[Federal Register Volume 82, Number 62 (Monday, April 3, 2017)]
[Proposed Rules]
[Pages 16150-16152]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-06540]



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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-P2]
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: Proposed rule.

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SUMMARY: This proposed rule would delay 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. The current effective date for the final 
rule is July 13, 2017, and this rule proposes to delay the effective 
date for an additional 6 months until January 13, 2018. This proposed 
rule would also make two conforming changes to dates that are included 
in the regulations text.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on June 2, 2017.

ADDRESSES: In commenting, please refer to file code CMS-3819-P2. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of four ways (please choose only one 
of the ways listed):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-3819-P2, P.O. Box 8010, 
Baltimore, MD 21244-1850.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-3819-P2, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    4. By hand or courier. Alternatively, you may deliver (by hand or 
courier) your written comments ONLY to the following addresses prior to 
the close of the comment period:
    a. For delivery in Washington, DC--Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, Room 445-G, Hubert 
H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 
20201.
    (Because access to the interior of the Hubert H. Humphrey Building 
is not readily available to persons without Federal government 
identification, commenters are encouraged to leave their comments in 
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing 
by stamping in and retaining an extra copy of the comments being 
filed.)
    b. For delivery in Baltimore, MD-- Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, 7500 Security 
Boulevard, Baltimore, MD 21244-1850.
    If you intend to deliver your comments to the Baltimore address, 
call telephone number (410) 786-9994 in advance to schedule your 
arrival with one of our staff members.
    Comments erroneously mailed to the addresses indicated as 
appropriate for hand or courier delivery may be delayed and received 
after the comment period.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

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

SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments 
received before the close of the comment period are available for 
viewing by the public, including any personally identifiable or 
confidential business information that is included in a comment. We 
post all comments received before the close of the comment period on 
the following Web site as soon as possible after they have been 
received: http://www.regulations.gov. Follow the search instructions on 
that Web site to view public comments.
    Comments received timely will also be available for public 
inspection as they are received, generally beginning approximately 3 
weeks after publication of a document, at the headquarters of the 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 
a.m. to 4 p.m. To schedule an appointment to view public comments, 
phone 1-800-743-3951.

I. Background

    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

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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 propose 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 propose 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 provisions of the January 2017 HHA CoPs 
final rule become effective. Therefore, we propose 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 propose 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 propose 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. 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.).

IV. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble, 
and, when we proceed with a subsequent document, we will respond to the 
comments in the preamble to that document.

V. Regulatory Impact Statement

    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 (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), 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 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 proposed rule would not have a 
significant economic impact on a substantial number of small entities.
    In addition, section 1102(b) of the Social Security Act requires us 
to prepare a regulatory impact analysis if a rule may have a 
significant impact on the operations of a substantial number of small 
rural hospitals. This analysis must conform to the provisions of 
section 603 of the RFA. For purposes of section 1102(b) of the Act, we 
define a small rural hospital as a hospital that is located outside of 
a Metropolitan Statistical Area 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 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 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. Currently, 
that threshold is approximately $146 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). Section 2(a) of Executive Order

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13771 requires an agency, unless prohibited by law, to identify at 
least two existing regulations to be repealed when the agency publicly 
proposes for notice and comment or otherwise promulgates a new 
regulation. In furtherance of this requirement, section 2(c) of 
Executive Order 13771 requires that the new incremental costs 
associated with new regulations shall, to the extent permitted by law, 
be offset by the elimination of existing costs associated with at least 
two prior regulations. OMB's interim guidance, issued on February 2, 
2017, https://www.whitehouse.gov/the-press-office/2017/02/02/interim-guidance-implementing-section-2-executive-order-january-30-2017, 
explains that for Fiscal Year 2017 the above requirements only apply to 
each new ``significant regulatory action that imposes costs.'' It has 
been determined that this proposed rule is not a ``significant 
regulatory action that imposes costs'' and thus does not trigger the 
above requirements of Executive Order 13771.
    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, the Centers for Medicare 
& Medicaid Services proposes to delay the effective date for the final 
rule published on January 13, 2017 (82 FR 4504) and to further amend 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  [Amend]

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


Sec.  484.115  [Amend]

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

    Dated: March 28, 2017.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
    Dated: March 28, 2017.
Thomas E. Price,
Secretary, Department of Health and Human Services.
[FR Doc. 2017-06540 Filed 3-31-17; 8:45 am]
BILLING CODE 4120-01-P