[Federal Register Volume 82, Number 130 (Monday, July 10, 2017)]
[Rules and Regulations]
[Pages 31729-31732]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14347]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 409, 410, 418, 440, 484, 485 and 488

[CMS-3819-F2]
RIN 0938-AG81


Medicare and Medicaid Programs; Conditions of Participation for 
Home Health Agencies; Delay of Effective Date

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

ACTION: Final rule; delay of effective date.

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SUMMARY: This final rule delays the effective date for the final rule 
entitled ``Medicare and Medicaid Programs: Conditions of Participation 
for Home Health Agencies'' published in the Federal Register on January 
13, 2017 (82 FR 4504). The published effective date for the final rule 
was July 13, 2017, and this rule delays the effective date for an 
additional 6 months until January 13, 2018. This final rule also 
includes two conforming changes to dates that are included in the 
regulations text.

DATES: The effective date of the final rule published on January 13, 
2017 (82 FR 4504) is delayed until January 13, 2018. Additionally, the 
conforming amendments (to Sec.  484.65 and Sec.  484.115) in this rule 
are effective January 13, 2018.

FOR FURTHER INFORMATION CONTACT: Danielle Shearer (410) 786-6617, Mary 
Rossi-Coajou (410) 786-6051, or Maria Hammel (410) 786-1775.

SUPPLEMENTARY INFORMATION: 

I. Background

    On October 9, 2014, we published the proposed rule ``Medicare and 
Medicaid Programs: Conditions of Participation for Home Health 
Agencies'' (hereinafter ``October 2014 HHA CoPs proposed rule'') in the 
Federal Register (79 FR 61164) and provided a 60 day comment period. On 
December 1, 2014, in response to public comments requesting additional 
time to respond to the proposed rule, we published a notice of 
extension of the comment period (79 FR 71081), which extended the 
public comment period for the October 2014 HHA CoPs proposed rule an 
additional 30 days, from December 8, 2014 to January 7, 2015. The vast 
majority of commenters on the October 2014 HHA CoPs proposed rule made 
suggestions related to the effective date of the final rule (``Medicare 
and Medicaid Programs; Conditions of Participation for Home Health 
Agencies'', January 13, 2017, (82 FR 4504), hereinafter ``January 2017 
HHA CoPs final rule''). Commenters strongly expressed a need for a 
significant period of time to prepare for implementation of the new 
rules, noting that HHAs would need to adjust resource allocation, 
staffing, and potentially even infrastructure. Recommended effective 
date time frames ranged from 6 months after publication of the final 
rule to 5 years after publication of the final rule. The most frequent 
recommendation received was to finalize an effective date that was 1 
year after the publication of the final rule. We agreed with commenters 
that it was appropriate to allow additional time for HHAs to prepare 
for the changes being set forth in the HHA CoPs final rule. Therefore, 
when we published the January 2017 HHA CoPs final rule in the Federal 
Register on January 13, 2017, we finalized an effective date of July 
13, 2017 (that is, 6 months after the final rule was published in the 
Federal Register).
    The January 2017 HHA CoPs final rule revised the CoPs that HHAs 
must meet in order to participate in the Medicare and Medicaid 
programs. The requirements focus on the care delivered to patients by 
HHAs, reflect an interdisciplinary view of patient care, allow HHAs 
greater flexibility in meeting quality care standards, and eliminate 
unnecessary procedural requirements. These changes are an integral part 
of our overall effort to achieve broad-based, measurable improvements 
in the quality of care furnished through the Medicare and Medicaid 
programs, while at the same time eliminating unnecessary procedural 
burdens on providers. We believe that the overall approach of the CoPs 
provides HHAs with greatly enhanced flexibility. At the same time, we 
believe the new requirements help HHAs achieve needed and desired 
outcomes for patients, increasing patient satisfaction with the 
services provided.

II. Provisions of the Proposed Regulations

    Following publication of the January 2017 HHA CoPs final rule, we 
received inquiries that represented a large number of HHAs requesting 
that the agency delay the effective date for the new HHA CoPs. The 
inquiries asserted that HHAs were not able to effectively implement the 
new CoPs until CMS issued its revised Interpretive Guidelines (State 
Operations Manual, CMS Pub. 100-07, Appendix B). In addition, one of 
the inquiries stated that HHAs were unable to effectively implement the 
new CoPs until CMS issued further sub-regulatory guidance related to 
converting subunits to branches or independent HHAs, which would impact 
216 HHAs nationwide. One of the inquiries cited the estimated $300 
million cost to implement the new requirements as a reason for delaying 
the effective date.
    We believe that the concerns expressed in the inquiries have merit, 
so in response to the concerns summarized above, we published a 
proposed rule on April 3, 2017 (82 FR 16150) entitled ``Medicare and 
Medicaid Programs; Conditions of Participation for Home Health 
Agencies; Delay of Effective Date'' to delay the effective date of the 
January 2017 HHA CoPs final rule for an additional 6 months. The 
effective date for the January 2017 HHA CoPs final rule, which is 
currently set to become effective on July 13, 2017, would be delayed 
until January 13, 2018.
    We also proposed to make two conforming changes to dates that 
appear in the regulations text of the January 2017 HHA CoPs final rule. 
First, we included a phase-in date for the requirements at Sec.  
484.65(d)--``Standard: Performance improvement projects.'' This phase-
in date allowed HHAs an additional 6 months after the January 2017 HHA 
CoPs final rule became effective to collect data before implementing 
data-driven performance improvement projects. We continue to believe 
that it is appropriate to phase-in the performance improvement project 
requirement 6 months after the

[[Page 31730]]

provisions of the January 2017 HHA CoPs final rule become effective. 
Therefore, we proposed to revise the phase-in date for the requirements 
at Sec.  484.65(d) by replacing the January 13, 2018 date with a July 
13, 2018 date.
    Second, we proposed to revise Sec.  484.115(a)--``Standard: 
Administrator, home health agency.'' In this provision, we 
grandfathered in all administrators employed by HHAs prior to the 
effective date of the January 2017 HHA CoPs final rule, meaning that 
those administrators employed by an HHA prior to July 13, 2017 would 
not have to meet the new personnel requirements. We proposed to replace 
the July 13, 2017 effective date at Sec.  484.115(a)(1) and (2) with 
the proposed effective date of January 13, 2018.

III. Analysis of and Responses to Public Comments

    We received 48 letters of public comment from HHA industry 
associations, surveyors, HHAs, and individuals. A summary of the major 
issues and our responses follow.
    Comment: The majority of comments that were submitted expressed 
support for the proposed January 13, 2018 effective date for the 
January 2017 HHA CoPs final rule. One commenter disagreed with the 
proposal, stating that HHAs should already be implementing most of the 
new requirements as part of good practice. Another commenter agreed 
with the proposed effective date and stated that the date should not be 
delayed beyond January 13, 2018. However, other commenters stated that 
the rule should be delayed until July 13, 2018 or until 6 months or 1 
year after CMS issues revised Interpretive Guidelines.
    Response: We appreciate the support from commenters regarding our 
proposal to delay the effective date of the January 2017 HHA CoPs final 
rule for an additional 6 months, until January 13, 2018. While we agree 
that the changes in the new CoPs reflect good practice, and we continue 
to believe that many HHAs already implemented a significant number of 
these changes prior to the issuance of the new CoPs, we also 
acknowledge that the new CoPs contain numerous changes that require 
time for planning, testing, training, and implementation. In order to 
assure that HHAs have adequate time for all preparation activities, we 
are finalizing the proposed 6 month delay of the effective date of the 
January 2017 HHA CoPs final rule. The new HHA CoPs will be effective on 
January 13, 2018. We do not believe that delaying the effective date of 
the new HHA CoPs beyond January 2018 would be in the interest of 
improving patient safety and quality of care.
    Comment: Several commenters supported the proposed effective date 
delay for implementing performance improvement projects, as required at 
Sec.  484.65(d). A commenter did not support the delayed effective date 
as it was proposed. This commenter stated that the effective date for 
the entire quality assessment and performance improvement (QAPI) 
requirement should be delayed 18 months beyond the effective date for 
the rest of the rule (meaning July 2019).
    Response: We appreciate the support of the commenters. As stated in 
the January 2017 HHA CoPs final rule, we believe that a phased-in 
implementation timeframe is appropriate for the requirement that HHAs 
conduct performance improvement projects because it will take 
additional time to collect the data necessary to identify areas for 
performance improvement. The additional phase-in period allows HHAs the 
time necessary to collect data prior to implementing performance 
improvement projects. Allowing HHAs until July 13, 2018 to implement 
performance improvement projects provides for a full 18 month period 
between the date that the final rule was published and the date that we 
would expect HHAs to initiate performance improvement activities. To 
delay the entire QAPI requirement for 18 months beyond the effective 
date for the rest of the rule would not require HHAs to begin data 
collection until July 2019; HHAs would also need 6 months to collect 
data before initiating performance improvement activities in January 
2020. We do not believe that waiting 3 full years to initiate 
performance improvement activities is in the best interest of patient 
safety, patient care efficacy, or patient care efficiency. Therefore, 
we are finalizing the revised July 13, 2018 phase-in date for 
performance improvement projects. All other QAPI requirements are 
effective on January 13, 2018.
    Comment: A commenter supported the inclusion of a grandfather 
clause related to the personnel training and education requirements for 
HHA administrators at Sec.  484.115(a).
    Response: We appreciate the support and are finalizing the proposal 
at Sec.  484.115(a) without change. HHA administrators that start 
employment with an HHA beginning on or after January 13, 2018 will be 
required to meet the training and education requirements set forth in 
the final rule.
    Comment: Several commenters submitted comments regarding the 
content of the January 2017 HHA CoPs final rule. For example, a 
commenter submitted comments on the plan of care update requirements 
while another submitted comments on the requirements for supervision of 
home health aides and another submitted comments regarding the 
comprehensive assessment. One commenter requested that the removal of 
the Condition of Participation entitled ``Group of professional 
personnel'' become effective on the original effective date of July 13, 
2017.
    Response: While we understand that commenters have technical 
questions regarding how to implement the requirements of the January 
2017 HHA CoPs final rule, or desire to see changes to the policies set 
forth in the final rule, these comments are outside the scope of this 
rule. Likewise, making a single change effective prior to the effective 
date of the rest of the rule is beyond the scope of our original 
proposal. Questions related to the content of the January 2017 HHA CoPs 
final rule and suggestions for future rulemaking may be submitted to 
[email protected].
    Comment: Numerous commenters requested additional information 
regarding the expected timeframe for release of the Interpretive 
Guidelines. Commenters also suggested that CMS work with stakeholders 
to develop the content of the guidance.
    Response: We appreciate the opportunity to provide additional 
information regarding the Interpretive Guidelines for HHAs. Existing 
Guidance to Surveyors for HHAs can currently be found in Appendix B of 
the State Operations Manual (SOM). Updates to the Interpretive 
Guidelines to reflect the requirements of the January 2017 HHA CoPs 
final rule are currently under development. We expect to release a 
preliminary draft of the revised guidelines to HHA stakeholders for 
informal input in the fall of 2017. Comments from stakeholders will be 
taken into consideration as the draft is finalized. We intend to 
publish a final version of the Interpretive Guidelines in December 
2017. We note that the Interpretive Guidelines are intended to provide 
guidance to surveyors when reviewing providers for substantial 
compliance with the HHA requirements and promote nationwide consistency 
in the survey process. All deficient practices are cited against the 
requirements in the regulations. Even absent a final version of the 
Interpretive Guidelines published in the SOM, surveyors will still be 
able to survey HHAs to assess compliance with the regulations. A delay 
in the release of Interpretive Guidelines would not

[[Page 31731]]

require a further delay of the effective date for the new HHA CoPs.
    Comment: A commenter suggested that CMS should make training 
regarding the HHA CoPs available to all interested parties.
    Response: We will undertake training for state surveyors on an as-
needed basis to assure that those individuals have the necessary 
knowledge to assess compliance with the new regulations. As previously 
discussed, we have established an email box ([email protected]) 
for individuals to submit questions regarding the content of the HHA 
CoPs. We encourage those with specific questions to use this mailbox. 
We also note that the January 2017 HHA CoPs final rule is intentionally 
flexible and outcome-oriented to allow for HHA innovation. Our goal is 
not to specify how HHAs must accomplish the end goal, but rather to 
establish what the outcome-oriented requirement is and allow HHAs to 
determine their own processes for achieving it.
    Comment: A few commenters submitted suggestions related to guidance 
for transitioning existing subunits to standalone HHAs or branches. 
Commenter suggestions ranged from permitting subunits to automatically 
convert to a parent or branch without completing provider enrollment 
paperwork and the survey process, permitting a subunit to maintain 
subunit status while any transition to parent-HHA or branch is pending, 
permitting a subunit to qualify as a stand-alone HHA automatically with 
the filing of a CMS-855A that is effective upon filing, modifying the 
current branch approval process, and creating a separate delayed 
effective date for the subunit requirement.
    Response: Guidance related to the conversion of subunits to 
standalone HHAs and branches is beyond the scope of this rule. We 
appreciate these suggestions and have shared them with the appropriate 
CMS staff. We will continue to monitor our conversion processes for 
subunits, and will consider future rulemaking to revise the effective 
date of the subunit elimination should the need arise.
    Comment: A few commenters recommended that CMS review the content 
of the final home health CoPs to ensure they are reasonable and 
necessary, and rescind any provisions that are found to unduly burden 
HHA providers.
    Response: We believe that the provisions of the home health CoPs 
final rule are reasonable and necessary, and that all burdens created 
are directly related to patient health and safety, and to improving the 
quality of care provided to HHA patients.
    Comment: A commenter stated that CMS should align the effective 
date for the new emergency preparedness regulations with the January 
2018 proposed effective date for the new home health CoPs.
    Response: Changing the effective date for the emergency 
preparedness requirements is outside the scope of this rule as the 
emergency preparedness requirements were established in separate 
rulemaking (Emergency Preparedness Requirements for Medicare and 
Medicaid Participating Providers and Suppliers, (81 FR 63859)).
    Comment: A commenter requested that CMS provide further explanation 
of home health occupational therapy policy by including specific 
examples in Chapter 7, Section 30.4 of the Medicare Benefit Policy 
Manual.
    Response: Changes to the Medicare Benefit Policy Manual are not 
within the scope of this rule. However, we have shared this 
recommendation with the appropriate CMS staff.

IV. Provisions of the Final Regulations

    We are adopting as final the provisions set forth in the January 
2017 HHA CoPs final rule with the following modifications:
     Delaying the effective date for the January 2017 HHA CoPs 
final rule, which is currently set to become effective on July 13, 
2017, until January 13, 2018.
     Revising the phase-in date for the requirements at Sec.  
484.65(d) by replacing the January 13, 2018 date with a July 13, 2018 
date.
     Replacing the July 13, 2017 effective date at Sec.  
484.115(a)(1) and (2) with the effective date of January 13, 2018.

V. Waiver of 60-Day Delay in the Effective Date

    We ordinarily provide a 60-day delay in the effective date of the 
provisions of a rule in accordance with the Administrative Procedure 
Act (APA) (5 U.S.C. 553(d)), which requires a 30-day delayed effective 
date; the Congressional Review Act (5 U.S.C. 801(a)(3)), which requires 
a 60-day delayed effective date for major rules; and section 
1871(e)(1)(B)(i) of the Act prohibits substantive Medicare rules from 
becoming effective less than 30 days before issuance. However, we can 
waive the delay in the effective date if the Secretary finds, for good 
cause, that the delay is impracticable, unnecessary, or contrary to the 
public interest, and incorporates a statement of the finding and the 
reasons in the rule issued. 5 U.S.C. 553(d)(3); 5 U.S.C. 808(2); 
section 1871(e)(1)(B)(ii) of the Act.
    Providing a 60-day delay in the effective date of this rule is 
contrary to public interest because it would negate the purpose of this 
rule, which is to postpone the effective date of the HHA CoP final rule 
from July 13, 2017 to January 13, 2018. If the changes in this rule do 
not become effective until 60 days following publication in the Federal 
Register, then HHAs will be required to comply with the July 13, 2017 
effective date of the January 2017 HHA CoPs final rule during the 60-
day delay period. As discussed above, in response to the publication of 
the January 2017 HHA CoPs final rule, we received inquiries that 
represented a large number of HHAs requesting that the agency delay the 
effective date for the new HHA CoPs. Additionally, in response to the 
April 3, 2017 proposed rule, commenters strongly expressed a need for a 
significant period of time to prepare for implementation of the new 
rules, noting that HHAs would need to adjust resource allocation, 
staffing, and potentially even infrastructure in order to effectively 
plan and test implementation strategies, and train staff on those 
strategies that prove to be effective. We believe that HHAs need 
additional time for all preparation activities. Implementing all of the 
changes in July 2017, without adequate planning, testing, and training, 
may negatively impact patient care and safety, as well as HHA 
operations. We believe it is in the public interest to avoid these 
negative impacts; therefore, we believe that good cause exists to waive 
the statutory delayed-effective-date requirements.

VI. Collection of Information Requirements

    This document does not impose information collection requirements, 
that is, reporting, recordkeeping or third-party disclosure 
requirements. Consequently, there is no need for review by the Office 
of Management and Budget under the authority of the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501 et seq.).

VII. Regulatory Impact Statement

    We have examined the impact 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 (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

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22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 
4, 1999), the Congressional Review Act (5 U.S.C. 804(2)), and Executive 
Order 13771 on Reducing Regulation and Controlling Regulatory Costs 
(January 30, 2017).
    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). A 
regulatory impact analysis (RIA) must be prepared for major rules with 
economically significant effects ($100 million or more in any 1 year). 
This rule does not reach the economic threshold and thus is not 
considered a major rule.
    The Regulatory Flexibility Act (RFA) requires agencies to analyze 
options for regulatory relief of small entities. For purposes of the 
RFA, small entities include small businesses, nonprofit organizations, 
and small governmental jurisdictions. Most hospitals and most other 
providers and suppliers are small entities, either by nonprofit status 
or by having revenues of less than $7.5 million to $38.5 million in any 
1 year. Individuals and States are not included in the definition of a 
small entity. We are not preparing an analysis for the RFA because we 
have determined, and the Secretary certifies, that this final rule 
would not have a significant economic impact on a substantial number of 
small entities.
    In addition, section 1102(b) of the Social Security Act requires us 
to prepare a regulatory impact analysis if a rule may have a 
significant impact on the operations of a substantial number of small 
rural hospitals. This analysis must conform to the provisions of 
section 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 for Medicare payment regulations and 
has fewer than 100 beds. We are not preparing an analysis for section 
1102(b) of the Act because we have determined, and the Secretary 
certifies, that this final 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 of 1995 also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates require spending in any 1 year of $100 
million in 1995 dollars, updated annually for inflation. In 2017, that 
threshold is approximately $148 million. This rule will have no 
consequential effect on state, local, or tribal governments 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.
    Executive Order 13771, entitled ``Reducing Regulation and 
Controlling Regulatory Costs,'' was issued on January 30, 2017 (82 FR 
9339, February 3, 2017). Under E.O. 13771, this rule has been 
determined to be deregulatory.
    In accordance with the provisions of Executive Order 12866, this 
regulation was reviewed by the Office of Management and Budget.

List of Subjects

42 CFR Part 409

    Health facilities, Medicare.

42 CFR Part 410

    Health facilities, Health professions, Kidney diseases, 
Laboratories, Medicare, Reporting and recordkeeping requirements, Rural 
areas, X-rays.

42 CFR Part 418

    Health facilities, Hospice care, Medicare, Reporting and 
recordkeeping requirements.

42 CFR Part 440

    Grant programs--health, Medicaid.

42 CFR Part 484

    Health facilities, Health professions, Medicare, Reporting and 
recordkeeping requirements.

42 CFR Part 485

    Grant programs--health, Health facilities, Medicaid, Medicare, 
Reporting and recordkeeping requirements.

42 CFR Part 488

    Administrative practice and procedure, Health facilities, Medicare, 
Reporting and recordkeeping requirements.
    For the reasons set forth in the preamble, effective January 13, 
2018, the Centers for Medicare & Medicaid Services amends 42 CFR 
chapter IV as set forth below:

PART 484--HOME HEALTH SERVICES

0
1. The authority citation for part 484 continues to read as follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395(hh)) unless otherwise indicated.


Sec.  484.65  [Amended]

0
2. In Sec.  484.65, amend paragraph (d) introductory text by removing 
the date ``January 13, 2018'' and adding in its place ``July 13, 
2018''.


Sec.  484.115  [Amended]

0
3. In Sec.  484.115, amend paragraphs (a)(1) introductory text and 
(a)(2) introductory text by removing the date ``July 13, 2017'' and 
adding in its place ``January 13, 2018''.

    Dated: June 28, 2017.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
    Dated: June 30, 2017.
Thomas E. Price,
Secretary, Department of Health and Human Services.
[FR Doc. 2017-14347 Filed 7-7-17; 8:45 am]
BILLING CODE 4120-01-P