It
should be noted that for dually-eligible individuals, the Medicare
program will likely reimburse for the encounter itself, whether
conducted by a physician or NPP. Therefore, the practitioners would
need to adhere to Medicare provider qualifications.
Comment: One commenter stated that for beneficiaries participating
in section 1115 demonstrations or section 1915(c) HCBS waivers
requiring an encounter by a physician or one by the proposed list of
NPPs, it may be problematic for benefits such as non-skilled home
health, DME, and supplies. Physicians may not always be able to visit
beneficiaries in the settings where the benefit determinations are made
(for example, assisted living, nursing homes, and other residential
care settings). The commenter also stated that the assumption under
this proposed rule is that a physician would be the health care
professional who orders home health services. However, for non-medical
in-home services such as
[[Page 5550]]
personal care, the healthcare professional ordering the service is
often not a physician.
Response: Section 6407 of the Affordable Care Act has changed the
requirements for a person to receive Medicaid home health services. As
a condition of receiving covered home health services, a physician or
NPP must conduct a face-to-face encounter, and the home health services
must be ordered by a physician. These requirements are applicable
regardless of where a person lives. Usually people who reside in
assisted living facilities and residential care settings are still
responsible for arranging for and attending their own doctor's visits.
Although dependent upon state licensing standards, assisted living
facilities and residential care settings are not likely to have
physicians on staff. Physicians are available by arrangement to people
who reside in nursing homes if the person does not have a physician in
the community. The physicians could conduct the face-to-face encounter
and order the home health service on behalf of the person who lives in
the nursing home but is transitioning to a setting that comports with
Sec. 440.70(c)(1). We clarify that personal care services are outside
the scope of this regulation and are not subject to the face-to-face
requirements. Any component of home health services would need to be
authorized in accordance with the requirements.
Comment: One commenter reported that NPs and PAs can be primary
care providers in some states for Medicaid.
Response: Although NPs and PAs may be primary care providers in
some states, the law requires the certifying physician to document that
the physician or an allowed NPP has had a face-to-face encounter with
the beneficiary.
Comment: Many commenters recommended that CMS establish standards
to permit physician residents to meet the face-to-face requirements for
Medicaid beneficiaries, permit Medicare enrolled physicians to perform
the face-to-face for dual eligible beneficiaries, and permit physicians
with limited Medicaid and/or Medicare beneficiaries, including
federally-employed physicians to utilize an abbreviated enrollment
process.
Response: Physician residents would be permitted to perform the
face-to-face encounter as long as state law in which the resident is
practicing recognizes residents as physicians. We would defer to states
to make this determination. We recognize the potential issues
surrounding dually-eligible individuals and the face-to-face
requirement. To clarify, if a Medicare enrolled physician has completed
the face-to-face requirement for a dually-eligible individual, an
additional face-to-face requirement would not be needed by a Medicaid
enrolled physician, should the benefit change to Medicaid services, as
long as there was no new start of care. However, if a new face-to-face
encounter is needed under Medicaid, the physician must be Medicaid-
enrolled. This rule does not change any requirements of the laws
surrounding the provider enrollment process.
Comment: Many commenters suggested allowing any physician to
conduct a face-to-face encounter and certify eligibility for home
health services, regardless of whether that physician or another
physician is responsible for the plan of care.
Response: Any physician enrolled as a Medicaid provider (or in the
case of a beneficiary dually eligible for Medicare and Medicaid,
enrolled in the Medicare program) can perform the face-to-face
encounter and order home health services, provided they also develop
the written plan of care in accordance with Sec. 440.70.
Comment: One commenter recommended that CMS clarify that the
ordering/prescribing physician who completes the plan of care also be
allowed to rely on the in-person assessment of an emergency department
physician or of a physician working on behalf of an inpatient rehab or
skilled nursing facility prior to the beneficiary's discharge.
Response: To clarify, the commenter's understanding is accurate.
Comment: Commenters suggested allowing any physician to work with
another physician colleague sharing the face-to-face encounter and
documentation responsibilities along with the certification authority.
Response: We see no reason to prohibit this arrangement.
Comment: Commenters suggested that audiologists and podiatrists be
permitted to conduct the face-to-face encounter and then communicate
the information to the physician who is responsible for documenting the
face-to-face encounter.
Response: This is beyond our authority as statute did not include
audiologists and podiatrists as NPPs.
Comment: One commenter stated that it is imperative that the
Medicaid home health face-to-face encounter requirements mirror those
of the Medicare program in allowing PAs to personally perform the face-
to-face visits.
Response: Under the supervision of the physician, PAs are
authorized to perform the face-to-face encounter for Medicaid home
health.
Comment: One commenter proposed that the regulation specifically
state that home care and DME providers can contract with physicians
(for example, medical directors) or NPP/physician collaborating teams
to complete the necessary face-to-face visits in the patient's home.
The home health agency or DME provider should be permitted to
compensate time associated with such visits in a manner that would
allow the physician or NPP to earn hourly compensation consistent with
community standards.
Response: Such an arrangement would need to include a physician who
would continue to oversee the provision of home health services in
accordance with the written plan of care, as specified in Sec. 440.70.
Comment: Some commenters recommended increasing the role of
advanced practice nursing in the ordering of home health services. One
commenter also suggested allowing a wider range of practitioners to
certify home health care (for example, nurses in advanced practice).
One commenter suggested allowing states to determine whether physicians
need to order home care and endorse the performance of a face-to-face
encounter.
Response: Section 6407 of the Affordable Care Act requires the
ordering physician to document that the physician or an allowed NPP has
had a face-to-face encounter with the patient. However, the Medicare
Access and CHIP Reauthorization Act of 2015 allows for certain
authorized NPPs to document the face-to-face encounter for medical
equipment. We are using this final rule to conform with this change to
statute. With regard to the ordering of services, a change in the
statute and current regulatory requirements would be required to allow
an NPP to order home health services.
Upon consideration of the public comments received, we are revising
this section to clarify that any physician, including the physician who
attended to the beneficiary in the hospital or post-acute setting may
serve as the ordering physician for home health services provided that,
in accordance with Sec. 440.70, the ordering physician also completes
the written plan of care.
G. NPP Communication to Ordering Physician (Sec. 440.70(f)(3))
We proposed to add Sec. 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 NPP
is required to communicate the
[[Page 5551]]
clinical findings of the face-to-face encounter to the physician, for
the physician to document the face-to-face encounter accordingly. We
indicated that 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 proposed to specify that the clinical
findings must be reflected in a written or electronic document included
in the beneficiary's medical record (whether by the physician or by the
NPP).
Comment: Many commenters requested additional information regarding
communication. Several commenters suggested that the rule should
clarify if there are any limits on what would constitute
``communication'' under the Medicaid rule with regards to moving
information from the face-to-face physician to the ordering physician.
Commenters wondered whether such communications would include fax,
phone, voice, text, etc., and recommended the broadest definition of
communication to help assure access for the Medicaid population. One
commenter asked for CMS to clarify what type of communication would be
expected to occur between the NPP conducting the face-to-face visit and
the ordering physician who is documenting the face-to-face encounter.
One commenter requested that CMS elaborate or further define what
constitutes communication between the inpatient physician/hospitalist
and community physician. The commenter inquired whether communication
necessarily meant a verbal conversation or could it also include
receipt or access to the beneficiary's discharge summary from the
hospital. One commenter indicated that the regulation does not specify
what documentation is to be sent to the ordering physician or specify
what documentation the home health agency must secure.
Response: We are not prescribing at the federal level what
constitutes communication, rather we simply require that the clinical
findings of the face-to-face encounter must be communicated to the
ordering physician. This information can be included in clinical and
progress notes and discharge summaries.
Comment: One commenter advocated for reducing documentation
requirements. The commenter believes it is critical that any additional
changes made to the Medicare rule are also made at the Medicaid level.
One commenter suggested that CMS consider very clear documentation
requirements for when a hospitalist would complete a face-to-face
document and report off to the ordering physician who would sign the
orders. Another commenter supported that the proposed rule gives states
flexibility on the content and form of documentation for the Medicaid
face-to-face. The commenter stated that the proposed rule allows states
to continue to use their existing form or improve their forms to
reflect the face-to-face encounter and that this approach reduces
confusion.
Response: Our philosophy is to align face-to-face requirements
across the two programs to the extent feasible and practical. In
response to the commenter who requested clear documentation
requirements for a hospitalist completed face-to-face encounter, as
indicated above, our rule permits states considerable flexibility to
allow this information to be included in clinical and progress notes
and discharge summaries. We appreciate the support of the last
commenter.
Comment: One commenter believes that the statement ``this enhanced
communication will result in an improved transition of care from the
hospital or post-acute setting to the home health setting'' is not
true. In fact it has decreased the effectiveness of discharge planning
and cost home health agencies a great deal of time tracking down the
forms.
Response: The intent of this provision was not to delay transitions
from hospitals to community settings. We recognize the importance of
smooth transitions that do not negatively impact individuals. As
previously stated, we are clarifying in the final rule, that in
accordance with Sec. 440.70, home health services must be ordered by
the individual's physician. We encourage all parties to collaborate in
ensuring timely transitions to community care, including home health
services.
Comment: One commenter stated that the proposal requiring the
(inpatient) physician to communicate the clinical findings of the face-
to-face to the (community) physician is not clear. The commenter asked
whether CMS was now precluding the facility physician from documenting
the face-to-face encounter and certifying the beneficiary.
Additionally, the commenter stated that the proposal requires the
findings be communicated to the physician and be in the beneficiary's
medical record and asked how this documentation will be assured.
Response: As previously stated, we are finalizing this rule to
indicate that any physician can order home health services, provided
that the ordering physician also establishes the written plan of care
in accordance with Sec. 440.70. Additionally, the ordering physician
must document that the face-to-face encounter requirements were met
regardless of whether the physician performed the face-to-face
encounter himself or herself. It is the physician's responsibility as a
provider to ensure that the appropriate medical records are kept.
Additionally, the home health agency should maintain a copy of the
face-to-face documentation.
Comment: One commenter urged CMS to clarify this provision to
clearly state that a NP may conduct the face-to-face evaluation and
provide written or electronic documentation that will meet the
requirements of both communicating the clinical findings to the
physician and including them in the beneficiary's medical record.
Response: We confirm that the commenter's understanding is correct.
Comment: Some commenters requested clarification pertaining to
physicians in the hospital setting and the face-to-face requirement.
One commenter requested that CMS clarify that it will still be
acceptable for an inpatient physician or hospitalist to initiate the
plan of care for home health services, conduct the face-to-face
encounter, complete and sign the face-to-face form (or support
personnel completes the form based upon the physician's documentation
in the medical record and then the inpatient physician or hospitalist
signs it) and upon the beneficiary's discharge, the community physician
develops and signs the plan of care and oversees beneficiary care.
Another commenter questioned why a hospital-employed physician cannot
complete a face-to-face document on a home health beneficiary.
Response: To clarify, the inpatient physician or hospitalist may
also serve as the ordering physician and establish the plan of care. If
this is the case, then the community physician's role in the
commenter's scenario would be removed. A hospital-employed physician
can also complete the face-to-face documentation for a home health
beneficiary. Additionally, as previously stated, we are clarifying that
the hospital-employed physician may also order home health services in
accordance with the written plan of care.
Comment: One commenter stated that Sec. 440.70(f)(3)(v), which
stated ``those clinical findings must be incorporated into a written or
electronic document included in the beneficiary's medical record,''
lacks clarity. The commenter stated that normally, documentation of
clinical findings would be carried out by the NPP or inpatient
physician in his
[[Page 5552]]
or her own patient medical record, then applicable information
extracted and transmitted to the ordering physician to incorporate into
his or her own medical record, followed by extraction of the
information required at Sec. 440.70(f)(5)(i) into a document that is
sent to the home health agency for its medical record.
Response: We agree with the process outlined in this scenario and
believe that the regulatory requirements support this process.
Comment: One commenter reported that the inpatient physician
refuses to provide the necessary information to document a face-to-face
encounter to an ordering physician frequently, necessitating another
face-to-face encounter once the beneficiary returns to the community.
Response: We are establishing a process that meets statutory
requirements and aligns with Medicare requirements. Issues of physician
cooperation are beyond the scope of this regulation, and would be
better raised on an individual, institutional, or state level. While we
agree that care should be provided in the most effective and efficient
manner, this rule does not mandate specific roles for treating
physicians.
Comment: One commenter suggested removing the documentation
requirements for beneficiaries who have been in the hospital and
instead require a statement from the inpatient or post-acute physician
that the beneficiary had the encounter. Another commenter questioned
why CMS is requiring the face-to-face encounter at all, since the
hospital attending physician obviously saw the beneficiary 90 days
prior to the start of care.
Response: We thank the commenters for their suggestions. However,
there is a value to the statutorily required documentation of a
specific face-to-face encounter that informed the physician ordering
the home health or DME service. We do not think a blanket exception for
hospital discharges would ensure that the ordering physician was
informed by a face-to-face encounter.
Comment: One commenter recommended that the regulation clarify that
it is permissible for the home care or DME provider to obtain the
documentation of a recent face-to-face visit in acute or post-acute
care and to make that documentation available upon request by the
ordering physician, rather than require that the acute or post-acute
physician routinely communicate directly to the ordering physician.
Response: We believe that it is essential that the practitioner who
completed the face-to-face encounter communicate the clinical findings
to the ordering physician to ensure that the physician has sufficient
information to understand the need for home health services in the
absence of conducting the face-to-face encounter himself or herself. As
indicated above, we are not prescribing the communication at a federal
level. This information can be included in clinical and progress notes
and discharge summaries. To permit otherwise would not only violate the
statute, it would facilitate disconnect between beneficiary health
status and ordering of home health services.
Comment: One commenter indicated that the rule regarding
communication of the clinical findings of the encounter to an ordering
physician, should not apply to Medicaid unless there is a physician
involved in the beneficiary's care.
Response: Current regulations at Sec. 440.70(a)(2) require an
individual's physician to order home health services as part of a
written plan of care reviewed every 60 days. Therefore, the expectation
is that there is always a physician involved in the beneficiary's care
as a physician is required to order home health services.
Comment: Some commenters stated that NPPs should also be allowed to
certify the need for home health services.
Response: The statute sets forth the requirement that only a
physician is authorized to order the need for home health services. It
is beyond our statutory authority to expand the role of NPPs.
Comment: One commenter stated that the proposed policy implies that
NPs are somehow incapable of authorizing the ordering of appropriate
home health services. The commenter indicated that states should have
the flexibility to allow NPs to order home health services as well as
conducting the face-to-face encounter.
Response: We disagree that this proposed policy implies that NPs
are incapable of authorizing the ordering of appropriate home health
services. Furthermore, the proposed rule does not replace the existing
regulatory language requiring that a physician order home health
services. We believe that the statute recognizes the role of NPs
working in collaboration with the physician by including NPs as NPPs
authorized to complete the face-to-face encounter. The statute requires
that physicians order (certify) home health services.
Comment: One commenter suggested that if a physician extender
performs the encounter, such as an NP or PA, the extenders should be
permitted to document on the face-to-face encounter form itself, sign
and date, followed by a separate physician face-to-face form review,
signature and date section. The commenter also suggested that reference
to attached documentation showing that an encounter within the 90 day
time period occurred (such as an office note), should be permitted.
Response: As indicated above, we are not prescribing at the federal
level the communication procedures, rather the requirement that the
clinical findings of the face-to-face encounter are communicated to the
ordering physician. This information can be included in clinical and
progress notes and discharge summaries. There is no federal prohibition
on a NPP documenting the face-to-face encounter and having the
physician sign the documentation.
Comment: Commenters stated that CMS should clarify that inpatient
physicians retain the authority to perform both the face-to-face
encounter and complete the documentation and certification for the
beneficiary's plan of care.
Response: We agree with the commenters and are revising the final
rule to clarify that inpatient physicians may perform the face-to-face
encounter, complete the documentation, and order home health services
as documented in a written plan of care.
Comment: One commenter suggested that there should be one universal
form for everyone.
Response: To provide states flexibility in administering and
managing their Medicaid programs, we are not mandating utilization of a
common form in the documentation of Medicaid services. However, there
is no prohibition on states agreeing to utilize a common form to
facilitate standardization.
Comment: One commenter supported a collaborative relationship
between a physician and NPP.
Response: We agree with the commenter.
Comment: Some commenters expressed concern regarding the scope of
providers that may order medical supplies, equipment, and appliances in
the Medicaid program. One commenter believed that home health agencies
should be permitted to include medical supplies in Medicaid
beneficiaries' plan of care and be separately paid for those medical
supplies. Another commenter stated that they believe increasing the
role of advanced practice nursing would make a valuable contribution to
the ordering of all service modalities under both Medicare and
Medicaid.
[[Page 5553]]
Response: There is no prohibition on home health agencies being
reimbursed for medical supplies, equipment, and appliances provided to
a Medicaid beneficiary. They are part of the home health benefit, and
can be included in a plan of care when ordered by a physician, as
required in Sec. 440.70. We agree with the value added to the
provision of health care by advanced practice nurses; their role in the
ordering of services depends on the benefit authority being utilized.
In the provision of home health services, services must be ordered by a
physician.
After consideration of the public comments and to align with
Medicare's requirements we are finalizing this section with
clarifications. Specifically, we are clarifying that we are not
prescribing the communication between the NPP who performed the face-
to-face encounter and the physician, rather the requirement that the
clinical findings of the face-to-face encounter are communicated to the
ordering physician. This information can be included in clinical and
progress notes and discharge summaries. Additionally, we have clarified
that attending acute or post-acute physicians may serve as the ordering
physician of home health services.
H. Physician Documentation of the Face-to-Face Encounter (Sec.
440.70(f)(4))
In Sec. 440.70(f)(5)(i), we proposed 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 beneficiary's
medical record. The documentation must also describe how the health
status of the beneficiary at the time of the face-to-face encounter is
related to the primary reason the beneficiary requires home health
services. In Sec. 440.70(f)(5)(ii), we proposed to require that the
physician's documentation of the face-to-face encounter be clearly
titled, and state that either the physician himself or herself, or the
applicable NPP, has conducted a face-to-face encounter with the
beneficiary and include the date of that encounter.
Comment: One commenter appreciated the modifications to the
documentation rules and the clarification regarding the ``homebound''
requirement.
Response: We appreciate the commenter's support.
Comment: We received many comments pertaining to documentation
requirements. One commenter suggested limiting documentation of a face-
to-face encounter to a statement that services are medically necessary,
the date of the encounter, the statement that the primary reason for
home health services was addressed during the encounter, physician's
signature and date. Another commenter suggested limiting documentation
of a face-to-face encounter to a physician, NPP, or physician resident
signature and date, and the date of the encounter. One commenter
suggested that the face-to-face encounter be documented through a check
box on the plan of care rather than a separate document. One commenter
stated that documentation of any face-to-face encounter needs to be
flexible enough to permit the physician or a physician designee to
complete the form, prior to the physician review and signature. One
commenter advocated for reducing documentation requirements. The
commenter stated that it is critical that any additional changes made
to the Medicare rule are also made at the Medicaid level. One commenter
suggested that the documentation be limited to a few basic fields: The
identity of the physician or NPP who performed the encounter;
confirmation that the clinical findings support the need for home
health care; the date of the encounter; and if documentation is by a
different physician, the name of the physician who sent the
documentation. One commenter suggested that a more broad certification
requirement stating that the physician has personally reviewed the
examination and certifies the need for home health care would be a more
appropriate and effective use of the physician's time and efforts. One
commenter believed that the requirement is simply duplicating
documentation already on the plan of care where the physician is
certifying the need for skilled care, the services needed, and the
diagnoses supporting the need.
Response: To clarify, we are revising the proposed documentation
requirements to remove the requirement that the documentation 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 beneficiary's
medical record and specify what is required which is described in Sec.
440.70(f)(5)(i) and (ii). We are not proscribing a specific method of
capturing the requirements. The documentation should support the need
for what was ordered. We defer to states for details; we do not see any
federal barriers to making the documentation requirements
administratively simple.
Comment: One commenter stated that leaving the discretion to state
Medicaid programs to determine what constitutes appropriate
documentation flies in the face of the desire of attempting to bring
greater consistency to regulatory requirements. Another commenter
stated that varying standards for documentation will create problems
for all. The commenter recommended an effort to create a national
standard, with an allowance for states to apply for a waiver. One
commenter requested further clarification prohibiting state from
requiring additional face-to-face documentation. A few commenters
indicated that states should not be permitted to require additional
face-to-face documentation. Some commenters urged CMS to rescind
guidance that allows states to require information in excess of what is
proposed by CMS to document the face-to-face encounter. One commenter
stated that CMS should limit, rather than encourage, a state's
opportunity to impose additional documentation requirements on home
health agencies beyond those already included in the regulation. Some
commenters indicated that with regard to the additional flexibility
already proposed under the Medicaid face-to-face regulation, such as
the opportunity for states to limit the face-to-face documentation
requirements, they certainly support and would encourage CMS in the
final rule to maximize the flexibility given to the states to be more
accommodating in their own interpretation of the Medicaid face-to-face
rule.
Response: As indicated above, we are revising the proposed
documentation requirements as described in Sec. 440.70(f)(5)(i) and
(ii). From the federal perspective, our goal is to ensure that required
documentation by the state is sufficient to make the linkage between
the individual's health conditions, the services ordered, an
appropriate face-to-face encounter, and actual service provision. We
encourage documentation requirements established by states to meet this
goal, while not imposing additional actual or perceived administrative
burden. Electronic Health Records may be of use to support the
operational requirements and provide a clear audit trail.
Comment: One commenter believed that the ordering physician should
be able to rely on the discharge summary identifying a beneficiary's
need.
Response: As stated in the proposed rule, we believe that it is
necessary that clinical findings of the face-to-face encounter are
communicated to the
[[Page 5554]]
ordering physician 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 not proscribing the acceptable form of communication to meet this
requirement.
Comment: One commenter indicated that residents, NPs, and Pas
should not only be allowed to perform the face-to-face encounter but
complete the necessary documentation. Another commenter encouraged CMS
to honor the laws of states that permit advanced practice registered
nurses (APRNs) to manage beneficiaries independently and allow APRNs
not only to conduct the face-to-face visit, but to document that they
have done so. Another commenter stated that PAs and other NPPs
authorized to personally perform the face-to-face encounter should be
able to document the results of the exam in the patient's medical
record.
Response: As previously indicated, effective April 16, 2015, for
medical equipment, certain authorized NPPs are authorized to document
the face-to-face encounter. For home health services, residents, NPs,
and PAs, as NPPs defined in statute can complete the necessary face-to-
face documentation, but the physician must sign off as the practitioner
responsible for ordering home health services.
Comment: Many commenters indicated that the rule should limit the
documentation required, and specify where the record of the Medicaid
face-to-face encounter must be maintained or if there is a requirement
in that regard. One commenter stated that CMS should revise the
physician documentation requirements regarding the face-to-face
encounter to reduce the paperwork burden on physicians. This approach
would allow the use of the model Physician Certification and Plan of
Care form with a modification of the form's certification language to
include certification of the encounter date and reason related to the
need for home health care. The commenter also stated that physicians,
hospitals, discharge planners, home health agencies, and beneficiary
groups agree that the physician requirements are a barrier to access to
home health care for bona fide beneficiaries who meet coverage
standards. Additionally, the commenter stated that CMS has
unnecessarily expanded the scope of the required documentation. The
additional documentation is not needed because the physician is already
required to compose a detailed plan of treatment that sets out the
patient's clinical condition and prescribed care. One commenter stated
that proposed changes help to ease the burden by a small amount;
however, it still creates redundant and unnecessary paperwork by
requiring a certifying physician to restate the findings of the
hospitalist and/or discharging physician. The commenter stated that do
not understand how adding a second layer of physician review serves the
purpose of CMS or the needs of beneficiaries. One commenter believed
that this requirement will negatively impact access and serve as a
barrier to care because of the additional administrative burden to
physicians filling out the face-to-face form. Another commenter stated
that many doctors are stating that they do not like the additional
documentation requirements. One commenter indicated that physicians
have been hostile to the new requirement, particularly the
documentation standards. The face-to-face-encounters and documentation
create unnecessary roadblocks to care. Another commenter reported that
physician compliance with the documentation requirements has been
``horrific.'' One commenter stated that face-to-face documentation
itself is viewed as an additional burden by physicians. Some commenters
stated that CMS must guard against an increase in resistance and
opposition from community physicians who may view the new rule as
shifting documentation burdens from one physician sector to another.
Response: We agree with the goal of assuring the program
requirements are not overly burdensome. In general, the documentation
requirements and specifically the provision that the community
physician retain documentation that describes how the beneficiary's
health status warranted the ordering of home health services is
consistent with current standard practice of care. However, we
recognize that requiring a certifying physician to restate the findings
of the hospitalist and/or discharging physician could create an
additional burden. As previously stated, we are revising the final rule
to allow any attending physician to order home health services,
therefore, reducing the documentation requirements between inpatient
physician and community physician as indicated in the proposed rule.
Comment: A few commenters requested better clarification of the
requirement that the documentation of the face-to-face encounter be
separated from the order. Specifically, the commenters requested that
the regulation explicitly state that a copy of the face-to-face
encounter documentation which contains required elements be considered
valid documentation.
Response: Based on comments we are removing the requirement that
the face-to-face documentation be on a separate and distinct area on
the written order. In response to the commenters' second request that a
copy of the face-to-face encounter documentation be considered valid
documentation, it is not clear exactly what is intended. The
documentation of the face-to-face encounter is not necessarily
sufficient to document the physician order for home health services,
which should be part of the plan of care. But if the question is
whether a state would require an original or a copy, while we generally
defer to states on the operational details, we expect that the
documentation will generally be included in an individual's electronic
health records.
Comment: One commenter stated that CMS should refrain from
requiring physicians to document a face-to-face visit using specific
language or by including specific criteria; record of the visit should
be sufficient. The commenter also discouraged CMS from requiring
detailed descriptions of the beneficiary's needs for the item the
doctor orders, as it would be inconsistent with typical physician
practices and could result in decreased beneficiary access. Another
commenter suggested that CMS remove the requirement that the physician
document how the health status relates to the primary reason the
individual needs home care. The commenter believed that the clinical
findings are sufficient to describe this necessity and that this
section adds a documentation burden for the physician when the
diagnosis and/or medical condition is already included on the plan of
care the physician signs.
Response: Based on comments and Medicare requirements, we are
revising the documentation requirements to align them as much as
possible with Medicare documentation requirements. Specifically, for
home health services, the physician responsible for ordering the
services, and for medical equipment, the physician responsible for
ordering services or certain authorized NPPs must document that the
face-to-face encounter was related to the primary reason the patient
requires home health services, occurred within the required timeframes,
was performed by an authorized practitioner, and include the date of
the encounter.
Comment: One commenter stated that it should suffice that the
individual's physician saw the individual, and based on that visit and
the physician's and
[[Page 5555]]
other health care providers' records of the individuals health
diagnoses and needs, the physician ordered home health care. The
particular ``primary reason'' for the face-to-face encounter between
the individual and the physician should be of no relevance to the
validity of the physician's order and plan of care. The commenter
believed that with regard to Sec. 440.70(f)(5)(i) it should suffice
that documentation is made in a manner that is useful to health care
providers and can be explained to state and federal authorities upon
request.
Response: It is important to achieving the purposes of the
requirement that the face-to-face encounter focus on the medical issues
that result in the need for home health services. An encounter that
focuses only on unrelated issues will not ensure accountability and
utilization control. Therefore, we are retaining the proposed
requirement that documentation of the encounter include an explanation
of how the individual's observed health status relates to the primary
reason the home health services are needed.
Comment: One commenter suggested expanding the physicians who may
document this encounter to include partners of the certifying physician
or urgent care center physician (for non-acute inpatient settings). If
a patient goes to an outpatient clinic and sees an alternate physician,
this alternate physician should be allowed to document the encounter
and hand off to the primary physician to sign the plan of care. The
commenter also stated that the homebound documentation requirement is
not clearly addressed. The commenter suggested removing this
requirement from both Medicare and Medicaid regulations and requested
that CMS add to the rule that if this section is completed by the
physician, it is to be disregarded.
Response: To be able to attest to the completion of the face-to-
face requirement, an urgent care physician must satisfy the general
requirements of Sec. 440.70 in terms of physician development of plan
of care and review of the plan of care every 60 days. Otherwise, an
additional physician performing the functions must be brought in. We
interpret physician to include partners as well. The homebound
requirement is an area of disparity between Medicare and Medicaid as
the homebound requirement is prohibited by Medicaid. However, this
requirement is part of Medicare statute which we cannot waive.
Comment: One commenter expressed that specifying the guidelines for
documentation at the federal level provides an opportunity for greater
alignment with Medicare requirements.
Response: We agree and as indicated above, we are revising the
proposed documentation requirements to align with Medicare
requirements.
Comment: One commenter suggested that the face-to-face document be
permitted to be completed by physician designees, who should sign and
date the form, followed by the physician reviewing, signing, and
dating. The commenter also stated that if a physician extender performs
the encounter, the extenders should be permitted to document on the
face-to-face encounter form itself, sign and date, followed by a
separate physician face-to-face form review, signature, and date. One
commenter requested clarification regarding whether or not an NPP can
write an order and a physician can simply sign the order, rather than
writing the order himself or herself.
Response: We are not prescribing who completes the documentation,
but the documentation requirements must be met. As previously stated,
administrative simplification is supported.
Comment: One commenter indicated that further clarification is
needed from CMS on the documentation that is required from the
beneficiary's primary physician, when the face-to-face encounter is
conducted by NPs or PAs.
Response: The physician documentation requirements are described in
Sec. 440.70(f)(5)(i) and (ii). This documentation is required
regardless of whether the physician or one of the permitted NPPs
performed the face-to-face encounter.
Comment: One commenter requested guidance from the federal
government regarding whether or not a physician must approve findings
and referrals of NPs in cases where a NP is unable to obtain a
physician's documented approval of findings to authorize an order of
home health services.
Response: To clarify, we are retaining the requirement under Sec.
440.70(a)(2) that covered Medicaid home health services must be
supported by a physician order, as part of a written plan of care,
regardless of whether NPs are authorized under state law to order home
health services. That order should be based on the physician's own
professional judgment after reviewing all available information, which
can include the findings of the NP and patient medical records.
Comment: One commenter indicated that the documentation
requirements are not found in statute.
Response: In accordance with section 6407 of the Affordable Care
Act, the physician's order must document and be based in part on a
face-to-face encounter. While it does not specify the form in which the
face-to-face encounter must be documented, it clearly requires such
documentation.
Comment: Some commenters stated that the person-centered-plan of
care process described will add more quality and integrity to the
Medicaid services than insisting that physicians add more paperwork.
Response: We agree that the person-centered-plan of care process is
integral to ensuring quality Medicaid services are not inconsistent
with requirements for physician orders, face-to-face encounters, and a
written plan of care.
Comment: One commenter requested that CMS consider further
clarification or definition of the person-centered philosophy with
regard to the home health plan of care requirements for children and
youth under the age of 18. The commenter indicated that their state
program does not discuss clients' protected health information,
including their medical treatment plans, with non-legal caregivers.
Response: We have not yet issued guidance on person-centered
planning as it relates to home health. However, this process should be
implemented consistent with other federal requirements that protect
confidential health information such as Health Insurance Portability
and Accountability Act of 1996 (HIPAA).
Comment: One commenter stated that the need to collect additional
documentation could delay urgently needed care and payment for
services.
Response: We are confident that providers can determine ways that
they can work together without delaying services to beneficiaries.
After consideration of the public comments and to better align with
Medicare requirements, this section is being finalized with the
following revisions:
We are revising the documentation requirements to remove
the requirement that the documentation 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 beneficiary's medical record.
We are clarifying the documentation requirements and
specify what is required which is described in Sec. 440.70(f)(5)(i)
and (ii).
We are clarifying that for medical equipment, in addition
to the physician, the allowed NPP, as described in
[[Page 5556]]
paragraph (f)(3)(ii) through (v) are authorized to document the face-
to-face encounter.
I. Face-to-Face Encounter Through Telehealth (Sec. 440.70(f)(6))
Proposed Sec. 440.70(f)(6) outlined that the face-to-face
encounters may be performed through the use of telehealth.
Comment: Several commenters expressed support of the provision. One
commenter supported CMS's proposal on the use of telehealth to conduct
a home health face-to-face encounter. Another commenter was encouraged
that CMS stated that states should ``implement [the telehealth]
provision in a way that does not result in barriers to service
delivery'' and that states should ``work with the home health provider
community to incorporate the face-to-face visits in creative and
flexible ways to account for individual circumstances.'' The commenter
was also pleased that CMS is ready to offer technical assistance to
state Medicaid agencies to use telehealth as an alternative so that the
requirement may be implemented in a way that protects the continuity of
services. One commenter supported CMS's decision to permit the face-to-
face encounters to occur through the use of telehealth. Another
commenter viewed the provision of allowing a telehealth encounter
instead of a face-to-face encounter as a positive development and would
like to see this option expanded whenever possible. Yet, another
commenter appreciated that the proposed rule allows states that
currently use telehealth or telemedicine when delivering services under
Medicaid to be able to use the techniques to fulfill the face-to-face
encounter. One commenter appreciated that the coverage of telehealth is
discretionary.
Response: We appreciate the support of the commenters.
Comment: Commenters believed that the allowance to use telehealth
or telemedicine should extend to all forms of electronic communication
in compliance with the face-to-face requirement for home health
services. Conversely, one commenter indicated that the proposed
regulation as written could allow managed care plans and FFS providers
to bill for telephone calls, emails, and faxes with another provider
when the beneficiary is still at the originating site or not present in
the room at all, and stated that this would have to be built into
capitation rates for managed care plans. One commenter indicated that
telehealth and telemedicine are two different approaches in providing
health care. The use of the term ``telehealth'' implies that the
provider will be able to use a telephone, email or other
telecommunications to contact the beneficiary to provide the face-to-
face requirements. It is unclear if it is the intention of CMS to allow
telephone calls and emails to replace a face-to-face visit. One
commenter commended us for the use of the term ``telehealth,'' which
correctly describes the universe of health services provided by the
diverse array of providers, versus ``telemedicine,'' which can be
interpreted to focus on a more limited array of services offered by a
particular set of providers.
Response: Telehealth and telemedicine are service delivery
modalities that have very specific protocols that ensure quality
patient care, and do not include all electronic communications. We
recognize that there may be confusion surrounding the terms
``telehealth'' and ``telemedicine'' as the terms may have different
meanings as recognized by a state in accordance with Medicaid policy,
and as recognized under the Medicare statute and regulation. The
Medicaid ``telemedicine'' description is modeled on Medicare's
definition of telehealth services located at Sec. 410.78, but allows
states flexibility in keeping with their general authority to regulate
the medical professions. It is not our intention to allow telephone
calls or emails to replace the face-to-face encounter. In other words,
telehealth and telemedicine are service delivery models and do not
replace the requirement that a physician or NPP must have a face-to-
face encounter with a beneficiary. Rather, the face-to-face encounter
can be met though a telehealth delivery model that is recognized by the
state as a physician or NPP encounter under its approved state plan.
See http://www.medicaid.gov/Medicaid-CHIP-Program-Information/By-Topics/Delivery-Systems/Telemedicine.html.
Comment: Commenters urged CMS to allow states to define the form
and extent of telehealth that can be used for meeting the face-to-face
requirements. The commenters suggested that the rule should be amended
to state: ``states can permit the use of any two-way audio/video
communication medium as allowed by state law to connect the beneficiary
to the physician/NPP to meet the face-to-face requirements.'' One
commenter stated that telehealth services should be defined in a way
that allows a beneficiary to meet the face-to-face encounter
requirements through modern technologies available in their home,
including two-way audio and video communications. Another commenter
recommended that federal telehealth policy be revised to make the home
an approved site and to encourage state Medicaid programs to pay for
telehealth visits. Other commenters recommended that CMS require state
Medicaid programs (and the Medicare program) to allow face-to-face
encounters to take place via telehealth technology deployed in
beneficiaries' homes and reimburse agencies and practitioners for the
costs involved. One commenter expressed concern that the face-to-face
encounter requirement will erect a barrier to timely care for
beneficiaries who are homebound and have difficulty traveling to a
location that is equipped with telehealth technology. One commenter
requested that for special circumstances, CMS broaden the definition to
include Skype encounters with beneficiary/physician or allow home
monitoring devices used by home care agencies to be established in
physician offices. One commenter believed that it is important that CMS
maintain the telehealth flexibility which state Medicaid programs
currently have of not limiting telehealth to rural health professional
areas. One commenter recommended that the use of telehealth be an
option in non-rural areas, in addition to rural areas. One commenter
requested that CMS clarify whether a state may, through a state plan
amendment, limit the use of telehealth for conducting the face-to-face
encounters to rural or other geographic areas where there are issues
related to transportation or access to practitioners. One commenter
believed that there are many regulatory and procedural constraints
which will need to be amended to enable full and successful
implementation of telehealth services by all healthcare providers. One
commenter stated that the telehealth requirement for Medicaid purposes
should include sites of service where the patient may receive the home
care or use the DME. For example, a home visiting or adult day care
nurse should be permitted to establish a video visit to an office based
physician, allowing the physician to assess the beneficiary's need for
home care or DME. Existing tablet computer and wireless technologies
make such visits practical in any setting. In rural areas, without
broadband cellular service, portable videoconferencing tools that use
``plain old telephone service'' exist for this purpose. One commenter
stated that the benefits of this provision are limited for Medicaid
beneficiaries due to restrictions on the use of RPM (remote patient
monitoring) in Medicare law.
[[Page 5557]]
The commenter indicated that CMS should include a provision for dual
eligibles to have care coordinating access to RPM technologies under
Medicare and Medicaid.
Response: In the absence of specific Medicaid statutory
requirements, we are hesitant to proscribe the locations and/or
technologies that states may use to meet the face-to-face requirement
through telehealth. Under Medicaid policy, states have the flexibility
to define coverage of telehealth including what types of telehealth to
cover; where in the state it can be covered; and how it is provided.
Our expectation is that care delivered using various technologies will
lead to good outcomes and meet the needs of the individual while
adhering to privacy requirements, including the requirements under the
Health Insurance Portability and Accountability Act of 1996 (HIPAA). We
recognize the need for updated Medicaid telehealth guidance, which will
be forthcoming. In the meantime, we are available to provide technical
assistance.
Comment: One commenter indicated that video or recording used in
telehealth or telemedicine should be confidential and done in a manner
to protect beneficiary's rights.
Response: We agree with the commenter. As previously stated, the
use of telehealth or telemedicine does not negate HIPAA or Medicaid
privacy requirements.
Comment: One commenter stated that CMS should monitor and make
known which state Medicaid agencies permit face-to-face encounters via
telehealth for certification of home health services under Medicaid.
The commenter also recommended that CMS develop and implement a
mechanism to track which states permit the face-to-face encounter to
occur through telehealth. The commenter believed that CMS should know
whether and to what extent Medicaid beneficiaries have access to
services via telehealth. Additionally, the commenter stated that for
those state Medicaid programs that do not permit the face-to-face
encounter prior to the ordering for home health services to occur via
telehealth, CMS should endeavor to learn what barriers exist to prevent
the use of telehealth and assist states to overcome those barriers. The
commenter stated that CMS should be proactive in determining what
states need to realize the goal of expanding the use of telehealth
services and that CMS should encourage state Medicaid agencies to take
advantage of the relative flexibility they have regarding implementing
and paying for telehealth services under Medicaid. The commenter stated
that when possible, CMS should adopt the innovative and cost-saving
telehealth systems, as developed and implemented by states, into the
Medicare regulations and policy for telehealth services. Additionally,
the commenter indicated that CMS should hold state Medicaid agencies
accountable for dual eligibles' access to telehealth services in
general and the face-to-face pre-certification encounter in particular.
Response: We will consider the recommendations of the commenter for
future action. We recognize that there are differences between Medicare
and Medicaid on the issue of telemedicine and telehealth. But the
general requirements for telehealth and telemedicine are not the
subject of this rulemaking.
Comments: One commenter appreciated allowing telehealth as a means
of meeting the face-to-face requirement, but was concerned that it will
not be enough.
Response: We recognize that there may be individual circumstances
and we encourage states to work with the home health provider community
to incorporate the use of telehealth to meet the face-to-face
requirement in creative and flexible ways to account for individual
circumstances. We are available to provide technical assistance to
states in achieving this goal.
Comment: Some commenters requested clarification. One commenter
requested clarification on Medicaid coverage of telehealth equipment,
facilities, and transmission costs. Another commenter requested that
CMS clarify that telehealth encounters would qualify for FFP as a
reimbursable visit.
Response: Medicaid does not reimburse for telecommunications
equipment or facility costs separately. However, states could build
reimbursement for the costs into the rate and states can include in the
rate a separate amount for such costs. Reimbursement for services
provided through telehealth is voluntary on the part of state Medicaid
agencies as they are viewed as alternative methods of providing
services, not as a separate type of service. Therefore, reimbursement
is only available if the state has chosen to cover services provided
via telehealth or telemedicine and only in the circumstances selected
by the state.
After consideration of the public comments, this section is being
finalized as proposed.
J. Face-to-Face-Encounter for Medical Supplies, Equipment and
Appliances (Sec. 440.70(g))
As proposed, Sec. 440.70(g) applies all of the requirements of
Sec. 440.70(f) to the provision of medical supplies, equipment and
appliances as described in Sec. 440.70(b)(3), to the extent that a
face-to-face encounter would be required under the Medicare program for
DME, with one exception from the requirements at Sec. 440.70(f). Per
the statute, as amended by the Affordable Care Act, certified nurse
midwives are not permitted to conduct face-to-face encounters required
for the items, as proposed at Sec. 440.70(g)(2). To maximize
consistency between the Medicaid and Medicare programs and reduce the
administrative burden on the provider community, we proposed to limit
the face-to-face requirements to items that would be subject to such
requirements as DME under the Medicare program. Thus, we would only
require that, for items of DME 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 beneficiary requires the item has occurred no
more than 90 days before the order is written or within 30 days after
the order is written. Medical supplies, equipment and appliances for
which a face-to-face encounter would not be required under the Medicare
program as DME, would not require a face-to-face encounter before the
ordering of items under the Medicaid program. The items will be of a
smaller dollar value, and at a decreased risk for fraud, waste, and
abuse.
Comment: Some commenters supported the proposed requirement that a
face-to-face encounter must be performed prior to a physician ordering
medical supplies and DME. One commenter applauded CMS' decision to
limit the applicability of the face-to-face encounter requirement to
the medical equipment, supplies, and appliances that are included on
the Medicare program list of specific DME. Another commenter supported
the consistency with Medicare timeframes for orders for DME.
Response: We appreciate the support expressed by the commenters We
agree that there should be consistency with the timeframes for the
face-to-face encounter for DME in Medicare and medical equipment in
Medicaid. Since the proposal and comment period of this rule, Medicare
has finalized their DME face-to-face rule requiring the face-to-face
encounter for DME to occur no
[[Page 5558]]
more than 6 months prior to the start of services. Therefore, we have
revised the Medicaid medical equipment face-to-face timeframes to align
with the Medicare timeframe.
Comment: One commenter asked that we clarify the effective date for
the face-to-face requirement for certification of Medicaid DME
services. Additionally, the commenter requested clarification as to
whether the face-to-face encounter for DME applies to DME furnished
solely as a home health benefit or whether it also applies to DME paid
for by Medicaid that is not covered as part of the home health benefit.
Another commenter requested that CMS clarify whether a state may choose
to extend the face-to-face requirements to include equipment, supplies,
or appliances that are covered under the state's Medicaid program, but
are not Medicare benefits. One commenter requested that CMS clarify
that the proposals, if finalized, would not apply to medical equipment
under the Medicaid program until CMS has issued a final Medicare face-
to-face rule.
Response: The provisions of section 6407 of the Affordable Care Act
became effective in 2010 and added the requirement that physicians
document the existence of a face-to-face encounter for home health
services including medical supplies, equipment and appliances. However,
as previously indicated, we are delaying the effective date of this
rule to July 1, 2016 and we are allowing states and providers up to one
year from the effective date of the final rule to come into compliance
with the rule if the state's legislature has met in that year,
otherwise 2 years.
Any medical supplies, equipment, and appliances provided under the
home health benefit must meet the face-to-face requirement. If the
state is providing supplies, equipment or appliances under a benefit
category other than home health, such as the therapy services
authorized at Sec. 440.110, or prosthetics authorized under Sec.
440.120, the state would need to adhere to the requirements of that
particular benefit. In response to the concern that we clarify that the
final rule will not apply to medical equipment under the Medicaid
program until we have issued a final Medicare face-to-face rule,
Medicare's DME face-to-face rule was effective on July 1, 2013. Our
alignment of the scope of items requiring the face-to-face encounter
with Medicare does not depend on Medicare regulation. The list of DME
items subject to the face-to-face encounter can be found at https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Medical-Review/Downloads/DME_List_of_Specified_Covered_Items_updated_March_26_2015.pdf. States
may decide to apply face-to-face requirements to a broader range of
medical supplies, equipment, and appliances than those for which
Medicare requires an encounter, but are not required to do so.
Comment: One commenter stated that with regards to the face-to-face
requirement for DME, the regulation is vague as to which party is
responsible for the face-to-face documentation for billing purposes and
does not sufficiently define the items that will be subject to this
requirement.
Response: The physician or the NPP who completed the face-to-face
encounter is responsible for documenting the encounter. However, as
previously stated, this rule does not replace the existing Medicaid
regulatory requirements related to physician orders. In response to the
comment that the regulation does not sufficiently define the items that
will be subject to the face-to-face requirement, we intend to issue
guidance to states indicating how they, and providers, can access the
current Medicare list of specific DME 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 DME, would not require a face-to-face encounter before the ordering
of items under the Medicaid program.
Comment: One commenter stated that it is a rare physician who is
able to determine what DME is appropriate for a beneficiary without the
advice of rehabilitation therapists. In addition, almost all DME
requires training of beneficiaries and caregivers. The commenter
encouraged reconsideration of state discretion in relation to
rehabilitation when DME is required.
Response: We recognize that the recommendation and determination of
appropriate medical equipment is often made by providers other than the
physician and we encourage a collaborative approach to determining a
beneficiary's needs. The statute sets forth the practitioners who are
authorized to complete the face-to-face encounter for medical supplies,
equipment, and appliances and maintains the role of the physician in
the actual ordering of medical supplies, equipment, and appliances.
However, as stated in the preamble, only items of DME specified by CMS
under the Medicare program would be subject to a face-to-face encounter
requirement.
Comment: Many commenters had suggestions pertaining to CMS's
proposal of exceptions to the face-to-face encounter for certain DME as
specified by under the Medicare program. Commenters suggested that the
face-to-face exceptions for home health medical equipment should be
expanded so that only those items that are most likely to be abused
require a face-to-face visit. Another commenter believed that CMS can
develop a suggested list of DME that requires face-to-face encounters,
but state Medicaid programs should be able to make the final decision
on which items will require the face-to-face encounter. Other
commenters suggested that the requirement of face-to-face encounter
should apply to all medical supplies and DME.
Response: We believe that by aligning with Medicare's
implementation of this provision, we will ensure that beneficiaries are
receiving needed items and provide clear and consistent guidance to
states. Therefore, we will not be expanding the exceptions from the
face-to-face requirement beyond the list used in Medicare. Based on the
previously stated rationale, state Medicaid programs could require
face-to-face encounters on more items than would be required under
Medicare, but not fewer items. In response to the comments suggesting
that the face-to-face encounter should apply to all medical supplies
and DME, we disagree as we believe that this alignment and consistency
will reduce the administrative burden on the provider community.
Comment: One commenter suggested that CMS look first to its
Medicare national and local coverage determinations to determine what
DME items require an in-person physician visit. Additionally, the
commenter stated that CMS should adhere to already established Medicare
coverage policies regarding the need for a beneficiary to see his or
her physician for DME rather than expand the face-to-face requirements
to more routine types of DME such as canes, walkers, and commodes. The
commenter also recommended that CMS not require beneficiaries who need
supplies, refills, repairs, or service of their equipment to have
follow-up face-to-face physician visits. Another commenter indicated
that DME and medical supplies items also include basic needs such as
canes, crutches, walkers, diapers, applicator sticks, just to name a
few. The commenter specified that to require a physician endorsement of
each of the items for a population that is already under-served and
receives care exclusively from NPs in a large number of states, is not
only unreasonable, but
[[Page 5559]]
increases costs and causes delays in care.
Response: As previously stated, only items of DME specified by CMS
under the Medicare program would be subject to a face-to-face encounter
requirement for the Medicaid program. Additionally, to clarify, an
additional face-to-face encounter would not be required for refills,
repairs, or service of equipment. The face-to-face encounter is
required for the initial ordering of medical supplies, equipment, and
appliances. As this rule does not preclude existing regulations, the
need for medical supplies, equipment, and appliances must be reviewed
by a physician annually. We believe that the requirements may be met
without causing undue hardship on beneficiaries or the provider
community.
Comment: One commenter strongly recommended that there be an
explicit prohibition on any ownership relationship between the
physician ordering the equipment/supplies/appliances and the provider
of those items.
Response: We thank the commenter for the recommendation, but this
is beyond the scope of this regulation.
Comment: One commenter indicated that for beneficiaries
participating in a section 1115 demonstration or section 1915(c) HCBS
waiver, benefits such as DME and supplies requiring a physician
encounter, or one by the proposed list of NPPs, may be problematic as
the benefits are often determined by non-physician case managers and
the physician requirement could add additional costs to strained state
Medicaid budgets.
Response: We recognize the commenter's concern. However, statute
mandates the face-to-face encounter for medical supplies, equipment,
and appliances under the home health services benefit. We note that
this rule applies to the home health benefit as implemented in the
Medicaid state plan. To the extent that state plan service is provided
through a waiver or demonstration, the requirements would continue to
apply.
Comment: One commenter stated that PAs should be authorized to
order medical supplies and equipment for Medicaid beneficiaries,
consistent with DME supplies and equipment within the Medicare program.
Another commenter urged CMS to allow NPs to continue to order durable
medical supplies, equipment, and appliances, as they are able to do
under current regulations. One commenter was concerned about the limits
being placed on NPs regarding the ordering of DME. Other commenters
urged CMS to allow other practitioners who may prescribe medical
supplies and DME under state law, to do so under Medicaid as well. The
commenters also suggested that audiologists and podiatrists be
permitted to conduct the face-to-face encounter and then communicate
the information to the physician who is responsible for documenting the
face-to-face encounter.
Response: We appreciate the suggestions. As previously stated, this
rule does not supplant existing regulatory requirements that provide
that a physician must order an individual's services under the Medicaid
home health benefit. The statute maintains the role of the physician in
the actual ordering of medical supplies, equipment, and appliances.
Additionally, the statute sets forth the NPPs who are authorized to
conduct the face-to-face encounters before the start of home health
services. It is beyond our authority to change statute.
Comment: One commenter stated that certified nurse-midwives should
not be prohibited from ordering DME for their beneficiaries.
Response: The statute and current regulations maintains the role of
the physician in the ordering of medical supplies, equipment, and
appliances.
Comment: One commenter believed home health agencies should be
permitted to include medical supplies in their plan of care and be
separately paid for those medical supplies.
Response: If the home health agency is a Medicaid provider of
medical supplies, equipment and appliances, then it can receive payment
for medical supplies, equipment, and appliances based on the
physician's order and plan of care.
Comment: Many commenters recommended that the requisite timeframe
be extended to 6 months for medical equipment and appliances.
Response: As indicated above, we are revising the timeframe
requirements to no more than 6 months prior to the start of services.
We believe that this alignment will provide consistency among the
programs and less fragmented services for beneficiaries who are dually
eligible.
Comment: Several commenters recommended that when home health care
is complicated (for example, certain medical equipment), CMS permit a
greater period of time between the face-to-face visit and receipt of
services.
Response: We believe that the 6 month timeframe for the face-to-
face encounter will meet the needs of beneficiaries and permit
sufficient time for providers to analyze beneficiary needs.
Comment: One commenter indicated that they are confident that the
overwhelming majority of orders for medical equipment are already made
in an appropriate medical context. The commenter believed that it would
be unnecessary for CMS to create, or require a state to create, new in-
person evaluation or documentation requirements for many categories of
medical equipment. Additionally, the commenter stated that when medical
equipment is ordered on discharge from an inpatient stay, it would be
unnecessary for CMS to impose additional face-to-face physician visit
or documentation requirements because the beneficiary's need for
equipment would have been evaluated during their stay.
Response: The face-to-face requirement is mandated by statute
regardless of whether the majority of orders for medical equipment are
already made in an appropriate medical context. We allow for the face-
to-face documentation to be part of the order or an addendum to it. As
previously stated, we have clarified in this final rule that the
inpatient physician can order home health services, which would include
medical equipment, supplies, and appliances, in accordance with Sec.
440.70. Therefore, if the inpatient physician orders the medical
equipment following all of the face-to-face requirements, including
documentation of the face-to-face encounter, there would be no need for
an additional face-to-face visit upon discharge. However, if the
inpatient physician was not the ordering physician, it would be
acceptable for the community physician (or his or her support staff) to
attach a communication from a physician who cared for the beneficiary
in an acute or post-acute facility, who performed the encounter (such
as a discharge summary), to the order as an addendum. If, for example,
a discharge summary from a physician who cared for the beneficiary in
an acute or post-acute facility contains all of the needed
documentation content, the ordering physician would simply need to sign
and date the discharge summary and ensure it is attached as an addendum
to the order. We believe that this process will help to insure
continuity of care between the hospital and the community physician.
Comment: One commenter stated that there may be times where a
physician might order an item such as a walker based on self-reports
from the beneficiary or his or her caregiver. For example, a
beneficiary may report recent falls within the home and a
[[Page 5560]]
doctor might order a cane or a walker before he examines the
beneficiary in person. Similarly, the beneficiary may have a
progressive condition and the physician determines, based on the
beneficiary's self-reports and clinical history, that he or she needs
different equipment. When the physician orders DME in these situations,
CMS should not require a face-to-face encounter because the physician
prescription is based on the beneficiary's medical history and is made
in response to predictable changes in the beneficiary's condition.
Response: We appreciate the comment, however, we do not have the
authority to revise the requirements of the statute which requires a
face-to-face encounter for home health services as they apply to
medical supplies, equipment, and appliances under the home health
services benefit. Since the encounter can be conducted up to 6 months
prior to the ordering of equipment, this provision should not prevent
the provision of timely care.
Comment: One commenter believed that CMS should not require an
additional face-to-face visit for DME identified by the home health
agency nurse or other skilled clinician and communicated to the
physician overseeing the plan of care. The commenter also believed that
CMS should not impose a physician visit requirement for prescription
renewals, supplies, and/or accessories used with a particular device,
and repairs or replacement of equipment. Additionally, CMS should not
extend the face-to-face requirement to ongoing supplies or other items
that are ancillary to the DME prescribed but nonetheless necessary to
deliver appropriate therapy.
Response: The statute identifies the authorized NPPs who may
conduct the face-to-face encounter. It is beyond our authority to
expand this list to include the home health agency nurse or other
skilled clinician not included as an authorized NPP. We clarify that an
additional face-to-face requirement would only be required if a new
medical equipment, supply or appliance is needed. Renewals, repairs and
the need for ancillary equipment would not trigger the need for an
encounter.
Comment: One commenter stated that the extension of a requirement
for a physician order to provide DME to Medicaid enrollees is an
additional barrier to beneficiaries receiving the medical supplies and
equipment they need.
Response: We appreciate the commenter's concern. However, as
previously stated, the statute mandated the face-to-face requirement
for home health services, including medical equipment, supplies, and
appliances. The purpose of this regulation is to implement that
statutory directive.
After consideration of the public comments, this section is being
finalized with revisions to the timeframes for the face-to-face
encounter for DME. Specifically, we are adding Sec. 440.70(f)(5)(ii)
which indicates that for the initiation of DME, the face-to-face
encounter must be related to the primary reason the beneficiary
requires home health services and must occur no more than 6 months
prior to the start of services.
Additionally, as previously indicated, we are using this rule to
conform with the Medicare Access and CHIP Reauthorization Act of 2015
and clarifying that for medical equipment, in addition to the
physician, the allowed NPPs, as described in paragraph (f)(3)(ii)
through (v) are authorized to document the face-to-face encounter.
IV. Provisions of the Final Regulation
For the most part, this final rule incorporates the July 12, 2011
provisions of the proposed rule. Those provisions of this final rule
that differ from the proposed rule are as follows:
We are revising Sec. 440.70(b) introductory text to state
that coverage of home health services cannot be contingent upon the
beneficiary needing a nursing or therapy services.
We are amending Sec. 440.70(b)(3)(ii) to include the term
``disability'' to the definition of equipment and appliances and to
clarify that state Medicaid programs are not restricted to the items
covered under DME in the Medicare program.
We are adding Sec. 440.70(b)(3)(v), to state that states
can have a list of preapproved medical equipment supplies and
appliances for administrative ease, but not as an absolute limit on
coverage; states must provide and make available to individuals a
reasonable and meaningful procedure for individuals to request items
not on the list; and individuals are informed of their right to a fair
hearing.
We are revising Sec. 440.70(c)(1) to codify the homebound
prohibition for Medicaid home health services; home health services may
not be subject to a requirement that the individual be ``homebound.''
Additionally, we are clarifying the settings in which home health
services may be provided. Specifically, we are adding the clarification
that home health services may be provided in settings where normal life
activities take place, other than a hospital, nursing facility;
intermediate care facility for individuals with intellectual
disabilities; or any setting in which payment is or could be made under
Medicaid for inpatient services that include room and board.
We are adding 440.70(f)(5)(i) and (ii) to specify that the
ordering physician must document the face-to-face encounter which is
related to the primary reason the patient requires home health
services, occurred within the required timeframes prior to the start of
home health services; must indicate the practitioner who conducted the
encounter, and the date of the encounter.
We are adding Sec. 440.70(f)(2) which indicates that for
the initiation of DME, the face-to-face encounter must be related to
the primary reason the beneficiary requires home health services and
must occur no more than 6 months prior to the start of services.
V. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995 (PRA), we are required to
publish a 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.
To fairly evaluate whether an information collection should be
approved by OMB, PRA section 3506(c)(2)(A) 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.
The accuracy of our burden estimates.
The quality, utility, and clarity of the information to be
collected.
Our effort to minimize the information collection burden
on the affected public, including the use of automated collection
techniques.
On July 12, 2011 (76 FR 41032), we solicited public comment on each
of the section 3506(c)(2)(A)-required issues for the following
information collection requirements (ICRs). See below for a summary of
the PRA-related comments along with our response.
Subsequent to the publication of the proposed rule, we have revised
our cost estimates by using the most current U.S. Bureau of Labor
Statistics' wage estimates along with our fringe benefit adjustment
factor. An additional change is discussed in Collection of Information
section V.B.2.
[[Page 5561]]
A. Wage Estimates
To derive average costs, we used data from the U.S. Bureau of Labor
Statistics' May 2014 National Occupational Employment and Wage
Estimates for all salary estimates (www.bls.gov/oes/current/oes_nat.htm). In this regard, the following table presents the mean
hourly wage, the cost of fringe benefits (calculated at 100 percent of
salary), and the adjusted hourly wage.
Table 1--Wage Estimates
----------------------------------------------------------------------------------------------------------------
Adjusted
Occupation title Occupation Mean hourly Fringe benefit hourly wage ($/
code wage ($/hr) ($/hr) hr)
----------------------------------------------------------------------------------------------------------------
Family and General Practitioners................ 29-1062 89.58 89.58 179.16
Nurse Practitioners............................. 29-1171 47.11 47.11 94.22
Physician Assistants............................ 29-1071 46.77 46.77 93.54
----------------------------------------------------------------------------------------------------------------
As indicated, we are adjusting our employee hourly wage estimates
by a factor of 100 percent. This is necessarily a rough adjustment,
both because fringe benefits and overhead costs vary significantly from
employer to employer, and because methods of estimating these costs
vary widely from study to study. Nonetheless, there is no practical
alternative and we believe that doubling the hourly wage to estimate
total cost is a reasonably accurate estimation method.
B. ICRs Carried Over From the July 12, 2011, Proposed Rule
1. ICRs Regarding Home Health Services: Physician Documentation of the
Face-to-Face Encounter (Sec. 440.70(f) and (g))
Section 440.70(f) and (g) requires that physicians (or for medical
equipment, authorized non-physician practitioners (NPPs) including
nurse practitioners, clinical nurse specialists and physician
assistants) document that there was a face-to-face encounter with the
Medicaid beneficiary. The burden associated with this requirement is
the time and effort to complete and maintain this documentation. The
documentation must clearly demonstrate that the face-to-face encounter
occurred within the required timeframes and indicate the practitioner
who conducted the encounter along with the date of the encounter. The
burden also includes writing, typing, or dictating the face-to-face
documentation and signing/dating the documentation. In this regard, we
estimate 10 minutes for each encounter. We also estimate that there are
approximately 1,143,443 initial home health episodes in a given year
(this estimate is based on our 2008 claims data which is also our most
recent data). Due to the lack of data for each provider type, we are
dividing our 1,143,443 episode estimate into 3 equal parts of
381,147.67 for each of the three respondent types (family and general
practitioners, nurse practitioners, and physician assistants). Our
estimated burden for documenting, signing, and dating the beneficiary's
face-to-face encounter is 190,574 hours (this estimate is based on our
CY 2011 data which is also our most recent data). We acknowledge that
this figure is inflated by instances in which the physician conducted
the face-to-face encounter with the beneficiary, making this second 10-
minute documentation burden unnecessary.
The estimated cost to document the face-to-face encounter, which
varies by practitioner, consists of $29.74 (0.167 hr x $179.16/hr) for
a family and general practitioner, $15.64 (0.167 hr x $94.22/hr) for a
nurse practitioner, and $15.52 (0.167 hr x $93.54/hr) for a physician
assistant. We estimate an aggregated cost of $23,355,067 (see the
burden table in section V.C. of this final rule). The requirements and
burden will be submitted to OMB under control number: 0938-1188 (CMS-
10434).
Upon consideration of the public comments received, we are
finalizing this section as proposed.
Comment: Several commenters reported that the estimated burden does
not accurately account for home health agency burden. One commenter
further stated that 35 minutes per beneficiary should be added to home
care agency time if the form is completed correctly the first time. If
the form is not correct, 25 to 45 minutes should be added to 25 percent
of the beneficiaries. Another commenter stated that in reality, the
face-to-face is already taking up another 30 to 45 minutes on the home
health agency side plus at least 15 minutes on the physician side.
Another commenter stated that the estimate does not include the time
that is required for home health agencies and medical equipment
companies to ensure that the encounter occurred and that the
documentation is received and in compliance with federal and state
requirements. To ensure that the encounter has occurred and the
required documentation is in place, the commenter reported that state
home health agencies would need an additional 0.5 FTE in an agency with
an average census of 100 to 120 beneficiaries. Another commenter stated
that the estimates do not include the time and effort for the home
health agency to contact and recontact the physicians to obtain the
correct documentation. The commenter estimated that the burden on home
health agencies is at least as much as it is on the physicians and
requested that this burden be included in our estimate.
Response: We do not agree that the new requirements will add
administrative requirements to home health agencies. Home health
agencies are currently required to obtain the physician's order prior
to implementing home health services. We do not believe that the
additional documentation requirements as defined at Sec. 440.70(f)(5)
will add to the existing requirements.
Comment: One commenter stated that home health agencies do not
typically cover costs through Medicaid reimbursement when serving
Medicaid beneficiaries. Consequently, the additional administrative
burden that would be placed on home health agencies because of the
face-to-face requirement would further exacerbate this problem.
Response: We recognize the commenter's concern. This is a statutory
requirement that is applicable across Medicare and Medicaid. We
encourage home care agencies to communicate with their state Medicaid
agencies to discuss the impact of the requirements on current Medicaid
reimbursement rates. We also encourage home care agencies to share best
practices for complying with the requirements in cost effective ways.
Comment: Many commenters provided feedback on additional items to
include in our burden estimates. One commenter specified the following
items: The education of each physician on how to complete the form (10
minutes); time for the home care agency to audit each form (10 minutes
per form) and to notify the physician of the
[[Page 5562]]
missing or incomplete information (5 minutes per notification--and
consider that 25 percent of the forms are inaccurate and must be
returned to the physician for revision); time for home care intake to
coordinate and access the form (10 minutes) and time for home care
office personnel to track and log the form (10 minutes); time for home
care agency staff to educate beneficiaries on the requirement (5
minutes); time for home care agency staff to track the appointment
compliance if the encounter was not completed by the time the
beneficiary was admitted to home care (10 minutes); if the physician
did not complete the form correctly the first time, add physician
office personnel time to communicate the issue to the physician and
pull the medical records and physician time to review the medical
record and redocument (10 minutes minimum); and add burden for the home
care agency to obtain the encounter documentation from the community
physician if it was performed in a hospital. These commenters indicated
that this new interpretation could add up to 30 minutes to coordinate.
Another commenter indicated that additional support personnel time is
required in physicians' offices as staff field the telephone calls from
home health beneficiaries and agencies to request documentation,
schedule encounters, and secure the documentation in an acceptable and
compliant condition.
Response: We would like to remind commenters that we do not have
any standard form that we require to be completed. Rather, we defer to
state Medicaid agencies to work with the provider community to develop
a documentation form that will best meet the documentation requirement.
Since this provision became effective in 2010, we believe that
documentation forms should be already in place.
Comment: Many commenters indicated that CMS did not include
components in its burden estimates. One commenter stated that no impact
was estimated for the implementation of the requirement for medical
equipment, supplies, and devices. The commenter also indicated that our
estimate does not include the cost to both state and federal
governments of the additional physician visits that will occur and have
to be paid for in order to meet the requirements. Another commenter
stated that the burden estimate does not account for the time it may
take to collect and review pertinent test results, specialist reports
or assessments performed by clinicians such as physical therapists and
occupational therapists. Another commenter indicated that there is no
time identified for getting the documentation from the NP to the
physician for endorsement and back, nor the time and personnel to
support such coordination.
Response: We believe that our estimates accurately reflect new
burdens. In response to the comment pertaining to the services
performed by physical therapists and occupational therapists, we did
not account for additional time for physical therapy and occupational
therapy services as the services are presumed covered in existing
regulatory language. We do not believe that the burden for the
situations described would be significant. We view administrative
functions such as the transmission of information between NPs and
physicians as an existing part of the duties of administrative
personnel and do not need to be quantified as additional burden.
Comment: One commenter requested that CMS clarify its plans to
collect the additional documentation from physicians about the face-to-
face encounters and what role states and health plans may have in the
process.
Response: The intention of the comment is not clear. We defer
operational procedures for implementing this provision to the states
and therefore, the state will communicate to fee-for-service providers
and managed care plans the details of how it will be implemented. We
will not be collecting documentation from physicians.
Comment: One commenter reported that physicians complain that they
receive different forms from agencies and suggested that there be one
universal form for everyone. Additionally, the commenter reported that
the forms are returned incomplete and not timely and the education of
how to complete the documentation is lengthy.
Response: We defer to state Medicaid agencies for operational
details. We encourage states to use universal forms where appropriate.
As previously indicated, the statutory provision became effective in
2010 and therefore, states should have appropriate forms in place.
2. ICRs Regarding Home Health Services: Communication of Clinical
Findings (Sec. 440.70(f)(4))
Section 440.70(f)(4) requires that NPPs and attending acute or
post-acute physicians communicate the clinical findings of the face-to-
face encounter to the ordering physician. The clinical findings must be
incorporated into a written or electronic document that is included in
the beneficiary's medical record. While we set out burden in the
proposed rule, we believe the requirement and burden are exempt from
the PRA in accordance with 5 CFR 1320.3(b)(2). Specifically, we believe
that the time, effort, and financial resources to communicate the
findings of the encounter would be incurred by persons during the
normal course of their activities and, therefore, should be considered
a usual and customary business practice.
Comment: Several commenters indicated that the proposed burden is
underestimated. One commenter further stated that the proposal
significantly underestimates the burden to both FFS providers and to
managed care plans. Another commenter stated that not all face-to-face
encounters will be limited to 10 minutes, depending on the health state
of the beneficiary being examined. Another commenter indicated that 10
minutes for NPPs and attending acute or post-acute physicians to
communicate the findings of the face-to-face encounter to the ordering
physician does not account for the time required for each face-to-face
encounter nor for the time for staff to send endorsements back and
forth between the involved parties.
Response: We are not attempting to be overly burdensome. We are
requiring a general description of beneficiary's health condition. We
believe that 10 minutes on average is an appropriate amount of time as
this should be a routine provision of care. We note that the time
required to conduct the actual encounter with the beneficiary could
vary widely. The 10 minute estimate had referred to the time it would
take for the health status to be communicated to the ordering
physician. Although we set out burden in the proposed rule, we believe
that that the requirement is a usual and customary business practice
and the burden is therefore exempt from formal OMB approval under the
authority of the PRA.
Comment: One commenter recommended that we work to streamline the
requirements for documenting the in-person visit.
Response: We believe that providing states with the flexibility to
determine their own documentation requirements will best meet the
unique needs of the beneficiaries served, states, and providers. We
would like to reiterate that we are not prescribing the specific types
of information that has to be documented, but rather we are requiring
an overall description of the linkage of the health status and the
services ordered.
C. Summary of Annual Burden Estimates
[[Page 5563]]
Table 2--Annual Recordkeeping and Reporting Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Total capital/
Regulation section(s) in Title 42 of OMB Control No. (CMS ID Respondents Total Time per response Total annual Labor rate ($/ maintenance Total cost
the CFR No.) responses burden (hr) hr) costs ($) ($)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
440.70(f) and (g)....................... 0938-1188 (CMS-10434)..... 381,147.67 381,147.67 10 min (0.167 hr)......... 63,651.66 179.16 0 11,403,831.41
381,147.67 381,147.67 10 min (0.167 hr)......... 63,651.66 94.22 0 5,997,259.41
381,147.67 381,147.67 10 min (0.167 hr)......... 63,651.66 93.54 0 5,953,976.28
---------------------------------------------------------------------------------------------------------------------------
Total............................... .......................... 1,143,443.01 1,143,443.01 10 min (0.167 hr)......... 190,954.98 n/a 0 23,355,067.10
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
D. Submission of PRA-Related Comments
We have submitted a copy of this rule to OMB for its review of the
rule's information collection and recordkeeping requirements. These
requirements are not effective until they have been approved by the
OMB.
To obtain copies of the supporting statement and any related forms
for the proposed collections discussed above, please visit CMS' Web
site at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995, or call the Reports Clearance Office at
410-786-1326.
We invite public comments on these potential information collection
requirements. If you wish to comment, please identify the rule (CMS-
2348-F) the ICR's CFR citation, CMS ID number and OMB control number,
and submit your comments to the OMB desk officer via one of the
following transmissions:
Mail: OMB, Office of Information and Regulatory Affairs, Attention:
CMS Desk Officer;
Fax Number: (202) 395-5806 or
Email: [email protected].
ICR-related comments are due March 3, 2016.
VI. Regulatory Impact Statement (or Analysis)
A. Statement of Need
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 NPPs, document a face-to-face encounter with the beneficiary
(including through the use of telehealth, subject to the requirements
in section 1834(m) of the Act), before 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 NP or CNS (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 PA (as defined in section 1861(aa)(5) of the Act), under the
supervision of the physician, may conduct the face-to-face encounters
before 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 DME. The NPPs authorized to conduct a face-to-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 before 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.
The Affordable Care Act applied both of the provisions to the
Medicaid program.
B. Public Comments on the Regulatory Impact Analysis
Comment: We received many comments pertaining to the fiscal impact
of this regulation. One commenter stated that the regulation needs to
look further into the overall cost of changing the common practice for
in-home care providers and make sure the quoted $100 million is on
target. One commenter stated that the need for frequent documented
encounters outlined in the rule will result in a duplication of effort
and result in unnecessary costs. Increased costs will result from both
the increase in encounters and from additional administrative oversight
to monitor compliance with encounter and documentation requirements.
Another commenter stated that the expansion of services that will
result from the proposed regulations will come at considerable and
untenable cost to the states. Another commenter reported that the
fiscal impact of the face-to-face requirement for the commenter's state
would be an increase of over $3 million per year in additional
expenditures. The commenter stated that the regulation specifies that
home health care services are a mandatory service to all categorically
needy Medicaid beneficiaries, as well as mandatory to all medically
needy if the state makes this population eligible for nursing home
care. The fiscal impact of this change is estimated to be an additional
$5 million per year for the state. Another commenter reported that
states will incur costs and administrative burdens regarding the
following: (1) Providing notice to providers through Medicaid
bulletins, billing guides and provider handbooks about the face-to-face
encounter requirement; (2) examining medical records by program
integrity staff to ensure the face-to-face requirement has been met;
and (3) providing notice to providers of the updated list of DME items
that require a face-to-face encounter, as periodically updated by CMS.
Another commenter stated that the proposed regulation would vastly
expand the program. If the changes are made, a state and its taxpayers
would be obligated to pay for a seemingly limitless benefit. One
commenter recommended that CMS estimate the additional costs associated
with the proposed expansion of home health services.
Response: While we recognize that states may have initial increases
in costs, we do not believe that the potential increases outweigh the
possible offsetting benefits to both beneficiaries and state budgets.
The face-to-face encounter provision promotes program integrity and an
effectively implemented home health benefit will enable beneficiaries
to receive high quality care in the community, rather than rely on care
in more expensive institutional settings. However, to allow states time
for
[[Page 5564]]
budgetary planning and operational changes, we are allowing states up
to one year to come into compliance with this rule if the state's
legislature has met in that year, otherwise 2 years.
Comment: A few commenters reported on the regulatory impact with
regard to health care providers. One commenter stated that an increased
cost will be imposed on every order to accommodate the endorsement of a
physician for the order. Another commenter reported that they expect
that practitioners and physicians will ask for an increase in their
fees. Another commenter stated that managed care plans and fee-for-
service providers would also suffer from reduced physician
productivity, which would increase the cost of treatment authorization.
Another commenter stated that state Medicaid payment rates for
physicians are significantly below Medicare rates and additional
requirements are not likely to encourage practitioners and providers to
serve the Medicaid population at the current depressed reimbursement
rates.
Response: In response to the concerns that an increased cost will
be imposed on every order to accommodate the endorsement of a physician
for the order, we do not view implementation of section 6407 of the
Affordable Care Act as supplanting the existing Medicaid regulatory
requirements related to current practice for physician orders but is
consistent with those practices. We do not agree that this rule will
reduce physician productivity or have an impact on current cost
structure. We encourage the provider community to collaborate with
their State Medicaid Agencies to ensure continued dialogue on rate
structures and reimbursement methodologies.
Comment: One commenter stated that the additional documentation
would also impose a burden on the managed care plans and vendors under
contract to perform billing services. The vendors would have to create
protocols to ensure review of the appropriate documentation, which may
include software development and system changes. The commenter
indicated that the placement of face-to-face documentation into a
beneficiary's medical record under the proposed rule would require new
software development. This would occur at significant cost to managed
care plans, fee-for-service providers, and/or software companies. The
commenter also stated that the increased cost of treatment
authorization for managed care plans would have to be incorporated into
the capitation rates and if face-to-face visits are not billable, plans
and fee-for-service providers would bear increased costs for treatment
authorization due to higher transportation expenses and/or costs of
telehealth equipment, facilities, and transmission. The commenter also
believed that his state would incur significant costs in staff time and
system changes to enact the proposed rule, including: (1) Drafting an
analysis and possible state plan amendment; (2) preparing a regulation
package; (3) providing training and education materials to providers;
(4) developing changes to billing systems; (5) revising health plan
contracts and recalculating capitation rates; and (6) performing
periodic audits and investigations to ensure compliance. Additionally,
the commenter stated that the increased cost of treatment authorization
for managed care plans would have to be incorporated into the
capitation rates. Another commenter reported that the current level of
payment for home health agencies does not begin to cover the costs of
providing services. The commenter stated that adding an additional
documentation requirement to every admission further diminishes the
impact of this substandard payment.
Response: As previously stated, this rule does not require states
to apply the face-to-face requirement to Medicaid managed care. We
defer to states to determine the application of the face-to-face
requirement in managed care plans to best meet the needs of their
beneficiaries. We are requiring that if states direct their managed
care plans to comply with face-to-face encounter requirements, the
plans report on this in a manner similar to fee-for-service. We do
agree that when states choose to require their managed care plans to
meet these requirements they should take this into consideration while
setting actuarially sound rates. While the rates may increase, this is
not a certainty as managed care prior authorization requirements and/or
existing reporting structures may already be in place within capitation
rates to adequately cover the costs. We reiterate that the face-to-face
encounter is an appropriate activity for which to be reimbursed under
the Medicaid physician benefit, or, if a NPP is the practitioner
performing the encounter, under the appropriate benefit established to
reimburse those providers under the state plan. This reimbursement is
provided for the face-to-face encounter. If a NPP performs the face-to-
face encounter, there is no additional reimbursement available for the
physician to document that the face-to-face encounter occurred. Managed
care plans, providers, and State Medicaid Agencies are encouraged to
collaborate to determine appropriate reimbursement structures and once
those are determined, the state's actuary should be informed in order
to consider those assumptions during the capitation rate development.
Comment: One commenter stated that the face-to-face encounter
increases the burden on home care agencies by placing the onus on the
providers to ensure that the encounter takes place in the manner
prescribed by the final rule. Additionally, the commenter stated that
the proposed rule did not address or consider the financial and
operational burdens imposed on agencies and that it is home care
agencies and not physicians that risk non-payment for services rendered
if discrepancies regarding the face-to-face encounter arise. The
commenter further stated that much of the Medicare face-to-face
education was done by home care providers, resulting in even greater
burden on agencies. Another commenter stated that the entirety of the
face-to-face requirement is extraordinarily burdensome on small home
health agencies and unnecessary for quality care outcomes and cost
savings. Additionally, the commenter indicated that the face-to-face
requirement penalizes home health agencies that are unable, due to size
or geographic location, to secure the services of an independent
physician.
Response: We do not view the implementation of the face-to-face
requirement as replacing existing regulatory requirements, but rather
enhancing existing regulatory language. We believe that aligning with
Medicare's implementation of this requirement will allow for
consistency and reduce the burden on providers. Additionally, the rule
expands the providers who may complete the face-to-face encounter to
include NPPs and allows for the use of telehealth, which we believe
will reduce the burden on home health agencies securing the services of
an independent physician.
Comment: One commenter stated that they believe that the existing
Medicare face-to-face requirement has proven in many ways to be an
ineffective and burdensome requirement on physicians, home health
agencies, and patients, with little positive impact on program
integrity, which should not be replicated for Medicaid cases.
Response: The face-to-face requirement for both the Medicare and
the Medicaid programs is required by statute, and we anticipate that
Medicaid agencies will work with providers to
[[Page 5565]]
effectively and efficiently implement the provision.
Comment: Some commenters reported that many providers have needed
to devote full-time staff to the task of tracking down paperwork and
following up with the physicians' offices on face-to-face documentation
that is already duplicative of long-established service authorization
records and standards.
Response: We appreciate the commenters' concerns. We believe that
providers have established administrative procedures in place, and
therefore, do not believe that the additional face-to-face requirements
will be overly burdensome or result in significant costs.
After consideration of the public comments, this section is being
finalized without revisions. However, as previously indicated, to allow
time for budgetary planning and operational changes, we are allowing
states up to one year to come into compliance with this rule if the
state's legislature has met in that year, otherwise 2 years.
C. 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 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 estimate that this rulemaking is ``economically
significant'' as measured by the $100 million threshold, and,
therefore, is a major rule under the Congressional Review Act.
Accordingly, we have prepared a final Regulatory Impact Analysis which
to the best of our ability presents the costs and benefits of the
rulemaking.
According to the CMS Actuarial estimates, section 6407 of the
Affordable Care Act would bring an estimated $920 million in savings to
the Medicare program from 2010-2014 and $2.29 billion in savings from
2010-2019. Although this provision applies to Medicaid in the same
manner and to the same extent as the Medicare program, there were no
estimates (costs or savings) generated for the Medicaid program as data
to determine these estimates is unavailable.
The certification of the need for home health care by a physician
would be a covered physician service or, at state option, could be
covered as a component part of home health care services. States have
substantial flexibility to design payment methodologies for covered
services. These payment methodologies can be tailored by benefit and/or
provider type. Therefore, there may be an increase in costs, but the
scope of these increases are not measurable due to state flexibilities.
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
Sec. 440.70(b)(3), we acknowledge 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
beneficiaries 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 the benefits, they nonetheless should be taken into
account. In the proposed rule, we specifically solicited comment
regarding the potential increased costs and benefits associated with
this provision, as well as the various sections throughout the RIA.
After consideration of public comments, we are finalizing the burden
costs estimates associated with the provisions in this regulation with
no revision.
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
$7.5 million to $38.5 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 that this final rule will not have a significant economic
impact on a substantial number of small entities. Entities affected by
this rule should already be administering these changes for Medicare
purposes as the statutory change was effective in 2010. Entities should
already have systems in place to accommodate this change for the
Medicaid population.
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 604 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 2015, that
threshold level is $144 million. This final rule will not result in an
impact of $144 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 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.
D. Conclusion
We estimate that this final rule will be ``economically
significant'' as measured by the $100 million threshold as set forth by
Executive Order 12866, as well
[[Page 5566]]
as the Congressional Review Act. The analysis above provides our final
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.
List of Subjects in 42 CFR Part 440
Grant programs-health, Medicaid.
The Centers for Medicare & Medicaid Services amends 42 CFR chapter
IV as follows:
PART 440--SERVICES: GENERAL PROVISIONS
0
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).
0
2. Section 440.70 is amended by--
0
a. Revising paragraph (b) introductory text.
0
b. Revising paragraph (b)(3) introductory text.
0
c. Redesignating paragraphs (b)(3)(i) and (ii) as paragraphs
(b)(3)(iii) and (iv), respectively.
0
d. Adding new paragraphs (b)(3)(i) and (ii) and paragraph (b)(3)(v).
0
e. Adding paragraphs (c)(1) and (2).
0
f. Adding paragraphs (f) and (g).
The revisions and additions read as follows:
Sec. 440.70 Home health services.
* * * * *
(b) Home health services include the following services and items.
Paragraphs (b)(1), (2) and (3) of this section are required services
and items that must be covered according to the home health coverage
parameters. Services in paragraph (b)(4) of this section are optional.
Coverage of home health services cannot be contingent upon the
beneficiary needing nursing or therapy services.
* * * * *
(3) Medical supplies, equipment, and appliances suitable for use in
any setting in which normal life activities take place, as defined at
Sec. 440.70(c)(1).
(i) Supplies are health care related items that are consumable or
disposable, or cannot withstand repeated use by more than one
individual, that are required to address an individual medical
disability, illness or injury.
(ii) Equipment and appliances are items that are primarily and
customarily used to serve a medical purpose, generally are not useful
to an individual in the absence of a disability, illness or injury, can
withstand repeated use, and can be reusable or removable. State
Medicaid coverage of equipment and appliances is not restricted to the
items covered as durable medical equipment in the Medicare program.
* * * * *
(v) States can have a list of preapproved medical equipment
supplies and appliances for administrative ease but States are
prohibited from having absolute exclusions of coverage on medical
equipment, supplies, or appliances. States must have processes and
criteria for requesting medical equipment that is made available to
individuals to request items not on the State's list. The procedure
must use reasonable and specific criteria to assess items for coverage.
When denying a request, a State must inform the beneficiary of the
right to a fair hearing.
(c) * * *
(1) Nothing in this section should be read to prohibit a
beneficiary from receiving home health services in any setting in which
normal life activities take place, other than a hospital, nursing
facility; intermediate care facility for individuals with intellectual
disabilities; or any setting in which payment is or could be made under
Medicaid for inpatient services that include room and board. Home
health services cannot be limited to services furnished to
beneficiaries who are homebound.
(2) Additional services or service hours may, at the State's
option, be authorized to account for medical needs that arise in the
settings home health services are provided.
* * * * *
(f) No payment may be made for services referenced in paragraphs
(b)(1) through (4) of this section, unless the physician referenced in
paragraph (a)(2) of this section or for medical equipment, the allowed
non-physician practitioner, as described in paragraph (f)(3)(ii)
through (v), with the exception of certified nurse-midwives, as
described in paragraph (f)(3)(iii) documents that there was a face-to-
face encounter with the beneficiary that meets the following
requirements:
(1) For the initiation of home health services, the face-to-face
encounter must be related to the primary reason the beneficiary
requires home health services and must occur within the 90 days before
or within the 30 days after the start of the services.
(2) For the initiation of medical equipment, the face-to-face
encounter must be related to the primary reason the beneficiary
requires medical equipment and must occur no more than 6 months prior
to the start of services.
(3) 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 referenced 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 referenced in paragraph
(a) of this section; or
(v) For beneficiaries admitted to home health immediately after an
acute or post-acute stay, the attending acute or post-acute physician.
(4) The allowed non-physician practitioner, as described in
paragraph (f)(3)(ii) through (v) of this section, performing the face-
to-face 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 beneficiary's medical record.
(5) To assure clinical correlation between the face-to-face
encounter and the associated home health services, the physician
responsible for ordering the services must:
(i) Document the face-to-face encounter which is related to the
primary reason the patient requires home health services, occurred
within the required timeframes prior to the start of home health
services.
(ii) Must indicate the practitioner who conducted the encounter,
and the date of the encounter.
(6) 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 (DME) under the Medicare program, unless the
physician referenced in paragraph (a)(2) of this section or allowed
non-physician practitioner, as described in paragraph (f)(3)(ii)
through (v) of this section documents a face-to-face encounter with
[[Page 5567]]
the beneficiary consistent with the requirements of paragraph (f) of
this section except as indicated in paragraph (g)(2) of this section.
(2) The face-to-face encounter may be performed by any of the
practitioners described in paragraph (f)(3) of this section, with the
exception of certified nurse-midwives, as described in paragraph
(f)(3)(iii) of this section.
Dated: July 28, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
Dated: December 21, 2015.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2016-01585 Filed 1-27-16; 4:15 pm]
BILLING CODE 4120-01-P